Are physicians liable for medical malpractice if an off-label drug they prescribe causes adverse effects? That question is at the heart of a lawsuit now moving through the Jefferson County District court in Beaumont, TX.
In a Sept. 4 lawsuit, Donald Moss, a 54-year-old refinery worker in Beaumont, alleged that the atypical antipsychotic his psychiatrist prescribed for depression and anxiety — 40 mg ziprasidone (Geodone) daily — constituted “off-label” use, and that the medication caused extrapyramidal symptoms and tardive dyskinesia.
Moss alleges that Kashi Bagri, MD, who treated him from August 2004 to July 2006, failed to warn him about potential adverse effects, according to the Southeast Texas Record, a legal journal based in Beaumont.
Moss was prescribed ziprasidone and sertraline (Zoloft), which is indicated for depression. Ziprasidone is FDA-approved for acute mania and mixed episodes associated with bipolar disorder, as well as schizophrenia.
Moss, who had a history of diabetes, hypertension, and hyperlipidemia, experienced a transient ischemic stroke while taking ziprasidone but continued to take the drug for two years. A few months after discontinuing the therapy, he had tardive blepharospasm and tardive dyskinesia (diagnosed by a neurologist in 2007).
Because the case is currently pending, Moss's lawyer, Ken Lewis, of the Beaumont law firm Bush Lewis PLLC, declined to comment for this article. But several risk-management experts, not involved in the lawsuit, agreed to discuss the implications of the case for neurologists.
OFF-LABEL USE IS NOT ILLEGAL
Jacqueline M. Melonas, JD, RN, a health care attorney and the vice president of risk management at Professional Risk Management Services, Inc. (PRMS), noted that off-label use of medications is a routine and established part of medical practice and is not, in and of itself, a professional liability risk.
The FDA and American Medical Association (AMA) agree that physicians may lawfully use an FDA-approved drug or medical device for an off-label indication when there is sound scientific evidence to support its use, Melonas noted.
But what about malpractice risk or higher premiums when a drug is prescribed off label and it causes serious adverse events?
“Although it is not unusual for adverse effects of medications to be a trigger for medical malpractice lawsuits, the mere fact that a prescription was off-label does not by itself increase risk,” Melonas said. She added that in her experience with The Neurologists' Program, a medical malpractice insurance program designed specifically for neurologists, “allegations of negligent off-label prescribing are rarely substantiated.”
Christopher B. Hopkins, a lawyer specializing in medical malpractice for Butzel Long, PC, a Detroit-based international firm, said he has “been involved in medical negligence cases where the plaintiff lawyer has seized upon off-label use of medications and tried to turn that into an illegal or reckless act — in effect, saying: ‘You realize that the FDA has explicitly said that doing what you did was wrong?’”
That approach, however, rests upon an incorrect generalization, he said, because while manufacturers cannot market off-label use, it's not a crime for doctors to prescribe a drug off-label.
DOCUMENTATION OF EVIDENCE-BASED DECISIONS
Neurologists should inquire with their professional liability carrier about the potential for increased professional liability premiums, particularly before prescribing unconventional or controversial off-label therapies, said Peggy Nakamura, assistant vice president, chief risk officer, and associate counsel at Adventist Health in Roseville, CA. Adventist Health operates health care facilities throughout California, Hawaii, Oregon, and Washington.
But most cases involving off-label use in standard practice won't result in higher premiums as long as the physician uses sound medical judgment and obtains a patient's comprehensive informed consent.
In order to prove a claim of negligence, it must be established that a doctor's actions were a departure from the accepted standard of care — and if the physician deviated from the standard, he or she must prove there was justification, experts agreed.
The decision to prescribe off-label should have been evidence-based, Nakamura said, and the documentation needs to reflect the physician's clinical judgment for prescribing the drug in that particular instance for the particular patient.
The documentation should include the neurologist's clinical assessment, a record that the patient or decision maker has provided informed consent, and that the risks and benefits of the proposed treatment — and its alternatives — have been discussed.
Education is perhaps the best strategy for increasing patient safety and reducing malpractice risks when prescribing [on- and] off-label, Melonas and Nakamura agreed. Neurologists should stay up-to date on safety information and the latest clinical data from peer-reviewed or published studies, CME, and the FDA's Medwatch Web site.
Discussion of risks and ongoing scrutiny of patients are particularly important when prescribing drugs with black box warnings and that pose risks of increased suicide ideation and depression. Extra care needs to be taken when assessing and prescribing for the elderly, who not only face a significant number of fatal medical errors in hospital settings, but also are generally at increased risk for suicide.
The federal law governs the FDA labeling of a drug, but individual states may also have requirements related to informed consent and clinical research. Any institutional policies or procedures applicable to off-label drug administration also need to be followed and documented, said Nakamura.
Effective communication is crucial, she concluded: “A truly informed patient is less likely to sue, and makes better choices when the risks are significant.”
Managing Risk for Neurologists
The Neurologists' Program (TNP), managed by Professional Risk Management Services, Inc., offers policy and risk management advice for AAN members through the AAN Partners Program, through which AAN members receive a 5 percent premium discount.
TNP is currently available in select states but will be available nationally within the next year. Benefits include complimentary one-on-one risk management consultations, articles and resources, online multimedia tutorials, and e-alerts.
Call (800) 245-3333 or visit www.tnpinsurance.com to learn about more features and benefits.
Document Decisions to Avoid Liability Risks
Risk management experts recommend that physicians carefully document all clinical decision-making to avoid liability risks. Files should include:
- the neurologist's clinical assessment and judgment for treatment recommendations and prescribing decisions for the patient
- a record that the patient or decision-maker has provided informed consent
- a record that the clinical indications and risks and benefits of the proposed treatment have been discussed
- a record that there has been discussion of the risks and benefits of the treatment's alternatives — and why these alternatives will not work in this particular patient situation
- notes that the risk and benefits of doing nothing has been discussed.