Kelly v. Wyeth

Opposition to drug company’s federal preemption defense in case involving the drug metaclopramide, which was prescribed to the plaintiff in generic form to remedy her so-called “delayed gastric emptying.” When she went off the drug, she experienced severe “akathisia” for over a year – a state of extreme anxiety and restlessness. Her complaint alleges failure to warn in various respects. In its motion to dismiss, the defendant argues that the plaintiff’s failure-to-warn claims are preempted because they conflict with the FDA’s approval of the drug’s warning label. Public Justice and CCL joined the case to assist in briefing and arguing the preemption issue at all stages of the case. Lou Bograd of CCL and Public Justice’s Leslie Brueckner are lead counsel; Jerome F. O’Neill of Burlington, Vermont, Ralph Pittle of Bellevue, Washington, and Hector Pineiro of Worcester, Massachusetts, are plaintiff’s trial counsel.

Case Documents

Decision

U.S. Supreme Court

Plaintiff''s Memorandum

Plaintiff''s Memorandum in Opposition to Defendant's Motion for Summary Judgment. In its motion for summary judgment, defendant Teva Pharmaceuticals USA, Inc., a pharmaceutical company, argued that the plaintiff's failure to warn claims involving a generic version of the drug metoclopramide should be dismissed on the ground that they conflict with the U.S. Food and Drug Administration's approval of the drug's label. In their opposition brief, the plaintiff argued, among other things, that the federal preemption motion must fail because the plaintiff's claims do not conflict with the federal regulatory scheme and that the FDA's recently published regulatory preamble, in which the agency stated its view that common-law failure to warn claims are preempted by federal law, is not entitled to deference.

Massachusetts State Court, Civil Action

Docket: 03-3314-F