The last few years have brought on a slew of litigation aimed at combatting the opioid epidemic. Most recently, however, a complaint has been lodged against the United States, which has great potential to shape future litigation. Specifically, on October 22, 2020, Walmart Inc. filed a complaint against the Department of Justice (“DOJ”) for declaratory relief in the Eastern District of Texas which requested that the Court clarify a pharmacists’ obligations under the Controlled Substance Act (“CSA”) and, additionally, requesting that the DOJ “follow [its] own regulations and not base any enforceable legal positions on alleged violation of agency guidance rather than the obligations found in a statute or duly promulgated rule or regulation.” Walmart’s requests were made in anticipation of the DOJ’s civil complaint against it, filed on December 22, 2020, which alleges, in part, that Walmart, through its agents and employees, failed to adhere to the usual course of the professional practice of pharmacy in filling prescriptions for controlled substances, further insinuating that Walmart is responsible for its pharmacies’ role in the opioid epidemic.
The Government’s complaint against Walmart alleges that Walmart, with over 5,000 pharmacies within their stores, as both distributor and pharmacy, should be held accountable for its role in the opioid crisis. The DOJ alleged that Walmart, under the CSA, was required to take steps to prevent diversion of prescription drugs by recognizing “red flags” (as defined by the DOJ in their guidance) which the DOJ alleged Walmart failed to do by, for example, knowingly continuing to fill prescriptions issued by prescribers who were reported to be “pill mills.” The complaint goes on to allege that Walmart impeded the ability of its pharmacists to comply with the CSA’s requirements by pressuring pharmacists to fill prescriptions quickly and by not disseminating, to its pharmacists, information pertaining to red flags which was collected by its compliance department. While this set of allegations relates specifically to compliance at the corporate level, the Government additionally alleges that pharmacists filled many prescriptions which, on their face, raised “glaring red flags” which should have alerted pharmacists that the prescriptions had a “very high probability of being invalid.”
It is expected that the Government’s claims against Walmart related to its operations as a pharmacy will encourage state and federal governments to look closer at pharmacies’ roles in the opioid crisis. To be sure, two Ohio counties already attempted to include Walgreens, as a pharmacy, in multi-district litigation in 2020 only to have those claims dismissed for late amendment. The Government’s claims against Walmart, however, will be vital in signaling how the government will proceed with claims against other pharmacies.
However, Walmart’s complaint in anticipation of the DOJ’s allegations may be just as telling as to the future of opioid litigation. Specifically, to combat the anticipated allegations, Walmart points out that pharmacies are positioned rather uniquely in the distribution chain. For example, Walmart’s complaint submits that Congress tasked the DOJ and DEA to prevent drug abuse, a task which Walmart alleges the DEA failed to accomplish, evidenced by the current opioid crisis. Walmart’s complaint further submits that in evaluating a prescription for a controlled substance, a pharmacist cannot fill a prescription if, in part, the prescriber lacks an active DEA registration, pointing out that, where the DEA is entrusted to evaluate and assess whether a prescriber should be permitted to prescribe controlled substances in the first instance, pharmacies should be permitted to rely on a prescriber’s DEA licensure in determining whether a prescription is written for a legitimate medical purpose. The Walmart Complaint alleges that the DEA has continued to renew prescriber’s DEA registrations despite reports made to the DEA of suspicious prescribing practices for relevant prescribers. Moreover, Walmart submits that the DOJ’s claims were based on nothing but its own guidance (as distinct from regulation) which regulates when prescriptions should not be filled.
In addition to the failure of DEA to appropriately regulate the prescribers’ licensure, Walmart claims that federal agencies attempted to apply requirements unsubstantiated by law on pharmacists. The DOJ and the DEA, by charging pharmacies in these types of actions which seek to hold the pharmacy responsible for dispensing on a valid prescription, aim to impose unsubstantiated requirements not found within State law which oversee the practice of medicine. Both, the DOJ and DEA, through these types of actions would require pharmacists, when presented with a facially valid controlled substance prescription, to interject themselves in the patient-prescriber relationship and to second-guess a prescriber’s medical judgment without access to the patient’s medical records and history.
Ultimately, though Walmart’s complaint was dismissed based on procedural grounds, which Walmart plans to appeal, its arguments hold value for many pharmacies facing similar charges lodged by the DOJ. Overall, each of Walmart and the DOJ’s complaints will influence not only the current litigations but may shape generally the type of allegations permitted to be lodged against healthcare providers, and the future practice of pharmacy as well.
How Frier Levitt Can Help
Frier Levitt represents dozens of pharmacies in combatting allegations lodged by the federal government. As a result, Frier Levitt prioritizes remaining current with the ever-changing pharmacy compliance, litigation, and defense trends. If you believe your pharmacy may be under investigation or that some of your practices may have fallen out of compliance, contact us to speak with our attorneys today.
