CVS pharmacy and Walgreens store signs. Photos: Diego M. Radzinschi/ALM

The Justice Department (DOJ) alleges that CVS Pharmacy filled “unlawful” prescriptions, in violation of the federal the Controlled Substances Act, in a whistleblower lawsuit brought by a former CVS employee in intervention with a DOJ civil complaint newly unsealed yesterday in Providence, Rhode Island.

The complaint also alleges CVS, which is the country’s largest pharmacy chain with more than 9,000 pharmacies across the United States, sought reimbursement from federal health care programs for unlawful prescriptions in violation of the False Claims Act (FCA). Whistleblower Hillary Estright filed an action on Oct. 17, 2019, under the FCA, which authorizes private parties to sue on behalf of the United States for false claims and share in any recovery.

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The DOJ claims that for the last decade – from Oct. 17, 2013, to the present – CVS “knowingly filled prescriptions for controlled substances that lacked a legitimate medical purpose, were not valid, and/or were not issued in the usual course of professional practice,” according to the complaint.

The DOJ intervening in the lawsuit signals a ramp-up in federal activity to rectify the opioid crisis and its efforts to combat health care fraud. This comes after the DOJ recently obtained a $409 million settlement in a similar whistleblower case against Rite Aid that was filed by Baron & Budd, the law firm that originally filed the CVS complaint.

“We are pleased that the DOJ has decided to intervene in this case and hold CVS accountable for the blatant violations of their duty to responsibly dispense controlled substances, which has led to an immeasurable amount of harm to customers and millions of taxpayer dollars spent on fraudulent prescriptions,” said Baron & Budd Shareholder Scott Simmer. “The greed of pharmacies has resulted in the largest public health crisis our country has seen with nearly every American touched in some way by the opioid epidemic.”

Among the large number of unlawful prescriptions that CVS allegedly filled were prescriptions for “trinity” prescriptions, an especially dangerous and abused combination of drugs made up of an opioid, a benzodiazepine and a muscle relaxant.

CVS also allegedly filled large quantities of prescriptions for controlled substances written by prescribers it knew to be engaged in “pill mill practices” — that is, prescribers who issue large numbers of controlled substance prescriptions without any medical purpose. CVS ignored substantial evidence from multiple sources, including its own pharmacists and internal data, indicating that its stores were dispensing unlawful prescriptions, according to the complaint. CVS filled more than 8,000 prescriptions from one particular Alabama doctor, who was well-known in his community for doling out excessive amounts of narcotics to young, healthy patients, even though pharmacists even left notes in databases to warn others about him.

CVS’ violations resulted from corporate-mandated performance metrics, incentive compensation, and staffing policies that prioritized corporate profits over patient safety, alleges the complaint. CVS set staffing levels far too low for pharmacists to both meet their performance metrics and comply with their legal obligations. CVS also allegedly deprived its pharmacists of crucial information (including by, for example, preventing pharmacists from warning one another about certain prescribers) that could have reduced the number of unlawful prescriptions filled.

The complaint alleges that CVS’ actions helped to fuel the opioid crisis and that, in some particularly tragic instances, patients died after overdosing on opioids shortly after filling unlawful prescriptions at CVS. The complaint described 10 individual patients who died, allegedly after filling illegal prescriptions for opioids and other drugs at CVS.

"We have cooperated with the DOJ's investigation for more than four years, and we strongly disagree with the allegations and false narrative within this complaint," CVS said in a statement.

Related: Rite Aid files for bankruptcy, facing $33B in debt and opioid lawsuits


“CVS is alleged to have dispensed large amounts of highly addictive opioid medications to persons they knew had no medical need for them ...,” said Administrator Anne Milgram of the Drug Enforcement Administration. “They put profits over their obligation to keep their customers safe. A pharmacy is the final step in the pharmaceutical distribution process that is in place to keep customers safe. In the fight against the opioid epidemic, DEA will continue to be relentless in holding those accountable who violate our drug laws and place our communities in danger whether they are a criminal cartel or large pharmacy chain.”

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Lynn Cavanaugh

Lynn Varacalli Cavanaugh is Senior Editor, Retirement at BenefitsPRO. Prior, she was editor-in-chief of the What's New in Benefits & Compensation newsletter. She has worked for major firms in the employee benefits space, Vanguard and Willis Towers Watson, as well as top media companies, including Condé Nast and American Media.