Manufacturers of prescription drugs often claim that they cannot provide a warning label in accordance with state law because the changes would be prohibited by federal law, a defense known as impossibility preemption. Impossibility preemption is a situation where compliance with both federal and state regulations is a physical impossibility for one engaged in interstate commerce.
In Wyeth v. Levine (2009), the U.S. Supreme Court held that drug manufactures who claimed impossibility prevention were required to produce “clear evidence” that the FDA would have prohibited their additional warning as required under state law. This ruling lacked a strong test to determine what “clear evidence” meant, which caused confusion and allowed drug manufacturers to bring forward weaker claims of impossibility preemption.
The Merck Sharp & Dohme Corp. v. Albrecht decision in May of 2019 provides those injured by prescription drugs with much-needed clarity in combatting a claim of impossibility preemption. The Supreme Court stated that “the possibility of impossibility” is not enough, meaning that it is not sufficient to say that it was “possible” that state and federal law were in conflict. Under Merck, drug manufacturers claiming impossibility preemption must now provide clear evidence of an actual conflict between state and federal law that makes it impossible to comply with both.
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