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From Products Liability Law Daily, June 26, 2013

Patient’s claim that generic drug maker was liable for failing to communicate a change drug’s label was preempted by federal law

By Sarah E. Baumann, J.D.

A patient could not proceed with claims against a generic drug manufacturer for failure to adequately communicate important label changes to medical providers because they were preempted by federal law (Guarino v Wyeth, LLC, June 25, 2013, Wilson, T). Andrea Guarino’s (Guarino) claims were essentially failure-to-warn claims that were explicitly preempted by federal law requiring that generic drug labels be the same as brand-name drug labels. As a result, the Eleventh Circuit upheld a federal district court’s dismissal of the patient’s claim against the generic drug manufacturer. It also granted the brand name manufacturers’ motion for summary judgment because Guarino had never used the brand name drug.

Background. Guarino took metoclopramide, a generic prescription drug used to treat symptomatic gastroesophageal reflux and recurrent diabetic gastric stasis, for more than twelve weeks in 2007. As a result, she allegedly developed tardive dyskinesia, a neurological disorder. In 2004, the FDA had required that the label explicitly provide that therapy should not exceed twelve weeks. In 2009, after Guarino had consumed the drug, the FDA required the drug to carry a black box warning, the strongest warning available, to the same effect.

Guarino sued the generic manufacturer, Teva Pharmaceuticals, USA, Inc. (Teva), as well as the manufacturers of the brand name drug, Reglan®, Wyeth, LLC and Schwarz Pharma, Inc. (the Brand Manufacturers). The district court dismissed the case against Teva after the U.S. Supreme Court issued its decision in Pliva v Mensing (131 S.Ct. 2567 (2011)), holding that failure-to-warn lawsuits against generic manufacturers were preempted by federal law. It granted the Brand Manufacturers’ motion for summary judgment because Guarino never used Reglan. Guarino appealed.

Analysis. In Mensing, the U.S. Supreme Court held that, because the Federal Food, Drug, and Cosmetic Act required generic drug labels to be the same as brand name labels, generic manufacturers could not change their labels on their own without violating federal law. As a result, failure-to-warn lawsuits against generic manufacturers were prohibited by preemption. Guarino’s claims, premised upon inadequate warnings, were, thus, preempted. Her modified argument that Teva failed to adequately communicate the label change to consumers was still essentially a failure-to-warn claim preempted by Mensing, as generic manufacturers could not provide additional warning information to consumers unless the Brand Manufacturers had done so or they had been directed to by the FDA.

Had the claims not been preempted, they would have failed because Florida subscribes to the learned intermediary doctrine, which holds that manufacturers are responsible for notifying physicians of product risks, since physicians are in the best position to explain risks to consumers. Guarino did not allege that Teva failed to include the 2004 label change, but instead argued that it should have taken additional actions to warn consumers. Teva thus complied with Florida law by adequately warning physicians of the risks of long-term use. As a result, the Eleventh Circuit upheld the grant of summary judgment as to the Brand Manufacturers.

The case number is 12-13263.

Attorneys: David Joseph Sales (David J. Sales, PA), Brent R. Bigger (Abrahamson & Uiterwyk), and Daniel J. McGlynn (McGlynn Glisson Mouton) for Andrea Guarino. Kevin Christopher Newsom (Bradley Arant Boult Cummings, LLP), Kannon K. Shanmugam (Williams & Connolly, LLP), and Hildy M. Sastre (Shook Hardy & Bacon, LLP) for Wyeth, LLC. Henninger Bullock (Mayer Brown, LLP) and Brian Oltchick (Garrison Yount Forte Mulcahy and Lehner LLC) for Schwarz Pharma, Inc. David C. Banker (Bush Ross, PA), Richard A. Oetheimer (Goodwin Procter, LLP), and Jay P. Lefkowitz (Kirkland & Ellis, LLP) for Teva Pharmaceuticals USA, Inc.

Companies: Wyeth, LLC, Schwarz Pharma, Inc., and Teva Pharmaceuticals USA, Inc.

MainStory: TopStory PreemptionNews WarningsNews DrugsNews AlabamaNews FloridaNews GeorgiaNews

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