SEATTLE (Legal Newsline) - Attorneys defending three of the country’s biggest opioid drug distributors presented motions on Monday asking the King County Superior Court to dismiss a case alleging the companies caused an overdose epidemic in Washington State.
Instead, they said the epidemic was caused by societal abuse of illegal drugs like heroin and more recently fentanyl and not by distributors legally supplying opioids for the proscriptions of doctors.
State attorneys countered by saying the companies failed to provide due diligence in checking for suspicious drug orders that could be diverted into the wrong hands and recklessly shipped drugs violating the Controlled Substances Act (CSA), Consumer Protection Act (CPA) and directives of the U.S. Drug Enforcement Administration (DEA). In addition to the CSA and CPA violations is the alleged creation of a public nuisance.
The fourth month long bench trial has been heard by Judge Michael Scott in Seattle and is being streamed live courtesy of Courtroom View Network.
Prescription drug distributors McKesson, Cardinal Health and AmerisourceBergen Corp. are accused of irresponsibly over-promoting and distributing opioid drugs to pharmacies and doctors' offices that led to hundreds of overdose deaths in the state. The Washington State Department of Health estimated 1,200 in 2020.
Distributors take pills from the manufacturers and supply them to hospitals, doctor’s offices and pharmacies. The most commonly shipped opioid drugs include OxyContin, Hydrocodone, methadone and fentanyl.
Washington State Attorney General Bob Ferguson is asking for $32 billion in damages to enact anti-drug programs, but a state victory could result in a much higher award when surrendered profits and penalties are added in.
The trial, which began in November, saw plaintiff attorneys contending that the epidemic took off in the years after 2002, fueled in part by what they said was the growth in "rogue internet pharmacies" and pill dispensing clinics referred to as "pill mills." The attorneys argued that even though the three companies had anti-drug-diversion programs in place to satisfy requirements of the DEA, there were not enough checkers at the companies to investigate numerous suspicious orders (larger or more frequent than usual). Some orders that had been red-flagged as suspicious and reported to the DEA by company officials were shipped to the customers anyway.
The three companies (plus Johnson & Johnson) agreed last month to pay $590 million to Native American tribes to settle lawsuits filed by those entities, considered their own sovereign nations. Plaintiff attorneys have said the drug epidemic hit the tribes the worst of any ethnic group.
On Friday, attorneys for the defendants announced they were filing motions asking Scott to toss out the case saying the state’s argument had proved nothing.
During Monday's session, attorney Ashley Hardin spoke on behalf of the three defendants.
“The defendants shipped suspicious orders without due diligence? The answer is no,” she said.
Hardin accused state attorneys of changing their stance, agreeing at the start of the trial they had to prove violations of the CPA, and then in recent weeks maintaining they didn’t have to.
“They (plaintiff attorneys) retreated,” Hardin said. “The notion the companies failed to maintain effective (drug diversion) controls, it requires proof. They haven’t done it.”
Hardin said a key witness called by the state, Ruth Carter, a former anti-drug diversion officer for the DEA before retiring in 2019, admitted she had not looked at suspicious orders individually in detail.
“Not one individual order,” Hardin said.
“She (Carter) said she had looked at overall patterns. Is that not sufficient?” Judge Scott asked.
“Overall does not tell you about individual suspicious orders,” Hardin responded.
Hardin displayed a chart with a quote from Joe Rannazzisi saying that 99% of drug prescribing doctors were treating their patients appropriately.
Rannazzisi, former head of the Office for Diversion Control with the DEA, appeared as a witness for the state in November. He testified that the drug distribution system had been out of control. While at the DEA until shortly before he retired in 2015, Rannazzisi oversaw the massive increase in the quotas that set how many opioid pills manufacturers can sell. He came to national fame in 2018 after appearing on “60 Minutes” criticizing federal opioid policy as too lax.
Rannazzisi has since become a $500-an-hour expert for private lawyers representing state and local governments suing the opioid industry.
Hardin said there was a requirement to report a suspicious order prior to 2007, but it was then okay to ship the order. This policy DEA officials understood, she said. Hardin added that after Rannazzisi requested in a letter (2007) to revise the process, to report and then block suspicious orders, the companies changed their anti-diversion programs to comply.
“Opioids have legitimate uses like end-of-life, surgeries and cancer,” Hardin said. “The overwhelming majority are conducted responsibly. There’s been a lot of rhetoric about millions of pills (shipped wrongly). They (plaintiffs) haven't proved any of it.”
Susan Llorens, the state’s attorney, said the defendants were liable under rules of the CPA.
“Their (anti-diversion) systems failed,” she said.
Llorens displayed a chart that read, “Prior to 2008, McKesson shipped all orders regardless of suspicion.”
Scott told Llorens he saw a compliance system that was evolving over time.
“It was up to the distributors and the DEA said we’re not going to tell them how to do it (programs),” Judge Scott said. “It wasn’t considered a problem until 2008.”
“When the customers exceeded threshold (order limits), McKesson’s due diligence was inadequate,” Llorens said. “There was not enough staff. They didn’t have the capacity or the resources. They did not follow investigation protocols.”
Lloreans said one pharmacy had ordered 62 times its normal amount of hydrocodone.
“Ruth Carter said she found this disturbing,” Llorens said. “Diligence did not take place. Under any common sense scenario, this (62 times more) should have raised concerns.”
Llorens said the companies had used a simple checklist for customers without detailed investigation or follow-up. She said company checkers had 70 suspicious orders a day to consider.
“The compliance was so poor they could not have met their obligation to prevent diversion,” she said. “If compliance factors don’t exist there is a system failure.”