Kirkland & Ellis LLP achieved a significant victory today for client Teva Pharmaceuticals when the U.S. Supreme Court ruled that federal law preempts state-law tort claims against manufacturers of generic drugs.
"The Supreme Court hit the nail on the head today by making clear that federal law does not permit states to hold generic drug manufacturers liable for using the very warnings federal law required them to use," said Kirkland partner Jay Lefkowitz, who argued the case before the Supreme Court.
The plaintiffs alleged that they were injured when they took generic versions of the brand-name drug Reglan (metoclopramide), and later filed state-law failure-to-warn claims against several manufacturers of those products, including Teva.
The generic manufacturers asserted that the plaintiffs' claims were preempted by the federal statutory scheme, because federal law precludes generic manufacturers from deviating from the brand manufacturer's FDA-approved product warnings. Nonetheless, virtually every lower court that considered these issues had ruled that plaintiffs' state-law claims could proceed because the defendants at least could have asked the FDA to approve changes to the product warnings.
The Supreme Court flatly rejected that theory, declaring that "the only action the Manufacturers could independently take - asking for the FDA's help - is not a matter of state-law concern."
Kirkland partners Michael Shumsky, Philippa Scarlett, Susan Engel and John O'Quinn, and associates Aaron Nielson and Katie Einspanier, assisted with the briefing and argument preparation.
Kirkland & Ellis LLP (www.kirkland.com) is a 1,500-attorney law firm representing global clients in complex litigation and dispute resolution/arbitration, corporate, restructuring, tax, and intellectual property and technology matters. The Firm has offices in Chicago, Hong Kong, London, Los Angeles, Munich, New York, Palo Alto, San Francisco, Shanghai and Washington, D.C.