BioCentury
ARTICLE | Politics & Policy

Supreme Court hears Merck label preemption case

January 7, 2019 10:18 PM UTC

Merck & Co. Inc. (NYSE:MRK) received support during oral arguments Monday from at least four Supreme Court justices regarding its position that FDA’s rejection of a proposed warning about the company’s Fosamax alendronate precludes failure-to-warn suits filed in state courts. Two justices, however, suggested that Merck may have muddied the waters by requesting that FDA approve a scientifically inaccurate warning.

Merck requested in 2008 that FDA add language to Fosamax's label to warn about an increased risk of stress fractures. FDA rejected the request, saying there wasn’t sufficient evidence to support the warning. Later, the agency launched an investigation into the association between Fosamax and fractures, and in 2010 required a warning about atypical femoral fractures...

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