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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).