The Justice Department (DOJ) released a statement last Friday, stating that at it has charged ApothéCure Inc., a compounding pharmacy, and Gary D. Osborn, the owner of the Dallas corporation, with two misdemeanor criminal violations of the Federal Food, Drug and Cosmetic Act (FDCA) in connection with an interstate shipment of two lots of colchicine injectable solution. The information claims that the lots were mislabeled, and are believed to be responsible for causing the deaths of three people. The drug at issue, colchicine, is used for gout, both to prevent attacks, and for pain management.
The government’s charges are based on ApothéCure’s February 2007 shipment of 72 vials of compounded colchicine to a medical center in Portland, Oregon.
According to the DOJ's statement, one patient who received colchicine from this shipment, died shortly after an infusion of the medicine from the lot. The medical examiner in the case determined that the cause of death of the patient was multiple organ failure and acute colchicine toxicity.
In separate incidents, the DOJ states, colchicine from ApothéCure was administered to two other patients who were suffering from back pain, and within hours of receiving the colchicine injections, both patients became ill, and after being rushed to hospitals, died soon thereafter. The medical examiner in Oregon determined colchicine toxicity to be the cause of death for both patients.
The FDA tested vials from the two shipments, and discovered that some of the vials were too concentrated, containing 640 percent of the level of colchicine stated on the label. Other vials were determined to be not as concentrated as stated , and contained less than 62 percent of the stated levels.
Assistant Attorney General of the Civil Division of the Department of Justice, Tony West, said in a statement, “The criminal charges we are filing today allege that the drugs mixed by Mr. Osborn’s company were mislabeled which led to the tragic deaths of three people. We can’t allow those who fail to take care that their products are safe to escape accountability, and today's enforcement action demonstrates we won’t.”
In addition to the federal government’s criminal charges, according to the DOJ, Attorneys General have also pursued civil actions in Texas (the state where ApothéCure is located), and Oregon (the state where the colchicine was shipped) against Mr. Osborn and ApothéCure.
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