FDA Drug Labeling, Approval Process Help Minimize Lawsuits Against Pharmaceutical Companies

Like many people, I am up early and in the gym most days. Although I don’t seem to get anywhere new on the stationary bicycle or the elliptical machine, I do get to keep up with the pundits on the early morning talk shows. In contrast to the television series I binge on later in the evening, the morning talk shows are punctuated by commercials.

I am gratified to see that many of these commercials end with an exhortation to “Ask your rheumatologist …,” but many other commercials with cartoons or strangely dressed characters representing misbehaving bladders or intestines in people who suffer from an acronym I have never heard before are of less interest to me. I also see a lot of commercials that tell you to ask your doctor if you are healthy enough to have sex, as if a physical exam is now foreplay.

More recently, advertisements asking whether you have had a medical misadventure with a specific product and suffered an injury or commercials showing happy winners of a tort lottery claiming that a law firm “got me many times what the insurance company offered” have been replacing pharmaceutical advertisements. Oddly, judging by the types of potential lawsuits advertised or the cases that make the news, few torts seem to be filed because a drug failed to live up to its promise.

Although unskilled in the dark arts of the legal profession, I would surmise the absence of lawsuits for false or misleading advertising about drugs that fail to successfully treat the conditions for which they are approved results from the rigorous approval process and detailed labeling of pharmaceuticals mandated by the FDA. If a drug is labeled an effective therapy for 70% of patients and you are unlucky enough to be one of the other 30%, then it’s difficult to make the case that the advertising for the drug was false or misleading because the drug claims made clear that some people might not benefit. Moreover, if the labeling includes a description of a specific toxicity or side effect, then it will be difficult to successfully argue that you were not informed of the risks.

I was reminded of this situation recently when meeting with potential investors in an early-stage startup built around something developed in my laboratory. One of these investors remarked that the drug approval process was remarkably cumbersome and that it should be radically changed. He thought too many potentially great drugs/devices were not making it to market and the ones that do take far too long to be approved.