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Will the Supreme Court Reverse Wyeth v. Levine?

December 2020 - Drug & Device Law Blog
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In the last few weeks, there has been much speculation about whether Justice Amy Coney Barrett’s elevation to the Supreme Court would result in the elimination of the Affordable Care Act or lead to a reversal of Roe v. Wade, 410 U.S. 113, 93 S. Ct. 705 (1973). But in our sandbox, a big question is whether her addition to the court will lead to a reversal of Wyeth v. Levine, 555 U.S. 555 (2009) (finding that a jury can second guess whether an FDA-approved label is adequate) (“Levine”). It should first be noted that there is little left of this decision given the fact that courts now determine the “newly acquired information” and “clear evidence” issues as a matter of law. But under Levine a jury still decides adequacy if there are any open issues after the aforementioned legal issues are adjudicated.

Read the blog post here.

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