Federal complaint alleging false claims and quality‑assurance violations by GlaxoSmithKline's drug manufacturing operations.
The document is a third amended complaint and jury demand filed in the United States District Court for the District of Massachusetts. It alleges that GlaxoSmithKline (formerly SmithKlineBeecham) submitted false claims for payment to the U.S. government and state Medicaid programs for defective or misidentified pharmaceutical products.
The complaint details numerous quality‑assurance failures at GSK's Cidra, Puerto Rico plant, including product mix‑ups, contamination, and inadequate process validation, and cites violations of the Federal False Claims Act and related state statutes.
The complaint lists drugs such as Paxil, Paxil CR, Avandia, Avandamet, Coreg, Bactroban, Abreva, Cimetidine, Compazine, Denavir, Dyazide, Thorazine, Stelazine, Ecotrin, Tagamet, Relafen, Kytril, Factive, Dyrenium and Albenza.