On March 13, 2023, just a week after announcing the creation of the Opioid Epidemic Civil Litigation Task Force, the Department of Justice intervened in an FCA suit in the Northern District of Ohio against Rite Aid Corporation and several of its subsidiaries, alleging that the pharmacy chain knowingly filled unlawful prescriptions for controlled substances, including opioids. The suit was initially filed in 2019 by three former Rite Aid pharmacists. In addition to joining the relators' FCA claims, DOJ asserts violations of the Controlled Substances Act ("CSA") for dispensing controlled substances pursuant to prescriptions that were issued without a legitimate medical purpose and outside the usual course of professional practice.
DOJ's complaint-in-intervention alleges that Rite Aid filled
hundreds of thousands of unlawful prescriptions from May 2014
through June 2019, despite knowing that those prescriptions lacked
a legitimate medical purpose, were not for a medically accepted
indication or were not issued in the course of professional
practice. DOJ alleges that Rite Aid pharmacists filled those
prescriptions despite obvious "red flags" indicating that
the prescriptions were unlawful. Those "red flags"
included: (1) prescriptions for a combination of drugs known as
"the trinity"—a dangerous combination of an opioid,
a benzodiazepine and a muscle relaxant known to be highly
abused;
(2) prescriptions for "early fills" and excessive
quantities of opioids; (3) prescriptions for opioids from multiple
providers for one patient; and (4) prescriptions issued by
prescribers whom Rite Aid pharmacists had identified internally as
writers of illegitimate prescriptions.
DOJ alleges that Rite Aid not only ignored those red flags on specific prescribers and prescriptions, it also ignored reports from certain of its pharmacists about potentially unlawful prescriptions, concerns of its distributor about the volume of opioids certain Rite Aid stores were dispensing and its own internal data indicating red flags about prescriptions being filled. According to DOJ, Rite Aid's protocol for reviewing potentially problematic prescriptions was nothing more than a "fig leaf": pharmacists simply approved them and, in certain instances, even intentionally deleted internal notes about suspicious prescribers. In one instance, the pharmacy allegedly directed its pharmacists "to be mindful of everything that is put in writing."
DOJ's lawsuit against Rite Aid comes a few months after the Department filed suit against AmerisourceBergen Corporation, alleging violations of the CSA in connection with the company's distribution of opioids—including failure to report suspicious orders of opioids and other controlled substances placed by its pharmacy customers. The suit also comes on the heels of several state opioid-related settlements last year with various pharmacy chains, including CVS, Walgreens and Walmart.
We here at Qui Notes will continue to monitor this case, including Rite Aid's response to DOJ's complaint, and will keep our readers updated.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
