The pharmaceutical industry received another free pass last week when the Supreme Court ruled that under state law, generic drug manufacturers can’t be sued for adverse reactions to their products. The recent 5-4 decision usurping common law should concern all Americans.
This is the second Supreme Court decision that gives the generic drug industry immunity, at a time when more than 80 percent of prescription drugs dispensed are generic. In 2011, the Court decided generic drugmakers can’t be held responsible for failing to warn about a drug’s side effects, arguing the generic manufacturer is only making a “copy” of the brand drug and must follow the brand drug’s label.
The case Mutual Pharmaceutical v. Bartlett involved Karen Bartlett, a woman who permanently suffers from Stevens-Johnson syndrome after taking the generic drug sulindac for shoulder pain. The disease left Karen nearly blind and burned off more than 60 percent of her skin. Bartlett spent months in a coma and a year with a feeding tube. She is permanently disfigured and will need care for the rest of her life.
A Federal jury in New Hampshire found sulindac was unreasonably dangerous and awarded Karen $21 million. The Court of Appeals for the first circuit affirmed, and the Supreme Court snuffed out the award.
Senator Leahy and Senator Landrieu have sent letters to the U.S. Food and Drug Administration (FDA), calling on the agency to address generic drug accountability. Public Citizen filed a citizen petition asking the FDA to address the PLIVA, Inc. v. Mensing decision, and the American Association for Justice (AAJ) has filed comments in support of the petition.
At Anapol Schwartz, we remain committed to protecting people from unsafe drugs and defective medical devices.