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Analysis

Justices Lay Out Failure To Warn 'Clear Evidence' Standard

Law360 (May 21, 2019, 4:13 PM EDT) -- The U.S. Supreme Court’s decision this week that it’s up to a judge —not a jury — to decide if consumers' claims are barred by federal regulations when the U.S. Food and Drug Administration rejects a proposed labeling change has also provided some clarity for the "clear evidence" standard it set out for failure-to-warn cases a decade ago.

In a case over the fracture risks in Merck’s osteoporosis drug Fosamax, the court unanimously found that “clear evidence” means there’s evidence showing a drugmaker fully informed the FDA of the reasons for the label change and the FDA in turn rejected the...

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