Justia U.S. 6th Circuit Court of Appeals Opinion Summaries

The plaintiffs allege that they ingested metoclopramide, the generic equivalent of the prescription drug Reglan, and, as a result, developed a serious neurological disorder, tardive dyskinesia. The labeling for the drugs recommends short-term use for heartburn and acute and recurrent bloating: up to 12 weeks in adults for heartburn. Reglan and metoclopramide have not been shown to be either efficacious or safe for long-term treatment; the drugs affect the brain’s movement center, typically causing involuntary, repetitive movements. Overuse can result in symptoms including tardive dyskinesia, dystonia, and akathisia, Parkinsonism, and Reglan-induced tremors. Reglan and metoclopramide have also been associated with central nervous system disorders, depression with suicidal ideation, visual disturbances, and other problems. The plaintiffs sued both the generic and brand-name manufacturers, alleging various product-liability claims. The district court dismissed, finding the metoclopramide claims preempted by the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 301-399f, and that the brand-name manufacturers are not liable because none of the plaintiffs ingested Reglan. The Sixth Circuit affirmed and denied the plaintiffs’ motion to certify a proposed question to the Tennessee Supreme Court. View "Speed v. Wyeth Pharm., Inc." on Justia Law