The United States of America filed suit against defendants Stevens Pharmacy, Inc. and Steven W. Gough on Tuesday in the Middle District of Louisiana. The complaint alleges that the defendants violated the federal Controlled Substances Act (CSA) by filling hundreds of invalid prescriptions for controlled substances, which they argue enables drug abuse and diversion.
The complaint explained that the CSA was passed in 1970 and is intended to “conquer drug abuse and to control the legitimate and illegitimate traffic in controlled substances.” The act makes it illegal to manufacture or distribute any controlled substances in a manner not authorized by the CSA. There are strict requirements outlined in the CSA regarding the registration, labeling, packaging, production quotas, drug security, and recordkeeping of controlled substances.
The United States has undergone an opioid crisis in the years since the passage of the CSA, resulting in the CDC estimation that 91 Americans die every day from overdosing on opioids. Specifically, Louisiana had the fourth highest dispensing rate in the United States in 2020.
The complaint alleges that the defendants violated the CSA by filling “hundreds of facially invalid prescriptions for controlled substances, including opioids.” The invalid prescriptions, which were unlawfully fulfilled, lacked required data elements. The defendants also reportedly dispensed more controlled substances than were prescribed, and filled prescriptions earlier than they were dated.
A 2020 audit by the Drug Enforcement Administration revealed that the defendant also “failed to maintain accurate inventories of its controlled substances, including opioids, resulting in unexplained overages and shortages in its drug stocks.”
The defendants have a long history of similar violations that were noted by the Louisiana Board of Pharmacy which resulted in consent agreements between the two parties. The complaint explains that the aforementioned violations occurred despite this history and consent agreements.
The complaint concludes that since the defendants have “increased the likelihood of abuse and diversion of controlled substances,” any substantial civil penalties given under the CSA are justified. The plaintiff is seeking civil penalties, legal interest and costs, and any other legal and equitable relief deemed just by the court.