GlaxoSmithKline paid a $3 billion settlement in 2012 over unlawful marketing, including promoting drugs for unapproved uses.
The July 2012 resolution covered both criminal and civil allegations and was the largest healthcare fraud settlement in U.S. history at the time. GSK agreed to plead guilty to criminal charges involving the misbranding of Paxil and Wellbutrin and failure to report safety data about the diabetes drug Avandia.
The civil portion also addressed alleged off-label promotion of Paxil, Wellbutrin, Advair, Lamictal, and Zofran, along with alleged kickbacks to doctors, misleading safety statements, and inaccurate Medicaid price reporting. “Off-label” does not automatically mean a drug is ineffective; it means the use was not approved by the FDA for that indication, population, or circumstance. The legal issue was the company’s marketing conduct.
The $3 billion figure combined $1 billion in criminal fines and forfeitures with $2 billion in civil payments. The case is often confused with later pharmaceutical settlements involving other companies, but this landmark 2012 resolution was GSK’s.