US Supreme Court to rule on liability of generic drugmakers

The US Supreme Court on Tuesday heard arguments on whether Americans who suffer side effects caused by generic drugs can hold the drugmaker liable.  This case, Mutual Pharmaceutical v Bartlett, will decide the responsibility generic makers have in the overall design of the drugs they produce. The Court is expected to announce its ruling later this year.

Three lower courts concurred, awarding Karen Bartlett $21 million in damages for her serious injuries caused by the analgesic sulindac, an off-patent NSAID indicated for arthritis marketed by Mutual Pharmaceutical. Mutual argues it is only making a copy of the brand drug, and therefore it has no legal responsibility for its design or safety.

Court decision could undermine FDA’s authority, says GPhA