Pharmaceutical company Merck has asked the U.S. Supreme Court to remedy what it perceived to be “unduly high hurdles” imposed by courts on pharmaceutical drug manufacturers asserting federal pre-emption in tort cases.

In an opening brief filed on Thursday, Merck counsel Shay Dvoretzky, a Jones Day partner in the Washington, D.C., office, urged the Supreme Court to clarify its holding in Wyeth v. Levine that manufacturers must show “clear evidence” that the U.S. Food and Drug Administration would have rejected certain warning labels in order to assert federal pre-emption. In asking to reverse a 2017 decision by the U.S. Court of Appeals for the Third Circuit that reinstated more than 500 cases over its osteoporosis drug Fosamax, Merck argued that its case, like many others, was a “slam dunk,” because the FDA actually rejected its proposed warnings about the drug’s possible risk of causing bone fractures, specifically of the femur.

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