S. Y. Tan, MD, JD

Question: Mr. M, a car mechanic, was treated with long-term ACTH and Kenalog after he developed severe contact dermatitis from daily exposure to petroleum-based solvents. His subsequent course was complicated by cataracts and osteoporosis. Which of the following is true in case he files a malpractice action?



A. Treatment with steroids was medically indicated for Mr. Mechanic’s dermatologic condition, so the doctor could not have breached the standard of care.

B. Under the “Learned Intermediary” doctrine, both the manufacturer and the prescribing doctor are jointly liable.

C. Corticosteroids are a known cause of osteoporosis and other complications, but not of cataracts, so that part of the malpractice action should be thrown out.

D. The plaintiff would prevail even if he could not find an expert witnesses to testify as to standard of care, since it is “common knowledge” that steroids cause osteoporosis.

E. Lack of informed consent may be his best legal theory of liability, as many jurisdictions now use the patient-centered standard, which does not require expert testimony.



Answer: E. The above hypothetical was modified from an old Montana case¹ in which the patient failed in his negligence lawsuit because he did not have expert witnesses to testify as to standard of care and to adequacy of warning label. However, in some jurisdictions under today’s case law, informed consent relies on a subjective, i.e., patient-oriented standard, and expert testimony is unnecessary to prove breach of duty, although still needed to prove causation.
 

Steroid-related litigation

Steroid-related malpractice litigation is quite prevalent. In a retrospective study of a tertiary medical center from 1996 to 2008, Nash and coworkers identified 83 such cases.² Steroids were prescribed for pain (23%), asthma or another pulmonary condition (20%), a dermatologic condition (18%), an autoimmune condition (17%), or allergies (6%).

Learned intermediary

“Drug reps” have a responsibility to inform doctors of both benefits and risks of their medications, a process termed “fair balance.” Generally speaking, if a doctor fails to warn the patient of a medication risk, and injury results, the patient may have a claim against the doctor but not the drug manufacturer. This is termed the “learned intermediary” doctrine, which is also applicable to medical devices such as dialysis equipment, breast implants, and blood products.

The justification is that manufacturers can reasonably rely on the treating doctor to warn of adverse effects, which are disclosed to the profession through their sales reps and in the package insert and PDR. The treating doctor, in turn, is expected to use his or her professional judgment to adequately warn the patient. It is simply not feasible for the manufacturer to directly warn every patient without usurping the doctor-patient relationship. However, where known complications were undisclosed to the FDA and the profession, then plaintiff attorneys can file class action lawsuits directed at the manufacturer.
 

Complications

Complications arising out of the use of steroids are typical examples of medical products liability. This may be on the basis of the doctor having prescribed the medication without a proper indication or where contraindicated, or may have prescribed “the wrong dose for the wrong patient by the wrong route.” In addition, there may have been a lack of informed consent, i.e., failure to explain the underlying condition and the material risks associated with using the drug. Other acts of negligence, e.g., vicarious liability, may also apply.

Corticosteroids such as Prednisone, Decadron, Kenalog, etc., are widely prescribed, and can cause serious complications, especially when used in high doses for extended periods. Examples include suppression of the immune system with supervening infections, steroid osteoporosis and fractures,³ aseptic necrosis, steroid diabetes, hypertension, emotional changes, weight gain, cataracts, neurological complications, and many others. As in all malpractice actions, the plaintiff bears the burden of proof covering the four requisite tort elements, i.e., duty, breach of duty, causation, and damages. Expert testimony is almost always needed in a professional negligence lawsuit.

Aseptic necrosis is a feared complication of steroid therapy.

A recent report⁴ featured a nurse in her 40s who developed aseptic necrosis of the right shoulder and both hips after taking high dose prednisone for 6 months. She was being treated for idiopathic thrombocytopenic purpura by a hematologist as well as sarcoidosis by a pulmonologist. The plaintiff claimed that both defendants negligently prescribed the medication for an extended period of time without proper monitoring, which caused her severe bone complications requiring a hip and shoulder replacement. The defendants maintained that the steroid medication was necessary to treat the life-threatening conditions from which the plaintiff suffered and that the dosage was carefully monitored and was not excessive. However, in a jury trial, the defendant hematologist and pulmonologist were each found 50% negligent, and the patient was awarded $4.1 million in damages.

In a case⁵ of steroid-related neurological sequelae, a Colorado jury awarded $14.9 million to a couple against an outpatient surgery center for negligently administering an epidural dose of Kenalog that rendered the patient paraplegic, and for failure to obtain informed consent. The jury awarded the woman, age 57, approximately $1.7 million in past and future medical expenses; $3.2 million in unspecified economic damages; and $6.5 million in past and future noneconomic damages such as pain and suffering. Her husband will receive $3.5 million in past and future noneconomic damages for loss of consortium, according to the verdict. Two years before the injection date of 2013, the drug maker had announced that Kenalog should not be used for epidural procedures because of cord complications including infarction and paraplegia.
 

Contributory role

The putative offending drug does not have to be the sole cause of injury; if it played a contributory role, the court may find the presence of liability. For example, a Kansas appeals court⁶ upheld a jury award of $2.88 million in the case of a 40-year-old man who took his life after neurologic complications followed an epidural injection. During one of patient’s visits for chronic low back pain, the defendant-anesthesiologist administered an epidural steroid injection into an area left swollen from a previous injection.

The patient developed neurologic symptoms, and lumbar puncture yielded green pus caused by methicillin-resistant Staphylococcus aureus. He went on to develop arachnoiditis, which left him with impotence, incontinence, and excruciating pain. His lawsuit contended the injection needle had passed through an infected edematous area, causing meningitis and arachnoiditis. Before the case went to trial, the patient took his life because of unremitting pain.

In March 2014, a Johnson County jury found the doctor 75% at fault and the clinic 25% at fault and awarded damages, which were reduced to $1.67 million because Kansas caps noneconomic damages at $250,000. The court rejected the defendants’ argument that the trial judge improperly instructed the jury it could find liability only if negligence “caused” rather than merely “contributed to” the patient’s death, holding that “... one who contributes to a wrongful death is a cause of that death as contemplated by the wrongful death statute.”
 

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

References

1. Hill v. Squibb Sons, E.R, 592 P.2d 1383 (Mont. 1979).

2. Nash JJ et al, Medical malpractice and corticosteroid use. Otolaryngol Head Neck Surg. 2011; 144:10-5.

3. Buckley L. et al, Glucocorticoid-Induced Osteoporosis. N Engl J Med 2018; 379:2547-56.

4. Zarin’s Jury Verdict: Review and Analysis. Article ID 40229, Philadelphia County.

5. Robbin Smith et al. v. The Surgery Center at Lone Tree, 2015-CV-30922, Douglas County District Court, Colo. Verdict for plaintiff, March 23, 2017.

6. Burnette v. Kimber L. Eubanks, M.D., & Paincare, P.A., 379 P.3d 372 (Kan. Ct. App. 2016).

Question: Mr. M, a car mechanic, was treated with long-term ACTH and Kenalog after he developed severe contact dermatitis from daily exposure to petroleum-based solvents. His subsequent course was complicated by cataracts and osteoporosis. Which of the following is true in case he files a malpractice action?



A. Treatment with steroids was medically indicated for Mr. Mechanic’s dermatologic condition, so the doctor could not have breached the standard of care.

B. Under the “Learned Intermediary” doctrine, both the manufacturer and the prescribing doctor are jointly liable.

C. Corticosteroids are a known cause of osteoporosis and other complications, but not of cataracts, so that part of the malpractice action should be thrown out.

D. The plaintiff would prevail even if he could not find an expert witnesses to testify as to standard of care, since it is “common knowledge” that steroids cause osteoporosis.

E. Lack of informed consent may be his best legal theory of liability, as many jurisdictions now use the patient-centered standard, which does not require expert testimony.



Answer: E. The above hypothetical was modified from an old Montana case¹ in which the patient failed in his negligence lawsuit because he did not have expert witnesses to testify as to standard of care and to adequacy of warning label. However, in some jurisdictions under today’s case law, informed consent relies on a subjective, i.e., patient-oriented standard, and expert testimony is unnecessary to prove breach of duty, although still needed to prove causation.
 

Steroid-related litigation

Steroid-related malpractice litigation is quite prevalent. In a retrospective study of a tertiary medical center from 1996 to 2008, Nash and coworkers identified 83 such cases.² Steroids were prescribed for pain (23%), asthma or another pulmonary condition (20%), a dermatologic condition (18%), an autoimmune condition (17%), or allergies (6%).

Learned intermediary

“Drug reps” have a responsibility to inform doctors of both benefits and risks of their medications, a process termed “fair balance.” Generally speaking, if a doctor fails to warn the patient of a medication risk, and injury results, the patient may have a claim against the doctor but not the drug manufacturer. This is termed the “learned intermediary” doctrine, which is also applicable to medical devices such as dialysis equipment, breast implants, and blood products.

The justification is that manufacturers can reasonably rely on the treating doctor to warn of adverse effects, which are disclosed to the profession through their sales reps and in the package insert and PDR. The treating doctor, in turn, is expected to use his or her professional judgment to adequately warn the patient. It is simply not feasible for the manufacturer to directly warn every patient without usurping the doctor-patient relationship. However, where known complications were undisclosed to the FDA and the profession, then plaintiff attorneys can file class action lawsuits directed at the manufacturer.
 

Complications

Complications arising out of the use of steroids are typical examples of medical products liability. This may be on the basis of the doctor having prescribed the medication without a proper indication or where contraindicated, or may have prescribed “the wrong dose for the wrong patient by the wrong route.” In addition, there may have been a lack of informed consent, i.e., failure to explain the underlying condition and the material risks associated with using the drug. Other acts of negligence, e.g., vicarious liability, may also apply.

Corticosteroids such as Prednisone, Decadron, Kenalog, etc., are widely prescribed, and can cause serious complications, especially when used in high doses for extended periods. Examples include suppression of the immune system with supervening infections, steroid osteoporosis and fractures,³ aseptic necrosis, steroid diabetes, hypertension, emotional changes, weight gain, cataracts, neurological complications, and many others. As in all malpractice actions, the plaintiff bears the burden of proof covering the four requisite tort elements, i.e., duty, breach of duty, causation, and damages. Expert testimony is almost always needed in a professional negligence lawsuit.

Aseptic necrosis is a feared complication of steroid therapy.

A recent report⁴ featured a nurse in her 40s who developed aseptic necrosis of the right shoulder and both hips after taking high dose prednisone for 6 months. She was being treated for idiopathic thrombocytopenic purpura by a hematologist as well as sarcoidosis by a pulmonologist. The plaintiff claimed that both defendants negligently prescribed the medication for an extended period of time without proper monitoring, which caused her severe bone complications requiring a hip and shoulder replacement. The defendants maintained that the steroid medication was necessary to treat the life-threatening conditions from which the plaintiff suffered and that the dosage was carefully monitored and was not excessive. However, in a jury trial, the defendant hematologist and pulmonologist were each found 50% negligent, and the patient was awarded $4.1 million in damages.

In a case⁵ of steroid-related neurological sequelae, a Colorado jury awarded $14.9 million to a couple against an outpatient surgery center for negligently administering an epidural dose of Kenalog that rendered the patient paraplegic, and for failure to obtain informed consent. The jury awarded the woman, age 57, approximately $1.7 million in past and future medical expenses; $3.2 million in unspecified economic damages; and $6.5 million in past and future noneconomic damages such as pain and suffering. Her husband will receive $3.5 million in past and future noneconomic damages for loss of consortium, according to the verdict. Two years before the injection date of 2013, the drug maker had announced that Kenalog should not be used for epidural procedures because of cord complications including infarction and paraplegia.
 

Contributory role

The putative offending drug does not have to be the sole cause of injury; if it played a contributory role, the court may find the presence of liability. For example, a Kansas appeals court⁶ upheld a jury award of $2.88 million in the case of a 40-year-old man who took his life after neurologic complications followed an epidural injection. During one of patient’s visits for chronic low back pain, the defendant-anesthesiologist administered an epidural steroid injection into an area left swollen from a previous injection.

The patient developed neurologic symptoms, and lumbar puncture yielded green pus caused by methicillin-resistant Staphylococcus aureus. He went on to develop arachnoiditis, which left him with impotence, incontinence, and excruciating pain. His lawsuit contended the injection needle had passed through an infected edematous area, causing meningitis and arachnoiditis. Before the case went to trial, the patient took his life because of unremitting pain.

In March 2014, a Johnson County jury found the doctor 75% at fault and the clinic 25% at fault and awarded damages, which were reduced to $1.67 million because Kansas caps noneconomic damages at $250,000. The court rejected the defendants’ argument that the trial judge improperly instructed the jury it could find liability only if negligence “caused” rather than merely “contributed to” the patient’s death, holding that “... one who contributes to a wrongful death is a cause of that death as contemplated by the wrongful death statute.”
 

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

References

1. Hill v. Squibb Sons, E.R, 592 P.2d 1383 (Mont. 1979).

2. Nash JJ et al, Medical malpractice and corticosteroid use. Otolaryngol Head Neck Surg. 2011; 144:10-5.

3. Buckley L. et al, Glucocorticoid-Induced Osteoporosis. N Engl J Med 2018; 379:2547-56.

4. Zarin’s Jury Verdict: Review and Analysis. Article ID 40229, Philadelphia County.

5. Robbin Smith et al. v. The Surgery Center at Lone Tree, 2015-CV-30922, Douglas County District Court, Colo. Verdict for plaintiff, March 23, 2017.

6. Burnette v. Kimber L. Eubanks, M.D., & Paincare, P.A., 379 P.3d 372 (Kan. Ct. App. 2016).

Question: Mr. M, a car mechanic, was treated with long-term ACTH and Kenalog after he developed severe contact dermatitis from daily exposure to petroleum-based solvents. His subsequent course was complicated by cataracts and osteoporosis. Which of the following is true in case he files a malpractice action?



A. Treatment with steroids was medically indicated for Mr. Mechanic’s dermatologic condition, so the doctor could not have breached the standard of care.

B. Under the “Learned Intermediary” doctrine, both the manufacturer and the prescribing doctor are jointly liable.

C. Corticosteroids are a known cause of osteoporosis and other complications, but not of cataracts, so that part of the malpractice action should be thrown out.

D. The plaintiff would prevail even if he could not find an expert witnesses to testify as to standard of care, since it is “common knowledge” that steroids cause osteoporosis.

E. Lack of informed consent may be his best legal theory of liability, as many jurisdictions now use the patient-centered standard, which does not require expert testimony.



Answer: E. The above hypothetical was modified from an old Montana case¹ in which the patient failed in his negligence lawsuit because he did not have expert witnesses to testify as to standard of care and to adequacy of warning label. However, in some jurisdictions under today’s case law, informed consent relies on a subjective, i.e., patient-oriented standard, and expert testimony is unnecessary to prove breach of duty, although still needed to prove causation.
 

Steroid-related litigation

Steroid-related malpractice litigation is quite prevalent. In a retrospective study of a tertiary medical center from 1996 to 2008, Nash and coworkers identified 83 such cases.² Steroids were prescribed for pain (23%), asthma or another pulmonary condition (20%), a dermatologic condition (18%), an autoimmune condition (17%), or allergies (6%).

Learned intermediary

“Drug reps” have a responsibility to inform doctors of both benefits and risks of their medications, a process termed “fair balance.” Generally speaking, if a doctor fails to warn the patient of a medication risk, and injury results, the patient may have a claim against the doctor but not the drug manufacturer. This is termed the “learned intermediary” doctrine, which is also applicable to medical devices such as dialysis equipment, breast implants, and blood products.

The justification is that manufacturers can reasonably rely on the treating doctor to warn of adverse effects, which are disclosed to the profession through their sales reps and in the package insert and PDR. The treating doctor, in turn, is expected to use his or her professional judgment to adequately warn the patient. It is simply not feasible for the manufacturer to directly warn every patient without usurping the doctor-patient relationship. However, where known complications were undisclosed to the FDA and the profession, then plaintiff attorneys can file class action lawsuits directed at the manufacturer.
 

Complications

Complications arising out of the use of steroids are typical examples of medical products liability. This may be on the basis of the doctor having prescribed the medication without a proper indication or where contraindicated, or may have prescribed “the wrong dose for the wrong patient by the wrong route.” In addition, there may have been a lack of informed consent, i.e., failure to explain the underlying condition and the material risks associated with using the drug. Other acts of negligence, e.g., vicarious liability, may also apply.

Corticosteroids such as Prednisone, Decadron, Kenalog, etc., are widely prescribed, and can cause serious complications, especially when used in high doses for extended periods. Examples include suppression of the immune system with supervening infections, steroid osteoporosis and fractures,³ aseptic necrosis, steroid diabetes, hypertension, emotional changes, weight gain, cataracts, neurological complications, and many others. As in all malpractice actions, the plaintiff bears the burden of proof covering the four requisite tort elements, i.e., duty, breach of duty, causation, and damages. Expert testimony is almost always needed in a professional negligence lawsuit.

Aseptic necrosis is a feared complication of steroid therapy.

A recent report⁴ featured a nurse in her 40s who developed aseptic necrosis of the right shoulder and both hips after taking high dose prednisone for 6 months. She was being treated for idiopathic thrombocytopenic purpura by a hematologist as well as sarcoidosis by a pulmonologist. The plaintiff claimed that both defendants negligently prescribed the medication for an extended period of time without proper monitoring, which caused her severe bone complications requiring a hip and shoulder replacement. The defendants maintained that the steroid medication was necessary to treat the life-threatening conditions from which the plaintiff suffered and that the dosage was carefully monitored and was not excessive. However, in a jury trial, the defendant hematologist and pulmonologist were each found 50% negligent, and the patient was awarded $4.1 million in damages.

In a case⁵ of steroid-related neurological sequelae, a Colorado jury awarded $14.9 million to a couple against an outpatient surgery center for negligently administering an epidural dose of Kenalog that rendered the patient paraplegic, and for failure to obtain informed consent. The jury awarded the woman, age 57, approximately $1.7 million in past and future medical expenses; $3.2 million in unspecified economic damages; and $6.5 million in past and future noneconomic damages such as pain and suffering. Her husband will receive $3.5 million in past and future noneconomic damages for loss of consortium, according to the verdict. Two years before the injection date of 2013, the drug maker had announced that Kenalog should not be used for epidural procedures because of cord complications including infarction and paraplegia.
 

Contributory role

The putative offending drug does not have to be the sole cause of injury; if it played a contributory role, the court may find the presence of liability. For example, a Kansas appeals court⁶ upheld a jury award of $2.88 million in the case of a 40-year-old man who took his life after neurologic complications followed an epidural injection. During one of patient’s visits for chronic low back pain, the defendant-anesthesiologist administered an epidural steroid injection into an area left swollen from a previous injection.

The patient developed neurologic symptoms, and lumbar puncture yielded green pus caused by methicillin-resistant Staphylococcus aureus. He went on to develop arachnoiditis, which left him with impotence, incontinence, and excruciating pain. His lawsuit contended the injection needle had passed through an infected edematous area, causing meningitis and arachnoiditis. Before the case went to trial, the patient took his life because of unremitting pain.

In March 2014, a Johnson County jury found the doctor 75% at fault and the clinic 25% at fault and awarded damages, which were reduced to $1.67 million because Kansas caps noneconomic damages at $250,000. The court rejected the defendants’ argument that the trial judge improperly instructed the jury it could find liability only if negligence “caused” rather than merely “contributed to” the patient’s death, holding that “... one who contributes to a wrongful death is a cause of that death as contemplated by the wrongful death statute.”
 

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

References

1. Hill v. Squibb Sons, E.R, 592 P.2d 1383 (Mont. 1979).

2. Nash JJ et al, Medical malpractice and corticosteroid use. Otolaryngol Head Neck Surg. 2011; 144:10-5.

3. Buckley L. et al, Glucocorticoid-Induced Osteoporosis. N Engl J Med 2018; 379:2547-56.

4. Zarin’s Jury Verdict: Review and Analysis. Article ID 40229, Philadelphia County.

5. Robbin Smith et al. v. The Surgery Center at Lone Tree, 2015-CV-30922, Douglas County District Court, Colo. Verdict for plaintiff, March 23, 2017.

6. Burnette v. Kimber L. Eubanks, M.D., & Paincare, P.A., 379 P.3d 372 (Kan. Ct. App. 2016).

Question: Which one of the following statements is incorrect?

A. Office of Inspector General (OIG) is a federal agency of Department of Health & Human Services (HHS) that investigates statutory violations of health care fraud and abuse.

B. The three main legal minefields for physicians are false claims, kickbacks, and self-referrals.

C. Jail terms are part of the penalties provided by law.

D. OIG is also responsible for excluding violators from participating in Medicare/Medicaid programs, as well as curtailing a physician’s license to practice.

E. A private citizen can file a qui tam lawsuit against an errant practitioner or health care entity for fraud and abuse.



Answer: D. Health care fraud, waste, and abuse consume some 10% of federal health expenditures despite well-established laws that attempt to prevent and reduce such losses. The three key fraud and abuse laws that affect physicians are the False Claims Act (FCA), Anti-Kickback Statute (AKS), and Physician Self-Referral Law (Stark law). The Department of Health & Human Services (HHS) Office of Inspector General, as well as the Department of Justice and the Centers for Medicare & Medicaid Services are charged with enforcing these and other laws like the Emergency Medical Treatment and Labor Act. Their web pages, referenced throughout this article, contain a wealth of information for the practitioner.

The term “Office of Inspector General” (OIG) refers to the oversight division of a federal or state agency charged with identifying and investigating fraud, waste, abuse, and mismanagement within that department or agency. There are currently 73 separate federal offices of inspectors general, which employ armed and unarmed criminal investigators, auditors, forensic auditors called “audigators,” and a variety of other specialists. An Act of Congress in 1976 established the first OIG under HHS. Besides being the first, HHS-OIG is also the largest, with a staff of approximately 1,600. A majority of resources goes toward the oversight of Medicare and Medicaid, as well as programs under other HHS institutions such as the Centers for Disease Control and Prevention, National Institutes of Health, and the Food and Drug Administration.¹

HHS-OIG has the authority to seek civil monetary penalties, assessments, and exclusion against an individual or entity based on a wide variety of prohibited conduct affecting federal health care programs. Stiff penalties are regularly assessed against violators, and jail terms are not uncommon; however, it has no direct jurisdictions over physician licensure or nonfederal programs. The government maintains a pictorial list of its most wanted health care fugitives2 and provides an excellent set of Physician Education Training Materials on its website.³
 

False Claims Act (FCA)

In the health care arena, violation of FCA (31 U.S.C. §§3729-3733) is the foremost infraction. False claims by physicians can include billing for noncovered services such as experimental treatments, double billing, billing the government as the primary payer, or regularly waiving deductibles and copayments, as well as quality of care issues and unnecessary services. Wrongdoing also includes knowingly using another patient’s name for purposes of, say, federal drug coverage, billing for no-shows, and misrepresenting the diagnosis to justify services, as well as other claims. In the modern doctor’s office, the EMR enables easy check-offs on a preprinted form as documentation of actual work done. However, fraud is implicated if the information is deliberately misleading such as for purposes of upcoding. Importantly, physicians are liable for the actions of their office staff, so it is prudent to oversee and supervise all such activities. Naturally, one should document all claims that are sent and know the rules for allowable and excluded services.

FCA is an old law that was first enacted 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. Intent to defraud is not a required element but knowing or showing reckless disregard of the truth is. However, an error that is negligently committed 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 and criminal fines. A so-called whistle-blower may file a lawsuit on behalf of the government and is entitled to a percentage of any recoveries. Whistle-blowers may be current or ex-business partners, hospital or office staff, patients, or competitors. The fact that a claim results from a kickback or is made in violation of the Stark law (discussed below) may also render it fraudulent, thus creating additional liability under FCA.

HHS-OIG, as well as the Department of Justice, discloses named cases of statutory violations on their websites. A few random 2019 examples include a New York licensed doctor was convicted of nine counts in connection with Oxycodone and Fentanyl diversion scheme; a Newton, Mass., geriatrician agreed to pay $680,000 to resolve allegations that he violated the False Claims Act by submitting inflated claims to Medicare and the Massachusetts Medicaid program (MassHealth) for care rendered to nursing home patients; and two Clermont, Fla., ophthalmologists agreed to pay a combined total of $157,312.32 to resolve allegations that they violated FCA by knowingly billing the government for mutually exclusive eyelid repair surgeries.
 

Anti-Kickback Statute (AKS)

AKS (42 U.S.C. § 1320a-7b[b]) is a criminal law that prohibits the knowing and willful payment of “remuneration” to induce or reward patient referrals or the generation of business involving any item or service payable by federal health care programs. Remuneration includes anything of value and can take many forms besides cash, such as free rent, lavish travel, and excessive compensation for medical directorships or consultancies. Rewarding a referral source may be acceptable in some industries, but is a crime in federal health care programs.

Moreover, the statute covers both the payers of kickbacks (those who offer or pay remuneration) and the recipients of kickbacks. Each party’s intent is a key element of their liability under AKS. Physicians who pay or accept kickbacks face penalties of up to $50,000 per kickback plus three times the amount of the remuneration and criminal prosecution. As an example, a Tulsa, Okla., doctor earlier this year agreed to pay the government $84,666.42 for allegedly accepting illegal kickback payments from a pharmacy, and in another case, a marketer agreed to pay nearly $340,000 for receiving kickbacks in exchange for prescription referrals.

A physician is an attractive target for kickback schemes. The kickback prohibition applies to all sources, even patients. For example, where the Medicare and Medicaid programs require patients to be responsible for copays for services, the health care provider is generally required to collect that money from the patients. Advertising the forgiveness of copayments or routinely waiving these copays would violate AKS. However, one may waive a copayment when a patient cannot afford to pay one or is uninsured. AKS also imposes civil monetary penalties on physicians who offer remuneration to Medicare and Medicaid beneficiaries to influence them to use their services. Note that the government does not need to prove patient harm or financial loss to show that a violation has occurred, and physicians can be guilty even if they rendered services that are medically necessary.

There are so-called safe harbors that protect certain payment and business practices from running afoul of AKS. The rules and requirements are complex, and require full understanding and strict adherence.⁴
 

Physician Self-Referral Law

The Physician Self-Referral Law (42 U.S.C. § 1395nn), commonly referred to as the Stark law, prohibits physicians from referring patients to receive “designated health services” payable by Medicare or Medicaid from entities with which the physician or an immediate family member has a financial relationship, unless an exception applies. Financial relationships include both ownership/investment interests and compensation arrangements. A partial list of “designated health services” includes services related to clinical laboratory, physical therapy, radiology, parenteral and enteral supplies, prosthetic devices and supplies, home health care outpatient prescription drugs, and inpatient and outpatient hospital services. This list is not meant to be an exhaustive one.

Stark is a strict liability statute, which means proof of specific intent to violate the law is not required. The law prohibits the submission, or causing the submission, of claims in violation of the law’s restrictions on referrals. Penalties for physicians who violate the Stark law include fines, as well as exclusion from participation in federal health care programs. Like AKS, Stark law features its own safe harbors.
 

Dr. Tan is professor emeritus 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 materials may have been discussed in earlier columns. For additional information, readers may contact the author at siang@hawaii.edu.
 

References

1. HHS Office of Inspector General. About OIG. https://oig.hhs.gov/about-oig/about-us/index.asp

2. HHS Office of Inspector General. OIG most wanted fugitives.

3. HHS Office of Inspector General. “Physician education training materials.” A roadmap for new physicians: Avoiding Medicare and Medicaid fraud and abuse.

4. HHS Office of Inspector General. Safe harbor regulations.
 

Question: Which one of the following statements is incorrect?

A. Office of Inspector General (OIG) is a federal agency of Department of Health & Human Services (HHS) that investigates statutory violations of health care fraud and abuse.

B. The three main legal minefields for physicians are false claims, kickbacks, and self-referrals.

C. Jail terms are part of the penalties provided by law.

D. OIG is also responsible for excluding violators from participating in Medicare/Medicaid programs, as well as curtailing a physician’s license to practice.

E. A private citizen can file a qui tam lawsuit against an errant practitioner or health care entity for fraud and abuse.



Answer: D. Health care fraud, waste, and abuse consume some 10% of federal health expenditures despite well-established laws that attempt to prevent and reduce such losses. The three key fraud and abuse laws that affect physicians are the False Claims Act (FCA), Anti-Kickback Statute (AKS), and Physician Self-Referral Law (Stark law). The Department of Health & Human Services (HHS) Office of Inspector General, as well as the Department of Justice and the Centers for Medicare & Medicaid Services are charged with enforcing these and other laws like the Emergency Medical Treatment and Labor Act. Their web pages, referenced throughout this article, contain a wealth of information for the practitioner.

The term “Office of Inspector General” (OIG) refers to the oversight division of a federal or state agency charged with identifying and investigating fraud, waste, abuse, and mismanagement within that department or agency. There are currently 73 separate federal offices of inspectors general, which employ armed and unarmed criminal investigators, auditors, forensic auditors called “audigators,” and a variety of other specialists. An Act of Congress in 1976 established the first OIG under HHS. Besides being the first, HHS-OIG is also the largest, with a staff of approximately 1,600. A majority of resources goes toward the oversight of Medicare and Medicaid, as well as programs under other HHS institutions such as the Centers for Disease Control and Prevention, National Institutes of Health, and the Food and Drug Administration.¹

HHS-OIG has the authority to seek civil monetary penalties, assessments, and exclusion against an individual or entity based on a wide variety of prohibited conduct affecting federal health care programs. Stiff penalties are regularly assessed against violators, and jail terms are not uncommon; however, it has no direct jurisdictions over physician licensure or nonfederal programs. The government maintains a pictorial list of its most wanted health care fugitives2 and provides an excellent set of Physician Education Training Materials on its website.³
 

False Claims Act (FCA)

In the health care arena, violation of FCA (31 U.S.C. §§3729-3733) is the foremost infraction. False claims by physicians can include billing for noncovered services such as experimental treatments, double billing, billing the government as the primary payer, or regularly waiving deductibles and copayments, as well as quality of care issues and unnecessary services. Wrongdoing also includes knowingly using another patient’s name for purposes of, say, federal drug coverage, billing for no-shows, and misrepresenting the diagnosis to justify services, as well as other claims. In the modern doctor’s office, the EMR enables easy check-offs on a preprinted form as documentation of actual work done. However, fraud is implicated if the information is deliberately misleading such as for purposes of upcoding. Importantly, physicians are liable for the actions of their office staff, so it is prudent to oversee and supervise all such activities. Naturally, one should document all claims that are sent and know the rules for allowable and excluded services.

FCA is an old law that was first enacted 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. Intent to defraud is not a required element but knowing or showing reckless disregard of the truth is. However, an error that is negligently committed 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 and criminal fines. A so-called whistle-blower may file a lawsuit on behalf of the government and is entitled to a percentage of any recoveries. Whistle-blowers may be current or ex-business partners, hospital or office staff, patients, or competitors. The fact that a claim results from a kickback or is made in violation of the Stark law (discussed below) may also render it fraudulent, thus creating additional liability under FCA.

HHS-OIG, as well as the Department of Justice, discloses named cases of statutory violations on their websites. A few random 2019 examples include a New York licensed doctor was convicted of nine counts in connection with Oxycodone and Fentanyl diversion scheme; a Newton, Mass., geriatrician agreed to pay $680,000 to resolve allegations that he violated the False Claims Act by submitting inflated claims to Medicare and the Massachusetts Medicaid program (MassHealth) for care rendered to nursing home patients; and two Clermont, Fla., ophthalmologists agreed to pay a combined total of $157,312.32 to resolve allegations that they violated FCA by knowingly billing the government for mutually exclusive eyelid repair surgeries.
 

Anti-Kickback Statute (AKS)

AKS (42 U.S.C. § 1320a-7b[b]) is a criminal law that prohibits the knowing and willful payment of “remuneration” to induce or reward patient referrals or the generation of business involving any item or service payable by federal health care programs. Remuneration includes anything of value and can take many forms besides cash, such as free rent, lavish travel, and excessive compensation for medical directorships or consultancies. Rewarding a referral source may be acceptable in some industries, but is a crime in federal health care programs.

Moreover, the statute covers both the payers of kickbacks (those who offer or pay remuneration) and the recipients of kickbacks. Each party’s intent is a key element of their liability under AKS. Physicians who pay or accept kickbacks face penalties of up to $50,000 per kickback plus three times the amount of the remuneration and criminal prosecution. As an example, a Tulsa, Okla., doctor earlier this year agreed to pay the government $84,666.42 for allegedly accepting illegal kickback payments from a pharmacy, and in another case, a marketer agreed to pay nearly $340,000 for receiving kickbacks in exchange for prescription referrals.

A physician is an attractive target for kickback schemes. The kickback prohibition applies to all sources, even patients. For example, where the Medicare and Medicaid programs require patients to be responsible for copays for services, the health care provider is generally required to collect that money from the patients. Advertising the forgiveness of copayments or routinely waiving these copays would violate AKS. However, one may waive a copayment when a patient cannot afford to pay one or is uninsured. AKS also imposes civil monetary penalties on physicians who offer remuneration to Medicare and Medicaid beneficiaries to influence them to use their services. Note that the government does not need to prove patient harm or financial loss to show that a violation has occurred, and physicians can be guilty even if they rendered services that are medically necessary.

There are so-called safe harbors that protect certain payment and business practices from running afoul of AKS. The rules and requirements are complex, and require full understanding and strict adherence.⁴
 

Physician Self-Referral Law

The Physician Self-Referral Law (42 U.S.C. § 1395nn), commonly referred to as the Stark law, prohibits physicians from referring patients to receive “designated health services” payable by Medicare or Medicaid from entities with which the physician or an immediate family member has a financial relationship, unless an exception applies. Financial relationships include both ownership/investment interests and compensation arrangements. A partial list of “designated health services” includes services related to clinical laboratory, physical therapy, radiology, parenteral and enteral supplies, prosthetic devices and supplies, home health care outpatient prescription drugs, and inpatient and outpatient hospital services. This list is not meant to be an exhaustive one.

Stark is a strict liability statute, which means proof of specific intent to violate the law is not required. The law prohibits the submission, or causing the submission, of claims in violation of the law’s restrictions on referrals. Penalties for physicians who violate the Stark law include fines, as well as exclusion from participation in federal health care programs. Like AKS, Stark law features its own safe harbors.
 

Dr. Tan is professor emeritus 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 materials may have been discussed in earlier columns. For additional information, readers may contact the author at siang@hawaii.edu.
 

References

1. HHS Office of Inspector General. About OIG. https://oig.hhs.gov/about-oig/about-us/index.asp

2. HHS Office of Inspector General. OIG most wanted fugitives.

3. HHS Office of Inspector General. “Physician education training materials.” A roadmap for new physicians: Avoiding Medicare and Medicaid fraud and abuse.

4. HHS Office of Inspector General. Safe harbor regulations.
 

Question: Which one of the following statements is incorrect?

A. Office of Inspector General (OIG) is a federal agency of Department of Health & Human Services (HHS) that investigates statutory violations of health care fraud and abuse.

B. The three main legal minefields for physicians are false claims, kickbacks, and self-referrals.

C. Jail terms are part of the penalties provided by law.

D. OIG is also responsible for excluding violators from participating in Medicare/Medicaid programs, as well as curtailing a physician’s license to practice.

E. A private citizen can file a qui tam lawsuit against an errant practitioner or health care entity for fraud and abuse.



Answer: D. Health care fraud, waste, and abuse consume some 10% of federal health expenditures despite well-established laws that attempt to prevent and reduce such losses. The three key fraud and abuse laws that affect physicians are the False Claims Act (FCA), Anti-Kickback Statute (AKS), and Physician Self-Referral Law (Stark law). The Department of Health & Human Services (HHS) Office of Inspector General, as well as the Department of Justice and the Centers for Medicare & Medicaid Services are charged with enforcing these and other laws like the Emergency Medical Treatment and Labor Act. Their web pages, referenced throughout this article, contain a wealth of information for the practitioner.

The term “Office of Inspector General” (OIG) refers to the oversight division of a federal or state agency charged with identifying and investigating fraud, waste, abuse, and mismanagement within that department or agency. There are currently 73 separate federal offices of inspectors general, which employ armed and unarmed criminal investigators, auditors, forensic auditors called “audigators,” and a variety of other specialists. An Act of Congress in 1976 established the first OIG under HHS. Besides being the first, HHS-OIG is also the largest, with a staff of approximately 1,600. A majority of resources goes toward the oversight of Medicare and Medicaid, as well as programs under other HHS institutions such as the Centers for Disease Control and Prevention, National Institutes of Health, and the Food and Drug Administration.¹

HHS-OIG has the authority to seek civil monetary penalties, assessments, and exclusion against an individual or entity based on a wide variety of prohibited conduct affecting federal health care programs. Stiff penalties are regularly assessed against violators, and jail terms are not uncommon; however, it has no direct jurisdictions over physician licensure or nonfederal programs. The government maintains a pictorial list of its most wanted health care fugitives2 and provides an excellent set of Physician Education Training Materials on its website.³
 

False Claims Act (FCA)

In the health care arena, violation of FCA (31 U.S.C. §§3729-3733) is the foremost infraction. False claims by physicians can include billing for noncovered services such as experimental treatments, double billing, billing the government as the primary payer, or regularly waiving deductibles and copayments, as well as quality of care issues and unnecessary services. Wrongdoing also includes knowingly using another patient’s name for purposes of, say, federal drug coverage, billing for no-shows, and misrepresenting the diagnosis to justify services, as well as other claims. In the modern doctor’s office, the EMR enables easy check-offs on a preprinted form as documentation of actual work done. However, fraud is implicated if the information is deliberately misleading such as for purposes of upcoding. Importantly, physicians are liable for the actions of their office staff, so it is prudent to oversee and supervise all such activities. Naturally, one should document all claims that are sent and know the rules for allowable and excluded services.

FCA is an old law that was first enacted 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. Intent to defraud is not a required element but knowing or showing reckless disregard of the truth is. However, an error that is negligently committed 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 and criminal fines. A so-called whistle-blower may file a lawsuit on behalf of the government and is entitled to a percentage of any recoveries. Whistle-blowers may be current or ex-business partners, hospital or office staff, patients, or competitors. The fact that a claim results from a kickback or is made in violation of the Stark law (discussed below) may also render it fraudulent, thus creating additional liability under FCA.

HHS-OIG, as well as the Department of Justice, discloses named cases of statutory violations on their websites. A few random 2019 examples include a New York licensed doctor was convicted of nine counts in connection with Oxycodone and Fentanyl diversion scheme; a Newton, Mass., geriatrician agreed to pay $680,000 to resolve allegations that he violated the False Claims Act by submitting inflated claims to Medicare and the Massachusetts Medicaid program (MassHealth) for care rendered to nursing home patients; and two Clermont, Fla., ophthalmologists agreed to pay a combined total of $157,312.32 to resolve allegations that they violated FCA by knowingly billing the government for mutually exclusive eyelid repair surgeries.
 

Anti-Kickback Statute (AKS)

AKS (42 U.S.C. § 1320a-7b[b]) is a criminal law that prohibits the knowing and willful payment of “remuneration” to induce or reward patient referrals or the generation of business involving any item or service payable by federal health care programs. Remuneration includes anything of value and can take many forms besides cash, such as free rent, lavish travel, and excessive compensation for medical directorships or consultancies. Rewarding a referral source may be acceptable in some industries, but is a crime in federal health care programs.

Moreover, the statute covers both the payers of kickbacks (those who offer or pay remuneration) and the recipients of kickbacks. Each party’s intent is a key element of their liability under AKS. Physicians who pay or accept kickbacks face penalties of up to $50,000 per kickback plus three times the amount of the remuneration and criminal prosecution. As an example, a Tulsa, Okla., doctor earlier this year agreed to pay the government $84,666.42 for allegedly accepting illegal kickback payments from a pharmacy, and in another case, a marketer agreed to pay nearly $340,000 for receiving kickbacks in exchange for prescription referrals.

A physician is an attractive target for kickback schemes. The kickback prohibition applies to all sources, even patients. For example, where the Medicare and Medicaid programs require patients to be responsible for copays for services, the health care provider is generally required to collect that money from the patients. Advertising the forgiveness of copayments or routinely waiving these copays would violate AKS. However, one may waive a copayment when a patient cannot afford to pay one or is uninsured. AKS also imposes civil monetary penalties on physicians who offer remuneration to Medicare and Medicaid beneficiaries to influence them to use their services. Note that the government does not need to prove patient harm or financial loss to show that a violation has occurred, and physicians can be guilty even if they rendered services that are medically necessary.

There are so-called safe harbors that protect certain payment and business practices from running afoul of AKS. The rules and requirements are complex, and require full understanding and strict adherence.⁴
 

Physician Self-Referral Law

The Physician Self-Referral Law (42 U.S.C. § 1395nn), commonly referred to as the Stark law, prohibits physicians from referring patients to receive “designated health services” payable by Medicare or Medicaid from entities with which the physician or an immediate family member has a financial relationship, unless an exception applies. Financial relationships include both ownership/investment interests and compensation arrangements. A partial list of “designated health services” includes services related to clinical laboratory, physical therapy, radiology, parenteral and enteral supplies, prosthetic devices and supplies, home health care outpatient prescription drugs, and inpatient and outpatient hospital services. This list is not meant to be an exhaustive one.

Stark is a strict liability statute, which means proof of specific intent to violate the law is not required. The law prohibits the submission, or causing the submission, of claims in violation of the law’s restrictions on referrals. Penalties for physicians who violate the Stark law include fines, as well as exclusion from participation in federal health care programs. Like AKS, Stark law features its own safe harbors.
 

Dr. Tan is professor emeritus 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 materials may have been discussed in earlier columns. For additional information, readers may contact the author at siang@hawaii.edu.
 

References

1. HHS Office of Inspector General. About OIG. https://oig.hhs.gov/about-oig/about-us/index.asp

2. HHS Office of Inspector General. OIG most wanted fugitives.

3. HHS Office of Inspector General. “Physician education training materials.” A roadmap for new physicians: Avoiding Medicare and Medicaid fraud and abuse.

4. HHS Office of Inspector General. Safe harbor regulations.
 

Question: Which of the following statements regarding “common knowledge” is correct?

A. In any negligence action absent common knowledge, expert testimony is then required to prove requisite standard of care and causation.

B. The res ipsa loquitur doctrine, also referred to as the common knowledge rule, exempts the plaintiff from producing an expert witness.

C. An expert is needed in the first place to establish whether something constitutes common knowledge.

D. The jury is the one who determines whether a plaintiff can invoke the common knowledge exception.

E. An example of common knowledge in malpractice law is where a delay in stroke diagnosis results in loss of brain function.

Answer: B. The judge, not the jury or anyone else, makes the decision regarding res ipsa loquitur (the thing speaks for itself) or common knowledge, which exempts a plaintiff from producing an expert witness to testify as to the standard of care and causation. However, this is only true in actions arising out of professional negligence such as medical malpractice, whereas most common negligence actions – for example, slips and falls – do not require expert testimony.

Only a professional, duly qualified by the court as an expert witness, is allowed to offer medical testimony, while the plaintiff will typically be disqualified from playing this role because of the complexity of issues involved unless there is common knowledge. In general, courts are reluctant to grant this exception, which favors the plaintiff.

The best example of res ipsa loquitur is where a surgeon inadvertently leaves behind a sponge or instrument inside a body cavity. Other successfully litigated examples include cardiac arrest in the operating room, hypoxia in the recovery room, burns to the buttock, gangrene after the accidental injection of penicillin into an artery, air trapped subcutaneously from a displaced needle, and a pierced eyeball during a procedure. The factual circumstances of each case are critical to its outcome. For example, in a 2013 New York case, the plaintiff was barred from using the res doctrine.¹ The defendant doctor had left a guide wire in the plaintiff’s chest following a biopsy and retrieved it 2 months later. The plaintiff did not call any expert witness, relying instead on the “foreign object” basis for invoking the res doctrine. However, the Court of Appeals reasoned that the object was left behind deliberately, not unintentionally, and that under the circumstances of the case, an expert witness was needed to set out the applicable standard of care, without which a jury could not determine whether the doctor’s professional judgment breached the requisite standard.

The Supreme Court of Kentucky recently rejected the use of common knowledge in a stroke case.² In 2010, David Shackelford’s rheumatologist referred him to Paul Lewis, MD, an interventional radiologist, for a four-vessel cerebral angiogram to assist with diagnosing the cause of Mr. Shackelford’s chronic headaches. The procedure itself was uneventful, but while in the recovery room, Mr. Shackelford reported a frontal headache and scotoma, which resolved on its own. The headache improved with medication, and the patient experienced no other symptoms. There were no other visual changes, weakness, slurred speech, or facial palsies. Mr. Shackelford was discharged but had to return to the hospital the next morning via ambulance after becoming disoriented at his home. An MRI indicated multiple scattered small infarcts, and he was left with residual short-term memory loss and visual problems.

There was no allegation that the stroke itself was caused by negligence; rather, Mr. Shackelford alleged that the failure to examine and diagnose the stroke after the angiogram was negligent and caused injury greater than that which the stroke would have caused with earlier intervention. To support his claims, Mr. Shackelford’s expert, Michael David Khoury, MD, a vascular surgeon, criticized Dr. Lewis’s failure to examine Mr. Shackelford when his symptoms were consistent with a stroke. However, Dr. Khoury did not opine that Dr. Lewis could have limited the effects of the stroke through earlier intervention. When asked specifically whether he could state within a reasonable degree of medical probability that Dr. Lewis’s postprocedure care was a substantial factor in causing harm to Mr. Shackelford, Dr. Khoury responded that it was “impossible to tell.”

Based largely upon Dr. Khoury’s deposition testimony, the defendants successfully moved for summary judgment on the basis that the expert had failed to opine that the alleged negligence caused any injury to Mr. Shackelford. As a result, Mr. Shackelford could not prove an essential element of his medical malpractice claim. Defense expert Peter J. Pema, MD, a neuroradiologist, acknowledged the general proposition that strokes require timely diagnosis and treatment but did not provide an opinion on causation under the specific facts of this case. Another defense expert, Gregory Postal, MD, opined that Mr. Shackelford began to present symptoms of a stroke after leaving the hospital.

Notwithstanding the lower court’s ruling to summarily dismiss the case, the Court of Appeals found that, in this case, the issue of causation did not require expert medical testimony. It explained that given the ubiquity of information regarding stroke symptom identification and the necessity of prompt treatment, it had become common knowledge that “time lost is brain lost” as to timely medical intervention. In other words, a jury of laymen with this general knowledge could resolve the causation issue without the aid of expert testimony.

However, the Supreme Court of Kentucky held otherwise, writing: “We disagree with the Court of Appeals’ analysis. Although public service campaigns have increased public awareness and knowledge about stroke symptoms and timely intervention, that general information cannot provide the medical expertise necessary to evaluate this particular claim of medical malpractice. In other words, the question is not simply whether ‘time lost is brain lost.’ Rather, the specific facts and circumstances of this case play a significant role in determining whether the alleged negligent conduct was a substantial factor in Shackelford’s injuries, and to what extent. For example, as Dr. Lewis’s deposition testimony illustrates, a variety of factors influenced his diagnosis and treatment of Shackelford, including Shackelford’s medical history and history of cluster headaches; the common side effects of the angiogram procedure, including headache and scotoma; and the manner in which Shackelford’s headache and scotoma presented, as well as their timing. The complexities of these factors and how they affected Dr. Lewis’s evaluation of Shackelford may have also influenced the severity of the injury. These matters are clearly relevant to the determination of an alleged breach of the standard of care. Despite public perception about timely intervention, the average layperson cannot properly weigh such complex medical evidence without the aid of expert opinion. … To conclude otherwise is to drastically expand the res ipsa loquitor exception and to virtually eliminate the need for expert opinion evidence in similar medical malpractice actions that involve common or highly publicized conditions (e.g., stroke, heart attack, and even some cancers).”

Dr. Tan is professor emeritus 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. The author published an earlier version of this topic in the April 19, 2016, issue of Internal Medicine News, available at https://www.mdedge.com/internalmedicine/law-medicine. For additional information, readers may contact the author at siang@hawaii.edu.
 

References

1. James v. Wormuth, 997 N.E.2d 133 (N.Y. 2013).

2. Lewis/Ashland Hospital v. Shackelford, Supreme Court of Kentucky, Opinion of the Court by Justice Keller, rendered August 29, 2019.

Question: Which of the following statements regarding “common knowledge” is correct?

A. In any negligence action absent common knowledge, expert testimony is then required to prove requisite standard of care and causation.

B. The res ipsa loquitur doctrine, also referred to as the common knowledge rule, exempts the plaintiff from producing an expert witness.

C. An expert is needed in the first place to establish whether something constitutes common knowledge.

D. The jury is the one who determines whether a plaintiff can invoke the common knowledge exception.

E. An example of common knowledge in malpractice law is where a delay in stroke diagnosis results in loss of brain function.

Answer: B. The judge, not the jury or anyone else, makes the decision regarding res ipsa loquitur (the thing speaks for itself) or common knowledge, which exempts a plaintiff from producing an expert witness to testify as to the standard of care and causation. However, this is only true in actions arising out of professional negligence such as medical malpractice, whereas most common negligence actions – for example, slips and falls – do not require expert testimony.

Only a professional, duly qualified by the court as an expert witness, is allowed to offer medical testimony, while the plaintiff will typically be disqualified from playing this role because of the complexity of issues involved unless there is common knowledge. In general, courts are reluctant to grant this exception, which favors the plaintiff.

The best example of res ipsa loquitur is where a surgeon inadvertently leaves behind a sponge or instrument inside a body cavity. Other successfully litigated examples include cardiac arrest in the operating room, hypoxia in the recovery room, burns to the buttock, gangrene after the accidental injection of penicillin into an artery, air trapped subcutaneously from a displaced needle, and a pierced eyeball during a procedure. The factual circumstances of each case are critical to its outcome. For example, in a 2013 New York case, the plaintiff was barred from using the res doctrine.¹ The defendant doctor had left a guide wire in the plaintiff’s chest following a biopsy and retrieved it 2 months later. The plaintiff did not call any expert witness, relying instead on the “foreign object” basis for invoking the res doctrine. However, the Court of Appeals reasoned that the object was left behind deliberately, not unintentionally, and that under the circumstances of the case, an expert witness was needed to set out the applicable standard of care, without which a jury could not determine whether the doctor’s professional judgment breached the requisite standard.

The Supreme Court of Kentucky recently rejected the use of common knowledge in a stroke case.² In 2010, David Shackelford’s rheumatologist referred him to Paul Lewis, MD, an interventional radiologist, for a four-vessel cerebral angiogram to assist with diagnosing the cause of Mr. Shackelford’s chronic headaches. The procedure itself was uneventful, but while in the recovery room, Mr. Shackelford reported a frontal headache and scotoma, which resolved on its own. The headache improved with medication, and the patient experienced no other symptoms. There were no other visual changes, weakness, slurred speech, or facial palsies. Mr. Shackelford was discharged but had to return to the hospital the next morning via ambulance after becoming disoriented at his home. An MRI indicated multiple scattered small infarcts, and he was left with residual short-term memory loss and visual problems.

There was no allegation that the stroke itself was caused by negligence; rather, Mr. Shackelford alleged that the failure to examine and diagnose the stroke after the angiogram was negligent and caused injury greater than that which the stroke would have caused with earlier intervention. To support his claims, Mr. Shackelford’s expert, Michael David Khoury, MD, a vascular surgeon, criticized Dr. Lewis’s failure to examine Mr. Shackelford when his symptoms were consistent with a stroke. However, Dr. Khoury did not opine that Dr. Lewis could have limited the effects of the stroke through earlier intervention. When asked specifically whether he could state within a reasonable degree of medical probability that Dr. Lewis’s postprocedure care was a substantial factor in causing harm to Mr. Shackelford, Dr. Khoury responded that it was “impossible to tell.”

Based largely upon Dr. Khoury’s deposition testimony, the defendants successfully moved for summary judgment on the basis that the expert had failed to opine that the alleged negligence caused any injury to Mr. Shackelford. As a result, Mr. Shackelford could not prove an essential element of his medical malpractice claim. Defense expert Peter J. Pema, MD, a neuroradiologist, acknowledged the general proposition that strokes require timely diagnosis and treatment but did not provide an opinion on causation under the specific facts of this case. Another defense expert, Gregory Postal, MD, opined that Mr. Shackelford began to present symptoms of a stroke after leaving the hospital.

Notwithstanding the lower court’s ruling to summarily dismiss the case, the Court of Appeals found that, in this case, the issue of causation did not require expert medical testimony. It explained that given the ubiquity of information regarding stroke symptom identification and the necessity of prompt treatment, it had become common knowledge that “time lost is brain lost” as to timely medical intervention. In other words, a jury of laymen with this general knowledge could resolve the causation issue without the aid of expert testimony.

However, the Supreme Court of Kentucky held otherwise, writing: “We disagree with the Court of Appeals’ analysis. Although public service campaigns have increased public awareness and knowledge about stroke symptoms and timely intervention, that general information cannot provide the medical expertise necessary to evaluate this particular claim of medical malpractice. In other words, the question is not simply whether ‘time lost is brain lost.’ Rather, the specific facts and circumstances of this case play a significant role in determining whether the alleged negligent conduct was a substantial factor in Shackelford’s injuries, and to what extent. For example, as Dr. Lewis’s deposition testimony illustrates, a variety of factors influenced his diagnosis and treatment of Shackelford, including Shackelford’s medical history and history of cluster headaches; the common side effects of the angiogram procedure, including headache and scotoma; and the manner in which Shackelford’s headache and scotoma presented, as well as their timing. The complexities of these factors and how they affected Dr. Lewis’s evaluation of Shackelford may have also influenced the severity of the injury. These matters are clearly relevant to the determination of an alleged breach of the standard of care. Despite public perception about timely intervention, the average layperson cannot properly weigh such complex medical evidence without the aid of expert opinion. … To conclude otherwise is to drastically expand the res ipsa loquitor exception and to virtually eliminate the need for expert opinion evidence in similar medical malpractice actions that involve common or highly publicized conditions (e.g., stroke, heart attack, and even some cancers).”

Dr. Tan is professor emeritus 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. The author published an earlier version of this topic in the April 19, 2016, issue of Internal Medicine News, available at https://www.mdedge.com/internalmedicine/law-medicine. For additional information, readers may contact the author at siang@hawaii.edu.
 

References

1. James v. Wormuth, 997 N.E.2d 133 (N.Y. 2013).

2. Lewis/Ashland Hospital v. Shackelford, Supreme Court of Kentucky, Opinion of the Court by Justice Keller, rendered August 29, 2019.

Question: Which of the following statements regarding “common knowledge” is correct?

A. In any negligence action absent common knowledge, expert testimony is then required to prove requisite standard of care and causation.

B. The res ipsa loquitur doctrine, also referred to as the common knowledge rule, exempts the plaintiff from producing an expert witness.

C. An expert is needed in the first place to establish whether something constitutes common knowledge.

D. The jury is the one who determines whether a plaintiff can invoke the common knowledge exception.

E. An example of common knowledge in malpractice law is where a delay in stroke diagnosis results in loss of brain function.

Answer: B. The judge, not the jury or anyone else, makes the decision regarding res ipsa loquitur (the thing speaks for itself) or common knowledge, which exempts a plaintiff from producing an expert witness to testify as to the standard of care and causation. However, this is only true in actions arising out of professional negligence such as medical malpractice, whereas most common negligence actions – for example, slips and falls – do not require expert testimony.

Only a professional, duly qualified by the court as an expert witness, is allowed to offer medical testimony, while the plaintiff will typically be disqualified from playing this role because of the complexity of issues involved unless there is common knowledge. In general, courts are reluctant to grant this exception, which favors the plaintiff.

The best example of res ipsa loquitur is where a surgeon inadvertently leaves behind a sponge or instrument inside a body cavity. Other successfully litigated examples include cardiac arrest in the operating room, hypoxia in the recovery room, burns to the buttock, gangrene after the accidental injection of penicillin into an artery, air trapped subcutaneously from a displaced needle, and a pierced eyeball during a procedure. The factual circumstances of each case are critical to its outcome. For example, in a 2013 New York case, the plaintiff was barred from using the res doctrine.¹ The defendant doctor had left a guide wire in the plaintiff’s chest following a biopsy and retrieved it 2 months later. The plaintiff did not call any expert witness, relying instead on the “foreign object” basis for invoking the res doctrine. However, the Court of Appeals reasoned that the object was left behind deliberately, not unintentionally, and that under the circumstances of the case, an expert witness was needed to set out the applicable standard of care, without which a jury could not determine whether the doctor’s professional judgment breached the requisite standard.

The Supreme Court of Kentucky recently rejected the use of common knowledge in a stroke case.² In 2010, David Shackelford’s rheumatologist referred him to Paul Lewis, MD, an interventional radiologist, for a four-vessel cerebral angiogram to assist with diagnosing the cause of Mr. Shackelford’s chronic headaches. The procedure itself was uneventful, but while in the recovery room, Mr. Shackelford reported a frontal headache and scotoma, which resolved on its own. The headache improved with medication, and the patient experienced no other symptoms. There were no other visual changes, weakness, slurred speech, or facial palsies. Mr. Shackelford was discharged but had to return to the hospital the next morning via ambulance after becoming disoriented at his home. An MRI indicated multiple scattered small infarcts, and he was left with residual short-term memory loss and visual problems.

There was no allegation that the stroke itself was caused by negligence; rather, Mr. Shackelford alleged that the failure to examine and diagnose the stroke after the angiogram was negligent and caused injury greater than that which the stroke would have caused with earlier intervention. To support his claims, Mr. Shackelford’s expert, Michael David Khoury, MD, a vascular surgeon, criticized Dr. Lewis’s failure to examine Mr. Shackelford when his symptoms were consistent with a stroke. However, Dr. Khoury did not opine that Dr. Lewis could have limited the effects of the stroke through earlier intervention. When asked specifically whether he could state within a reasonable degree of medical probability that Dr. Lewis’s postprocedure care was a substantial factor in causing harm to Mr. Shackelford, Dr. Khoury responded that it was “impossible to tell.”

Based largely upon Dr. Khoury’s deposition testimony, the defendants successfully moved for summary judgment on the basis that the expert had failed to opine that the alleged negligence caused any injury to Mr. Shackelford. As a result, Mr. Shackelford could not prove an essential element of his medical malpractice claim. Defense expert Peter J. Pema, MD, a neuroradiologist, acknowledged the general proposition that strokes require timely diagnosis and treatment but did not provide an opinion on causation under the specific facts of this case. Another defense expert, Gregory Postal, MD, opined that Mr. Shackelford began to present symptoms of a stroke after leaving the hospital.

Notwithstanding the lower court’s ruling to summarily dismiss the case, the Court of Appeals found that, in this case, the issue of causation did not require expert medical testimony. It explained that given the ubiquity of information regarding stroke symptom identification and the necessity of prompt treatment, it had become common knowledge that “time lost is brain lost” as to timely medical intervention. In other words, a jury of laymen with this general knowledge could resolve the causation issue without the aid of expert testimony.

However, the Supreme Court of Kentucky held otherwise, writing: “We disagree with the Court of Appeals’ analysis. Although public service campaigns have increased public awareness and knowledge about stroke symptoms and timely intervention, that general information cannot provide the medical expertise necessary to evaluate this particular claim of medical malpractice. In other words, the question is not simply whether ‘time lost is brain lost.’ Rather, the specific facts and circumstances of this case play a significant role in determining whether the alleged negligent conduct was a substantial factor in Shackelford’s injuries, and to what extent. For example, as Dr. Lewis’s deposition testimony illustrates, a variety of factors influenced his diagnosis and treatment of Shackelford, including Shackelford’s medical history and history of cluster headaches; the common side effects of the angiogram procedure, including headache and scotoma; and the manner in which Shackelford’s headache and scotoma presented, as well as their timing. The complexities of these factors and how they affected Dr. Lewis’s evaluation of Shackelford may have also influenced the severity of the injury. These matters are clearly relevant to the determination of an alleged breach of the standard of care. Despite public perception about timely intervention, the average layperson cannot properly weigh such complex medical evidence without the aid of expert opinion. … To conclude otherwise is to drastically expand the res ipsa loquitor exception and to virtually eliminate the need for expert opinion evidence in similar medical malpractice actions that involve common or highly publicized conditions (e.g., stroke, heart attack, and even some cancers).”

Dr. Tan is professor emeritus 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. The author published an earlier version of this topic in the April 19, 2016, issue of Internal Medicine News, available at https://www.mdedge.com/internalmedicine/law-medicine. For additional information, readers may contact the author at siang@hawaii.edu.
 

References

1. James v. Wormuth, 997 N.E.2d 133 (N.Y. 2013).

2. Lewis/Ashland Hospital v. Shackelford, Supreme Court of Kentucky, Opinion of the Court by Justice Keller, rendered August 29, 2019.

Question: Driver D strikes a pedestrian after losing control of his vehicle from insulin-induced hypoglycemia. Both Driver D and pedestrian were seriously injured. Driver D was recently diagnosed with diabetes, and his physician had started him on insulin, but did not warn of driving risks associated with hypoglycemia. The injured pedestrian is a total stranger to both Driver D and his doctor. Given these facts, which one of the following choices is correct?

A. Driver D can sue his doctor for failure to disclose hypoglycemic risk of insulin therapy under the doctrine of informed consent.

B. The pedestrian can sue Driver D for negligent driving.

C. The pedestrian may succeed in suing Driver D’s doctor for failure to warn of hypoglycemia.

D. The pedestrian’s lawsuit against Driver D’s doctor may fail in a jurisdiction that does not recognize a doctor’s legal duty to an unidentifiable, nonpatient third party.

E. All statements above are correct.
 

Answer: E. A doctor owes a duty of care only to his/her own patients. This legal duty grows out of the doctor-patient relationship, and is normally owed to the patient and to no one else. However, in limited circumstances, it may be extended to other individuals, so-called third parties, who may be total strangers. Injured nonpatient third parties from driving accidents have successfully sued doctors for failing to warn their patients that their medical conditions and/or medications can adversely affect driving ability.

Vizzoni v. Mulford-Dera is a New Jersey malpractice case that is currently before the state’s appellate court. The issue is whether Dr. Lerner, a psychiatrist, can be found negligent for the death of a bicyclist caused by the psychiatrist’s patient, Ms. Mulford-Dera, whose car struck and killed the cyclist. The decedent’s estate alleged that the physician should have warned the patient of the risks of driving while taking psychotropic medications. Dr. Lerner had been treating Ms. Mulford-Dera for psychological conditions, including major depression, panic disorder, and attention deficit disorder. As part of her treatment, Dr. Lerner prescribed several medications, allegedly without disclosing their potential adverse impact on driving. The trial court granted summary judgment and dismissed the case, ruling that the doctor owed no direct or indirect duty to the victim.

The case is currently on appeal. The AMA has filed an amicus brief in support of Dr. Lerner,¹ pointing out that third-party claims had previously been rejected in New Jersey, where the injured victim is not readily identifiable. The brief emphasizes the folly of placing the physician or therapist in the untenable position of serving two potentially competing interests when a physician’s priority should be providing care to the patient. It referenced a similar case in Kansas, where a motorist who had fallen asleep at the wheel struck a bicyclist. The motorist was being treated by a neurologist for a sleep disorder.² The Kansas Supreme Court held that there was no special relationship between the doctor and the cyclist that would impose a duty to warn the motorist about harming a third party.

Other jurisdictions have likewise rejected attempts at “derivative duties” in automobile accident cases. The Connecticut Supreme Court has ruled³ that doctors are immune from third party traffic accident lawsuits, as such litigation would detract from what’s best for the patient (“a physician’s desire to avoid lawsuits may result in far more restrictive advice than necessary for the patient’s well-being”). In that case, the defendant-gastroenterologist, Dr. Troncale, was treating a patient with hepatic encephalopathy and had not warned of the associated risk of driving. And an Illinois court dismissed a third party’s case against a hospital when one of its physicians fell asleep at the wheel after working excessive hours.⁴

In contrast, other jurisdictions have found a legal duty for physicians toward nonpatient victims. For example, in McKenzie v. Hawaii Permanente Medical Group,⁵ a car suddenly veered across five lanes of traffic, striking an 11-year-old girl and crushing her against a cement planter. The driver alleged that the prescription medication, Prazosin, caused him to lose control of the car, and that the treating physician was negligent, first in prescribing an inappropriate type and dose of medication, and second in failing to warn of potential side effects that could affect driving ability. The Hawaii Supreme Court emphasized that the risk of tort liability to an individual physician already discourages negligent prescribing; therefore, a physician does not have a duty to third parties where the alleged negligence involves prescribing decisions, i.e., whether to prescribe medication at all, which medication to prescribe, and what dosage to use. On the other hand, physicians have a duty to their patients to warn of potential adverse effects and this responsibility should therefore extend to third parties. Thus, liability would attach to injuries of innocent third parties as a result of failing to warn of a medication’s effects on driving—unless a reasonable person could be expected to be aware of this risk without the warning.

A foreseeable and unreasonable risk of harm is an important but not the only decisive factor in construing the existence of legal duty. Under some circumstances, the term “special relationship” has been employed based on a consideration of existing social values, customs, and policy considerations. In a Massachusetts case,⁶ a family physician had failed to warn his patient of the risk of diabetes drugs when operating a vehicle. Some 45 minutes after the patient’s discharge from the hospital, he developed hypoglycemia, losing consciousness and injuring a motorcyclist who then sued the doctor. The court invoked the “special relationship” rationale in ruling that the doctor owed a duty to the motorcyclist for public policy reasons.
 

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

References

1. Vizzoni v. Mulford-Dera, In the Superior Court of New Jersey Appellate Division, Docket No. A-001255-18T3.

2. Calwell v. Hassan, 925 P.2d 422, 430 (Kan. 1996).

3. Jarmie v. Troncale, 50 A.3d 802 (Conn. 2012).

4. Brewster v. Rush-Presbyterian-St. Luke’s Med. Ctr., 836 N.E.2d 635 (Ill. Ct. App. 2005).

5. McKenzie v. Hawaii Permanente Medical Group, 47 P.3d 1209 (Haw. 2002).

6. Arsenault v. McConarty, 21 Mass. L. Rptr. 500 (2006).

Question: Driver D strikes a pedestrian after losing control of his vehicle from insulin-induced hypoglycemia. Both Driver D and pedestrian were seriously injured. Driver D was recently diagnosed with diabetes, and his physician had started him on insulin, but did not warn of driving risks associated with hypoglycemia. The injured pedestrian is a total stranger to both Driver D and his doctor. Given these facts, which one of the following choices is correct?

A. Driver D can sue his doctor for failure to disclose hypoglycemic risk of insulin therapy under the doctrine of informed consent.

B. The pedestrian can sue Driver D for negligent driving.

C. The pedestrian may succeed in suing Driver D’s doctor for failure to warn of hypoglycemia.

D. The pedestrian’s lawsuit against Driver D’s doctor may fail in a jurisdiction that does not recognize a doctor’s legal duty to an unidentifiable, nonpatient third party.

E. All statements above are correct.
 

Answer: E. A doctor owes a duty of care only to his/her own patients. This legal duty grows out of the doctor-patient relationship, and is normally owed to the patient and to no one else. However, in limited circumstances, it may be extended to other individuals, so-called third parties, who may be total strangers. Injured nonpatient third parties from driving accidents have successfully sued doctors for failing to warn their patients that their medical conditions and/or medications can adversely affect driving ability.

Vizzoni v. Mulford-Dera is a New Jersey malpractice case that is currently before the state’s appellate court. The issue is whether Dr. Lerner, a psychiatrist, can be found negligent for the death of a bicyclist caused by the psychiatrist’s patient, Ms. Mulford-Dera, whose car struck and killed the cyclist. The decedent’s estate alleged that the physician should have warned the patient of the risks of driving while taking psychotropic medications. Dr. Lerner had been treating Ms. Mulford-Dera for psychological conditions, including major depression, panic disorder, and attention deficit disorder. As part of her treatment, Dr. Lerner prescribed several medications, allegedly without disclosing their potential adverse impact on driving. The trial court granted summary judgment and dismissed the case, ruling that the doctor owed no direct or indirect duty to the victim.

The case is currently on appeal. The AMA has filed an amicus brief in support of Dr. Lerner,¹ pointing out that third-party claims had previously been rejected in New Jersey, where the injured victim is not readily identifiable. The brief emphasizes the folly of placing the physician or therapist in the untenable position of serving two potentially competing interests when a physician’s priority should be providing care to the patient. It referenced a similar case in Kansas, where a motorist who had fallen asleep at the wheel struck a bicyclist. The motorist was being treated by a neurologist for a sleep disorder.² The Kansas Supreme Court held that there was no special relationship between the doctor and the cyclist that would impose a duty to warn the motorist about harming a third party.

Other jurisdictions have likewise rejected attempts at “derivative duties” in automobile accident cases. The Connecticut Supreme Court has ruled³ that doctors are immune from third party traffic accident lawsuits, as such litigation would detract from what’s best for the patient (“a physician’s desire to avoid lawsuits may result in far more restrictive advice than necessary for the patient’s well-being”). In that case, the defendant-gastroenterologist, Dr. Troncale, was treating a patient with hepatic encephalopathy and had not warned of the associated risk of driving. And an Illinois court dismissed a third party’s case against a hospital when one of its physicians fell asleep at the wheel after working excessive hours.⁴

In contrast, other jurisdictions have found a legal duty for physicians toward nonpatient victims. For example, in McKenzie v. Hawaii Permanente Medical Group,⁵ a car suddenly veered across five lanes of traffic, striking an 11-year-old girl and crushing her against a cement planter. The driver alleged that the prescription medication, Prazosin, caused him to lose control of the car, and that the treating physician was negligent, first in prescribing an inappropriate type and dose of medication, and second in failing to warn of potential side effects that could affect driving ability. The Hawaii Supreme Court emphasized that the risk of tort liability to an individual physician already discourages negligent prescribing; therefore, a physician does not have a duty to third parties where the alleged negligence involves prescribing decisions, i.e., whether to prescribe medication at all, which medication to prescribe, and what dosage to use. On the other hand, physicians have a duty to their patients to warn of potential adverse effects and this responsibility should therefore extend to third parties. Thus, liability would attach to injuries of innocent third parties as a result of failing to warn of a medication’s effects on driving—unless a reasonable person could be expected to be aware of this risk without the warning.

A foreseeable and unreasonable risk of harm is an important but not the only decisive factor in construing the existence of legal duty. Under some circumstances, the term “special relationship” has been employed based on a consideration of existing social values, customs, and policy considerations. In a Massachusetts case,⁶ a family physician had failed to warn his patient of the risk of diabetes drugs when operating a vehicle. Some 45 minutes after the patient’s discharge from the hospital, he developed hypoglycemia, losing consciousness and injuring a motorcyclist who then sued the doctor. The court invoked the “special relationship” rationale in ruling that the doctor owed a duty to the motorcyclist for public policy reasons.
 

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

References

1. Vizzoni v. Mulford-Dera, In the Superior Court of New Jersey Appellate Division, Docket No. A-001255-18T3.

2. Calwell v. Hassan, 925 P.2d 422, 430 (Kan. 1996).

3. Jarmie v. Troncale, 50 A.3d 802 (Conn. 2012).

4. Brewster v. Rush-Presbyterian-St. Luke’s Med. Ctr., 836 N.E.2d 635 (Ill. Ct. App. 2005).

5. McKenzie v. Hawaii Permanente Medical Group, 47 P.3d 1209 (Haw. 2002).

6. Arsenault v. McConarty, 21 Mass. L. Rptr. 500 (2006).

Question: Driver D strikes a pedestrian after losing control of his vehicle from insulin-induced hypoglycemia. Both Driver D and pedestrian were seriously injured. Driver D was recently diagnosed with diabetes, and his physician had started him on insulin, but did not warn of driving risks associated with hypoglycemia. The injured pedestrian is a total stranger to both Driver D and his doctor. Given these facts, which one of the following choices is correct?

A. Driver D can sue his doctor for failure to disclose hypoglycemic risk of insulin therapy under the doctrine of informed consent.

B. The pedestrian can sue Driver D for negligent driving.

C. The pedestrian may succeed in suing Driver D’s doctor for failure to warn of hypoglycemia.

D. The pedestrian’s lawsuit against Driver D’s doctor may fail in a jurisdiction that does not recognize a doctor’s legal duty to an unidentifiable, nonpatient third party.

E. All statements above are correct.
 

Answer: E. A doctor owes a duty of care only to his/her own patients. This legal duty grows out of the doctor-patient relationship, and is normally owed to the patient and to no one else. However, in limited circumstances, it may be extended to other individuals, so-called third parties, who may be total strangers. Injured nonpatient third parties from driving accidents have successfully sued doctors for failing to warn their patients that their medical conditions and/or medications can adversely affect driving ability.

Vizzoni v. Mulford-Dera is a New Jersey malpractice case that is currently before the state’s appellate court. The issue is whether Dr. Lerner, a psychiatrist, can be found negligent for the death of a bicyclist caused by the psychiatrist’s patient, Ms. Mulford-Dera, whose car struck and killed the cyclist. The decedent’s estate alleged that the physician should have warned the patient of the risks of driving while taking psychotropic medications. Dr. Lerner had been treating Ms. Mulford-Dera for psychological conditions, including major depression, panic disorder, and attention deficit disorder. As part of her treatment, Dr. Lerner prescribed several medications, allegedly without disclosing their potential adverse impact on driving. The trial court granted summary judgment and dismissed the case, ruling that the doctor owed no direct or indirect duty to the victim.

The case is currently on appeal. The AMA has filed an amicus brief in support of Dr. Lerner,¹ pointing out that third-party claims had previously been rejected in New Jersey, where the injured victim is not readily identifiable. The brief emphasizes the folly of placing the physician or therapist in the untenable position of serving two potentially competing interests when a physician’s priority should be providing care to the patient. It referenced a similar case in Kansas, where a motorist who had fallen asleep at the wheel struck a bicyclist. The motorist was being treated by a neurologist for a sleep disorder.² The Kansas Supreme Court held that there was no special relationship between the doctor and the cyclist that would impose a duty to warn the motorist about harming a third party.

Other jurisdictions have likewise rejected attempts at “derivative duties” in automobile accident cases. The Connecticut Supreme Court has ruled³ that doctors are immune from third party traffic accident lawsuits, as such litigation would detract from what’s best for the patient (“a physician’s desire to avoid lawsuits may result in far more restrictive advice than necessary for the patient’s well-being”). In that case, the defendant-gastroenterologist, Dr. Troncale, was treating a patient with hepatic encephalopathy and had not warned of the associated risk of driving. And an Illinois court dismissed a third party’s case against a hospital when one of its physicians fell asleep at the wheel after working excessive hours.⁴

In contrast, other jurisdictions have found a legal duty for physicians toward nonpatient victims. For example, in McKenzie v. Hawaii Permanente Medical Group,⁵ a car suddenly veered across five lanes of traffic, striking an 11-year-old girl and crushing her against a cement planter. The driver alleged that the prescription medication, Prazosin, caused him to lose control of the car, and that the treating physician was negligent, first in prescribing an inappropriate type and dose of medication, and second in failing to warn of potential side effects that could affect driving ability. The Hawaii Supreme Court emphasized that the risk of tort liability to an individual physician already discourages negligent prescribing; therefore, a physician does not have a duty to third parties where the alleged negligence involves prescribing decisions, i.e., whether to prescribe medication at all, which medication to prescribe, and what dosage to use. On the other hand, physicians have a duty to their patients to warn of potential adverse effects and this responsibility should therefore extend to third parties. Thus, liability would attach to injuries of innocent third parties as a result of failing to warn of a medication’s effects on driving—unless a reasonable person could be expected to be aware of this risk without the warning.

A foreseeable and unreasonable risk of harm is an important but not the only decisive factor in construing the existence of legal duty. Under some circumstances, the term “special relationship” has been employed based on a consideration of existing social values, customs, and policy considerations. In a Massachusetts case,⁶ a family physician had failed to warn his patient of the risk of diabetes drugs when operating a vehicle. Some 45 minutes after the patient’s discharge from the hospital, he developed hypoglycemia, losing consciousness and injuring a motorcyclist who then sued the doctor. The court invoked the “special relationship” rationale in ruling that the doctor owed a duty to the motorcyclist for public policy reasons.
 

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

References

1. Vizzoni v. Mulford-Dera, In the Superior Court of New Jersey Appellate Division, Docket No. A-001255-18T3.

2. Calwell v. Hassan, 925 P.2d 422, 430 (Kan. 1996).

3. Jarmie v. Troncale, 50 A.3d 802 (Conn. 2012).

4. Brewster v. Rush-Presbyterian-St. Luke’s Med. Ctr., 836 N.E.2d 635 (Ill. Ct. App. 2005).

5. McKenzie v. Hawaii Permanente Medical Group, 47 P.3d 1209 (Haw. 2002).

6. Arsenault v. McConarty, 21 Mass. L. Rptr. 500 (2006).

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: The First Amendment guarantees the right of free speech, but the U.S. Supreme Court has held that under a strict scrutiny standard, the government may regulate:

A. Obscenity.

B. Fighting words.

C. Professional speech.

D. A and B.

E. A, B, and C.

Answer: D. The First Amendment forbids the government from “abridging the freedom of speech,” which extends to certain nonverbal conduct, such as flag burning. At the same time, the U.S. Supreme Court has also ruled that certain categories of speech such as obscenity and fighting words can be regulated under a strict scrutiny standard. However, it remains unsettled whether and to what extent professional speech – such as in the context of the doctor-patient relationship – may be curtailed.

Two recent cases grapple with this issue of free speech – with rather unexpected results.

The first, overturning a decades-old prohibition of the off-label detailing of drugs, surprisingly was decided against the government. The second challenges a Florida statute censoring the discussion of firearms safety between a doctor and a patient. An early decision, under reconsideration, in fact supported the state’s regulation of physicians’ freedom of speech under the circumstances.

References

1. U.S. v. Caronia, 703 F.3d 149 (2d Cir. 2012).

2. Sorrell v. IMS Health, 131 S. Ct. 2653 (2011).

3. N Engl J Med. 2013 Jan 10;368(2):103-5.

4. Fla. St. 381.026, 456.072, 790.338.

5. Wollschlaeger v. Governor of Florida, 797 F.3d 859 (11th Cir. 2015).

6. N Engl J Med. 2016 Jun 16;374(24):2304-7.
 

Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, and currently directs the St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at siang@hawaii.edu.

Question: The First Amendment guarantees the right of free speech, but the U.S. Supreme Court has held that under a strict scrutiny standard, the government may regulate:

A. Obscenity.

B. Fighting words.

C. Professional speech.

D. A and B.

E. A, B, and C.

Answer: D. The First Amendment forbids the government from “abridging the freedom of speech,” which extends to certain nonverbal conduct, such as flag burning. At the same time, the U.S. Supreme Court has also ruled that certain categories of speech such as obscenity and fighting words can be regulated under a strict scrutiny standard. However, it remains unsettled whether and to what extent professional speech – such as in the context of the doctor-patient relationship – may be curtailed.

Two recent cases grapple with this issue of free speech – with rather unexpected results.

The first, overturning a decades-old prohibition of the off-label detailing of drugs, surprisingly was decided against the government. The second challenges a Florida statute censoring the discussion of firearms safety between a doctor and a patient. An early decision, under reconsideration, in fact supported the state’s regulation of physicians’ freedom of speech under the circumstances.

References

1. U.S. v. Caronia, 703 F.3d 149 (2d Cir. 2012).

2. Sorrell v. IMS Health, 131 S. Ct. 2653 (2011).

3. N Engl J Med. 2013 Jan 10;368(2):103-5.

4. Fla. St. 381.026, 456.072, 790.338.

5. Wollschlaeger v. Governor of Florida, 797 F.3d 859 (11th Cir. 2015).

6. N Engl J Med. 2016 Jun 16;374(24):2304-7.
 

Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, and currently directs the St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at siang@hawaii.edu.

Question: The First Amendment guarantees the right of free speech, but the U.S. Supreme Court has held that under a strict scrutiny standard, the government may regulate:

A. Obscenity.

B. Fighting words.

C. Professional speech.

D. A and B.

E. A, B, and C.

Answer: D. The First Amendment forbids the government from “abridging the freedom of speech,” which extends to certain nonverbal conduct, such as flag burning. At the same time, the U.S. Supreme Court has also ruled that certain categories of speech such as obscenity and fighting words can be regulated under a strict scrutiny standard. However, it remains unsettled whether and to what extent professional speech – such as in the context of the doctor-patient relationship – may be curtailed.

Two recent cases grapple with this issue of free speech – with rather unexpected results.

The first, overturning a decades-old prohibition of the off-label detailing of drugs, surprisingly was decided against the government. The second challenges a Florida statute censoring the discussion of firearms safety between a doctor and a patient. An early decision, under reconsideration, in fact supported the state’s regulation of physicians’ freedom of speech under the circumstances.

References

1. U.S. v. Caronia, 703 F.3d 149 (2d Cir. 2012).

2. Sorrell v. IMS Health, 131 S. Ct. 2653 (2011).

3. N Engl J Med. 2013 Jan 10;368(2):103-5.

4. Fla. St. 381.026, 456.072, 790.338.

5. Wollschlaeger v. Governor of Florida, 797 F.3d 859 (11th Cir. 2015).

6. N Engl J Med. 2016 Jun 16;374(24):2304-7.
 

Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, and currently directs the St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at siang@hawaii.edu.

Question: A doctor may owe a duty of care in the setting of:

A. A cyber relationship.

B. A special relationship.

C. Both A and B.

D. Neither A nor B.

Answer: C. Ascertaining whether a defendant owes a duty to a claimant is the first inquiry in the tort of negligence. To say there is no duty owed is to deny liability altogether, however obvious the breach or horrendous the foreseeable injuries.

Thus, duty is used as a filter mechanism to reduce frivolous suits or otherwise control the tide of litigation, to prevent “liability in an indeterminate amount for an indeterminate time to an indeterminate class.”

Duty in the context of medical negligence is not usually in dispute, as it is plainly owed by a doctor to his or her patient. It arises out of the doctor-patient relationship. Whether a relationship has been formed in the first place is a threshold inquiry. Where a doctor accepts a patient who is seeking his or her services, the relationship is readily evident. Duty is also established when the doctor begins the evaluation process in a typical encounter.

However, a phone inquiry by a potential patient, without more, may be insufficient to create this relationship, although this may depend on the nature of the phone conversation and the doctor’s response.

Likewise, a “curbside” consultation sought by a colleague does not normally translate into a duty for the doctor offering the opinion. Presumably casual advice given freely and understood as such at social gatherings does not add up to a doctor-patient relationship, and courts will look to reasonableness as the touchstone in deciding whether such a relationship was ever formed.

Still, there are some medical situations where a legitimate question of duty can be raised. With the growth of electronic medical records and communication, medical encounters in cyberspace will emerge as an increasing source of litigation.

Internet liability can be far reaching. In addition to risks governing negligence, informed consent, and privacy/confidentiality, there are additional issues of product liability, cross-border jurisdictional conflicts, and others.

The threshold question when assessing cyberspace liability arising, for example, from the use of doctor-operated medical websites concerns duty, because its existence or denial will determine whether the case can go forward in the first place. Although not the typical office or hospital patient, a plaintiff may argue successfully that a doctor-patient relationship had nonetheless been formed in cyberspace.

It is possible that such a relationship will be found in some circumstances, relevant factors being knowledge of names of subscribers, frequency of interactions, specificity of queries, and so on. In particular, a subscription fee is likely to be construed as evidence of soliciting and accepting a more committed interaction, so it places the operator of the website at greater legal risk. A specific disclaimer is a standard precaution but may not be enough to definitively protect against a lawsuit.

Courts have ruled in favor of plaintiffs despite the absence of face-to-face interaction with a physician. In one case, a doctor speaking to a patient from the emergency department was deemed to have formed a doctor-patient relationship (O’Neill v. Montefiore Hospital, 11 A.D.2d 132 (N.Y.A.D. 1 Dept. 1960). In another, an on-call neurologist’s telephone advice to the treating doctor likewise raised the issue of legal duty (Lection v. Dyll, 65 S.W.3d 696 (Tex. App. Dallas 2001).

The state of Hawaii now permits telehealth services to be reimbursable, notwithstanding the absence of face-to-face contact (HI Rev Stat § 431:10A-116.3[a]). With this law, an online encounter will likely translate into a professional relationship – with corresponding legal duty of due care.

In the case of a Good Samaritan physician – i.e., one who offers gratuitous aid to a stranger in need of medical assistance – courts are unlikely to find a professional relationship, because there is no common law duty to help a stranger.

However, once treatment has begun, there is a duty not to make matters worse. So, all 50 states have enacted Good Samaritan statutes, which protect against liability arising out of negligent rescue. Note that statutory protection is generally excluded for Good Samaritan acts performed within a hospital setting, under the theory that doctors have an ongoing relationship with the hospital and are already obligated to provide emergency care within its walls.

Another category of legal duty concerns nonpatient third parties. The complaint may relate to a failure to warn family members of a patient’s contagious disease, or the transmissible condition may have been missed and an innocent third party was injured as a result.

Another situation where duty to a third party might arise is the learning of a credible threat of harm directed at a named individual. This is famously known as the Tarasoff doctrine, after a California case in which the court imposed a duty on a college psychologist to directly warn an intended victim of harm by his patient – even though that meant breaching confidentiality of a professional relationship, and the victim was a nonpatient third party (Tarasoff v. Regents of University of California, 551 P.2d 334 [Cal. 1976]).

A doctor may also incur liability for automobile injuries sustained by one other than his or her own patient. In a Hawaii case, a car suddenly veered across five lanes of traffic, striking an 11-year-old bystander. The driver alleged that the prescription medication prazosin caused him to lose control of the car.

In ruling that the health care provider was liable to the injured bystander, the Hawaii Supreme Court held that physicians have a duty to warn their patients of potential adverse medication effects, and this responsibility should extend to third parties (McKenzie v. Hawaii Permanente Medical Group, 47 P.3d 1209 [Haw. 2002]).

A foreseeable and unreasonable risk of harm is an important factor, but not the only decisive factor, in construing the existence of a legal duty. Under some circumstances, the term “special relationship” has been employed based on a consideration of “existing social values, customs, and considerations of policy.”

In a Massachusetts case, a family practitioner had failed to warn his patient of the risk of diabetic drugs when operating a vehicle. Just 45 minutes after the patient’s discharge from the hospital, he developed hypoglycemia, losing consciousness and injuring a motorcyclist who then sued the doctor. The court used the “special relationship” rationale in ruling that the doctor owed a duty to the motorcyclist (Arsenault v. McConarty, 21 Mass. L. Rptr. 500 [2006]).

Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, and currently directs the St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at siang@hawaii.edu.

Question: A doctor may owe a duty of care in the setting of:

A. A cyber relationship.

B. A special relationship.

C. Both A and B.

D. Neither A nor B.

Answer: C. Ascertaining whether a defendant owes a duty to a claimant is the first inquiry in the tort of negligence. To say there is no duty owed is to deny liability altogether, however obvious the breach or horrendous the foreseeable injuries.

Thus, duty is used as a filter mechanism to reduce frivolous suits or otherwise control the tide of litigation, to prevent “liability in an indeterminate amount for an indeterminate time to an indeterminate class.”

Duty in the context of medical negligence is not usually in dispute, as it is plainly owed by a doctor to his or her patient. It arises out of the doctor-patient relationship. Whether a relationship has been formed in the first place is a threshold inquiry. Where a doctor accepts a patient who is seeking his or her services, the relationship is readily evident. Duty is also established when the doctor begins the evaluation process in a typical encounter.

However, a phone inquiry by a potential patient, without more, may be insufficient to create this relationship, although this may depend on the nature of the phone conversation and the doctor’s response.

Likewise, a “curbside” consultation sought by a colleague does not normally translate into a duty for the doctor offering the opinion. Presumably casual advice given freely and understood as such at social gatherings does not add up to a doctor-patient relationship, and courts will look to reasonableness as the touchstone in deciding whether such a relationship was ever formed.

Still, there are some medical situations where a legitimate question of duty can be raised. With the growth of electronic medical records and communication, medical encounters in cyberspace will emerge as an increasing source of litigation.

Internet liability can be far reaching. In addition to risks governing negligence, informed consent, and privacy/confidentiality, there are additional issues of product liability, cross-border jurisdictional conflicts, and others.

The threshold question when assessing cyberspace liability arising, for example, from the use of doctor-operated medical websites concerns duty, because its existence or denial will determine whether the case can go forward in the first place. Although not the typical office or hospital patient, a plaintiff may argue successfully that a doctor-patient relationship had nonetheless been formed in cyberspace.

It is possible that such a relationship will be found in some circumstances, relevant factors being knowledge of names of subscribers, frequency of interactions, specificity of queries, and so on. In particular, a subscription fee is likely to be construed as evidence of soliciting and accepting a more committed interaction, so it places the operator of the website at greater legal risk. A specific disclaimer is a standard precaution but may not be enough to definitively protect against a lawsuit.

Courts have ruled in favor of plaintiffs despite the absence of face-to-face interaction with a physician. In one case, a doctor speaking to a patient from the emergency department was deemed to have formed a doctor-patient relationship (O’Neill v. Montefiore Hospital, 11 A.D.2d 132 (N.Y.A.D. 1 Dept. 1960). In another, an on-call neurologist’s telephone advice to the treating doctor likewise raised the issue of legal duty (Lection v. Dyll, 65 S.W.3d 696 (Tex. App. Dallas 2001).

The state of Hawaii now permits telehealth services to be reimbursable, notwithstanding the absence of face-to-face contact (HI Rev Stat § 431:10A-116.3[a]). With this law, an online encounter will likely translate into a professional relationship – with corresponding legal duty of due care.

In the case of a Good Samaritan physician – i.e., one who offers gratuitous aid to a stranger in need of medical assistance – courts are unlikely to find a professional relationship, because there is no common law duty to help a stranger.

However, once treatment has begun, there is a duty not to make matters worse. So, all 50 states have enacted Good Samaritan statutes, which protect against liability arising out of negligent rescue. Note that statutory protection is generally excluded for Good Samaritan acts performed within a hospital setting, under the theory that doctors have an ongoing relationship with the hospital and are already obligated to provide emergency care within its walls.

Another category of legal duty concerns nonpatient third parties. The complaint may relate to a failure to warn family members of a patient’s contagious disease, or the transmissible condition may have been missed and an innocent third party was injured as a result.

Another situation where duty to a third party might arise is the learning of a credible threat of harm directed at a named individual. This is famously known as the Tarasoff doctrine, after a California case in which the court imposed a duty on a college psychologist to directly warn an intended victim of harm by his patient – even though that meant breaching confidentiality of a professional relationship, and the victim was a nonpatient third party (Tarasoff v. Regents of University of California, 551 P.2d 334 [Cal. 1976]).

A doctor may also incur liability for automobile injuries sustained by one other than his or her own patient. In a Hawaii case, a car suddenly veered across five lanes of traffic, striking an 11-year-old bystander. The driver alleged that the prescription medication prazosin caused him to lose control of the car.

In ruling that the health care provider was liable to the injured bystander, the Hawaii Supreme Court held that physicians have a duty to warn their patients of potential adverse medication effects, and this responsibility should extend to third parties (McKenzie v. Hawaii Permanente Medical Group, 47 P.3d 1209 [Haw. 2002]).

A foreseeable and unreasonable risk of harm is an important factor, but not the only decisive factor, in construing the existence of a legal duty. Under some circumstances, the term “special relationship” has been employed based on a consideration of “existing social values, customs, and considerations of policy.”

In a Massachusetts case, a family practitioner had failed to warn his patient of the risk of diabetic drugs when operating a vehicle. Just 45 minutes after the patient’s discharge from the hospital, he developed hypoglycemia, losing consciousness and injuring a motorcyclist who then sued the doctor. The court used the “special relationship” rationale in ruling that the doctor owed a duty to the motorcyclist (Arsenault v. McConarty, 21 Mass. L. Rptr. 500 [2006]).

Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, and currently directs the St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at siang@hawaii.edu.

Question: A doctor may owe a duty of care in the setting of:

A. A cyber relationship.

B. A special relationship.

C. Both A and B.

D. Neither A nor B.

Answer: C. Ascertaining whether a defendant owes a duty to a claimant is the first inquiry in the tort of negligence. To say there is no duty owed is to deny liability altogether, however obvious the breach or horrendous the foreseeable injuries.

Thus, duty is used as a filter mechanism to reduce frivolous suits or otherwise control the tide of litigation, to prevent “liability in an indeterminate amount for an indeterminate time to an indeterminate class.”

Duty in the context of medical negligence is not usually in dispute, as it is plainly owed by a doctor to his or her patient. It arises out of the doctor-patient relationship. Whether a relationship has been formed in the first place is a threshold inquiry. Where a doctor accepts a patient who is seeking his or her services, the relationship is readily evident. Duty is also established when the doctor begins the evaluation process in a typical encounter.

However, a phone inquiry by a potential patient, without more, may be insufficient to create this relationship, although this may depend on the nature of the phone conversation and the doctor’s response.

Likewise, a “curbside” consultation sought by a colleague does not normally translate into a duty for the doctor offering the opinion. Presumably casual advice given freely and understood as such at social gatherings does not add up to a doctor-patient relationship, and courts will look to reasonableness as the touchstone in deciding whether such a relationship was ever formed.

Still, there are some medical situations where a legitimate question of duty can be raised. With the growth of electronic medical records and communication, medical encounters in cyberspace will emerge as an increasing source of litigation.

Internet liability can be far reaching. In addition to risks governing negligence, informed consent, and privacy/confidentiality, there are additional issues of product liability, cross-border jurisdictional conflicts, and others.

The threshold question when assessing cyberspace liability arising, for example, from the use of doctor-operated medical websites concerns duty, because its existence or denial will determine whether the case can go forward in the first place. Although not the typical office or hospital patient, a plaintiff may argue successfully that a doctor-patient relationship had nonetheless been formed in cyberspace.

It is possible that such a relationship will be found in some circumstances, relevant factors being knowledge of names of subscribers, frequency of interactions, specificity of queries, and so on. In particular, a subscription fee is likely to be construed as evidence of soliciting and accepting a more committed interaction, so it places the operator of the website at greater legal risk. A specific disclaimer is a standard precaution but may not be enough to definitively protect against a lawsuit.

Courts have ruled in favor of plaintiffs despite the absence of face-to-face interaction with a physician. In one case, a doctor speaking to a patient from the emergency department was deemed to have formed a doctor-patient relationship (O’Neill v. Montefiore Hospital, 11 A.D.2d 132 (N.Y.A.D. 1 Dept. 1960). In another, an on-call neurologist’s telephone advice to the treating doctor likewise raised the issue of legal duty (Lection v. Dyll, 65 S.W.3d 696 (Tex. App. Dallas 2001).

The state of Hawaii now permits telehealth services to be reimbursable, notwithstanding the absence of face-to-face contact (HI Rev Stat § 431:10A-116.3[a]). With this law, an online encounter will likely translate into a professional relationship – with corresponding legal duty of due care.

In the case of a Good Samaritan physician – i.e., one who offers gratuitous aid to a stranger in need of medical assistance – courts are unlikely to find a professional relationship, because there is no common law duty to help a stranger.

However, once treatment has begun, there is a duty not to make matters worse. So, all 50 states have enacted Good Samaritan statutes, which protect against liability arising out of negligent rescue. Note that statutory protection is generally excluded for Good Samaritan acts performed within a hospital setting, under the theory that doctors have an ongoing relationship with the hospital and are already obligated to provide emergency care within its walls.

Another category of legal duty concerns nonpatient third parties. The complaint may relate to a failure to warn family members of a patient’s contagious disease, or the transmissible condition may have been missed and an innocent third party was injured as a result.

Another situation where duty to a third party might arise is the learning of a credible threat of harm directed at a named individual. This is famously known as the Tarasoff doctrine, after a California case in which the court imposed a duty on a college psychologist to directly warn an intended victim of harm by his patient – even though that meant breaching confidentiality of a professional relationship, and the victim was a nonpatient third party (Tarasoff v. Regents of University of California, 551 P.2d 334 [Cal. 1976]).

A doctor may also incur liability for automobile injuries sustained by one other than his or her own patient. In a Hawaii case, a car suddenly veered across five lanes of traffic, striking an 11-year-old bystander. The driver alleged that the prescription medication prazosin caused him to lose control of the car.

In ruling that the health care provider was liable to the injured bystander, the Hawaii Supreme Court held that physicians have a duty to warn their patients of potential adverse medication effects, and this responsibility should extend to third parties (McKenzie v. Hawaii Permanente Medical Group, 47 P.3d 1209 [Haw. 2002]).

A foreseeable and unreasonable risk of harm is an important factor, but not the only decisive factor, in construing the existence of a legal duty. Under some circumstances, the term “special relationship” has been employed based on a consideration of “existing social values, customs, and considerations of policy.”

In a Massachusetts case, a family practitioner had failed to warn his patient of the risk of diabetic drugs when operating a vehicle. Just 45 minutes after the patient’s discharge from the hospital, he developed hypoglycemia, losing consciousness and injuring a motorcyclist who then sued the doctor. The court used the “special relationship” rationale in ruling that the doctor owed a duty to the motorcyclist (Arsenault v. McConarty, 21 Mass. L. Rptr. 500 [2006]).

Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, and currently directs the St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at siang@hawaii.edu.

Question: One hour into an Air France international flight out of New York, Dr. Internist responded to a call for emergency medical assistance. A U.S. passenger had briefly passed out but then appeared to recover. Dr. Internist made a tentative diagnosis of a transient ischemic attack, but did not think an immediate divert was necessary. Based on the doctor’s assessment, the pilot continued on the previously scheduled flight path, landing several hours later in Paris. Meanwhile, the passenger’s condition worsened, and he expired shortly after arrival.

Which of the following statements is correct?

A. Under the common law, there is no legal duty to aid a stranger in distress; but under French law, a doctor is legally obligated to provide emergency assistance.

B. The U.S. federal Aviation Medical Assistance Act may immunize the doctor against liability for negligence during a midair medical emergency.

C. A tort action may still lie against the airline, notwithstanding the doctor’s advice not to divert.

D. Expect jurisdictional conflicts in the event there is a lawsuit.

E. All are correct.

Answer: E. Under the common law, there is no legal duty for anyone, even a doctor, to come to the aid of a stranger. However, doctors are generally held to have an ethical duty to offer emergency care. The American Medical Association’s Code of Medical Ethics states: “Physicians are free to choose whom they will serve. The physician should, however, respond to the best of his or her ability in cases of emergency where first aid treatment is essential.”¹

In contrast, Australia and most civil law jurisdictions, e.g., many European countries, impose a legal obligation to render assistance. Under French law, for example, failure to render assistance to a person in urgent need of help can be met with fines of up to 75,000 euros and 5 years imprisonment.

Medical “emergencies” occur in roughly 1 of every 600 flights, which may be an underestimate because of underreporting. The most common medical reasons for aircraft diversion are cardiac, respiratory, and neurologic emergencies. According to a recent review in the New England Journal of Medicine, the decision to divert lies solely with the captain of the aircraft, who must also consider factors such as fuel, costs, the ability to land, and the medical resources available at that airport.² The review also summarizes medical steps to be taken during midair medical emergencies.

Two related laws other than international aviation treaties govern medical liability during commercial flights: the generic “Good Samaritan” statute, which all 50 U.S. states have enacted, and the more specific federal Aviation Medical Assistance Act.

In 1959, California enacted the first Good Samaritan statute, whose intent is to encourage the helping of people in distress. In general, the law protects against liability arising out of nonreimbursed negligent rescue, but it does not affirmatively require doctors to come to the aid of strangers. Vermont, however, is an exception, and imposes a legal duty to assist a victim in need.

Typically, there is legal immunity against ordinary negligence but not gross misconduct, although California appears to excuse even gross negligence so long as the act was done in good faith. In a litigated case, a California court eloquently declared: “The goodness of the Samaritan is a description of the quality of his or her intention, not the quality of the aid delivered.”³

There is no universal definition of gross negligence, but the term frequently is equated with willful, wanton, or reckless conduct. One can think of gross negligence as aggravated negligence, involving more than mere mistake, inadvertence, or inattention, and representing highly unreasonable conduct or an extreme departure from ordinary care where a high degree of danger is apparent.⁴ An example may be an obviously inebriated physician attempting to provide treatment and causing harm to the victim.

However, the Good Samaritan statute, being state based, may not be applicable to scenarios with cross-border jurisdictional issues. The specific law that incorporates Good Samaritan assistance during commercial flights is the federal Aviation Medical Assistance Act (AMAA), which Congress enacted in 1998. In addition to Federal Aviation Administration mandates such as requisite medical supplies on board and training of flight crew, this federal law shields providers who respond to in-flight medical emergencies.

The AMAA covers claims arising from domestic flights and those arising from international flights involving U.S. carriers or residents, but it does not protect a provider who exhibits flagrant disregard for the patient’s health and safety. Liability is generally determined under the law of the country in which the aircraft is registered, but the citizenship status of the parties and where the incident occurs are also relevant.⁵

Under the facts of the hypothetical given above, one can expect jurisdictional conflicts in the event the plaintiff files a lawsuit, because it is unclear whether the AMAA is applicable where a foreign airline is on an international flight over the Atlantic, even one out of New York involving a U.S. citizen.

There does not appear to be an appellate court opinion on physician negligence during an in-flight medical emergency, but there have been lower court decisions and settlements adverse to the airline.⁶

For example, Northwest Airlines reportedly settled out of court following the death of a passenger on a flight from Manila to Tokyo, despite its claim that three doctors on board the aircraft did not feel an emergency landing was warranted. In a similar case, a Miami federal judge ordered Lufthansa German Airlines to pay damages of $2.7 million to a passenger having a heart attack during a 9-hour flight, after the captain heeded the recommendation from a doctor on board against diverting. In neither case were the doctors apparently named as defendants.

In summary, a doctor is ethically obligated to provide medical assistance in a midair emergency situation. It is highly unlikely that any adverse legal repercussion will ensue. Good Samaritan statutes and, more specifically, the AMAA, properly provide immunity against any allegation of ordinary negligence. Finally, one should be mindful of the need for the patient’s consent before examination and treatment, and, as always, keep written notes of what you have done.

References

1. AMA Code of Medical Ethics §8.11, 2012-2013 edition.

2. N Engl J Med. 2015 Sep 3;373(10):939-45.

3. Perkins v. Howard, 232 Cal.App.3d 708 (1991).

4. Prosser and Keeton on Torts, 5th ed. 1984, p. 211-4.

5. Aviation Medical Assistance Act of 1998, Pub L. No. 105-170. Washington, DC.

6. Aviat Space Environ Med. 1997 Dec;68(12):1134-8.

Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, and currently directs the St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at siang@hawaii.edu.

Question: One hour into an Air France international flight out of New York, Dr. Internist responded to a call for emergency medical assistance. A U.S. passenger had briefly passed out but then appeared to recover. Dr. Internist made a tentative diagnosis of a transient ischemic attack, but did not think an immediate divert was necessary. Based on the doctor’s assessment, the pilot continued on the previously scheduled flight path, landing several hours later in Paris. Meanwhile, the passenger’s condition worsened, and he expired shortly after arrival.

Which of the following statements is correct?

A. Under the common law, there is no legal duty to aid a stranger in distress; but under French law, a doctor is legally obligated to provide emergency assistance.

B. The U.S. federal Aviation Medical Assistance Act may immunize the doctor against liability for negligence during a midair medical emergency.

C. A tort action may still lie against the airline, notwithstanding the doctor’s advice not to divert.

D. Expect jurisdictional conflicts in the event there is a lawsuit.

E. All are correct.

Answer: E. Under the common law, there is no legal duty for anyone, even a doctor, to come to the aid of a stranger. However, doctors are generally held to have an ethical duty to offer emergency care. The American Medical Association’s Code of Medical Ethics states: “Physicians are free to choose whom they will serve. The physician should, however, respond to the best of his or her ability in cases of emergency where first aid treatment is essential.”¹

In contrast, Australia and most civil law jurisdictions, e.g., many European countries, impose a legal obligation to render assistance. Under French law, for example, failure to render assistance to a person in urgent need of help can be met with fines of up to 75,000 euros and 5 years imprisonment.

Medical “emergencies” occur in roughly 1 of every 600 flights, which may be an underestimate because of underreporting. The most common medical reasons for aircraft diversion are cardiac, respiratory, and neurologic emergencies. According to a recent review in the New England Journal of Medicine, the decision to divert lies solely with the captain of the aircraft, who must also consider factors such as fuel, costs, the ability to land, and the medical resources available at that airport.² The review also summarizes medical steps to be taken during midair medical emergencies.

Two related laws other than international aviation treaties govern medical liability during commercial flights: the generic “Good Samaritan” statute, which all 50 U.S. states have enacted, and the more specific federal Aviation Medical Assistance Act.

In 1959, California enacted the first Good Samaritan statute, whose intent is to encourage the helping of people in distress. In general, the law protects against liability arising out of nonreimbursed negligent rescue, but it does not affirmatively require doctors to come to the aid of strangers. Vermont, however, is an exception, and imposes a legal duty to assist a victim in need.

Typically, there is legal immunity against ordinary negligence but not gross misconduct, although California appears to excuse even gross negligence so long as the act was done in good faith. In a litigated case, a California court eloquently declared: “The goodness of the Samaritan is a description of the quality of his or her intention, not the quality of the aid delivered.”³

There is no universal definition of gross negligence, but the term frequently is equated with willful, wanton, or reckless conduct. One can think of gross negligence as aggravated negligence, involving more than mere mistake, inadvertence, or inattention, and representing highly unreasonable conduct or an extreme departure from ordinary care where a high degree of danger is apparent.⁴ An example may be an obviously inebriated physician attempting to provide treatment and causing harm to the victim.

However, the Good Samaritan statute, being state based, may not be applicable to scenarios with cross-border jurisdictional issues. The specific law that incorporates Good Samaritan assistance during commercial flights is the federal Aviation Medical Assistance Act (AMAA), which Congress enacted in 1998. In addition to Federal Aviation Administration mandates such as requisite medical supplies on board and training of flight crew, this federal law shields providers who respond to in-flight medical emergencies.

The AMAA covers claims arising from domestic flights and those arising from international flights involving U.S. carriers or residents, but it does not protect a provider who exhibits flagrant disregard for the patient’s health and safety. Liability is generally determined under the law of the country in which the aircraft is registered, but the citizenship status of the parties and where the incident occurs are also relevant.⁵

Under the facts of the hypothetical given above, one can expect jurisdictional conflicts in the event the plaintiff files a lawsuit, because it is unclear whether the AMAA is applicable where a foreign airline is on an international flight over the Atlantic, even one out of New York involving a U.S. citizen.

There does not appear to be an appellate court opinion on physician negligence during an in-flight medical emergency, but there have been lower court decisions and settlements adverse to the airline.⁶

For example, Northwest Airlines reportedly settled out of court following the death of a passenger on a flight from Manila to Tokyo, despite its claim that three doctors on board the aircraft did not feel an emergency landing was warranted. In a similar case, a Miami federal judge ordered Lufthansa German Airlines to pay damages of $2.7 million to a passenger having a heart attack during a 9-hour flight, after the captain heeded the recommendation from a doctor on board against diverting. In neither case were the doctors apparently named as defendants.

In summary, a doctor is ethically obligated to provide medical assistance in a midair emergency situation. It is highly unlikely that any adverse legal repercussion will ensue. Good Samaritan statutes and, more specifically, the AMAA, properly provide immunity against any allegation of ordinary negligence. Finally, one should be mindful of the need for the patient’s consent before examination and treatment, and, as always, keep written notes of what you have done.

References

1. AMA Code of Medical Ethics §8.11, 2012-2013 edition.

2. N Engl J Med. 2015 Sep 3;373(10):939-45.

3. Perkins v. Howard, 232 Cal.App.3d 708 (1991).

4. Prosser and Keeton on Torts, 5th ed. 1984, p. 211-4.

5. Aviation Medical Assistance Act of 1998, Pub L. No. 105-170. Washington, DC.

6. Aviat Space Environ Med. 1997 Dec;68(12):1134-8.

Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, and currently directs the St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at siang@hawaii.edu.

Question: One hour into an Air France international flight out of New York, Dr. Internist responded to a call for emergency medical assistance. A U.S. passenger had briefly passed out but then appeared to recover. Dr. Internist made a tentative diagnosis of a transient ischemic attack, but did not think an immediate divert was necessary. Based on the doctor’s assessment, the pilot continued on the previously scheduled flight path, landing several hours later in Paris. Meanwhile, the passenger’s condition worsened, and he expired shortly after arrival.

Which of the following statements is correct?

A. Under the common law, there is no legal duty to aid a stranger in distress; but under French law, a doctor is legally obligated to provide emergency assistance.

B. The U.S. federal Aviation Medical Assistance Act may immunize the doctor against liability for negligence during a midair medical emergency.

C. A tort action may still lie against the airline, notwithstanding the doctor’s advice not to divert.

D. Expect jurisdictional conflicts in the event there is a lawsuit.

E. All are correct.

Answer: E. Under the common law, there is no legal duty for anyone, even a doctor, to come to the aid of a stranger. However, doctors are generally held to have an ethical duty to offer emergency care. The American Medical Association’s Code of Medical Ethics states: “Physicians are free to choose whom they will serve. The physician should, however, respond to the best of his or her ability in cases of emergency where first aid treatment is essential.”¹

In contrast, Australia and most civil law jurisdictions, e.g., many European countries, impose a legal obligation to render assistance. Under French law, for example, failure to render assistance to a person in urgent need of help can be met with fines of up to 75,000 euros and 5 years imprisonment.

Medical “emergencies” occur in roughly 1 of every 600 flights, which may be an underestimate because of underreporting. The most common medical reasons for aircraft diversion are cardiac, respiratory, and neurologic emergencies. According to a recent review in the New England Journal of Medicine, the decision to divert lies solely with the captain of the aircraft, who must also consider factors such as fuel, costs, the ability to land, and the medical resources available at that airport.² The review also summarizes medical steps to be taken during midair medical emergencies.

Two related laws other than international aviation treaties govern medical liability during commercial flights: the generic “Good Samaritan” statute, which all 50 U.S. states have enacted, and the more specific federal Aviation Medical Assistance Act.

In 1959, California enacted the first Good Samaritan statute, whose intent is to encourage the helping of people in distress. In general, the law protects against liability arising out of nonreimbursed negligent rescue, but it does not affirmatively require doctors to come to the aid of strangers. Vermont, however, is an exception, and imposes a legal duty to assist a victim in need.

Typically, there is legal immunity against ordinary negligence but not gross misconduct, although California appears to excuse even gross negligence so long as the act was done in good faith. In a litigated case, a California court eloquently declared: “The goodness of the Samaritan is a description of the quality of his or her intention, not the quality of the aid delivered.”³

There is no universal definition of gross negligence, but the term frequently is equated with willful, wanton, or reckless conduct. One can think of gross negligence as aggravated negligence, involving more than mere mistake, inadvertence, or inattention, and representing highly unreasonable conduct or an extreme departure from ordinary care where a high degree of danger is apparent.⁴ An example may be an obviously inebriated physician attempting to provide treatment and causing harm to the victim.

However, the Good Samaritan statute, being state based, may not be applicable to scenarios with cross-border jurisdictional issues. The specific law that incorporates Good Samaritan assistance during commercial flights is the federal Aviation Medical Assistance Act (AMAA), which Congress enacted in 1998. In addition to Federal Aviation Administration mandates such as requisite medical supplies on board and training of flight crew, this federal law shields providers who respond to in-flight medical emergencies.

The AMAA covers claims arising from domestic flights and those arising from international flights involving U.S. carriers or residents, but it does not protect a provider who exhibits flagrant disregard for the patient’s health and safety. Liability is generally determined under the law of the country in which the aircraft is registered, but the citizenship status of the parties and where the incident occurs are also relevant.⁵

Under the facts of the hypothetical given above, one can expect jurisdictional conflicts in the event the plaintiff files a lawsuit, because it is unclear whether the AMAA is applicable where a foreign airline is on an international flight over the Atlantic, even one out of New York involving a U.S. citizen.

There does not appear to be an appellate court opinion on physician negligence during an in-flight medical emergency, but there have been lower court decisions and settlements adverse to the airline.⁶

For example, Northwest Airlines reportedly settled out of court following the death of a passenger on a flight from Manila to Tokyo, despite its claim that three doctors on board the aircraft did not feel an emergency landing was warranted. In a similar case, a Miami federal judge ordered Lufthansa German Airlines to pay damages of $2.7 million to a passenger having a heart attack during a 9-hour flight, after the captain heeded the recommendation from a doctor on board against diverting. In neither case were the doctors apparently named as defendants.

In summary, a doctor is ethically obligated to provide medical assistance in a midair emergency situation. It is highly unlikely that any adverse legal repercussion will ensue. Good Samaritan statutes and, more specifically, the AMAA, properly provide immunity against any allegation of ordinary negligence. Finally, one should be mindful of the need for the patient’s consent before examination and treatment, and, as always, keep written notes of what you have done.

References

1. AMA Code of Medical Ethics §8.11, 2012-2013 edition.

2. N Engl J Med. 2015 Sep 3;373(10):939-45.

3. Perkins v. Howard, 232 Cal.App.3d 708 (1991).

4. Prosser and Keeton on Torts, 5th ed. 1984, p. 211-4.

5. Aviation Medical Assistance Act of 1998, Pub L. No. 105-170. Washington, DC.

6. Aviat Space Environ Med. 1997 Dec;68(12):1134-8.

Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, and currently directs the St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at siang@hawaii.edu.

Question: Choose the single best answer to complete the statement, “A class-action lawsuit ...”

A. Is a legal cause of action for a wrongful act perpetrated by a class of wrongdoers.

B. Requires prior certification by a judge before it can go forward.

C. Is appropriate where the claims of a few injured victims can be joined together against a common wrongdoer.

D. Fulfills twin criteria of numerosity and commonality.

E. Can only be filed where there are substantial monetary damages at issue.

Answer: B. A class-action lawsuit describes a legal cause of action where a representative plaintiff(s), known as the lead plaintiff, asserts claims on behalf of a large class of similarly injured members, who then give up their rights to pursue an individual lawsuit. Class-action suits are distinguished from the usual lawsuit, which characteristically affects only one or a few plaintiffs.

Four prerequisites govern an action before it can be deemed a class action: numerosity, commonality, typicality, and adequacy. These are words of art, with specific definitions.

Numerosity denotes a large class membership, usually exceeding 30-40, and sometimes numbering in the thousands, such that the usual joining together of a few injured plaintiffs is not practical. Commonality speaks to common questions of fact and law, typicality requires the claim(s) of the representative plaintiff to match that of the class members, and adequacy demands that the representation of the class members be adequate.

These rules, as well as other important technicalities governing class action, are enumerated in the Federal Rules of Civil Procedure under Rule 23.¹²Wal-Mart Stores, Inc. v. Dukes et al^., where Wal-Mart was alleged to have violated Title VII of the Civil Rights Act of 1964 by having disparate wages and promotion reflecting gender discrimination.³ The plaintiffs sought an injunction against the alleged practice, as well as monetary damages. An earlier ruling of the U.S. Court of Appeals for the Ninth Circuit gave the green light to this sprawling nationwide class action.

It had started out with Betty Dukes and five other women employees, but grew to more than 1.5 million female Wal-Mart employees. However, on appeal, the U.S. Supreme Court reversed, holding that the certification of the plaintiff class was not consistent with Rule 23(a), as the prerequisite of commonality was not fulfilled. The Supreme Court also disallowed the claim for monetary relief, as it was not incidental or secondary to the injunction sought.

Class-action suits are commonly encountered in mass torts, where a product or accident causes injury to numerous individuals. Other situations include environmental pollution, securities fraud, and improper employment practices.

A favorite target is in the health care industry, where manufacturers of drugs and medical devices face allegations that defective products have been allowed to enter the market, causing harm to end users.

An example is the silicon breast implant litigation of the 1990s. The Food and Drug Administration had placed breast implants in the category of medical products and learned that the Dow Corning Corporation, which manufactured the silicon implants, had withheld safety information. The FDA severely restricted the use of these implants, which predictably led to widespread litigation with billions of dollars of judgment awards and settlements.⁴⁵ and the FDA subsequently required the revision of the package insert of Lipitor and other statins to warn of this association. In 2013, a large Canadian study confirmed the increased incidence of new-onset diabetes in patients taking atorvastatin (hazard ratio, 1.22) or simvastatin.⁶

However, the outcome of the trial may turn on whether the clear health benefit of lowering serum cholesterol outweighs any purported safety concern.

A fast-growing trend is the filing of class-action suits against nursing homes for providing inadequate care. This is not unexpected, because large numbers of nursing home residents have a common concern over any breach of safety, hygiene, or other statutorily mandated standards of nursing home care. This important topic will be taken up in a subsequent column.

References

1. Available at www.classactionlitigation.com/rule23.html.

2. Mullenix LS. Ending class actions as we know them: rethinking the American class action. Emory Law J. 2014;64:399-449.

3. Wal-Mart Stores, Inc. v. Dukes et al.131 S. Ct. 2541 (2011).

4. Snyder JW. Silicon breast implants. Can emerging medical, legal and scientific concepts be reconciled? J. Leg. Med. 1997;18:133-220.

5. Sattar N, et al. Statins and risk of incident diabetes: a collaborative meta-analysis of randomised statin trials. Lancet 2010;375:735-42.

6. Carter AC, et al. Risk of incident diabetes among patients treated with statins: population based study. BMJ 2013;346:f2610.

Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, and currently directs the St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at siang@hawaii.edu.

Question: Choose the single best answer to complete the statement, “A class-action lawsuit ...”

A. Is a legal cause of action for a wrongful act perpetrated by a class of wrongdoers.

B. Requires prior certification by a judge before it can go forward.

C. Is appropriate where the claims of a few injured victims can be joined together against a common wrongdoer.

D. Fulfills twin criteria of numerosity and commonality.

E. Can only be filed where there are substantial monetary damages at issue.

Answer: B. A class-action lawsuit describes a legal cause of action where a representative plaintiff(s), known as the lead plaintiff, asserts claims on behalf of a large class of similarly injured members, who then give up their rights to pursue an individual lawsuit. Class-action suits are distinguished from the usual lawsuit, which characteristically affects only one or a few plaintiffs.

Four prerequisites govern an action before it can be deemed a class action: numerosity, commonality, typicality, and adequacy. These are words of art, with specific definitions.

Numerosity denotes a large class membership, usually exceeding 30-40, and sometimes numbering in the thousands, such that the usual joining together of a few injured plaintiffs is not practical. Commonality speaks to common questions of fact and law, typicality requires the claim(s) of the representative plaintiff to match that of the class members, and adequacy demands that the representation of the class members be adequate.

These rules, as well as other important technicalities governing class action, are enumerated in the Federal Rules of Civil Procedure under Rule 23.¹²Wal-Mart Stores, Inc. v. Dukes et al^., where Wal-Mart was alleged to have violated Title VII of the Civil Rights Act of 1964 by having disparate wages and promotion reflecting gender discrimination.³ The plaintiffs sought an injunction against the alleged practice, as well as monetary damages. An earlier ruling of the U.S. Court of Appeals for the Ninth Circuit gave the green light to this sprawling nationwide class action.

It had started out with Betty Dukes and five other women employees, but grew to more than 1.5 million female Wal-Mart employees. However, on appeal, the U.S. Supreme Court reversed, holding that the certification of the plaintiff class was not consistent with Rule 23(a), as the prerequisite of commonality was not fulfilled. The Supreme Court also disallowed the claim for monetary relief, as it was not incidental or secondary to the injunction sought.

Class-action suits are commonly encountered in mass torts, where a product or accident causes injury to numerous individuals. Other situations include environmental pollution, securities fraud, and improper employment practices.

A favorite target is in the health care industry, where manufacturers of drugs and medical devices face allegations that defective products have been allowed to enter the market, causing harm to end users.

An example is the silicon breast implant litigation of the 1990s. The Food and Drug Administration had placed breast implants in the category of medical products and learned that the Dow Corning Corporation, which manufactured the silicon implants, had withheld safety information. The FDA severely restricted the use of these implants, which predictably led to widespread litigation with billions of dollars of judgment awards and settlements.⁴⁵ and the FDA subsequently required the revision of the package insert of Lipitor and other statins to warn of this association. In 2013, a large Canadian study confirmed the increased incidence of new-onset diabetes in patients taking atorvastatin (hazard ratio, 1.22) or simvastatin.⁶

However, the outcome of the trial may turn on whether the clear health benefit of lowering serum cholesterol outweighs any purported safety concern.

A fast-growing trend is the filing of class-action suits against nursing homes for providing inadequate care. This is not unexpected, because large numbers of nursing home residents have a common concern over any breach of safety, hygiene, or other statutorily mandated standards of nursing home care. This important topic will be taken up in a subsequent column.

References

1. Available at www.classactionlitigation.com/rule23.html.

2. Mullenix LS. Ending class actions as we know them: rethinking the American class action. Emory Law J. 2014;64:399-449.

3. Wal-Mart Stores, Inc. v. Dukes et al.131 S. Ct. 2541 (2011).

4. Snyder JW. Silicon breast implants. Can emerging medical, legal and scientific concepts be reconciled? J. Leg. Med. 1997;18:133-220.

5. Sattar N, et al. Statins and risk of incident diabetes: a collaborative meta-analysis of randomised statin trials. Lancet 2010;375:735-42.

6. Carter AC, et al. Risk of incident diabetes among patients treated with statins: population based study. BMJ 2013;346:f2610.

Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, and currently directs the St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at siang@hawaii.edu.

Question: Choose the single best answer to complete the statement, “A class-action lawsuit ...”

A. Is a legal cause of action for a wrongful act perpetrated by a class of wrongdoers.

B. Requires prior certification by a judge before it can go forward.

C. Is appropriate where the claims of a few injured victims can be joined together against a common wrongdoer.

D. Fulfills twin criteria of numerosity and commonality.

E. Can only be filed where there are substantial monetary damages at issue.

Answer: B. A class-action lawsuit describes a legal cause of action where a representative plaintiff(s), known as the lead plaintiff, asserts claims on behalf of a large class of similarly injured members, who then give up their rights to pursue an individual lawsuit. Class-action suits are distinguished from the usual lawsuit, which characteristically affects only one or a few plaintiffs.

Four prerequisites govern an action before it can be deemed a class action: numerosity, commonality, typicality, and adequacy. These are words of art, with specific definitions.

Numerosity denotes a large class membership, usually exceeding 30-40, and sometimes numbering in the thousands, such that the usual joining together of a few injured plaintiffs is not practical. Commonality speaks to common questions of fact and law, typicality requires the claim(s) of the representative plaintiff to match that of the class members, and adequacy demands that the representation of the class members be adequate.

These rules, as well as other important technicalities governing class action, are enumerated in the Federal Rules of Civil Procedure under Rule 23.¹²Wal-Mart Stores, Inc. v. Dukes et al^., where Wal-Mart was alleged to have violated Title VII of the Civil Rights Act of 1964 by having disparate wages and promotion reflecting gender discrimination.³ The plaintiffs sought an injunction against the alleged practice, as well as monetary damages. An earlier ruling of the U.S. Court of Appeals for the Ninth Circuit gave the green light to this sprawling nationwide class action.

It had started out with Betty Dukes and five other women employees, but grew to more than 1.5 million female Wal-Mart employees. However, on appeal, the U.S. Supreme Court reversed, holding that the certification of the plaintiff class was not consistent with Rule 23(a), as the prerequisite of commonality was not fulfilled. The Supreme Court also disallowed the claim for monetary relief, as it was not incidental or secondary to the injunction sought.

Class-action suits are commonly encountered in mass torts, where a product or accident causes injury to numerous individuals. Other situations include environmental pollution, securities fraud, and improper employment practices.

A favorite target is in the health care industry, where manufacturers of drugs and medical devices face allegations that defective products have been allowed to enter the market, causing harm to end users.

An example is the silicon breast implant litigation of the 1990s. The Food and Drug Administration had placed breast implants in the category of medical products and learned that the Dow Corning Corporation, which manufactured the silicon implants, had withheld safety information. The FDA severely restricted the use of these implants, which predictably led to widespread litigation with billions of dollars of judgment awards and settlements.⁴⁵ and the FDA subsequently required the revision of the package insert of Lipitor and other statins to warn of this association. In 2013, a large Canadian study confirmed the increased incidence of new-onset diabetes in patients taking atorvastatin (hazard ratio, 1.22) or simvastatin.⁶

However, the outcome of the trial may turn on whether the clear health benefit of lowering serum cholesterol outweighs any purported safety concern.

A fast-growing trend is the filing of class-action suits against nursing homes for providing inadequate care. This is not unexpected, because large numbers of nursing home residents have a common concern over any breach of safety, hygiene, or other statutorily mandated standards of nursing home care. This important topic will be taken up in a subsequent column.

References

1. Available at www.classactionlitigation.com/rule23.html.

2. Mullenix LS. Ending class actions as we know them: rethinking the American class action. Emory Law J. 2014;64:399-449.

3. Wal-Mart Stores, Inc. v. Dukes et al.131 S. Ct. 2541 (2011).

4. Snyder JW. Silicon breast implants. Can emerging medical, legal and scientific concepts be reconciled? J. Leg. Med. 1997;18:133-220.

5. Sattar N, et al. Statins and risk of incident diabetes: a collaborative meta-analysis of randomised statin trials. Lancet 2010;375:735-42.

6. Carter AC, et al. Risk of incident diabetes among patients treated with statins: population based study. BMJ 2013;346:f2610.

Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, and currently directs the St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at siang@hawaii.edu.