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Merck disappoints pharmaceutical industry in the Supreme Court

May 22, 2019

Merck manufactures a drug called Fosamax that treats and prevents osteoporosis. In addition, however, Fosamax increases a user’s chance of getting a certain type of bone fracture — an atypical femoral fracture.

The connection wasn’t proven at the time Merck originally got FDA approval, so the original drug warning label didn’t mention it. The evidence had become more clear by 2008, and Merck applied to the FDA to add a warning about stress fractures, but the FDA rejected the request. The FDA decided the discussion of stress fractures didn’t match the fractures established in the literature.

In 2010, Merck got sued. Over 500 Fosamax users had developed atypical femoral fractures. The plaintiffs claimed Merck’s failure to mention atypical femoral fractures on the Fosamax warning label violated state laws. Merck said, actually, we tried to add a warning back in 2008 and the FDA rejected it. The FDA wouldn’t have allowed the label you are seeking.

On May 20, 2019 the Supreme Court clarified how a drug manufacturer can prove FDA labeling actions prevent the manufacturer from complying with state law warning requirements. Drug manufacturers were hopeful that the new conservative-leaning Court would relax the standard. But it didn’t. Both Gorsuch and Thomas joined the opinion written by Breyer (along with the more expected Ginsburg, Kagan and Sotomayor).


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