Off-label prescriptions, side effects, and lawsuits: Navigating ethical and legal dilemmas


A recent TV advertisement attempted to recruit clients for a class action suit against a pharmaceutical manufacturer (PM) for a medication side effect (SE). The “cause of action” was unstated: was it the side effect’s existence or that the company failed to emphasize its severity?

The SE was acknowledged not only by the company but also the FDA, which nonetheless approved the medication (RX), determining that its benefits outweighed the side effect for a certain class of individuals. Subsequently, it was learned that the medication was useful for another, though unapproved purpose, for which people demanded it and physicians had no difficulty complying, as off-label use is an unwritten standard of care. As happens with increasing use, more people experienced the SE, and this growing population becomes a potentially profitable market for civil liability attorneys, and as the PM has deep pockets, these attorneys created an assumption of corporate guilt.

The FDA is tasked with determining the safety of an RX in addition to its efficacy, and many drugs that are approved have serious SEs but are permitted because benefits are judged to outweigh harms. Thus, there are approved cancer medications for life extension with SEs that may shorten life, and drugs for skin conditions whose SEs may cause cancer or life-threatening infections. Generally, the FDA does a respectable job; at times, it does not. It approved two drugs to slow Alzheimer’s dementia with significant side effects based on meager evidence of potential good. Was the FDA too optimistic? Some of its safety review committee members for the first drug thought so and resigned in protest of the approval. The Public Citizen’s Health Research Group reviewed the information supporting these RXs presented to the FDA and concluded that neither should have been approved. Similarly, in reviewing the class of drugs generating the potential lawsuit, they again concluded, contrary to the FDA, that they too should have been disapproved because of their SEs. Could this difference between two credible organizations lend credence to a legal argument?

Another possible de jure contention is that the company did not sufficiently notify potential users of SE severity and that if it had done so, they would not have used it. But, this argument is questionable. Cognitive research has shown that people use mental shortcuts in decision-making, including selective filtering of information. People prefer information that is favorable to what they wish to hear or read and ignore or minimize that which is less favorable. There is also a preference for the easiest or simplest solution. Thus, a pill promising weight loss without dieting or exercise would be favored over a weight loss plan including both. Or a politician providing a simplistic solution to inflation will be preferred to one with an erudite approach to remediation. Another constant is one’s emotions, through which an individual will believe that something will work for them regardless of contrary evidence. Thus, it would likely have made a trivial difference, if any, in patient choice if the PM had used a larger print or a distinct color to emphasize the side effect.

If in the present situation, the manufacturer restrained individuals and forced them to ingest the medication, I would agree that it bore responsibility for the side effect. But the PM did not do this. Either the patient requested the RX (off-label), or their physician recommended it, and the patient agreed to its use. In either case, patient choice, biased or not, but uncoerced, was involved.

Before taking a new medication, one is encouraged to read the package insert. This information is available online or from a pharmacist and can be read and questions asked before purchase. Researchers have reported that while 60% of people claimed usually reading the insert (I suspect this is falsely high), a substantial proportion did not comprehend what was written. However, the consumer failed in their responsibility by not questioning the physician or pharmacist about what was not understood. I would contend that if an individual did not raise these questions, then this information was not a concern for them, nullifying corporate responsibility regarding notification.

An argument could be made that it is a physician’s duty to protect a patient from harm and that providing an off-label RX with a significant SE is a breach of this duty. However, provision of off-label medications, as noted, is a common and accepted practice that should absolve any doctor of liability of its provision. At best, the physician’s responsibility is no greater than indicating that the drug is not approved for off-label use and has a serious SE. But if the patient still desires it, it would be better to be provided by a doctor familiar with him/her and not one unfamiliar with the patient and his/her medical history.

The responsibility lies with the individual who chose to use this RX. We can feel sorry for those who experience the severe SE, but we cannot hold the PM responsible for what users considered sufficient information, and for freely choosing to take the medication, especially if safer alternatives to the off-label use exist, as they did in this instance.

M. Bennet Broner is a medical ethicist.


Prev





Source link

About The Author

Scroll to Top