CHARLESTON – A former employee of Teva, one of the defendants in a West Virginia trial accusing opioid drug suppliers of causing an epidemic, admitted the company could be held responsible.
“Could Teva be a contributor to the epidemic?” an attorney for the state asked during April 28 testimony.
“In some ways,” Colleen McGinn responded. “We were one part of the supply chain.”
“Teva was partly responsible for the epidemic?”
“In some part, yes.”
Teva is the largest generic manufacturer of opioids in the country. A generic drug is one copied from an original or brand drug after a patent expires.
The trial, which is taking place in the Kanawha Circuit Court, is being streamed live courtesy of Courtroom View Network.
Opioid suppliers Teva, Cephalon (now part of Teva) and Allergen are accused of recklessly flooding West Virginia with pills causing an epidemic.
In 2019, West Virginia Attorney General Patrick Morrisey filed lawsuits against the drug manufacturers in the Boone Circuit Court. The case was subsequently moved to the Kanawha Court and is being heard by a state Mass Litigation Panel in a bench trial with no jury. Judge Derek Swope will decide the verdict.
Plaintiffs’ attorneys in West Virginia seek to prove the companies ignored the addictive dangers of the drugs for profits and encouraged their selling by sales reps, minimizing the risks of addiction, endangering the public by creating a public nuisance and violating the West Virginia Consumer Protection and Control Act.
They claim the epidemic started in the 1990s when the medical community, in the beginning encouraged by a few "opioid revisionist doctors" and later supported by drug manufacturers and distributors, abandoned what had been a former tighter policy of prescribing opioids mostly for terminal and cancer treatments. Instead they alleged, backers of more opioids began to recklessly prescribe and promote the drugs for less serious conditions, describing pain as a fifth vital sign (as in a pulse).
It is a claim the plaintiffs dispute.
Anti-drug diversion in-house programs required of the companies by the U.S. Drug Enforcement Administration were ineffective, the attorneys contended.
Janssen, the drug subsidiary of Johnson & Johnson, settled with the state on April 18, agreeing to pay $99 million although company officials denied any wrongdoing. An additional defendant Endo also settled with the state in March for $26 million.
Defense attorneys argue the epidemic was caused by societal problems, illegal drug abuse including heroin and fentanyl, and not by manufacturing companies legally supplying doctors and hospitals with the pain pills they prescribed.
McGinn was a director of controlled substances (an anti-diversion) program with Cephalon and later Teva, which acquired Cephalon. Today employed at Pfizer Pharmaceuticals, she was responsible at Teva for ensuring the company’s compliance with satisfying standards of the DEA.
In a deposition taped in December of 2018 and played for the court April 28, McGinn appeared to agree that Teva had a lack of resources to adequately investigate suspicious orders, saying that she wanted a stronger program.
“You would agree there is an opioid epidemic?”
“Yes,” McGinn said.
“You agree it’s a public health emergency?”
“I’ve heard it called that.”
McGinn agreed Teva is a large volume drug supplier with a 14 percent market share.
“You found a lack of resources (to investigate), right?”
“I wanted people who were dedicated to investigating,” McGinn said.
“The company (Teva) might lose sales.”
“It’s possible,” McGinn said. “The sales team would not want to damage a relationship with a customer, but they would still want to be (DEA) compliant.”
In 2012, an audit was done of the company’s suspicious order checking program and described it as “rudimentary.”
“In all the years Teva was selling and manufacturing drugs, it never identified a suspicious order that was reported to the DEA,” the state’s attorney said.
“That’s what it (audit) says,” McGinn said.
The audit specified that the company’s checking system was “limited,” checking on a few customer backgrounds such as “credit worthiness.” It added that the company’s due diligence was “minimal.”
“There was no program to review downstream distribution, is it correct to say that?”
“Yes,” McGinn said.
More than once the state attorney referred to the drugs as “high risk.” McGinn called them instead “schedule two” drugs.
“From 2006 to 2012, Teva never once identified a single suspicious order?”
“That was my understanding,” McGinn said. “That’s what I heard. I wanted to see if we could improve the suspicious order monitoring system.”
McGinn said DEA requirements changed over time and described them as a “moving target.” The requirements could be different from a year to a few years later.
Teva had been found in an investigation to have breached its obligations and was not doing what was needed including an insufficient computer (checking) algorithm.
McGinn said that did not mean checking procedures were not being performed; just that the procedure wasn’t written down.
“There was no formal written procedure, that doesn’t mean there wasn’t some kind of procedure,” she added.
“Auditors said there was no organized risk management process, do you disagree?”
“I would disagree,” McGinn said.
"There was unfocused handling of your department?”
“I would disagree.”
“Your department was found to be high risk for risk management.”
“That was his (auditor’s) opinion,” McGinn said.
The state’s attorney said that eventually there were two suspicious reports (made to DEA), out of 120,000 orders.
“Teva didn’t start identifying suspicious orders until 2013?”
“Based on the documents, yes,” McGinn said.
“They never found one until 2013?”
“Yes.”
Documents presented by the state said that from 2012 to 2016, 70 million prescriptions had been written for bottles containing 30, 60 or 90 pills. During those years, six suspicious orders had been found.
“Yes,” McGinn agreed.
