Federal power expanded in the case of mutual pharmaceutical versus barlett

mut pharm co v bartlett 133 s ct 2466 2013

The plaintiff brought suit in New Hampshire state court, asserting a state law claim for design defect. In finding the claims preempted on that basis, the Court rejected the suggestion that the generic could have complied with both state and federal law simply by choosing not to make the drug at all.

Whether the remaining four will align will be interesting to see.

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In an era of proliferating pharmaceutical litigation, preemption—which can put an early end to a case—is a key defense for drug manufacturers. Mensing and Wyeth v. The U. Supreme] Court—and produced widely divergent view—in recent years.

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While Mensing and Bartlett involved generic drugs, they have become part of the framework for evaluating impossibility preemption in branded cases, where the alleged inadequacies are in the initial product labeling.

Mensing is not limited to failure-to-warn claims, but covers any state-law cause of action that would require a pharmaceutical manufacturer to change its product labeling in a manner inconsistent with federal statutes and regulations.

Her practice focuses on complex commercial litigation, primarily mass torts and product liability actions. Bartlett expanded the reasoning and application of Mensing to design defect claims against generics. In a decision, the Court reversed the First Circuit and held that federal regulation preempts design-defect claims against manufacturers of generic drugs. The U. The company is asserting, however that her suit is barred by federal regulation of generic prescription drugs and, even further, that federal regulation preempts design-defect claims concerning brand-name prescription drugs as well. In the nine years since Levine, the Court has undergone significant change. Email Karen Bartlett was severely injured by the prescription pain reliever Sulindac, which she took in generic form. In our view, In re Fosamax illustrates the need for the Supreme Court to pick up where the Levine, Mensing, and Bartlett trilogy left off. Where the record shows that a branded manufacturer submitted not only a proposed label change but also the underlying data and analysis to the FDA, and the agency rejected that proposal, the manufacturer has satisfied its preemption burden. See 21 U. The manufacturer has two avenues for updating risk information. Fosamax is an osteoporosis drug known as a bisphosphonate that allegedly causes atypical femur fractures.

To view all formatting for this article eg, tables, footnotesplease access the original here. But multiple other scenarios are also in play. Mensing, S. Petition for Writ of Certiorari, Albrecht No.

This includes analyzing whether the FDA has taken specific action with respect to product labeling that may conflict with a state-law duty. Generic drugs gain FDA approval simply by showing equivalence to an already approved brand-name drug. While Mensing and Bartlett involved generic drugs, they have become part of the framework for evaluating impossibility preemption in branded cases, where the alleged inadequacies are in the initial product labeling. Bartlett, U. Mensing, U. Whether the remaining four will align will be interesting to see. The Court could uphold the Third Circuit in its entirety—though this result seems unlikely. The plaintiff brought suit in New Hampshire state court, asserting a state law claim for design defect. Two years later, after reviewing additional data, the agency announced it would require all bisphosphonate manufacturers to warn about atypical femoral fractures. Mensing is not limited to failure-to-warn claims, but covers any state-law cause of action that would require a pharmaceutical manufacturer to change its product labeling in a manner inconsistent with federal statutes and regulations. Bristol-Myers Squibb Co. Mutual Pharmaceutical Co. Specifically, the Court held that state law design defect claims that impose a duty to alter generic drug labeling inconsistent with federal law are preempted under PLIVA, Inc. Because federal law requires that a generic drug have the same chemical composition as its branded equivalent, see 21 U.
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Mutual Pharmaceutical Co. v. Bartlett