FDA Sued Over Refusal to Accept Imports of Lethal Injection Drug

The FDA unlawfully delayed the admission of the drug thiopental sodium, a general anesthetic used to impose capital sentences through lethal injection, the Texas Department of Criminal Justice contends.

The one-count lawsuit alleges that, in July 2015, FDA tentatively detained a shipment of 1,000 thiopental sodium vials on three invalid legal grounds — the imported drug had inadequate directions, insufficient warnings, and no new drug application to warrant its market introduction. 

Those legal requirements did not apply to the imported drugs used by law enforcement for capital punishment. Label warnings and comprehensive directions are required for treatment therapies, the lawsuit states.