An official of the U.S. Drug Enforcement Administration told attorneys defending suppliers of opioid drugs on May 2 that the companies were supposed to protect against suspicious drug orders without specific guidance from the DEA.
“Not every order of unusual size is indicative of diversion, correct?” Enu Mainigi a defense attorney asked.
“Correct,” Thomas Prevoznik, DEA deputy assistant administrator agreed.
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.
The May 2 session began with Donna Welch the attorney for Allergen questioning a report made by Maureen Gorman, an advertising researcher with MGS Consulting called as a witness by the state. Gorman tabulated in charts emails and advertisements on the internet from drug companies called “message disseminating,” calling attention to opioid products.
Welch contended Gorman’s figures and the impact of the advertising were inflated.
Prevoznik appeared next in a taped deposition recorded in 2019. He told Mainigi he had been with the DEA for more than 28 years.
“In (DEA) field offices and corporate headquarters?” Mainigi asked.
“Field offices, training centers and headquarters,” Prevoznik agreed.
He said in 2008 companies were required to report suspicious drug orders to the DEA electronically.
“Could (DEA) headquarters start an investigation?” Mainigi asked.
“True,” Prevoznik said.
Prevoznik explained that Automation of Reports and Consolidated Ordering System data reporting schedule one and two (opioid drug transactions) were required to be reported monthly or quarterly from drug suppliers, manufacturers and distributors.
Mainigi asked how long this had been a requirement of companies.
“Since 1996,” Prevoznik said.
He added that the information was used for the setting of quotas by the DEA, the amount of drugs a producer could manufacture, and ordering trends, to be shared with federal agencies and law enforcement, and for the DEA to investigate compliance.
“Does the DEA believe that (drug) diversion is detrimental to public safety?” Mainigi asked.
“Yes.”
DEA officials have stated that suspicious orders include those showing sudden changes in ordering patterns, for example larger or more frequent orders of drugs.
“Why would an order get larger?” Mainigi asked.
Prevoznik said a new hospital opening could be one reason, a new hospice center or a doctor’s office.
“An unusual ordering pattern or frequency (ordering) is not indicative of diversion, correct?”
“Correct.”
“The DEA has not issued any (specific) guidelines on how due diligence should be conducted?” Mainigi asked.
“No,” Prevoznik said.
“The DEA has not issued and guidelines on how long (a distributor) should hold on to due diligence?”
“Correct?”
“Why has the DEA never issued any guidelines?”
“I don’t know,” Prevoznik said.
Mainigi asked Prevoznik if there was any DEA requirement for a distributor or manufacturer to hold on to (not ship) a suspicious order.
“No,” he said.
“Some suspicious orders were phoned or faxed in (from the companies) to the DEA?”
“Correct.”
Prevoznik said a suspicious order reported by a distributor should not be shipped and should be held until the suspicion is removed.
“The registrant (distributor) reports (to DEA),” he said. “From their (in-house anti diversion) system. But they should not ship. If they haven’t alleviated the suspicion, it’s still a suspicious order.”
“Should they cut off all orders?” Mainigi asked. “Are they required to hold other orders they don’t view as suspicious?”
“They can ship (other orders),” Prevoznik said.