Two Alabama pharmacists have agreed to plead guilty to criminal charges in connection with the 2011 deaths of nine Birmingham-area patients who allegedly received a contaminated intravenous drug.
David Allen, former pharmacist-in-charge of Meds IV, and William Timothy Rogers, a pharmacist and former president of Meds IV, have agreed to plead guilty to two misdemeanor violations of the federal Food, Drug and Cosmetic Act, according to the U.S. Justice Department.
“It's certainly an incredibly tragic event for the victims of what happened here,” said Tommy Spina, an attorney for Rogers. He noted that his client's guilty plea will be to what's considered a strict liability offense, meaning his actions were not intentional.
Attempts to reach Allen's lawyer for comment were not immediately successful Thursday afternoon.
According to federal prosecutors, the nine patients died after they developed bloodstream infections caused by bacteria within an intravenous drug known as total parenteral nutrition (TPN). The pharmacists worked for the now-defunct compounding pharmacy Advanced Specialty Pharmacy, doing business as Meds IV, which compounded the drug using its own amino acid solution.
According to federal prosecutors, the amino acid may have been contaminated from being prepared, packed or held in unsanitary conditions. The amino acid was allegedly prepared outside a workbench meant to prevent contamination, and kept unrefrigerated in a room that wasn't sterile, in a large pot sitting on the floor before it was sterilized and used.
The nine patients had underlying medical conditions that may have contributed to their deaths, but some of the patients' medical records suggested the bacteria within the contaminated drug may also have been a significant factor, according to the government.
During a later inspection of Meds IV, investigators from the Centers for Disease Control and Prevention found the same bacteria on a water faucet in an open container of amino acid powder, and on the surface of mixing equipment that had been used to make the drug, according to federal prosecutors.
Allen allegedly supervised all compounding at Meds IV and was responsible for reviewing and approving TPN formulations, and Rogers allegedly was responsible for overseeing all of the compounder's daily operations.
Allen and Rogers have each agreed to plead guilty to two misdemeanor counts. For each count they face a maximum of one year in prison and a fine of up to $250,000, or both.
The safety of compounded drugs has been in the spotlight in recent years after an outbreak of fungal meningitis that led to 64 deaths. That outbreak was linked to a Massachusetts compounding pharmacy. In response, HHS' Office of Inspector General released a study (PDF) last year that found significant gaps in ensuring the safety of compounded drugs administered in hospitals.