The U.S. Supreme Court ruled recently regarding the liability of a generic drugmaker whose pain reliever left a woman severely disabled.
The lawsuit itself, Mutual Pharmaceutical Co., Inc. v. Bartlett, centered on the fact that the label for the anti-inflammatory did not carry a warning regarding the potential rare side effect of developing Stevens-Johnson syndrome (SJS), which is precisely what happened to the plaintiff in the case. It also accused the maker of producing a dangerous product. The plaintiff’s reaction was so severe, that she developed toxic epidermal necrolysis, spent 10 weeks in the hospital, suffered two incidents of septic shock, suffered burns to 60% of her body, endured a medically induced coma, and required 12 separate eye surgeries.
At the time the plaintiff took the medication, the label did not have a warning regarding the risk of SJS, although the package insert did. Following the ordeal, the FDA recommended that all drugs within this class (non-steroidal anti-inflammatory or NSAID) carry a warning regarding toxic epidermal necrolysis.
The plaintiff in the case sued the drug manufacter, claiming that the drug was defectively designed. A lower court awared her $21 million in damages, including amounts for pain and suffering, loss of enjoyment of life, and past and future medical expenses. The drugmaker appealed, alleging that federal law preempts lawsuits for the defective design of drugs against generic drugmakers; the argument being that the original manufacturer designed and sought approval from the FDA for the chemical makeup of the drug. There were also allegations regarding the label, which the drugmaker challenged on the same grounds.