Showing 1 post by Mitchell P. Morinec.
LIFE SCIENCES CLIENT ALERT: United States Supreme Court holds that the judge, not the jury, makes pre-emption determination in failure-to-warn pharmaceutical cases.
It is the role of the district judge—not the jury—to determine if the FDA would have approved a drug’s warning label that state law requires when deciding whether a failure-to-warn claim is pre-empted, the United States Supreme Court held on Monday. The unanimous decision provides clarity to the high court’s “clear evidence” standard it introduced over a decade ago in Wyeth v. Levine, and resolves a split between the circuit courts in how to apply the standard. More »
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