This case arose when the First Circuit upheld a strict-liability verdict premised on the finding that a generic version of sulindac was unreasonably dangerous.
Source/Credit: SCOTUS Blog
By Ronald Mann | July 1st, 2013
The smoke finally cleared last Monday in Mutual Pharmaceutical Co. v. Bartlett, and the message is that the Justices saw this case as essentially a replay of last year’s decision in PLIVA, Inc. v. Mensing: All five of the Justices in the PLIVA majority held for the manufacturer here, and the four PLIVA dissenters would have held for the plaintiff.
Bartlett is the third case in the last five Terms on the question of FDA pre-emption of state torts related to pharmaceutical labels. First, in 2009 in Wyeth v. Levine, the Court held that a failure-to-warn claim related to a branded pharmaceutical was not pre-empted. Last year, the Court held in PLIVA, Inc. v. Mensing that a negligence claim for failure to warn by a generic manufacturer was pre-empted. The distinction on which those cases turn was the freedom to make changes to the product’s label: available under federal law to the branded manufacturer in Wyeth, but denied to the generic manufacturer in PLIVA. Because federal law denied the generic manufacturer in PLIVA discretion to use a different label, the Court could not tolerate a state-tort action premised on the poor quality of that label.
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