Law & Medicine

In May 2014, a 70-year-old retiree underwent repair of a fracture of her left ankle. The procedure was performed at a local hospital. A splint was applied to the ankle, and a nurse provided crutches.

Following discharge from the hospital, the patient hailed a taxi to take her home. As she was exiting the taxi at her residence, the patient fell and sustained comminuted fractures to the distal radius and distal ulna of her right (dominant) wrist and a trimalleolar fracture to her repaired left ankle.

The plaintiff was transported back to the hospital via ambulance. She underwent closed reduction of her wrist fractures and 11 days later was transferred to another facility for open reduction and internal fixation of her left ankle fracture. Her hospitalizations totaled 13 days and were followed by a course of inpatient rehabilitative therapy; the latter lasted until late August 2014, with a brief interruption in June when she underwent open reduction and internal fixation of her wrist fractures. When she returned home in August, the patient required the assistance of visiting aides and 3 additional months of rehabilitative therapy.

At trial, the plaintiff claimed that her left ankle and her right wrist remained painful, that she sustained a mild residual diminution of each area’s range of motion, and that these residual effects hindered her performance of basic physical activities (eg, cleaning and cooking).

The plaintiff alleged that her fall while exiting the taxi resulted from unsteadiness, which was a lingering effect of morphine that was administered during the repair of her fracture. She sought recovery of damages for past and future pain and suffering from the hospital’s operator. The lawsuit alleged that the nurse had failed to provide instructions on the proper use of crutches, that the nurse had failed to undertake measures that would have diminished the plaintiff’s likelihood of falling, that the nurse’s failures constituted malpractice and negligence, and that the hospital operator was vicariously liable for the nurse’s actions.

The plaintiff claimed that she repeatedly warned that she did not believe that she could safely use the crutches provided by the nurse. She claimed that she was unsteady and lightheaded, and that when she requested a wheelchair, an escort, or an ambulance, the nurse rejected the request. The nursing standards expert for the plaintiff opined that the request should have been satisfied or alternatively, that the nurse should have explained the manner in which a crutch-dependent person could safely enter and exit a vehicle.

Defense counsel claimed that the nurse explained proper use of the crutches, the plaintiff indicated that she understood the explanation, and the plaintiff demonstrated proper use and did not express concern. The defense’s expert contended that the nurse did not have to explain how a crutch-dependent person could safely enter and exit a vehicle and that the plaintiff’s fall resulted from her own failure to exercise appropriate caution. The defense further contended that the plaintiff achieved an excellent recovery.

Continue to: After a 7-day trial...

After a 7-day trial and 3 hours and 45 minutes’ deliberation, the jury found in favor of the plaintiff. It found that the nurse was negligent in her provision of crutches and that the act was a substantial cause of the plaintiff’s injuries. The jury also found that the nurse did not properly explain the use of crutches but determined that the error was not a substantial cause of the plaintiff’s injuries.

VERDICT

The jury awarded the plaintiff a total of $850,000 in damages. The plaintiff also recovered stipulated medical expenses.

COMMENTARY

Medical malpractice litigation involves recovery for acts or omissions that constitute a departure from the standard of care. We all recognize injurious acts—improper esophageal intubation in the emergency department, transection of a nerve in the operating room, or prescription of a contraindicated medication to an allergic patient—and acknowledge damaging omissions, such as failure to screen for colon cancer or recognize treatable diabetes.

However, some cases are disposition related; they arise from how patients are discharged, what instructions they are given, where they go, and what they do after discharge. These cases involve the patient’s medical issues engrafted on his or her transportation, job, and more generally, living environment.

The lay public expects patients to have a right of self-determination, to control the nature and course of their medical care. Yet, the modern lay public also expects the medical profession to act as an authority figure—exercising a degree of paternalism to safeguard patients from harm. This expectation is commonly articulated in retrospect, after something has gone wrong. Consequently, clinicians must be aware of what will happen to the patient after discharge.

Continue to: With all interventions...

With all interventions, weigh the post-discharge consequences. If you give an injection of hydromorphone, you cannot discharge the patient to drive home 45 minutes later. If you have diagnosed vertigo in a patient, you cannot prescribe meclizine and return that patient to her job working on scaffolding 50 ft above ground. If a frail patient lives alone and cannot safely walk, and you’ve started him on furosemide, you cannot discharge him without considering how he will get to the bathroom. Other concerns are even more difficult—for example, the homeless patient who does not have the environment or resources to follow your instructions.

It is tempting to view these concerns as not our responsibility or dismiss them as “not medicine.” Clinicians can feel frustrated at being pulled into the realm of social work, where we are ill equipped to deal with and sort out the patient’s “life problems.” For one thing, we don’t often have the resources to deal with these issues. And for another, addressing the patient’s postdischarge living situation takes time—something in short supply and intangible to the other patients in the waiting room, who are expecting your attention and wondering, “What’s the holdup?”

In the case presented, the plaintiff was a 70-year-old retiree. She was discharged from the hospital with crutches. Crutches are age-old and familiar devices. Nevertheless, crutches are for people who are able to use their arms for weight bearing and propulsion and require a fair amount of physical strength, timing, and dexterity. While a potentially debatable point, an assumption that a 70-year-old patient has the arm strength and dexterity to properly propel herself with crutches may be faulty. There was disagreement between the patient, who claimed she could not safely use the crutches, and the nurse, who said the patient accepted the crutches without concern. The safest course of action would be for discharge personnel to demonstrate the use of crutches, observe the patient using the crutches, and document that in the record.

In this case, it is unclear if the nurse demonstrated how to use the crutches or witnessed the plaintiff demonstrating she could safely use them. The jury found the nurse was negligent “in her provision” of crutches—an act they deemed a substantial cause of the plaintiff’s injuries. Interestingly, the jury did not consider the lack of explanation on the crutches’ use to be a substantial cause of injury. But the bottom line is, they faulted the nurse for the act of giving this patient crutches and awarded $850,000 in damages.

Society is changing. Fifty years ago, jurors would expect people to be familiar with crutches, and if you fell while using them, that was your own fault. Modern jurors expect hospitals and providers to get more involved in what happens to a patient after discharge. The news media has heavily publicized cases of alleged “patient dumping.”

Continue to: As a result...

As a result, we see legislative changes, such as the recently passed California Senate Bill 1152, which requires that homeless patients be fed; provided weather-appropriate clothing, filled prescriptions, and vaccinations; given medical screening, examination, and evaluation that requires the “treating physician” to arrange behavioral health care; and enrolled in “any affordable health insurance coverage for which he or she is eligible.”

Whether it is appropriate to ask hospitals and clinicians to get this involved is beyond the scope of this column. What is clear is that society increasingly expects clinicians and hospitals to take responsibility for patients. This societal change has an impact on the lay public’s perception of what is expected of health care providers. Tomorrow’s juror comes to court with a belief that hospitals and clinicians owe a duty of care that extends beyond the walls of the exam room.

IN SUMMARY

Reality test your post-treatment instructions to be sure they will work for the patient and are not grossly incompatible with his or her known postdischarge environment. To the extent possible, involve discharge planning personnel in your practice. Let your record reflect that you are acting in the patient’s best interest, and evade the temptation to squint narrowly to avoid seeing circumstances in the patient’s life that prevent safe implementation of your plan.

In May 2014, a 70-year-old retiree underwent repair of a fracture of her left ankle. The procedure was performed at a local hospital. A splint was applied to the ankle, and a nurse provided crutches.

Following discharge from the hospital, the patient hailed a taxi to take her home. As she was exiting the taxi at her residence, the patient fell and sustained comminuted fractures to the distal radius and distal ulna of her right (dominant) wrist and a trimalleolar fracture to her repaired left ankle.

The plaintiff was transported back to the hospital via ambulance. She underwent closed reduction of her wrist fractures and 11 days later was transferred to another facility for open reduction and internal fixation of her left ankle fracture. Her hospitalizations totaled 13 days and were followed by a course of inpatient rehabilitative therapy; the latter lasted until late August 2014, with a brief interruption in June when she underwent open reduction and internal fixation of her wrist fractures. When she returned home in August, the patient required the assistance of visiting aides and 3 additional months of rehabilitative therapy.

At trial, the plaintiff claimed that her left ankle and her right wrist remained painful, that she sustained a mild residual diminution of each area’s range of motion, and that these residual effects hindered her performance of basic physical activities (eg, cleaning and cooking).

The plaintiff alleged that her fall while exiting the taxi resulted from unsteadiness, which was a lingering effect of morphine that was administered during the repair of her fracture. She sought recovery of damages for past and future pain and suffering from the hospital’s operator. The lawsuit alleged that the nurse had failed to provide instructions on the proper use of crutches, that the nurse had failed to undertake measures that would have diminished the plaintiff’s likelihood of falling, that the nurse’s failures constituted malpractice and negligence, and that the hospital operator was vicariously liable for the nurse’s actions.

The plaintiff claimed that she repeatedly warned that she did not believe that she could safely use the crutches provided by the nurse. She claimed that she was unsteady and lightheaded, and that when she requested a wheelchair, an escort, or an ambulance, the nurse rejected the request. The nursing standards expert for the plaintiff opined that the request should have been satisfied or alternatively, that the nurse should have explained the manner in which a crutch-dependent person could safely enter and exit a vehicle.

Defense counsel claimed that the nurse explained proper use of the crutches, the plaintiff indicated that she understood the explanation, and the plaintiff demonstrated proper use and did not express concern. The defense’s expert contended that the nurse did not have to explain how a crutch-dependent person could safely enter and exit a vehicle and that the plaintiff’s fall resulted from her own failure to exercise appropriate caution. The defense further contended that the plaintiff achieved an excellent recovery.

Continue to: After a 7-day trial...

After a 7-day trial and 3 hours and 45 minutes’ deliberation, the jury found in favor of the plaintiff. It found that the nurse was negligent in her provision of crutches and that the act was a substantial cause of the plaintiff’s injuries. The jury also found that the nurse did not properly explain the use of crutches but determined that the error was not a substantial cause of the plaintiff’s injuries.

VERDICT

The jury awarded the plaintiff a total of $850,000 in damages. The plaintiff also recovered stipulated medical expenses.

COMMENTARY

Medical malpractice litigation involves recovery for acts or omissions that constitute a departure from the standard of care. We all recognize injurious acts—improper esophageal intubation in the emergency department, transection of a nerve in the operating room, or prescription of a contraindicated medication to an allergic patient—and acknowledge damaging omissions, such as failure to screen for colon cancer or recognize treatable diabetes.

However, some cases are disposition related; they arise from how patients are discharged, what instructions they are given, where they go, and what they do after discharge. These cases involve the patient’s medical issues engrafted on his or her transportation, job, and more generally, living environment.

The lay public expects patients to have a right of self-determination, to control the nature and course of their medical care. Yet, the modern lay public also expects the medical profession to act as an authority figure—exercising a degree of paternalism to safeguard patients from harm. This expectation is commonly articulated in retrospect, after something has gone wrong. Consequently, clinicians must be aware of what will happen to the patient after discharge.

Continue to: With all interventions...

With all interventions, weigh the post-discharge consequences. If you give an injection of hydromorphone, you cannot discharge the patient to drive home 45 minutes later. If you have diagnosed vertigo in a patient, you cannot prescribe meclizine and return that patient to her job working on scaffolding 50 ft above ground. If a frail patient lives alone and cannot safely walk, and you’ve started him on furosemide, you cannot discharge him without considering how he will get to the bathroom. Other concerns are even more difficult—for example, the homeless patient who does not have the environment or resources to follow your instructions.

It is tempting to view these concerns as not our responsibility or dismiss them as “not medicine.” Clinicians can feel frustrated at being pulled into the realm of social work, where we are ill equipped to deal with and sort out the patient’s “life problems.” For one thing, we don’t often have the resources to deal with these issues. And for another, addressing the patient’s postdischarge living situation takes time—something in short supply and intangible to the other patients in the waiting room, who are expecting your attention and wondering, “What’s the holdup?”

In the case presented, the plaintiff was a 70-year-old retiree. She was discharged from the hospital with crutches. Crutches are age-old and familiar devices. Nevertheless, crutches are for people who are able to use their arms for weight bearing and propulsion and require a fair amount of physical strength, timing, and dexterity. While a potentially debatable point, an assumption that a 70-year-old patient has the arm strength and dexterity to properly propel herself with crutches may be faulty. There was disagreement between the patient, who claimed she could not safely use the crutches, and the nurse, who said the patient accepted the crutches without concern. The safest course of action would be for discharge personnel to demonstrate the use of crutches, observe the patient using the crutches, and document that in the record.

In this case, it is unclear if the nurse demonstrated how to use the crutches or witnessed the plaintiff demonstrating she could safely use them. The jury found the nurse was negligent “in her provision” of crutches—an act they deemed a substantial cause of the plaintiff’s injuries. Interestingly, the jury did not consider the lack of explanation on the crutches’ use to be a substantial cause of injury. But the bottom line is, they faulted the nurse for the act of giving this patient crutches and awarded $850,000 in damages.

Society is changing. Fifty years ago, jurors would expect people to be familiar with crutches, and if you fell while using them, that was your own fault. Modern jurors expect hospitals and providers to get more involved in what happens to a patient after discharge. The news media has heavily publicized cases of alleged “patient dumping.”

Continue to: As a result...

As a result, we see legislative changes, such as the recently passed California Senate Bill 1152, which requires that homeless patients be fed; provided weather-appropriate clothing, filled prescriptions, and vaccinations; given medical screening, examination, and evaluation that requires the “treating physician” to arrange behavioral health care; and enrolled in “any affordable health insurance coverage for which he or she is eligible.”

Whether it is appropriate to ask hospitals and clinicians to get this involved is beyond the scope of this column. What is clear is that society increasingly expects clinicians and hospitals to take responsibility for patients. This societal change has an impact on the lay public’s perception of what is expected of health care providers. Tomorrow’s juror comes to court with a belief that hospitals and clinicians owe a duty of care that extends beyond the walls of the exam room.

IN SUMMARY

Reality test your post-treatment instructions to be sure they will work for the patient and are not grossly incompatible with his or her known postdischarge environment. To the extent possible, involve discharge planning personnel in your practice. Let your record reflect that you are acting in the patient’s best interest, and evade the temptation to squint narrowly to avoid seeing circumstances in the patient’s life that prevent safe implementation of your plan.

In May 2014, a 70-year-old retiree underwent repair of a fracture of her left ankle. The procedure was performed at a local hospital. A splint was applied to the ankle, and a nurse provided crutches.

Following discharge from the hospital, the patient hailed a taxi to take her home. As she was exiting the taxi at her residence, the patient fell and sustained comminuted fractures to the distal radius and distal ulna of her right (dominant) wrist and a trimalleolar fracture to her repaired left ankle.

The plaintiff was transported back to the hospital via ambulance. She underwent closed reduction of her wrist fractures and 11 days later was transferred to another facility for open reduction and internal fixation of her left ankle fracture. Her hospitalizations totaled 13 days and were followed by a course of inpatient rehabilitative therapy; the latter lasted until late August 2014, with a brief interruption in June when she underwent open reduction and internal fixation of her wrist fractures. When she returned home in August, the patient required the assistance of visiting aides and 3 additional months of rehabilitative therapy.

At trial, the plaintiff claimed that her left ankle and her right wrist remained painful, that she sustained a mild residual diminution of each area’s range of motion, and that these residual effects hindered her performance of basic physical activities (eg, cleaning and cooking).

The plaintiff alleged that her fall while exiting the taxi resulted from unsteadiness, which was a lingering effect of morphine that was administered during the repair of her fracture. She sought recovery of damages for past and future pain and suffering from the hospital’s operator. The lawsuit alleged that the nurse had failed to provide instructions on the proper use of crutches, that the nurse had failed to undertake measures that would have diminished the plaintiff’s likelihood of falling, that the nurse’s failures constituted malpractice and negligence, and that the hospital operator was vicariously liable for the nurse’s actions.

The plaintiff claimed that she repeatedly warned that she did not believe that she could safely use the crutches provided by the nurse. She claimed that she was unsteady and lightheaded, and that when she requested a wheelchair, an escort, or an ambulance, the nurse rejected the request. The nursing standards expert for the plaintiff opined that the request should have been satisfied or alternatively, that the nurse should have explained the manner in which a crutch-dependent person could safely enter and exit a vehicle.

Defense counsel claimed that the nurse explained proper use of the crutches, the plaintiff indicated that she understood the explanation, and the plaintiff demonstrated proper use and did not express concern. The defense’s expert contended that the nurse did not have to explain how a crutch-dependent person could safely enter and exit a vehicle and that the plaintiff’s fall resulted from her own failure to exercise appropriate caution. The defense further contended that the plaintiff achieved an excellent recovery.

Continue to: After a 7-day trial...

After a 7-day trial and 3 hours and 45 minutes’ deliberation, the jury found in favor of the plaintiff. It found that the nurse was negligent in her provision of crutches and that the act was a substantial cause of the plaintiff’s injuries. The jury also found that the nurse did not properly explain the use of crutches but determined that the error was not a substantial cause of the plaintiff’s injuries.

VERDICT

The jury awarded the plaintiff a total of $850,000 in damages. The plaintiff also recovered stipulated medical expenses.

COMMENTARY

Medical malpractice litigation involves recovery for acts or omissions that constitute a departure from the standard of care. We all recognize injurious acts—improper esophageal intubation in the emergency department, transection of a nerve in the operating room, or prescription of a contraindicated medication to an allergic patient—and acknowledge damaging omissions, such as failure to screen for colon cancer or recognize treatable diabetes.

However, some cases are disposition related; they arise from how patients are discharged, what instructions they are given, where they go, and what they do after discharge. These cases involve the patient’s medical issues engrafted on his or her transportation, job, and more generally, living environment.

The lay public expects patients to have a right of self-determination, to control the nature and course of their medical care. Yet, the modern lay public also expects the medical profession to act as an authority figure—exercising a degree of paternalism to safeguard patients from harm. This expectation is commonly articulated in retrospect, after something has gone wrong. Consequently, clinicians must be aware of what will happen to the patient after discharge.

Continue to: With all interventions...

With all interventions, weigh the post-discharge consequences. If you give an injection of hydromorphone, you cannot discharge the patient to drive home 45 minutes later. If you have diagnosed vertigo in a patient, you cannot prescribe meclizine and return that patient to her job working on scaffolding 50 ft above ground. If a frail patient lives alone and cannot safely walk, and you’ve started him on furosemide, you cannot discharge him without considering how he will get to the bathroom. Other concerns are even more difficult—for example, the homeless patient who does not have the environment or resources to follow your instructions.

It is tempting to view these concerns as not our responsibility or dismiss them as “not medicine.” Clinicians can feel frustrated at being pulled into the realm of social work, where we are ill equipped to deal with and sort out the patient’s “life problems.” For one thing, we don’t often have the resources to deal with these issues. And for another, addressing the patient’s postdischarge living situation takes time—something in short supply and intangible to the other patients in the waiting room, who are expecting your attention and wondering, “What’s the holdup?”

In the case presented, the plaintiff was a 70-year-old retiree. She was discharged from the hospital with crutches. Crutches are age-old and familiar devices. Nevertheless, crutches are for people who are able to use their arms for weight bearing and propulsion and require a fair amount of physical strength, timing, and dexterity. While a potentially debatable point, an assumption that a 70-year-old patient has the arm strength and dexterity to properly propel herself with crutches may be faulty. There was disagreement between the patient, who claimed she could not safely use the crutches, and the nurse, who said the patient accepted the crutches without concern. The safest course of action would be for discharge personnel to demonstrate the use of crutches, observe the patient using the crutches, and document that in the record.

In this case, it is unclear if the nurse demonstrated how to use the crutches or witnessed the plaintiff demonstrating she could safely use them. The jury found the nurse was negligent “in her provision” of crutches—an act they deemed a substantial cause of the plaintiff’s injuries. Interestingly, the jury did not consider the lack of explanation on the crutches’ use to be a substantial cause of injury. But the bottom line is, they faulted the nurse for the act of giving this patient crutches and awarded $850,000 in damages.

Society is changing. Fifty years ago, jurors would expect people to be familiar with crutches, and if you fell while using them, that was your own fault. Modern jurors expect hospitals and providers to get more involved in what happens to a patient after discharge. The news media has heavily publicized cases of alleged “patient dumping.”

Continue to: As a result...

As a result, we see legislative changes, such as the recently passed California Senate Bill 1152, which requires that homeless patients be fed; provided weather-appropriate clothing, filled prescriptions, and vaccinations; given medical screening, examination, and evaluation that requires the “treating physician” to arrange behavioral health care; and enrolled in “any affordable health insurance coverage for which he or she is eligible.”

Whether it is appropriate to ask hospitals and clinicians to get this involved is beyond the scope of this column. What is clear is that society increasingly expects clinicians and hospitals to take responsibility for patients. This societal change has an impact on the lay public’s perception of what is expected of health care providers. Tomorrow’s juror comes to court with a belief that hospitals and clinicians owe a duty of care that extends beyond the walls of the exam room.

IN SUMMARY

Reality test your post-treatment instructions to be sure they will work for the patient and are not grossly incompatible with his or her known postdischarge environment. To the extent possible, involve discharge planning personnel in your practice. Let your record reflect that you are acting in the patient’s best interest, and evade the temptation to squint narrowly to avoid seeing circumstances in the patient’s life that prevent safe implementation of your plan.

Question: Which one of the following statements regarding complementary and alternative medicine (CAM) is correct?

A. CAM practitioners are just as likely as medical doctors to be sued.

B. Damages arising out of the use of CAM may be compensable if there is clear and convincing evidence of substandard care, and the plaintiff can prove legal causation.

C. An acupuncturist who treats an asthmatic patient will be sued if he/she fails to refer the patient to a medical specialist.

D. Obtaining informed consent after discussing all therapeutic options and material risks is especially important for those who practice CAM.

E. It is not a valid defense that the patient had fully and willingly assumed the risk of treatment.

Answer: D. Compared with medical doctors, non-MD practitioners of CAM pay lower malpractice insurance premiums, as they are much less likely to be sued, and patient injuries are usually less severe.

CAM covers a broad range of healing philosophies, approaches, and therapies that are typically outside mainstream Western medicine. It comprises modalities such as chiropractic, acupuncture, massage therapy, naturopathic medicine, nutritional therapy, and others.

More than half of the U.S. population uses some form of CAM, which is widely perceived as a natural and effective means of promoting overall well being in addition to treating a specific illness. The scope of practice for CAM providers is defined and limited by state rather than federal statutes, and enforced by regulatory bodies.

CAM treatments are generally noninvasive, and there are fewer than 50 indemnity insurers in the country for chiropractors, massage therapists, and acupuncturists, underwriting some 5% of the total medical malpractice insurance market.

In the event of an injury, damages are recoverable if there is a preponderance of evidence to indicate substandard care. “Clear and convincing” is a higher evidentiary level of legal proof, and it is not required in a negligence action. Whether an acupuncturist will be sued successfully for treating an asthmatic patient will depend on many factors, for example, whether it is an acceptable CAM practice in the jurisdiction, whether there is any statutory restriction on such treatment, whether there was a failure of a timely referral, etc.

Finally, assumption of risk is a valid defense in a negligence tort action under some circumstances.

For a negligence claim to prevail, the plaintiff must establish breach of duty, i.e., that the defendant deviated from the standard of care ordinarily exercised by a similarly situated practitioner. In addition to falling below that level of skill, practitioners may also be sued for having failed to refer to a medical doctor, for practicing outside the scope of CAM, or for venturing into traditional Western medical practice.

In one instance, a plaintiff alleged that he was led to believe that chiropractic manipulation would help his diabetes. The court found in favor of the plaintiff and awarded damages.¹ In another, the plaintiff successfully sued a chiropractor for failing to take x-rays and refer to a medical doctor. The court held that the defendant fell below the standard of care, as the state licensing board required physician referral when the problem extended beyond the limits of chiropractic practice.²

However, an injured party does not always prevail. In Miyamoto v. Lazo, the plaintiff claimed that Dr. Lazo, a chiropractor, negligently treated his injuries from a car accident.³ The patient was taking Coumadin and developed a hematoma in his left shoulder following chiropractic treatment. This was complicated by neuropathy in his left hand when the hematoma expanded and required surgical drainage.

The jury, however, found Dr. Lazo not liable, because of evidence that a hematoma could spontaneously arise in someone on an anticoagulant.

Injured patients have also filed lawsuits against other CAM practitioners. Allegations against acupuncturists have included cases of pneumothorax, wrongful death in an adolescent girl with asthma, and burns from a heat lamp.⁴ And in Wallman v. Kelley,a plaintiff developed liver damage and filed negligence and breach of implied warranty claims against a seller of Chinese herbal medicine.⁵ The court held that the defendant was not liable, as the plaintiff failed to prove causation or give timely notice of suit.

Medical doctors are increasingly incorporating CAM into their practices, so they must adhere to CAM standards in addition to their own medical standards.

In Charell v. Gonzalez, a cancer patient refused conventional treatment by oncologists and opted instead for nutritional therapy by a physician.⁶ Her cancer metastasized, and she alleged negligence and failure to warn of risks. The jury found the physician 51% liable for departure from standard of care and lack of informed consent. The plaintiff was found to be 49% at fault for choosing to ignore the recommendations of her oncologists.

Even if it’s the patient’s choice, physicians must still exercise due care when implementing therapy.

In Gonzalez v. New York State Department of Health, Dr. Gonzales was charged with gross negligence and incompetence after he used nutritional therapies to treat six patients with incurable cancer who had failed or rejected conventional treatment.⁷

The hearing committee found that he missed signs of disease progression and failed to perform adequate assessments, testing, and follow-up evaluations. The court held that a patient’s consent to or even insistence upon a certain treatment does not relieve the physician from the obligation of treating the patient with the usual standard of care.

In general, a physician may employ several legal defenses to avert liability following an adverse event.

One defense is to assert the “respectable minority” standard of care, if it can be shown that a respectable minority in the medical community also accepts the treatment in question.

A second defense is assumption of risk. In Schneider v. Revici, a physician delivered nutritional (selenium and dietary restrictions) and other nonsurgical treatment for breast cancer after the patient refused conventional treatments offered by other physicians.⁸ The patient signed a detailed consent form releasing the physician from liability and acknowledging that the defendant’s treatments lacked Food and Drug Administration approval, and that no results could be guaranteed.

The cancer spread, and the patient sued for common law fraud, medical malpractice, and lack of informed consent. The court of appeals held that assumption of risk is a complete defense to malpractice. The same court also held in another case that a patient’s failure to sign a consent form did not preclude the jury from considering the assumption of risk defense.

A third defense, rarely successful, is to invoke “clinical innovation” when CAM is used to alleviate a desperate situation, for example, if the patient is terminal or has failed conventional therapy. The defendant-physician may plead involvement in a clinical trial study, or show that the unorthodox treatment is based on extensive personal experience or some newly discovered developments in the field.

When discussing CAM, the physician should first fully inform the patient about conventional treatments and their limitations. Next, the physician should explain why the “novel” rather than the recognized conventional therapy is being considered. Finally, whether the physician intends to carry out CAM therapy or refer to another practitioner, the patient must be warned about the potential risks associated with such therapy.
 

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

References

1. Wengel v. Herfert, 473 N.W.2d 741 (1991).

2. Salazar v. Ehmann, 505 P.2d 387 (1972).

3. Miyamoto v. Lum and Lazo, 84 P.3d 509 (2004).

4. Rosenberg v. Jing Jiang, 153 A.D.3d 744 (2017).

5. Wallman v. Kelley, 976 P.2d 330 (1998).

6. Charell v. Gonzales, 673 N.Y.S. 2d 685 (1998).

7. Gonzales v. NYS DOH, 232 A.D.2d 886 (1996).

8. Schneider v. Revici, 817 F. 2d 987 (1987).

Question: Which one of the following statements regarding complementary and alternative medicine (CAM) is correct?

A. CAM practitioners are just as likely as medical doctors to be sued.

B. Damages arising out of the use of CAM may be compensable if there is clear and convincing evidence of substandard care, and the plaintiff can prove legal causation.

C. An acupuncturist who treats an asthmatic patient will be sued if he/she fails to refer the patient to a medical specialist.

D. Obtaining informed consent after discussing all therapeutic options and material risks is especially important for those who practice CAM.

E. It is not a valid defense that the patient had fully and willingly assumed the risk of treatment.

Answer: D. Compared with medical doctors, non-MD practitioners of CAM pay lower malpractice insurance premiums, as they are much less likely to be sued, and patient injuries are usually less severe.

CAM covers a broad range of healing philosophies, approaches, and therapies that are typically outside mainstream Western medicine. It comprises modalities such as chiropractic, acupuncture, massage therapy, naturopathic medicine, nutritional therapy, and others.

More than half of the U.S. population uses some form of CAM, which is widely perceived as a natural and effective means of promoting overall well being in addition to treating a specific illness. The scope of practice for CAM providers is defined and limited by state rather than federal statutes, and enforced by regulatory bodies.

CAM treatments are generally noninvasive, and there are fewer than 50 indemnity insurers in the country for chiropractors, massage therapists, and acupuncturists, underwriting some 5% of the total medical malpractice insurance market.

In the event of an injury, damages are recoverable if there is a preponderance of evidence to indicate substandard care. “Clear and convincing” is a higher evidentiary level of legal proof, and it is not required in a negligence action. Whether an acupuncturist will be sued successfully for treating an asthmatic patient will depend on many factors, for example, whether it is an acceptable CAM practice in the jurisdiction, whether there is any statutory restriction on such treatment, whether there was a failure of a timely referral, etc.

Finally, assumption of risk is a valid defense in a negligence tort action under some circumstances.

For a negligence claim to prevail, the plaintiff must establish breach of duty, i.e., that the defendant deviated from the standard of care ordinarily exercised by a similarly situated practitioner. In addition to falling below that level of skill, practitioners may also be sued for having failed to refer to a medical doctor, for practicing outside the scope of CAM, or for venturing into traditional Western medical practice.

In one instance, a plaintiff alleged that he was led to believe that chiropractic manipulation would help his diabetes. The court found in favor of the plaintiff and awarded damages.¹ In another, the plaintiff successfully sued a chiropractor for failing to take x-rays and refer to a medical doctor. The court held that the defendant fell below the standard of care, as the state licensing board required physician referral when the problem extended beyond the limits of chiropractic practice.²

However, an injured party does not always prevail. In Miyamoto v. Lazo, the plaintiff claimed that Dr. Lazo, a chiropractor, negligently treated his injuries from a car accident.³ The patient was taking Coumadin and developed a hematoma in his left shoulder following chiropractic treatment. This was complicated by neuropathy in his left hand when the hematoma expanded and required surgical drainage.

The jury, however, found Dr. Lazo not liable, because of evidence that a hematoma could spontaneously arise in someone on an anticoagulant.

Injured patients have also filed lawsuits against other CAM practitioners. Allegations against acupuncturists have included cases of pneumothorax, wrongful death in an adolescent girl with asthma, and burns from a heat lamp.⁴ And in Wallman v. Kelley,a plaintiff developed liver damage and filed negligence and breach of implied warranty claims against a seller of Chinese herbal medicine.⁵ The court held that the defendant was not liable, as the plaintiff failed to prove causation or give timely notice of suit.

Medical doctors are increasingly incorporating CAM into their practices, so they must adhere to CAM standards in addition to their own medical standards.

In Charell v. Gonzalez, a cancer patient refused conventional treatment by oncologists and opted instead for nutritional therapy by a physician.⁶ Her cancer metastasized, and she alleged negligence and failure to warn of risks. The jury found the physician 51% liable for departure from standard of care and lack of informed consent. The plaintiff was found to be 49% at fault for choosing to ignore the recommendations of her oncologists.

Even if it’s the patient’s choice, physicians must still exercise due care when implementing therapy.

In Gonzalez v. New York State Department of Health, Dr. Gonzales was charged with gross negligence and incompetence after he used nutritional therapies to treat six patients with incurable cancer who had failed or rejected conventional treatment.⁷

The hearing committee found that he missed signs of disease progression and failed to perform adequate assessments, testing, and follow-up evaluations. The court held that a patient’s consent to or even insistence upon a certain treatment does not relieve the physician from the obligation of treating the patient with the usual standard of care.

In general, a physician may employ several legal defenses to avert liability following an adverse event.

One defense is to assert the “respectable minority” standard of care, if it can be shown that a respectable minority in the medical community also accepts the treatment in question.

A second defense is assumption of risk. In Schneider v. Revici, a physician delivered nutritional (selenium and dietary restrictions) and other nonsurgical treatment for breast cancer after the patient refused conventional treatments offered by other physicians.⁸ The patient signed a detailed consent form releasing the physician from liability and acknowledging that the defendant’s treatments lacked Food and Drug Administration approval, and that no results could be guaranteed.

The cancer spread, and the patient sued for common law fraud, medical malpractice, and lack of informed consent. The court of appeals held that assumption of risk is a complete defense to malpractice. The same court also held in another case that a patient’s failure to sign a consent form did not preclude the jury from considering the assumption of risk defense.

A third defense, rarely successful, is to invoke “clinical innovation” when CAM is used to alleviate a desperate situation, for example, if the patient is terminal or has failed conventional therapy. The defendant-physician may plead involvement in a clinical trial study, or show that the unorthodox treatment is based on extensive personal experience or some newly discovered developments in the field.

When discussing CAM, the physician should first fully inform the patient about conventional treatments and their limitations. Next, the physician should explain why the “novel” rather than the recognized conventional therapy is being considered. Finally, whether the physician intends to carry out CAM therapy or refer to another practitioner, the patient must be warned about the potential risks associated with such therapy.
 

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

References

1. Wengel v. Herfert, 473 N.W.2d 741 (1991).

2. Salazar v. Ehmann, 505 P.2d 387 (1972).

3. Miyamoto v. Lum and Lazo, 84 P.3d 509 (2004).

4. Rosenberg v. Jing Jiang, 153 A.D.3d 744 (2017).

5. Wallman v. Kelley, 976 P.2d 330 (1998).

6. Charell v. Gonzales, 673 N.Y.S. 2d 685 (1998).

7. Gonzales v. NYS DOH, 232 A.D.2d 886 (1996).

8. Schneider v. Revici, 817 F. 2d 987 (1987).

Question: Which one of the following statements regarding complementary and alternative medicine (CAM) is correct?

A. CAM practitioners are just as likely as medical doctors to be sued.

B. Damages arising out of the use of CAM may be compensable if there is clear and convincing evidence of substandard care, and the plaintiff can prove legal causation.

C. An acupuncturist who treats an asthmatic patient will be sued if he/she fails to refer the patient to a medical specialist.

D. Obtaining informed consent after discussing all therapeutic options and material risks is especially important for those who practice CAM.

E. It is not a valid defense that the patient had fully and willingly assumed the risk of treatment.

Answer: D. Compared with medical doctors, non-MD practitioners of CAM pay lower malpractice insurance premiums, as they are much less likely to be sued, and patient injuries are usually less severe.

CAM covers a broad range of healing philosophies, approaches, and therapies that are typically outside mainstream Western medicine. It comprises modalities such as chiropractic, acupuncture, massage therapy, naturopathic medicine, nutritional therapy, and others.

More than half of the U.S. population uses some form of CAM, which is widely perceived as a natural and effective means of promoting overall well being in addition to treating a specific illness. The scope of practice for CAM providers is defined and limited by state rather than federal statutes, and enforced by regulatory bodies.

CAM treatments are generally noninvasive, and there are fewer than 50 indemnity insurers in the country for chiropractors, massage therapists, and acupuncturists, underwriting some 5% of the total medical malpractice insurance market.

In the event of an injury, damages are recoverable if there is a preponderance of evidence to indicate substandard care. “Clear and convincing” is a higher evidentiary level of legal proof, and it is not required in a negligence action. Whether an acupuncturist will be sued successfully for treating an asthmatic patient will depend on many factors, for example, whether it is an acceptable CAM practice in the jurisdiction, whether there is any statutory restriction on such treatment, whether there was a failure of a timely referral, etc.

Finally, assumption of risk is a valid defense in a negligence tort action under some circumstances.

For a negligence claim to prevail, the plaintiff must establish breach of duty, i.e., that the defendant deviated from the standard of care ordinarily exercised by a similarly situated practitioner. In addition to falling below that level of skill, practitioners may also be sued for having failed to refer to a medical doctor, for practicing outside the scope of CAM, or for venturing into traditional Western medical practice.

In one instance, a plaintiff alleged that he was led to believe that chiropractic manipulation would help his diabetes. The court found in favor of the plaintiff and awarded damages.¹ In another, the plaintiff successfully sued a chiropractor for failing to take x-rays and refer to a medical doctor. The court held that the defendant fell below the standard of care, as the state licensing board required physician referral when the problem extended beyond the limits of chiropractic practice.²

However, an injured party does not always prevail. In Miyamoto v. Lazo, the plaintiff claimed that Dr. Lazo, a chiropractor, negligently treated his injuries from a car accident.³ The patient was taking Coumadin and developed a hematoma in his left shoulder following chiropractic treatment. This was complicated by neuropathy in his left hand when the hematoma expanded and required surgical drainage.

The jury, however, found Dr. Lazo not liable, because of evidence that a hematoma could spontaneously arise in someone on an anticoagulant.

Injured patients have also filed lawsuits against other CAM practitioners. Allegations against acupuncturists have included cases of pneumothorax, wrongful death in an adolescent girl with asthma, and burns from a heat lamp.⁴ And in Wallman v. Kelley,a plaintiff developed liver damage and filed negligence and breach of implied warranty claims against a seller of Chinese herbal medicine.⁵ The court held that the defendant was not liable, as the plaintiff failed to prove causation or give timely notice of suit.

Medical doctors are increasingly incorporating CAM into their practices, so they must adhere to CAM standards in addition to their own medical standards.

In Charell v. Gonzalez, a cancer patient refused conventional treatment by oncologists and opted instead for nutritional therapy by a physician.⁶ Her cancer metastasized, and she alleged negligence and failure to warn of risks. The jury found the physician 51% liable for departure from standard of care and lack of informed consent. The plaintiff was found to be 49% at fault for choosing to ignore the recommendations of her oncologists.

Even if it’s the patient’s choice, physicians must still exercise due care when implementing therapy.

In Gonzalez v. New York State Department of Health, Dr. Gonzales was charged with gross negligence and incompetence after he used nutritional therapies to treat six patients with incurable cancer who had failed or rejected conventional treatment.⁷

The hearing committee found that he missed signs of disease progression and failed to perform adequate assessments, testing, and follow-up evaluations. The court held that a patient’s consent to or even insistence upon a certain treatment does not relieve the physician from the obligation of treating the patient with the usual standard of care.

In general, a physician may employ several legal defenses to avert liability following an adverse event.

One defense is to assert the “respectable minority” standard of care, if it can be shown that a respectable minority in the medical community also accepts the treatment in question.

A second defense is assumption of risk. In Schneider v. Revici, a physician delivered nutritional (selenium and dietary restrictions) and other nonsurgical treatment for breast cancer after the patient refused conventional treatments offered by other physicians.⁸ The patient signed a detailed consent form releasing the physician from liability and acknowledging that the defendant’s treatments lacked Food and Drug Administration approval, and that no results could be guaranteed.

The cancer spread, and the patient sued for common law fraud, medical malpractice, and lack of informed consent. The court of appeals held that assumption of risk is a complete defense to malpractice. The same court also held in another case that a patient’s failure to sign a consent form did not preclude the jury from considering the assumption of risk defense.

A third defense, rarely successful, is to invoke “clinical innovation” when CAM is used to alleviate a desperate situation, for example, if the patient is terminal or has failed conventional therapy. The defendant-physician may plead involvement in a clinical trial study, or show that the unorthodox treatment is based on extensive personal experience or some newly discovered developments in the field.

When discussing CAM, the physician should first fully inform the patient about conventional treatments and their limitations. Next, the physician should explain why the “novel” rather than the recognized conventional therapy is being considered. Finally, whether the physician intends to carry out CAM therapy or refer to another practitioner, the patient must be warned about the potential risks associated with such therapy.
 

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

References

1. Wengel v. Herfert, 473 N.W.2d 741 (1991).

2. Salazar v. Ehmann, 505 P.2d 387 (1972).

3. Miyamoto v. Lum and Lazo, 84 P.3d 509 (2004).

4. Rosenberg v. Jing Jiang, 153 A.D.3d 744 (2017).

5. Wallman v. Kelley, 976 P.2d 330 (1998).

6. Charell v. Gonzales, 673 N.Y.S. 2d 685 (1998).

7. Gonzales v. NYS DOH, 232 A.D.2d 886 (1996).

8. Schneider v. Revici, 817 F. 2d 987 (1987).

Question: You are moonlighting in the emergency department and have just finished treating a 5-year-old boy with an apparent Colles’ fracture, who was accompanied by his mother with bruises on her face. Her exam revealed additional bruises over her abdominal wall. The mother said they accidentally tripped and fell down the stairs, and spontaneously denied any acts of violence in the family.

Given this scenario, which of the following is best?

A. You suspect both child and spousal abuse, but lack sufficient evidence to report the incident.

B. Failure to report based on reasonable suspicion alone may amount to a criminal offense punishable by possible imprisonment.

C. You may face a potential malpractice lawsuit if subsequent injuries caused by abuse could have been prevented had you reported.

D. Mandatory reporting laws apply not only to abuse of children and spouses, but also of the elderly and other vulnerable adults.

E. All are correct except A.

Answer: E. All doctors, especially those working in emergency departments, treat injuries on a regular basis. Accidents probably account for the majority of these injuries, but the most pernicious are those caused by willful abuse or neglect. Such conduct, believed to be widespread and underrecognized, victimizes children, women, the elderly, and other vulnerable groups.

Mandatory reporting laws arose from the need to identify and prevent these activities that cause serious harm and loss of lives. Physicians and other health care workers are in a prime position to diagnose or raise the suspicion of abuse and neglect. This article focuses on laws that mandate physician reporting of such behavior. Not addressed are other reportable situations such as certain infectious diseases, gunshot wounds, threats to third parties, and so on.
 

Child abuse

The best-known example of a mandatory reporting law relates to child abuse, which is broadly defined as when a parent or caretaker emotionally, physically, or sexually abuses, neglects, or abandons a child. Child abuse laws are intended to protect children from serious harm without abridging parental discipline of their children.

Cases of child abuse are pervasive; four or five children are tragically killed by abuse or neglect every day, and each year, some 6 million children are reported as victims of child abuse. Henry Kempe’s studies on the “battered child syndrome” in 1962 served to underscore the physician’s role in exposing child maltreatment, and 1973 saw the enactment of the Child Abuse Prevention and Treatment Act, which set standards for mandatory reporting as a condition for federal funding.

All U.S. states have statutes identifying persons who are required to report suspected child maltreatment to an appropriate agency, such as child protective services. Reasonable suspicion, without need for proof, is sufficient to trigger the mandatory reporting duty. A summary of the general reporting requirements, as well as each state’s key statutory features, are available at Child Welfare Information Gateway.¹

Bruises, fractures, and burns are recurring examples of injuries resulting from child abuse, but there are many others, including severe emotional harm, which is an important consequence. Clues to abuse include a child’s fearful and anxious demeanor, wearing clothes to hide injuries, and inappropriate sexual conduct.² The perpetrators and/or complicit parties typically blame an innocent home accident for the victim’s injuries to mislead the health care provider.
 

Elder abuse

Elder abuse is broadly construed to include physical, sexual, and psychological abuse, as well as financial exploitation and caregiver neglect.³ It is a serious problem in the United States, estimated in 2008 to affect 1 in 10 elders. The figure is likely an underestimate, because many elderly victims are afraid or unwilling to lodge a complaint against the abuser whom they love and may depend upon.⁴

The law, which protects the “elderly” (e.g., those aged 62 years or older in Hawaii), may also be extended to other younger vulnerable adults, who because of an impairment, are unable to 1) communicate or make responsible decisions to manage one’s own care or resources, 2) carry out or arrange for essential activities of daily living, or 3) protect one’s self from abuse.⁵

The law mandates reporting where there is reason to believe abuse has occurred or the vulnerable adult is in danger of abuse if immediate action is not taken. Reporting statutes for elder abuse vary somewhat on the identity of mandated reporters (health care providers are always included), the victim’s mental capacity, dwelling place (home or in an assisted-living facility), and type of purported activity that warrants reporting.
 

Domestic violence

As defined by the National Coalition Against Domestic Violence, “Domestic violence is the willful intimidation, physical assault, battery, sexual assault, and/or other abusive behavior as part of a systematic pattern of power and control perpetrated by one intimate partner against another. ... The frequency and severity of domestic violence can vary dramatically; however, the one constant component of domestic violence is one partner’s consistent efforts to maintain power and control over the other.”⁶ Domestic violence is said to have reached epidemic proportions, with one in four women experiencing it at some point in her life.

Virtually all states mandate the reporting of domestic violence by health care providers if there is a reasonable suspicion that observed patient injuries are the result of physical abuse.⁷ California, for example, requires the provider to call local law enforcement as soon as possible or to send in a written report within 48 hours.

There may be exceptions to required reporting, as when an adult victim withholds consent but accepts victim referral services. State laws encourage but do not always require that the health care provider inform the patient about the report, but federal law dictates otherwise unless this puts the patient at risk. Hawaii’s domestic violence laws were originally enacted to deter spousal abuse, but they now also protect other household members.⁸

Any individual who assumes a duty or responsibility pursuant to all of these reporting laws is immunized from criminal or civil liability. On the other hand, a mandated reporter who knowingly fails to report an incident or who willfully prevents another person from reporting such an incident commits a criminal offence.

In the case of a physician, there is the added risk of a malpractice lawsuit based on “violation of statute” (breach of a legal duty), should another injury occur down the road that was arguably preventable by his or her failure to report.

Experts generally believe that mandatory reporting laws are important in identifying child maltreatment. However, it has been asserted that despite a 5-decade history of mandatory reporting, no clear endpoints attest to the efficacy of this approach, and it is argued that no data exist to demonstrate that incremental increases in reporting have contributed to child safety.

Particularly challenging are attempts at impact comparisons between states with different policies. A number of countries, including the United Kingdom, do not have mandatory reporting laws and regulate reporting by professional societies.⁹

In addition, some critics of mandatory reporting raise concerns surrounding law enforcement showing up at the victim’s house to question the family about abuse, or to make an arrest or issue warnings. They posit that when the behavior of an abuser is under scrutiny, this can paradoxically create a potentially more dangerous environment for the patient-victim, whom the perpetrator now considers to have betrayed his or her trust. Others bemoan that revealing patient confidences violates the physician’s ethical code.

However, the intolerable incidence of violence against the vulnerable has properly made mandatory reporting the law of the land. Although the criminal penalty is currently light for failure to report, there is a move toward increasing its severity. Hawaii, for example, recently introduced Senate Bill 2477 that makes nonreporting by those required to do so a Class C felony punishable by up to 5 years in prison. The offense currently is a petty misdemeanor punishable by up to 30 days in jail.
 

Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. For additional information, readers may contact the author at siang@hawaii.edu.

References

1. Child Welfare Information Gateway (2016). Mandatory reporters of child abuse and neglect. Washington, D.C.: U.S. Department of Health and Human Services, Children’s Bureau. Available at www.childwelfare.gov; email: info@childwelfare.gov; phone: 800-394-3366.

2. Available at www.childwelfare.gov/topics/can.

3. Available at www.justice.gov/elderjustice/elder-justice-statutes-0.

4. Available at www.cdc.gov/violenceprevention/elderabuse/index.html.

5. Hawaii Revised Statutes, Sec. 346-222, 346-224, 346-250, 412:3-114.5.

6. Available at ncadv.org.

7. Ann Emerg Med. 2002 Jan;39(1):56-60.

8. Hawaii Revised Statutes, Sec. 709-906.

9. Pediatrics. 2017 Apr;139(4). pii: e20163511.

Question: You are moonlighting in the emergency department and have just finished treating a 5-year-old boy with an apparent Colles’ fracture, who was accompanied by his mother with bruises on her face. Her exam revealed additional bruises over her abdominal wall. The mother said they accidentally tripped and fell down the stairs, and spontaneously denied any acts of violence in the family.

Given this scenario, which of the following is best?

A. You suspect both child and spousal abuse, but lack sufficient evidence to report the incident.

B. Failure to report based on reasonable suspicion alone may amount to a criminal offense punishable by possible imprisonment.

C. You may face a potential malpractice lawsuit if subsequent injuries caused by abuse could have been prevented had you reported.

D. Mandatory reporting laws apply not only to abuse of children and spouses, but also of the elderly and other vulnerable adults.

E. All are correct except A.

Answer: E. All doctors, especially those working in emergency departments, treat injuries on a regular basis. Accidents probably account for the majority of these injuries, but the most pernicious are those caused by willful abuse or neglect. Such conduct, believed to be widespread and underrecognized, victimizes children, women, the elderly, and other vulnerable groups.

Mandatory reporting laws arose from the need to identify and prevent these activities that cause serious harm and loss of lives. Physicians and other health care workers are in a prime position to diagnose or raise the suspicion of abuse and neglect. This article focuses on laws that mandate physician reporting of such behavior. Not addressed are other reportable situations such as certain infectious diseases, gunshot wounds, threats to third parties, and so on.
 

Child abuse

The best-known example of a mandatory reporting law relates to child abuse, which is broadly defined as when a parent or caretaker emotionally, physically, or sexually abuses, neglects, or abandons a child. Child abuse laws are intended to protect children from serious harm without abridging parental discipline of their children.

Cases of child abuse are pervasive; four or five children are tragically killed by abuse or neglect every day, and each year, some 6 million children are reported as victims of child abuse. Henry Kempe’s studies on the “battered child syndrome” in 1962 served to underscore the physician’s role in exposing child maltreatment, and 1973 saw the enactment of the Child Abuse Prevention and Treatment Act, which set standards for mandatory reporting as a condition for federal funding.

All U.S. states have statutes identifying persons who are required to report suspected child maltreatment to an appropriate agency, such as child protective services. Reasonable suspicion, without need for proof, is sufficient to trigger the mandatory reporting duty. A summary of the general reporting requirements, as well as each state’s key statutory features, are available at Child Welfare Information Gateway.¹

Bruises, fractures, and burns are recurring examples of injuries resulting from child abuse, but there are many others, including severe emotional harm, which is an important consequence. Clues to abuse include a child’s fearful and anxious demeanor, wearing clothes to hide injuries, and inappropriate sexual conduct.² The perpetrators and/or complicit parties typically blame an innocent home accident for the victim’s injuries to mislead the health care provider.
 

Elder abuse

Elder abuse is broadly construed to include physical, sexual, and psychological abuse, as well as financial exploitation and caregiver neglect.³ It is a serious problem in the United States, estimated in 2008 to affect 1 in 10 elders. The figure is likely an underestimate, because many elderly victims are afraid or unwilling to lodge a complaint against the abuser whom they love and may depend upon.⁴

The law, which protects the “elderly” (e.g., those aged 62 years or older in Hawaii), may also be extended to other younger vulnerable adults, who because of an impairment, are unable to 1) communicate or make responsible decisions to manage one’s own care or resources, 2) carry out or arrange for essential activities of daily living, or 3) protect one’s self from abuse.⁵

The law mandates reporting where there is reason to believe abuse has occurred or the vulnerable adult is in danger of abuse if immediate action is not taken. Reporting statutes for elder abuse vary somewhat on the identity of mandated reporters (health care providers are always included), the victim’s mental capacity, dwelling place (home or in an assisted-living facility), and type of purported activity that warrants reporting.
 

Domestic violence

As defined by the National Coalition Against Domestic Violence, “Domestic violence is the willful intimidation, physical assault, battery, sexual assault, and/or other abusive behavior as part of a systematic pattern of power and control perpetrated by one intimate partner against another. ... The frequency and severity of domestic violence can vary dramatically; however, the one constant component of domestic violence is one partner’s consistent efforts to maintain power and control over the other.”⁶ Domestic violence is said to have reached epidemic proportions, with one in four women experiencing it at some point in her life.

Virtually all states mandate the reporting of domestic violence by health care providers if there is a reasonable suspicion that observed patient injuries are the result of physical abuse.⁷ California, for example, requires the provider to call local law enforcement as soon as possible or to send in a written report within 48 hours.

There may be exceptions to required reporting, as when an adult victim withholds consent but accepts victim referral services. State laws encourage but do not always require that the health care provider inform the patient about the report, but federal law dictates otherwise unless this puts the patient at risk. Hawaii’s domestic violence laws were originally enacted to deter spousal abuse, but they now also protect other household members.⁸

Any individual who assumes a duty or responsibility pursuant to all of these reporting laws is immunized from criminal or civil liability. On the other hand, a mandated reporter who knowingly fails to report an incident or who willfully prevents another person from reporting such an incident commits a criminal offence.

In the case of a physician, there is the added risk of a malpractice lawsuit based on “violation of statute” (breach of a legal duty), should another injury occur down the road that was arguably preventable by his or her failure to report.

Experts generally believe that mandatory reporting laws are important in identifying child maltreatment. However, it has been asserted that despite a 5-decade history of mandatory reporting, no clear endpoints attest to the efficacy of this approach, and it is argued that no data exist to demonstrate that incremental increases in reporting have contributed to child safety.

Particularly challenging are attempts at impact comparisons between states with different policies. A number of countries, including the United Kingdom, do not have mandatory reporting laws and regulate reporting by professional societies.⁹

In addition, some critics of mandatory reporting raise concerns surrounding law enforcement showing up at the victim’s house to question the family about abuse, or to make an arrest or issue warnings. They posit that when the behavior of an abuser is under scrutiny, this can paradoxically create a potentially more dangerous environment for the patient-victim, whom the perpetrator now considers to have betrayed his or her trust. Others bemoan that revealing patient confidences violates the physician’s ethical code.

However, the intolerable incidence of violence against the vulnerable has properly made mandatory reporting the law of the land. Although the criminal penalty is currently light for failure to report, there is a move toward increasing its severity. Hawaii, for example, recently introduced Senate Bill 2477 that makes nonreporting by those required to do so a Class C felony punishable by up to 5 years in prison. The offense currently is a petty misdemeanor punishable by up to 30 days in jail.
 

Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. For additional information, readers may contact the author at siang@hawaii.edu.

References

1. Child Welfare Information Gateway (2016). Mandatory reporters of child abuse and neglect. Washington, D.C.: U.S. Department of Health and Human Services, Children’s Bureau. Available at www.childwelfare.gov; email: info@childwelfare.gov; phone: 800-394-3366.

2. Available at www.childwelfare.gov/topics/can.

3. Available at www.justice.gov/elderjustice/elder-justice-statutes-0.

4. Available at www.cdc.gov/violenceprevention/elderabuse/index.html.

5. Hawaii Revised Statutes, Sec. 346-222, 346-224, 346-250, 412:3-114.5.

6. Available at ncadv.org.

7. Ann Emerg Med. 2002 Jan;39(1):56-60.

8. Hawaii Revised Statutes, Sec. 709-906.

9. Pediatrics. 2017 Apr;139(4). pii: e20163511.

Question: You are moonlighting in the emergency department and have just finished treating a 5-year-old boy with an apparent Colles’ fracture, who was accompanied by his mother with bruises on her face. Her exam revealed additional bruises over her abdominal wall. The mother said they accidentally tripped and fell down the stairs, and spontaneously denied any acts of violence in the family.

Given this scenario, which of the following is best?

A. You suspect both child and spousal abuse, but lack sufficient evidence to report the incident.

B. Failure to report based on reasonable suspicion alone may amount to a criminal offense punishable by possible imprisonment.

C. You may face a potential malpractice lawsuit if subsequent injuries caused by abuse could have been prevented had you reported.

D. Mandatory reporting laws apply not only to abuse of children and spouses, but also of the elderly and other vulnerable adults.

E. All are correct except A.

Answer: E. All doctors, especially those working in emergency departments, treat injuries on a regular basis. Accidents probably account for the majority of these injuries, but the most pernicious are those caused by willful abuse or neglect. Such conduct, believed to be widespread and underrecognized, victimizes children, women, the elderly, and other vulnerable groups.

Mandatory reporting laws arose from the need to identify and prevent these activities that cause serious harm and loss of lives. Physicians and other health care workers are in a prime position to diagnose or raise the suspicion of abuse and neglect. This article focuses on laws that mandate physician reporting of such behavior. Not addressed are other reportable situations such as certain infectious diseases, gunshot wounds, threats to third parties, and so on.
 

Child abuse

The best-known example of a mandatory reporting law relates to child abuse, which is broadly defined as when a parent or caretaker emotionally, physically, or sexually abuses, neglects, or abandons a child. Child abuse laws are intended to protect children from serious harm without abridging parental discipline of their children.

Cases of child abuse are pervasive; four or five children are tragically killed by abuse or neglect every day, and each year, some 6 million children are reported as victims of child abuse. Henry Kempe’s studies on the “battered child syndrome” in 1962 served to underscore the physician’s role in exposing child maltreatment, and 1973 saw the enactment of the Child Abuse Prevention and Treatment Act, which set standards for mandatory reporting as a condition for federal funding.

All U.S. states have statutes identifying persons who are required to report suspected child maltreatment to an appropriate agency, such as child protective services. Reasonable suspicion, without need for proof, is sufficient to trigger the mandatory reporting duty. A summary of the general reporting requirements, as well as each state’s key statutory features, are available at Child Welfare Information Gateway.¹

Bruises, fractures, and burns are recurring examples of injuries resulting from child abuse, but there are many others, including severe emotional harm, which is an important consequence. Clues to abuse include a child’s fearful and anxious demeanor, wearing clothes to hide injuries, and inappropriate sexual conduct.² The perpetrators and/or complicit parties typically blame an innocent home accident for the victim’s injuries to mislead the health care provider.
 

Elder abuse

Elder abuse is broadly construed to include physical, sexual, and psychological abuse, as well as financial exploitation and caregiver neglect.³ It is a serious problem in the United States, estimated in 2008 to affect 1 in 10 elders. The figure is likely an underestimate, because many elderly victims are afraid or unwilling to lodge a complaint against the abuser whom they love and may depend upon.⁴

The law, which protects the “elderly” (e.g., those aged 62 years or older in Hawaii), may also be extended to other younger vulnerable adults, who because of an impairment, are unable to 1) communicate or make responsible decisions to manage one’s own care or resources, 2) carry out or arrange for essential activities of daily living, or 3) protect one’s self from abuse.⁵

The law mandates reporting where there is reason to believe abuse has occurred or the vulnerable adult is in danger of abuse if immediate action is not taken. Reporting statutes for elder abuse vary somewhat on the identity of mandated reporters (health care providers are always included), the victim’s mental capacity, dwelling place (home or in an assisted-living facility), and type of purported activity that warrants reporting.
 

Domestic violence

As defined by the National Coalition Against Domestic Violence, “Domestic violence is the willful intimidation, physical assault, battery, sexual assault, and/or other abusive behavior as part of a systematic pattern of power and control perpetrated by one intimate partner against another. ... The frequency and severity of domestic violence can vary dramatically; however, the one constant component of domestic violence is one partner’s consistent efforts to maintain power and control over the other.”⁶ Domestic violence is said to have reached epidemic proportions, with one in four women experiencing it at some point in her life.

Virtually all states mandate the reporting of domestic violence by health care providers if there is a reasonable suspicion that observed patient injuries are the result of physical abuse.⁷ California, for example, requires the provider to call local law enforcement as soon as possible or to send in a written report within 48 hours.

There may be exceptions to required reporting, as when an adult victim withholds consent but accepts victim referral services. State laws encourage but do not always require that the health care provider inform the patient about the report, but federal law dictates otherwise unless this puts the patient at risk. Hawaii’s domestic violence laws were originally enacted to deter spousal abuse, but they now also protect other household members.⁸

Any individual who assumes a duty or responsibility pursuant to all of these reporting laws is immunized from criminal or civil liability. On the other hand, a mandated reporter who knowingly fails to report an incident or who willfully prevents another person from reporting such an incident commits a criminal offence.

In the case of a physician, there is the added risk of a malpractice lawsuit based on “violation of statute” (breach of a legal duty), should another injury occur down the road that was arguably preventable by his or her failure to report.

Experts generally believe that mandatory reporting laws are important in identifying child maltreatment. However, it has been asserted that despite a 5-decade history of mandatory reporting, no clear endpoints attest to the efficacy of this approach, and it is argued that no data exist to demonstrate that incremental increases in reporting have contributed to child safety.

Particularly challenging are attempts at impact comparisons between states with different policies. A number of countries, including the United Kingdom, do not have mandatory reporting laws and regulate reporting by professional societies.⁹

In addition, some critics of mandatory reporting raise concerns surrounding law enforcement showing up at the victim’s house to question the family about abuse, or to make an arrest or issue warnings. They posit that when the behavior of an abuser is under scrutiny, this can paradoxically create a potentially more dangerous environment for the patient-victim, whom the perpetrator now considers to have betrayed his or her trust. Others bemoan that revealing patient confidences violates the physician’s ethical code.

However, the intolerable incidence of violence against the vulnerable has properly made mandatory reporting the law of the land. Although the criminal penalty is currently light for failure to report, there is a move toward increasing its severity. Hawaii, for example, recently introduced Senate Bill 2477 that makes nonreporting by those required to do so a Class C felony punishable by up to 5 years in prison. The offense currently is a petty misdemeanor punishable by up to 30 days in jail.
 

Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. For additional information, readers may contact the author at siang@hawaii.edu.

References

1. Child Welfare Information Gateway (2016). Mandatory reporters of child abuse and neglect. Washington, D.C.: U.S. Department of Health and Human Services, Children’s Bureau. Available at www.childwelfare.gov; email: info@childwelfare.gov; phone: 800-394-3366.

2. Available at www.childwelfare.gov/topics/can.

3. Available at www.justice.gov/elderjustice/elder-justice-statutes-0.

4. Available at www.cdc.gov/violenceprevention/elderabuse/index.html.

5. Hawaii Revised Statutes, Sec. 346-222, 346-224, 346-250, 412:3-114.5.

6. Available at ncadv.org.

7. Ann Emerg Med. 2002 Jan;39(1):56-60.

8. Hawaii Revised Statutes, Sec. 709-906.

9. Pediatrics. 2017 Apr;139(4). pii: e20163511.

Question: Hospice liability may exist in which of the following?

A. False claims in violation of Medicare rules regarding eligible beneficiaries.

B. False claims for continuous home care services.

C. Negligent billing practices.

D. Only A and B are correct.

E. A, B, and C are correct.

Answer: D. With an aging population and better end-of-life care, the United States has in the last decade witnessed about a 50% increase in the number of hospices. Hospice care is a Medicare-covered benefit, and most hospices operate on a for-profit basis. Although occasionally institution based, services are more often offered as an outpatient or home-care option. In 2016, hospice care reached 1.4 million beneficiaries, with total Medicare expenditure of $16.7 billion.¹

There are two broad categories of legal jeopardy that hospices face: Medicare fraud and malpractice lawsuits. This article will address these two issues. In addition, hospices, like all health care institutions, face numerous other liabilities, such as negligent hiring, breach of confidentiality, premise liability, HIPAA violations, sexual harassment, vicarious liability, and many others.

Medicare fraud

The False Claims Act (FCA) is an old law enacted by Congress way back in 1863. It imposes liability for submitting a payment demand to the federal government where there is actual or constructive knowledge that the claim is false.²

Intent to defraud is not a required element. But knowing or reckless disregard of the truth or material misrepresentation are required, although negligence is insufficient to constitute a violation. Penalties include treble damages, costs and attorney fees, and fines of $11,000 per false claim – as well as possible imprisonment. The FCA is the most prominent health care antifraud statute.³ Two others are the federal Anti-Kickback Statute and the Stark Law.

A recent example of hospice fraud involved Ohio’s Chemed and Vitas Hospice Services, which were accused of knowingly billing for hospice-ineligible patients and inflated levels of care.⁴

The government alleged that the defendants rewarded employees with bonuses based on the number of patients receiving hospice services, irrespective of whether they were actually terminally ill or needed continuous home care services (CHCS). CHCS commands the highest Medicare daily rate and is meant only for the temporary treatment of acute symptoms constituting a medical crisis.

According to the complaint, the defendants set aggressive billing goals for CHCS without regard to whether the patients actually required such a level of service. The defendants agreed to pay $75 million to settle the lawsuit, the largest in the history of hospice false-claim settlements.

Can an alleged wrong prognosis regarding life expectancy amount to a false claim? Under Medicare rules, a physician certifying that a patient is eligible for hospice care must attest that the condition is terminal, with death expected within 6 months.

AseraCare, a hospice company, was accused of knowingly submitting false claims to Medicare by certifying patients as eligible for hospice. The government claimed that the medical records of the 123 patients at issue did not contain clinical information and other documentation that supported the medical prognosis, and thus, AseraCare’s claims for those patients were false.

AseraCare won a summary judgment defending against the $200 million lawsuit in a federal district court in Alabama. The court opined that, when hospice-certifying physicians and government medical experts look at the very same medical records and disagree about eligibility, the opinion of one medical expert alone cannot prove falsity without further evidence of an objective falsehood.⁵ The government, however, has appealed the decision to the Court of Appeals for the Eleventh Circuit.

Malpractice

Hospices have their share of malpractice litigation, and judgments may be substantial because of noneconomic losses such as pain and suffering, not to mention punitive damages.

For example, in 2013a Maryland jury awarded more than $950,000 to a family that alleged that the decedent’s death was caused by the excessive use of morphine and oxycodone in treating her infected ulcers. Such treatment was deemed suitable for a hospice-type situation, but in fact, the patient was not expected to die within 6 months.

Her husband and two children argued successfully that the hospital committed malpractice by misdiagnosing her need for hospice care and by performing unnecessary surgery. The bulk of the judgment was for pain and suffering and other noneconomic damages.

In another negligence suit, a 66-year-old woman died in a hospice after receiving an overdose of Dilaudid for pancreatic cancer, which an autopsy revealed she did not have. In that case, the plaintiffs were awarded $4.5 million in a wrongful death lawsuit filed against Hospice Ministries and its medical director. The jury awarded the family $4 million in monetary compensation and $500,000 in punitive damages.

The case of McGregor v. Hospice Care of Louisiana is illustrative of a malpractice action with a focus on expert testimony.⁶ The issue in this case was whether the testimony of the plaintiffs’ expert, Bruce Samuels, MD, was admissible and whether it correctly addressed the requisite standard of care.

The decedent had terminal metastatic prostate cancer and was under the care of an oncologist. He eventually enrolled as a patient of Hospice of Baton Rouge, whose nurses visited him in his home several times a week. They reported their findings to the attending oncologist, who prescribed a total of 40 morphine suppositories to be administered 1-2 per hour as needed for pain. However, the prescription noted that only half – that is, 20 suppositories – were to be filled, and stipulated when the remaining 20 suppositories could be released.

Believing that his father was in pain, the patient’s son demanded the early release of the remaining 20 morphine suppositories; he also refused to allow the nurse to assess the patient and exhibited threatening behavior toward her. After conferring with the oncologist on call, the hospice discharged the patient from its care. An ambulance later took the patient to a hospital, where he died that evening.

The family filed a lawsuit against the hospice, alleging negligence in failing to release the remaining 20 morphine suppositories and in abandoning the patient by discharging him. At trial, the jury rendered a verdict in favor of the hospice, after the court excluded the testimony of the plaintiffs’ expert as being outside his expertise. However, the Louisiana Supreme Court found that the trial court erred in excluding his testimony.

On remand, the appellate court affirmed the trial court’s judgment that the plaintiffs had failed to meet the burden of proof showing negligence. It found that the expert, Dr. Samuels, admitted he had never written a partial-fill prescription before and that he did not know who had the authority to authorize the pharmacist to release the remainder of the partial fill prescription in this case.

In addition, Dr. Samuels acknowledged that a nurse has the obligation to assess a patient and report her findings to the physician and follow any orders of the physician. Further, the nurse indicated that the doctor had instructed her to discharge the patient, not from the doctor’s care, but for treatment to be continued at the hospital.

Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the materials have been taken from earlier columns in Internal Medicine News. For additional information, readers may contact the author at siang@hawaii.edu.

References

1. “Medicare’s most indefensible fraud hotspot: Hospice care.” CNBC, Modern Medicine, Aug. 3, 2018.

2. 31 U.S. Code, Section 3729(a)(1)(A).

3. Tan SY. “Update on the False Claims Act.” Internal Medicine News, April 5, 2017.

4. U.S. Department of Justice, Office of Public Affairs, Oct. 30, 2017.

5. U.S. ex rel. Paradies et al. v. AseraCare Inc. et al., case number 2:12-CV-245-KOB, in the U.S. District Court for the Northern District of Alabama, March 31, 2016.

6. McGregor v. Hospice Care of Louisiana in Baton Rouge, LLC, No. 2013 CA 1979R, consolidated with No. 2013 CA 1980R. Court of Appeals of Louisiana, First Circuit, judgment rendered Sept. 21, 2015.

Question: Hospice liability may exist in which of the following?

A. False claims in violation of Medicare rules regarding eligible beneficiaries.

B. False claims for continuous home care services.

C. Negligent billing practices.

D. Only A and B are correct.

E. A, B, and C are correct.

Answer: D. With an aging population and better end-of-life care, the United States has in the last decade witnessed about a 50% increase in the number of hospices. Hospice care is a Medicare-covered benefit, and most hospices operate on a for-profit basis. Although occasionally institution based, services are more often offered as an outpatient or home-care option. In 2016, hospice care reached 1.4 million beneficiaries, with total Medicare expenditure of $16.7 billion.¹

There are two broad categories of legal jeopardy that hospices face: Medicare fraud and malpractice lawsuits. This article will address these two issues. In addition, hospices, like all health care institutions, face numerous other liabilities, such as negligent hiring, breach of confidentiality, premise liability, HIPAA violations, sexual harassment, vicarious liability, and many others.

Medicare fraud

The False Claims Act (FCA) is an old law enacted by Congress way back in 1863. It imposes liability for submitting a payment demand to the federal government where there is actual or constructive knowledge that the claim is false.²

Intent to defraud is not a required element. But knowing or reckless disregard of the truth or material misrepresentation are required, although negligence is insufficient to constitute a violation. Penalties include treble damages, costs and attorney fees, and fines of $11,000 per false claim – as well as possible imprisonment. The FCA is the most prominent health care antifraud statute.³ Two others are the federal Anti-Kickback Statute and the Stark Law.

A recent example of hospice fraud involved Ohio’s Chemed and Vitas Hospice Services, which were accused of knowingly billing for hospice-ineligible patients and inflated levels of care.⁴

The government alleged that the defendants rewarded employees with bonuses based on the number of patients receiving hospice services, irrespective of whether they were actually terminally ill or needed continuous home care services (CHCS). CHCS commands the highest Medicare daily rate and is meant only for the temporary treatment of acute symptoms constituting a medical crisis.

According to the complaint, the defendants set aggressive billing goals for CHCS without regard to whether the patients actually required such a level of service. The defendants agreed to pay $75 million to settle the lawsuit, the largest in the history of hospice false-claim settlements.

Can an alleged wrong prognosis regarding life expectancy amount to a false claim? Under Medicare rules, a physician certifying that a patient is eligible for hospice care must attest that the condition is terminal, with death expected within 6 months.

AseraCare, a hospice company, was accused of knowingly submitting false claims to Medicare by certifying patients as eligible for hospice. The government claimed that the medical records of the 123 patients at issue did not contain clinical information and other documentation that supported the medical prognosis, and thus, AseraCare’s claims for those patients were false.

AseraCare won a summary judgment defending against the $200 million lawsuit in a federal district court in Alabama. The court opined that, when hospice-certifying physicians and government medical experts look at the very same medical records and disagree about eligibility, the opinion of one medical expert alone cannot prove falsity without further evidence of an objective falsehood.⁵ The government, however, has appealed the decision to the Court of Appeals for the Eleventh Circuit.

Malpractice

Hospices have their share of malpractice litigation, and judgments may be substantial because of noneconomic losses such as pain and suffering, not to mention punitive damages.

For example, in 2013a Maryland jury awarded more than $950,000 to a family that alleged that the decedent’s death was caused by the excessive use of morphine and oxycodone in treating her infected ulcers. Such treatment was deemed suitable for a hospice-type situation, but in fact, the patient was not expected to die within 6 months.

Her husband and two children argued successfully that the hospital committed malpractice by misdiagnosing her need for hospice care and by performing unnecessary surgery. The bulk of the judgment was for pain and suffering and other noneconomic damages.

In another negligence suit, a 66-year-old woman died in a hospice after receiving an overdose of Dilaudid for pancreatic cancer, which an autopsy revealed she did not have. In that case, the plaintiffs were awarded $4.5 million in a wrongful death lawsuit filed against Hospice Ministries and its medical director. The jury awarded the family $4 million in monetary compensation and $500,000 in punitive damages.

The case of McGregor v. Hospice Care of Louisiana is illustrative of a malpractice action with a focus on expert testimony.⁶ The issue in this case was whether the testimony of the plaintiffs’ expert, Bruce Samuels, MD, was admissible and whether it correctly addressed the requisite standard of care.

The decedent had terminal metastatic prostate cancer and was under the care of an oncologist. He eventually enrolled as a patient of Hospice of Baton Rouge, whose nurses visited him in his home several times a week. They reported their findings to the attending oncologist, who prescribed a total of 40 morphine suppositories to be administered 1-2 per hour as needed for pain. However, the prescription noted that only half – that is, 20 suppositories – were to be filled, and stipulated when the remaining 20 suppositories could be released.

Believing that his father was in pain, the patient’s son demanded the early release of the remaining 20 morphine suppositories; he also refused to allow the nurse to assess the patient and exhibited threatening behavior toward her. After conferring with the oncologist on call, the hospice discharged the patient from its care. An ambulance later took the patient to a hospital, where he died that evening.

The family filed a lawsuit against the hospice, alleging negligence in failing to release the remaining 20 morphine suppositories and in abandoning the patient by discharging him. At trial, the jury rendered a verdict in favor of the hospice, after the court excluded the testimony of the plaintiffs’ expert as being outside his expertise. However, the Louisiana Supreme Court found that the trial court erred in excluding his testimony.

On remand, the appellate court affirmed the trial court’s judgment that the plaintiffs had failed to meet the burden of proof showing negligence. It found that the expert, Dr. Samuels, admitted he had never written a partial-fill prescription before and that he did not know who had the authority to authorize the pharmacist to release the remainder of the partial fill prescription in this case.

In addition, Dr. Samuels acknowledged that a nurse has the obligation to assess a patient and report her findings to the physician and follow any orders of the physician. Further, the nurse indicated that the doctor had instructed her to discharge the patient, not from the doctor’s care, but for treatment to be continued at the hospital.

Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the materials have been taken from earlier columns in Internal Medicine News. For additional information, readers may contact the author at siang@hawaii.edu.

References

1. “Medicare’s most indefensible fraud hotspot: Hospice care.” CNBC, Modern Medicine, Aug. 3, 2018.

2. 31 U.S. Code, Section 3729(a)(1)(A).

3. Tan SY. “Update on the False Claims Act.” Internal Medicine News, April 5, 2017.

4. U.S. Department of Justice, Office of Public Affairs, Oct. 30, 2017.

5. U.S. ex rel. Paradies et al. v. AseraCare Inc. et al., case number 2:12-CV-245-KOB, in the U.S. District Court for the Northern District of Alabama, March 31, 2016.

6. McGregor v. Hospice Care of Louisiana in Baton Rouge, LLC, No. 2013 CA 1979R, consolidated with No. 2013 CA 1980R. Court of Appeals of Louisiana, First Circuit, judgment rendered Sept. 21, 2015.

Question: Hospice liability may exist in which of the following?

A. False claims in violation of Medicare rules regarding eligible beneficiaries.

B. False claims for continuous home care services.

C. Negligent billing practices.

D. Only A and B are correct.

E. A, B, and C are correct.

Answer: D. With an aging population and better end-of-life care, the United States has in the last decade witnessed about a 50% increase in the number of hospices. Hospice care is a Medicare-covered benefit, and most hospices operate on a for-profit basis. Although occasionally institution based, services are more often offered as an outpatient or home-care option. In 2016, hospice care reached 1.4 million beneficiaries, with total Medicare expenditure of $16.7 billion.¹

There are two broad categories of legal jeopardy that hospices face: Medicare fraud and malpractice lawsuits. This article will address these two issues. In addition, hospices, like all health care institutions, face numerous other liabilities, such as negligent hiring, breach of confidentiality, premise liability, HIPAA violations, sexual harassment, vicarious liability, and many others.

Medicare fraud

The False Claims Act (FCA) is an old law enacted by Congress way back in 1863. It imposes liability for submitting a payment demand to the federal government where there is actual or constructive knowledge that the claim is false.²

Intent to defraud is not a required element. But knowing or reckless disregard of the truth or material misrepresentation are required, although negligence is insufficient to constitute a violation. Penalties include treble damages, costs and attorney fees, and fines of $11,000 per false claim – as well as possible imprisonment. The FCA is the most prominent health care antifraud statute.³ Two others are the federal Anti-Kickback Statute and the Stark Law.

A recent example of hospice fraud involved Ohio’s Chemed and Vitas Hospice Services, which were accused of knowingly billing for hospice-ineligible patients and inflated levels of care.⁴

The government alleged that the defendants rewarded employees with bonuses based on the number of patients receiving hospice services, irrespective of whether they were actually terminally ill or needed continuous home care services (CHCS). CHCS commands the highest Medicare daily rate and is meant only for the temporary treatment of acute symptoms constituting a medical crisis.

According to the complaint, the defendants set aggressive billing goals for CHCS without regard to whether the patients actually required such a level of service. The defendants agreed to pay $75 million to settle the lawsuit, the largest in the history of hospice false-claim settlements.

Can an alleged wrong prognosis regarding life expectancy amount to a false claim? Under Medicare rules, a physician certifying that a patient is eligible for hospice care must attest that the condition is terminal, with death expected within 6 months.

AseraCare, a hospice company, was accused of knowingly submitting false claims to Medicare by certifying patients as eligible for hospice. The government claimed that the medical records of the 123 patients at issue did not contain clinical information and other documentation that supported the medical prognosis, and thus, AseraCare’s claims for those patients were false.

AseraCare won a summary judgment defending against the $200 million lawsuit in a federal district court in Alabama. The court opined that, when hospice-certifying physicians and government medical experts look at the very same medical records and disagree about eligibility, the opinion of one medical expert alone cannot prove falsity without further evidence of an objective falsehood.⁵ The government, however, has appealed the decision to the Court of Appeals for the Eleventh Circuit.

Malpractice

Hospices have their share of malpractice litigation, and judgments may be substantial because of noneconomic losses such as pain and suffering, not to mention punitive damages.

For example, in 2013a Maryland jury awarded more than $950,000 to a family that alleged that the decedent’s death was caused by the excessive use of morphine and oxycodone in treating her infected ulcers. Such treatment was deemed suitable for a hospice-type situation, but in fact, the patient was not expected to die within 6 months.

Her husband and two children argued successfully that the hospital committed malpractice by misdiagnosing her need for hospice care and by performing unnecessary surgery. The bulk of the judgment was for pain and suffering and other noneconomic damages.

In another negligence suit, a 66-year-old woman died in a hospice after receiving an overdose of Dilaudid for pancreatic cancer, which an autopsy revealed she did not have. In that case, the plaintiffs were awarded $4.5 million in a wrongful death lawsuit filed against Hospice Ministries and its medical director. The jury awarded the family $4 million in monetary compensation and $500,000 in punitive damages.

The case of McGregor v. Hospice Care of Louisiana is illustrative of a malpractice action with a focus on expert testimony.⁶ The issue in this case was whether the testimony of the plaintiffs’ expert, Bruce Samuels, MD, was admissible and whether it correctly addressed the requisite standard of care.

The decedent had terminal metastatic prostate cancer and was under the care of an oncologist. He eventually enrolled as a patient of Hospice of Baton Rouge, whose nurses visited him in his home several times a week. They reported their findings to the attending oncologist, who prescribed a total of 40 morphine suppositories to be administered 1-2 per hour as needed for pain. However, the prescription noted that only half – that is, 20 suppositories – were to be filled, and stipulated when the remaining 20 suppositories could be released.

Believing that his father was in pain, the patient’s son demanded the early release of the remaining 20 morphine suppositories; he also refused to allow the nurse to assess the patient and exhibited threatening behavior toward her. After conferring with the oncologist on call, the hospice discharged the patient from its care. An ambulance later took the patient to a hospital, where he died that evening.

The family filed a lawsuit against the hospice, alleging negligence in failing to release the remaining 20 morphine suppositories and in abandoning the patient by discharging him. At trial, the jury rendered a verdict in favor of the hospice, after the court excluded the testimony of the plaintiffs’ expert as being outside his expertise. However, the Louisiana Supreme Court found that the trial court erred in excluding his testimony.

On remand, the appellate court affirmed the trial court’s judgment that the plaintiffs had failed to meet the burden of proof showing negligence. It found that the expert, Dr. Samuels, admitted he had never written a partial-fill prescription before and that he did not know who had the authority to authorize the pharmacist to release the remainder of the partial fill prescription in this case.

In addition, Dr. Samuels acknowledged that a nurse has the obligation to assess a patient and report her findings to the physician and follow any orders of the physician. Further, the nurse indicated that the doctor had instructed her to discharge the patient, not from the doctor’s care, but for treatment to be continued at the hospital.

Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the materials have been taken from earlier columns in Internal Medicine News. For additional information, readers may contact the author at siang@hawaii.edu.

References

1. “Medicare’s most indefensible fraud hotspot: Hospice care.” CNBC, Modern Medicine, Aug. 3, 2018.

2. 31 U.S. Code, Section 3729(a)(1)(A).

3. Tan SY. “Update on the False Claims Act.” Internal Medicine News, April 5, 2017.

4. U.S. Department of Justice, Office of Public Affairs, Oct. 30, 2017.

5. U.S. ex rel. Paradies et al. v. AseraCare Inc. et al., case number 2:12-CV-245-KOB, in the U.S. District Court for the Northern District of Alabama, March 31, 2016.

6. McGregor v. Hospice Care of Louisiana in Baton Rouge, LLC, No. 2013 CA 1979R, consolidated with No. 2013 CA 1980R. Court of Appeals of Louisiana, First Circuit, judgment rendered Sept. 21, 2015.

Question: Regarding medical care aboard cruise ships, which of the following is incorrect?

A. It is difficult to prove negligence because of jurisdictional issues.

B. The American College of Emergency Physicians has published practice guidelines.

C. Cruise line owners are immune from liability under the Barbetta rule.

D. The Franza decision may be a game changer.

E. Lawsuits are on the increase.

Answer: A. More and more people are cruising, with the number of passengers on North American lines reaching nearly 18 million in 2017, about one-third out of Florida. Medical illnesses and accidents predictably occur at sea, and unfortunately, substandard and negligent care occasionally follows some of these mishaps.

However, up until recently, courts have immunized cruise line owners from legal liability by relying on the so-called Barbetta rule, which is based on historical notions of limited resources at sea and the impossibility of exerting control over the conduct of a ship’s health care providers.

A 2007 Florida case is illustrative. The doctor aboard a Carnival cruise ship failed to diagnose acute appendicitis in a 14-year-old girl who had complained of several days of abdominal symptoms. As a result, the patient ruptured her appendix, and this eventually resulted in sterility. The parents sued the cruise line, which denied liability because the doctor was not an employee, a fact specifically disclosed in the cruise ticket.

Although the doctor’s contract stated that he was an independent contractor, the District Court of Appeal of Florida reasoned that, in a claim based on agency, it is the right of control rather than actual control itself that matters.

It therefore held that: “for purposes of fulfilling cruise line’s duty to exercise reasonable care, the ship’s doctor is an agent of cruise line whose negligence should be imputed to cruise line ... regardless of the contractual status ascribed to the doctor” and to the extent cruise ticket sought to limit cruise line’s liability for negligence of doctor, it was invalid.

However, the Florida Supreme Court quashed this decision, because federal maritime law has historically protected shipowners from liability flowing from the medical negligence of shipboard physicians.¹

The Barbetta rule was named after a 1988 case in which Florence L. Barbetta suffered serious medical complications during a Mexican cruise out of Florida. The ship’s doctor was alleged to have been negligent for his failure to diagnose diabetes.² The lower court dismissed the case, and the appellate court affirmed.

The appellate court noted that an impressive number of courts from many jurisdictions have, for almost 100 years, followed the same basic rule: If the doctor is negligent in treating a passenger, that negligence will not be imputed to the carrier unless the carrier itself was negligent in hiring the doctor.

Citing approvingly from another case, the appellate court noted: “[A] shipping company is not in the business of providing medical services to passengers; it does not possess the expertise requisite to supervise a physician or surgeon carried on board a ship as a convenience to passengers. A ship is not a floating hospital; a ship’s physician is an independent medical expert engaged on the basis of his professional qualifications and carried on board a ship for the convenience of passengers, who are free to contract with him for any medical services they may require.”

However, courts now appear ready to jettison this rule.

In the 2014 case of Franza v. Royal Caribbean Cruises, Ltd., a passenger fell and hit his head while his ship was at port in Bermuda.³ He died several days later, allegedly because of negligence and delay by the ship’s medical staff. The lower courts barred the lawsuit, based on Barbetta, but on appeal, the 11th Circuit Court reversed. It rejected the historical justifications for immunizing shipowners from liability, concluding that past reasons were no longer applicable to modern-day cruise ships.

The court wrote: “Here, the roots of the Barbetta rule snake back to a wholly different world. Instead of 19th-century steamships, we now confront state-of-the-art cruise ships that house thousands of people and operate as floating cities complete with well-stocked modern infirmaries and urgent-care centers. In place of independent doctors and nurses, we must now acknowledge that medical professionals routinely work for corporate masters. And whereas ships historically went ‘off the grid’ when they set sail, modern technology enables distant ships to communicate instantaneously with the mainland in meaningful ways.”

However, the injured person must still prove that the doctor or nurse was acting as a ship employee rather than an independent contractor. Some of the factors to be considered include whether the cruise line advertised its medical center or medical staff to passengers, whether it retained the right to hire and fire medical staff, and methods of payment.

This 2014 11th Circuit Court ruling has particular impact on Florida, because the state’s federal court system falls within its jurisdiction, and many cruise lines – such as Carnival, Celebrity, Disney, Norwegian, Royal Caribbean, and Silversea Cruises – are headquartered in Florida. Because most ocean liners hire medical professionals who are foreign nationals, seeking legal remedy against the individuals can be difficult.

As a result, suing the cruise line directly can serve as the simplest way to obtain compensation. Some major cruise lines have already seen an increase in personal injury lawsuits. According to Bloomberg Law, there were 164 such federal injury suits in 2016, 188 in 2017, and 83 cases in just the first 3 months of 2018.

The popular press recently highlighted the latest example of medical malpractice at sea. A cruise worker was awarded $3.34 million after a young, inexperienced doctor prescribed a large dose of intravenous promethazine for nausea. Instead of using 6.25 mg, the usual dose, he prescribed 25 mg, which was inadvertently injected into the ulnar artery. The caustic drug, known to injure vascular walls, caused severe damage with extravasation, and tissue swelling, ending in compartment syndrome.

Furthermore, he had to wait 24 hours before arriving in port for treatment. By then, his arm was gangrenous and had to be amputated. The defense had argued unsuccessfully that the plaintiff had a venous anomaly to account for the injury.⁴

These changes in the law augur well for the cruising public. The Franza decision puts cruise line owners on notice that they no longer enjoy blanket immunity, and will be held responsible for the negligence of their health care providers. Hopefully, this will ensure a more uniform and adequate standard of care.

The American College of Emergency Physicians has published specific guidelines regarding medical standards aboard cruise ships. In addition to having established medical policies and procedures, and a dedicated medical emergency telephone number, they must have at least one doctor available 24/7 to provide emergency medical care and maintain certain equipment on board, such as pulse oximeters, cardiac monitors, defibrillators, an EKG device, as well as a laboratory.

Norwegian Cruise Line has taken a step further: It recently installed the capability to consult in real time with the Cleveland Clinic for diagnostic and treatment advice.
 

Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. For additional information, readers may contact the author at siang@hawaii.edu.

References

1. Carlisle v. Carnival Corporation, et al., 953 So.2d 461, 2007.

2. Barbetta v. S/S Bermuda Star, 848 F.2d 1364 (5th Cir. 1988).

3. Franza v. Royal Caribbean Cruises Ltd., 772 F.3d 1225 (11th Cir. 2014).

4. Loncar v. NCL Bahamas, International Center for Dispute Resolution, Case # 01-16-0004-3640, June 13, 2018.

Question: Regarding medical care aboard cruise ships, which of the following is incorrect?

A. It is difficult to prove negligence because of jurisdictional issues.

B. The American College of Emergency Physicians has published practice guidelines.

C. Cruise line owners are immune from liability under the Barbetta rule.

D. The Franza decision may be a game changer.

E. Lawsuits are on the increase.

Answer: A. More and more people are cruising, with the number of passengers on North American lines reaching nearly 18 million in 2017, about one-third out of Florida. Medical illnesses and accidents predictably occur at sea, and unfortunately, substandard and negligent care occasionally follows some of these mishaps.

However, up until recently, courts have immunized cruise line owners from legal liability by relying on the so-called Barbetta rule, which is based on historical notions of limited resources at sea and the impossibility of exerting control over the conduct of a ship’s health care providers.

A 2007 Florida case is illustrative. The doctor aboard a Carnival cruise ship failed to diagnose acute appendicitis in a 14-year-old girl who had complained of several days of abdominal symptoms. As a result, the patient ruptured her appendix, and this eventually resulted in sterility. The parents sued the cruise line, which denied liability because the doctor was not an employee, a fact specifically disclosed in the cruise ticket.

Although the doctor’s contract stated that he was an independent contractor, the District Court of Appeal of Florida reasoned that, in a claim based on agency, it is the right of control rather than actual control itself that matters.

It therefore held that: “for purposes of fulfilling cruise line’s duty to exercise reasonable care, the ship’s doctor is an agent of cruise line whose negligence should be imputed to cruise line ... regardless of the contractual status ascribed to the doctor” and to the extent cruise ticket sought to limit cruise line’s liability for negligence of doctor, it was invalid.

However, the Florida Supreme Court quashed this decision, because federal maritime law has historically protected shipowners from liability flowing from the medical negligence of shipboard physicians.¹

The Barbetta rule was named after a 1988 case in which Florence L. Barbetta suffered serious medical complications during a Mexican cruise out of Florida. The ship’s doctor was alleged to have been negligent for his failure to diagnose diabetes.² The lower court dismissed the case, and the appellate court affirmed.

The appellate court noted that an impressive number of courts from many jurisdictions have, for almost 100 years, followed the same basic rule: If the doctor is negligent in treating a passenger, that negligence will not be imputed to the carrier unless the carrier itself was negligent in hiring the doctor.

Citing approvingly from another case, the appellate court noted: “[A] shipping company is not in the business of providing medical services to passengers; it does not possess the expertise requisite to supervise a physician or surgeon carried on board a ship as a convenience to passengers. A ship is not a floating hospital; a ship’s physician is an independent medical expert engaged on the basis of his professional qualifications and carried on board a ship for the convenience of passengers, who are free to contract with him for any medical services they may require.”

However, courts now appear ready to jettison this rule.

In the 2014 case of Franza v. Royal Caribbean Cruises, Ltd., a passenger fell and hit his head while his ship was at port in Bermuda.³ He died several days later, allegedly because of negligence and delay by the ship’s medical staff. The lower courts barred the lawsuit, based on Barbetta, but on appeal, the 11th Circuit Court reversed. It rejected the historical justifications for immunizing shipowners from liability, concluding that past reasons were no longer applicable to modern-day cruise ships.

The court wrote: “Here, the roots of the Barbetta rule snake back to a wholly different world. Instead of 19th-century steamships, we now confront state-of-the-art cruise ships that house thousands of people and operate as floating cities complete with well-stocked modern infirmaries and urgent-care centers. In place of independent doctors and nurses, we must now acknowledge that medical professionals routinely work for corporate masters. And whereas ships historically went ‘off the grid’ when they set sail, modern technology enables distant ships to communicate instantaneously with the mainland in meaningful ways.”

However, the injured person must still prove that the doctor or nurse was acting as a ship employee rather than an independent contractor. Some of the factors to be considered include whether the cruise line advertised its medical center or medical staff to passengers, whether it retained the right to hire and fire medical staff, and methods of payment.

This 2014 11th Circuit Court ruling has particular impact on Florida, because the state’s federal court system falls within its jurisdiction, and many cruise lines – such as Carnival, Celebrity, Disney, Norwegian, Royal Caribbean, and Silversea Cruises – are headquartered in Florida. Because most ocean liners hire medical professionals who are foreign nationals, seeking legal remedy against the individuals can be difficult.

As a result, suing the cruise line directly can serve as the simplest way to obtain compensation. Some major cruise lines have already seen an increase in personal injury lawsuits. According to Bloomberg Law, there were 164 such federal injury suits in 2016, 188 in 2017, and 83 cases in just the first 3 months of 2018.

The popular press recently highlighted the latest example of medical malpractice at sea. A cruise worker was awarded $3.34 million after a young, inexperienced doctor prescribed a large dose of intravenous promethazine for nausea. Instead of using 6.25 mg, the usual dose, he prescribed 25 mg, which was inadvertently injected into the ulnar artery. The caustic drug, known to injure vascular walls, caused severe damage with extravasation, and tissue swelling, ending in compartment syndrome.

Furthermore, he had to wait 24 hours before arriving in port for treatment. By then, his arm was gangrenous and had to be amputated. The defense had argued unsuccessfully that the plaintiff had a venous anomaly to account for the injury.⁴

These changes in the law augur well for the cruising public. The Franza decision puts cruise line owners on notice that they no longer enjoy blanket immunity, and will be held responsible for the negligence of their health care providers. Hopefully, this will ensure a more uniform and adequate standard of care.

The American College of Emergency Physicians has published specific guidelines regarding medical standards aboard cruise ships. In addition to having established medical policies and procedures, and a dedicated medical emergency telephone number, they must have at least one doctor available 24/7 to provide emergency medical care and maintain certain equipment on board, such as pulse oximeters, cardiac monitors, defibrillators, an EKG device, as well as a laboratory.

Norwegian Cruise Line has taken a step further: It recently installed the capability to consult in real time with the Cleveland Clinic for diagnostic and treatment advice.
 

Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. For additional information, readers may contact the author at siang@hawaii.edu.

References

1. Carlisle v. Carnival Corporation, et al., 953 So.2d 461, 2007.

2. Barbetta v. S/S Bermuda Star, 848 F.2d 1364 (5th Cir. 1988).

3. Franza v. Royal Caribbean Cruises Ltd., 772 F.3d 1225 (11th Cir. 2014).

4. Loncar v. NCL Bahamas, International Center for Dispute Resolution, Case # 01-16-0004-3640, June 13, 2018.

Question: Regarding medical care aboard cruise ships, which of the following is incorrect?

A. It is difficult to prove negligence because of jurisdictional issues.

B. The American College of Emergency Physicians has published practice guidelines.

C. Cruise line owners are immune from liability under the Barbetta rule.

D. The Franza decision may be a game changer.

E. Lawsuits are on the increase.

Answer: A. More and more people are cruising, with the number of passengers on North American lines reaching nearly 18 million in 2017, about one-third out of Florida. Medical illnesses and accidents predictably occur at sea, and unfortunately, substandard and negligent care occasionally follows some of these mishaps.

However, up until recently, courts have immunized cruise line owners from legal liability by relying on the so-called Barbetta rule, which is based on historical notions of limited resources at sea and the impossibility of exerting control over the conduct of a ship’s health care providers.

A 2007 Florida case is illustrative. The doctor aboard a Carnival cruise ship failed to diagnose acute appendicitis in a 14-year-old girl who had complained of several days of abdominal symptoms. As a result, the patient ruptured her appendix, and this eventually resulted in sterility. The parents sued the cruise line, which denied liability because the doctor was not an employee, a fact specifically disclosed in the cruise ticket.

Although the doctor’s contract stated that he was an independent contractor, the District Court of Appeal of Florida reasoned that, in a claim based on agency, it is the right of control rather than actual control itself that matters.

It therefore held that: “for purposes of fulfilling cruise line’s duty to exercise reasonable care, the ship’s doctor is an agent of cruise line whose negligence should be imputed to cruise line ... regardless of the contractual status ascribed to the doctor” and to the extent cruise ticket sought to limit cruise line’s liability for negligence of doctor, it was invalid.

However, the Florida Supreme Court quashed this decision, because federal maritime law has historically protected shipowners from liability flowing from the medical negligence of shipboard physicians.¹

The Barbetta rule was named after a 1988 case in which Florence L. Barbetta suffered serious medical complications during a Mexican cruise out of Florida. The ship’s doctor was alleged to have been negligent for his failure to diagnose diabetes.² The lower court dismissed the case, and the appellate court affirmed.

The appellate court noted that an impressive number of courts from many jurisdictions have, for almost 100 years, followed the same basic rule: If the doctor is negligent in treating a passenger, that negligence will not be imputed to the carrier unless the carrier itself was negligent in hiring the doctor.

Citing approvingly from another case, the appellate court noted: “[A] shipping company is not in the business of providing medical services to passengers; it does not possess the expertise requisite to supervise a physician or surgeon carried on board a ship as a convenience to passengers. A ship is not a floating hospital; a ship’s physician is an independent medical expert engaged on the basis of his professional qualifications and carried on board a ship for the convenience of passengers, who are free to contract with him for any medical services they may require.”

However, courts now appear ready to jettison this rule.

In the 2014 case of Franza v. Royal Caribbean Cruises, Ltd., a passenger fell and hit his head while his ship was at port in Bermuda.³ He died several days later, allegedly because of negligence and delay by the ship’s medical staff. The lower courts barred the lawsuit, based on Barbetta, but on appeal, the 11th Circuit Court reversed. It rejected the historical justifications for immunizing shipowners from liability, concluding that past reasons were no longer applicable to modern-day cruise ships.

The court wrote: “Here, the roots of the Barbetta rule snake back to a wholly different world. Instead of 19th-century steamships, we now confront state-of-the-art cruise ships that house thousands of people and operate as floating cities complete with well-stocked modern infirmaries and urgent-care centers. In place of independent doctors and nurses, we must now acknowledge that medical professionals routinely work for corporate masters. And whereas ships historically went ‘off the grid’ when they set sail, modern technology enables distant ships to communicate instantaneously with the mainland in meaningful ways.”

However, the injured person must still prove that the doctor or nurse was acting as a ship employee rather than an independent contractor. Some of the factors to be considered include whether the cruise line advertised its medical center or medical staff to passengers, whether it retained the right to hire and fire medical staff, and methods of payment.

This 2014 11th Circuit Court ruling has particular impact on Florida, because the state’s federal court system falls within its jurisdiction, and many cruise lines – such as Carnival, Celebrity, Disney, Norwegian, Royal Caribbean, and Silversea Cruises – are headquartered in Florida. Because most ocean liners hire medical professionals who are foreign nationals, seeking legal remedy against the individuals can be difficult.

As a result, suing the cruise line directly can serve as the simplest way to obtain compensation. Some major cruise lines have already seen an increase in personal injury lawsuits. According to Bloomberg Law, there were 164 such federal injury suits in 2016, 188 in 2017, and 83 cases in just the first 3 months of 2018.

The popular press recently highlighted the latest example of medical malpractice at sea. A cruise worker was awarded $3.34 million after a young, inexperienced doctor prescribed a large dose of intravenous promethazine for nausea. Instead of using 6.25 mg, the usual dose, he prescribed 25 mg, which was inadvertently injected into the ulnar artery. The caustic drug, known to injure vascular walls, caused severe damage with extravasation, and tissue swelling, ending in compartment syndrome.

Furthermore, he had to wait 24 hours before arriving in port for treatment. By then, his arm was gangrenous and had to be amputated. The defense had argued unsuccessfully that the plaintiff had a venous anomaly to account for the injury.⁴

These changes in the law augur well for the cruising public. The Franza decision puts cruise line owners on notice that they no longer enjoy blanket immunity, and will be held responsible for the negligence of their health care providers. Hopefully, this will ensure a more uniform and adequate standard of care.

The American College of Emergency Physicians has published specific guidelines regarding medical standards aboard cruise ships. In addition to having established medical policies and procedures, and a dedicated medical emergency telephone number, they must have at least one doctor available 24/7 to provide emergency medical care and maintain certain equipment on board, such as pulse oximeters, cardiac monitors, defibrillators, an EKG device, as well as a laboratory.

Norwegian Cruise Line has taken a step further: It recently installed the capability to consult in real time with the Cleveland Clinic for diagnostic and treatment advice.
 

Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. For additional information, readers may contact the author at siang@hawaii.edu.

References

1. Carlisle v. Carnival Corporation, et al., 953 So.2d 461, 2007.

2. Barbetta v. S/S Bermuda Star, 848 F.2d 1364 (5th Cir. 1988).

3. Franza v. Royal Caribbean Cruises Ltd., 772 F.3d 1225 (11th Cir. 2014).

4. Loncar v. NCL Bahamas, International Center for Dispute Resolution, Case # 01-16-0004-3640, June 13, 2018.

Question: Which of the following regarding medical trainee liability is best?

A. Trainees are commonly named as codefendants with their attending physician in a medical malpractice lawsuit.

B. “From a culture of blame to a culture of safety” is a rallying cry against poor work conditions.

C. House officers are always judged by a lower standard, because they are not fully qualified.

D. A, B, and C are correct.

E. A and C are correct.

Answer: A. A recent case of trainee liability in the United Kingdom resulted in criminal prosecution followed by the trainee being struck off the medical register.¹ Dr. Hadiza Bawa-Garba, a pediatric trainee in the U.K. National Health Service, was prosecuted in a court of law and found guilty of manslaughter by gross negligence for the septic death of a 6-year-old boy with Down syndrome. The General Medical Council (GMC), the U.K. medical regulatory agency, voted to take away her license. The decision aroused the ire of physicians worldwide, who noted the poor supervision and undue pressures she was under.

In August 2018, the U.K. Court of Appeal noted that the general clinical competency of Dr. Bawa-Garba was never at issue, and that “the risk of her clinical practice suddenly and without explanation falling below the standards expected on any given day is no higher than for any other reasonably competent doctor.” It reversed the expulsion order and reinstated the 1-year suspension recommended by the Medical Practitioners Tribunal.

Even as the GMC accepted this appellate decision and had convened a commission to look into criminal negligence, it nonetheless received heavy criticism for having overreacted – and for its failure to speak out more forcefully to support those practicing under oppressive conditions.

For example, the Doctors’ Association UK said the GMC had shown it could not be trusted to be objective and nonpunitive. The case, it noted, had “united the medical profession in fear and outrage,” whereby “a pediatrician in training ... a highly regarded doctor, with a previously unblemished record, [was] convicted of [the criminal offence of] gross negligence manslaughter for judgments made whilst doing the jobs of several doctors at once, covering six wards across four floors, responding to numerous pediatric emergencies, without a functioning IT system, and in the absence of a consultant [senior physician], all when just returning from 14 months of maternity leave.”

The Royal College of Pediatrics and Child Health said it had “previously flagged the importance of fostering a culture of supporting doctors to learn from their mistakes, rather than one which seeks to blame.” And the British Medical Association said, “lessons must be learned from this case, which raises wider issues about the multiple factors that affect patient safety in an NHS under extreme pressure, rather than narrowly focusing only on individuals.”²

The fiasco surrounding the Dr. Bawa-Garba case will hopefully result in action similar to that following the seminal report that medical errors account for nearly 100,000 annual hospital deaths in the United States. That study was not restricted to house staff mistakes, but involved multiple hospitals and hospital staff members. It spawned a nationwide reappraisal of how to approach medical errors, and it spurred the Institute of Medicine to recommend that the profession shift “from a culture of blame to a culture of safety.”³

Criminal prosecution in the United States is decidedly rare in death or injury occurring during the course of patient care – for either trainees or attending physicians. A malpractice lawsuit would have been a far more likely outcome had the Dr. Bawa-Garba case taken place in the United States.

Lawsuits against U.S. house staff are not rare, and resident physicians are regularly joined as codefendants with their supervisors, who may be medical school faculty or community practitioners admitting to “team care.” Regulatory actions are typically directed against fully licensed physicians, rather than the trainees. Instead, the director of the training program itself would take corrective action against an errant resident, if warranted, which can range from a warning to outright dismissal from the program.

How is negligence law applied to a trainee? Should it demand the same standard of care as it would a fully qualified attending physician?⁴ Surprisingly, the courts are split on this question. Some have favored using a dual standard of conduct, with trainees being held to a lower standard.

This was articulated in Rush v. Akron General Hospital, which involved a patient who had fallen through a glass door. The patient suffered several lacerations to his shoulder, which the intern treated. However, when two remaining pieces of glass were later discovered in the area of injury, the patient sued the intern for negligence.

The court dismissed the claim, finding that the intern had practiced with the skill and care of his peers of similar training. “It would be unreasonable to exact from an intern, doing emergency work in a hospital, that high degree of skill which is impliedly possessed by a physician and surgeon in the general practice of his profession, with an extensive and constant practice in hospitals and the community,” the court noted.⁵

However, not all courts have embraced this dual standard of review. The New Jersey Superior Court held that licensed residents should be judged by a standard applicable to a general practitioner, because any reduction in the standard of care would set a problematic precedent.⁶ In that case, the residents allegedly failed to reinsert a nasogastric tube, which caused the patient to aspirate.

And in Pratt v. Stein, a second-year resident was judged by an even higher standard – that of a specialist – after he had allegedly administered a toxic dose of neomycin to a postoperative patient, which resulted in deafness. Although the lower court had ruled that the resident should be held to the standard of an ordinary physician, the Pennsylvania appellate court disagreed, reasoning that “a resident should be held to the standard of a specialist when the resident is acting within his field of specialty. In our estimation, this is a sound conclusion. A resident is already a physician who has chosen to specialize, and thus possesses a higher degree of knowledge and skill in the chosen specialty than does the nonspecialist.”⁷

However, a subsequent decision from the same jurisdiction suggests a retreat from this unrealistic standard.

An orthopedic resident allegedly applied a cast with insufficient padding to the broken wrist of a patient. The plaintiff claimed this led to soft-tissue infection with Staphylococcus aureus, with complicating septicemia, staphylococcal endocarditis, and eventual death.

The court held that the resident’s standard of care should be “higher than that for general practitioners but less than that for fully trained orthopedic specialists. ... To require a resident to meet the same standard of care as fully trained specialists would be unrealistic. A resident may have had only days or weeks of training in the specialized residency program; a specialist, on the other hand, will have completed the residency program and may also have had years of experience in the specialized field. If we were to require the resident to exercise the same degree of skill and training as the specialist, we would, in effect, be requiring the resident to do the impossible.”⁸
 

Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. For additional information, readers may contact the author at siang@hawaii.edu.

References

1. Saurabh Jha, “To Err Is Homicide in Britain: The Case of Hadiza Bawa-Garba.” The Health Care Blog, Jan. 30, 2018.

2. “‘Lessons Must Be Learned’: UK Societies on Bawa-Garba Ruling.” Medscape, Aug. 14, 2018.

3. “To Err is Human: Building a Safer Health System.” Institute of Medicine, National Academies Press, Washington D.C., 1999.

4. JAMA. 2004 Sep 1;292(9):1051-6.

5. Rush v. Akron General Hospital, 171 N.E.2d 378 (Ohio Ct. App. 1987).

6. Clark v. University Hospital, 914 A.2d 838 (N.J. Super. 2006).

7. Pratt v. Stein, 444 A.2d 674 (Pa. Super. 1980).

8. Jistarri v. Nappi, 549 A.2d 210 (Pa. Super. 1988).

Question: Which of the following regarding medical trainee liability is best?

A. Trainees are commonly named as codefendants with their attending physician in a medical malpractice lawsuit.

B. “From a culture of blame to a culture of safety” is a rallying cry against poor work conditions.

C. House officers are always judged by a lower standard, because they are not fully qualified.

D. A, B, and C are correct.

E. A and C are correct.

Answer: A. A recent case of trainee liability in the United Kingdom resulted in criminal prosecution followed by the trainee being struck off the medical register.¹ Dr. Hadiza Bawa-Garba, a pediatric trainee in the U.K. National Health Service, was prosecuted in a court of law and found guilty of manslaughter by gross negligence for the septic death of a 6-year-old boy with Down syndrome. The General Medical Council (GMC), the U.K. medical regulatory agency, voted to take away her license. The decision aroused the ire of physicians worldwide, who noted the poor supervision and undue pressures she was under.

In August 2018, the U.K. Court of Appeal noted that the general clinical competency of Dr. Bawa-Garba was never at issue, and that “the risk of her clinical practice suddenly and without explanation falling below the standards expected on any given day is no higher than for any other reasonably competent doctor.” It reversed the expulsion order and reinstated the 1-year suspension recommended by the Medical Practitioners Tribunal.

Even as the GMC accepted this appellate decision and had convened a commission to look into criminal negligence, it nonetheless received heavy criticism for having overreacted – and for its failure to speak out more forcefully to support those practicing under oppressive conditions.

For example, the Doctors’ Association UK said the GMC had shown it could not be trusted to be objective and nonpunitive. The case, it noted, had “united the medical profession in fear and outrage,” whereby “a pediatrician in training ... a highly regarded doctor, with a previously unblemished record, [was] convicted of [the criminal offence of] gross negligence manslaughter for judgments made whilst doing the jobs of several doctors at once, covering six wards across four floors, responding to numerous pediatric emergencies, without a functioning IT system, and in the absence of a consultant [senior physician], all when just returning from 14 months of maternity leave.”

The Royal College of Pediatrics and Child Health said it had “previously flagged the importance of fostering a culture of supporting doctors to learn from their mistakes, rather than one which seeks to blame.” And the British Medical Association said, “lessons must be learned from this case, which raises wider issues about the multiple factors that affect patient safety in an NHS under extreme pressure, rather than narrowly focusing only on individuals.”²

The fiasco surrounding the Dr. Bawa-Garba case will hopefully result in action similar to that following the seminal report that medical errors account for nearly 100,000 annual hospital deaths in the United States. That study was not restricted to house staff mistakes, but involved multiple hospitals and hospital staff members. It spawned a nationwide reappraisal of how to approach medical errors, and it spurred the Institute of Medicine to recommend that the profession shift “from a culture of blame to a culture of safety.”³

Criminal prosecution in the United States is decidedly rare in death or injury occurring during the course of patient care – for either trainees or attending physicians. A malpractice lawsuit would have been a far more likely outcome had the Dr. Bawa-Garba case taken place in the United States.

Lawsuits against U.S. house staff are not rare, and resident physicians are regularly joined as codefendants with their supervisors, who may be medical school faculty or community practitioners admitting to “team care.” Regulatory actions are typically directed against fully licensed physicians, rather than the trainees. Instead, the director of the training program itself would take corrective action against an errant resident, if warranted, which can range from a warning to outright dismissal from the program.

How is negligence law applied to a trainee? Should it demand the same standard of care as it would a fully qualified attending physician?⁴ Surprisingly, the courts are split on this question. Some have favored using a dual standard of conduct, with trainees being held to a lower standard.

This was articulated in Rush v. Akron General Hospital, which involved a patient who had fallen through a glass door. The patient suffered several lacerations to his shoulder, which the intern treated. However, when two remaining pieces of glass were later discovered in the area of injury, the patient sued the intern for negligence.

The court dismissed the claim, finding that the intern had practiced with the skill and care of his peers of similar training. “It would be unreasonable to exact from an intern, doing emergency work in a hospital, that high degree of skill which is impliedly possessed by a physician and surgeon in the general practice of his profession, with an extensive and constant practice in hospitals and the community,” the court noted.⁵

However, not all courts have embraced this dual standard of review. The New Jersey Superior Court held that licensed residents should be judged by a standard applicable to a general practitioner, because any reduction in the standard of care would set a problematic precedent.⁶ In that case, the residents allegedly failed to reinsert a nasogastric tube, which caused the patient to aspirate.

And in Pratt v. Stein, a second-year resident was judged by an even higher standard – that of a specialist – after he had allegedly administered a toxic dose of neomycin to a postoperative patient, which resulted in deafness. Although the lower court had ruled that the resident should be held to the standard of an ordinary physician, the Pennsylvania appellate court disagreed, reasoning that “a resident should be held to the standard of a specialist when the resident is acting within his field of specialty. In our estimation, this is a sound conclusion. A resident is already a physician who has chosen to specialize, and thus possesses a higher degree of knowledge and skill in the chosen specialty than does the nonspecialist.”⁷

However, a subsequent decision from the same jurisdiction suggests a retreat from this unrealistic standard.

An orthopedic resident allegedly applied a cast with insufficient padding to the broken wrist of a patient. The plaintiff claimed this led to soft-tissue infection with Staphylococcus aureus, with complicating septicemia, staphylococcal endocarditis, and eventual death.

The court held that the resident’s standard of care should be “higher than that for general practitioners but less than that for fully trained orthopedic specialists. ... To require a resident to meet the same standard of care as fully trained specialists would be unrealistic. A resident may have had only days or weeks of training in the specialized residency program; a specialist, on the other hand, will have completed the residency program and may also have had years of experience in the specialized field. If we were to require the resident to exercise the same degree of skill and training as the specialist, we would, in effect, be requiring the resident to do the impossible.”⁸
 

Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. For additional information, readers may contact the author at siang@hawaii.edu.

References

1. Saurabh Jha, “To Err Is Homicide in Britain: The Case of Hadiza Bawa-Garba.” The Health Care Blog, Jan. 30, 2018.

2. “‘Lessons Must Be Learned’: UK Societies on Bawa-Garba Ruling.” Medscape, Aug. 14, 2018.

3. “To Err is Human: Building a Safer Health System.” Institute of Medicine, National Academies Press, Washington D.C., 1999.

4. JAMA. 2004 Sep 1;292(9):1051-6.

5. Rush v. Akron General Hospital, 171 N.E.2d 378 (Ohio Ct. App. 1987).

6. Clark v. University Hospital, 914 A.2d 838 (N.J. Super. 2006).

7. Pratt v. Stein, 444 A.2d 674 (Pa. Super. 1980).

8. Jistarri v. Nappi, 549 A.2d 210 (Pa. Super. 1988).

Question: Which of the following regarding medical trainee liability is best?

A. Trainees are commonly named as codefendants with their attending physician in a medical malpractice lawsuit.

B. “From a culture of blame to a culture of safety” is a rallying cry against poor work conditions.

C. House officers are always judged by a lower standard, because they are not fully qualified.

D. A, B, and C are correct.

E. A and C are correct.

Answer: A. A recent case of trainee liability in the United Kingdom resulted in criminal prosecution followed by the trainee being struck off the medical register.¹ Dr. Hadiza Bawa-Garba, a pediatric trainee in the U.K. National Health Service, was prosecuted in a court of law and found guilty of manslaughter by gross negligence for the septic death of a 6-year-old boy with Down syndrome. The General Medical Council (GMC), the U.K. medical regulatory agency, voted to take away her license. The decision aroused the ire of physicians worldwide, who noted the poor supervision and undue pressures she was under.

In August 2018, the U.K. Court of Appeal noted that the general clinical competency of Dr. Bawa-Garba was never at issue, and that “the risk of her clinical practice suddenly and without explanation falling below the standards expected on any given day is no higher than for any other reasonably competent doctor.” It reversed the expulsion order and reinstated the 1-year suspension recommended by the Medical Practitioners Tribunal.

Even as the GMC accepted this appellate decision and had convened a commission to look into criminal negligence, it nonetheless received heavy criticism for having overreacted – and for its failure to speak out more forcefully to support those practicing under oppressive conditions.

For example, the Doctors’ Association UK said the GMC had shown it could not be trusted to be objective and nonpunitive. The case, it noted, had “united the medical profession in fear and outrage,” whereby “a pediatrician in training ... a highly regarded doctor, with a previously unblemished record, [was] convicted of [the criminal offence of] gross negligence manslaughter for judgments made whilst doing the jobs of several doctors at once, covering six wards across four floors, responding to numerous pediatric emergencies, without a functioning IT system, and in the absence of a consultant [senior physician], all when just returning from 14 months of maternity leave.”

The Royal College of Pediatrics and Child Health said it had “previously flagged the importance of fostering a culture of supporting doctors to learn from their mistakes, rather than one which seeks to blame.” And the British Medical Association said, “lessons must be learned from this case, which raises wider issues about the multiple factors that affect patient safety in an NHS under extreme pressure, rather than narrowly focusing only on individuals.”²

The fiasco surrounding the Dr. Bawa-Garba case will hopefully result in action similar to that following the seminal report that medical errors account for nearly 100,000 annual hospital deaths in the United States. That study was not restricted to house staff mistakes, but involved multiple hospitals and hospital staff members. It spawned a nationwide reappraisal of how to approach medical errors, and it spurred the Institute of Medicine to recommend that the profession shift “from a culture of blame to a culture of safety.”³

Criminal prosecution in the United States is decidedly rare in death or injury occurring during the course of patient care – for either trainees or attending physicians. A malpractice lawsuit would have been a far more likely outcome had the Dr. Bawa-Garba case taken place in the United States.

Lawsuits against U.S. house staff are not rare, and resident physicians are regularly joined as codefendants with their supervisors, who may be medical school faculty or community practitioners admitting to “team care.” Regulatory actions are typically directed against fully licensed physicians, rather than the trainees. Instead, the director of the training program itself would take corrective action against an errant resident, if warranted, which can range from a warning to outright dismissal from the program.

How is negligence law applied to a trainee? Should it demand the same standard of care as it would a fully qualified attending physician?⁴ Surprisingly, the courts are split on this question. Some have favored using a dual standard of conduct, with trainees being held to a lower standard.

This was articulated in Rush v. Akron General Hospital, which involved a patient who had fallen through a glass door. The patient suffered several lacerations to his shoulder, which the intern treated. However, when two remaining pieces of glass were later discovered in the area of injury, the patient sued the intern for negligence.

The court dismissed the claim, finding that the intern had practiced with the skill and care of his peers of similar training. “It would be unreasonable to exact from an intern, doing emergency work in a hospital, that high degree of skill which is impliedly possessed by a physician and surgeon in the general practice of his profession, with an extensive and constant practice in hospitals and the community,” the court noted.⁵

However, not all courts have embraced this dual standard of review. The New Jersey Superior Court held that licensed residents should be judged by a standard applicable to a general practitioner, because any reduction in the standard of care would set a problematic precedent.⁶ In that case, the residents allegedly failed to reinsert a nasogastric tube, which caused the patient to aspirate.

And in Pratt v. Stein, a second-year resident was judged by an even higher standard – that of a specialist – after he had allegedly administered a toxic dose of neomycin to a postoperative patient, which resulted in deafness. Although the lower court had ruled that the resident should be held to the standard of an ordinary physician, the Pennsylvania appellate court disagreed, reasoning that “a resident should be held to the standard of a specialist when the resident is acting within his field of specialty. In our estimation, this is a sound conclusion. A resident is already a physician who has chosen to specialize, and thus possesses a higher degree of knowledge and skill in the chosen specialty than does the nonspecialist.”⁷

However, a subsequent decision from the same jurisdiction suggests a retreat from this unrealistic standard.

An orthopedic resident allegedly applied a cast with insufficient padding to the broken wrist of a patient. The plaintiff claimed this led to soft-tissue infection with Staphylococcus aureus, with complicating septicemia, staphylococcal endocarditis, and eventual death.

The court held that the resident’s standard of care should be “higher than that for general practitioners but less than that for fully trained orthopedic specialists. ... To require a resident to meet the same standard of care as fully trained specialists would be unrealistic. A resident may have had only days or weeks of training in the specialized residency program; a specialist, on the other hand, will have completed the residency program and may also have had years of experience in the specialized field. If we were to require the resident to exercise the same degree of skill and training as the specialist, we would, in effect, be requiring the resident to do the impossible.”⁸
 

Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. For additional information, readers may contact the author at siang@hawaii.edu.

References

1. Saurabh Jha, “To Err Is Homicide in Britain: The Case of Hadiza Bawa-Garba.” The Health Care Blog, Jan. 30, 2018.

2. “‘Lessons Must Be Learned’: UK Societies on Bawa-Garba Ruling.” Medscape, Aug. 14, 2018.

3. “To Err is Human: Building a Safer Health System.” Institute of Medicine, National Academies Press, Washington D.C., 1999.

4. JAMA. 2004 Sep 1;292(9):1051-6.

5. Rush v. Akron General Hospital, 171 N.E.2d 378 (Ohio Ct. App. 1987).

6. Clark v. University Hospital, 914 A.2d 838 (N.J. Super. 2006).

7. Pratt v. Stein, 444 A.2d 674 (Pa. Super. 1980).

8. Jistarri v. Nappi, 549 A.2d 210 (Pa. Super. 1988).

QUESTION: A groundskeeper alleges he developed terminal lymphoma from the use of the weed killer Roundup. A homeowner injures his leg while using a lawnmower. One thousand litigants allege Lipitor caused them to develop diabetes. A patient sues his doctor for a serious allergic reaction to an antibiotic.

Which of the following statements is incorrect?

A. These are all examples of product liability.

B. If successful, the groundskeeper may be awarded hundreds of millions of dollars in damages.

C. The homeowner has a cause of action against the manufacturer, even if it’s a borrowed lawnmower from a neighbor.

D. It is now harder to include multiple plaintiffs in a class-action lawsuit.

E. The “learned intermediary doctrine” immunizes the drug manufacturer from liability for a patient’s allergic reaction.



ANSWER: A. Johnson v. Monsanto was a recent case in San Francisco that resulted in a verdict for the plaintiff to the tune of $289 million.¹ DeWayne Johnson, a 46-year-old groundskeeper, had developed non-Hodgkin lymphoma after using the weed killer, Roundup, to treat the school grounds, sometimes spraying the herbicide for several hours a day. Mr. Johnson alleged that Roundup’s active ingredient, glyphosate, is a known carcinogen, and that Monsanto, its manufacturer, failed to provide appropriate warning regarding this dangerous product.

The judge in the case allowed into evidence internal emails and experts’ warnings, as well as a critical 2015 position paper of the World Health Organization’s international agency for research on cancer, which classified glyphosate as “probably carcinogenic to humans.”² Yet the herbicide, used widely in households and in commerce, is registered in 130 countries and approved for use on more than 100 crops. It was the first such case involving Roundup.

At trial, the jury unanimously found that Roundup was a substantial contributing factor in causing Mr. Johnson’s malignancy, that Monsanto failed to warn him of its health hazards (marketing “defect”), and that it knew or should have known that its product was unreasonably dangerous. The main portion, $250 million (of the $289 million award), was awarded as punitive damages.

Tort damages are of two types: compensatory and punitive. The former is to compensate the victim for past and future losses such as wages and medical expenses, pain and suffering, and/or emotional distress. On the other hand, punitive damages, also called exemplary damages, are awarded where there is a reckless, willful, or wanton disregard of the obvious risk of harm.

The case is currently under appeal. Meanwhile, another Roundup trial will soon take place in St. Louis, and the company is facing a class-action suit in U.S. district court in San Francisco, as well as several thousand claims in state courts throughout the country.

Johnson v. Monsanto is a typical product liability action. According to Section 102(2) of the Uniform Product Liability Act, product liability includes “all claims or action brought for personal injury, death, or property damage caused by the manufacture, design, formula, preparation, assembly, installation, testing, warnings, instructions, marketing, packaging, or labeling of any product.”

There are basically three legal theories in a product liability claim: negligence, breach of warranty, and strict product liability. The latter is the most favored by plaintiffs, as there is no need to prove fault or warranty.

In a seminal case in 1963, William Greenman was injured when he used a power tool that was given to him as a gift.³ He sued the manufacturer, although there was no direct contract of warranty between him and the manufacturer, as he did not make the purchase himself.

Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. For additional information, readers may contact the author at siang@hawaii.edu.

References

1. DeWayne Johnson v. Monsanto Co., Superior Court of California, County of San Francisco, Case No. CGC-16-550128, June 18, 2018.

2. The Monsanto Papers: Roundup (Glyphosate) Cancer Case Key Documents & Analysis. Available at usrtk.org.

3. Greenman v. Yuba Power Products Inc., 377 P.2d 897 (Cal. 1963).

4. “Defective and unreasonably dangerous,” Internal Medicine News, Nov. 4, 2014.

5. “Class-action lawsuits,” Internal Medicine News, April 1, 2015.

6. Bristol-Myers Squibb Co. v. Superior Court of California, 582 U.S. ____ (2017).

QUESTION: A groundskeeper alleges he developed terminal lymphoma from the use of the weed killer Roundup. A homeowner injures his leg while using a lawnmower. One thousand litigants allege Lipitor caused them to develop diabetes. A patient sues his doctor for a serious allergic reaction to an antibiotic.

Which of the following statements is incorrect?

A. These are all examples of product liability.

B. If successful, the groundskeeper may be awarded hundreds of millions of dollars in damages.

C. The homeowner has a cause of action against the manufacturer, even if it’s a borrowed lawnmower from a neighbor.

D. It is now harder to include multiple plaintiffs in a class-action lawsuit.

E. The “learned intermediary doctrine” immunizes the drug manufacturer from liability for a patient’s allergic reaction.



ANSWER: A. Johnson v. Monsanto was a recent case in San Francisco that resulted in a verdict for the plaintiff to the tune of $289 million.¹ DeWayne Johnson, a 46-year-old groundskeeper, had developed non-Hodgkin lymphoma after using the weed killer, Roundup, to treat the school grounds, sometimes spraying the herbicide for several hours a day. Mr. Johnson alleged that Roundup’s active ingredient, glyphosate, is a known carcinogen, and that Monsanto, its manufacturer, failed to provide appropriate warning regarding this dangerous product.

The judge in the case allowed into evidence internal emails and experts’ warnings, as well as a critical 2015 position paper of the World Health Organization’s international agency for research on cancer, which classified glyphosate as “probably carcinogenic to humans.”² Yet the herbicide, used widely in households and in commerce, is registered in 130 countries and approved for use on more than 100 crops. It was the first such case involving Roundup.

At trial, the jury unanimously found that Roundup was a substantial contributing factor in causing Mr. Johnson’s malignancy, that Monsanto failed to warn him of its health hazards (marketing “defect”), and that it knew or should have known that its product was unreasonably dangerous. The main portion, $250 million (of the $289 million award), was awarded as punitive damages.

Tort damages are of two types: compensatory and punitive. The former is to compensate the victim for past and future losses such as wages and medical expenses, pain and suffering, and/or emotional distress. On the other hand, punitive damages, also called exemplary damages, are awarded where there is a reckless, willful, or wanton disregard of the obvious risk of harm.

The case is currently under appeal. Meanwhile, another Roundup trial will soon take place in St. Louis, and the company is facing a class-action suit in U.S. district court in San Francisco, as well as several thousand claims in state courts throughout the country.

Johnson v. Monsanto is a typical product liability action. According to Section 102(2) of the Uniform Product Liability Act, product liability includes “all claims or action brought for personal injury, death, or property damage caused by the manufacture, design, formula, preparation, assembly, installation, testing, warnings, instructions, marketing, packaging, or labeling of any product.”

There are basically three legal theories in a product liability claim: negligence, breach of warranty, and strict product liability. The latter is the most favored by plaintiffs, as there is no need to prove fault or warranty.

In a seminal case in 1963, William Greenman was injured when he used a power tool that was given to him as a gift.³ He sued the manufacturer, although there was no direct contract of warranty between him and the manufacturer, as he did not make the purchase himself.

Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. For additional information, readers may contact the author at siang@hawaii.edu.

References

1. DeWayne Johnson v. Monsanto Co., Superior Court of California, County of San Francisco, Case No. CGC-16-550128, June 18, 2018.

2. The Monsanto Papers: Roundup (Glyphosate) Cancer Case Key Documents & Analysis. Available at usrtk.org.

3. Greenman v. Yuba Power Products Inc., 377 P.2d 897 (Cal. 1963).

4. “Defective and unreasonably dangerous,” Internal Medicine News, Nov. 4, 2014.

5. “Class-action lawsuits,” Internal Medicine News, April 1, 2015.

6. Bristol-Myers Squibb Co. v. Superior Court of California, 582 U.S. ____ (2017).

QUESTION: A groundskeeper alleges he developed terminal lymphoma from the use of the weed killer Roundup. A homeowner injures his leg while using a lawnmower. One thousand litigants allege Lipitor caused them to develop diabetes. A patient sues his doctor for a serious allergic reaction to an antibiotic.

Which of the following statements is incorrect?

A. These are all examples of product liability.

B. If successful, the groundskeeper may be awarded hundreds of millions of dollars in damages.

C. The homeowner has a cause of action against the manufacturer, even if it’s a borrowed lawnmower from a neighbor.

D. It is now harder to include multiple plaintiffs in a class-action lawsuit.

E. The “learned intermediary doctrine” immunizes the drug manufacturer from liability for a patient’s allergic reaction.



ANSWER: A. Johnson v. Monsanto was a recent case in San Francisco that resulted in a verdict for the plaintiff to the tune of $289 million.¹ DeWayne Johnson, a 46-year-old groundskeeper, had developed non-Hodgkin lymphoma after using the weed killer, Roundup, to treat the school grounds, sometimes spraying the herbicide for several hours a day. Mr. Johnson alleged that Roundup’s active ingredient, glyphosate, is a known carcinogen, and that Monsanto, its manufacturer, failed to provide appropriate warning regarding this dangerous product.

The judge in the case allowed into evidence internal emails and experts’ warnings, as well as a critical 2015 position paper of the World Health Organization’s international agency for research on cancer, which classified glyphosate as “probably carcinogenic to humans.”² Yet the herbicide, used widely in households and in commerce, is registered in 130 countries and approved for use on more than 100 crops. It was the first such case involving Roundup.

At trial, the jury unanimously found that Roundup was a substantial contributing factor in causing Mr. Johnson’s malignancy, that Monsanto failed to warn him of its health hazards (marketing “defect”), and that it knew or should have known that its product was unreasonably dangerous. The main portion, $250 million (of the $289 million award), was awarded as punitive damages.

Tort damages are of two types: compensatory and punitive. The former is to compensate the victim for past and future losses such as wages and medical expenses, pain and suffering, and/or emotional distress. On the other hand, punitive damages, also called exemplary damages, are awarded where there is a reckless, willful, or wanton disregard of the obvious risk of harm.

The case is currently under appeal. Meanwhile, another Roundup trial will soon take place in St. Louis, and the company is facing a class-action suit in U.S. district court in San Francisco, as well as several thousand claims in state courts throughout the country.

Johnson v. Monsanto is a typical product liability action. According to Section 102(2) of the Uniform Product Liability Act, product liability includes “all claims or action brought for personal injury, death, or property damage caused by the manufacture, design, formula, preparation, assembly, installation, testing, warnings, instructions, marketing, packaging, or labeling of any product.”

There are basically three legal theories in a product liability claim: negligence, breach of warranty, and strict product liability. The latter is the most favored by plaintiffs, as there is no need to prove fault or warranty.

In a seminal case in 1963, William Greenman was injured when he used a power tool that was given to him as a gift.³ He sued the manufacturer, although there was no direct contract of warranty between him and the manufacturer, as he did not make the purchase himself.

Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. For additional information, readers may contact the author at siang@hawaii.edu.

References

1. DeWayne Johnson v. Monsanto Co., Superior Court of California, County of San Francisco, Case No. CGC-16-550128, June 18, 2018.

2. The Monsanto Papers: Roundup (Glyphosate) Cancer Case Key Documents & Analysis. Available at usrtk.org.

3. Greenman v. Yuba Power Products Inc., 377 P.2d 897 (Cal. 1963).

4. “Defective and unreasonably dangerous,” Internal Medicine News, Nov. 4, 2014.

5. “Class-action lawsuits,” Internal Medicine News, April 1, 2015.

6. Bristol-Myers Squibb Co. v. Superior Court of California, 582 U.S. ____ (2017).

Question: Which of the following statements regarding the law on evidence is incorrect?

A. Expert testimony is always needed to establish the applicable standard of care in a negligence lawsuit.

B. According to the Federal Rules of Evidence, a witness may be qualified as an expert based on knowledge, skill, experience, training, or education.

C. It is the judge, not the jury, who determines whether a witness is admissible as an expert.

D. Expert testimony is a requirement in medical malpractice lawsuits, unless a plaintiff can successfully invoke the res ipsa loquitur doctrine.

E. Only a few states have enacted statutes specifying that an expert must be in the same specialty as the defendant, and in some cases, a nonphysician such as a nurse or pharmacist may be allowed to testify.

Answer: A. Under the tort of negligence, a defendant’s conduct is measured by what is expected of the reasonable person – the man on the street. The jury can usually decide on its own, without the aid of an expert, what that level of care ought to be. However, in medical malpractice lawsuits, the law requires an expert to testify to the requisite standard of care, as this determination is believed to be beyond the scope of the layperson.

An exception, rarely invoked, is the res ipsa loquitur doctrine, where “the thing speaks for itself.” There, an expert is not necessary because of common knowledge, e.g., when a surgeon inadvertently leaves a sponge or instrument inside a body cavity.

Whether one is admitted as an expert is within the sole discretion of the judge, who is guided by the Federal Rules of Evidence. Typically, an expert is in the same medical specialty, but there are instances of professionals of unlike specialties qualifying as experts. Examples include a nephrologist testifying against a urologist, an infectious disease specialist offering an expert opinion in a stroke case, a pharmacist testifying on the issue of a medication side effect, and a nurse on bedsores.

We had previously reviewed the law governing expert medical testimony in these columns.¹ However, three recent cases awaiting final adjudication caught our attention, as they raise important and serious legal issues.

The first frontally suggests that jury members may rely on their own notion of what constitutes an appropriate standard of care. Although it is established law in Maryland that expert testimony is required to set that standard in medical malpractice litigation, the recent Maryland case of Armacost v. Davis appeared to modify this principle, leading to a plaintiff verdict.²

The facts involved a neurosurgeon’s anterior cervical discectomy and fusion surgery, which was complicated by a pinpoint opening at the end of the incision. This eventually developed into a MRSA abscess. In his lawsuit, the plaintiff alleged that surgery was neither medically necessary nor appropriate, that there was no proper informed consent, and that the diagnosis of his postoperative infection was delayed.

A pivotal part of the trial centered on a Baltimore county judge’s instructions to the jury that it could consider what a layperson would deem reasonable standard of care. Moreover, the judge refused to modify the jury instructions when the doctor-defendant objected and asked that the standard of care be measured by the expectations for a neurosurgeon. The jury returned a verdict in favor of the plaintiff in the amount of $329,000.

Upon appeal, the Court of Special Appeals of Maryland ruled that the jury instructions were improper and therefore ordered a new trial. It held: “Medical malpractice claims are not general negligence claims, and so jury instructions on general negligence, although correct statements of Maryland law, are not supported by the facts of a case centered on the allegedly negligent conduct of a physician. Accordingly, we hold that the trial court erred in giving general negligence instructions in a medical malpractice case.”

The case is now before Maryland’s highest court, the Court of Appeals of Maryland, which is expected to uphold this decision and reject the reasonable person (instead of reasonable doctor) standard used by the lower court.

The second case deals with whether a jury in a medical liability trial may be prejudiced if they hear four medical experts testify for the physician and just one expert testify for the plaintiff. In Shallow v. Follwell, the defendant doctor performed a laparoscopic hernia repair, which was complicated by bowel perforation, atrial fibrillation, sepsis, and death.³

At trial, plaintiffs produced one expert witness, whereas Dr. Follwell had four, with expertise in cardiology, critical care, vascular surgery, and colorectal surgery. The trial court judge instructed the jury not to give weight to the number of experts on either side, and based on the testimony, the jury found that Dr. Follwell did not cause the perforated bowel or the patient’s death.

However, on appeal, the Missouri Court of Appeals overturned the verdict after finding that the trial court erred in allowing “unfairly cumulative and prejudicial repetition of certain expert opinions.” The Missouri Supreme Court is currently being asked to render a final opinion on the matter. In its supporting brief, the American Medical Association’s Litigation Center is urging the high court to “ensure that Missouri trial judges are empowered to safeguard the use of sound science in their courtrooms,” and that “given the highly specialized nature of medicine today, multiple experts may be required to ensure a jury has a proper understanding of the relevant medical science.”⁴

The third case addresses whether trial judges can suppress expert witness testimony attesting that a known complication of a medical procedure can occur absent any negligence.

The case involved a laparoscopic hysterectomy performed by a gynecologist. The patient’s bowel was perforated during the procedure.⁵ Expert witnesses from both sides testified about bowel perforation and professional standards, and the trial court allowed the defendant’s expert to state that such an injury was a commonplace risk even if surgery was performed properly.

The plaintiff objected to this testimony; but the trial judge overruled the plaintiff’s objection, and the jury found in favor of the gynecologist. Upon appeal, the Pennsylvania Superior Court reversed, concluding that the defendant’s expert testimony was irrelevant and misleading, and immaterial to the issue of whether the defendant’s treatment met the standard of care. It held that the evidence was inadmissible and ordered a new trial. The case is now before the Pennsylvania Supreme Court.

The foregoing three cases are yet to be finally adjudicated, but controversies in these and similar issues can be expected to continue. Expert testimony is dispositive at trial, and both sides rely heavily on it. Little wonder malpractice litigation is frequently framed as a “battle of the experts.”
 

Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. For additional information, readers may contact the author at siang@hawaii.edu.

References

1. Internal Medicine News, “Expert medical testimony,” Sept. 9, 2010; “Qualifying as an expert,” Jan. 2, 2015; “Dispensing with expert testimony,” April 19, 2016.

2. Armacost v. Davis, 175 A.3d 150 (Ct. App. Md, 2017).

3. Shallow v. Follwell, (No. ED103811, Mo. App., Eastern Dist., Div. 4, 2017).

4. Henry TA, “Is it OK to have 4-to-1 expert ratio in medical liability case?” AMA Wire, June 22, 2018.

5. Mitchell v. Shikora, 161 A.3d 970 (Pa. Super. 2017).

Question: Which of the following statements regarding the law on evidence is incorrect?

A. Expert testimony is always needed to establish the applicable standard of care in a negligence lawsuit.

B. According to the Federal Rules of Evidence, a witness may be qualified as an expert based on knowledge, skill, experience, training, or education.

C. It is the judge, not the jury, who determines whether a witness is admissible as an expert.

D. Expert testimony is a requirement in medical malpractice lawsuits, unless a plaintiff can successfully invoke the res ipsa loquitur doctrine.

E. Only a few states have enacted statutes specifying that an expert must be in the same specialty as the defendant, and in some cases, a nonphysician such as a nurse or pharmacist may be allowed to testify.

Answer: A. Under the tort of negligence, a defendant’s conduct is measured by what is expected of the reasonable person – the man on the street. The jury can usually decide on its own, without the aid of an expert, what that level of care ought to be. However, in medical malpractice lawsuits, the law requires an expert to testify to the requisite standard of care, as this determination is believed to be beyond the scope of the layperson.

An exception, rarely invoked, is the res ipsa loquitur doctrine, where “the thing speaks for itself.” There, an expert is not necessary because of common knowledge, e.g., when a surgeon inadvertently leaves a sponge or instrument inside a body cavity.

Whether one is admitted as an expert is within the sole discretion of the judge, who is guided by the Federal Rules of Evidence. Typically, an expert is in the same medical specialty, but there are instances of professionals of unlike specialties qualifying as experts. Examples include a nephrologist testifying against a urologist, an infectious disease specialist offering an expert opinion in a stroke case, a pharmacist testifying on the issue of a medication side effect, and a nurse on bedsores.

We had previously reviewed the law governing expert medical testimony in these columns.¹ However, three recent cases awaiting final adjudication caught our attention, as they raise important and serious legal issues.

The first frontally suggests that jury members may rely on their own notion of what constitutes an appropriate standard of care. Although it is established law in Maryland that expert testimony is required to set that standard in medical malpractice litigation, the recent Maryland case of Armacost v. Davis appeared to modify this principle, leading to a plaintiff verdict.²

The facts involved a neurosurgeon’s anterior cervical discectomy and fusion surgery, which was complicated by a pinpoint opening at the end of the incision. This eventually developed into a MRSA abscess. In his lawsuit, the plaintiff alleged that surgery was neither medically necessary nor appropriate, that there was no proper informed consent, and that the diagnosis of his postoperative infection was delayed.

A pivotal part of the trial centered on a Baltimore county judge’s instructions to the jury that it could consider what a layperson would deem reasonable standard of care. Moreover, the judge refused to modify the jury instructions when the doctor-defendant objected and asked that the standard of care be measured by the expectations for a neurosurgeon. The jury returned a verdict in favor of the plaintiff in the amount of $329,000.

Upon appeal, the Court of Special Appeals of Maryland ruled that the jury instructions were improper and therefore ordered a new trial. It held: “Medical malpractice claims are not general negligence claims, and so jury instructions on general negligence, although correct statements of Maryland law, are not supported by the facts of a case centered on the allegedly negligent conduct of a physician. Accordingly, we hold that the trial court erred in giving general negligence instructions in a medical malpractice case.”

The case is now before Maryland’s highest court, the Court of Appeals of Maryland, which is expected to uphold this decision and reject the reasonable person (instead of reasonable doctor) standard used by the lower court.

The second case deals with whether a jury in a medical liability trial may be prejudiced if they hear four medical experts testify for the physician and just one expert testify for the plaintiff. In Shallow v. Follwell, the defendant doctor performed a laparoscopic hernia repair, which was complicated by bowel perforation, atrial fibrillation, sepsis, and death.³

At trial, plaintiffs produced one expert witness, whereas Dr. Follwell had four, with expertise in cardiology, critical care, vascular surgery, and colorectal surgery. The trial court judge instructed the jury not to give weight to the number of experts on either side, and based on the testimony, the jury found that Dr. Follwell did not cause the perforated bowel or the patient’s death.

However, on appeal, the Missouri Court of Appeals overturned the verdict after finding that the trial court erred in allowing “unfairly cumulative and prejudicial repetition of certain expert opinions.” The Missouri Supreme Court is currently being asked to render a final opinion on the matter. In its supporting brief, the American Medical Association’s Litigation Center is urging the high court to “ensure that Missouri trial judges are empowered to safeguard the use of sound science in their courtrooms,” and that “given the highly specialized nature of medicine today, multiple experts may be required to ensure a jury has a proper understanding of the relevant medical science.”⁴

The third case addresses whether trial judges can suppress expert witness testimony attesting that a known complication of a medical procedure can occur absent any negligence.

The case involved a laparoscopic hysterectomy performed by a gynecologist. The patient’s bowel was perforated during the procedure.⁵ Expert witnesses from both sides testified about bowel perforation and professional standards, and the trial court allowed the defendant’s expert to state that such an injury was a commonplace risk even if surgery was performed properly.

The plaintiff objected to this testimony; but the trial judge overruled the plaintiff’s objection, and the jury found in favor of the gynecologist. Upon appeal, the Pennsylvania Superior Court reversed, concluding that the defendant’s expert testimony was irrelevant and misleading, and immaterial to the issue of whether the defendant’s treatment met the standard of care. It held that the evidence was inadmissible and ordered a new trial. The case is now before the Pennsylvania Supreme Court.

The foregoing three cases are yet to be finally adjudicated, but controversies in these and similar issues can be expected to continue. Expert testimony is dispositive at trial, and both sides rely heavily on it. Little wonder malpractice litigation is frequently framed as a “battle of the experts.”
 

Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. For additional information, readers may contact the author at siang@hawaii.edu.

References

1. Internal Medicine News, “Expert medical testimony,” Sept. 9, 2010; “Qualifying as an expert,” Jan. 2, 2015; “Dispensing with expert testimony,” April 19, 2016.

2. Armacost v. Davis, 175 A.3d 150 (Ct. App. Md, 2017).

3. Shallow v. Follwell, (No. ED103811, Mo. App., Eastern Dist., Div. 4, 2017).

4. Henry TA, “Is it OK to have 4-to-1 expert ratio in medical liability case?” AMA Wire, June 22, 2018.

5. Mitchell v. Shikora, 161 A.3d 970 (Pa. Super. 2017).

Question: Which of the following statements regarding the law on evidence is incorrect?

A. Expert testimony is always needed to establish the applicable standard of care in a negligence lawsuit.

B. According to the Federal Rules of Evidence, a witness may be qualified as an expert based on knowledge, skill, experience, training, or education.

C. It is the judge, not the jury, who determines whether a witness is admissible as an expert.

D. Expert testimony is a requirement in medical malpractice lawsuits, unless a plaintiff can successfully invoke the res ipsa loquitur doctrine.

E. Only a few states have enacted statutes specifying that an expert must be in the same specialty as the defendant, and in some cases, a nonphysician such as a nurse or pharmacist may be allowed to testify.

Answer: A. Under the tort of negligence, a defendant’s conduct is measured by what is expected of the reasonable person – the man on the street. The jury can usually decide on its own, without the aid of an expert, what that level of care ought to be. However, in medical malpractice lawsuits, the law requires an expert to testify to the requisite standard of care, as this determination is believed to be beyond the scope of the layperson.

An exception, rarely invoked, is the res ipsa loquitur doctrine, where “the thing speaks for itself.” There, an expert is not necessary because of common knowledge, e.g., when a surgeon inadvertently leaves a sponge or instrument inside a body cavity.

Whether one is admitted as an expert is within the sole discretion of the judge, who is guided by the Federal Rules of Evidence. Typically, an expert is in the same medical specialty, but there are instances of professionals of unlike specialties qualifying as experts. Examples include a nephrologist testifying against a urologist, an infectious disease specialist offering an expert opinion in a stroke case, a pharmacist testifying on the issue of a medication side effect, and a nurse on bedsores.

We had previously reviewed the law governing expert medical testimony in these columns.¹ However, three recent cases awaiting final adjudication caught our attention, as they raise important and serious legal issues.

The first frontally suggests that jury members may rely on their own notion of what constitutes an appropriate standard of care. Although it is established law in Maryland that expert testimony is required to set that standard in medical malpractice litigation, the recent Maryland case of Armacost v. Davis appeared to modify this principle, leading to a plaintiff verdict.²

The facts involved a neurosurgeon’s anterior cervical discectomy and fusion surgery, which was complicated by a pinpoint opening at the end of the incision. This eventually developed into a MRSA abscess. In his lawsuit, the plaintiff alleged that surgery was neither medically necessary nor appropriate, that there was no proper informed consent, and that the diagnosis of his postoperative infection was delayed.

A pivotal part of the trial centered on a Baltimore county judge’s instructions to the jury that it could consider what a layperson would deem reasonable standard of care. Moreover, the judge refused to modify the jury instructions when the doctor-defendant objected and asked that the standard of care be measured by the expectations for a neurosurgeon. The jury returned a verdict in favor of the plaintiff in the amount of $329,000.

Upon appeal, the Court of Special Appeals of Maryland ruled that the jury instructions were improper and therefore ordered a new trial. It held: “Medical malpractice claims are not general negligence claims, and so jury instructions on general negligence, although correct statements of Maryland law, are not supported by the facts of a case centered on the allegedly negligent conduct of a physician. Accordingly, we hold that the trial court erred in giving general negligence instructions in a medical malpractice case.”

The case is now before Maryland’s highest court, the Court of Appeals of Maryland, which is expected to uphold this decision and reject the reasonable person (instead of reasonable doctor) standard used by the lower court.

The second case deals with whether a jury in a medical liability trial may be prejudiced if they hear four medical experts testify for the physician and just one expert testify for the plaintiff. In Shallow v. Follwell, the defendant doctor performed a laparoscopic hernia repair, which was complicated by bowel perforation, atrial fibrillation, sepsis, and death.³

At trial, plaintiffs produced one expert witness, whereas Dr. Follwell had four, with expertise in cardiology, critical care, vascular surgery, and colorectal surgery. The trial court judge instructed the jury not to give weight to the number of experts on either side, and based on the testimony, the jury found that Dr. Follwell did not cause the perforated bowel or the patient’s death.

However, on appeal, the Missouri Court of Appeals overturned the verdict after finding that the trial court erred in allowing “unfairly cumulative and prejudicial repetition of certain expert opinions.” The Missouri Supreme Court is currently being asked to render a final opinion on the matter. In its supporting brief, the American Medical Association’s Litigation Center is urging the high court to “ensure that Missouri trial judges are empowered to safeguard the use of sound science in their courtrooms,” and that “given the highly specialized nature of medicine today, multiple experts may be required to ensure a jury has a proper understanding of the relevant medical science.”⁴

The third case addresses whether trial judges can suppress expert witness testimony attesting that a known complication of a medical procedure can occur absent any negligence.

The case involved a laparoscopic hysterectomy performed by a gynecologist. The patient’s bowel was perforated during the procedure.⁵ Expert witnesses from both sides testified about bowel perforation and professional standards, and the trial court allowed the defendant’s expert to state that such an injury was a commonplace risk even if surgery was performed properly.

The plaintiff objected to this testimony; but the trial judge overruled the plaintiff’s objection, and the jury found in favor of the gynecologist. Upon appeal, the Pennsylvania Superior Court reversed, concluding that the defendant’s expert testimony was irrelevant and misleading, and immaterial to the issue of whether the defendant’s treatment met the standard of care. It held that the evidence was inadmissible and ordered a new trial. The case is now before the Pennsylvania Supreme Court.

The foregoing three cases are yet to be finally adjudicated, but controversies in these and similar issues can be expected to continue. Expert testimony is dispositive at trial, and both sides rely heavily on it. Little wonder malpractice litigation is frequently framed as a “battle of the experts.”
 

Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. For additional information, readers may contact the author at siang@hawaii.edu.

References

1. Internal Medicine News, “Expert medical testimony,” Sept. 9, 2010; “Qualifying as an expert,” Jan. 2, 2015; “Dispensing with expert testimony,” April 19, 2016.

2. Armacost v. Davis, 175 A.3d 150 (Ct. App. Md, 2017).

3. Shallow v. Follwell, (No. ED103811, Mo. App., Eastern Dist., Div. 4, 2017).

4. Henry TA, “Is it OK to have 4-to-1 expert ratio in medical liability case?” AMA Wire, June 22, 2018.

5. Mitchell v. Shikora, 161 A.3d 970 (Pa. Super. 2017).

Question: A new patient with severe back pain sought treatment at the Ease-Your-Pain Clinic, a facility run by medical specialists. Following a history and physical, he was given a prescription for high-dose oxycodone. Shortly after filing the prescription, he became unresponsive, and toxicology studies postmortem revealed elevated blood levels.

In a wrongful death lawsuit against the doctor and clinic, which of the following statements is best?
 

A. A wrongful death lawsuit deals with a special type of malpractice in which criminal sanctions are likely.

B. The facts here fall within the domain of common knowledge, or res ipsa loquitur; so the case will not have to depend on an expert witness.

C. Substandard care is clearly evident from the fact that this opioid-naive patient was prescribed a much higher than usual starting dose of the drug.

D. The elevated blood levels indicate that the cause of death was an opioid overdose.

E. To prevail, the plaintiff has the burden of proving, by a preponderance of evidence and through expert testimony, that the defendant’s breach of duty of due care legally caused the patient’s death.

Answer: E. Criminal prosecution for homicide is quite different from a civil lawsuit for wrongful death, requiring state action with proof beyond reasonable doubt and a showing of intent. It is rare in medical malpractice cases, which require expert testimony to prove breach of duty and causation.

Choices C and D are incorrect, as the facts given are deliberately brief and vague. For example, the medical history may have revealed this patient to be a chronic user of opioid drugs rather than being opioid naive, thus the need for higher dosing. In addition, we cannot be certain of the actual cause of death; opioid levels obtained in body fluids postmortem may be difficult to interpret and are apt to be higher in chronic users (see Dallier v. Hsu, discussed below).

We are currently in the throes of an epidemic of opioid deaths involving both illicit street drugs such as heroin and synthetic fentanyl, as well as FDA-approved controlled substances such as morphine and codeine derivatives. Overdose now exceeds motor vehicle accidents as the leading cause of injury-related deaths, with nearly 100 Americans dying every day from an opioid overdose.

In an earlier column, we drew attention to physician and manufacturer criminality associated with opioid prescription deaths.¹ In this article, we will focus on the civil liability facing doctors who treat patients afflicted with pain.

The onslaught of warnings, caution, and threats of criminal prosecution has prompted Medicare and pharmacy chains to impose restrictions on opioid prescriptions. Even more troubling, doctors are increasingly cutting back or stopping entirely their prescriptions. As a result, some patients may resort to desperate measures to obtain their drugs.

A recent article in the Washington Post draws attention to this situation.² It tells the story of a 49-year-old trucker who had been taking large amounts of prescription opioids ever since hip surgery left him with nerve damage. Because no doctor nearby would write an opioid prescription, he had to drive 367 miles to his old pain clinic each month for a refill. According to the article, chronic pain patients may turn to unregulated alternatives such as kratom, and some have threatened suicide.

Citing data from the IQVIA Institute for Human Data Science, the article reported that the annual volume of prescription opioids shrank 29% between 2011 and 2017, even as the number of overdose deaths climbed ever higher. The drop in prescriptions was greatest for patients receiving high doses, most of whom had chronic pain.

Failure to treat pain can constitute substandard care. In Bergman v. Eden Medical Center, an Alameda County jury in California turned in a verdict against an internist charged with elder abuse and reckless negligence for failing to give enough pain medication to a patient dying of cancer.³ William Bergman was an 85-year-old retired railroad worker who complained of severe back pain. During his 6-day stay at the hospital, nurses consistently charted his pain in the 7-10 range, and on the day of discharge, his pain was at level 10. He died at home shortly thereafter.

After 4 days of deliberation, the jury, in a 9-3 vote, entered a guilty verdict, and awarded $1.5 million in general damages. That amount was subsequently reduced to $250,000 because of California’s cap on noneconomic damages. The Bergman case is notable for being the first of its kind, and it squarely put physicians on notice regarding their duty to adequately provide pain relief.

At the same time, prescribing opioid drugs that result in harm can be the basis of a successful claim – if the plaintiff can prove the tort elements of negligence. However, this may be harder than it looks.

For example, a Connecticut malpractice case alleging negligent opioid prescriptions resulted in a judgment in favor of the defendant.⁴ The patient had a congenital skeletal deformity called Madelung’s disease, and she suffered from many years of severe pain requiring chronic opioids such as oxycodone, methadone, morphine, fentanyl, and hydrocodone, in combination and with other types of medications for anxiety, sleep problems, and depression. She was not a compliant patient and had a history of inconsistent pill counts and urine tests, and a history of stockpiling and hoarding pills.

Following a recent fracture of her right arm and shoulder, she visited several doctors for narcotic prescriptions before consulting the defendant doctor, who concluded that hers was an emergency and urgent situation. He believed that if he did not prescribe medications to address her pain, she would engage in unsafe drug-seeking behaviors. Accordingly, the doctor prescribed the following: methadone, 40 mg, 4 pills per day; extended-release morphine sulfate, 60 mg, 2 per day; alprazolam, 1 mg, 3 per day. Within hours of filing her prescription, she began to stumble, developed slurred speech, and then became unresponsive and died.

The court was unpersuaded that the requisite standard of care was to contact the patient’s prior treaters or pharmacy, or to obtain her current records to determine her level of drug naiveté or tolerance, or that the defendant should have initiated treatment with starting doses of drugs. It held that that reflected “a narrow textbook approach to the practice of pain management and ignores the role of patient-physician interaction.”

Based on all the evidence, the patient’s tolerance for opiates had greatly escalated, and her level of pain remained at 10 on a scale of 10. The defendant had independently assessed the patient, determined her needs, and ruled out that she was opiate naive. Based on all the circumstances, he prescribed morphine, methadone, and alprazolam. The morphine prescription of 60 mg extended release every 12 hours was not lethal to her and was not her first opioid analgesic. The court ruled that the plaintiff had failed to sustain the burden of proving causation, there being no finding that the patient took more medications than prescribed or overdosed. It was unimpressed by the various calculations offered by the experts on postmortem drug levels and causation.

A recent report from the Doctor’s Company, a major malpractice carrier, reviewed 1,770 claims closed between 2007 and 2015 in which patient harm involved medication factors.⁵ In 272 of those claims (15%), the medications were narcotic analgesics, most often prescribed in the outpatient setting and involving methadone and oxycodone. The Centers for Disease Control and Prevention has recently published treatment guidelines noting that long-term opioid use among patients with chronic pain increased the likelihood of addiction and overdose and had uncertain benefits. They discouraged doses higher than the equivalent of 90 mg of morphine.⁶

While it is true that opioid-related malpractice lawsuits are not infrequent, stopping entirely the prescribing of controlled narcotic analgesics in the name of “first do no harm” is simplistic and misguided.

It is better to adopt widely recommended strategies in opioid prescribing, recognizing that, as Howard Marcus, MD, chair of the Texas Alliance for Patient Access, has said, “It is possible to prescribe opioids responsibly and safely for patients with chronic pain who do not obtain sufficient relief and reasonable function with nonopioid treatment. However, to do so, it is necessary to have adequate knowledge of the pharmacology of opioids, risk factors, and side effects. Safe opioid prescribing requires thorough patient evaluation, attention to detail, and familiarity with guidelines and regulations.”⁷

To this might be added the suggestion that, in tough cases, one should make a referral to a pain specialist skilled in the use of such drugs.

Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. For additional information, readers may contact the author at siang@hawaii.edu.

References

1. “Physician liability in opioid deaths.” Internal Medicine News, July 13, 2017.

2. “Unintended consequences: Inside the fallout of America’s crackdown on opioids.” Washington Post, May 31, 2018.

3. Bergman v. Eden Medical Center, No. H205732-1 (Sup. Ct. Alameda Co., Cal., June 13, 2001).

4. Dallaire v. Hsu, CV 07-5004043 (Conn. Sup. Ct., May 18, 2010).

5. “Prescription opioid abuse epidemic: analysis of medication-related claims.” The Doctor’s Advocate, first quarter 2017.

6. N Engl J Med. 2016 Apr 21;374(16):1501-4.

7. “Prescribing opioids safely.” The Doctor’s Advocate, second quarter 2017.

Question: A new patient with severe back pain sought treatment at the Ease-Your-Pain Clinic, a facility run by medical specialists. Following a history and physical, he was given a prescription for high-dose oxycodone. Shortly after filing the prescription, he became unresponsive, and toxicology studies postmortem revealed elevated blood levels.

In a wrongful death lawsuit against the doctor and clinic, which of the following statements is best?
 

A. A wrongful death lawsuit deals with a special type of malpractice in which criminal sanctions are likely.

B. The facts here fall within the domain of common knowledge, or res ipsa loquitur; so the case will not have to depend on an expert witness.

C. Substandard care is clearly evident from the fact that this opioid-naive patient was prescribed a much higher than usual starting dose of the drug.

D. The elevated blood levels indicate that the cause of death was an opioid overdose.

E. To prevail, the plaintiff has the burden of proving, by a preponderance of evidence and through expert testimony, that the defendant’s breach of duty of due care legally caused the patient’s death.

Answer: E. Criminal prosecution for homicide is quite different from a civil lawsuit for wrongful death, requiring state action with proof beyond reasonable doubt and a showing of intent. It is rare in medical malpractice cases, which require expert testimony to prove breach of duty and causation.

Choices C and D are incorrect, as the facts given are deliberately brief and vague. For example, the medical history may have revealed this patient to be a chronic user of opioid drugs rather than being opioid naive, thus the need for higher dosing. In addition, we cannot be certain of the actual cause of death; opioid levels obtained in body fluids postmortem may be difficult to interpret and are apt to be higher in chronic users (see Dallier v. Hsu, discussed below).

We are currently in the throes of an epidemic of opioid deaths involving both illicit street drugs such as heroin and synthetic fentanyl, as well as FDA-approved controlled substances such as morphine and codeine derivatives. Overdose now exceeds motor vehicle accidents as the leading cause of injury-related deaths, with nearly 100 Americans dying every day from an opioid overdose.

In an earlier column, we drew attention to physician and manufacturer criminality associated with opioid prescription deaths.¹ In this article, we will focus on the civil liability facing doctors who treat patients afflicted with pain.

The onslaught of warnings, caution, and threats of criminal prosecution has prompted Medicare and pharmacy chains to impose restrictions on opioid prescriptions. Even more troubling, doctors are increasingly cutting back or stopping entirely their prescriptions. As a result, some patients may resort to desperate measures to obtain their drugs.

A recent article in the Washington Post draws attention to this situation.² It tells the story of a 49-year-old trucker who had been taking large amounts of prescription opioids ever since hip surgery left him with nerve damage. Because no doctor nearby would write an opioid prescription, he had to drive 367 miles to his old pain clinic each month for a refill. According to the article, chronic pain patients may turn to unregulated alternatives such as kratom, and some have threatened suicide.

Citing data from the IQVIA Institute for Human Data Science, the article reported that the annual volume of prescription opioids shrank 29% between 2011 and 2017, even as the number of overdose deaths climbed ever higher. The drop in prescriptions was greatest for patients receiving high doses, most of whom had chronic pain.

Failure to treat pain can constitute substandard care. In Bergman v. Eden Medical Center, an Alameda County jury in California turned in a verdict against an internist charged with elder abuse and reckless negligence for failing to give enough pain medication to a patient dying of cancer.³ William Bergman was an 85-year-old retired railroad worker who complained of severe back pain. During his 6-day stay at the hospital, nurses consistently charted his pain in the 7-10 range, and on the day of discharge, his pain was at level 10. He died at home shortly thereafter.

After 4 days of deliberation, the jury, in a 9-3 vote, entered a guilty verdict, and awarded $1.5 million in general damages. That amount was subsequently reduced to $250,000 because of California’s cap on noneconomic damages. The Bergman case is notable for being the first of its kind, and it squarely put physicians on notice regarding their duty to adequately provide pain relief.

At the same time, prescribing opioid drugs that result in harm can be the basis of a successful claim – if the plaintiff can prove the tort elements of negligence. However, this may be harder than it looks.

For example, a Connecticut malpractice case alleging negligent opioid prescriptions resulted in a judgment in favor of the defendant.⁴ The patient had a congenital skeletal deformity called Madelung’s disease, and she suffered from many years of severe pain requiring chronic opioids such as oxycodone, methadone, morphine, fentanyl, and hydrocodone, in combination and with other types of medications for anxiety, sleep problems, and depression. She was not a compliant patient and had a history of inconsistent pill counts and urine tests, and a history of stockpiling and hoarding pills.

Following a recent fracture of her right arm and shoulder, she visited several doctors for narcotic prescriptions before consulting the defendant doctor, who concluded that hers was an emergency and urgent situation. He believed that if he did not prescribe medications to address her pain, she would engage in unsafe drug-seeking behaviors. Accordingly, the doctor prescribed the following: methadone, 40 mg, 4 pills per day; extended-release morphine sulfate, 60 mg, 2 per day; alprazolam, 1 mg, 3 per day. Within hours of filing her prescription, she began to stumble, developed slurred speech, and then became unresponsive and died.

The court was unpersuaded that the requisite standard of care was to contact the patient’s prior treaters or pharmacy, or to obtain her current records to determine her level of drug naiveté or tolerance, or that the defendant should have initiated treatment with starting doses of drugs. It held that that reflected “a narrow textbook approach to the practice of pain management and ignores the role of patient-physician interaction.”

Based on all the evidence, the patient’s tolerance for opiates had greatly escalated, and her level of pain remained at 10 on a scale of 10. The defendant had independently assessed the patient, determined her needs, and ruled out that she was opiate naive. Based on all the circumstances, he prescribed morphine, methadone, and alprazolam. The morphine prescription of 60 mg extended release every 12 hours was not lethal to her and was not her first opioid analgesic. The court ruled that the plaintiff had failed to sustain the burden of proving causation, there being no finding that the patient took more medications than prescribed or overdosed. It was unimpressed by the various calculations offered by the experts on postmortem drug levels and causation.

A recent report from the Doctor’s Company, a major malpractice carrier, reviewed 1,770 claims closed between 2007 and 2015 in which patient harm involved medication factors.⁵ In 272 of those claims (15%), the medications were narcotic analgesics, most often prescribed in the outpatient setting and involving methadone and oxycodone. The Centers for Disease Control and Prevention has recently published treatment guidelines noting that long-term opioid use among patients with chronic pain increased the likelihood of addiction and overdose and had uncertain benefits. They discouraged doses higher than the equivalent of 90 mg of morphine.⁶

While it is true that opioid-related malpractice lawsuits are not infrequent, stopping entirely the prescribing of controlled narcotic analgesics in the name of “first do no harm” is simplistic and misguided.

It is better to adopt widely recommended strategies in opioid prescribing, recognizing that, as Howard Marcus, MD, chair of the Texas Alliance for Patient Access, has said, “It is possible to prescribe opioids responsibly and safely for patients with chronic pain who do not obtain sufficient relief and reasonable function with nonopioid treatment. However, to do so, it is necessary to have adequate knowledge of the pharmacology of opioids, risk factors, and side effects. Safe opioid prescribing requires thorough patient evaluation, attention to detail, and familiarity with guidelines and regulations.”⁷

To this might be added the suggestion that, in tough cases, one should make a referral to a pain specialist skilled in the use of such drugs.

Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. For additional information, readers may contact the author at siang@hawaii.edu.

References

1. “Physician liability in opioid deaths.” Internal Medicine News, July 13, 2017.

2. “Unintended consequences: Inside the fallout of America’s crackdown on opioids.” Washington Post, May 31, 2018.

3. Bergman v. Eden Medical Center, No. H205732-1 (Sup. Ct. Alameda Co., Cal., June 13, 2001).

4. Dallaire v. Hsu, CV 07-5004043 (Conn. Sup. Ct., May 18, 2010).

5. “Prescription opioid abuse epidemic: analysis of medication-related claims.” The Doctor’s Advocate, first quarter 2017.

6. N Engl J Med. 2016 Apr 21;374(16):1501-4.

7. “Prescribing opioids safely.” The Doctor’s Advocate, second quarter 2017.

Question: A new patient with severe back pain sought treatment at the Ease-Your-Pain Clinic, a facility run by medical specialists. Following a history and physical, he was given a prescription for high-dose oxycodone. Shortly after filing the prescription, he became unresponsive, and toxicology studies postmortem revealed elevated blood levels.

In a wrongful death lawsuit against the doctor and clinic, which of the following statements is best?
 

A. A wrongful death lawsuit deals with a special type of malpractice in which criminal sanctions are likely.

B. The facts here fall within the domain of common knowledge, or res ipsa loquitur; so the case will not have to depend on an expert witness.

C. Substandard care is clearly evident from the fact that this opioid-naive patient was prescribed a much higher than usual starting dose of the drug.

D. The elevated blood levels indicate that the cause of death was an opioid overdose.

E. To prevail, the plaintiff has the burden of proving, by a preponderance of evidence and through expert testimony, that the defendant’s breach of duty of due care legally caused the patient’s death.

Answer: E. Criminal prosecution for homicide is quite different from a civil lawsuit for wrongful death, requiring state action with proof beyond reasonable doubt and a showing of intent. It is rare in medical malpractice cases, which require expert testimony to prove breach of duty and causation.

Choices C and D are incorrect, as the facts given are deliberately brief and vague. For example, the medical history may have revealed this patient to be a chronic user of opioid drugs rather than being opioid naive, thus the need for higher dosing. In addition, we cannot be certain of the actual cause of death; opioid levels obtained in body fluids postmortem may be difficult to interpret and are apt to be higher in chronic users (see Dallier v. Hsu, discussed below).

We are currently in the throes of an epidemic of opioid deaths involving both illicit street drugs such as heroin and synthetic fentanyl, as well as FDA-approved controlled substances such as morphine and codeine derivatives. Overdose now exceeds motor vehicle accidents as the leading cause of injury-related deaths, with nearly 100 Americans dying every day from an opioid overdose.

In an earlier column, we drew attention to physician and manufacturer criminality associated with opioid prescription deaths.¹ In this article, we will focus on the civil liability facing doctors who treat patients afflicted with pain.

The onslaught of warnings, caution, and threats of criminal prosecution has prompted Medicare and pharmacy chains to impose restrictions on opioid prescriptions. Even more troubling, doctors are increasingly cutting back or stopping entirely their prescriptions. As a result, some patients may resort to desperate measures to obtain their drugs.

A recent article in the Washington Post draws attention to this situation.² It tells the story of a 49-year-old trucker who had been taking large amounts of prescription opioids ever since hip surgery left him with nerve damage. Because no doctor nearby would write an opioid prescription, he had to drive 367 miles to his old pain clinic each month for a refill. According to the article, chronic pain patients may turn to unregulated alternatives such as kratom, and some have threatened suicide.

Citing data from the IQVIA Institute for Human Data Science, the article reported that the annual volume of prescription opioids shrank 29% between 2011 and 2017, even as the number of overdose deaths climbed ever higher. The drop in prescriptions was greatest for patients receiving high doses, most of whom had chronic pain.

Failure to treat pain can constitute substandard care. In Bergman v. Eden Medical Center, an Alameda County jury in California turned in a verdict against an internist charged with elder abuse and reckless negligence for failing to give enough pain medication to a patient dying of cancer.³ William Bergman was an 85-year-old retired railroad worker who complained of severe back pain. During his 6-day stay at the hospital, nurses consistently charted his pain in the 7-10 range, and on the day of discharge, his pain was at level 10. He died at home shortly thereafter.

After 4 days of deliberation, the jury, in a 9-3 vote, entered a guilty verdict, and awarded $1.5 million in general damages. That amount was subsequently reduced to $250,000 because of California’s cap on noneconomic damages. The Bergman case is notable for being the first of its kind, and it squarely put physicians on notice regarding their duty to adequately provide pain relief.

At the same time, prescribing opioid drugs that result in harm can be the basis of a successful claim – if the plaintiff can prove the tort elements of negligence. However, this may be harder than it looks.

For example, a Connecticut malpractice case alleging negligent opioid prescriptions resulted in a judgment in favor of the defendant.⁴ The patient had a congenital skeletal deformity called Madelung’s disease, and she suffered from many years of severe pain requiring chronic opioids such as oxycodone, methadone, morphine, fentanyl, and hydrocodone, in combination and with other types of medications for anxiety, sleep problems, and depression. She was not a compliant patient and had a history of inconsistent pill counts and urine tests, and a history of stockpiling and hoarding pills.

Following a recent fracture of her right arm and shoulder, she visited several doctors for narcotic prescriptions before consulting the defendant doctor, who concluded that hers was an emergency and urgent situation. He believed that if he did not prescribe medications to address her pain, she would engage in unsafe drug-seeking behaviors. Accordingly, the doctor prescribed the following: methadone, 40 mg, 4 pills per day; extended-release morphine sulfate, 60 mg, 2 per day; alprazolam, 1 mg, 3 per day. Within hours of filing her prescription, she began to stumble, developed slurred speech, and then became unresponsive and died.

The court was unpersuaded that the requisite standard of care was to contact the patient’s prior treaters or pharmacy, or to obtain her current records to determine her level of drug naiveté or tolerance, or that the defendant should have initiated treatment with starting doses of drugs. It held that that reflected “a narrow textbook approach to the practice of pain management and ignores the role of patient-physician interaction.”

Based on all the evidence, the patient’s tolerance for opiates had greatly escalated, and her level of pain remained at 10 on a scale of 10. The defendant had independently assessed the patient, determined her needs, and ruled out that she was opiate naive. Based on all the circumstances, he prescribed morphine, methadone, and alprazolam. The morphine prescription of 60 mg extended release every 12 hours was not lethal to her and was not her first opioid analgesic. The court ruled that the plaintiff had failed to sustain the burden of proving causation, there being no finding that the patient took more medications than prescribed or overdosed. It was unimpressed by the various calculations offered by the experts on postmortem drug levels and causation.

A recent report from the Doctor’s Company, a major malpractice carrier, reviewed 1,770 claims closed between 2007 and 2015 in which patient harm involved medication factors.⁵ In 272 of those claims (15%), the medications were narcotic analgesics, most often prescribed in the outpatient setting and involving methadone and oxycodone. The Centers for Disease Control and Prevention has recently published treatment guidelines noting that long-term opioid use among patients with chronic pain increased the likelihood of addiction and overdose and had uncertain benefits. They discouraged doses higher than the equivalent of 90 mg of morphine.⁶

While it is true that opioid-related malpractice lawsuits are not infrequent, stopping entirely the prescribing of controlled narcotic analgesics in the name of “first do no harm” is simplistic and misguided.

It is better to adopt widely recommended strategies in opioid prescribing, recognizing that, as Howard Marcus, MD, chair of the Texas Alliance for Patient Access, has said, “It is possible to prescribe opioids responsibly and safely for patients with chronic pain who do not obtain sufficient relief and reasonable function with nonopioid treatment. However, to do so, it is necessary to have adequate knowledge of the pharmacology of opioids, risk factors, and side effects. Safe opioid prescribing requires thorough patient evaluation, attention to detail, and familiarity with guidelines and regulations.”⁷

To this might be added the suggestion that, in tough cases, one should make a referral to a pain specialist skilled in the use of such drugs.

Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. For additional information, readers may contact the author at siang@hawaii.edu.

References

1. “Physician liability in opioid deaths.” Internal Medicine News, July 13, 2017.

2. “Unintended consequences: Inside the fallout of America’s crackdown on opioids.” Washington Post, May 31, 2018.

3. Bergman v. Eden Medical Center, No. H205732-1 (Sup. Ct. Alameda Co., Cal., June 13, 2001).

4. Dallaire v. Hsu, CV 07-5004043 (Conn. Sup. Ct., May 18, 2010).

5. “Prescription opioid abuse epidemic: analysis of medication-related claims.” The Doctor’s Advocate, first quarter 2017.

6. N Engl J Med. 2016 Apr 21;374(16):1501-4.

7. “Prescribing opioids safely.” The Doctor’s Advocate, second quarter 2017.