Medicolegal Issues

The Supreme Court’s usual processes were disrupted this term. The COVID-19 pandemic required audio hearings rather than in-person, and it resulted in a number of emergency legal appeals. As the Court began its regular sessions on October 5, 2020, there were only 8 justices—Justice Ruth Bader Ginsburg had passed away and Amy Coney Barrett had not yet been confirmed by the Senate. The Court decided many important cases this term, including dealing with the delivery of drugs to induce abortions, a Centers for Disease Control and Prevention (CDC) moratorium on housing evictions, yet another case on the Affordable Care Act, state laws concerning pharmacy benefit managers, and the Hologic and Minerva endometrial ablation systems patents. After considering these cases, we also will briefly look at other cases of general interest.

Abortion

Patient access to mifepristone

In May 2020, the American College of Obstetricians and Gynecologists (ACOG) was the named plaintiff in a lawsuit against the US Food and Drug Administration (FDA) regarding the drugs mifepristone and misoprostol that are used to induce medical abortions.¹ The case was filed by the American Civil Liberties Union on behalf of ACOG and others^2,3 and raised the issue of patients’ access to these medications. The basic claim of the case was that during the pandemic, the FDA’s regulation of mifepristone was unconstitutional in that they imposed an undue burden on the decision of women to have an abortion.⁴ (Although misoprostol is a part of the medical abortion regimen, it is not subject to special regulation and was not part of the litigation.)

The FDA regulation of mifepristone, begun in 2000 but modified since then, includes 3 elements to assure safe use:

• prescribers must have special training or certification
• the drug can be dispensed to patients only in a hospital, clinic, or medical office under the supervision of a certified health care provider (known as the “in-person dispensing requirement” because retail pharmacy or mail distribution are prohibited)
• the health care provider must review a “patient agreement form” with the patient and have the patient sign the consent form in the provider’s presence.⁵

The pandemic made fulfilling these requirements substantially more burdensome and difficult. The question was whether the FDA was constitutionally required to modify its regulations during a pandemic to take account of the undue burden of the regulation created by the pandemic. That is, the question was not whether the FDA could have or should have chosen to make the modification, but whether it was required to do so.

In July 2020, a federal district court in Maryland held that the FDA regulation was an unconstitutional burden on the abortion rights of women during the pandemic and issued a preliminary injunction to stop the FDA from enforcing the in-person dispensing and signature rules. The district judge applied the injunction to Maryland, but also made it a nationwide injunction. (The issue of district court nationwide injunctions is considered in, “District court ‘nationwide injunctions’”). 

The FDA asked the Fourth Circuit Court of Appeals to stay the enforcement of the injunction, which the appeals court denied. The FDA then appealed to the Supreme Court, asking it to stay the injunction. In October 2020, the Court announced that it was holding the FDA’s request “in abeyance” to allow the district court to consider a motion by the FDA to dissolve or change the injunction. It gave the district court 40 days in which to act. That decision by the Court was in the “Shadow Docket” (see sidebar on page XX), so the exact vote of the Court in October is not clear, but 2 Justices (Alito and Thomas) dissented and would have stayed the injunction.⁶ Over the next 40 days, the district court did not withdraw its nationwide injunction.

Thus, on January 12, 2021, the case was again before the Supreme Court, which let the FDA’s regulations regarding mifepristone remain in place by lifting the district court’s injunction. Most of the justices supporting the stay did not write to explain their decision, although their dissent in the earlier cases may have served that purpose. (Maryland was permitting many kinds of activity that were more risky than visiting a clinic—indoor dining, with open hair salons, gyms, and casinos.)⁷ Chief Justice Roberts wrote a concurrence to indicate that, in his view, the issue was not whether the FDA’s regulations placed an undue burden on a right to an abortion generally, but that “My view is that courts owe significant deference” to the public health authorities (here meaning the FDA). Justices Sotomayor and Kagan dissented, saying that the issue was the undue burden on women, given the difficulties of the pandemic, particularly going to medical facilities during the COVID-19 pandemic.⁸

The injunction, sought by ACOG and others, was issued by the district court and was in effect for several months before it was dissolved by the Supreme Court. Following the change in presidential administrations, in April 2021 the FDA announced that it was going to “exercise enforcement discretion with respect to the in-person dispensing requirement…during the COVID-19 public health emergency.”⁹

Continue to: The Texas abortion case...

The Texas abortion case

The Court, on September 1, 2021, declined to block a Texas abortion statute from taking effect.¹⁰ This law precludes abortions after a fetal heartbeat is present at about 6 weeks of gestation. The Fifth Circuit declined to grant an injunction delaying implementation of the Texas law, and the Court did not reverse that decision.

Over the years, a variety of states have placed limitations on abortion, and those almost always have been enjoined by federal courts before they went into effect. However, the Texas statute, which undoubtedly is unconstitutional, was creatively constructed to avoid an early injunction.¹¹ The statute does not allow state officials to enforce the new law, but rather it allows almost any private citizen to seek monetary damages from anyone performing an abortion or who “aids and abets” an abortion. Thus, it is difficult to tailor a lawsuit before this law is enforced. First, courts do not enjoin laws; they usually enjoin individuals from enforcing the law, and in this case it is difficult to know which individuals will be enforcing the laws and what their decisions might be. There also are some questions about the degree to which federal courts can enjoin state courts from deciding lawsuits under state law. For these procedural reasons, the majority of the Court found that those attacking the Texas law had not met their burden of showing that that they would win their case.

Even 3 of the dissenting justices said the defendants may be right that “existing doctrines preclude judicial intervention,” but that the consequences are such that the Court should delay the law until there is time for briefing and argument. The other 3 dissenting justices thought there would be ways of getting around the clever roadblock Texas had erected for the federal courts.

There has been some commentary that this case portends the abandonment of Roe v Wade and Casey,¹² but that conclusion does not seem warranted by this case. The Court has accepted a Mississippi abortion law to be heard next term.¹³ In addition, the Texas statute is likely to be back in federal court once a private individual has filed a claim for money from an abortion provider (and likely even before that).

COVID-19 cases

The Supreme Court decided several cases related to COVID-19, including adjustments to election procedures, church services, and CDC eviction moratoria. As a general matter early in the pandemic, the Court deferred to government authorities, generally upholding government actions. Chief Justice Roberts emphasized the importance of the Court deferring to government officials in emergencies. As the pandemic progressed into 2021, however, the Court became less and less sympathetic to government actions that were not consistent, permitted by existing law, or reasonably necessary. For example, regulations of churches that were inconsistent with the regulation of similar organizations were struck down.¹⁴

Among the most interesting of the summer 2021 cases was the CDC eviction moratorium that essentially prohibited landlords nationwide from evicting tenants for nonpayment of rent. When the challenges to these CDC regulations first reached the Court, the moratorium was about to expire; in a 5-4 decision, the Court did not enjoin the CDC from continuing that policy. Justice Kavanaugh (the fifth vote) warned that “clear and specific congressional authorization…would be necessary to extend the moratorium past July 31.”¹⁵ Despite telling the Court that the moratorium would expire on July 31, just 3 days after the expiration and without any congressional authorization, the CDC reinstated what was practically the same moratorium.¹⁶ On August 26, the Court struck down the reinstated regulation, probably by a 6-3 margin. (Because this case arose in the “Shadow Docket,” the vote of some justices is not certain).¹⁷

Continue to: The Affordable Care Act...

The Affordable Care Act

The Affordable Care Act was challenged in the Court for the third time.¹⁸ In this term’s case, several states argued that when Congress essentially eliminated the penalty/tax for not purchasing insurance coverage, there was no longer a constitutional basis for the individual mandate. With that centerpiece gone, they claimed, the whole statute should be declared unconstitutional.

Along with many other specialty groups, ACOG joined an amicus curiae brief sponsored by the American Medical Association (AMA).¹⁹ An amicus brief is one not filed by the parties to the case, but by organizations or individuals who have information that may be of use to the Court in considering the case. Among other things, the filing of an amicus brief indicates the interest of the organization in the outcome of the case. In this case, the crux of the amicus was that even if the individual mandate currently is not constitutional, the Court should sever that provision and retain the rest of the ACA.

Despite some wild predictions about what the Court might do, it did not decide any substantive issue. Rather, it found that none of the parties to the case had “standing” to challenge the constitutionality of the ACA. Therefore, in effect, the Court dismissed the case without deciding the substantive legal issues.
 

Pharmacy Benefit Managers

The powerful Pharmacy Benefit Managers (PBMs) are a hidden part of the health care system; however, in recent years there has been increasing regulatory attention paid to them. Some states have begun regulating aspects of PBMs. In this term, the Court considered an Arkansas law that sought to protect local pharmacies from PBM pricing practices.²⁰ The AMA filed an amicus brief in the case which made legal arguments, most of which had been made by the parties to the litigation.²¹

PBMs generally tell pharmacies how much they will reimburse the pharmacy for filling a prescription for a particular drug. In some instances, PBMs will set a reimbursement price that is lower than the wholesale price at which local pharmacies can purchase the drug. The Arkansas law prohibited PBMs in the state from reimbursing pharmacies for less than the wholesale cost the pharmacy paid for the drug.

The claim of the PBMs was that the Arkansas law violated the Employee Retirement Income Security Act (ERISA). In part, this act preempts state law that relates to fringe benefit plans. States have the authority to regulate insurance, but ERISA limits what they can do when the insurance relates to fringe benefits. The Court held that ERISA does not preempt the Arkansas law or similar state laws in other states. Because the state law was not preempted by the state law, the Arkansas regulation was upheld. The fact that this was a unanimous decision (8-0, because Justice Barrett was not on the Court when the case was heard) suggests that states may have leeway in additional regulations of PBMs, and it would not be surprising to see more of that state regulation in the future.

Continue to: Patent uncertainty...

Patent uncertainty

Csaba Truckai invented and patented the NovaSure System ablation device with a “moisture permeable” head. He sold his company and the related patents, which eventually were purchased by Hologic. Over time, Hologic added claims to the original patent. In the meantime, Truckai went on to invent another device, the Minerva Endometrial Ablation System (MEAS), which had a “moisture impermeable” head. (Note that the “Minerva Surgical, Inc.” involved in this case is not related to the company “Minerva Industries,” which some identified as a “patent troll.”)²²

Hologic sued Minerva, claiming that Truckai’s second device (MEAS) infringed on its patent for the first device (NovaSure). Truckai’s defense was that the patent on NovaSure was invalid. Hologic felt that since Truckai had obtained that patent and then sold it, it was improper for him now to claim it was invalid. There is a doctrine for that: assignor estoppel—the person who sold (assigned) the patent is prevented from later claiming it was invalid. The question in this case was whether assignor estoppel is part of the patent law of the United States. It is not in the patent statutes, so it is a court-determined part of the law.

In a 5-4 decision this Term, the Court held that assignor estoppel is recognized, but that it is narrow.²³ The Court identified several exceptions to assignor estoppel, notably for this case, including the situation in which the purchaser of the patent, after the purchase, returns to the Patent and Trademark Office to expand (amend) the patent’s claims. In that case, the seller could not be estopped by the amended terms of the patent. Minerva claimed that it was attacking the expanded patent that included changes made after it sold the patent. The Court, therefore, returned the case to the Federal Circuit to apply the principles it laid out about assignor estoppel.

Biotech and other fast-moving fields frequently have new technology building on slightly earlier technology. The current patent system often leaves uncertainty about who owns which part of a valid patent. This uncertainty is a drag on innovation, and the patent system is supposed to spur innovation. Assignor estoppel is likely to create additional complexity and uncertainty in some patents, which is regrettable.
 

Review of the Term

In addition to the other disruptions of the Term, during the first part of the Term, Amy Coney Barrett was not yet confirmed by the Senate, so there were only 8 justices until October 27. She did not participate in those cases that were heard before she joined the Court. The consensus is that the Court heard 67 cases: 57 were formally briefed and argued along with 8 summary reversals and 2 religious cases in the Shadow Docket. In my opinion, this undercounts both the number and the importance of the Shadow Docket cases, but the following data use the 67 case convention.²⁴

The Court was unanimous in 43% of the cases, including some of the most divisive issues. That unanimity reflects very narrow decisions. There were (by conventional count) only eight 5-4 opinions (12%), an unusually low number. Justice Kavanaugh is viewed as the “median” justice. He was in the majority in 97% of all cases. Chief Justice Roberts and Justice Barrett were in the majority 91%, and Justice Gorsuch 90%. As for the other justices, they were in the majority (all cases) most of the time: Justice Alito, 83%; Justice Thomas, 81%; Justice Breyer, 76%; Justice Kagan, 75%; and Justice Sotomayor, 69%. In “divided cases” (when unanimous cases are removed), the percentages are: Justice Kavanaugh, 95%; Chief Justice Roberts and Justice Barrett, 84%; Justice Gorsuch, 82%; Justice Alito, 70%; Justice Thomas, 66%; Justice Breyer, 58%; Justice Kagan, 55%; and Justice Sotomayor, 45%.

When the term began, many Court watchers expected a relatively uninteresting term, dealing with many technical legal details. In fact, it turned out to be more interesting and important than expected, even with narrow holdings in important cases. Part of the secret of the term was that a lot of the real action was in the Shadow Docket. The end of the term is sometimes the moment when a justice announces a plan to retire. Many commentators expected Justice Breyer might announce—he has been under pressure to do so, to allow President Biden to nominate and a Democratic Senate to confirm a progressive justice. However, he did not do so. It is possible that he will announce his retirement to be effective when his successor is confirmed, but that is pure speculation.
 

Continue to: Next Term...

Next Term

The next term began on Monday, October 4, 2021. With the considerable current activity in the Shadow Docket, there was not much of a summer break. The coming term looks extraordinary. The headline case is an abortion case from Mississippi, Dobbs v Jackson Women’s Health Organization.²⁵ The legal question is the constitutionality of Mississippi law that prohibits most abortions after 15 weeks of gestation. The Texas abortion law will also be back before the Court. As we saw this term, big cases may produce very narrow results, but this case has the potential for being a notable abortion decision.

In a different case the Court will decide whether a state attorney general can step in to defend an abortion law when the state health secretary does not do so.²⁶

The Court also has accepted 3 cases dealing with reimbursement for health services. One deals with whether or not the Department of Health and Human Services can set reimbursement rates without good survey data regarding costs,²⁷ another involves the calculation of additional payments for hospitals that serve a “disproportionate number of low-income patients,”²⁸ and the third whether state Medicaid programs can take funds from an injured beneficiary’s tort recovery to cover future Medicaid costs.²⁹

In other cases, the Court will review a gun control law from New York. The Court’s earlier Second Amendment cases involved guns in the home used for self-defense, but this case raises the question of whether a state can practically preclude “concealed-carry licenses.”³⁰ Many experts believe the Court will accept a case dealing with racial preferences in college admissions, perhaps the Harvard case in which the claim is discrimination against Asian Americans.³¹

The ACOG mifepristone case was interesting, in part because the federal district court issued a nationwide injunction against the Americans with Disabilities Act, enforcing its rules anywhere in the country. The effect of these orders is for a single district judge to create the “law of the land,” at least until that is reviewed—which can take months. The advantage of the nationwide injunction is that it avoids having to repeatedly litigate the same issues in multiple courts around the country. The downside is that plaintiffs can seek out a nonrepresentative judge or circuit and receive an injunction that would be granted by few other circuits. In addition, a nationwide injunction can apply to specific circumstances that are not before the court issuing the injunction. In the mifepristone case, for example, 10 states requested to intervene in the ACOG case. The court rejected the request, but the nationwide injunction applied to those states.¹

Although federal judges have had the authority to issue nationwide injunctions for years, they are becoming much more common. One reason is the ease of forum shopping noted earlier—organizations can cherry-pick district courts and circuits sympathetic to their views. Both left- and right-leaning organizations have learned this lesson, so left-leaning groups are likely to file in specific districts in the Ninth Circuit, and right-leaning groups to districts in the Fifth Circuit.

If the current trend of increasing nationwide injunctions continues, either the rules for the federal courts or congressional action may be required to reduce some of the abuses by both sides of the political spectrum.

The Supreme Court’s usual processes were disrupted this term. The COVID-19 pandemic required audio hearings rather than in-person, and it resulted in a number of emergency legal appeals. As the Court began its regular sessions on October 5, 2020, there were only 8 justices—Justice Ruth Bader Ginsburg had passed away and Amy Coney Barrett had not yet been confirmed by the Senate. The Court decided many important cases this term, including dealing with the delivery of drugs to induce abortions, a Centers for Disease Control and Prevention (CDC) moratorium on housing evictions, yet another case on the Affordable Care Act, state laws concerning pharmacy benefit managers, and the Hologic and Minerva endometrial ablation systems patents. After considering these cases, we also will briefly look at other cases of general interest.

Abortion

Patient access to mifepristone

In May 2020, the American College of Obstetricians and Gynecologists (ACOG) was the named plaintiff in a lawsuit against the US Food and Drug Administration (FDA) regarding the drugs mifepristone and misoprostol that are used to induce medical abortions.¹ The case was filed by the American Civil Liberties Union on behalf of ACOG and others^2,3 and raised the issue of patients’ access to these medications. The basic claim of the case was that during the pandemic, the FDA’s regulation of mifepristone was unconstitutional in that they imposed an undue burden on the decision of women to have an abortion.⁴ (Although misoprostol is a part of the medical abortion regimen, it is not subject to special regulation and was not part of the litigation.)

The FDA regulation of mifepristone, begun in 2000 but modified since then, includes 3 elements to assure safe use:

• prescribers must have special training or certification
• the drug can be dispensed to patients only in a hospital, clinic, or medical office under the supervision of a certified health care provider (known as the “in-person dispensing requirement” because retail pharmacy or mail distribution are prohibited)
• the health care provider must review a “patient agreement form” with the patient and have the patient sign the consent form in the provider’s presence.⁵

The pandemic made fulfilling these requirements substantially more burdensome and difficult. The question was whether the FDA was constitutionally required to modify its regulations during a pandemic to take account of the undue burden of the regulation created by the pandemic. That is, the question was not whether the FDA could have or should have chosen to make the modification, but whether it was required to do so.

In July 2020, a federal district court in Maryland held that the FDA regulation was an unconstitutional burden on the abortion rights of women during the pandemic and issued a preliminary injunction to stop the FDA from enforcing the in-person dispensing and signature rules. The district judge applied the injunction to Maryland, but also made it a nationwide injunction. (The issue of district court nationwide injunctions is considered in, “District court ‘nationwide injunctions’”). 

The FDA asked the Fourth Circuit Court of Appeals to stay the enforcement of the injunction, which the appeals court denied. The FDA then appealed to the Supreme Court, asking it to stay the injunction. In October 2020, the Court announced that it was holding the FDA’s request “in abeyance” to allow the district court to consider a motion by the FDA to dissolve or change the injunction. It gave the district court 40 days in which to act. That decision by the Court was in the “Shadow Docket” (see sidebar on page XX), so the exact vote of the Court in October is not clear, but 2 Justices (Alito and Thomas) dissented and would have stayed the injunction.⁶ Over the next 40 days, the district court did not withdraw its nationwide injunction.

Thus, on January 12, 2021, the case was again before the Supreme Court, which let the FDA’s regulations regarding mifepristone remain in place by lifting the district court’s injunction. Most of the justices supporting the stay did not write to explain their decision, although their dissent in the earlier cases may have served that purpose. (Maryland was permitting many kinds of activity that were more risky than visiting a clinic—indoor dining, with open hair salons, gyms, and casinos.)⁷ Chief Justice Roberts wrote a concurrence to indicate that, in his view, the issue was not whether the FDA’s regulations placed an undue burden on a right to an abortion generally, but that “My view is that courts owe significant deference” to the public health authorities (here meaning the FDA). Justices Sotomayor and Kagan dissented, saying that the issue was the undue burden on women, given the difficulties of the pandemic, particularly going to medical facilities during the COVID-19 pandemic.⁸

The injunction, sought by ACOG and others, was issued by the district court and was in effect for several months before it was dissolved by the Supreme Court. Following the change in presidential administrations, in April 2021 the FDA announced that it was going to “exercise enforcement discretion with respect to the in-person dispensing requirement…during the COVID-19 public health emergency.”⁹

Continue to: The Texas abortion case...

The Texas abortion case

The Court, on September 1, 2021, declined to block a Texas abortion statute from taking effect.¹⁰ This law precludes abortions after a fetal heartbeat is present at about 6 weeks of gestation. The Fifth Circuit declined to grant an injunction delaying implementation of the Texas law, and the Court did not reverse that decision.

Over the years, a variety of states have placed limitations on abortion, and those almost always have been enjoined by federal courts before they went into effect. However, the Texas statute, which undoubtedly is unconstitutional, was creatively constructed to avoid an early injunction.¹¹ The statute does not allow state officials to enforce the new law, but rather it allows almost any private citizen to seek monetary damages from anyone performing an abortion or who “aids and abets” an abortion. Thus, it is difficult to tailor a lawsuit before this law is enforced. First, courts do not enjoin laws; they usually enjoin individuals from enforcing the law, and in this case it is difficult to know which individuals will be enforcing the laws and what their decisions might be. There also are some questions about the degree to which federal courts can enjoin state courts from deciding lawsuits under state law. For these procedural reasons, the majority of the Court found that those attacking the Texas law had not met their burden of showing that that they would win their case.

Even 3 of the dissenting justices said the defendants may be right that “existing doctrines preclude judicial intervention,” but that the consequences are such that the Court should delay the law until there is time for briefing and argument. The other 3 dissenting justices thought there would be ways of getting around the clever roadblock Texas had erected for the federal courts.

There has been some commentary that this case portends the abandonment of Roe v Wade and Casey,¹² but that conclusion does not seem warranted by this case. The Court has accepted a Mississippi abortion law to be heard next term.¹³ In addition, the Texas statute is likely to be back in federal court once a private individual has filed a claim for money from an abortion provider (and likely even before that).

COVID-19 cases

The Supreme Court decided several cases related to COVID-19, including adjustments to election procedures, church services, and CDC eviction moratoria. As a general matter early in the pandemic, the Court deferred to government authorities, generally upholding government actions. Chief Justice Roberts emphasized the importance of the Court deferring to government officials in emergencies. As the pandemic progressed into 2021, however, the Court became less and less sympathetic to government actions that were not consistent, permitted by existing law, or reasonably necessary. For example, regulations of churches that were inconsistent with the regulation of similar organizations were struck down.¹⁴

Among the most interesting of the summer 2021 cases was the CDC eviction moratorium that essentially prohibited landlords nationwide from evicting tenants for nonpayment of rent. When the challenges to these CDC regulations first reached the Court, the moratorium was about to expire; in a 5-4 decision, the Court did not enjoin the CDC from continuing that policy. Justice Kavanaugh (the fifth vote) warned that “clear and specific congressional authorization…would be necessary to extend the moratorium past July 31.”¹⁵ Despite telling the Court that the moratorium would expire on July 31, just 3 days after the expiration and without any congressional authorization, the CDC reinstated what was practically the same moratorium.¹⁶ On August 26, the Court struck down the reinstated regulation, probably by a 6-3 margin. (Because this case arose in the “Shadow Docket,” the vote of some justices is not certain).¹⁷

Continue to: The Affordable Care Act...

The Affordable Care Act

The Affordable Care Act was challenged in the Court for the third time.¹⁸ In this term’s case, several states argued that when Congress essentially eliminated the penalty/tax for not purchasing insurance coverage, there was no longer a constitutional basis for the individual mandate. With that centerpiece gone, they claimed, the whole statute should be declared unconstitutional.

Along with many other specialty groups, ACOG joined an amicus curiae brief sponsored by the American Medical Association (AMA).¹⁹ An amicus brief is one not filed by the parties to the case, but by organizations or individuals who have information that may be of use to the Court in considering the case. Among other things, the filing of an amicus brief indicates the interest of the organization in the outcome of the case. In this case, the crux of the amicus was that even if the individual mandate currently is not constitutional, the Court should sever that provision and retain the rest of the ACA.

Despite some wild predictions about what the Court might do, it did not decide any substantive issue. Rather, it found that none of the parties to the case had “standing” to challenge the constitutionality of the ACA. Therefore, in effect, the Court dismissed the case without deciding the substantive legal issues.
 

Pharmacy Benefit Managers

The powerful Pharmacy Benefit Managers (PBMs) are a hidden part of the health care system; however, in recent years there has been increasing regulatory attention paid to them. Some states have begun regulating aspects of PBMs. In this term, the Court considered an Arkansas law that sought to protect local pharmacies from PBM pricing practices.²⁰ The AMA filed an amicus brief in the case which made legal arguments, most of which had been made by the parties to the litigation.²¹

PBMs generally tell pharmacies how much they will reimburse the pharmacy for filling a prescription for a particular drug. In some instances, PBMs will set a reimbursement price that is lower than the wholesale price at which local pharmacies can purchase the drug. The Arkansas law prohibited PBMs in the state from reimbursing pharmacies for less than the wholesale cost the pharmacy paid for the drug.

The claim of the PBMs was that the Arkansas law violated the Employee Retirement Income Security Act (ERISA). In part, this act preempts state law that relates to fringe benefit plans. States have the authority to regulate insurance, but ERISA limits what they can do when the insurance relates to fringe benefits. The Court held that ERISA does not preempt the Arkansas law or similar state laws in other states. Because the state law was not preempted by the state law, the Arkansas regulation was upheld. The fact that this was a unanimous decision (8-0, because Justice Barrett was not on the Court when the case was heard) suggests that states may have leeway in additional regulations of PBMs, and it would not be surprising to see more of that state regulation in the future.

Continue to: Patent uncertainty...

Patent uncertainty

Csaba Truckai invented and patented the NovaSure System ablation device with a “moisture permeable” head. He sold his company and the related patents, which eventually were purchased by Hologic. Over time, Hologic added claims to the original patent. In the meantime, Truckai went on to invent another device, the Minerva Endometrial Ablation System (MEAS), which had a “moisture impermeable” head. (Note that the “Minerva Surgical, Inc.” involved in this case is not related to the company “Minerva Industries,” which some identified as a “patent troll.”)²²

Hologic sued Minerva, claiming that Truckai’s second device (MEAS) infringed on its patent for the first device (NovaSure). Truckai’s defense was that the patent on NovaSure was invalid. Hologic felt that since Truckai had obtained that patent and then sold it, it was improper for him now to claim it was invalid. There is a doctrine for that: assignor estoppel—the person who sold (assigned) the patent is prevented from later claiming it was invalid. The question in this case was whether assignor estoppel is part of the patent law of the United States. It is not in the patent statutes, so it is a court-determined part of the law.

In a 5-4 decision this Term, the Court held that assignor estoppel is recognized, but that it is narrow.²³ The Court identified several exceptions to assignor estoppel, notably for this case, including the situation in which the purchaser of the patent, after the purchase, returns to the Patent and Trademark Office to expand (amend) the patent’s claims. In that case, the seller could not be estopped by the amended terms of the patent. Minerva claimed that it was attacking the expanded patent that included changes made after it sold the patent. The Court, therefore, returned the case to the Federal Circuit to apply the principles it laid out about assignor estoppel.

Biotech and other fast-moving fields frequently have new technology building on slightly earlier technology. The current patent system often leaves uncertainty about who owns which part of a valid patent. This uncertainty is a drag on innovation, and the patent system is supposed to spur innovation. Assignor estoppel is likely to create additional complexity and uncertainty in some patents, which is regrettable.
 

Review of the Term

In addition to the other disruptions of the Term, during the first part of the Term, Amy Coney Barrett was not yet confirmed by the Senate, so there were only 8 justices until October 27. She did not participate in those cases that were heard before she joined the Court. The consensus is that the Court heard 67 cases: 57 were formally briefed and argued along with 8 summary reversals and 2 religious cases in the Shadow Docket. In my opinion, this undercounts both the number and the importance of the Shadow Docket cases, but the following data use the 67 case convention.²⁴

The Court was unanimous in 43% of the cases, including some of the most divisive issues. That unanimity reflects very narrow decisions. There were (by conventional count) only eight 5-4 opinions (12%), an unusually low number. Justice Kavanaugh is viewed as the “median” justice. He was in the majority in 97% of all cases. Chief Justice Roberts and Justice Barrett were in the majority 91%, and Justice Gorsuch 90%. As for the other justices, they were in the majority (all cases) most of the time: Justice Alito, 83%; Justice Thomas, 81%; Justice Breyer, 76%; Justice Kagan, 75%; and Justice Sotomayor, 69%. In “divided cases” (when unanimous cases are removed), the percentages are: Justice Kavanaugh, 95%; Chief Justice Roberts and Justice Barrett, 84%; Justice Gorsuch, 82%; Justice Alito, 70%; Justice Thomas, 66%; Justice Breyer, 58%; Justice Kagan, 55%; and Justice Sotomayor, 45%.

When the term began, many Court watchers expected a relatively uninteresting term, dealing with many technical legal details. In fact, it turned out to be more interesting and important than expected, even with narrow holdings in important cases. Part of the secret of the term was that a lot of the real action was in the Shadow Docket. The end of the term is sometimes the moment when a justice announces a plan to retire. Many commentators expected Justice Breyer might announce—he has been under pressure to do so, to allow President Biden to nominate and a Democratic Senate to confirm a progressive justice. However, he did not do so. It is possible that he will announce his retirement to be effective when his successor is confirmed, but that is pure speculation.
 

Continue to: Next Term...

Next Term

The next term began on Monday, October 4, 2021. With the considerable current activity in the Shadow Docket, there was not much of a summer break. The coming term looks extraordinary. The headline case is an abortion case from Mississippi, Dobbs v Jackson Women’s Health Organization.²⁵ The legal question is the constitutionality of Mississippi law that prohibits most abortions after 15 weeks of gestation. The Texas abortion law will also be back before the Court. As we saw this term, big cases may produce very narrow results, but this case has the potential for being a notable abortion decision.

In a different case the Court will decide whether a state attorney general can step in to defend an abortion law when the state health secretary does not do so.²⁶

The Court also has accepted 3 cases dealing with reimbursement for health services. One deals with whether or not the Department of Health and Human Services can set reimbursement rates without good survey data regarding costs,²⁷ another involves the calculation of additional payments for hospitals that serve a “disproportionate number of low-income patients,”²⁸ and the third whether state Medicaid programs can take funds from an injured beneficiary’s tort recovery to cover future Medicaid costs.²⁹

In other cases, the Court will review a gun control law from New York. The Court’s earlier Second Amendment cases involved guns in the home used for self-defense, but this case raises the question of whether a state can practically preclude “concealed-carry licenses.”³⁰ Many experts believe the Court will accept a case dealing with racial preferences in college admissions, perhaps the Harvard case in which the claim is discrimination against Asian Americans.³¹

The ACOG mifepristone case was interesting, in part because the federal district court issued a nationwide injunction against the Americans with Disabilities Act, enforcing its rules anywhere in the country. The effect of these orders is for a single district judge to create the “law of the land,” at least until that is reviewed—which can take months. The advantage of the nationwide injunction is that it avoids having to repeatedly litigate the same issues in multiple courts around the country. The downside is that plaintiffs can seek out a nonrepresentative judge or circuit and receive an injunction that would be granted by few other circuits. In addition, a nationwide injunction can apply to specific circumstances that are not before the court issuing the injunction. In the mifepristone case, for example, 10 states requested to intervene in the ACOG case. The court rejected the request, but the nationwide injunction applied to those states.¹

Although federal judges have had the authority to issue nationwide injunctions for years, they are becoming much more common. One reason is the ease of forum shopping noted earlier—organizations can cherry-pick district courts and circuits sympathetic to their views. Both left- and right-leaning organizations have learned this lesson, so left-leaning groups are likely to file in specific districts in the Ninth Circuit, and right-leaning groups to districts in the Fifth Circuit.

If the current trend of increasing nationwide injunctions continues, either the rules for the federal courts or congressional action may be required to reduce some of the abuses by both sides of the political spectrum.

The Supreme Court’s usual processes were disrupted this term. The COVID-19 pandemic required audio hearings rather than in-person, and it resulted in a number of emergency legal appeals. As the Court began its regular sessions on October 5, 2020, there were only 8 justices—Justice Ruth Bader Ginsburg had passed away and Amy Coney Barrett had not yet been confirmed by the Senate. The Court decided many important cases this term, including dealing with the delivery of drugs to induce abortions, a Centers for Disease Control and Prevention (CDC) moratorium on housing evictions, yet another case on the Affordable Care Act, state laws concerning pharmacy benefit managers, and the Hologic and Minerva endometrial ablation systems patents. After considering these cases, we also will briefly look at other cases of general interest.

Abortion

Patient access to mifepristone

In May 2020, the American College of Obstetricians and Gynecologists (ACOG) was the named plaintiff in a lawsuit against the US Food and Drug Administration (FDA) regarding the drugs mifepristone and misoprostol that are used to induce medical abortions.¹ The case was filed by the American Civil Liberties Union on behalf of ACOG and others^2,3 and raised the issue of patients’ access to these medications. The basic claim of the case was that during the pandemic, the FDA’s regulation of mifepristone was unconstitutional in that they imposed an undue burden on the decision of women to have an abortion.⁴ (Although misoprostol is a part of the medical abortion regimen, it is not subject to special regulation and was not part of the litigation.)

The FDA regulation of mifepristone, begun in 2000 but modified since then, includes 3 elements to assure safe use:

• prescribers must have special training or certification
• the drug can be dispensed to patients only in a hospital, clinic, or medical office under the supervision of a certified health care provider (known as the “in-person dispensing requirement” because retail pharmacy or mail distribution are prohibited)
• the health care provider must review a “patient agreement form” with the patient and have the patient sign the consent form in the provider’s presence.⁵

The pandemic made fulfilling these requirements substantially more burdensome and difficult. The question was whether the FDA was constitutionally required to modify its regulations during a pandemic to take account of the undue burden of the regulation created by the pandemic. That is, the question was not whether the FDA could have or should have chosen to make the modification, but whether it was required to do so.

In July 2020, a federal district court in Maryland held that the FDA regulation was an unconstitutional burden on the abortion rights of women during the pandemic and issued a preliminary injunction to stop the FDA from enforcing the in-person dispensing and signature rules. The district judge applied the injunction to Maryland, but also made it a nationwide injunction. (The issue of district court nationwide injunctions is considered in, “District court ‘nationwide injunctions’”). 

The FDA asked the Fourth Circuit Court of Appeals to stay the enforcement of the injunction, which the appeals court denied. The FDA then appealed to the Supreme Court, asking it to stay the injunction. In October 2020, the Court announced that it was holding the FDA’s request “in abeyance” to allow the district court to consider a motion by the FDA to dissolve or change the injunction. It gave the district court 40 days in which to act. That decision by the Court was in the “Shadow Docket” (see sidebar on page XX), so the exact vote of the Court in October is not clear, but 2 Justices (Alito and Thomas) dissented and would have stayed the injunction.⁶ Over the next 40 days, the district court did not withdraw its nationwide injunction.

Thus, on January 12, 2021, the case was again before the Supreme Court, which let the FDA’s regulations regarding mifepristone remain in place by lifting the district court’s injunction. Most of the justices supporting the stay did not write to explain their decision, although their dissent in the earlier cases may have served that purpose. (Maryland was permitting many kinds of activity that were more risky than visiting a clinic—indoor dining, with open hair salons, gyms, and casinos.)⁷ Chief Justice Roberts wrote a concurrence to indicate that, in his view, the issue was not whether the FDA’s regulations placed an undue burden on a right to an abortion generally, but that “My view is that courts owe significant deference” to the public health authorities (here meaning the FDA). Justices Sotomayor and Kagan dissented, saying that the issue was the undue burden on women, given the difficulties of the pandemic, particularly going to medical facilities during the COVID-19 pandemic.⁸

The injunction, sought by ACOG and others, was issued by the district court and was in effect for several months before it was dissolved by the Supreme Court. Following the change in presidential administrations, in April 2021 the FDA announced that it was going to “exercise enforcement discretion with respect to the in-person dispensing requirement…during the COVID-19 public health emergency.”⁹

Continue to: The Texas abortion case...

The Texas abortion case

The Court, on September 1, 2021, declined to block a Texas abortion statute from taking effect.¹⁰ This law precludes abortions after a fetal heartbeat is present at about 6 weeks of gestation. The Fifth Circuit declined to grant an injunction delaying implementation of the Texas law, and the Court did not reverse that decision.

Over the years, a variety of states have placed limitations on abortion, and those almost always have been enjoined by federal courts before they went into effect. However, the Texas statute, which undoubtedly is unconstitutional, was creatively constructed to avoid an early injunction.¹¹ The statute does not allow state officials to enforce the new law, but rather it allows almost any private citizen to seek monetary damages from anyone performing an abortion or who “aids and abets” an abortion. Thus, it is difficult to tailor a lawsuit before this law is enforced. First, courts do not enjoin laws; they usually enjoin individuals from enforcing the law, and in this case it is difficult to know which individuals will be enforcing the laws and what their decisions might be. There also are some questions about the degree to which federal courts can enjoin state courts from deciding lawsuits under state law. For these procedural reasons, the majority of the Court found that those attacking the Texas law had not met their burden of showing that that they would win their case.

Even 3 of the dissenting justices said the defendants may be right that “existing doctrines preclude judicial intervention,” but that the consequences are such that the Court should delay the law until there is time for briefing and argument. The other 3 dissenting justices thought there would be ways of getting around the clever roadblock Texas had erected for the federal courts.

There has been some commentary that this case portends the abandonment of Roe v Wade and Casey,¹² but that conclusion does not seem warranted by this case. The Court has accepted a Mississippi abortion law to be heard next term.¹³ In addition, the Texas statute is likely to be back in federal court once a private individual has filed a claim for money from an abortion provider (and likely even before that).

COVID-19 cases

The Supreme Court decided several cases related to COVID-19, including adjustments to election procedures, church services, and CDC eviction moratoria. As a general matter early in the pandemic, the Court deferred to government authorities, generally upholding government actions. Chief Justice Roberts emphasized the importance of the Court deferring to government officials in emergencies. As the pandemic progressed into 2021, however, the Court became less and less sympathetic to government actions that were not consistent, permitted by existing law, or reasonably necessary. For example, regulations of churches that were inconsistent with the regulation of similar organizations were struck down.¹⁴

Among the most interesting of the summer 2021 cases was the CDC eviction moratorium that essentially prohibited landlords nationwide from evicting tenants for nonpayment of rent. When the challenges to these CDC regulations first reached the Court, the moratorium was about to expire; in a 5-4 decision, the Court did not enjoin the CDC from continuing that policy. Justice Kavanaugh (the fifth vote) warned that “clear and specific congressional authorization…would be necessary to extend the moratorium past July 31.”¹⁵ Despite telling the Court that the moratorium would expire on July 31, just 3 days after the expiration and without any congressional authorization, the CDC reinstated what was practically the same moratorium.¹⁶ On August 26, the Court struck down the reinstated regulation, probably by a 6-3 margin. (Because this case arose in the “Shadow Docket,” the vote of some justices is not certain).¹⁷

Continue to: The Affordable Care Act...

The Affordable Care Act

The Affordable Care Act was challenged in the Court for the third time.¹⁸ In this term’s case, several states argued that when Congress essentially eliminated the penalty/tax for not purchasing insurance coverage, there was no longer a constitutional basis for the individual mandate. With that centerpiece gone, they claimed, the whole statute should be declared unconstitutional.

Along with many other specialty groups, ACOG joined an amicus curiae brief sponsored by the American Medical Association (AMA).¹⁹ An amicus brief is one not filed by the parties to the case, but by organizations or individuals who have information that may be of use to the Court in considering the case. Among other things, the filing of an amicus brief indicates the interest of the organization in the outcome of the case. In this case, the crux of the amicus was that even if the individual mandate currently is not constitutional, the Court should sever that provision and retain the rest of the ACA.

Despite some wild predictions about what the Court might do, it did not decide any substantive issue. Rather, it found that none of the parties to the case had “standing” to challenge the constitutionality of the ACA. Therefore, in effect, the Court dismissed the case without deciding the substantive legal issues.
 

Pharmacy Benefit Managers

The powerful Pharmacy Benefit Managers (PBMs) are a hidden part of the health care system; however, in recent years there has been increasing regulatory attention paid to them. Some states have begun regulating aspects of PBMs. In this term, the Court considered an Arkansas law that sought to protect local pharmacies from PBM pricing practices.²⁰ The AMA filed an amicus brief in the case which made legal arguments, most of which had been made by the parties to the litigation.²¹

PBMs generally tell pharmacies how much they will reimburse the pharmacy for filling a prescription for a particular drug. In some instances, PBMs will set a reimbursement price that is lower than the wholesale price at which local pharmacies can purchase the drug. The Arkansas law prohibited PBMs in the state from reimbursing pharmacies for less than the wholesale cost the pharmacy paid for the drug.

The claim of the PBMs was that the Arkansas law violated the Employee Retirement Income Security Act (ERISA). In part, this act preempts state law that relates to fringe benefit plans. States have the authority to regulate insurance, but ERISA limits what they can do when the insurance relates to fringe benefits. The Court held that ERISA does not preempt the Arkansas law or similar state laws in other states. Because the state law was not preempted by the state law, the Arkansas regulation was upheld. The fact that this was a unanimous decision (8-0, because Justice Barrett was not on the Court when the case was heard) suggests that states may have leeway in additional regulations of PBMs, and it would not be surprising to see more of that state regulation in the future.

Continue to: Patent uncertainty...

Patent uncertainty

Csaba Truckai invented and patented the NovaSure System ablation device with a “moisture permeable” head. He sold his company and the related patents, which eventually were purchased by Hologic. Over time, Hologic added claims to the original patent. In the meantime, Truckai went on to invent another device, the Minerva Endometrial Ablation System (MEAS), which had a “moisture impermeable” head. (Note that the “Minerva Surgical, Inc.” involved in this case is not related to the company “Minerva Industries,” which some identified as a “patent troll.”)²²

Hologic sued Minerva, claiming that Truckai’s second device (MEAS) infringed on its patent for the first device (NovaSure). Truckai’s defense was that the patent on NovaSure was invalid. Hologic felt that since Truckai had obtained that patent and then sold it, it was improper for him now to claim it was invalid. There is a doctrine for that: assignor estoppel—the person who sold (assigned) the patent is prevented from later claiming it was invalid. The question in this case was whether assignor estoppel is part of the patent law of the United States. It is not in the patent statutes, so it is a court-determined part of the law.

In a 5-4 decision this Term, the Court held that assignor estoppel is recognized, but that it is narrow.²³ The Court identified several exceptions to assignor estoppel, notably for this case, including the situation in which the purchaser of the patent, after the purchase, returns to the Patent and Trademark Office to expand (amend) the patent’s claims. In that case, the seller could not be estopped by the amended terms of the patent. Minerva claimed that it was attacking the expanded patent that included changes made after it sold the patent. The Court, therefore, returned the case to the Federal Circuit to apply the principles it laid out about assignor estoppel.

Biotech and other fast-moving fields frequently have new technology building on slightly earlier technology. The current patent system often leaves uncertainty about who owns which part of a valid patent. This uncertainty is a drag on innovation, and the patent system is supposed to spur innovation. Assignor estoppel is likely to create additional complexity and uncertainty in some patents, which is regrettable.
 

Review of the Term

In addition to the other disruptions of the Term, during the first part of the Term, Amy Coney Barrett was not yet confirmed by the Senate, so there were only 8 justices until October 27. She did not participate in those cases that were heard before she joined the Court. The consensus is that the Court heard 67 cases: 57 were formally briefed and argued along with 8 summary reversals and 2 religious cases in the Shadow Docket. In my opinion, this undercounts both the number and the importance of the Shadow Docket cases, but the following data use the 67 case convention.²⁴

The Court was unanimous in 43% of the cases, including some of the most divisive issues. That unanimity reflects very narrow decisions. There were (by conventional count) only eight 5-4 opinions (12%), an unusually low number. Justice Kavanaugh is viewed as the “median” justice. He was in the majority in 97% of all cases. Chief Justice Roberts and Justice Barrett were in the majority 91%, and Justice Gorsuch 90%. As for the other justices, they were in the majority (all cases) most of the time: Justice Alito, 83%; Justice Thomas, 81%; Justice Breyer, 76%; Justice Kagan, 75%; and Justice Sotomayor, 69%. In “divided cases” (when unanimous cases are removed), the percentages are: Justice Kavanaugh, 95%; Chief Justice Roberts and Justice Barrett, 84%; Justice Gorsuch, 82%; Justice Alito, 70%; Justice Thomas, 66%; Justice Breyer, 58%; Justice Kagan, 55%; and Justice Sotomayor, 45%.

When the term began, many Court watchers expected a relatively uninteresting term, dealing with many technical legal details. In fact, it turned out to be more interesting and important than expected, even with narrow holdings in important cases. Part of the secret of the term was that a lot of the real action was in the Shadow Docket. The end of the term is sometimes the moment when a justice announces a plan to retire. Many commentators expected Justice Breyer might announce—he has been under pressure to do so, to allow President Biden to nominate and a Democratic Senate to confirm a progressive justice. However, he did not do so. It is possible that he will announce his retirement to be effective when his successor is confirmed, but that is pure speculation.
 

Continue to: Next Term...

Next Term

The next term began on Monday, October 4, 2021. With the considerable current activity in the Shadow Docket, there was not much of a summer break. The coming term looks extraordinary. The headline case is an abortion case from Mississippi, Dobbs v Jackson Women’s Health Organization.²⁵ The legal question is the constitutionality of Mississippi law that prohibits most abortions after 15 weeks of gestation. The Texas abortion law will also be back before the Court. As we saw this term, big cases may produce very narrow results, but this case has the potential for being a notable abortion decision.

In a different case the Court will decide whether a state attorney general can step in to defend an abortion law when the state health secretary does not do so.²⁶

The Court also has accepted 3 cases dealing with reimbursement for health services. One deals with whether or not the Department of Health and Human Services can set reimbursement rates without good survey data regarding costs,²⁷ another involves the calculation of additional payments for hospitals that serve a “disproportionate number of low-income patients,”²⁸ and the third whether state Medicaid programs can take funds from an injured beneficiary’s tort recovery to cover future Medicaid costs.²⁹

In other cases, the Court will review a gun control law from New York. The Court’s earlier Second Amendment cases involved guns in the home used for self-defense, but this case raises the question of whether a state can practically preclude “concealed-carry licenses.”³⁰ Many experts believe the Court will accept a case dealing with racial preferences in college admissions, perhaps the Harvard case in which the claim is discrimination against Asian Americans.³¹

The ACOG mifepristone case was interesting, in part because the federal district court issued a nationwide injunction against the Americans with Disabilities Act, enforcing its rules anywhere in the country. The effect of these orders is for a single district judge to create the “law of the land,” at least until that is reviewed—which can take months. The advantage of the nationwide injunction is that it avoids having to repeatedly litigate the same issues in multiple courts around the country. The downside is that plaintiffs can seek out a nonrepresentative judge or circuit and receive an injunction that would be granted by few other circuits. In addition, a nationwide injunction can apply to specific circumstances that are not before the court issuing the injunction. In the mifepristone case, for example, 10 states requested to intervene in the ACOG case. The court rejected the request, but the nationwide injunction applied to those states.¹

Although federal judges have had the authority to issue nationwide injunctions for years, they are becoming much more common. One reason is the ease of forum shopping noted earlier—organizations can cherry-pick district courts and circuits sympathetic to their views. Both left- and right-leaning organizations have learned this lesson, so left-leaning groups are likely to file in specific districts in the Ninth Circuit, and right-leaning groups to districts in the Fifth Circuit.

If the current trend of increasing nationwide injunctions continues, either the rules for the federal courts or congressional action may be required to reduce some of the abuses by both sides of the political spectrum.

For centuries, animals, especially dogs, have assisted humans in a variety of ways in their daily lives. Animals that assist people with disabilities fall into 2 broad categories: disability service animals, and emotional support animals (ESAs). Often there is confusion in how these categories differ because of the animal’s role and the laws related to them.

This article describes the differences between disability service animals and ESAs, and outlines the forensic and ethical concerns you should consider before agreeing to write a letter for a patient outlining their need for a disability service animal or ESA. A letter may protect a patient and their service animal or ESA in situations where laws and regulations typically prohibit animals, such as on a flight or when renting an apartment or house. Note that a description of how to conduct the formal patient evaluation before writing a verification letter is beyond the scope of this article.

The differences between disability service animals and ESAs

Purpose and training. Disability service animals, or service animals, are dogs of any breed (and in some cases miniature horses) that are specially trained to perform tasks for an individual with a disability (physical, sensory, psychiatric, intellectual, or other mental disability).^1-3 These tasks must be directly related to the individual’s disability.^1,2 On the other hand, ESAs, which can be any species of animal, provide support and minimize the impact of an individual’s emotional or psychological disability based on their presence alone. Unlike disability service animals, ESAs are not trained to perform a specific task or duty.^2,3

There is no legal requirement for service animals to know specific commands, and professional training is not required—individuals can train the animals themselves.¹ Service animals, mainly dogs, can be trained to perform numerous tasks, including⁴:

• attending to an individual’s mobility and activities of daily living
• guiding an individual who is deaf or hearing impaired
• helping to remind an individual to take their medications
• assisting an individual during and/or after a seizure
• alerting individuals with diabetes in advance of low or high blood sugar episodes
• supporting an individual with autism
• assisting an individual with a psychiatric or mental disability
• applying sensory commands such as lying on the person or resting their head on the individual’s lap to help the individual regain behavioral control.

Service dog verification works via an honor system, which can be problematic, especially in the case of psychiatric service dogs, whose handlers may not have a visible disability (Box 1^1,5).
 

Box 1

Legal protections. Under the Americans with Disabilities Act (ADA), individuals with disabilities can bring their service animals into buildings or facilities where members of the public, program participants, clients, customers, patrons, or invitees are allowed.² This does not include private clubs, religious organizations, or places of worship that are not open to the public.^6,7 ESAs do not qualify as service animals under the ADA and are not given the same legal accommodations as service animals.^1,3 Although ESAs were initially covered by the Air Carrier Access Act, they are no longer allowed in aircraft cabins after the US Department of Transportation revised this Act’s regulations in December 2020. ESAs are covered under the Fair Housing Act. Box 2^1-3,6-15 further discusses these laws and protections.

Evidence. In 1998, Dogs for Good (formerly Dogs for the Disabled), an organization based in the United Kingdom, conducted a survey that assessed the satisfaction of owners who were provided with trained assistance dogs.¹⁶ The results suggested that service dogs improved their owners’ mobility and helped ease the completion of tasks, thereby helping their owners integrate further on a society level and gain a strong bond with their animal.¹⁶ Another survey compared quality of life scores of individuals who owned a service dog vs individuals who were eligible to receive a dog, but did not yet have one.¹⁷ It found that service animals were able to help their owners gain a greater degree of freedom and enhance their ability to participate in everyday outings or tasks that may otherwise have been a struggle, or impossible, if the owner were alone.¹⁷ In addition to boosting confidence, self-esteem, and improving social integration, service dogs have been shown to improve their owners’ quality of life.¹⁷

Due to the difficulty in reconciling inconsistent definitions for ESAs, there is limited high-quality data pertaining to the potential benefits and risks of ESAs.⁹ Currently, ESAs are not an evidence-based treatment for psychiatric disorders. To date, a handful of small studies have focused on ESAs. However, data from actual tests of the clinical risks and benefits of ESAs do not exist.⁹ In practice, ESAs are equivalent to pets. It stands to reason that similar to pets, ESAs could reduce loneliness, improve life satisfaction, and provide a sense of well-being.⁹ A systematic review suggested that pets provide benefits to patients with mental health conditions “through the intensity of connectivity with their owners and the contribution they make to emotional support in times of crises together with their ability to help manage symptoms when they arise.”¹⁸ In response to a congressional mandate, the US Department of Veterans Affairs launched a multi-site study from December 2014 to June 2019 to examine how limitations on activity and quality of life in veterans with posttraumatic stress disorder are impacted by the provision of a service dog vs an emotional support dog.¹⁹ As of October 14, 2021, results had not been published.¹⁹

Continue to: What’s in a disability service animal/ESA letter?

What’s in a disability service animal/ESA letter?

If you decide to write a letter advocating for your patient to have a service animal or ESA, the letter should appear on letterhead, be written by a licensed mental health professional, and include the following^2,20:

• statement that the letter is being written at the patient’s request and is being given directly to the patient for use as the patient sees fit
• confirmation of the patient’s DSM-5 mental health diagnosis
• explanation of how the animal helps alleviate symptoms of the patient’s condition, briefly describing any interaction(s) between the animal and patient that you may have observed, and if applicable, a mention of any training the animal may have received from a qualified trainer if applicable
• explanation of the possible negative effects of the patient not having the animal with him or her
• statement that you are not vouching for the animal’s behavior
• verification of your involvement in your patient’s treatment and your assessment of the patient as their licensed mental health professional (including details such as date and type of license you have and the state/other jurisdiction where it was issued).

In a letter for a service animal, also indicate that your patient is psychiatrically disabled to the extent that your patient is not able to perform at least one major life task without the daily assistance of a service animal.²Should you write your patient a letter?

Writing a letter advocating for a patient to have a service animal or ESA may appear innocuous, but doing so may have serious ramifications. Writing a letter certifying a dog as a service animal does not make that animal a service animal; the dog must be specifically trained for a task or tasks directly related to that individual’s disability. There are no current standards for conducting evaluations to determine the need a patient has for a service animal or ESA. How to conduct such evaluations is beyond the scope of this article. There are meager opportunities for formal education and training on how to conduct these evaluations.⁹ Online resources may be incomplete or inaccurate, and this information is often produced by lay animal enthusiasts and organizations, which can lead to a biased depiction of these animals.⁹

If you decide to write a letter for your patient, consider the following forensic and ethical concerns.

Remain objective. As an advocate for your patient, you may find it difficult to remain neutral and objective when asked to determine if your patient has a disability, the severity of the disability, the impact of the disability on your patient’s life, and the need for a service animal or ESA. Ensure that your advocacy for your patient does not impair your objectivity; if that is difficult, consider referring your patient to a third party who can conduct an objective evaluation.

Understand the risks. If you make written recommendations for special accommodations in a letter and those recommendations are disputed by an agency, that agency could initiate legal action and you may be called to justify your recommendations in a deposition or open court.^9,21 Before writing the letter, ask yourself, “Can I defend my determination that my patient is disabled by a DSM-5 disorder and that this disability requires the presence of an animal in exception to existing policy?”²¹ Be prepared to state in a legal proceeding that the presence of a service animal or ESA is necessary. If you are unwilling to risk exposure to a legal action, then you should likely refrain from writing the letter. It is a crime to fraudulently certify an animal as a service animal in some jurisdictions, and such conduct could result in disciplinary action by your licensing board.²¹

Conduct a systematic examination. When you write a letter for your patient, you are explicitly declaring your patient has a disability or condition. Comprehensive disability determinations are complex and are best conducted by assessing for objective evidence of psychiatric disorders and impairment through the use of standard, systematic examination methods.²² Unstandardized measures (eg, asking patients open-ended questions and then relying on your clinical judgement and interpretation in arriving at conclusions) are not as effective.²² In addition, consider the possibility that your patient may malinger their symptoms in an effort to obtain a letter supporting a service animal or ESA. Assessing for malingering is essential to making a disability determination, especially if a disability claim is based primarily on self-report.²²

Anticipate pushback. Problems can arise when a patient wants a letter that you cannot or will not provide due to your scope of practice. Consider how you would resolve the situation when you do not believe your patient has a disability that requires the presence of a service animal or ESA—or you believe that your patient no longer needs a service animal or ESA—and the patient disagrees.²¹ Disagreeing with your patient’s assessment could result in a conflict of interest that could damage the therapeutic relationship.²¹

Box 2

Bottom Line 

Disability service animals and emotional support animals (ESAs) differ in their roles and legal protections. Before writing a letter in support of a patient’s request for a service animal or ESA, take into account the forensic and ethical implications of doing so.

Related Resources

• US Department of Justice. Civil Rights Division. Disability Rights Section. ADA requirements. Service animals. Updated February 24, 2020. https://www.ada.gov/service_ animals_2010.htm

• American Veterinary Medical Association. Service, emotional support and therapy animals. https://www. avma.org/resources-tools/animal-health-welfare/ service-emotional-support-and-therapy-animals

• US Department of Transportation. US Department of Transportation announces final rule on traveling by air with service animals. https://www.transportation.gov/briefingroom/us-department-transportation-announces-finalrule-traveling-air-service-animals

For centuries, animals, especially dogs, have assisted humans in a variety of ways in their daily lives. Animals that assist people with disabilities fall into 2 broad categories: disability service animals, and emotional support animals (ESAs). Often there is confusion in how these categories differ because of the animal’s role and the laws related to them.

This article describes the differences between disability service animals and ESAs, and outlines the forensic and ethical concerns you should consider before agreeing to write a letter for a patient outlining their need for a disability service animal or ESA. A letter may protect a patient and their service animal or ESA in situations where laws and regulations typically prohibit animals, such as on a flight or when renting an apartment or house. Note that a description of how to conduct the formal patient evaluation before writing a verification letter is beyond the scope of this article.

The differences between disability service animals and ESAs

Purpose and training. Disability service animals, or service animals, are dogs of any breed (and in some cases miniature horses) that are specially trained to perform tasks for an individual with a disability (physical, sensory, psychiatric, intellectual, or other mental disability).^1-3 These tasks must be directly related to the individual’s disability.^1,2 On the other hand, ESAs, which can be any species of animal, provide support and minimize the impact of an individual’s emotional or psychological disability based on their presence alone. Unlike disability service animals, ESAs are not trained to perform a specific task or duty.^2,3

There is no legal requirement for service animals to know specific commands, and professional training is not required—individuals can train the animals themselves.¹ Service animals, mainly dogs, can be trained to perform numerous tasks, including⁴:

• attending to an individual’s mobility and activities of daily living
• guiding an individual who is deaf or hearing impaired
• helping to remind an individual to take their medications
• assisting an individual during and/or after a seizure
• alerting individuals with diabetes in advance of low or high blood sugar episodes
• supporting an individual with autism
• assisting an individual with a psychiatric or mental disability
• applying sensory commands such as lying on the person or resting their head on the individual’s lap to help the individual regain behavioral control.

Service dog verification works via an honor system, which can be problematic, especially in the case of psychiatric service dogs, whose handlers may not have a visible disability (Box 1^1,5).
 

Box 1

Legal protections. Under the Americans with Disabilities Act (ADA), individuals with disabilities can bring their service animals into buildings or facilities where members of the public, program participants, clients, customers, patrons, or invitees are allowed.² This does not include private clubs, religious organizations, or places of worship that are not open to the public.^6,7 ESAs do not qualify as service animals under the ADA and are not given the same legal accommodations as service animals.^1,3 Although ESAs were initially covered by the Air Carrier Access Act, they are no longer allowed in aircraft cabins after the US Department of Transportation revised this Act’s regulations in December 2020. ESAs are covered under the Fair Housing Act. Box 2^1-3,6-15 further discusses these laws and protections.

Evidence. In 1998, Dogs for Good (formerly Dogs for the Disabled), an organization based in the United Kingdom, conducted a survey that assessed the satisfaction of owners who were provided with trained assistance dogs.¹⁶ The results suggested that service dogs improved their owners’ mobility and helped ease the completion of tasks, thereby helping their owners integrate further on a society level and gain a strong bond with their animal.¹⁶ Another survey compared quality of life scores of individuals who owned a service dog vs individuals who were eligible to receive a dog, but did not yet have one.¹⁷ It found that service animals were able to help their owners gain a greater degree of freedom and enhance their ability to participate in everyday outings or tasks that may otherwise have been a struggle, or impossible, if the owner were alone.¹⁷ In addition to boosting confidence, self-esteem, and improving social integration, service dogs have been shown to improve their owners’ quality of life.¹⁷

Due to the difficulty in reconciling inconsistent definitions for ESAs, there is limited high-quality data pertaining to the potential benefits and risks of ESAs.⁹ Currently, ESAs are not an evidence-based treatment for psychiatric disorders. To date, a handful of small studies have focused on ESAs. However, data from actual tests of the clinical risks and benefits of ESAs do not exist.⁹ In practice, ESAs are equivalent to pets. It stands to reason that similar to pets, ESAs could reduce loneliness, improve life satisfaction, and provide a sense of well-being.⁹ A systematic review suggested that pets provide benefits to patients with mental health conditions “through the intensity of connectivity with their owners and the contribution they make to emotional support in times of crises together with their ability to help manage symptoms when they arise.”¹⁸ In response to a congressional mandate, the US Department of Veterans Affairs launched a multi-site study from December 2014 to June 2019 to examine how limitations on activity and quality of life in veterans with posttraumatic stress disorder are impacted by the provision of a service dog vs an emotional support dog.¹⁹ As of October 14, 2021, results had not been published.¹⁹

Continue to: What’s in a disability service animal/ESA letter?

What’s in a disability service animal/ESA letter?

If you decide to write a letter advocating for your patient to have a service animal or ESA, the letter should appear on letterhead, be written by a licensed mental health professional, and include the following^2,20:

• statement that the letter is being written at the patient’s request and is being given directly to the patient for use as the patient sees fit
• confirmation of the patient’s DSM-5 mental health diagnosis
• explanation of how the animal helps alleviate symptoms of the patient’s condition, briefly describing any interaction(s) between the animal and patient that you may have observed, and if applicable, a mention of any training the animal may have received from a qualified trainer if applicable
• explanation of the possible negative effects of the patient not having the animal with him or her
• statement that you are not vouching for the animal’s behavior
• verification of your involvement in your patient’s treatment and your assessment of the patient as their licensed mental health professional (including details such as date and type of license you have and the state/other jurisdiction where it was issued).

In a letter for a service animal, also indicate that your patient is psychiatrically disabled to the extent that your patient is not able to perform at least one major life task without the daily assistance of a service animal.²Should you write your patient a letter?

Writing a letter advocating for a patient to have a service animal or ESA may appear innocuous, but doing so may have serious ramifications. Writing a letter certifying a dog as a service animal does not make that animal a service animal; the dog must be specifically trained for a task or tasks directly related to that individual’s disability. There are no current standards for conducting evaluations to determine the need a patient has for a service animal or ESA. How to conduct such evaluations is beyond the scope of this article. There are meager opportunities for formal education and training on how to conduct these evaluations.⁹ Online resources may be incomplete or inaccurate, and this information is often produced by lay animal enthusiasts and organizations, which can lead to a biased depiction of these animals.⁹

If you decide to write a letter for your patient, consider the following forensic and ethical concerns.

Remain objective. As an advocate for your patient, you may find it difficult to remain neutral and objective when asked to determine if your patient has a disability, the severity of the disability, the impact of the disability on your patient’s life, and the need for a service animal or ESA. Ensure that your advocacy for your patient does not impair your objectivity; if that is difficult, consider referring your patient to a third party who can conduct an objective evaluation.

Understand the risks. If you make written recommendations for special accommodations in a letter and those recommendations are disputed by an agency, that agency could initiate legal action and you may be called to justify your recommendations in a deposition or open court.^9,21 Before writing the letter, ask yourself, “Can I defend my determination that my patient is disabled by a DSM-5 disorder and that this disability requires the presence of an animal in exception to existing policy?”²¹ Be prepared to state in a legal proceeding that the presence of a service animal or ESA is necessary. If you are unwilling to risk exposure to a legal action, then you should likely refrain from writing the letter. It is a crime to fraudulently certify an animal as a service animal in some jurisdictions, and such conduct could result in disciplinary action by your licensing board.²¹

Conduct a systematic examination. When you write a letter for your patient, you are explicitly declaring your patient has a disability or condition. Comprehensive disability determinations are complex and are best conducted by assessing for objective evidence of psychiatric disorders and impairment through the use of standard, systematic examination methods.²² Unstandardized measures (eg, asking patients open-ended questions and then relying on your clinical judgement and interpretation in arriving at conclusions) are not as effective.²² In addition, consider the possibility that your patient may malinger their symptoms in an effort to obtain a letter supporting a service animal or ESA. Assessing for malingering is essential to making a disability determination, especially if a disability claim is based primarily on self-report.²²

Anticipate pushback. Problems can arise when a patient wants a letter that you cannot or will not provide due to your scope of practice. Consider how you would resolve the situation when you do not believe your patient has a disability that requires the presence of a service animal or ESA—or you believe that your patient no longer needs a service animal or ESA—and the patient disagrees.²¹ Disagreeing with your patient’s assessment could result in a conflict of interest that could damage the therapeutic relationship.²¹

Box 2

Bottom Line 

Disability service animals and emotional support animals (ESAs) differ in their roles and legal protections. Before writing a letter in support of a patient’s request for a service animal or ESA, take into account the forensic and ethical implications of doing so.

Related Resources

• US Department of Justice. Civil Rights Division. Disability Rights Section. ADA requirements. Service animals. Updated February 24, 2020. https://www.ada.gov/service_ animals_2010.htm

• American Veterinary Medical Association. Service, emotional support and therapy animals. https://www. avma.org/resources-tools/animal-health-welfare/ service-emotional-support-and-therapy-animals

• US Department of Transportation. US Department of Transportation announces final rule on traveling by air with service animals. https://www.transportation.gov/briefingroom/us-department-transportation-announces-finalrule-traveling-air-service-animals

For centuries, animals, especially dogs, have assisted humans in a variety of ways in their daily lives. Animals that assist people with disabilities fall into 2 broad categories: disability service animals, and emotional support animals (ESAs). Often there is confusion in how these categories differ because of the animal’s role and the laws related to them.

This article describes the differences between disability service animals and ESAs, and outlines the forensic and ethical concerns you should consider before agreeing to write a letter for a patient outlining their need for a disability service animal or ESA. A letter may protect a patient and their service animal or ESA in situations where laws and regulations typically prohibit animals, such as on a flight or when renting an apartment or house. Note that a description of how to conduct the formal patient evaluation before writing a verification letter is beyond the scope of this article.

The differences between disability service animals and ESAs

Purpose and training. Disability service animals, or service animals, are dogs of any breed (and in some cases miniature horses) that are specially trained to perform tasks for an individual with a disability (physical, sensory, psychiatric, intellectual, or other mental disability).^1-3 These tasks must be directly related to the individual’s disability.^1,2 On the other hand, ESAs, which can be any species of animal, provide support and minimize the impact of an individual’s emotional or psychological disability based on their presence alone. Unlike disability service animals, ESAs are not trained to perform a specific task or duty.^2,3

There is no legal requirement for service animals to know specific commands, and professional training is not required—individuals can train the animals themselves.¹ Service animals, mainly dogs, can be trained to perform numerous tasks, including⁴:

• attending to an individual’s mobility and activities of daily living
• guiding an individual who is deaf or hearing impaired
• helping to remind an individual to take their medications
• assisting an individual during and/or after a seizure
• alerting individuals with diabetes in advance of low or high blood sugar episodes
• supporting an individual with autism
• assisting an individual with a psychiatric or mental disability
• applying sensory commands such as lying on the person or resting their head on the individual’s lap to help the individual regain behavioral control.

Service dog verification works via an honor system, which can be problematic, especially in the case of psychiatric service dogs, whose handlers may not have a visible disability (Box 1^1,5).
 

Box 1

Legal protections. Under the Americans with Disabilities Act (ADA), individuals with disabilities can bring their service animals into buildings or facilities where members of the public, program participants, clients, customers, patrons, or invitees are allowed.² This does not include private clubs, religious organizations, or places of worship that are not open to the public.^6,7 ESAs do not qualify as service animals under the ADA and are not given the same legal accommodations as service animals.^1,3 Although ESAs were initially covered by the Air Carrier Access Act, they are no longer allowed in aircraft cabins after the US Department of Transportation revised this Act’s regulations in December 2020. ESAs are covered under the Fair Housing Act. Box 2^1-3,6-15 further discusses these laws and protections.

Evidence. In 1998, Dogs for Good (formerly Dogs for the Disabled), an organization based in the United Kingdom, conducted a survey that assessed the satisfaction of owners who were provided with trained assistance dogs.¹⁶ The results suggested that service dogs improved their owners’ mobility and helped ease the completion of tasks, thereby helping their owners integrate further on a society level and gain a strong bond with their animal.¹⁶ Another survey compared quality of life scores of individuals who owned a service dog vs individuals who were eligible to receive a dog, but did not yet have one.¹⁷ It found that service animals were able to help their owners gain a greater degree of freedom and enhance their ability to participate in everyday outings or tasks that may otherwise have been a struggle, or impossible, if the owner were alone.¹⁷ In addition to boosting confidence, self-esteem, and improving social integration, service dogs have been shown to improve their owners’ quality of life.¹⁷

Due to the difficulty in reconciling inconsistent definitions for ESAs, there is limited high-quality data pertaining to the potential benefits and risks of ESAs.⁹ Currently, ESAs are not an evidence-based treatment for psychiatric disorders. To date, a handful of small studies have focused on ESAs. However, data from actual tests of the clinical risks and benefits of ESAs do not exist.⁹ In practice, ESAs are equivalent to pets. It stands to reason that similar to pets, ESAs could reduce loneliness, improve life satisfaction, and provide a sense of well-being.⁹ A systematic review suggested that pets provide benefits to patients with mental health conditions “through the intensity of connectivity with their owners and the contribution they make to emotional support in times of crises together with their ability to help manage symptoms when they arise.”¹⁸ In response to a congressional mandate, the US Department of Veterans Affairs launched a multi-site study from December 2014 to June 2019 to examine how limitations on activity and quality of life in veterans with posttraumatic stress disorder are impacted by the provision of a service dog vs an emotional support dog.¹⁹ As of October 14, 2021, results had not been published.¹⁹

Continue to: What’s in a disability service animal/ESA letter?

What’s in a disability service animal/ESA letter?

If you decide to write a letter advocating for your patient to have a service animal or ESA, the letter should appear on letterhead, be written by a licensed mental health professional, and include the following^2,20:

• statement that the letter is being written at the patient’s request and is being given directly to the patient for use as the patient sees fit
• confirmation of the patient’s DSM-5 mental health diagnosis
• explanation of how the animal helps alleviate symptoms of the patient’s condition, briefly describing any interaction(s) between the animal and patient that you may have observed, and if applicable, a mention of any training the animal may have received from a qualified trainer if applicable
• explanation of the possible negative effects of the patient not having the animal with him or her
• statement that you are not vouching for the animal’s behavior
• verification of your involvement in your patient’s treatment and your assessment of the patient as their licensed mental health professional (including details such as date and type of license you have and the state/other jurisdiction where it was issued).

In a letter for a service animal, also indicate that your patient is psychiatrically disabled to the extent that your patient is not able to perform at least one major life task without the daily assistance of a service animal.²Should you write your patient a letter?

Writing a letter advocating for a patient to have a service animal or ESA may appear innocuous, but doing so may have serious ramifications. Writing a letter certifying a dog as a service animal does not make that animal a service animal; the dog must be specifically trained for a task or tasks directly related to that individual’s disability. There are no current standards for conducting evaluations to determine the need a patient has for a service animal or ESA. How to conduct such evaluations is beyond the scope of this article. There are meager opportunities for formal education and training on how to conduct these evaluations.⁹ Online resources may be incomplete or inaccurate, and this information is often produced by lay animal enthusiasts and organizations, which can lead to a biased depiction of these animals.⁹

If you decide to write a letter for your patient, consider the following forensic and ethical concerns.

Remain objective. As an advocate for your patient, you may find it difficult to remain neutral and objective when asked to determine if your patient has a disability, the severity of the disability, the impact of the disability on your patient’s life, and the need for a service animal or ESA. Ensure that your advocacy for your patient does not impair your objectivity; if that is difficult, consider referring your patient to a third party who can conduct an objective evaluation.

Understand the risks. If you make written recommendations for special accommodations in a letter and those recommendations are disputed by an agency, that agency could initiate legal action and you may be called to justify your recommendations in a deposition or open court.^9,21 Before writing the letter, ask yourself, “Can I defend my determination that my patient is disabled by a DSM-5 disorder and that this disability requires the presence of an animal in exception to existing policy?”²¹ Be prepared to state in a legal proceeding that the presence of a service animal or ESA is necessary. If you are unwilling to risk exposure to a legal action, then you should likely refrain from writing the letter. It is a crime to fraudulently certify an animal as a service animal in some jurisdictions, and such conduct could result in disciplinary action by your licensing board.²¹

Conduct a systematic examination. When you write a letter for your patient, you are explicitly declaring your patient has a disability or condition. Comprehensive disability determinations are complex and are best conducted by assessing for objective evidence of psychiatric disorders and impairment through the use of standard, systematic examination methods.²² Unstandardized measures (eg, asking patients open-ended questions and then relying on your clinical judgement and interpretation in arriving at conclusions) are not as effective.²² In addition, consider the possibility that your patient may malinger their symptoms in an effort to obtain a letter supporting a service animal or ESA. Assessing for malingering is essential to making a disability determination, especially if a disability claim is based primarily on self-report.²²

Anticipate pushback. Problems can arise when a patient wants a letter that you cannot or will not provide due to your scope of practice. Consider how you would resolve the situation when you do not believe your patient has a disability that requires the presence of a service animal or ESA—or you believe that your patient no longer needs a service animal or ESA—and the patient disagrees.²¹ Disagreeing with your patient’s assessment could result in a conflict of interest that could damage the therapeutic relationship.²¹

Box 2

Bottom Line 

Disability service animals and emotional support animals (ESAs) differ in their roles and legal protections. Before writing a letter in support of a patient’s request for a service animal or ESA, take into account the forensic and ethical implications of doing so.

Related Resources

• US Department of Justice. Civil Rights Division. Disability Rights Section. ADA requirements. Service animals. Updated February 24, 2020. https://www.ada.gov/service_ animals_2010.htm

• American Veterinary Medical Association. Service, emotional support and therapy animals. https://www. avma.org/resources-tools/animal-health-welfare/ service-emotional-support-and-therapy-animals

• US Department of Transportation. US Department of Transportation announces final rule on traveling by air with service animals. https://www.transportation.gov/briefingroom/us-department-transportation-announces-finalrule-traveling-air-service-animals

Mrs. W, age 35, presents to your clinic seeking treatment for anxiety and depression. She has no psychiatric history but reports feeling sad, overwhelmed, and stressed. Mrs. W has been married for 10 years, has 2 young children, and is currently pregnant. She recently discovered that her husband has been having an affair. Mrs. W tells you that she feels her marriage is unsalvageable and would like to ask her husband for a divorce, but worries that he will “put up a fight” and demand full custody of their children. When you ask why, she states that her husband is “pretty narcissistic” and tends to become combative when criticized or threatened, such as a recent discussion they had about his affair that ended with him concluding that if she were “sexier and more confident” he would not have cheated on her.

As Mrs. W is talking, you recall a conversation you recently overheard at a continuing medical education event. Two clinicians were discussing how their records had been subpoenaed in a child custody case, even though the patient’s mental health was not contested. You realize that Mrs. W’s situation may also fit under this exception to confidentiality or privilege. You wonder if you should have disclosed this possibility to her at the outset of your session and wonder what you should say now, because she is clearly in distress and in need of psychiatric treatment. On the other hand, you want her to be fully informed of the potential repercussions if she continues with treatment.

Confidentiality and privilege allow our patients to disclose sensitive details in a safe space. The psychiatrist’s duty is to keep the patient’s information confidential, except in limited circumstances. The patient’s privilege is their right to prevent someone in a special confidential relationship from testifying against them or releasing their private records. In certain instances, a patient may waive or be forced to waive privilege, and a psychiatrist may be compelled to testify or release treatment records to a court. This article reviews exceptions to confidentiality and privilege, focusing specifically on a little-known exception to privilege that arises in divorce and child custody cases. We discuss relevant legislation and provide recommendations for psychiatrists to better understand how to discuss these legal realities with patients who are or may go through a divorce or child custody case.

Understanding confidentiality and privilege

Confidentiality and privilege are related but distinct concepts. Confidentiality relates to the overall trusting relationship created between 2 parties, such as a physician and their patient, and the duty on the part of the trusted individual to keep information private. Privilege refers to a person’s specific legal right to prevent someone in that confidential, trusting relationship from testifying against them in court or releasing confidential records. Privilege is owned by the patient and must be asserted or waived by the patient in legal proceedings. The concepts of confidentiality and privilege are crucial in creating an open, candid therapeutic environment. Many courts, including the US Supreme Court,¹ have recognized the importance of confidentiality and privilege in establishing a positive therapeutic relationship between a psychotherapist and a patient. Without confidentiality and privilege, patients would be less likely to share sensitive yet clinically important information.

Commonly encountered exceptions to confidentiality (Table 1²) and privilege (Table 2) exist in medical practice. Psychiatrists should discuss these exceptions with patients at the outset of clinical treatment. A little-known exception to privilege that may compel a psychiatrist to disclose confidential records can occur in child custody proceedings. In certain states, the mere filing of a child custody claim constitutes an exception to physician-patient privilege. In these states, the parent filing for divorce and custody may automatically waive privilege and thus compel disclosure of psychiatric records, even if their mental health is not in question. The following recent Ohio Supreme Court case illustrates this exception.

Friedenberg v Friedenberg (2020)

Friedenberg v Friedenberg³ addressed the issue of privilege and release of mental health treatment records in custody disputes. Belinda Torres Friedenberg and Keith Friedenberg were married with 4 minor children. Mrs. Friedenberg filed for divorce in 2016, requesting custody of the children and spousal support. In response, Mr. Friedenberg also filed a complaint seeking custody. Mr. Friedenberg subpoenaed mental health treatment records for Mrs. Friedenberg, who responded by filing a request to prevent the release of these records given physician-patient privilege. Mr. Friedenberg argued that Mrs. Friedenberg had placed her physical and mental health at issue when she filed for divorce and custody. At no point did Mr. Friedenberg allege that Mrs. Friedenberg’s mental health made her an unfit parent. The court agreed with Mr. Friedenberg and compelled disclosure of Mrs. Friedenberg’s psychiatric records, stating it is “hard to imagine a scenario where the mental health records of a parent would not be relevant to issues around custody and the best interests of the children.” The judge reviewed Mrs. Friedenberg’s psychiatric records privately and released records deemed relevant to the custody proceedings. On appeal, the Ohio Supreme Court agreed with this approach, holding that a parent’s mental fitness is always an issue in child custody cases, even if not asserted by either party. The court further held that unnecessary disclosure of sensitive information was prevented by the judge’s private review of records before deciding which records to release to the opposing spouse.

Waiver of physician-patient privilege

Waiver of physician-patient privilege in custody and divorce proceedings varies by state (Table 3^3-6). The Friedenberg decision highlights the most restrictive approach, where the mere filing of a divorce and child custody request automatically waives privilege. Some states, such as Indiana,⁴ follow a similar scheme to Ohio. Other states are silent on this issue or explicitly prohibit a waiver of privilege, asserting that custody disputes alone do not trigger disclosure without additional justifications, such as aberrant parental behaviors or other historical information concerning for abuse, neglect, or lack of parental fitness, or if a parent places their mental health at issue.⁷

Continue to: Once privilege is waived...

Once privilege is waived, the next step is to determine who should examine psychiatric records, deem relevance, and disclose sensitive information to the court and the opposing party. A judge may make this determination, as in the Friedenberg case. Alternatively, an independent psychiatric examiner may be appointed by the court to examine one or both parties; to obtain collateral information, including psychiatric records; and to submit a report to the court with medicolegal opinions regarding parental fitness. For example, in Maryland,⁶ the mere filing of a custody suit does not waive privilege. If a parent’s mental health is questioned, the judge may order an independent psychiatric examination to determine the parent’s fitness, thus balancing the best interests of the child with the parent’s right to physician-patient privilege.

The problem with automatic waivers

The foundation of the physician-patient relationship is trust and confidentiality. While this holds true for every specialty, perhaps it is even more important in psychiatry, where our patients routinely disclose sensitive, personal information in hopes of healing. Patients may not be aware of exceptions to confidentiality, or only be aware of the most well-known exceptions, such as the clinician’s duty to report abuse, or to warn a third party about risk of harm by a patient. Furthermore, clinicians and patients alike may not be aware of less-common exceptions to privilege, such as those that may occur in custody proceedings. This is critically important in light of the high number of patients who are or may be seeking divorce and custody of their children.

As psychiatric clinicians, it is highly likely that we will see patients going through divorce and custody proceedings. In 2018, there were 2.24 marriages for every divorce,⁸ and in 2014, 27% of all American children were living with a custodial parent, with the other parent living elsewhere.⁹ Divorce can be a profoundly stressful time; thus, it would be expected that many individuals going through divorce would seek psychiatric treatment and support.

Our concern is that the Friedenberg approach, which results in automatic disclosure of sensitive mental health information when a party files for divorce and custody, could deter patients from seeking psychiatric treatment, especially those anticipating divorce. Importantly, because women are nearly twice as likely as men to experience depression and anxiety¹⁰ and are more likely to seek treatment, this approach could disproportionately impact them.¹¹ In general, an automatic waiver policy may create an additional obstacle for individuals who are already reticent to seek treatment.

How to handle these situations

As a psychiatrist, you should be familiar with your state’s laws regarding exceptions to patient-physician privilege, and should discuss exceptions at the outset of treatment. However, you will need to weigh the potential negative impacts of this information on the therapeutic relationship, including possible early termination. Furthermore, this information may impact a patient’s willingness to disclose all relevant information to mental health treatment if there is concern for later court disclosure. How should you balance these concerns? First, encourage patients to ask questions and raise concerns about confidentiality and privilege.¹² In addition, you may direct the patient to other resources, such as a family law attorney, if they have questions about how certain information may be used in a legal proceeding.

Continue to: Second, you should be...

Second, you should be transparent regarding documentation of psychiatric visits. While documentation must meet ethical, legal, and billing requirements, you should take care to include only relevant information needed to make a diagnosis and provide indicated treatment while maintaining a neutral tone and avoiding medical jargon.¹³ For instance, we frequently use the term “denied” in medical documentation, as in “Mr. X denied cough, sore throat, fever or chills.” However, in psychiatric notes, if a patient “denied alcohol use,” the colloquial interpretation of this word could imply a tone of distrust toward the patient. A more sensitive way to document this might be: “When screened, reported no alcohol use.” If a patient divulges information and then asks you to omit this from their chart, but you do not feel comfortable doing so, explain what and why you must include the information in the chart.¹⁴

Third, if you receive a subpoena or other document requesting privileged information, first contact the patient and inform them of the request, and then seek legal consultation through your employer or malpractice insurer.¹⁵ Not all subpoenas are valid and enforceable, so it is important for an attorney to examine the subpoena; in addition, the patient’s attorney may choose to challenge the subpoena and limit the disclosure of privileged information.

Finally, inform legislatures and courts about the potential harm of automatic waivers in custody proceedings. A judge’s examination of the psychiatric records, as in Friedenberg, is not an adequate safeguard. A judge is not a trained mental health professional and may deem “relevant” information to be nearly everything: a history of abuse, remote drug or alcohol use, disclosure of a past crime, or financial troubles. We advocate for courts to follow the Maryland model, where a spouse does not automatically waive privilege if filing for divorce or custody. If mental health becomes an issue in a case, then the court may seek an independent psychiatric examination. The independent examiner will have access to patient records but will be in a better position to determine which details are relevant in determining diagnosis and parental fitness, and to render an opinion to the court.

CASE CONTINUED

You inform Mrs. W about a possible exception to privilege in divorce and custody cases. She decides to first talk with a family law attorney before proceeding with treatment. You defer your diagnosis and wait to see if she wants to proceed with treatment. Unfortunately, she does not return to your office.

Bottom Line

Some states limit the confidentiality and privilege of parents who are in psychiatric treatment and also involved in divorce and child custody cases. Psychiatrists should be mindful of these exceptions, and discuss them with patients at the onset of treatment.

Related Resources

• Legal Information Institute. Child custody: an overview. www.law.cornell.edu/wex/child_custody
• Melton GB, Petrila J, Poythress NG, et al. Child custody in divorce. In: Melton GB, Petrila J, Poythress NG, et al. Psychological evaluations for the courts. Guilford Press; 2018:530-533.

Mrs. W, age 35, presents to your clinic seeking treatment for anxiety and depression. She has no psychiatric history but reports feeling sad, overwhelmed, and stressed. Mrs. W has been married for 10 years, has 2 young children, and is currently pregnant. She recently discovered that her husband has been having an affair. Mrs. W tells you that she feels her marriage is unsalvageable and would like to ask her husband for a divorce, but worries that he will “put up a fight” and demand full custody of their children. When you ask why, she states that her husband is “pretty narcissistic” and tends to become combative when criticized or threatened, such as a recent discussion they had about his affair that ended with him concluding that if she were “sexier and more confident” he would not have cheated on her.

As Mrs. W is talking, you recall a conversation you recently overheard at a continuing medical education event. Two clinicians were discussing how their records had been subpoenaed in a child custody case, even though the patient’s mental health was not contested. You realize that Mrs. W’s situation may also fit under this exception to confidentiality or privilege. You wonder if you should have disclosed this possibility to her at the outset of your session and wonder what you should say now, because she is clearly in distress and in need of psychiatric treatment. On the other hand, you want her to be fully informed of the potential repercussions if she continues with treatment.

Confidentiality and privilege allow our patients to disclose sensitive details in a safe space. The psychiatrist’s duty is to keep the patient’s information confidential, except in limited circumstances. The patient’s privilege is their right to prevent someone in a special confidential relationship from testifying against them or releasing their private records. In certain instances, a patient may waive or be forced to waive privilege, and a psychiatrist may be compelled to testify or release treatment records to a court. This article reviews exceptions to confidentiality and privilege, focusing specifically on a little-known exception to privilege that arises in divorce and child custody cases. We discuss relevant legislation and provide recommendations for psychiatrists to better understand how to discuss these legal realities with patients who are or may go through a divorce or child custody case.

Understanding confidentiality and privilege

Confidentiality and privilege are related but distinct concepts. Confidentiality relates to the overall trusting relationship created between 2 parties, such as a physician and their patient, and the duty on the part of the trusted individual to keep information private. Privilege refers to a person’s specific legal right to prevent someone in that confidential, trusting relationship from testifying against them in court or releasing confidential records. Privilege is owned by the patient and must be asserted or waived by the patient in legal proceedings. The concepts of confidentiality and privilege are crucial in creating an open, candid therapeutic environment. Many courts, including the US Supreme Court,¹ have recognized the importance of confidentiality and privilege in establishing a positive therapeutic relationship between a psychotherapist and a patient. Without confidentiality and privilege, patients would be less likely to share sensitive yet clinically important information.

Commonly encountered exceptions to confidentiality (Table 1²) and privilege (Table 2) exist in medical practice. Psychiatrists should discuss these exceptions with patients at the outset of clinical treatment. A little-known exception to privilege that may compel a psychiatrist to disclose confidential records can occur in child custody proceedings. In certain states, the mere filing of a child custody claim constitutes an exception to physician-patient privilege. In these states, the parent filing for divorce and custody may automatically waive privilege and thus compel disclosure of psychiatric records, even if their mental health is not in question. The following recent Ohio Supreme Court case illustrates this exception.

Friedenberg v Friedenberg (2020)

Friedenberg v Friedenberg³ addressed the issue of privilege and release of mental health treatment records in custody disputes. Belinda Torres Friedenberg and Keith Friedenberg were married with 4 minor children. Mrs. Friedenberg filed for divorce in 2016, requesting custody of the children and spousal support. In response, Mr. Friedenberg also filed a complaint seeking custody. Mr. Friedenberg subpoenaed mental health treatment records for Mrs. Friedenberg, who responded by filing a request to prevent the release of these records given physician-patient privilege. Mr. Friedenberg argued that Mrs. Friedenberg had placed her physical and mental health at issue when she filed for divorce and custody. At no point did Mr. Friedenberg allege that Mrs. Friedenberg’s mental health made her an unfit parent. The court agreed with Mr. Friedenberg and compelled disclosure of Mrs. Friedenberg’s psychiatric records, stating it is “hard to imagine a scenario where the mental health records of a parent would not be relevant to issues around custody and the best interests of the children.” The judge reviewed Mrs. Friedenberg’s psychiatric records privately and released records deemed relevant to the custody proceedings. On appeal, the Ohio Supreme Court agreed with this approach, holding that a parent’s mental fitness is always an issue in child custody cases, even if not asserted by either party. The court further held that unnecessary disclosure of sensitive information was prevented by the judge’s private review of records before deciding which records to release to the opposing spouse.

Waiver of physician-patient privilege

Waiver of physician-patient privilege in custody and divorce proceedings varies by state (Table 3^3-6). The Friedenberg decision highlights the most restrictive approach, where the mere filing of a divorce and child custody request automatically waives privilege. Some states, such as Indiana,⁴ follow a similar scheme to Ohio. Other states are silent on this issue or explicitly prohibit a waiver of privilege, asserting that custody disputes alone do not trigger disclosure without additional justifications, such as aberrant parental behaviors or other historical information concerning for abuse, neglect, or lack of parental fitness, or if a parent places their mental health at issue.⁷

Continue to: Once privilege is waived...

Once privilege is waived, the next step is to determine who should examine psychiatric records, deem relevance, and disclose sensitive information to the court and the opposing party. A judge may make this determination, as in the Friedenberg case. Alternatively, an independent psychiatric examiner may be appointed by the court to examine one or both parties; to obtain collateral information, including psychiatric records; and to submit a report to the court with medicolegal opinions regarding parental fitness. For example, in Maryland,⁶ the mere filing of a custody suit does not waive privilege. If a parent’s mental health is questioned, the judge may order an independent psychiatric examination to determine the parent’s fitness, thus balancing the best interests of the child with the parent’s right to physician-patient privilege.

The problem with automatic waivers

The foundation of the physician-patient relationship is trust and confidentiality. While this holds true for every specialty, perhaps it is even more important in psychiatry, where our patients routinely disclose sensitive, personal information in hopes of healing. Patients may not be aware of exceptions to confidentiality, or only be aware of the most well-known exceptions, such as the clinician’s duty to report abuse, or to warn a third party about risk of harm by a patient. Furthermore, clinicians and patients alike may not be aware of less-common exceptions to privilege, such as those that may occur in custody proceedings. This is critically important in light of the high number of patients who are or may be seeking divorce and custody of their children.

As psychiatric clinicians, it is highly likely that we will see patients going through divorce and custody proceedings. In 2018, there were 2.24 marriages for every divorce,⁸ and in 2014, 27% of all American children were living with a custodial parent, with the other parent living elsewhere.⁹ Divorce can be a profoundly stressful time; thus, it would be expected that many individuals going through divorce would seek psychiatric treatment and support.

Our concern is that the Friedenberg approach, which results in automatic disclosure of sensitive mental health information when a party files for divorce and custody, could deter patients from seeking psychiatric treatment, especially those anticipating divorce. Importantly, because women are nearly twice as likely as men to experience depression and anxiety¹⁰ and are more likely to seek treatment, this approach could disproportionately impact them.¹¹ In general, an automatic waiver policy may create an additional obstacle for individuals who are already reticent to seek treatment.

How to handle these situations

As a psychiatrist, you should be familiar with your state’s laws regarding exceptions to patient-physician privilege, and should discuss exceptions at the outset of treatment. However, you will need to weigh the potential negative impacts of this information on the therapeutic relationship, including possible early termination. Furthermore, this information may impact a patient’s willingness to disclose all relevant information to mental health treatment if there is concern for later court disclosure. How should you balance these concerns? First, encourage patients to ask questions and raise concerns about confidentiality and privilege.¹² In addition, you may direct the patient to other resources, such as a family law attorney, if they have questions about how certain information may be used in a legal proceeding.

Continue to: Second, you should be...

Second, you should be transparent regarding documentation of psychiatric visits. While documentation must meet ethical, legal, and billing requirements, you should take care to include only relevant information needed to make a diagnosis and provide indicated treatment while maintaining a neutral tone and avoiding medical jargon.¹³ For instance, we frequently use the term “denied” in medical documentation, as in “Mr. X denied cough, sore throat, fever or chills.” However, in psychiatric notes, if a patient “denied alcohol use,” the colloquial interpretation of this word could imply a tone of distrust toward the patient. A more sensitive way to document this might be: “When screened, reported no alcohol use.” If a patient divulges information and then asks you to omit this from their chart, but you do not feel comfortable doing so, explain what and why you must include the information in the chart.¹⁴

Third, if you receive a subpoena or other document requesting privileged information, first contact the patient and inform them of the request, and then seek legal consultation through your employer or malpractice insurer.¹⁵ Not all subpoenas are valid and enforceable, so it is important for an attorney to examine the subpoena; in addition, the patient’s attorney may choose to challenge the subpoena and limit the disclosure of privileged information.

Finally, inform legislatures and courts about the potential harm of automatic waivers in custody proceedings. A judge’s examination of the psychiatric records, as in Friedenberg, is not an adequate safeguard. A judge is not a trained mental health professional and may deem “relevant” information to be nearly everything: a history of abuse, remote drug or alcohol use, disclosure of a past crime, or financial troubles. We advocate for courts to follow the Maryland model, where a spouse does not automatically waive privilege if filing for divorce or custody. If mental health becomes an issue in a case, then the court may seek an independent psychiatric examination. The independent examiner will have access to patient records but will be in a better position to determine which details are relevant in determining diagnosis and parental fitness, and to render an opinion to the court.

CASE CONTINUED

You inform Mrs. W about a possible exception to privilege in divorce and custody cases. She decides to first talk with a family law attorney before proceeding with treatment. You defer your diagnosis and wait to see if she wants to proceed with treatment. Unfortunately, she does not return to your office.

Bottom Line

Some states limit the confidentiality and privilege of parents who are in psychiatric treatment and also involved in divorce and child custody cases. Psychiatrists should be mindful of these exceptions, and discuss them with patients at the onset of treatment.

Related Resources

• Legal Information Institute. Child custody: an overview. www.law.cornell.edu/wex/child_custody
• Melton GB, Petrila J, Poythress NG, et al. Child custody in divorce. In: Melton GB, Petrila J, Poythress NG, et al. Psychological evaluations for the courts. Guilford Press; 2018:530-533.

Mrs. W, age 35, presents to your clinic seeking treatment for anxiety and depression. She has no psychiatric history but reports feeling sad, overwhelmed, and stressed. Mrs. W has been married for 10 years, has 2 young children, and is currently pregnant. She recently discovered that her husband has been having an affair. Mrs. W tells you that she feels her marriage is unsalvageable and would like to ask her husband for a divorce, but worries that he will “put up a fight” and demand full custody of their children. When you ask why, she states that her husband is “pretty narcissistic” and tends to become combative when criticized or threatened, such as a recent discussion they had about his affair that ended with him concluding that if she were “sexier and more confident” he would not have cheated on her.

As Mrs. W is talking, you recall a conversation you recently overheard at a continuing medical education event. Two clinicians were discussing how their records had been subpoenaed in a child custody case, even though the patient’s mental health was not contested. You realize that Mrs. W’s situation may also fit under this exception to confidentiality or privilege. You wonder if you should have disclosed this possibility to her at the outset of your session and wonder what you should say now, because she is clearly in distress and in need of psychiatric treatment. On the other hand, you want her to be fully informed of the potential repercussions if she continues with treatment.

Confidentiality and privilege allow our patients to disclose sensitive details in a safe space. The psychiatrist’s duty is to keep the patient’s information confidential, except in limited circumstances. The patient’s privilege is their right to prevent someone in a special confidential relationship from testifying against them or releasing their private records. In certain instances, a patient may waive or be forced to waive privilege, and a psychiatrist may be compelled to testify or release treatment records to a court. This article reviews exceptions to confidentiality and privilege, focusing specifically on a little-known exception to privilege that arises in divorce and child custody cases. We discuss relevant legislation and provide recommendations for psychiatrists to better understand how to discuss these legal realities with patients who are or may go through a divorce or child custody case.

Understanding confidentiality and privilege

Confidentiality and privilege are related but distinct concepts. Confidentiality relates to the overall trusting relationship created between 2 parties, such as a physician and their patient, and the duty on the part of the trusted individual to keep information private. Privilege refers to a person’s specific legal right to prevent someone in that confidential, trusting relationship from testifying against them in court or releasing confidential records. Privilege is owned by the patient and must be asserted or waived by the patient in legal proceedings. The concepts of confidentiality and privilege are crucial in creating an open, candid therapeutic environment. Many courts, including the US Supreme Court,¹ have recognized the importance of confidentiality and privilege in establishing a positive therapeutic relationship between a psychotherapist and a patient. Without confidentiality and privilege, patients would be less likely to share sensitive yet clinically important information.

Commonly encountered exceptions to confidentiality (Table 1²) and privilege (Table 2) exist in medical practice. Psychiatrists should discuss these exceptions with patients at the outset of clinical treatment. A little-known exception to privilege that may compel a psychiatrist to disclose confidential records can occur in child custody proceedings. In certain states, the mere filing of a child custody claim constitutes an exception to physician-patient privilege. In these states, the parent filing for divorce and custody may automatically waive privilege and thus compel disclosure of psychiatric records, even if their mental health is not in question. The following recent Ohio Supreme Court case illustrates this exception.

Friedenberg v Friedenberg (2020)

Friedenberg v Friedenberg³ addressed the issue of privilege and release of mental health treatment records in custody disputes. Belinda Torres Friedenberg and Keith Friedenberg were married with 4 minor children. Mrs. Friedenberg filed for divorce in 2016, requesting custody of the children and spousal support. In response, Mr. Friedenberg also filed a complaint seeking custody. Mr. Friedenberg subpoenaed mental health treatment records for Mrs. Friedenberg, who responded by filing a request to prevent the release of these records given physician-patient privilege. Mr. Friedenberg argued that Mrs. Friedenberg had placed her physical and mental health at issue when she filed for divorce and custody. At no point did Mr. Friedenberg allege that Mrs. Friedenberg’s mental health made her an unfit parent. The court agreed with Mr. Friedenberg and compelled disclosure of Mrs. Friedenberg’s psychiatric records, stating it is “hard to imagine a scenario where the mental health records of a parent would not be relevant to issues around custody and the best interests of the children.” The judge reviewed Mrs. Friedenberg’s psychiatric records privately and released records deemed relevant to the custody proceedings. On appeal, the Ohio Supreme Court agreed with this approach, holding that a parent’s mental fitness is always an issue in child custody cases, even if not asserted by either party. The court further held that unnecessary disclosure of sensitive information was prevented by the judge’s private review of records before deciding which records to release to the opposing spouse.

Waiver of physician-patient privilege

Waiver of physician-patient privilege in custody and divorce proceedings varies by state (Table 3^3-6). The Friedenberg decision highlights the most restrictive approach, where the mere filing of a divorce and child custody request automatically waives privilege. Some states, such as Indiana,⁴ follow a similar scheme to Ohio. Other states are silent on this issue or explicitly prohibit a waiver of privilege, asserting that custody disputes alone do not trigger disclosure without additional justifications, such as aberrant parental behaviors or other historical information concerning for abuse, neglect, or lack of parental fitness, or if a parent places their mental health at issue.⁷

Continue to: Once privilege is waived...

Once privilege is waived, the next step is to determine who should examine psychiatric records, deem relevance, and disclose sensitive information to the court and the opposing party. A judge may make this determination, as in the Friedenberg case. Alternatively, an independent psychiatric examiner may be appointed by the court to examine one or both parties; to obtain collateral information, including psychiatric records; and to submit a report to the court with medicolegal opinions regarding parental fitness. For example, in Maryland,⁶ the mere filing of a custody suit does not waive privilege. If a parent’s mental health is questioned, the judge may order an independent psychiatric examination to determine the parent’s fitness, thus balancing the best interests of the child with the parent’s right to physician-patient privilege.

The problem with automatic waivers

The foundation of the physician-patient relationship is trust and confidentiality. While this holds true for every specialty, perhaps it is even more important in psychiatry, where our patients routinely disclose sensitive, personal information in hopes of healing. Patients may not be aware of exceptions to confidentiality, or only be aware of the most well-known exceptions, such as the clinician’s duty to report abuse, or to warn a third party about risk of harm by a patient. Furthermore, clinicians and patients alike may not be aware of less-common exceptions to privilege, such as those that may occur in custody proceedings. This is critically important in light of the high number of patients who are or may be seeking divorce and custody of their children.

As psychiatric clinicians, it is highly likely that we will see patients going through divorce and custody proceedings. In 2018, there were 2.24 marriages for every divorce,⁸ and in 2014, 27% of all American children were living with a custodial parent, with the other parent living elsewhere.⁹ Divorce can be a profoundly stressful time; thus, it would be expected that many individuals going through divorce would seek psychiatric treatment and support.

Our concern is that the Friedenberg approach, which results in automatic disclosure of sensitive mental health information when a party files for divorce and custody, could deter patients from seeking psychiatric treatment, especially those anticipating divorce. Importantly, because women are nearly twice as likely as men to experience depression and anxiety¹⁰ and are more likely to seek treatment, this approach could disproportionately impact them.¹¹ In general, an automatic waiver policy may create an additional obstacle for individuals who are already reticent to seek treatment.

How to handle these situations

As a psychiatrist, you should be familiar with your state’s laws regarding exceptions to patient-physician privilege, and should discuss exceptions at the outset of treatment. However, you will need to weigh the potential negative impacts of this information on the therapeutic relationship, including possible early termination. Furthermore, this information may impact a patient’s willingness to disclose all relevant information to mental health treatment if there is concern for later court disclosure. How should you balance these concerns? First, encourage patients to ask questions and raise concerns about confidentiality and privilege.¹² In addition, you may direct the patient to other resources, such as a family law attorney, if they have questions about how certain information may be used in a legal proceeding.

Continue to: Second, you should be...

Second, you should be transparent regarding documentation of psychiatric visits. While documentation must meet ethical, legal, and billing requirements, you should take care to include only relevant information needed to make a diagnosis and provide indicated treatment while maintaining a neutral tone and avoiding medical jargon.¹³ For instance, we frequently use the term “denied” in medical documentation, as in “Mr. X denied cough, sore throat, fever or chills.” However, in psychiatric notes, if a patient “denied alcohol use,” the colloquial interpretation of this word could imply a tone of distrust toward the patient. A more sensitive way to document this might be: “When screened, reported no alcohol use.” If a patient divulges information and then asks you to omit this from their chart, but you do not feel comfortable doing so, explain what and why you must include the information in the chart.¹⁴

Third, if you receive a subpoena or other document requesting privileged information, first contact the patient and inform them of the request, and then seek legal consultation through your employer or malpractice insurer.¹⁵ Not all subpoenas are valid and enforceable, so it is important for an attorney to examine the subpoena; in addition, the patient’s attorney may choose to challenge the subpoena and limit the disclosure of privileged information.

Finally, inform legislatures and courts about the potential harm of automatic waivers in custody proceedings. A judge’s examination of the psychiatric records, as in Friedenberg, is not an adequate safeguard. A judge is not a trained mental health professional and may deem “relevant” information to be nearly everything: a history of abuse, remote drug or alcohol use, disclosure of a past crime, or financial troubles. We advocate for courts to follow the Maryland model, where a spouse does not automatically waive privilege if filing for divorce or custody. If mental health becomes an issue in a case, then the court may seek an independent psychiatric examination. The independent examiner will have access to patient records but will be in a better position to determine which details are relevant in determining diagnosis and parental fitness, and to render an opinion to the court.

CASE CONTINUED

You inform Mrs. W about a possible exception to privilege in divorce and custody cases. She decides to first talk with a family law attorney before proceeding with treatment. You defer your diagnosis and wait to see if she wants to proceed with treatment. Unfortunately, she does not return to your office.

Bottom Line

Some states limit the confidentiality and privilege of parents who are in psychiatric treatment and also involved in divorce and child custody cases. Psychiatrists should be mindful of these exceptions, and discuss them with patients at the onset of treatment.

Related Resources

• Legal Information Institute. Child custody: an overview. www.law.cornell.edu/wex/child_custody
• Melton GB, Petrila J, Poythress NG, et al. Child custody in divorce. In: Melton GB, Petrila J, Poythress NG, et al. Psychological evaluations for the courts. Guilford Press; 2018:530-533.

Many physicians have seen advertisements that encourage women who took an antidepressant while they were pregnant and had a negative outcome to contact a law firm. These ads could make patients more reluctant to take prescribed antidepressants, and psychiatrists more hesitant to prescribe necessary medications during pregnancy—which is a disservice to the mother and child.

More recently, several headline-grabbing studies appeared to suggest that there is an increased risk to infants who are exposed to antidepressants prenatally. Unfortunately, many patients do not understand that replication of these studies is often lacking, and methodological and confounding issues abound. All of this makes it difficult for patients and their families to know if they should take an antidepressant during pregnancy, and for psychiatrists to know what to discuss about the risks and benefits of various antidepressants during pregnancy. This article reviews the rationale for treatment of depression in pregnancy; the risks of untreated depression in pregnancy, as well as the potential risks of medication; ethical issues in the treatment of depression in pregnancy; the limitations of available research; and best approaches for practice.

Risks of untreated depression in pregnancy

Pregnant women may have misconceptions about treatment during pregnancy, and psychiatrists often are hesitant to treat pregnant women. However, the risks of untreated depression during pregnancy are even greater than the risks of untreated depression at other points in a woman’s life. In addition to general psychiatric risks seen in depression, pregnant women may experience other issues, such as preeclampsia and liver metabolism changes.^1-2 Risks to the fetus related to untreated or partially treated mental health concerns include poor prenatal care related to poor self-care, an increased risk of exposure to illicit substances or alcohol related to “self-medication,” preterm delivery, and low birthweight (Table 1^3-8). Further risks for an infant of a mother with untreated depression include decreased cognitive performance and poor bonding with poor stress adaptation.^5,6 Thus, appropriate treatment of depression is even more important during pregnancy than at other times of life.

Potential risks of treating depression in pregnancy

When prescribing psychotropic medications to a pregnant woman, there are several naturally occurring adverse outcomes to consider. For example, miscarriages, stillbirths, and congenital malformations can occur without explanation in the general population. In addition, also consider the specific health history of the mother and the available research literature regarding the specific psychotropic agent (keeping in mind that there are ethical issues associated with conducting prospective research in pregnant women, such as it being unethical to withhold treatment to pregnant women who are depressed in order to have a control group, and that retrospective research is often confounded by recall bias). Potential risks to be aware of include miscarriage (spontaneous abortion), malformation (teratogenesis, birth defects), preterm delivery, neonatal adaptation syndrome, and behavioral teratogenesis (Table 1^3-8).

Selective serotonin reuptake inhibitors (SSRIs), the usual medication treatment of choice for depression, have at times been implicated in adverse pregnancy outcomes, but no strong evidence suggests they increase the miscarriage rate. Overall data are reassuring regarding the risk of malformation associated with SSRI use. Of note, the FDA had switched paroxetine from a Class C drug to a Class D drug after early reports of a potential 1.5% to 2% risk of fetal cardiac malformations compared with a 1% baseline risk in the general population (these FDA pregnancy risk letter categories have since been phased out).^9,10 Nevertheless, the absolute risk remains small. Another large study found that there was no substantial increased risk of cardiac malformations attributable to antidepressant use during the first trimester.¹¹

Lessons from a class action suit

Since we last reviewed pregnancy and antidepressants in 2013,⁸ several class action lawsuits against the manufacturers of psychotropic medications have been heard. Product liability actions brought against manufacturers are different from medical malpractice suits brought against individual physicians, which may result from lack of informed consent, suicide, or homicide.

One of the largest class action suits was against Zoloft (specifically Zoloft and Pfizer, since the brand manufacturer is responsible for the product insert information.)^12,13 At the time, sertraline was already commonly prescribed due to the relatively safe reproductive profile.

Continue to: Many of the more than 300...

Many of the more than 300 federal claims were united in a multi-district litigation (MDL) suit under the United States District Court of Eastern Pennsylvania (MDL 2342). Pfizer issued Daubert challenges (efforts to exclude the introduction of “junk science” into the courtroom) against the plaintiffs’ experts’ scientific methods and results.^12,13 The plaintiffs (those suing Pfizer) had to prove that the medications caused the negative outcome, not that they were merely temporally associated. Subsequently, 2 plaintiff experts—a PharmD and a biostatistician—were removed. Pfizer successfully challenged the methodological soundness of the plaintiffs’ experts’ testimony (Table 2^12,13), and the case was dismissed. In general, the courts identified the Bradford Hill criteria as often being important (though not definitive) methodology for determining causation (Table 3^12,13).

A concept raised in prior psychotropic lawsuits was the “learned intermediary doctrine,” in which pharmaceutical companies stated that once a risk is known, it is the responsibility of the prescribing physician to assess risks vs benefits and inform the patient.⁸ Many aspects of the larger class action lawsuits related to failure of the company to do adequate research to identify risks and appropriately inform the public and the medical community of these risks.¹⁴

Challenges in interpreting the literature

Some of the difficulties in interpreting the literature on the association of antidepressants and birth defects can be seen in a 2020 study by Anderson et al.¹⁵ This study was published in JAMA Psychiatry, received widespread coverage in the media, and was discussed on the CDC’s website.¹⁶ Anderson et al¹⁵ compared a large cohort of 30,630 infants with birth defects from the multicenter case-control National Birth Defects Prevention Study with 11,478 randomly selected controls with no defects. Three primary study groups were women whose pregnancies resulted in:

• birth defects with no antidepressant exposure (n = 28,719)
• birth defects with exposure to an antidepressant (n = 1,911)
• no birth defect control group (n = 10,886 no antidepressant exposure, n = 592 antidepressant exposure).

This study reported there were “some associations between maternal antidepressant use and specific birth defects” and “Venlafaxine was associated with more birth defects than other antidepressants, which needs confirmation.”¹⁵ However, in an accompanying editorial, Wisner et al¹⁷ discussed potential problems and limitations with this study and research of this nature in general (Table 4¹⁷). In addition, Anderson et al¹⁵ used certain “controversial” statistical practices.¹⁸ For example, “[T]o align with American Statistical Association guidelines to consider effect sizes when interpreting results instead of statistical significance, we noted associations as meaningfully elevated if [adjusted odds ratios] were 2.0 or greater and lower confidence interval bounds were 0.8 or greater.”¹⁵

Those who read only abstracts or news stories may believe this study of >40,000 participants included a large number of women who were receiving venlafaxine. However, the number of pregnant women who were prescribed venlafaxine was actually very small—112 who took venlafaxine experienced a birth defect. In addition, the authors noted “Venlafaxine was associated with many of the same defects across the samples (data not shown).”¹⁵ As discussed above, historically one of the areas the courts have considered was whether or not appropriate methodology was applied, and whether the results could be replicated with the data provided.

Continue to: Further, new studies...

Further, new studies need to be considered in context of the literature as a whole and collective clinical experience. A recent systematic review found that among 3,186 infants exposed to venlafaxine during the first trimester, there were 107 major malformations.¹⁹ This indicated a relative risk estimate of 1.12, with a 95% CI of 0.92 to 1.35. The authors concluded that venlafaxine exposure in the first trimester was not associated with an increased risk of malformations.

Expectant parents may come across a headline that implies a specific antidepressant causes problems, but have not read the study or know how to interpret it. Often it is best for a physician to find out what the basis of the concern is, and if possible, review the study with the patient to make sure it is in the right context, and if it applies to the individual patient’s situation.

Consider the ethical issues

In addition to preventive ethics, other critical ethical issues in pregnancy include omission bias, beneficence, and autonomy.^4,20-24 Omission bias occurs when physicians are more concerned about acts of commission (in which treatment leads to a negative outcome) than they are about acts of omission, which involve not treating the patient’s illness. To address this, it is important to discuss with the patient both the risks of treating and the risks of not treating maternal depression, so that the mother can make the best decision for her own specific set of circumstances.

Regarding beneficence (promoting the patient’s best interest), consider both the mother’s and the infant’s best interest, which usually are quite closely related. Women may feel guilty about taking a medication that they perceive is harmful for the fetus but good for their own mental health. Physicians can help with this by providing education about the benefits of treating depression for the fetus’ benefit as well. The fetus is completely dependent on the environment that the mother places them in, not merely the medication effects (eg, psychologic/physiologic stress effects, poor diet, lack of exercise, risk of “self-medication”).

Regarding autonomy (a woman’s own decision-making), Coverdale et al²¹ discussed strategies that can enhance a pregnant patient’s autonomy—including discussing treatment options and counselling about the effects of depression itself in pregnancy, as well as considering the effects of depression on the process of decision-making. For example, a woman with depression may see the world through a negative lens or may have difficulty concentrating. Patients may also require education about the concept of relative risk in comparison to absolute risk—especially in light of attention-grabbing headlines.

Continue to: Finally, as part of...

Finally, as part of preventative ethics, anticipate the ethical dilemmas before the common situation of pregnancy. Almost one-half of pregnancies are unplanned.²⁵ Many women thus expose their fetus to medication during the critical early period of organogenesis, before noticing they were pregnant. Therefore, even if a patient of childbearing age insists that she is not sexually active, the prudent psychiatrist should still begin discussions about medications in pregnancy.

An outline of best practices

Best practice includes preventive ethics, and when treating any woman of childbearing age, psychiatrists should consider prescribing medications that are known to be relatively safe in pregnancy rather than risky in pregnancy. Therefore, any psychiatrist whose practice includes women of childbearing age should have a working knowledge of which agents are relatively safe in pregnancy. After a woman is pregnant, careful decision-making about medication should continue. Consult with reproductive psychiatry colleagues where necessary.

A patient with depression would usually merit closer follow-up during the pregnancy. In some cases, psychotherapy alone can be effective in depression. However, approximately 6% to 13% of women are prescribed antidepressants during pregnancy, and this has been increasing.²⁶ Women who discontinue their antidepressant while pregnant are more likely to relapse than those who continue their medication,²⁷ thus exposing their fetus to negative effects of depression as well as medication (prior to discontinuation).

When possible, monotherapy (one agent) in the lowest effective dose is often the judicious approach to treatment. For a patient prescribed pre-existing polypharmacy at time of pregnancy, a risk-benefit analysis of which medications should remain, which should be stopped, and a plan for taper, if needed, should be discussed and documented. Using too little of an antidepressant dose would expose the fetus to both depression and medication, whereas using a maximum dose when not needed would expose the fetus to more medication than is necessary to treat the mother’s symptoms. This discussion with the mother (and her partner, if available) should be documented in the chart. The mother should understand both the risk of untreated illness and the potential risks of medications, as well as the benefits of medications and alternatives. It is important for the mother to realize that there is no risk-free option, and that malformations can occur in the general population as well as in individuals with untreated depression, separate from any medication exposure. In fact, most malformations do not have a known cause, and overall approximately 3% of pregnancies result in a birth defect.²⁸

If possible, discuss the treatment plan with the patient’s obstetrician, or ask the mother to discuss the plan with her obstetrician, so that everyone is on the same page. This discussion can help attenuate patient anxiety that results from hearing different things from different clinicians. Communication with other treating professionals (eg, OB/GYNs, pediatricians) can be beneficial and reduce liability if multiple physicians have agreed on a treatment plan—even if there is a negative outcome. With malpractice, a clinician is not necessarily at fault for a bad outcome or adverse effect, but is at fault for lack of informed consent or negligence (deviation from standard of care), which is harder for an attorney to demonstrate if there is deliberation, communication, and a plan that multiple doctors agree upon.

Continue to: Be aware that informed consent...

Be aware that informed consent is an ongoing process, and a woman may need to be reminded or informed of potential risks at varying stages of her life (eg, when starting a new relationship, getting married, etc.). Documentation can include that the clinician has discussed the risks, benefits, adverse effects, and alternatives of various medications, and a description of any patient-specific or medication-specific issues. In addition to verbal discussions, giving patients printed information can be helpful, as can directing them to appropriate websites (see Related Resources). Some physicians require patients to sign a form to indicate that they are aware of known risks.

Similar to being proactive before your patient becomes pregnant, think proactively regarding the postpartum period. Is your patient planning to breastfeed? Is the medication compatible with breastfeeding, or is bottle feeding the best option considering the mother’s specific circumstances? For example, developing severe symptoms, experiencing insomnia, needing to take a contraindicated medication, or having a vulnerable infant might sway a mother towards not breastfeeding. The expectant mother (and her partner, where possible) should be educated about postpartum risks and the importance of sleep in preventing postpartum depression.

Bottom Line

Concerns about being sued should not prevent appropriate care of depression in a woman who is pregnant. Discuss with your patient both the risk of untreated mental illness and the risk of medications to ensure she understands that avoiding antidepressants does not guarantee a safe or healthy pregnancy.

Related Resources

• MotherToBaby. www.mothertobaby.org/
• Centers for Disease Control and Prevention. Treating for two: medicine and pregnancy. www.cdc.gov/pregnancy/meds/treatingfortwo/index.html
• MGH Center for Women’s Mental Health. Reproductive psychiatry resource and information center. www.womensmentalhealth.org/

Drug Brand Names

Paroxetine • Paxil
Sertraline • Zoloft
Venlafaxine • Effexor

Many physicians have seen advertisements that encourage women who took an antidepressant while they were pregnant and had a negative outcome to contact a law firm. These ads could make patients more reluctant to take prescribed antidepressants, and psychiatrists more hesitant to prescribe necessary medications during pregnancy—which is a disservice to the mother and child.

More recently, several headline-grabbing studies appeared to suggest that there is an increased risk to infants who are exposed to antidepressants prenatally. Unfortunately, many patients do not understand that replication of these studies is often lacking, and methodological and confounding issues abound. All of this makes it difficult for patients and their families to know if they should take an antidepressant during pregnancy, and for psychiatrists to know what to discuss about the risks and benefits of various antidepressants during pregnancy. This article reviews the rationale for treatment of depression in pregnancy; the risks of untreated depression in pregnancy, as well as the potential risks of medication; ethical issues in the treatment of depression in pregnancy; the limitations of available research; and best approaches for practice.

Risks of untreated depression in pregnancy

Pregnant women may have misconceptions about treatment during pregnancy, and psychiatrists often are hesitant to treat pregnant women. However, the risks of untreated depression during pregnancy are even greater than the risks of untreated depression at other points in a woman’s life. In addition to general psychiatric risks seen in depression, pregnant women may experience other issues, such as preeclampsia and liver metabolism changes.^1-2 Risks to the fetus related to untreated or partially treated mental health concerns include poor prenatal care related to poor self-care, an increased risk of exposure to illicit substances or alcohol related to “self-medication,” preterm delivery, and low birthweight (Table 1^3-8). Further risks for an infant of a mother with untreated depression include decreased cognitive performance and poor bonding with poor stress adaptation.^5,6 Thus, appropriate treatment of depression is even more important during pregnancy than at other times of life.

Potential risks of treating depression in pregnancy

When prescribing psychotropic medications to a pregnant woman, there are several naturally occurring adverse outcomes to consider. For example, miscarriages, stillbirths, and congenital malformations can occur without explanation in the general population. In addition, also consider the specific health history of the mother and the available research literature regarding the specific psychotropic agent (keeping in mind that there are ethical issues associated with conducting prospective research in pregnant women, such as it being unethical to withhold treatment to pregnant women who are depressed in order to have a control group, and that retrospective research is often confounded by recall bias). Potential risks to be aware of include miscarriage (spontaneous abortion), malformation (teratogenesis, birth defects), preterm delivery, neonatal adaptation syndrome, and behavioral teratogenesis (Table 1^3-8).

Selective serotonin reuptake inhibitors (SSRIs), the usual medication treatment of choice for depression, have at times been implicated in adverse pregnancy outcomes, but no strong evidence suggests they increase the miscarriage rate. Overall data are reassuring regarding the risk of malformation associated with SSRI use. Of note, the FDA had switched paroxetine from a Class C drug to a Class D drug after early reports of a potential 1.5% to 2% risk of fetal cardiac malformations compared with a 1% baseline risk in the general population (these FDA pregnancy risk letter categories have since been phased out).^9,10 Nevertheless, the absolute risk remains small. Another large study found that there was no substantial increased risk of cardiac malformations attributable to antidepressant use during the first trimester.¹¹

Lessons from a class action suit

Since we last reviewed pregnancy and antidepressants in 2013,⁸ several class action lawsuits against the manufacturers of psychotropic medications have been heard. Product liability actions brought against manufacturers are different from medical malpractice suits brought against individual physicians, which may result from lack of informed consent, suicide, or homicide.

One of the largest class action suits was against Zoloft (specifically Zoloft and Pfizer, since the brand manufacturer is responsible for the product insert information.)^12,13 At the time, sertraline was already commonly prescribed due to the relatively safe reproductive profile.

Continue to: Many of the more than 300...

Many of the more than 300 federal claims were united in a multi-district litigation (MDL) suit under the United States District Court of Eastern Pennsylvania (MDL 2342). Pfizer issued Daubert challenges (efforts to exclude the introduction of “junk science” into the courtroom) against the plaintiffs’ experts’ scientific methods and results.^12,13 The plaintiffs (those suing Pfizer) had to prove that the medications caused the negative outcome, not that they were merely temporally associated. Subsequently, 2 plaintiff experts—a PharmD and a biostatistician—were removed. Pfizer successfully challenged the methodological soundness of the plaintiffs’ experts’ testimony (Table 2^12,13), and the case was dismissed. In general, the courts identified the Bradford Hill criteria as often being important (though not definitive) methodology for determining causation (Table 3^12,13).

A concept raised in prior psychotropic lawsuits was the “learned intermediary doctrine,” in which pharmaceutical companies stated that once a risk is known, it is the responsibility of the prescribing physician to assess risks vs benefits and inform the patient.⁸ Many aspects of the larger class action lawsuits related to failure of the company to do adequate research to identify risks and appropriately inform the public and the medical community of these risks.¹⁴

Challenges in interpreting the literature

Some of the difficulties in interpreting the literature on the association of antidepressants and birth defects can be seen in a 2020 study by Anderson et al.¹⁵ This study was published in JAMA Psychiatry, received widespread coverage in the media, and was discussed on the CDC’s website.¹⁶ Anderson et al¹⁵ compared a large cohort of 30,630 infants with birth defects from the multicenter case-control National Birth Defects Prevention Study with 11,478 randomly selected controls with no defects. Three primary study groups were women whose pregnancies resulted in:

• birth defects with no antidepressant exposure (n = 28,719)
• birth defects with exposure to an antidepressant (n = 1,911)
• no birth defect control group (n = 10,886 no antidepressant exposure, n = 592 antidepressant exposure).

This study reported there were “some associations between maternal antidepressant use and specific birth defects” and “Venlafaxine was associated with more birth defects than other antidepressants, which needs confirmation.”¹⁵ However, in an accompanying editorial, Wisner et al¹⁷ discussed potential problems and limitations with this study and research of this nature in general (Table 4¹⁷). In addition, Anderson et al¹⁵ used certain “controversial” statistical practices.¹⁸ For example, “[T]o align with American Statistical Association guidelines to consider effect sizes when interpreting results instead of statistical significance, we noted associations as meaningfully elevated if [adjusted odds ratios] were 2.0 or greater and lower confidence interval bounds were 0.8 or greater.”¹⁵

Those who read only abstracts or news stories may believe this study of >40,000 participants included a large number of women who were receiving venlafaxine. However, the number of pregnant women who were prescribed venlafaxine was actually very small—112 who took venlafaxine experienced a birth defect. In addition, the authors noted “Venlafaxine was associated with many of the same defects across the samples (data not shown).”¹⁵ As discussed above, historically one of the areas the courts have considered was whether or not appropriate methodology was applied, and whether the results could be replicated with the data provided.

Continue to: Further, new studies...

Further, new studies need to be considered in context of the literature as a whole and collective clinical experience. A recent systematic review found that among 3,186 infants exposed to venlafaxine during the first trimester, there were 107 major malformations.¹⁹ This indicated a relative risk estimate of 1.12, with a 95% CI of 0.92 to 1.35. The authors concluded that venlafaxine exposure in the first trimester was not associated with an increased risk of malformations.

Expectant parents may come across a headline that implies a specific antidepressant causes problems, but have not read the study or know how to interpret it. Often it is best for a physician to find out what the basis of the concern is, and if possible, review the study with the patient to make sure it is in the right context, and if it applies to the individual patient’s situation.

Consider the ethical issues

In addition to preventive ethics, other critical ethical issues in pregnancy include omission bias, beneficence, and autonomy.^4,20-24 Omission bias occurs when physicians are more concerned about acts of commission (in which treatment leads to a negative outcome) than they are about acts of omission, which involve not treating the patient’s illness. To address this, it is important to discuss with the patient both the risks of treating and the risks of not treating maternal depression, so that the mother can make the best decision for her own specific set of circumstances.

Regarding beneficence (promoting the patient’s best interest), consider both the mother’s and the infant’s best interest, which usually are quite closely related. Women may feel guilty about taking a medication that they perceive is harmful for the fetus but good for their own mental health. Physicians can help with this by providing education about the benefits of treating depression for the fetus’ benefit as well. The fetus is completely dependent on the environment that the mother places them in, not merely the medication effects (eg, psychologic/physiologic stress effects, poor diet, lack of exercise, risk of “self-medication”).

Regarding autonomy (a woman’s own decision-making), Coverdale et al²¹ discussed strategies that can enhance a pregnant patient’s autonomy—including discussing treatment options and counselling about the effects of depression itself in pregnancy, as well as considering the effects of depression on the process of decision-making. For example, a woman with depression may see the world through a negative lens or may have difficulty concentrating. Patients may also require education about the concept of relative risk in comparison to absolute risk—especially in light of attention-grabbing headlines.

Continue to: Finally, as part of...

Finally, as part of preventative ethics, anticipate the ethical dilemmas before the common situation of pregnancy. Almost one-half of pregnancies are unplanned.²⁵ Many women thus expose their fetus to medication during the critical early period of organogenesis, before noticing they were pregnant. Therefore, even if a patient of childbearing age insists that she is not sexually active, the prudent psychiatrist should still begin discussions about medications in pregnancy.

An outline of best practices

Best practice includes preventive ethics, and when treating any woman of childbearing age, psychiatrists should consider prescribing medications that are known to be relatively safe in pregnancy rather than risky in pregnancy. Therefore, any psychiatrist whose practice includes women of childbearing age should have a working knowledge of which agents are relatively safe in pregnancy. After a woman is pregnant, careful decision-making about medication should continue. Consult with reproductive psychiatry colleagues where necessary.

A patient with depression would usually merit closer follow-up during the pregnancy. In some cases, psychotherapy alone can be effective in depression. However, approximately 6% to 13% of women are prescribed antidepressants during pregnancy, and this has been increasing.²⁶ Women who discontinue their antidepressant while pregnant are more likely to relapse than those who continue their medication,²⁷ thus exposing their fetus to negative effects of depression as well as medication (prior to discontinuation).

When possible, monotherapy (one agent) in the lowest effective dose is often the judicious approach to treatment. For a patient prescribed pre-existing polypharmacy at time of pregnancy, a risk-benefit analysis of which medications should remain, which should be stopped, and a plan for taper, if needed, should be discussed and documented. Using too little of an antidepressant dose would expose the fetus to both depression and medication, whereas using a maximum dose when not needed would expose the fetus to more medication than is necessary to treat the mother’s symptoms. This discussion with the mother (and her partner, if available) should be documented in the chart. The mother should understand both the risk of untreated illness and the potential risks of medications, as well as the benefits of medications and alternatives. It is important for the mother to realize that there is no risk-free option, and that malformations can occur in the general population as well as in individuals with untreated depression, separate from any medication exposure. In fact, most malformations do not have a known cause, and overall approximately 3% of pregnancies result in a birth defect.²⁸

If possible, discuss the treatment plan with the patient’s obstetrician, or ask the mother to discuss the plan with her obstetrician, so that everyone is on the same page. This discussion can help attenuate patient anxiety that results from hearing different things from different clinicians. Communication with other treating professionals (eg, OB/GYNs, pediatricians) can be beneficial and reduce liability if multiple physicians have agreed on a treatment plan—even if there is a negative outcome. With malpractice, a clinician is not necessarily at fault for a bad outcome or adverse effect, but is at fault for lack of informed consent or negligence (deviation from standard of care), which is harder for an attorney to demonstrate if there is deliberation, communication, and a plan that multiple doctors agree upon.

Continue to: Be aware that informed consent...

Be aware that informed consent is an ongoing process, and a woman may need to be reminded or informed of potential risks at varying stages of her life (eg, when starting a new relationship, getting married, etc.). Documentation can include that the clinician has discussed the risks, benefits, adverse effects, and alternatives of various medications, and a description of any patient-specific or medication-specific issues. In addition to verbal discussions, giving patients printed information can be helpful, as can directing them to appropriate websites (see Related Resources). Some physicians require patients to sign a form to indicate that they are aware of known risks.

Similar to being proactive before your patient becomes pregnant, think proactively regarding the postpartum period. Is your patient planning to breastfeed? Is the medication compatible with breastfeeding, or is bottle feeding the best option considering the mother’s specific circumstances? For example, developing severe symptoms, experiencing insomnia, needing to take a contraindicated medication, or having a vulnerable infant might sway a mother towards not breastfeeding. The expectant mother (and her partner, where possible) should be educated about postpartum risks and the importance of sleep in preventing postpartum depression.

Bottom Line

Concerns about being sued should not prevent appropriate care of depression in a woman who is pregnant. Discuss with your patient both the risk of untreated mental illness and the risk of medications to ensure she understands that avoiding antidepressants does not guarantee a safe or healthy pregnancy.

Related Resources

• MotherToBaby. www.mothertobaby.org/
• Centers for Disease Control and Prevention. Treating for two: medicine and pregnancy. www.cdc.gov/pregnancy/meds/treatingfortwo/index.html
• MGH Center for Women’s Mental Health. Reproductive psychiatry resource and information center. www.womensmentalhealth.org/

Drug Brand Names

Paroxetine • Paxil
Sertraline • Zoloft
Venlafaxine • Effexor

Many physicians have seen advertisements that encourage women who took an antidepressant while they were pregnant and had a negative outcome to contact a law firm. These ads could make patients more reluctant to take prescribed antidepressants, and psychiatrists more hesitant to prescribe necessary medications during pregnancy—which is a disservice to the mother and child.

More recently, several headline-grabbing studies appeared to suggest that there is an increased risk to infants who are exposed to antidepressants prenatally. Unfortunately, many patients do not understand that replication of these studies is often lacking, and methodological and confounding issues abound. All of this makes it difficult for patients and their families to know if they should take an antidepressant during pregnancy, and for psychiatrists to know what to discuss about the risks and benefits of various antidepressants during pregnancy. This article reviews the rationale for treatment of depression in pregnancy; the risks of untreated depression in pregnancy, as well as the potential risks of medication; ethical issues in the treatment of depression in pregnancy; the limitations of available research; and best approaches for practice.

Risks of untreated depression in pregnancy

Pregnant women may have misconceptions about treatment during pregnancy, and psychiatrists often are hesitant to treat pregnant women. However, the risks of untreated depression during pregnancy are even greater than the risks of untreated depression at other points in a woman’s life. In addition to general psychiatric risks seen in depression, pregnant women may experience other issues, such as preeclampsia and liver metabolism changes.^1-2 Risks to the fetus related to untreated or partially treated mental health concerns include poor prenatal care related to poor self-care, an increased risk of exposure to illicit substances or alcohol related to “self-medication,” preterm delivery, and low birthweight (Table 1^3-8). Further risks for an infant of a mother with untreated depression include decreased cognitive performance and poor bonding with poor stress adaptation.^5,6 Thus, appropriate treatment of depression is even more important during pregnancy than at other times of life.

Potential risks of treating depression in pregnancy

When prescribing psychotropic medications to a pregnant woman, there are several naturally occurring adverse outcomes to consider. For example, miscarriages, stillbirths, and congenital malformations can occur without explanation in the general population. In addition, also consider the specific health history of the mother and the available research literature regarding the specific psychotropic agent (keeping in mind that there are ethical issues associated with conducting prospective research in pregnant women, such as it being unethical to withhold treatment to pregnant women who are depressed in order to have a control group, and that retrospective research is often confounded by recall bias). Potential risks to be aware of include miscarriage (spontaneous abortion), malformation (teratogenesis, birth defects), preterm delivery, neonatal adaptation syndrome, and behavioral teratogenesis (Table 1^3-8).

Selective serotonin reuptake inhibitors (SSRIs), the usual medication treatment of choice for depression, have at times been implicated in adverse pregnancy outcomes, but no strong evidence suggests they increase the miscarriage rate. Overall data are reassuring regarding the risk of malformation associated with SSRI use. Of note, the FDA had switched paroxetine from a Class C drug to a Class D drug after early reports of a potential 1.5% to 2% risk of fetal cardiac malformations compared with a 1% baseline risk in the general population (these FDA pregnancy risk letter categories have since been phased out).^9,10 Nevertheless, the absolute risk remains small. Another large study found that there was no substantial increased risk of cardiac malformations attributable to antidepressant use during the first trimester.¹¹

Lessons from a class action suit

Since we last reviewed pregnancy and antidepressants in 2013,⁸ several class action lawsuits against the manufacturers of psychotropic medications have been heard. Product liability actions brought against manufacturers are different from medical malpractice suits brought against individual physicians, which may result from lack of informed consent, suicide, or homicide.

One of the largest class action suits was against Zoloft (specifically Zoloft and Pfizer, since the brand manufacturer is responsible for the product insert information.)^12,13 At the time, sertraline was already commonly prescribed due to the relatively safe reproductive profile.

Continue to: Many of the more than 300...

Many of the more than 300 federal claims were united in a multi-district litigation (MDL) suit under the United States District Court of Eastern Pennsylvania (MDL 2342). Pfizer issued Daubert challenges (efforts to exclude the introduction of “junk science” into the courtroom) against the plaintiffs’ experts’ scientific methods and results.^12,13 The plaintiffs (those suing Pfizer) had to prove that the medications caused the negative outcome, not that they were merely temporally associated. Subsequently, 2 plaintiff experts—a PharmD and a biostatistician—were removed. Pfizer successfully challenged the methodological soundness of the plaintiffs’ experts’ testimony (Table 2^12,13), and the case was dismissed. In general, the courts identified the Bradford Hill criteria as often being important (though not definitive) methodology for determining causation (Table 3^12,13).

A concept raised in prior psychotropic lawsuits was the “learned intermediary doctrine,” in which pharmaceutical companies stated that once a risk is known, it is the responsibility of the prescribing physician to assess risks vs benefits and inform the patient.⁸ Many aspects of the larger class action lawsuits related to failure of the company to do adequate research to identify risks and appropriately inform the public and the medical community of these risks.¹⁴

Challenges in interpreting the literature

Some of the difficulties in interpreting the literature on the association of antidepressants and birth defects can be seen in a 2020 study by Anderson et al.¹⁵ This study was published in JAMA Psychiatry, received widespread coverage in the media, and was discussed on the CDC’s website.¹⁶ Anderson et al¹⁵ compared a large cohort of 30,630 infants with birth defects from the multicenter case-control National Birth Defects Prevention Study with 11,478 randomly selected controls with no defects. Three primary study groups were women whose pregnancies resulted in:

• birth defects with no antidepressant exposure (n = 28,719)
• birth defects with exposure to an antidepressant (n = 1,911)
• no birth defect control group (n = 10,886 no antidepressant exposure, n = 592 antidepressant exposure).

This study reported there were “some associations between maternal antidepressant use and specific birth defects” and “Venlafaxine was associated with more birth defects than other antidepressants, which needs confirmation.”¹⁵ However, in an accompanying editorial, Wisner et al¹⁷ discussed potential problems and limitations with this study and research of this nature in general (Table 4¹⁷). In addition, Anderson et al¹⁵ used certain “controversial” statistical practices.¹⁸ For example, “[T]o align with American Statistical Association guidelines to consider effect sizes when interpreting results instead of statistical significance, we noted associations as meaningfully elevated if [adjusted odds ratios] were 2.0 or greater and lower confidence interval bounds were 0.8 or greater.”¹⁵

Those who read only abstracts or news stories may believe this study of >40,000 participants included a large number of women who were receiving venlafaxine. However, the number of pregnant women who were prescribed venlafaxine was actually very small—112 who took venlafaxine experienced a birth defect. In addition, the authors noted “Venlafaxine was associated with many of the same defects across the samples (data not shown).”¹⁵ As discussed above, historically one of the areas the courts have considered was whether or not appropriate methodology was applied, and whether the results could be replicated with the data provided.

Continue to: Further, new studies...

Further, new studies need to be considered in context of the literature as a whole and collective clinical experience. A recent systematic review found that among 3,186 infants exposed to venlafaxine during the first trimester, there were 107 major malformations.¹⁹ This indicated a relative risk estimate of 1.12, with a 95% CI of 0.92 to 1.35. The authors concluded that venlafaxine exposure in the first trimester was not associated with an increased risk of malformations.

Expectant parents may come across a headline that implies a specific antidepressant causes problems, but have not read the study or know how to interpret it. Often it is best for a physician to find out what the basis of the concern is, and if possible, review the study with the patient to make sure it is in the right context, and if it applies to the individual patient’s situation.

Consider the ethical issues

In addition to preventive ethics, other critical ethical issues in pregnancy include omission bias, beneficence, and autonomy.^4,20-24 Omission bias occurs when physicians are more concerned about acts of commission (in which treatment leads to a negative outcome) than they are about acts of omission, which involve not treating the patient’s illness. To address this, it is important to discuss with the patient both the risks of treating and the risks of not treating maternal depression, so that the mother can make the best decision for her own specific set of circumstances.

Regarding beneficence (promoting the patient’s best interest), consider both the mother’s and the infant’s best interest, which usually are quite closely related. Women may feel guilty about taking a medication that they perceive is harmful for the fetus but good for their own mental health. Physicians can help with this by providing education about the benefits of treating depression for the fetus’ benefit as well. The fetus is completely dependent on the environment that the mother places them in, not merely the medication effects (eg, psychologic/physiologic stress effects, poor diet, lack of exercise, risk of “self-medication”).

Regarding autonomy (a woman’s own decision-making), Coverdale et al²¹ discussed strategies that can enhance a pregnant patient’s autonomy—including discussing treatment options and counselling about the effects of depression itself in pregnancy, as well as considering the effects of depression on the process of decision-making. For example, a woman with depression may see the world through a negative lens or may have difficulty concentrating. Patients may also require education about the concept of relative risk in comparison to absolute risk—especially in light of attention-grabbing headlines.

Continue to: Finally, as part of...

Finally, as part of preventative ethics, anticipate the ethical dilemmas before the common situation of pregnancy. Almost one-half of pregnancies are unplanned.²⁵ Many women thus expose their fetus to medication during the critical early period of organogenesis, before noticing they were pregnant. Therefore, even if a patient of childbearing age insists that she is not sexually active, the prudent psychiatrist should still begin discussions about medications in pregnancy.

An outline of best practices

Best practice includes preventive ethics, and when treating any woman of childbearing age, psychiatrists should consider prescribing medications that are known to be relatively safe in pregnancy rather than risky in pregnancy. Therefore, any psychiatrist whose practice includes women of childbearing age should have a working knowledge of which agents are relatively safe in pregnancy. After a woman is pregnant, careful decision-making about medication should continue. Consult with reproductive psychiatry colleagues where necessary.

A patient with depression would usually merit closer follow-up during the pregnancy. In some cases, psychotherapy alone can be effective in depression. However, approximately 6% to 13% of women are prescribed antidepressants during pregnancy, and this has been increasing.²⁶ Women who discontinue their antidepressant while pregnant are more likely to relapse than those who continue their medication,²⁷ thus exposing their fetus to negative effects of depression as well as medication (prior to discontinuation).

When possible, monotherapy (one agent) in the lowest effective dose is often the judicious approach to treatment. For a patient prescribed pre-existing polypharmacy at time of pregnancy, a risk-benefit analysis of which medications should remain, which should be stopped, and a plan for taper, if needed, should be discussed and documented. Using too little of an antidepressant dose would expose the fetus to both depression and medication, whereas using a maximum dose when not needed would expose the fetus to more medication than is necessary to treat the mother’s symptoms. This discussion with the mother (and her partner, if available) should be documented in the chart. The mother should understand both the risk of untreated illness and the potential risks of medications, as well as the benefits of medications and alternatives. It is important for the mother to realize that there is no risk-free option, and that malformations can occur in the general population as well as in individuals with untreated depression, separate from any medication exposure. In fact, most malformations do not have a known cause, and overall approximately 3% of pregnancies result in a birth defect.²⁸

If possible, discuss the treatment plan with the patient’s obstetrician, or ask the mother to discuss the plan with her obstetrician, so that everyone is on the same page. This discussion can help attenuate patient anxiety that results from hearing different things from different clinicians. Communication with other treating professionals (eg, OB/GYNs, pediatricians) can be beneficial and reduce liability if multiple physicians have agreed on a treatment plan—even if there is a negative outcome. With malpractice, a clinician is not necessarily at fault for a bad outcome or adverse effect, but is at fault for lack of informed consent or negligence (deviation from standard of care), which is harder for an attorney to demonstrate if there is deliberation, communication, and a plan that multiple doctors agree upon.

Continue to: Be aware that informed consent...

Be aware that informed consent is an ongoing process, and a woman may need to be reminded or informed of potential risks at varying stages of her life (eg, when starting a new relationship, getting married, etc.). Documentation can include that the clinician has discussed the risks, benefits, adverse effects, and alternatives of various medications, and a description of any patient-specific or medication-specific issues. In addition to verbal discussions, giving patients printed information can be helpful, as can directing them to appropriate websites (see Related Resources). Some physicians require patients to sign a form to indicate that they are aware of known risks.

Similar to being proactive before your patient becomes pregnant, think proactively regarding the postpartum period. Is your patient planning to breastfeed? Is the medication compatible with breastfeeding, or is bottle feeding the best option considering the mother’s specific circumstances? For example, developing severe symptoms, experiencing insomnia, needing to take a contraindicated medication, or having a vulnerable infant might sway a mother towards not breastfeeding. The expectant mother (and her partner, where possible) should be educated about postpartum risks and the importance of sleep in preventing postpartum depression.

Bottom Line

Concerns about being sued should not prevent appropriate care of depression in a woman who is pregnant. Discuss with your patient both the risk of untreated mental illness and the risk of medications to ensure she understands that avoiding antidepressants does not guarantee a safe or healthy pregnancy.

Related Resources

• MotherToBaby. www.mothertobaby.org/
• Centers for Disease Control and Prevention. Treating for two: medicine and pregnancy. www.cdc.gov/pregnancy/meds/treatingfortwo/index.html
• MGH Center for Women’s Mental Health. Reproductive psychiatry resource and information center. www.womensmentalhealth.org/

Drug Brand Names

Paroxetine • Paxil
Sertraline • Zoloft
Venlafaxine • Effexor

Disasters—both natural and human-caused—can strike at any time, causing severe trauma for those impacted. Disasters may create circumstances where the need for mental health resources could exceed capacity, and hospitals and clinics would be unable to meet the needs of the affected communities. As psychiatric clinicians, we may want to provide our services in such situations; however, we are still at risk for civil, criminal, or constitutional liability claims against us if we fail to meet our legal obligations related to psychiatric practice. Ideally, whether we live and work in an area affected by a disaster or volunteer from other states, we should be able to care for patients without fear of facing unreasonable liability risks. Although an exhaustive list of all relevant federal and state laws and regulations is beyond the scope of this article, here I discuss some of the federal and state laws and regulations that could provide protection from these risks, and some limitations of liability protection.

A familiar list of liability concerns

From a liability perspective, what should we be aware of when practicing during disasters? The same liability concerns we have during our day-to-day practice also exist during disasters, especially when there are suboptimal or adverse outcomes. Negligence, practicing without a proper state medical license, and abandonment are among the liability concerns that we could face when practicing during a disaster (Box^1,2).

Box

Liability protections

There are no comprehensive national liability protections for all practitioners during disasters.¹ Limited immunity is often provided through a patchwork of federal and state laws and regulations, which can be complex and are often modified. This immunity depends on several factors, such as applicable regulations, the type of services that are provided, and whether the clinicians are volunteering their services (ie, they are not being paid for providing services).² There is usually no immunity due to willful or wanton acts, gross negligence, providing care while intoxicated, or criminal acts.²

Federal laws and regulations

Most of the federal laws that provide liability protections are activated once a disaster is declared. However, some laws provide liability protections without requiring such declarations. Additional federal laws and regulations that provide additional liability protections, especially to volunteers, can be enacted after disasters occur.

Federal Tort Claims Act

The Federal Tort Claims Act (FTCA)³ protects federal government employees from tort liability by substituting the federal government as the defendant in certain types of suits brought against the federal government. These suits may involve injury, loss of personal property, personal injury, or death by the negligent or wrongful act or omission of any federal government employees while acting in the scope of their office or employment.^3,4 It does not require that an emergency be declared before immunity is conferred. FTCA covers all federal government employees, including volunteers.⁴ In the context of an emergency response, volunteers can assert the liability protections afforded to federal employees if they are designated as unpaid employees of the federal government.⁴ Federal employees are immune from suit under state tort law.⁴

Volunteer Protection Act

The Volunteer Protection Act (VPA) of 1997⁵ provides liability protections to uncompensated volunteer health professionals (VHPs) who perform services for nonprofit organizations or government entities against claims of ordinary negligence committed within the scope of their volunteer responsibilities.⁴ It does not require that an emergency be declared before immunity is conferred. Although VHPs are not liable for economic damages caused by providing medical care within the scope of their volunteer responsibilities, this exemption does not extend to non-economic damages, such as losses for suffering and mental anguish.⁵ VPA does not protect VHPs working in businesses (including for-profit hospitals) and organizational entities of any type (including nonprofit or governmental organizations) that use VHPs.⁴

VPA only protects VHPs practicing with a license as required by law in the state where the harm occurred, unless state authorities allow for licensure exceptions. VPA overrides state laws that are inconsistent with VPA, unless those state laws provide greater liability protection for VHPs.⁴ However, VPA protections are limited. VPA protects only volunteers, not clinicians working in their regular nonemergency roles and capacities.⁶ A nonprofit or government agent can still bring civil claims against VHPs.⁶ VPA does not override certain state laws that put conditions on volunteers, such as risk management requirements, vicarious liability, and a financially secure form of recovery for intended victims.⁶

Continue to: Health Insurance Portability and Accountability Act

The Health Insurance Portability and Accountability Act (HIPAA) of 1996,⁷ specifically Section 194, extends eligibility for FTCA liability protections to VHPs at qualifying free clinics, provided the clinic sponsors the VHPs by applying to the Health Resources and Services Administration.⁸ It does not require that an emergency be declared before immunity is conferred.

Public Readiness and Emergency Preparedness Act

The Public Readiness and Emergency Preparedness (PREP) Act of 2005⁹ authorizes the US Department of Health and Human Services (HHS) Secretary to issue a declaration that provides immunity to VHPs from tort liability for claims of loss caused by the use of authorized countermeasures (eg, vaccines) against diseases or other threats of public health emergencies.⁴ A separate emergency determination under Public Health Service Act Section 319 or another statute is not required for PREP Act immunities to take effect.⁴ The PREP Act covers individual persons and entities involved in the manufacture, testing, distribution, administration, and use of covered countermeasures.⁴

PREP Act immunity is not absolute and does not protect against claims of willful misconduct, violation of the Americans with Disabilities Act (ADA), or other civil rights violations.⁴ Liability protection under the PREP Act is limited to a specific emergency and includes only the countermeasures and other conditions listed in the PREP Act declaration by the HHS Secretary.⁴

State laws and regulations

States have a variety of standing liability protections that could apply to VHPs who provide care in an emergency. Some states have crafted executive orders to be put into effect during a disaster. Most of these executive orders, which can include extending liability protections, are similar to what other states have done by adopting model acts such as Model State Emergency Health Powers Act.⁶ These orders are not actually laws; they only become effective when the governor signs them at the time of the disaster. These orders also are time-limited and must be reissued in subsequent disasters.

State tort claims acts and state claims acts

Similar to the federal government, some states have waived sovereign immunity in certain circumstances through state tort claims or state claims acts.

Continue to: State tort claims act

State tort claims acts either abolish state sovereign immunity generally and provide immunity only in specific circumstances, or preserve sovereign immunity generally but identify certain exceptions in which immunity is waived.⁴

State claims acts limit state sovereign immunity by establishing procedures for making claims against the state.⁴ These acts typically immunize state government employees from tort liability for acts or omissions committed within the scope of their employment.⁴ Some states extend these protections to volunteers, and some states declare volunteers to be unpaid state employees during an emergency, which allows volunteers to assert the liability protections afforded of state employees.⁴

Emergency power statutes

State emergency laws can trigger additional powers, suspend certain administrative requirements, and provide or enhance liability protections to specified groups of volunteers and other responders upon a gubernatorial declaration of emergency.⁴ These statutes can extend the rights and immunities provided to governmental employees to volunteers performing work that is eligible for coverage under governmental immunity and state tort claims acts.⁴ There is a wide range in the types and degrees of coverage provided to volunteers under emergency powers statutes, and these provisions can be broad or duplicative of other provisions in state law.⁴

State volunteer protection statutes

All states have some statutory provisions for volunteers. Similar to the VPA, these state volunteer protection statutes generally do not require that an emergency be declared, apply to uncompensated individual volunteers for nonprofit and government entities only, and apply only to individuals and not to organizations.⁴ Many states have adopted specific liability protections for VHPs in addition to or to supplement their emergency powers and general volunteer protection statutes.⁴ These statutes confer immunity from civil liability provided that certain conditions are met and are not dependent on the declaration of an emergency.⁴ Each state statute differs in regard to who receives immunity, which acts are immune from liability, and what liability protections are available.

Good Samaritan laws

All 50 states and the District of Columbia have enacted Good Samaritan laws. These laws, which do not need an official declaration of an emergency in order to be applicable, generally protect VHPs from liability when volunteering in good faith and without compensation at the scene of an emergency.² Good Samaritan protections may also apply to care provided by VHPs in a hospital if the VHP is not on duty and does not charge a fee.² However, the effect and scope of Good Samaritan laws vary dramatically from state to state. Some states include hospital settings as an emergency scene in their statutes, while others expressly exclude hospitals from their statutes.⁶ Some state statutes only include declared emergencies, while others are drawn to broadly cover all emergency situations.⁶

Continue to: Limitations

Limitations. Many Good Samaritan statutes apply only to volunteers, and not all states have statutes that allow clinicians to be designated as such,⁶ so receiving compensation would take a clinician outside the scope of the statute. Further, most states only shield action taken at the scene of an accident, and immunity would not extend to a hospital emergency department, or in the aftermath of an emergency as normal conditions slowly return.⁶ Therefore, Good Samaritan liability protection would apply to the common scenario of assisting at the scene of a car crash, but not necessarily to treating individuals in the emergency department after a hurricane or during a pandemic.⁶ State laws vary considerably on what constitutes “good faith” and “without compensation,” which would determine whether protection applies for a clinician who is otherwise salaried in a regular job.¹

Mutual aid agreements

Mutual aid agreements are mechanisms through which jurisdictions can aid other jurisdictions during emergencies.⁴ These agreements also include provisions for reimbursing expenses, providing liability protections to governmental employees and volunteers who provide aid, and awarding compensation for injuries to personnel deployed under the agreement.⁴ These protections are not automatic and are limited in their applicability.

The Emergency Management Assistance Compact (EMAC), the most widely adopted mutual aid agreement in the United States, has been adopted by all 50 states, the District of Columbia, and some territories.¹⁰ It only becomes effective once an emergency has been declared. EMAC provides immunity to officers from the state that is rendering aid to the state requesting aid, in which officers are considered agents of the requesting state for tort liability and immunity purposes.⁸ These individuals, who must be properly dispatched in response to an EMAC request, are not to be held liable for acts or omissions rendered in good faith; however, EMAC does not provide liability protection for actions constituting willful misconduct, gross negligence, or recklessness.⁶ EMAC also provides reciprocity for individuals who are properly dispatched in response to an EMAC request who hold medical licenses to practice medicine in the receiving state, subject to any limitations imposed by the receiving state.⁴ Clinicians can familiarize themselves with a state’s medical licensing requirements by reviewing that state’s medical board website. For EMAC protections to apply, a state must make a request to another/other state(s) through EMAC, and such requests must be formally accepted by the rendering state.⁸ EMAC does not require participating states to actually provide aid.¹⁰

Non-volunteer health care clinicians

Non-volunteer (salaried or paid) health care clinicians are more likely to bear the brunt of providing care during a disaster, especially in the early stages before VHPs arrive; however, most legislation does not address the associated disproportionate liability risk burden of non-volunteer health care clinicians.^1,11 As opposed to VHPs and government employees, non-volunteer health care clinicians performing their regular job duties during a disaster are generally not provided immunity from negligence by most legislation.^1,6 One exception is the PREP Act, which provides immunity for all clinicians from claims that may arise from dispensing a specific counter­measure during a declared public health emergency.^1,9 Some states have enacted the Model State Emergency Health Powers Act, which may offer immunity from negligence if the non-volunteer clinician is rendering care under contract with or at the request of a state¹; however, non-volunteer clinicians who practice from their office or a local hospital will not receive protection through these laws.¹ Good Samaritan laws may not apply unless care is provided at a scene of an emergency.

A few states have attempted to narrow this legislative gap by enacting laws that provide immunity more broadly for clinicians, regardless of their volunteer or compensation status.¹ Elements of these states’ laws include acting in response to a declared emergency or disaster in which there is a recognized depletion of resources attributable to the disaster, at express or implied request of the state government, and consistent with emergency plans.¹

Continue to: Bottom Line

There are potential liability risks when treating patients during a disaster. Statutory protections that limit liability may be enacted when the US President or a state Governor declares an official state of emergency. Although some federal and state laws and regulations provide liability protections during these situations, there is a discrepancy in the protections offered to non-volunteer vs volunteer clinicians.

Related Resources

• Federal Emergency Management Agency. https://www.fema.gov/
• Federation of State Medical Boards. https://www.fsmb.org

Disasters—both natural and human-caused—can strike at any time, causing severe trauma for those impacted. Disasters may create circumstances where the need for mental health resources could exceed capacity, and hospitals and clinics would be unable to meet the needs of the affected communities. As psychiatric clinicians, we may want to provide our services in such situations; however, we are still at risk for civil, criminal, or constitutional liability claims against us if we fail to meet our legal obligations related to psychiatric practice. Ideally, whether we live and work in an area affected by a disaster or volunteer from other states, we should be able to care for patients without fear of facing unreasonable liability risks. Although an exhaustive list of all relevant federal and state laws and regulations is beyond the scope of this article, here I discuss some of the federal and state laws and regulations that could provide protection from these risks, and some limitations of liability protection.

A familiar list of liability concerns

From a liability perspective, what should we be aware of when practicing during disasters? The same liability concerns we have during our day-to-day practice also exist during disasters, especially when there are suboptimal or adverse outcomes. Negligence, practicing without a proper state medical license, and abandonment are among the liability concerns that we could face when practicing during a disaster (Box^1,2).

Box

Liability protections

There are no comprehensive national liability protections for all practitioners during disasters.¹ Limited immunity is often provided through a patchwork of federal and state laws and regulations, which can be complex and are often modified. This immunity depends on several factors, such as applicable regulations, the type of services that are provided, and whether the clinicians are volunteering their services (ie, they are not being paid for providing services).² There is usually no immunity due to willful or wanton acts, gross negligence, providing care while intoxicated, or criminal acts.²

Federal laws and regulations

Most of the federal laws that provide liability protections are activated once a disaster is declared. However, some laws provide liability protections without requiring such declarations. Additional federal laws and regulations that provide additional liability protections, especially to volunteers, can be enacted after disasters occur.

Federal Tort Claims Act

The Federal Tort Claims Act (FTCA)³ protects federal government employees from tort liability by substituting the federal government as the defendant in certain types of suits brought against the federal government. These suits may involve injury, loss of personal property, personal injury, or death by the negligent or wrongful act or omission of any federal government employees while acting in the scope of their office or employment.^3,4 It does not require that an emergency be declared before immunity is conferred. FTCA covers all federal government employees, including volunteers.⁴ In the context of an emergency response, volunteers can assert the liability protections afforded to federal employees if they are designated as unpaid employees of the federal government.⁴ Federal employees are immune from suit under state tort law.⁴

Volunteer Protection Act

The Volunteer Protection Act (VPA) of 1997⁵ provides liability protections to uncompensated volunteer health professionals (VHPs) who perform services for nonprofit organizations or government entities against claims of ordinary negligence committed within the scope of their volunteer responsibilities.⁴ It does not require that an emergency be declared before immunity is conferred. Although VHPs are not liable for economic damages caused by providing medical care within the scope of their volunteer responsibilities, this exemption does not extend to non-economic damages, such as losses for suffering and mental anguish.⁵ VPA does not protect VHPs working in businesses (including for-profit hospitals) and organizational entities of any type (including nonprofit or governmental organizations) that use VHPs.⁴

VPA only protects VHPs practicing with a license as required by law in the state where the harm occurred, unless state authorities allow for licensure exceptions. VPA overrides state laws that are inconsistent with VPA, unless those state laws provide greater liability protection for VHPs.⁴ However, VPA protections are limited. VPA protects only volunteers, not clinicians working in their regular nonemergency roles and capacities.⁶ A nonprofit or government agent can still bring civil claims against VHPs.⁶ VPA does not override certain state laws that put conditions on volunteers, such as risk management requirements, vicarious liability, and a financially secure form of recovery for intended victims.⁶

Continue to: Health Insurance Portability and Accountability Act

The Health Insurance Portability and Accountability Act (HIPAA) of 1996,⁷ specifically Section 194, extends eligibility for FTCA liability protections to VHPs at qualifying free clinics, provided the clinic sponsors the VHPs by applying to the Health Resources and Services Administration.⁸ It does not require that an emergency be declared before immunity is conferred.

Public Readiness and Emergency Preparedness Act

The Public Readiness and Emergency Preparedness (PREP) Act of 2005⁹ authorizes the US Department of Health and Human Services (HHS) Secretary to issue a declaration that provides immunity to VHPs from tort liability for claims of loss caused by the use of authorized countermeasures (eg, vaccines) against diseases or other threats of public health emergencies.⁴ A separate emergency determination under Public Health Service Act Section 319 or another statute is not required for PREP Act immunities to take effect.⁴ The PREP Act covers individual persons and entities involved in the manufacture, testing, distribution, administration, and use of covered countermeasures.⁴

PREP Act immunity is not absolute and does not protect against claims of willful misconduct, violation of the Americans with Disabilities Act (ADA), or other civil rights violations.⁴ Liability protection under the PREP Act is limited to a specific emergency and includes only the countermeasures and other conditions listed in the PREP Act declaration by the HHS Secretary.⁴

State laws and regulations

States have a variety of standing liability protections that could apply to VHPs who provide care in an emergency. Some states have crafted executive orders to be put into effect during a disaster. Most of these executive orders, which can include extending liability protections, are similar to what other states have done by adopting model acts such as Model State Emergency Health Powers Act.⁶ These orders are not actually laws; they only become effective when the governor signs them at the time of the disaster. These orders also are time-limited and must be reissued in subsequent disasters.

State tort claims acts and state claims acts

Similar to the federal government, some states have waived sovereign immunity in certain circumstances through state tort claims or state claims acts.

Continue to: State tort claims act

State tort claims acts either abolish state sovereign immunity generally and provide immunity only in specific circumstances, or preserve sovereign immunity generally but identify certain exceptions in which immunity is waived.⁴

State claims acts limit state sovereign immunity by establishing procedures for making claims against the state.⁴ These acts typically immunize state government employees from tort liability for acts or omissions committed within the scope of their employment.⁴ Some states extend these protections to volunteers, and some states declare volunteers to be unpaid state employees during an emergency, which allows volunteers to assert the liability protections afforded of state employees.⁴

Emergency power statutes

State emergency laws can trigger additional powers, suspend certain administrative requirements, and provide or enhance liability protections to specified groups of volunteers and other responders upon a gubernatorial declaration of emergency.⁴ These statutes can extend the rights and immunities provided to governmental employees to volunteers performing work that is eligible for coverage under governmental immunity and state tort claims acts.⁴ There is a wide range in the types and degrees of coverage provided to volunteers under emergency powers statutes, and these provisions can be broad or duplicative of other provisions in state law.⁴

State volunteer protection statutes

All states have some statutory provisions for volunteers. Similar to the VPA, these state volunteer protection statutes generally do not require that an emergency be declared, apply to uncompensated individual volunteers for nonprofit and government entities only, and apply only to individuals and not to organizations.⁴ Many states have adopted specific liability protections for VHPs in addition to or to supplement their emergency powers and general volunteer protection statutes.⁴ These statutes confer immunity from civil liability provided that certain conditions are met and are not dependent on the declaration of an emergency.⁴ Each state statute differs in regard to who receives immunity, which acts are immune from liability, and what liability protections are available.

Good Samaritan laws

All 50 states and the District of Columbia have enacted Good Samaritan laws. These laws, which do not need an official declaration of an emergency in order to be applicable, generally protect VHPs from liability when volunteering in good faith and without compensation at the scene of an emergency.² Good Samaritan protections may also apply to care provided by VHPs in a hospital if the VHP is not on duty and does not charge a fee.² However, the effect and scope of Good Samaritan laws vary dramatically from state to state. Some states include hospital settings as an emergency scene in their statutes, while others expressly exclude hospitals from their statutes.⁶ Some state statutes only include declared emergencies, while others are drawn to broadly cover all emergency situations.⁶

Continue to: Limitations

Limitations. Many Good Samaritan statutes apply only to volunteers, and not all states have statutes that allow clinicians to be designated as such,⁶ so receiving compensation would take a clinician outside the scope of the statute. Further, most states only shield action taken at the scene of an accident, and immunity would not extend to a hospital emergency department, or in the aftermath of an emergency as normal conditions slowly return.⁶ Therefore, Good Samaritan liability protection would apply to the common scenario of assisting at the scene of a car crash, but not necessarily to treating individuals in the emergency department after a hurricane or during a pandemic.⁶ State laws vary considerably on what constitutes “good faith” and “without compensation,” which would determine whether protection applies for a clinician who is otherwise salaried in a regular job.¹

Mutual aid agreements

Mutual aid agreements are mechanisms through which jurisdictions can aid other jurisdictions during emergencies.⁴ These agreements also include provisions for reimbursing expenses, providing liability protections to governmental employees and volunteers who provide aid, and awarding compensation for injuries to personnel deployed under the agreement.⁴ These protections are not automatic and are limited in their applicability.

The Emergency Management Assistance Compact (EMAC), the most widely adopted mutual aid agreement in the United States, has been adopted by all 50 states, the District of Columbia, and some territories.¹⁰ It only becomes effective once an emergency has been declared. EMAC provides immunity to officers from the state that is rendering aid to the state requesting aid, in which officers are considered agents of the requesting state for tort liability and immunity purposes.⁸ These individuals, who must be properly dispatched in response to an EMAC request, are not to be held liable for acts or omissions rendered in good faith; however, EMAC does not provide liability protection for actions constituting willful misconduct, gross negligence, or recklessness.⁶ EMAC also provides reciprocity for individuals who are properly dispatched in response to an EMAC request who hold medical licenses to practice medicine in the receiving state, subject to any limitations imposed by the receiving state.⁴ Clinicians can familiarize themselves with a state’s medical licensing requirements by reviewing that state’s medical board website. For EMAC protections to apply, a state must make a request to another/other state(s) through EMAC, and such requests must be formally accepted by the rendering state.⁸ EMAC does not require participating states to actually provide aid.¹⁰

Non-volunteer health care clinicians

Non-volunteer (salaried or paid) health care clinicians are more likely to bear the brunt of providing care during a disaster, especially in the early stages before VHPs arrive; however, most legislation does not address the associated disproportionate liability risk burden of non-volunteer health care clinicians.^1,11 As opposed to VHPs and government employees, non-volunteer health care clinicians performing their regular job duties during a disaster are generally not provided immunity from negligence by most legislation.^1,6 One exception is the PREP Act, which provides immunity for all clinicians from claims that may arise from dispensing a specific counter­measure during a declared public health emergency.^1,9 Some states have enacted the Model State Emergency Health Powers Act, which may offer immunity from negligence if the non-volunteer clinician is rendering care under contract with or at the request of a state¹; however, non-volunteer clinicians who practice from their office or a local hospital will not receive protection through these laws.¹ Good Samaritan laws may not apply unless care is provided at a scene of an emergency.

A few states have attempted to narrow this legislative gap by enacting laws that provide immunity more broadly for clinicians, regardless of their volunteer or compensation status.¹ Elements of these states’ laws include acting in response to a declared emergency or disaster in which there is a recognized depletion of resources attributable to the disaster, at express or implied request of the state government, and consistent with emergency plans.¹

Continue to: Bottom Line

There are potential liability risks when treating patients during a disaster. Statutory protections that limit liability may be enacted when the US President or a state Governor declares an official state of emergency. Although some federal and state laws and regulations provide liability protections during these situations, there is a discrepancy in the protections offered to non-volunteer vs volunteer clinicians.

Related Resources

• Federal Emergency Management Agency. https://www.fema.gov/
• Federation of State Medical Boards. https://www.fsmb.org

Disasters—both natural and human-caused—can strike at any time, causing severe trauma for those impacted. Disasters may create circumstances where the need for mental health resources could exceed capacity, and hospitals and clinics would be unable to meet the needs of the affected communities. As psychiatric clinicians, we may want to provide our services in such situations; however, we are still at risk for civil, criminal, or constitutional liability claims against us if we fail to meet our legal obligations related to psychiatric practice. Ideally, whether we live and work in an area affected by a disaster or volunteer from other states, we should be able to care for patients without fear of facing unreasonable liability risks. Although an exhaustive list of all relevant federal and state laws and regulations is beyond the scope of this article, here I discuss some of the federal and state laws and regulations that could provide protection from these risks, and some limitations of liability protection.

A familiar list of liability concerns

From a liability perspective, what should we be aware of when practicing during disasters? The same liability concerns we have during our day-to-day practice also exist during disasters, especially when there are suboptimal or adverse outcomes. Negligence, practicing without a proper state medical license, and abandonment are among the liability concerns that we could face when practicing during a disaster (Box^1,2).

Box

Liability protections

There are no comprehensive national liability protections for all practitioners during disasters.¹ Limited immunity is often provided through a patchwork of federal and state laws and regulations, which can be complex and are often modified. This immunity depends on several factors, such as applicable regulations, the type of services that are provided, and whether the clinicians are volunteering their services (ie, they are not being paid for providing services).² There is usually no immunity due to willful or wanton acts, gross negligence, providing care while intoxicated, or criminal acts.²

Federal laws and regulations

Most of the federal laws that provide liability protections are activated once a disaster is declared. However, some laws provide liability protections without requiring such declarations. Additional federal laws and regulations that provide additional liability protections, especially to volunteers, can be enacted after disasters occur.

Federal Tort Claims Act

The Federal Tort Claims Act (FTCA)³ protects federal government employees from tort liability by substituting the federal government as the defendant in certain types of suits brought against the federal government. These suits may involve injury, loss of personal property, personal injury, or death by the negligent or wrongful act or omission of any federal government employees while acting in the scope of their office or employment.^3,4 It does not require that an emergency be declared before immunity is conferred. FTCA covers all federal government employees, including volunteers.⁴ In the context of an emergency response, volunteers can assert the liability protections afforded to federal employees if they are designated as unpaid employees of the federal government.⁴ Federal employees are immune from suit under state tort law.⁴

Volunteer Protection Act

The Volunteer Protection Act (VPA) of 1997⁵ provides liability protections to uncompensated volunteer health professionals (VHPs) who perform services for nonprofit organizations or government entities against claims of ordinary negligence committed within the scope of their volunteer responsibilities.⁴ It does not require that an emergency be declared before immunity is conferred. Although VHPs are not liable for economic damages caused by providing medical care within the scope of their volunteer responsibilities, this exemption does not extend to non-economic damages, such as losses for suffering and mental anguish.⁵ VPA does not protect VHPs working in businesses (including for-profit hospitals) and organizational entities of any type (including nonprofit or governmental organizations) that use VHPs.⁴

VPA only protects VHPs practicing with a license as required by law in the state where the harm occurred, unless state authorities allow for licensure exceptions. VPA overrides state laws that are inconsistent with VPA, unless those state laws provide greater liability protection for VHPs.⁴ However, VPA protections are limited. VPA protects only volunteers, not clinicians working in their regular nonemergency roles and capacities.⁶ A nonprofit or government agent can still bring civil claims against VHPs.⁶ VPA does not override certain state laws that put conditions on volunteers, such as risk management requirements, vicarious liability, and a financially secure form of recovery for intended victims.⁶

Continue to: Health Insurance Portability and Accountability Act

The Health Insurance Portability and Accountability Act (HIPAA) of 1996,⁷ specifically Section 194, extends eligibility for FTCA liability protections to VHPs at qualifying free clinics, provided the clinic sponsors the VHPs by applying to the Health Resources and Services Administration.⁸ It does not require that an emergency be declared before immunity is conferred.

Public Readiness and Emergency Preparedness Act

The Public Readiness and Emergency Preparedness (PREP) Act of 2005⁹ authorizes the US Department of Health and Human Services (HHS) Secretary to issue a declaration that provides immunity to VHPs from tort liability for claims of loss caused by the use of authorized countermeasures (eg, vaccines) against diseases or other threats of public health emergencies.⁴ A separate emergency determination under Public Health Service Act Section 319 or another statute is not required for PREP Act immunities to take effect.⁴ The PREP Act covers individual persons and entities involved in the manufacture, testing, distribution, administration, and use of covered countermeasures.⁴

PREP Act immunity is not absolute and does not protect against claims of willful misconduct, violation of the Americans with Disabilities Act (ADA), or other civil rights violations.⁴ Liability protection under the PREP Act is limited to a specific emergency and includes only the countermeasures and other conditions listed in the PREP Act declaration by the HHS Secretary.⁴

State laws and regulations

States have a variety of standing liability protections that could apply to VHPs who provide care in an emergency. Some states have crafted executive orders to be put into effect during a disaster. Most of these executive orders, which can include extending liability protections, are similar to what other states have done by adopting model acts such as Model State Emergency Health Powers Act.⁶ These orders are not actually laws; they only become effective when the governor signs them at the time of the disaster. These orders also are time-limited and must be reissued in subsequent disasters.

State tort claims acts and state claims acts

Similar to the federal government, some states have waived sovereign immunity in certain circumstances through state tort claims or state claims acts.

Continue to: State tort claims act

State tort claims acts either abolish state sovereign immunity generally and provide immunity only in specific circumstances, or preserve sovereign immunity generally but identify certain exceptions in which immunity is waived.⁴

State claims acts limit state sovereign immunity by establishing procedures for making claims against the state.⁴ These acts typically immunize state government employees from tort liability for acts or omissions committed within the scope of their employment.⁴ Some states extend these protections to volunteers, and some states declare volunteers to be unpaid state employees during an emergency, which allows volunteers to assert the liability protections afforded of state employees.⁴

Emergency power statutes

State emergency laws can trigger additional powers, suspend certain administrative requirements, and provide or enhance liability protections to specified groups of volunteers and other responders upon a gubernatorial declaration of emergency.⁴ These statutes can extend the rights and immunities provided to governmental employees to volunteers performing work that is eligible for coverage under governmental immunity and state tort claims acts.⁴ There is a wide range in the types and degrees of coverage provided to volunteers under emergency powers statutes, and these provisions can be broad or duplicative of other provisions in state law.⁴

State volunteer protection statutes

All states have some statutory provisions for volunteers. Similar to the VPA, these state volunteer protection statutes generally do not require that an emergency be declared, apply to uncompensated individual volunteers for nonprofit and government entities only, and apply only to individuals and not to organizations.⁴ Many states have adopted specific liability protections for VHPs in addition to or to supplement their emergency powers and general volunteer protection statutes.⁴ These statutes confer immunity from civil liability provided that certain conditions are met and are not dependent on the declaration of an emergency.⁴ Each state statute differs in regard to who receives immunity, which acts are immune from liability, and what liability protections are available.

Good Samaritan laws

All 50 states and the District of Columbia have enacted Good Samaritan laws. These laws, which do not need an official declaration of an emergency in order to be applicable, generally protect VHPs from liability when volunteering in good faith and without compensation at the scene of an emergency.² Good Samaritan protections may also apply to care provided by VHPs in a hospital if the VHP is not on duty and does not charge a fee.² However, the effect and scope of Good Samaritan laws vary dramatically from state to state. Some states include hospital settings as an emergency scene in their statutes, while others expressly exclude hospitals from their statutes.⁶ Some state statutes only include declared emergencies, while others are drawn to broadly cover all emergency situations.⁶

Continue to: Limitations

Limitations. Many Good Samaritan statutes apply only to volunteers, and not all states have statutes that allow clinicians to be designated as such,⁶ so receiving compensation would take a clinician outside the scope of the statute. Further, most states only shield action taken at the scene of an accident, and immunity would not extend to a hospital emergency department, or in the aftermath of an emergency as normal conditions slowly return.⁶ Therefore, Good Samaritan liability protection would apply to the common scenario of assisting at the scene of a car crash, but not necessarily to treating individuals in the emergency department after a hurricane or during a pandemic.⁶ State laws vary considerably on what constitutes “good faith” and “without compensation,” which would determine whether protection applies for a clinician who is otherwise salaried in a regular job.¹

Mutual aid agreements

Mutual aid agreements are mechanisms through which jurisdictions can aid other jurisdictions during emergencies.⁴ These agreements also include provisions for reimbursing expenses, providing liability protections to governmental employees and volunteers who provide aid, and awarding compensation for injuries to personnel deployed under the agreement.⁴ These protections are not automatic and are limited in their applicability.

The Emergency Management Assistance Compact (EMAC), the most widely adopted mutual aid agreement in the United States, has been adopted by all 50 states, the District of Columbia, and some territories.¹⁰ It only becomes effective once an emergency has been declared. EMAC provides immunity to officers from the state that is rendering aid to the state requesting aid, in which officers are considered agents of the requesting state for tort liability and immunity purposes.⁸ These individuals, who must be properly dispatched in response to an EMAC request, are not to be held liable for acts or omissions rendered in good faith; however, EMAC does not provide liability protection for actions constituting willful misconduct, gross negligence, or recklessness.⁶ EMAC also provides reciprocity for individuals who are properly dispatched in response to an EMAC request who hold medical licenses to practice medicine in the receiving state, subject to any limitations imposed by the receiving state.⁴ Clinicians can familiarize themselves with a state’s medical licensing requirements by reviewing that state’s medical board website. For EMAC protections to apply, a state must make a request to another/other state(s) through EMAC, and such requests must be formally accepted by the rendering state.⁸ EMAC does not require participating states to actually provide aid.¹⁰

Non-volunteer health care clinicians

Non-volunteer (salaried or paid) health care clinicians are more likely to bear the brunt of providing care during a disaster, especially in the early stages before VHPs arrive; however, most legislation does not address the associated disproportionate liability risk burden of non-volunteer health care clinicians.^1,11 As opposed to VHPs and government employees, non-volunteer health care clinicians performing their regular job duties during a disaster are generally not provided immunity from negligence by most legislation.^1,6 One exception is the PREP Act, which provides immunity for all clinicians from claims that may arise from dispensing a specific counter­measure during a declared public health emergency.^1,9 Some states have enacted the Model State Emergency Health Powers Act, which may offer immunity from negligence if the non-volunteer clinician is rendering care under contract with or at the request of a state¹; however, non-volunteer clinicians who practice from their office or a local hospital will not receive protection through these laws.¹ Good Samaritan laws may not apply unless care is provided at a scene of an emergency.

A few states have attempted to narrow this legislative gap by enacting laws that provide immunity more broadly for clinicians, regardless of their volunteer or compensation status.¹ Elements of these states’ laws include acting in response to a declared emergency or disaster in which there is a recognized depletion of resources attributable to the disaster, at express or implied request of the state government, and consistent with emergency plans.¹

Continue to: Bottom Line

There are potential liability risks when treating patients during a disaster. Statutory protections that limit liability may be enacted when the US President or a state Governor declares an official state of emergency. Although some federal and state laws and regulations provide liability protections during these situations, there is a discrepancy in the protections offered to non-volunteer vs volunteer clinicians.

Related Resources

• Federal Emergency Management Agency. https://www.fema.gov/
• Federation of State Medical Boards. https://www.fsmb.org