District Court Enters Permanent Injunction Against Alabama Pharmacy and Individuals to Prevent Distribution of Adulterated and Misbranded Drugs and Unapproved New Drugs
The U.S. District Court for the Southern District of Alabama entered a consent decree of permanent injunction against defendants Medistat RX LLC (Medistat), Mark D. Acker who served as its Chief Executive Officer, Timothy L. Fickling, who served as its Production Manager, and V. Elaine Waller, who served as its Pharmacist-in-Charge and Quality Manager, the Justice Department announced today. The injunction permanently enjoins the defendants from distributing adulterated, misbranded and unapproved new drugs in violation of the federal Food, Drug, and Cosmetic Act.
The Department filed a complaint in the U.S. District Court for the Southern District of Alabama on May 23, at the request of the U.S. Food and Drug Administration (FDA), alleging that the defendants failed to adequately address insanitary conditions that resulted in contamination in sterile areas of the facility.
According to the complaint, Medistat manufactured, labeled and distributed both sterile and non-sterile drugs. Medistat’s sterile drugs included injectable vitamins and minerals, amino acids, hormones, steroids and vasodilators. The pharmacy distributed drugs to individual patients, surgery centers, and doctors’ offices throughout the United States.
In 2015, the Rhode Island Department of Health notified FDA of an outbreak of Staphylococcus aureus infections potentially linked to drugs manufactured by Medistat. FDA then conducted an inspection. FDA investigators found, from Medistat’s own documents, that the pharmacy itself identified several types of microorganisms in the air and on surfaces used for sterile processing. Yet, according to the complaint, upon identifying the microbial contamination, the defendants failed to adequately investigate or take sufficient corrective action to alleviate the insanitary conditions that resulted in the contamination in the sterile areas of the facility.
“Doctors and patients must be able to rely on the quality of drug products that are purported to be sterile,” said Acting Assistant Attorney General Chad A. Readler of the Justice Department’s Civil Division. “When insanitary conditions are identified in areas where sterile drugs are made, such conditions need to be corrected. The Department of Justice will continue to work actively with FDA to ensure that compounding pharmacies comply with the law and provide safe products to patients.”
According to the complaint, FDA investigators observed a number of insanitary conditions at Medistat, including the continuation of aseptic drug production when significant microbial contamination was present in the aseptic processing areas, and the failure to use sterile wipes to clean critical surfaces in the pharmacy. As noted in the complaint, FDA observed that defendants failed to establish an adequate system for maintaining equipment used to control the aseptic conditions and failed to ensure and validate that drug product containers and closures were adequately sterilized.
The complaint alleged that a 2014 FDA inspection of Medistat also revealed insanitary conditions. For example, FDA observed the pharmacy’s failure to adequately investigate the results of environmental monitoring, which recovered numerous microorganisms, including Penicillium aurantacium and Bacillus cereus, within the aseptic processing area.
“We commend the outstanding work of the FDA and the Justice Department’s Consumer Protection Branch in bringing to light these harmful conditions at Medistat,” said Acting U.S. Attorney Steve Butler for the Southern District of Alabama. “It was shocking to learn that pharmacists in our own district would produce medicines in a contaminated environment, jeopardizing the health and safety of our citizens.”
The defendants agreed to settle the litigation and be bound by a consent decree of permanent injunction. As part of the resolution, the defendants represented that Medistat ceased operations on Sept. 1, 2015. If Medistat seeks to resume manufacturing, holding or distributing drugs, the company must comply with specific remedial measures set forth in the order entered by the Court. In addition, if the individual defendants hold a legal interest or a supervisory or management responsibility at a facility that seeks to manufacture, hold or distribute drugs, they must comply with remedial provisions in the order entered by the district court.
This matter was handled by Trial Attorney Raquel Toledo of the Civil Division’s Consumer Protection Branch, with the assistance of Associate Chief Counsel for Enforcement Jennifer Argabright of FDA’s Office of General Counsel, Department of Health and Human Services.
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 Southern District of Alabama, visit its website at https://www.justice.gov/usao-sdal.