American Journal of Law & Medicine

Products liability: genuine issue of material fact over whether understating risk of side effects renders pharmaceutical drug labels misleading and ineffective.

Products Liability: Genuine Issue of Material Fact Over Whether Understating Risk of Side Effects Renders Pharmaceutical Drug Labels Misleading and Ineffective--McNeil v. Wyeth (1)--462 F.3d 364 (5th Cir. 2006).

The United States Court of Appeals for the Fifth Circuit recently held that a genuine issue of material fact existed as to whether a drug manufacturer's warning of a much lower risk than the actual risk of developing a side effect with long-term use of a drug renders the warning misleading and ineffective. (2)

Plaintiff Sue McNeil appealed a decision by the United States District Court for the Northern District of Texas granting summary judgment in favor of Defendant Wyeth, Inc., a pharmaceutical drug manufacturer. (3) McNeil claimed that Wyeth did not adequately warn physicians and consumers of the increased risk of tardive dyskinesia ("TD"), a severe neurological disorder, associated with long-term use of Reglan, a Wyeth-manufactured drug used to treat gastroesophageal reflux disease ("GERD"). (4) The district court found that the label was legally adequate because it mentioned the risk of the side effects complained of on the packaging, and therefore dismissed McNeil's complaint on the grounds that no evidence could support a reasonable finding in McNeil's favor. (5) The United States Court of Appeals for the Fifth Circuit reversed on several different grounds. (6) On the issue of whether the label was clearly misleading, the court held that there were enough arguments on either side that the issue could not clearly be decided in favor of Wyeth, thus finding that summary judgment was inappropriate and the issue should be decided by a judge or jury. …

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