Off-Label Drug Use Can Be Off-Putting to Jurors

We encounter a surprising number of medical malpractice lawsuits involving off-label use of a drug – to treat something other than for what the FDA approved – even if this isn’t the primary focus of the case.  And more often than not, at least a couple of focus group jurors attack the off-label use as “experimental” or “illegal.”

Plaintiff attorneys are savvy to this perception, and they often throw in an off-label allegation to inflame the jury and make them think the defendant caregiver was engaging in an unethical practice far outside the realm of acceptable medicine.

You and I know this isn’t the truth, but how do you convince jurors off-label isn’t synonymous with malpractice?

The key – as with so many things – is education, and through the years we’ve developed a multi-pronged education strategy to help normalize off-label use:

• Off-label use is extremely common.  The numbers are hard to pin down, but as many as half of all prescriptions written in the U.S. are for off-label uses, and the practice is a vital part of mainstream medicine.  We’ve found it’s helpful to educate jurors about common, well-known off-label drugs uses, such as the antidepressant Wellbutrin to help with smoking cessation.  By pointing to common examples most people have heard of, off-label prescriptions seem a little less out of the ordinary.
• It is not illegal.  There is no law prohibiting doctors from prescribing drugs for off-label uses.  The FDA regulates the sale, labeling and marketing of medications, not the practice of medicine.  No one wants a bunch of government bureaucrats telling doctors how to care for patients.​
• Unapproved does not mean dangerous or ineffective.  The FDA has approved these drugs for some purpose, so all of them have been through clinical trials to determine the side effects are acceptable.  The fact a drug is unapproved for a certain use usually just means the manufacturer did not think it was economically viable to go through the long, expensive approval process for another use since doctors are free to prescribe it for that anyway.
• Off-label use is not experimental.  Experiments are testing to see if a drug has any benefit.  In off-label use, the doctor knows through the medical literature and his own experience there is a benefit and is doing what he thinks will be most effective for the patient.
• It leads to advances in medicine.  Doctors discovering new uses for existing drugs is one of the major ways medical treatments advance.  They don’t do this by experimenting; rather, they prescribe the drug for an approved use and notice an unexpected side benefit, so begin prescribing it for that as well.  Often, off-label uses eventually become approved by the FDA and come to define the standard of care for an illness.

Of course, this broad-brush strategy must be tailored to the facts of each individual case.  If you have a case involving off-label drug use and want to understand more about juror perceptions, contact Senior Vice President Claire Luna at 714.754.1010 or cluna@juryimpact.net to find out how we can help.