CLEVELAND (Legal Newsline) - The judge overseeing federal multidistrict opioid litigation misinterpreted Ohio law and made up a requirement for pharmacy chains to monitor prescription records for signs of diversion and misuse, defendants said in their latest plea for reconsideration or appellate review.
The chains also say they face a new wave of class actions accusing them of restricting opioid prescriptions too much, at the same time as they defend themselves against thousands of lawsuits accusing them of causing a public nuisance by not restricting them enough.
In an Aug. 6 ruling denying the pharmacies’ motion to dismiss, U.S. District Judge Dan Aaron Polster agreed with plaintiff lawyers that CVS, Walgreen and other big chains were obligated under the federal Controlled Substances Act to actively monitor prescription records for “red flags” indicating patients were diverting opioids for unauthorized use. The judge also rejected the idea an Ohio law limits public nuisance claims over controlled substances to non-monetary injunctive relief, allowing plaintiffs to press claims for “abatement” that amounts to billions of dollars in damages.
The judge was wrong on both counts, the pharmacies say in an Aug. 26 filing. The term “red flags” doesn’t appear in any Drug Enforcement Administration rules governing pharmacy companies and no regulator or court has ever required them to do more than maintain accurate prescription records so law enforcement can examine them for their own investigations, the pharmacies say. Unless Judge Polster reconsiders or the Sixth Circuit Court of Appeals intervenes, they say, the judge’s interpretation of the rules “will upend long-standing pharmacy operations.”
Every pharmacy would have to implement systems to check each prescription against past records to make sure it hasn’t triggered a “red flag,” they say, even when a licensed pharmacist sees nothing wrong, disrupting distribution of medications the government still considers vital to treating chronic pain.
The pharmacies also asked the judge to allow them to appeal to the Ohio Supreme Court the question of whether state law allows monetary damages in public nuisance claims over controlled substances.
At the same time as the pharmacies are defending themselves against claims they failed to block suspicious prescriptions, plaintiff lawyers are suing them for blocking too many. In Smith v. Walgreens, a proposed class action in federal court in California, plaintiff lawyers say Walgreens is using its “Good Faith Dispensing” guidelines to “blacklist” patients with valid prescriptions or demanding comprehensive medical records before filling them.
The lawyers, Thomas D. Haklar in California and the Scott Hirsch Law Group in Florida, called these “misguided attempts to reduce illicit access to painkillers by punishing patients.” The pharmacies face a similar proposed class action in Rhode Island.
Pharmacy defendants, like distributors and manufacturers before them, have repeatedly complained that Judge Polster is focused on forcing them into a multibillion-dollar settlement instead of overseeing a fair trial process. They unsuccessfully asked the Sixth Circuit Court of Appeals in June to remove the judge from the litigation, which was assigned to his court in 2017 under federal laws allowing cases based on similar allegations to be concentrated in one court for pretrial discovery. From the beginning, Judge Polster has described his role as facilitating settlement and said “a trial will accomplish zero.”
The Sixth Circuit declined to remove the judge, but earlier did rule he had improperly allowed plaintiffs to modify their lawsuits against pharmacies to include so-called dispensing claims in addition to existing allegations they had violated their duties as wholesale distributors. Judge Polster responded by setting for trial lawsuits by two new counties, which the pharmacies criticized as “nothing short of punitive.”
Their latest filing continues that criticism, saying the judge incorrectly cited a 2008 Sixth Circuit ruling upholding the DEA’s revocation of a pharmacy license for failing to keep records. That decision didn’t mention any requirement to monitor those records for red flags, the pharmacy defendants said. And the regulation Judge Polster cited, CFR 1304.22(c), doesn’t require pharmacies to record the name of the prescriber, making it useless for detecting suspicious doctors. When the DEA authorized electronic prescription records for controlled substances in 2010, it expressly prohibited their use for “generalized collection or analysis” of data, the pharmacies say.
Judge Polster said he adopted a broad definition of the pharmacies’ obligations because their interpretation of the rules would lead to “a frightening abdication of responsibility” in which their only duty was to guard against theft. But the pharmacies said the judge misinterpreted their argument. They are only saying they can’t be expected to detect legally valid prescriptions that shouldn’t have been filled because the patient intended to misuse the drugs. If such a duty existed and depended upon aggregate data analysis, the companies said, only large pharmacy chains could dispense opioids.
To bolster their interpretation of federal law, they cited a recent decision in which a federal court dismissed a False Claims Act lawsuit accusing McKesson of failing to comply with the CSA. The regulations require companies handling controlled substances to guard against theft and keep certain records but don’t include specific security measures or monitoring programs, that court ruled in U.S. v. McKesson in the Northern District of California.