Lessons in compliance are learned from opioid lawsuits against retail pharmacy companies
According to court records, more than 3,000 opioid-related cases have been filed in state and federal courts with broad allegations that the actions and inactions of pharmaceutical companies, distributors, and retail pharmacies "led to a severe oversupply of prescription opioids, which ultimately created a public nuisance." Judge Dan Polster of the U.S. District Court for the Northern District of Ohio is overseeing the coordinated multidistrict opioid case.
As test cases for upcoming opioid-related litigation, the combined cases in this initial round of litigation are known as "bellwether" trials. A national opioid-related agreement has not yet been reached by any retail pharmacy chains, in contrast to certain significant drugmakers and distributors.
On August 17, Judge Polster ordered CVS, Walgreens, and Walmart to pay a total of roughly $650.6 million over 15 years to two Ohio counties—including an immediate payment of nearly $87 million to cover the first two years of the abatement remediation plan—in the first case to levy damages against retail pharmacy chains following a jury trial last fall.
The jury's finding that CVS, Walgreens, and Walmart "engaged in intentional and/or illegal conduct, which was a substantial factor in producing the public nuisance" led to the damages award, according to court documents, which also stated that each retailer "caused a significant and ongoing interference with a public right to health or safety."
The defendants "largely ignored the court’s directives to submit their own proposed abatement plan," according to Judge Polster, who expressed frustration during the hearing. Instead, the defendants submitted "three paragraphs suggesting a proper abatement remedy would be comprised of drug takeback programs to facilitate disposal of diverted opioids—and nothing more."
Pharmacies chains' corporate counsel should heed Judge Polster's advice: if that is the defense strategy chosen, be ready to present evidence, through witnesses or the cross-examination of experts, "that would support a finding that drug takeback programs, standing alone, would effectively abate the nuisance."
Before going to trial, the counties struck agreements with two additional drugstore defendants: Rite Aid and Giant Eagle. The firms gave Trumbull County a total payment of more over $2 million; Lake County's payment was not made public.
CVS, Walgreens, and Walmart disagreed with the jury's alleged egregious misapplication of the public nuisance legislation. Each will make an appeal.
"Instead of addressing the real causes of the opioid crisis—like pill mill doctors, illegal drugs, and regulators asleep at the switch—plaintiffs’ lawyers wrongly claimed that pharmacists must second-guess doctors in a way the law never intended," said Walmart.
"Pharmacists fill legal prescriptions written by [Drug Enforcement Administration]-licensed doctors who prescribe legal, [Food and Drug Administration]-approved substances to treat actual patients in need," CVS claimed in an emailed statement.
Now that Walgreens has lost two significant opioid-related cases, it is appealing both of them.
Fraser Engerman, senior director of external communications at Walgreens, stated, "As we have said throughout this process, we never manufactured or marketed opioids, nor did we distribute them to the pill mills and internet pharmacies that fueled this crisis."
Engerman continued, "The plaintiffs’ attempt to resolve the opioid crisis with an unprecedented expansion of public nuisance law is misguided and unsustainable. We look forward to the opportunity to address these issues on appeal."
On August 10, U.S. District Judge Charles Breyer rendered a verdict in favor of a plaintiff in the multidistrict opioid litigation's first bench trial. Walgreens was held responsible for "substantially contributing" to San Francisco's opioid problem by the Northern District of California District Court. The sum that the business must pay to the city of San Francisco will be decided at the trial's subsequent phase.
"Walgreens pharmacies in San Francisco dispensed hundreds of thousands of red-flag opioid prescriptions without performing adequate due diligence. Tens of thousands of these prescriptions were written by doctors with suspect prescribing patterns," as per the court records from the period 2006-2020.
"As a result of Walgreens’ 15-year failure to perform adequate due diligence, plaintiffs proved that it is more likely than not that Walgreens pharmacies dispensed large volumes of medically illegitimate opioid prescriptions that were diverted for illicit use and that substantially contributed to the opioid epidemic in San Francisco," Judge Breyer said.
Additionally, according to court records, "Walgreens did not provide its pharmacists with sufficient time, staffing, or resources to perform due diligence on these prescriptions. Pharmacists experienced constant pressure to fill prescriptions as quickly as possible and a shortage of resources to review them before dispensing."
The overall takeaway for other drugstore chains: According to Judge Breyer, "It is not enough for a pharmacy to simply ascertain that a licensed prescriber wrote the prescription.Pharmacies have a corresponding duty to exercise independent judgment in determining whether the prescription was written for a legitimate medical purpose."
Chief compliance officers in the retail pharmacy industry may develop a strong framework for a controlled drug compliance program using the instances (CSCP). A CSCP must have the elements listed in the lawsuit against CVS, Walgreens, and Walmart.
1. the creation of a committee for controlling substance compliance with members from the legal, compliance, pharmacy operations, and asset protection divisions.
2. appointment of a chief controlled drug compliance officer who should be knowledgeable about and experienced with the rules and legislation regulating controlled substances. This person is responsible for managing a controlled substance compliance department and serving on the controlled substance compliance committee.
3. Independent oversight: Employees in the compliance department, retail pharmacists, and supervisory staff may not receive commissions, bonuses, incentives, or any other benefits that are contingent on sales of restricted drugs, profitability objectives, or other expectations. No employee shall be subject to retaliation for failing to achieve revenue goals related to the sales of prohibited drugs.
4. establishing a hotline where staff members and/or clients can "report suspected inappropriate or illegitimate dispensing, prescribing, or diversion of controlled substances" or other CSCP breaches in an anonymous manner.
5. "A record of each hotline complaint regarding designated controlled substances and documentation regarding any investigation or response to such complaints," are among the mandatory reporting requirements.
6. CSCP rules and processes, including the prescription validation process, should be tested on a yearly basis for employees and contractors working as pharmacists and pharmacy technicians. The dispensing of banned drugs "believed to be prescribed or being used for other than a legitimate medical purpose," as stated in the training, must be refused by pharmacists.
7. Pharmacies are required to keep an eye out for both patient red flags and prescription red flags while monitoring red flags. Patients who seek to fill a controlled substance prescription "more than three days prior" to the prescription running out, patients who do so "from more than four prescribers, from separate practices, in a given six-month period," and/or patients who reside more than 50 miles from the location where the controlled substance prescription was submitted are all considered to be raising red flags. Red signs for a possible fraudulent prescription include those that appear to have been altered, include misspellings or unusual acronyms, or have several colors of ink or handwriting.
There will likely be additional bellwether cases as the multidistrict opioid litigation is still in its infancy. They do so while the American government continues to pursue financial penalties totaling tens of billions of dollars against drug manufacturers and distributors for their part in the opioid crisis.
By fLEXI tEAM