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Does FDA Rejection Of Label Warning Shield Manufacturers From Tort Suits?

 
• By Brenda Sandburg

US Supreme Court asks Solicitor General to weigh in on Merck petition requesting clarification of its Wyeth v. Levine ruling; Third Circuit says decision is 'cryptic and open-ended.'

US Supreme court building with 1st statue on left

The US Supreme Court could revisit its landmark ruling in Wyeth v. Levine that FDA-approved labeling does not block individuals from filing personal injury suits against pharma companies under state law. Merck has asked the court to specify that a drug manufacturer cannot be subject to failure-to-warn claims about a risk associated with its product if it informs FDA about the risk and the agency rejects adding it to the drug's label.

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