PROVIDENCE – The U.S. Justice Department has filed a federal lawsuit against CVS Health Corp., claiming the pharmacy chain unlawfully dispensed controlled substances, U.S. Attorney for the District of Rhode Island Zachary A. Cunha announced Wednesday.
The complaint claims that from Oct. 17, 2013, to the present, CVS knowingly filled unlawful prescriptions for controlled substances, a violation of the Controlled Substances Act, and then sought reimbursement from federal health care programs, violating the False Claims Act. The DOJ claims the filled prescriptions for controlled substances lacked a legitimate medical purpose, were not valid, and/or were not issued in the usual course of professional practice.
CVS allegedly filled unlawfully filed prescriptions for dangerous and excessive quantities of opioids, early fills of opioids and “trinity” prescriptions, an especially dangerous and abused combination of drugs made up of an opioid, a benzodiazepine and a muscle relaxant, according to the complaint.
“Opioid deaths remain a scourge on communities across Rhode Island and the nation, robbing families of loved ones and leaving a path of devastation in their wake,” Cunha said. “This lawsuit alleges that CVS failed to exercise its critical role as gatekeeper of dangerous prescription opioids and, instead, facilitated the illegal distribution of these highly addictive drugs, including by pill mill prescribers. When corporations such as CVS prize profits over patient safety and overburden their pharmacy staff so that they cannot carry out the basic responsibility of ensuring that prescriptions are legitimate, we will use every tool at our disposal to see that they answer for it.”
CVS also allegedly filled large quantities of prescriptions for controlled substances written by prescribers it knew to be engaged in “pill mill practices” – prescribers who issue large numbers of controlled substance prescriptions without any medical purpose.
The complaint includes 10,000 claims where CVS unlawfully filled prescriptions for controlled substances, though there are likely many more that will be discovered during a trial’s discovery phase, Cunha said during a press conference Wednesday. There is no estimate for how much CVS could owe if found guilty as that number depends on the number of claims CVS is found liable for.
According to the complaint, CVS ignored substantial evidence from multiple sources, including its own pharmacists and internal data, indicating that its stores were dispensing unlawful prescriptions.
The complaint alleges that CVS’ violations resulted from corporate-mandated performance metrics, incentive compensation and staffing policies that prioritized corporate profits over patient safety. 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.
Also, CVS failed to put in safeguards and in some cases, ignored safeguards that were in place, Cunha said.
The complaint also alleges that CVS’ actions helped to fuel the prescription opioid crisis and that, in some particularly tragic instances, patients died after overdosing on opioids shortly after filling unlawful prescriptions at CVS.
According to the complaint, CVS ignored substantial evidence from multiple sources, including its own pharmacists and internal data, indicating that its stores were dispensing unlawful prescriptions.
Kara Page, spokesperson for CVS, said the Woonsocket-based company has cooperated with the DOJ’s investigation for more than four years, and strongly disagrees with the allegations.
“The government’s lawsuit seeks to impose a shifting standard for pharmacy practice,” Page said in a statement to Providence Business News. “Many of the litigation theories laid out in the complaint are not found in any statute or regulation and relate to topics on which the government has declined to provide guidance. Each of the prescriptions in question was for an FDA-approved opioid medication prescribed by a practitioner who the government itself licensed, authorized and empowered to write controlled-substance prescriptions.
"The government’s lawsuit intensifies a serious dilemma for pharmacists, who are simultaneously second-guessed for dispensing too many opioids, and too few,” Page said.
(ADDS paragraphs 6, 10 with details from press conference.)
