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Product Liability Returning To Supreme Court With Government, Former FDA Officials On Opposite Sides

 
• By Brenda Sandburg

US government supports Merck, saying FDA labeling decision preempts Fosamax failure-to-warn claim. Joshua Sharfstein and two other former FDAers argue Merck sought warning on a lesser injury.

Supreme Court long shot

In a case that could limit drug product liability litigation, the US Supreme Court is to decide whether FDA rejection of a manufacturer's proposed label warning preempts claims under state law that the manufacturer failed to adequately warn of the product's risks.

The court is to hear oral argument in the case, Merck Sharp & Dohme Corp. v. Albrecht, Jan. 7. Merck & Co. Inc. is challenging a decision by the US Court of Appeals for the Third Circuit that revived hundreds of complaints in multidistrict litigation alleging the company did not provide sufficient warning of the risk of femur fractures with use of its osteoporosis drug Fosamax (alendronate). At issue is the interpretation of the Supreme Court's landmark 2009 Wyeth v

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