Gary D. Osborn, Misbranded Drug Shipment, Texas 2012

A Dallas compounding pharmacy owner has pleaded guilty to his role in a shipment of misbranded colchicine injectable solution that led to the deaths of three people in the Pacific Northwest.

Gary D. Osborn and his corporation, ApothéCure Inc., pleaded guilty to two misdemeanor criminal violations of the Food, Drug and Cosmetic Act (FDCA) in the U.S. District Court for the Northern District of Texas on February 2007, in connection with a shipment of two lots of misbranded colchicine.

The government’s charges were based on ApothéCure’s February 2007 shipment of 72 vials of compounded colchicine to a now-defunct medical center in Portland, Ore. On March 19, 2007, a patient in Yakima, Wash., who received colchicine from this shipment, died after receiving the infusion. The medical examiner determined that the cause of death was multiple organ failure and acute colchicine toxicity.

On March 30, 2007, colchicine from ApothéCure was administered to two other patients who were suffering from back pain. Within hours of receiving the colchicine injections, both patients became seriously ill, were taken to local hospitals, and died shortly thereafter. The medical examiner in Oregon determined colchicine toxicity to be the cause of death for both patients.

‘This plea shows that the government will enforce the Food, Drug and Cosmetic Act against responsible corporate officers of companies that fail to control the quality of their products,’ said Acting Assistant Attorney General Stuart F. Delery. ‘The drugs mixed by Mr. Osborn’s company were not merely misbranded, but lethal. Drug makers of all sizes, from large corporations to small compounding pharmacies, have a duty to ensure their products are safe.'

ApothéCure, a compounding pharmacy in Dallas, creates particular pharmaceutical products to fit the unique needs of patients by combining appropriate ingredients. Colchicine is used to prevent gout attacks in adults, and to relieve the pain of gout attacks when they occur.

Sentencing is scheduled for July 27, 2012.

Source: https://www.justice.gov/archives/opa/pr/dallas-compounding-pharmacy-owner-pleads-guilty-connection-misbranded-drug-shipment