Regulatory Guidance

Supreme Court sides with Merck in landmark decision

May 20, 2019

The U.S. Supreme Court gave Merck & Co. a major victory in a case that could be a milestone for further product liability claims. 

On Monday, the justices unanimously agreed to toss out a verdict against the drugmaker by a lower court that signaled the company failed to adequately warn patients about risks associated with its osteoporosis drug, Fosamax.  

In 2008, Merck in fact submitted data to the FDA showing that Fosamax could increase the risk of fractures in the thigh bone or below the hip joint. At the time the agency decided that the risk did not warrant a warning label — but then changed its decision in 2010 and asked Merck to include it, which the company did.  

Plaintiffs in the case argued that the FDA only rejected Merck’s warning label language — not the warning itself, and that the drugmaker had a responsibility to include it. A Philadelphia-based circuit court showed its support for the plaintiffs and said the case could proceed to trial. 

But because the original decision regarding the warning label involved a federal agency, Merck argued that it is preempted by federal law and the U.S. Constitution. The Supreme Court agreed, setting a precedent for whether or not pharma companies are liable for FDA-related decisions under state versus federal law. 

Merck argued to the court that, “If manufacturers must face tort suits even when the FDA has made clear that no warning is necessary, they will continue to face an onslaught of troubling, coercive litigation.” 

The Philadelphia-based circuit court will now have to reconsider the case using the Supreme Court’s decision as guidance. 

Read the full Reuters report.