June 21, 2016: Two Pharmacists Sentenced to Prison for Adulteration of Drugs in Connection with Alabama-Based Compounding Pharmacy
The Department of Justice announced today that two Alabama pharmacists have been sentenced to 12 and 10 months in prison for their roles in the distribution of adulterated drugs, which were compounded at the now-defunct compounding pharmacy Advanced Specialty Pharmacy doing business as Meds IV.
David Allen, 60, of McCalla, Alabama, was the former pharmacist-in-charge of Meds IV, and William Timothy Rogers, 48, of Hoover, Alabama, was the former president of Meds IV. Both men pleaded guilty in March 2016 to two misdemeanor violations of the Federal Food, Drug and Cosmetic Act (FDCA). Allen and Rogers were sentenced to 12 months and 10 months in prison, respectively, by U.S. District Court Judge Virginia Emerson Hopkins for the Northern District of Alabama. Judge Hopkins also sentenced both defendants to one year of supervised release following their imprisonment and a $5,000 fine.
“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.”
“Meds IV provided intravenous nutrition to patients, without taking legally required precautions in the preparation of its product,” said U.S. Attorney Joyce White Vance for the Northern District of Alabama. “As a result, a number of patients developed serious infections. We are committed to prosecuting this type of practice to the fullest extent of the law provides for and protecting the safety of our citizens.”
“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.”
As alleged in the information, 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.
As charged in the information, amino acid used in compounding the TPN was adulterated in that it was contaminated with Serratia marcescens (S. marcescens) and was prepared, packed, or held under insanitary conditions. S. marcescens is a bacteria that can cause bloodstream infections if introduced into the bloodstream through contaminated medications. These infections can cause serious medical complications, including death, because S. marcescens is resistant to many antibiotics.
According to the charging document, the amino acid was prepared by Meds IV outside a laminar airflow workbench and was kept unrefrigerated, in a room that was not sterile, in a large pot sitting on the floor, sometimes overnight, before it was sterilized and used.
As alleged in the information, 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.
According to the information, Meds IV was notified on March 14, 2011, by a hospital in the Birmingham area, that four patients receiving TPN had tested positive for S. marcescens. The information alleged that the TPN was compounded and distributed by Meds IV and that this notification was the first time Meds IV was informed of a link between its TPN and patients testing positive for S. marcescens. The information alleged that on or around March 16, 2011, Meds IV began notifying some customers that compounding of TPN was suspended until further notice.
As noted in the information, 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 charging document, the FDA and CDC investigators linked the S. marcescens to TPN that had been compounded by Meds IV.
As alleged in the information, Allen supervised all compounding at Meds IV, was specifically responsible for reviewing and approving TPN formulations and was also responsible for filling the individual prescriptions Meds IV received for patient-specific TPN products. The information alleged that Rogers was ultimately responsible for overseeing all of the day-to-day operations of Meds IV. Both defendants pleaded guilty to two misdemeanor counts, representing the two lots of amino acid which were determined to be adulterated in violation of the FDCA.
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.
Additional information about the Consumer Protection Branch and its enforcement efforts may be found at http://www.justice.gov/civil/consumer-protection-branch. For more information about the U.S. Attorney’s Office for the Northern District of Alabama, visit its website at https://www.justice.gov/usao-ndal.