Have you ever watched a prescription drug commercial on television or looked at a drug ad in a magazine? The side effects section often is very long, with a list of scary complications. Why do drugmakers do that?
We used to think that pharmaceutical companies reluctantly included a long list of adverse reactions because the Food and Drug Administration made them do it. That is no doubt true, but there may be a more self-serving reason. Telling patients about lots of side effects might provide a legal defense in case of litigation.
You may wonder how that would work. Here’s the latest example. A recent trial in Philadelphia resulted in an $8 billion verdict against Johnson & Johnson, the manufacturer of Risperdal. The plaintiff claimed that he was given this schizophrenia drug for autism spectrum disorder when he was a youngster. He developed prominent breasts, which caused him anguish as a teenager. The condition is known as gynecomastia.
Needless to say, J&J is not happy about this ruling. The company will appeal. Part of its defense is expected to be that it notified health professionals of this side effect in the prescribing information. The company responded to the verdict that “the jury did not hear evidence as to how the label for Risperdal clearly and appropriately outlined the risks associated with the medicine....”
We interpret that to mean if a patient takes a medication that causes serious harm, the drug manufacturer should not be liable for the damage, provided it has notified doctors about the risk. Most companies do this in the official prescribing information.
A patient who develops a life-threatening skin reaction brought on by a medicine probably cannot sue the manufacturer if the prescribing information lists Stevens-Johnson syndrome. Drug companies do not have to warn patients directly. For legal purposes, all they have to do is make sure prescribers and pharmacists have access to the information.
What is the take-home message from the latest lawsuit? Physicians must understand the pros and cons of every medication they prescribe. They should alert their patients to symptoms of potentially serious adverse reactions.
Even if a list of side effects is long and daunting, it is still essential to read and understand the implications. That’s the only way to realize that you might be running into trouble.