Nearly 108,000 Americans died of opioid overdoses in 2021. Back in 2017, the federal government declared opioids a public health emergency. But the National Center for Drug Abuse Statistics (NCDAS) is still reporting that 136 people are overdosing and dying each day. Calling pharmacies “critical gatekeepers against the unlawful dispensing of controlled substances,” the U.S. Attorney in Ohio has filed a complaint against Rite Aid, one of the nation’s largest pharmaceutical chains. It charges Rite Aid with violating its legal obligations and substantially contributing to the nation’s opioid crisis.

“Rite Aid filled…prescriptions with actual knowledge, or at least with willful blindness, that the prescriptions were unlawful,” the complaint charges. Rite Aid “knew of its obligations under federal and state law.” Yet, its pharmacists continuously filled prescriptions despite “obvious, often multiple red flags indicating prescription misuse by the prescriber, the customer or both.” Based on their training and experience, pharmacists know they have “a legal obligation not to fill them,” yet many ignored Rite Aid’s required validation process and dispensed suspect prescriptions anyway. They were also required to report suspicious activity before distributing controlled drugs. Many Rite Aid pharmacists did not do what they were told to do.

In a five-count “Complaint in Intervention and Demand for a Jury Trial,” filed in United States District Court in the Eastern Division of the Northern District of Ohio on March 13, the U.S. Attorney asked Judge Charles E. Fleming to enter a judgment against Rite Aid that would award damages and impose a civil penalty for each violation of the False Claims Act (FCA) and the Controlled Substances Act (CSA). The FCA prohibits the knowing presentation of false or fraudulent claims. The CSA regulates substances that may be abused or cause addiction.

Several Federal Health Programs, including Medicare, Medicaid, and military health programs as well as state health programs are also plaintiffs in the Complaint. Medicare only covers valid medical prescriptions for controlled substances issued for “legitimate medical purposes.” Because Rite Aid dispenses controlled substances, the CSA makes its responsibilities very clear when it says, “The responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription.”

The Complaint lists what tools are available to address Rite Aid’s “corresponding responsibility.” These include observing patients, calling prescribers to confirm the medical necessity for the drug listed on the prescription, and consulting state-run monitoring programs.

Although Rite Aid is a publicly held Delaware corporation with its headquarters in Philadelphia, Ohio has jurisdiction because Rite Aid does business in the state. The complaint alleges that from May 2014 through June 2019, Rite Aid and its subsidiaries in nine states filled hundreds of thousands of “medically unnecessary, unlawful prescriptions.” These were “not issued in the usual course of professional practice,” the complaint alleges. Rite Aid pharmacists, the complaint charges, should have noticed the “clear signs” of overuse when extremely high amounts of opioids like oxycodone, as well as depressants and muscle relaxants, were refilled before prior prescriptions had expired. A list of all suspect stores is included.

Equally disturbing were accounts that members of Rite Aid’s own Government Affairs Department ignored complaints and suspicions about problematic prescribing that they received from whistleblower pharmacists and drug distributors who questioned unusually large opioid orders. To make matters worse, Government Affairs “repeatedly directed employees in another Rite Aid department to delete…internal notes about suspicious prescribers such as “cash only pill mill???” One Government Affairs staff member even “admonished a Rite Aid pharmacist who added a cautionary note to “always be very cautious of what is put in writing.”

The complaint gives examples from several states of pharmacists who reported suspicious or inappropriate medications or wrote highly excessive prescriptions from doctors. These reports were routinely ignored.

The new Rite Aid complaint is not unique; rather, it is just the latest in a series of lawsuits against large retail pharmacies. In November 2022 CVS Health and Walgreens agreed to pay about $10 billion to states, cities and North American tribes to settle all the opioid suits against them. As part of the settlement agreement, neither company admitted wrongdoing, according to the Washington Post. Walmart also has a $3 billion settlement pending. All of these defendants, including Rite Aid, have refused press requests for comment. Some of the drug retailers have issued statements that blamed doctors for “overprescribing.”

It is not only pharmacies that are currently involved in litigation. Doctors who overprescribe opioids are facing disciplinary action and sometimes criminal charges. Some states, like California, have issued guidelines for prescribing controlled substances, and doctors who violate them could find their noncompliance used as evidence against them. There is plenty of blame to go around, but so far, the number of drug overdose deaths, 67.8% of which were due to opioids according to NCDAS, is still increasing. They went up 29.9% in 2020, the latest year for which statistics are available.

An attorney for some of the communities that joined the suits against the drug retailers told the Washington Post that he believes recent court decisions have “brought the companies to the table.” He said he is “100% confident that the message got back to the boardrooms...that once these verdicts start coming out in full force that they were going to have a very, very difficult resolution.”