Another victory over drugmakers' FDA preemption argument.

The Center for Constitutional Litigation (CCL) has achieved another victory against arguments that FDA labeling regulations preempt state failure-to-warn claims. (Kelly v. Wyeth, 2007 WL 1302589 (Mass. Super. Apr. 12, 2007) .)

The April ruling in Massachusetts was the first decision to reject a claim of preemption by a generic drug manufacturer after the adverse ruling in Colacicco v. Apotex, Inc. In that case, a Pennsylvania district court held that the FDA's preemption pronouncements were entitled to judicial deference and that a failure-to-warn claim involving a generic prescription drug was impliedly preempted. (432 F. Supp. 2d 514 (E.D. Pa. 2006).)

Janet Kelly's gastroenterologist prescribed Reglan (metoclopramide) to treat her delayed gastric emptying. After taking a generic version of the drug, manufactured by Teva Pharmaceuticals, Kelly experienced depression and akathisia, a profound motor restlessness. She sued, alleging that the warning label on metoclopramide dramatically understated the risks of akathisia and other symptoms relating to the part of the nervous system that regulates muscle reflexes.

Teva moved for summary judgment and argued that, as a generic manufacturer, it was not free to alter its drug labeling, the position asserted by the Bush FDA and adopted by the court in Colacicco.

At CCL's urging, the Kelly court rejected this reasoning. The court was persuaded by the analysis found in dicta in a 1994 Fourth Circuit decision, Foster v. American Home Products Corp.: "When a generic manufacturer adopts a name-brand manufacturer's warnings and representations without independent investigation, it does so at the risk that such warnings and representations may be flawed. Manufacturers of generic drugs, like all other manufacturers, are responsible for the representations they make regarding their products." (29 F.3d 165, 170 (4th Cir. 1994) (emphasis added).)

The Massachusetts court then went further: "Even if the court were to assume that Teva could not unilaterally make changes to its label ..., Teva still had the option and the obligation to apply [to the FDA] for a labeling change," a step that the generic manufacturer had declined to take. Because the FDA had never been asked to consider whether the warnings on metoclopramide regarding akathisia ought to be strengthened, there could be "no conflict between state and federal law, and preemption does not apply."

Kelly and a similar ruling against Teva in the Southern District of Alabama, Barnhill v. Teva Pharmaceuticals USA (No. 06-0282-CB-M (S.D. Ala. Apr. 24, 2007)), should go a long way toward defeating the efforts of drug companies to rely on the poorly reasoned Colacicco decision to escape liability for their failures to warn. And it represents another strike against the Bush FDA's attempt to use federal preemption to undermine state tort remedies for people injured by drug company misconduct.

Kelly was argued by CCL Senior Litigation Counsel Louis Bograd. CCL's cocounsel in Kelly are Hector Pineiro and Robert Beadel of the Law Offices of Hector Pineiro in Worcester, Massachusetts; Ralph Pittle of Medico Legal Consultants in Bellevue, Washington; and Leslie Brueckner of Public Justice in San Francisco.

The court's order in Kelly and the plaintiff's memorandum opposing summary judgment are available at www.publicjustice.net. Click on "Briefs and Documents," and scroll down to the list below "Consumer and Victim's Rights."