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Supreme Court Strengthens Generic Liability Shield; FDA Reg Change Could Create Opening

 
• By Brenda Sandburg

The high court rules 5-4 that generic drug makers cannot be sued for alleged design defects based on the adequacy of a drug’s label warnings; FDA continues to discuss revising its regulations to allow generic companies to change their labeling.

The Supreme Court blocked another avenue for product liability litigation against generic drug manufacturers, holding that they cannot be sued for alleged design defect claims “that turn on the adequacy of a drug’s warnings.”

The decision means that plaintiffs will have a tough time bringing any personal injury suits against generic drug makers. That...

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