Supreme Court unanimously blocks, for now, a class-action lawsuit against pharmaceutical giant Merck over 'atypical femoral fractures' caused by osteoporosis drug Fosamax.
A unanimous Supreme Court has blocked, for now, a class-action lawsuit against pharmaceutical giant Merck over"atypical femoral fractures" caused by osteoporosis drug Fosamax.
Merck, which does not dispute the risk and has included a warning with prescriptions since 2010, argued it cannot be held liable for damages in state courts because the Food and Drug Administration in 2009 rejected a proposed warning to patients. "For that reason, we have previously held that 'clear evidence' that the FDA would not have approved a change to the drug's label preempts a claim, grounded in state law, that a drug manufacturer failed to warn consumers of the change-related risks associated with using the drug," he wrote.The justices clarified that it should be left to a judge, not a jury, to decide the preemption question in class-action drug-harm suits, as occurred in this case.
Manufacturers are required by law to inform patients of potential adverse reactions to their drugs as soon as reasonable evidence exists. But the FDA has ultimate authority to approve or reject the wording that appears on drug labels.
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