The Justice Department has filed a civil complaint against Walgreens which operates more than 8,000 pharmacies throughout the United States alleging that they dispensed millions of illegal prescriptions in violation of the Controlled Substances Act (CSA).
According to Principal Deputy Assistant Attorney General Brian M. Boynton, head of the Justice Department’s Civil Division “Our complaint alleges that Walgreens pharmacists filled millions of controlled substance prescriptions with clear red flags that indicated the prescriptions were highly likely to be unlawful, and that Walgreens systematically pressured its pharmacists to fill prescriptions including controlled substance prescriptions, without taking the time needed to confirm their validity. These practices allowed millions of opioid pills and other controlled substances to flow illegally out of Walgreens stores.”
Records of the Centers for Disease Control (CDC) indicate that from 1999 to 2022 nearly 727,000 Americans died from opioid overdoses with approximately 82,000 people dying from opioid overdoses in just the year 2022. The rate of overdose deaths has quadrupled since 2002.
The Justice Department complaint alleges that since August of 2012 until now, Walgreens knowingly filled millions of prescriptions for controlled substances without a legitimate medical purpose, were not valid and were not issued in the usual course of professional practice including prescriptions for dangerous and excessive quantities of opioids, improper prescriptions for early refills of opioids and prescriptions for a dangerous and abused combination of drugs described a the ‘trinity” made up of an opioid, a benzodiazepine and a muscle relaxant taken by abusers for its increased euphoric effect.
The complaint alleges that in some instances patients died after overdosing on opioids shortly after filling invalid prescriptions at Walgreens.
The Justice Department accuses Walgreens pharmacists of filling these prescriptions despite clear red flags indicating that the prescriptions were highly likely to be unlawful. Walgreens is also accused of pressuring its pharmacists to fill prescriptions without taking the necessary time required to confirm each prescription’s validity.
The law requires all pharmacists to evaluate controlled substance prescriptions and investigate any indications of a possible invalidity of the prescription referred to in the industry as “red flags.”
Among the red flags that Walgreens is accused of not investigating are:
1. Prescriptions for high dosages and quantities of opioids;
2. Prescriptions for combinations of controlled substances such as the trinity which are unlikely to serve a legitimate purpose or are frequently abused;
3. Prescriptions for patients who had filled controlled substances prescriptions with multiple prescribers;
4. Prescriptions for early refills before their previous prescription has run out;
5. Prescriptions for controlled substances where the patient had traveled a long distance to a subscriber or pharmacy;
6. Prescriptions written by doctors with a pattern of writing prescriptions for the same drugs, quantities and strengths for multiple patients.
According to the Justice Department, when confronted by such red flags, it is the duty of the pharmacist to confirm the drug is appropriate for the patient’s condition, review the pharmacy’s dispensing history for the patient or doctor, contact the doctor or check the state prescription drug monitoring program (PDMP) database to see all the prescriptions of the patient.
Walgreens is also accused of depriving its own pharmacists of critical information by preventing pharmacists from warning each other about doctors known for regularly writing invalid opioid prescriptions. Further, Walgreens is accused of reprimanding their pharmacists who diligently attempted to verify the legitimacy of controlled substance prescriptions. The complaint also alleges that Walgreens for years refused to implement a system for blocking their pharmacies from filling prescriptions written by doctors that Walgreens already knew regularly wrote illegal opioid prescriptions even when some of their own pharmacists requested the company to do so.
The complaint also alleges that Walgreens took corporate actions that it knew prevented conscientious pharmacists from complying with their legal obligations to investigate red flags before providing such prescriptions. In particular, the complaint alleges that for much of the time since 2012 Walgreens had a policy that all prescriptions must be filled within 15 minutes regardless of the volume of prescriptions being filled and other duties required of the pharmacists such as vaccinations, taking patient phone calls and verifying insurance coverage. Pharmacists who failed to meet the 15 minutes rule were subject to discipline or termination.
The complaint further alleges that Walgreen pharmacists were pressured by managers including non-pharmacist store managers to fill controlled substance prescriptions rejected by the pharmacists.
As with so many corporate crimes, this case began through the actions of four whistleblowers who had previously worked for Walgreens including Elmer Mosley who retired from Walgreens after 42 years in the pharmacy industry. These four whistleblowers originally filed lawsuits under the qui tam provisions of the False Claims Act (FCA) which allows private individuals to sue on behalf of the United States for false claims and share in any money recovered because of their lawsuit. The FCA also provides for the Justice Department to intervene and take over the lawsuits which the Justice Department did in all four lawsuits.
For its part, Walgreens has not filed a legal answer to the complaint yet, but did issue a short response denying any wrongdoing.