Medication-related liability

Question: An 85-year-old woman with a hip fracture received a narcotic following open reduction and internal fixation. Over the first post-op hour, she received two intravenous doses of 0.5 mg Dilaudid (hydromorphone), followed by an additional 2 mg in divided doses over the next 4 hours. She sustained a cardiorespiratory arrest shortly thereafter. Which of the following statements is correct?

A. This is a likely case of opiate-induced respiratory arrest.

B. The dose of Dilaudid is relatively small and cannot be the cause of the arrest.

C. Monitoring of respiratory rate and pulse oximetry will always detect early opiate-induced respiratory depression.

D. This complication is unlikely to occur in previously healthy young adults.

E. Lawsuits over iatrogenic injuries are impossible to defend even if the doctor followed community standards regarding dosage, indication, and disclosure of risks.

Answer: A. Opiate-related complications typically occur in the first post-op day, and some physicians remain unaware of the updated guidelines regarding dosage reduction for Dilaudid.

For example, it has been recommended that the intravenous order for this drug be 0.2-0.6 mg every 2-3 hours for opiate-naive patients rather than the previous 1-2 mg every 2-4 hours. Respiratory depression is the feared complication; importantly, bradypnea and desaturation in those already on oxygen are late signs. Furthermore, seemingly healthy young adults may succumb, especially where there is the concurrent use of alcohol or other CNS-modifying drugs.

Preventable adverse injuries from medication errors are a common phenomenon, estimated by the Institute of Medicine to occur in at least 1.5 million cases in the United States each year. Not all medication-related adverse events are the result of an error, as some are unforeseen or unavoidable. An effective defense for the prescribing doctor is to always adhere to community standards and document all relevant patient discussions.

Under the law of negligence, medication-related claims against the doctor require the plaintiff to prove deviation from the standard ordinarily expected under the circumstances. In addition, the patient has to show proximate causation, that is, the medication at issue both factually and legally caused the injury.

Thus, in a lower-court case in which the plaintiff suffered a perforated bowel purportedly from the use of cholestyramine and codeine that resulted in severe constipation from huge fecaliths, the doctor defendant was able to escape liability because the patient failed to exclude a barium enema procedure as the cause of the perforation.

Remember that disclosure of material treatment risks is always necessary, as well as documentation that such a discussion took place and that the patient understood and accepted the risks. The required level of disclosure may vary from jurisdiction to jurisdiction, but it is best to use the patient-centered standard, that is, what a reasonable person would want to know under the circumstances, rather than the physician-centered standard, which stands for what a reasonable doctor would disclose.

One class of drugs – opiates – bears highlighting. The therapeutic window for these drugs is narrow. The doctor should always consider accidental or deliberate overdosing, especially in the elderly, drug abusers, or those using alcohol or other drugs – especially antidepressants. In 2010, nearly 40,000 deaths resulted from drug overdoses – three quarters of the overdoses being unintentional and 17% suicidal (JAMA 2013;309:657-9). Most were from prescription drugs.

The presence of comorbid states such as cardiorespiratory disease, hypothyroidism, and renal insufficiency can also predispose to opiate-related respiratory depression.

Doctors should take a detailed and careful drug history, especially in those patients exhibiting drug-seeking behavior. Another caveat is to avoid all online prescriptions, in particular for controlled substances. Both disciplinary actions as well as potential criminal sanctions may visit the professional who is prescribing over the Internet without an established doctor-patient relationship, or where the prescription is filled in a state where the doctor is unlicensed.

Finally, recall that under the learned intermediary doctrine, the doctor, not the drug manufacturer, is liable for injuries arising out of prescription drug use. This doctrine was recently endorsed by the Supreme Court of Texas in Centocor Inc. v. Hamilton (372 S.W.3d 140 [2012]), where a lupus-like syndrome resulted from the use of infliximab (Remicade) in a woman with Crohn’s disease. All states have adopted this doctrine except for West Virginia and New Jersey, which provide for manufacturer liability where there is direct marketing of a product to consumers.

On the other hand, so-called strict liability theories for "defective" products have been repeatedly held to be inapplicable to doctors who, unlike manufacturers, are not usually considered to be sellers of the product. Strict liability is the basis for most product liability lawsuits, and all the plaintiff has to show is that the product is defective, that is, unreasonably dangerous with foreseeable consequences. No proof of fault or negligence is necessary.

Still, doctors would do well to distance themselves from companies with negligent standards. In the recent steroid-preparation scandal that led to fatal fungal meningitis in some 45 patients nationwide, some of the prescribing doctors now face lawsuits, the compounding pharmacy at issue having declared bankruptcy in the interim.

Dr. Tan is emeritus professor of medicine and a former adjunct professor of law at the University of Hawaii. This article is meant to be educational and does not constitute medical, ethical, or legal advice. It is adapted from the author’s book, "Medical Malpractice: Understanding the Law, Managing the Risk" (2006). For additional information, readers may contact the author at siang@hawaii.edu.

Question: An 85-year-old woman with a hip fracture received a narcotic following open reduction and internal fixation. Over the first post-op hour, she received two intravenous doses of 0.5 mg Dilaudid (hydromorphone), followed by an additional 2 mg in divided doses over the next 4 hours. She sustained a cardiorespiratory arrest shortly thereafter. Which of the following statements is correct?

A. This is a likely case of opiate-induced respiratory arrest.

B. The dose of Dilaudid is relatively small and cannot be the cause of the arrest.

C. Monitoring of respiratory rate and pulse oximetry will always detect early opiate-induced respiratory depression.

D. This complication is unlikely to occur in previously healthy young adults.

E. Lawsuits over iatrogenic injuries are impossible to defend even if the doctor followed community standards regarding dosage, indication, and disclosure of risks.

Answer: A. Opiate-related complications typically occur in the first post-op day, and some physicians remain unaware of the updated guidelines regarding dosage reduction for Dilaudid.

For example, it has been recommended that the intravenous order for this drug be 0.2-0.6 mg every 2-3 hours for opiate-naive patients rather than the previous 1-2 mg every 2-4 hours. Respiratory depression is the feared complication; importantly, bradypnea and desaturation in those already on oxygen are late signs. Furthermore, seemingly healthy young adults may succumb, especially where there is the concurrent use of alcohol or other CNS-modifying drugs.

Preventable adverse injuries from medication errors are a common phenomenon, estimated by the Institute of Medicine to occur in at least 1.5 million cases in the United States each year. Not all medication-related adverse events are the result of an error, as some are unforeseen or unavoidable. An effective defense for the prescribing doctor is to always adhere to community standards and document all relevant patient discussions.

Under the law of negligence, medication-related claims against the doctor require the plaintiff to prove deviation from the standard ordinarily expected under the circumstances. In addition, the patient has to show proximate causation, that is, the medication at issue both factually and legally caused the injury.

Thus, in a lower-court case in which the plaintiff suffered a perforated bowel purportedly from the use of cholestyramine and codeine that resulted in severe constipation from huge fecaliths, the doctor defendant was able to escape liability because the patient failed to exclude a barium enema procedure as the cause of the perforation.

Remember that disclosure of material treatment risks is always necessary, as well as documentation that such a discussion took place and that the patient understood and accepted the risks. The required level of disclosure may vary from jurisdiction to jurisdiction, but it is best to use the patient-centered standard, that is, what a reasonable person would want to know under the circumstances, rather than the physician-centered standard, which stands for what a reasonable doctor would disclose.

One class of drugs – opiates – bears highlighting. The therapeutic window for these drugs is narrow. The doctor should always consider accidental or deliberate overdosing, especially in the elderly, drug abusers, or those using alcohol or other drugs – especially antidepressants. In 2010, nearly 40,000 deaths resulted from drug overdoses – three quarters of the overdoses being unintentional and 17% suicidal (JAMA 2013;309:657-9). Most were from prescription drugs.

The presence of comorbid states such as cardiorespiratory disease, hypothyroidism, and renal insufficiency can also predispose to opiate-related respiratory depression.

Doctors should take a detailed and careful drug history, especially in those patients exhibiting drug-seeking behavior. Another caveat is to avoid all online prescriptions, in particular for controlled substances. Both disciplinary actions as well as potential criminal sanctions may visit the professional who is prescribing over the Internet without an established doctor-patient relationship, or where the prescription is filled in a state where the doctor is unlicensed.

Finally, recall that under the learned intermediary doctrine, the doctor, not the drug manufacturer, is liable for injuries arising out of prescription drug use. This doctrine was recently endorsed by the Supreme Court of Texas in Centocor Inc. v. Hamilton (372 S.W.3d 140 [2012]), where a lupus-like syndrome resulted from the use of infliximab (Remicade) in a woman with Crohn’s disease. All states have adopted this doctrine except for West Virginia and New Jersey, which provide for manufacturer liability where there is direct marketing of a product to consumers.

On the other hand, so-called strict liability theories for "defective" products have been repeatedly held to be inapplicable to doctors who, unlike manufacturers, are not usually considered to be sellers of the product. Strict liability is the basis for most product liability lawsuits, and all the plaintiff has to show is that the product is defective, that is, unreasonably dangerous with foreseeable consequences. No proof of fault or negligence is necessary.

Still, doctors would do well to distance themselves from companies with negligent standards. In the recent steroid-preparation scandal that led to fatal fungal meningitis in some 45 patients nationwide, some of the prescribing doctors now face lawsuits, the compounding pharmacy at issue having declared bankruptcy in the interim.

Dr. Tan is emeritus professor of medicine and a former adjunct professor of law at the University of Hawaii. This article is meant to be educational and does not constitute medical, ethical, or legal advice. It is adapted from the author’s book, "Medical Malpractice: Understanding the Law, Managing the Risk" (2006). For additional information, readers may contact the author at siang@hawaii.edu.

Question: An 85-year-old woman with a hip fracture received a narcotic following open reduction and internal fixation. Over the first post-op hour, she received two intravenous doses of 0.5 mg Dilaudid (hydromorphone), followed by an additional 2 mg in divided doses over the next 4 hours. She sustained a cardiorespiratory arrest shortly thereafter. Which of the following statements is correct?

A. This is a likely case of opiate-induced respiratory arrest.

B. The dose of Dilaudid is relatively small and cannot be the cause of the arrest.

C. Monitoring of respiratory rate and pulse oximetry will always detect early opiate-induced respiratory depression.

D. This complication is unlikely to occur in previously healthy young adults.

E. Lawsuits over iatrogenic injuries are impossible to defend even if the doctor followed community standards regarding dosage, indication, and disclosure of risks.

Answer: A. Opiate-related complications typically occur in the first post-op day, and some physicians remain unaware of the updated guidelines regarding dosage reduction for Dilaudid.

For example, it has been recommended that the intravenous order for this drug be 0.2-0.6 mg every 2-3 hours for opiate-naive patients rather than the previous 1-2 mg every 2-4 hours. Respiratory depression is the feared complication; importantly, bradypnea and desaturation in those already on oxygen are late signs. Furthermore, seemingly healthy young adults may succumb, especially where there is the concurrent use of alcohol or other CNS-modifying drugs.

Preventable adverse injuries from medication errors are a common phenomenon, estimated by the Institute of Medicine to occur in at least 1.5 million cases in the United States each year. Not all medication-related adverse events are the result of an error, as some are unforeseen or unavoidable. An effective defense for the prescribing doctor is to always adhere to community standards and document all relevant patient discussions.

Under the law of negligence, medication-related claims against the doctor require the plaintiff to prove deviation from the standard ordinarily expected under the circumstances. In addition, the patient has to show proximate causation, that is, the medication at issue both factually and legally caused the injury.

Thus, in a lower-court case in which the plaintiff suffered a perforated bowel purportedly from the use of cholestyramine and codeine that resulted in severe constipation from huge fecaliths, the doctor defendant was able to escape liability because the patient failed to exclude a barium enema procedure as the cause of the perforation.

Remember that disclosure of material treatment risks is always necessary, as well as documentation that such a discussion took place and that the patient understood and accepted the risks. The required level of disclosure may vary from jurisdiction to jurisdiction, but it is best to use the patient-centered standard, that is, what a reasonable person would want to know under the circumstances, rather than the physician-centered standard, which stands for what a reasonable doctor would disclose.

One class of drugs – opiates – bears highlighting. The therapeutic window for these drugs is narrow. The doctor should always consider accidental or deliberate overdosing, especially in the elderly, drug abusers, or those using alcohol or other drugs – especially antidepressants. In 2010, nearly 40,000 deaths resulted from drug overdoses – three quarters of the overdoses being unintentional and 17% suicidal (JAMA 2013;309:657-9). Most were from prescription drugs.

The presence of comorbid states such as cardiorespiratory disease, hypothyroidism, and renal insufficiency can also predispose to opiate-related respiratory depression.

Doctors should take a detailed and careful drug history, especially in those patients exhibiting drug-seeking behavior. Another caveat is to avoid all online prescriptions, in particular for controlled substances. Both disciplinary actions as well as potential criminal sanctions may visit the professional who is prescribing over the Internet without an established doctor-patient relationship, or where the prescription is filled in a state where the doctor is unlicensed.

Finally, recall that under the learned intermediary doctrine, the doctor, not the drug manufacturer, is liable for injuries arising out of prescription drug use. This doctrine was recently endorsed by the Supreme Court of Texas in Centocor Inc. v. Hamilton (372 S.W.3d 140 [2012]), where a lupus-like syndrome resulted from the use of infliximab (Remicade) in a woman with Crohn’s disease. All states have adopted this doctrine except for West Virginia and New Jersey, which provide for manufacturer liability where there is direct marketing of a product to consumers.

On the other hand, so-called strict liability theories for "defective" products have been repeatedly held to be inapplicable to doctors who, unlike manufacturers, are not usually considered to be sellers of the product. Strict liability is the basis for most product liability lawsuits, and all the plaintiff has to show is that the product is defective, that is, unreasonably dangerous with foreseeable consequences. No proof of fault or negligence is necessary.

Still, doctors would do well to distance themselves from companies with negligent standards. In the recent steroid-preparation scandal that led to fatal fungal meningitis in some 45 patients nationwide, some of the prescribing doctors now face lawsuits, the compounding pharmacy at issue having declared bankruptcy in the interim.

Dr. Tan is emeritus professor of medicine and a former adjunct professor of law at the University of Hawaii. This article is meant to be educational and does not constitute medical, ethical, or legal advice. It is adapted from the author’s book, "Medical Malpractice: Understanding the Law, Managing the Risk" (2006). For additional information, readers may contact the author at siang@hawaii.edu.