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www.fdanews.com/articles/186977-administration-urges-scotus-to-review-merck-case-over-failure-to-warn-claims
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Administration Urges SCOTUS to Review Merck Case Over Failure-to-Warn Claims

May 25, 2018

The Trump administration is urging the Supreme Court to take up a case testing whether the FDA’s refusal to approve a warning label on drugs preempts state laws that may require such labels.

In an amicus brief, U.S. Solicitor General Noel Francisco acknowledges that the questions raised by litigation over Merck’s osteoporosis drug Fosamax are “on balance” worth the court’s time.

The administration’s brief is an incremental victory for Merck, which is appealing a 3rd Circuit Court of Appeals decision that reinstated a class-action lawsuit alleging that Merck failed to warn thousands of women taking Fosamax that they were at risk for thigh fractures.

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