In a split decision, the U.S. Supreme Court overturned a huge jury award against a generic drug manufacturer, finding that state laws do not trump federal statutes.
A New Hampshire court awarded Karen Bartlett $21 million in damages after she suffered a disfiguring reaction to sulindac, the generic version of Merck‘s (MRK) Clinoril. Mutual Pharmaceutical, the maker of sulindac, owned by India’s Sun Pharmaceutical, appealed, contending that the drug had received Food and Drug Administration (FDA) approval and that federal law barred such litigation, Reuters notes.
The Obama administration supported the company’s position. Sulindac carried to same warning labels are Clinoril. An earlier Supreme Court ruling affirmed that the manufacturers of brand-name drugs can be sued for deficiencies in warning labels, but not generic manufacturers.
In this case, the court ruled 5-4 in favor of the generic drug-maker.
A consumer advocacy group denounced the decision, noting that it removed any incentive for generic makers to review the safety of their medications.