Two former Jefferson County pharmacists were sentenced to federal prison – one to 12 months and the other 10 months – for their roles in the distribution of tainted drugs in 2011 that authorities say contributed to the deaths of nine patients at various Birmingham-area hospitals who developed bloodstream infections.
The two men had been charged and pleaded guilty to misdemeanor violations of the Federal Food, Drug and Cosmetic Act (FDCA), according to a statement from the U.S. Department of Justice Tuesday.
David Allen, 60, of McCalla, Alabama, was the former pharmacist-in-charge at the now-shuttered Advanced Specialty Pharmacy, doing business as Meds IV, was sentenced to 12 months in prison. Timothy Rogers, 48, of Hoover, Alabama, was the former president of Meds IV, was sentenced to 10 months in prison by U.S. District Court Judge Virginia Hopkins.
Hopkins also sentenced both defendants to one year of supervised release following their imprisonment and a $5,000 fine, according to the press release from the DOJ.
According to the DOJ statement:
Meds IV compounded various drugs for human use, including an intravenous drug known as Total Parenteral Nutrition (TPN). TPN is liquid nutrition administered intravenously to patients who cannot or should not receive their nutrition through eating. The information alleged that beginning in or around February 2011, Meds IV compounded its own amino acid solution, which it then mixed with other ingredients to form TPN.
However, the amino acid used in compounding the TPN was contaminated with bacteria, Serratia marcescens (S. marcescens), afrer it was prepared, packed, or held under insanitary conditions, according to the federal authorities’ statement.
As alleged in the charges against Allen and Rogers, between March 5 and 15, 2011, nine patients at various Birmingham-area hospitals who developed bloodstream infections caused by S. marcescens died, and several other hospital patients developed S. marcescens bloodstream infections but survived.
According to the charges, all of these patients had been given TPN that was compounded and distributed by Meds IV. As alleged in the information, while a number of the patients who died had underlying conditions which may have contributed to their deaths, medical records of some patients suggest that the S. marcescens bloodstream infections were also a significant factor.
During an inspection at Meds IV starting on March 22, 2011, investigators from the U.S. Centers for Disease Control and Prevention (CDC) found S. marcescens that was indistinguishable from the outbreak strain on a tap-water faucet, in an open container of amino acid powder, and on the surface of mixing equipment that had been used to make TPN, according to the DOJ statement. The FDA and CDC investigators linked the S. marcescens to TPN that had been compounded by Meds IV.
Officials with the DOJ, U.S. Attorney’s Office and the FDA’s Office of Criminal Investigations issued statements after the sentencings.
“Compounding pharmacies are entrusted with protecting the public’s health from any harm their drugs may impose and must comply with the law,” said Principal Deputy Assistant Attorney General Benjamin C. Mizer, head of the Justice Department’s Civil Division. “These cases demonstrate that the Department of Justice will continue to work aggressively with the U.S. Food and Drug Administration (FDA) to protect consumers from drugs compounded under insanitary conditions.”
U.S. Attorney Joyce White Vance for the Northern District of Alabama stated that: “Meds IV provided intravenous nutrition to patients, without taking legally required precautions in the preparation of its product.”
“Producing unsafe and contaminated drugs poses a serious threat to the U.S. public health and cannot be tolerated,” said Director George Karavetsos of the FDA’s Office of Criminal Investigations. “The FDA remains fully committed to aggressively pursuing those who place unsuspecting American consumers at risk by distributing adulterated drugs.”
The case was prosecuted by Trial Attorney Heide L. Herrmann of the Justice Department’s Consumer Protection Branch and Assistant U.S. Attorney Henry Cornelius of the Northern District of Alabama. They were assisted by Associate Chief Counsel Shannon M. Singleton of the Food and Drug Division, Office of General Counsel, Department of Health and Human Services. The case was investigated by the FDA’s Office of Criminal Investigations.