In its decision issued on June 24, 2013, the Supreme Court of the United States issued a ruling that further insulates makers of generic drugs from responsibility for harm caused by their products. In Mutual Pharmaceutical Co., Inc. v. Bartlett, the Court expanded generic drug makers’ immunity from liability by denying consumers a state law claim that a drug is defective in its design. This expanded the protections for generic drug makers in the Court’s 2011 decision, PLIVA v. Mensing, which held that generic drug makers are not responsible for ensuring that the label on their drugs gives patients and doctors an adequate warning of the risks.
This case involves Karen Bartlett, who took a sulindac, a generic pain reliever manufactured by Mutual Pharmaceuticals, for shoulder pain. Sulindac caused her to develop toxic epidermal necrosis. This disease caused between sixty to sixty-five percent of the skin on her body to either burn off or become an open sore. She spent fifty days in a hospital burn unit because of her injuries. She spent months in a medically-induced coma and was tube-fed for a year. She is now permanently disfigured, nearly blind, and will need care for the rest of her life.
Karen Bartlett’s doctor prescribed the brand name drug, Clinoril. Her pharmacist, however, dispensed the generic form of the drug, sulindac, manufactured by Mutual. A Federal jury in New Hampshire found sulindac was unreasonably dangerous and awarded Bartlett $21 million. The Court of Appeals for the First Circuit affirmed. However, because she was given the generic version of the pill instead of the brand version, the Supreme Court took away this award and left Karen Bartlett with no justice for her horrific injuries.
Patients and consumers should be very concerned. If your pharmacy or insurance company decides to provide you with the less expensive generic version of a pill, that could be the difference between being compensated for your injuries and being left to suffer with no remedy. Eighty percent of pharmaceuticals dispensed in this country are generic.
For further information on this story please contact Burg Simpson.