What is a pediatrician's ethical responsibility for informing parents about drug class action lawsuits?
If a drug has its label changed or is recalled, physicians have certain responsibilities. But what about when a drug is the subject of a class-action lawsuit?
When the lawsuits aren't about efficacy or the indicated use, prescribing habits don't need to be changed. In class-action lawsuits, a few parties sue on behalf of a larger pool for financial restitution. If the defendant is found guilty or settles out of court, the plaintiff's law firm equally divides the awarded funds to everyone qualified who applies.
Since there is a limited timeframe for these claims, only those who hear about the settlement in time can submit their paperwork. This could mean substantial monetary benefit for some patients.
Contemporary Pediatrics asked John D. Lantos, MD, about how physicians are expected to deal with class-action settlements. Dr. Lantos is an associate director of the McLean Center for Medical Ethics at the University of Chicago. His specialty is pediatric medical ethics. Dr. Lantos noted that each class-action lawsuit is different, so it is often hard to generalize on the ethical way to handle them. Still, some ground rules do apply.
Q: Is it a physician's duty to tell their patient about a class-action settlement?
A: No. There is no duty to inform patients about class-action lawsuits. It would be a good thing-as it would be good for doctors to tell parents if a toy has been recalled.
Q: Should physicians discuss how much the class-action suit is worth, or simply mention the suit?
A: If they know, they should tell, but they have no obligation to know or to find out.
Q: Does the situation change if the physician prescribed the drug in question off-label? Or if the lawsuit was about this off-label indication?
A: Whether it is "on-label" or "off-label" is not particularly relevant. Many medications are used off-label, particularly in pediatrics, but are nonetheless the standard of care.
Q: Is it enough to contact patients already in for visits, or should practices go through each file to see who had been prescribed what?
A: It would depend upon the information systems that are in place. If a practice could easily (ie, electronically) identify every patient who was prescribed the drug, then a phone call or letter to each would be wonderful. If the practice does not have the capability to do that, then a mass mailing to everyone would be acceptable. A poster in the waiting room or a flyer would be sufficient.
Q: Does the physician put him- or herself at risk, by opening up a crack in the armor of sacred medicine?
A: Absolutely not. Medicine lost its armor decades ago. Everybody knows that doctors, hospitals, drug companies, and the FDA all make mistakes. Acknowledging mistakes and helping to remedy them enhances professional reputations.
http://www.contemporarypediatrics.com/ is conducting a poll related to this issue. Please go online to answer the question below:
How does your practice notify patients about drug recalls or class-action lawsuits?
» We have an electronic information system in place to notify patients
» We notify patients via mass mailing
» We have flyers in our waiting room
» We have never thought about this issue