On February 7, 2019, the U.S. Department of Justice (DOJ) filed a “first-of-its-kind” civil complaint against two Tennessee pharmacies because of their alleged illegal dispensing of opioids that have been linked to at least two deaths and numerous overdoses. The DOJ has reported that this is the first time it has filed such an action under the Controlled Substances Act against pharmacies.

The DOJ’s complaint specifically alleges that pharmacists at Dale Hollow Pharmacy and Xpress Pharmacy regularly dispensed controlled substances while ignoring “red flags,” including filling orders for unusually high doses of opioids and dangerous combinations of controlled substance prescriptions. The DOJ also alleged that the pharmacists often filled prescriptions for patients who had traveled from unusually far away and paid uncommonly high cash prices for the prescription products.

The complaint alleges that, between 2015 and 2018, Dale Hollow Pharmacy, owned by Thomas Weir, ordered enough opioids from its distributors to be able to dispense one and a half maximum strength Vicodin to every man, woman, and child residing in its county. Additionally, Xpress Pharmacy, also owned by Weir, ordered enough maximum strength Percocet from its distributors to be able to dispense half a tablet to everybody in the county during the same period.

Additionally, the DOJ initially sought injunctive relief by filing a temporary restraining order (TRO) to immediately shut down the two pharmacies without first providing advance notice to the defendants. On February 7, 2019, Judge Aleta A. Trauger of the U.S. District Court for the Middle District of Tennessee granted the DOJ’s request for a TRO. Judge Trauger found that although the defendants did not have advance notice of the possible TRO, the defendants were aware of the government’s investigation, and there was a risk that defendants would destroy evidence prior to the government executing its search warrants. Thus, the defendant pharmacies are no longer in operation, and a hearing on the DOJ’s request for a preliminary injunction is currently scheduled for March 27, 2019. If the court grants the preliminary injunction, the defendant pharmacies will remain out of operation throughout the entire civil litigation.

The DOJ’s civil complaint seeks to impose civil monetary penalties for violations of the Controlled Substances Act, as well as to recover damages under the False Claims Act for allegations that the pharmacies illegally billed Medicare for invalid prescriptions. The execution of search warrants in the case indicates that the DOJ is also conducting a parallel criminal investigation.