The U.S. Supreme Court is set to make a ruling on a very important pharmaceutical case this term. At issue is whether a generic drug manufacturer can face a lawsuit for their inability to warn consumers of potentially dangerous side effects.
The case at issue involves the drug manufacturer Mutual Pharmaceutical Co., which has appealed a jury award of $21 million in a case where the plaintiff took a generic NSAID drug made by the company for shoulder pain as prescribed by her doctor, and instead suffered incredibly serious complications. The verdict was affirmed at both the trial and appeal levels.
In this case, three weeks after the woman took the drug at issue, she developed a rare and severe reaction, which caused her skin to peel off, leaving her with burn-like lesions over two-thirds of her body. She spent some of the nearly two months during which she was in a hospital burn unit in a medically induced coma, and has had to undergo 13 eye surgeries.
The reaction, which is considered to have been a severe form of Stevens-Johnson Syndrome, caused the woman to suffer permanent near-blindness, scarred lungs and a constricted esophagus, making it difficult to swallow. She originally sued the manufacturer under state law in 2008 for alleged design defects. Following a 14 day trial, the jury awarded her $21 million for her injuries and suffering.
The appeal centers on the applicability of two prior court rulings, particularly PLIVA v. Mensing, which held that generic drugmakers cannot be sued for failing to warn about certain health risks due to the fact that federal law requires generic drugs to carry the same warning label as their brand name equivalents. Therefore, it remains unclear whether the court will choose to distinguish this case in that it does not solely claim a failure to warn, but also argues a design defect, which again may potentially be excludable under prior case law.