US Supreme Court Tosses Ruling Against Merck on Fosamax Osteoporosis Drug



Category: Fosamax

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The U.S. Supreme Court on Monday handed a victory to Merck & Co – at least for now – by throwing out a lower court ruling that had revived hundreds of lawsuits accusing the company of failing to properly warn patients of debilitating thigh-bone fractures from taking its osteoporosis drug Fosamax.

The nine justices unanimously directed the Philadelphia-based 3rd U.S. Circuit Court of Appeals to reconsider its decision allowing the lawsuits to proceed even though federal regulators had rebuffed Merck when the company sought to add a warning to Fosamax’s label about the fracture risk.

The decision added clarity to a defense used by drug makers against product liability claims in which they argue that such litigation is preempted under federal law and the U.S. Constitution when a federal agency takes certain actions, as the Food and Drug Administration did in this case.

In a decision written by Justice Stephen Breyer, the court said that judges, not juries, must decide disputes over preemption, and that a drug manufacturer must show that it “fully informed” the FDA of the need for a warning before it was rebuffed. Lower courts now must revisit the case reflecting the Supreme Court’s guidance.

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See the original article here: https://www.claimsjournal.com/news/national/2019/05/20/291007.htm


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