Yesterday the Department of Justice filed criminal Information in the U.S. District Court for the Northern District of Alabama against David Allen, pharmacist-in-charge of compounding pharmacy Advanced Specialty Pharmacy doing business as “Meds IV,” and William Timothy Rogers, pharmacist and president of the now-defunct pharmacy. Both pharmacists have signed plea agreements, in which both individuals have agreed to plead guilty to two misdemeanor violations of the federal Food, Drug and Cosmetic Act (FDCA) as charged in the Information.
Meds IV compounded intravenous drugs for human use, including Total Parenteral Nutrition (“TPN”), an IV solution administered to patients who cannot receive nutrition through eating. The Information alleges the pharmacy 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 the following ways: it consisted in whole or in part of a filthy, putrid, or decomposed substance, namely Serratia marcescens (S. marcescens) and it was prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth or rendered injurious to health. S. marcescens is gram-negative 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.
Between March 5 and 15, 2011, nine patients at Birmingham area hospitals died from blood infections caused by S. marcescens, and several other patients developed S. marcescens bloodstream infections but survived. Meds IV was first notified that patients receiving TPN tested posted for S. marcescens on March 4, 2011 and began notifying some customers that the compounding of TPN was suspended around March 16. 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.
Investigators from the U.S. Centers for Disease Control and Prevention (“CDC”) found S. marcescens that was indistinguishable to 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 U.S. Food and Drug Administration (“FDA”) and CDC investigators linked the S. marcescens to TPN that had been compounded by Meds IV.
“The compounding of sterile drug products requires significant care, and the distribution of contaminated drug products can cause serious harm to patients,” said Principal Deputy Assistant Attorney General Benjamin C. Mizer, head of the Justice Department’s Civil Division. “This criminal case demonstrates the Justice Department’s commitment to protecting consumers and patients, and making sure pharmaceutical drugs are safe and effective.”
Both defendants have agreed to plead guilty to two misdemeanor counts, representing the two lots of amino acid which were determined to be adulterated in violation of the FDCA. For each count, the defendants face a statutory maximum sentence of up to one year in prison, a fine of up to $250,000, or both, and a term of supervised release after any imprisonment for up to one year.