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Eighth Circuit Permits Design Defect Claim Against Reglan® Generics To Proceed

On Monday, the United States Court of Appeals for the Eighth Circuit reopened a personal injury lawsuit against Pliva Inc. and Mutual Pharmaceutical Co., manufacturers of generic Reglan®. In the lawsuit, Joyce Fullerton claims that she developed a neurological disorder involving involuntary movements from a generic form of Reglan®. Her complaint is one of hundreds brought by individuals, who claim to have developed a movement disorder from Reglan® or its generic equivalent, metoclopramide.

The lower court had dismissed Fullerton’s complaint, based on recent Supreme Court decisions, which hold that federal law preempts design defect and failure to warn claims against generic drug manufacturers. Specifically, in Pliva Inc. v. Mensing, the Supreme Court held that failure to warn claims cannot be maintained against generic drugmakers, which are required by federal law to copy the labels of their brand-name counterparts. In Mutual Pharmaceutical v. Bartlett, the Supreme Court extended its holding to prohibit design defect claims against generic drugmakers, on the grounds that they are required to copy the brand name’s chemical makeup.

Notwithstanding these Supreme Court decisions, the Eighth Circuit remanded Fullerton’s case to the lower court. It reasoned that the Bartlett holding was premised on New Hampshire law. On remand, the lower court must consider whether design defect claims under Arkansas law are similarly barred. By passing judgment on the breadth of the Bartlett holding, the lower court’s decision will likely impact plaintiffs’ ability to sue generic drugmakers in the future.


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