CHARLESTON – A security manager for an opioid drug company testified that officers of the U.S. Drug Enforcement Administration turned “aggressive” around 2011 and sometimes “beat up” drug suppliers and manufacturers.
“You said the DEA likes to beat up on the (opioid) industry?” an attorney asked April 22 during the Mass Litigation Panel trial of suppliers accused of causing an epidemic in the state. “Why did you say that?”
“The DEA had been a partner,” responded Thomas Napoli, manager of security for opioid manufacturer Watson Pharmaceuticals (now Actavis Generics). “The DEA added special investigators and it became more aggressive.”
Napoli did not elaborate further on the alleged aggressive DEA tactics to prevent drug diversions into the wrong hands. The 2011 time period has been called the peak year for opioid distribution in West Virginia.
Napoli said his company had worked to make sure its suspicious order monitoring system was continually improving to meet DEA compliance requirements.
He indicated the epidemic was about more than just blaming the distributors and manufacturers of pain drugs.
“It’s a complex societal problem (opioid epidemic),” he said. “Not just manufacturers.”
The trial in the Kanawha Circuit Court is being streamed live courtesy of Courtroom View Network. Opioid suppliers Teva, Cephalon and Allergen are accused of recklessly flooding West Virginia with pills causing an epidemic.
Janssen, the drug subsidiary of Johnson & Johnson, settled with the state on April 18, agreeing to pay $99 million. Company officials defended their actions saying they had done nothing wrong and they were happy to contribute to solve the epidemic. An additional defendant Endo also settled with the state in late March for $26 million.
The case originated in 2019 when West Virginia Attorney General Patrick Morrisey filed lawsuits against the drug manufacturers in in the Boone Circuit Court. The case which began on April 4 was moved to the Kanawha Circuit Court where it is being heard by the state Mass Litigation Panel in a bench trial with no jury. Judge Derek Swope will decide the outcome.
Other state-conducted lawsuits including in Washington State and Florida are being held against opioid distributors and manufacturers.
Plaintiffs’ attorneys in West Virginia argue the companies ignored the addictive dangers of the drugs to increase profits and endangered the public creating a public nuisance and violating the West Virginia Consumer Protection and Control Act. They said the epidemic started in the 1990s when the medical community (doctors), misled by drug manufacturers and distributors, relaxed its former conservative policy of prescribing opioids mostly for end-of-life and cancer treatments, and instead recklessly prescribed opioid drugs for less serious non-cancer conditions.
Anti-drug diversion in-house programs required of the companies by the DEA were ineffective, the attorneys contended.
Defense attorneys argue that the epidemic was caused by illegal drug abuse including heroin and fentanyl, and not by manufacturing companies who were legally supplying doctors and hospitals with the prescribed pain pills they needed for their patients.
Napoli, in charge of making sure Watson and Actavis' anti-drug-diversion efforts complied with DEA regulations, appeared in the court in a deposition taped in January of 2019. He talked about the in-house program titled “Know Your Customer.”
“What does (Know Your Customer) it mean to you?” he was asked.
“Due diligence,” Napoli responded.
Napoli had written in an office communication, “The bad boys are always a step ahead.”
He was asked what he meant by the remark. Napoli said he meant the criminal element attempting to divert drugs into the wrong hands.
“We always sought to have a strong (anti-diversion) program,” he said.
One of the principal drugs the company supplied was Norco, a hydrocodone-based pain reliever.
Napoli said the company did systemic upgrades to increase security against diversions with the goals of improving the system and enhancing investigations of suspicious orders.
He was shown the minutes of a company meeting in 2011 in which the document noted that $498 million had been made providing drugs such as hydrocodone, oxycodone and fentanyl. The document noted that a goal was to “enable and sustain growth in our products.”
Napoli said he and his officers sought to make the suspicious order checking system more efficient because it was a “labor-intensive” operation.
“There were a lot of orders in the system,” he said. “Through automation, we wanted to sharpen the (system’s) sensitivity. We had an awful lot of false positives (falsely red flagged orders) in the system. The false positives we had to work through. We’d rather look at too many orders than not enough, to error on the conservative.”
Napoli said there were many different types of illegal drug diversion from cargo theft to negligent prescribing.
“We desired a system to ensure meeting (DEA) compliance,” he said.
However, he added that for a company to check down into every part of a supply chain was an “unrealistic” expectation. He said the pills were being marketed to reduce legitimate pain.
Napoli said a suspicious order would be reported to the DEA, and company officials looked for justification from pharmacies whose ordering habits had suddenly changed.
He said Watson had fewer than 100 drug customers.
“It was a very rare occasion if we took on a new customer for a controlled substance (drug),” Napoli said.