The Supreme Court has agreed that it will hear a case regarding whether a generic drug maker can be held liable in product-liability lawsuit claiming a design defect.
The hearing follows a federal court’s upholding of a $21 million award to Karen Bartlett, a New Hampshire woman who took a generic anti-inflammatory drug, sulindac, after her doctor prescribed it for shoulder pain. Doctors diagnosed a rare hypersensitivity reaction associated with the drug that developed three weeks after Ms. Bartlett started taking it. Her skin began to peel off, leaving her with burn-like lesions over two-thirds of her body. She spent close to two months in a hospital burn unit, some of that time in a medically induced coma, and has since undergone 13 eye surgeries. The reaction, a severe form of Stevens-Johnson Syndrome, left Ms. Bartlett legally blind, with scarred lungs, and a constricted esophagus that makes it difficult to swallow.
The Food and Drug Administration (FDA) is the federal agency that regulates whether a pharmaceutical can be released to the general public. Often with product-liability lawsuits involving pharmaceutical drugs, the courts have deferred to the FDA decision to allow the drugs to be released to the public and have limited awards to persons who have been injured by those drugs. Mutual Pharmaceuticals, the manufacturer of the generic drug taken by Ms. Bartlett, argues that because the FDA requires that generic drug manufacturers to mimic the design and labeling of the non-generic counterpart of a drug.
The Supreme Court recently held that generic drug manufacturers are not liable for improper labeling and warning on a drug. If the Supreme Court rules in favor of Mutual Pharmaceuticals, it will make it virtually impossible to hold a generic drug manufacturer liable for injuries caused by their products.