SEATTLE (Legal Newsline) - Attorneys defending three of the country’s biggest distributors of opioid drugs tried to undermine the testimony of a former U.S. Drug Enforcement Administration (DEA) official, while portraying their clients as innocent of causing an overdose epidemic in Washington State.
“Cardinal overhauled its anti-diversion program in period two (2008) after a DEA conference in 2007,” Enu Mainigi, the defense attorney for Cardinal Health said.
“Yes,” Ruth Carter agreed. Carter, a 30-year veteran of the DEA, served as diversion program manager up until her retirement in June of 2019.
King County Superior Court Judge Michael Scott is hearing the bench trial (no jury) in the case which is being streamed live via Courtroom View Network.
Prescription drug distributors Cardinal Health, McKesson Corp. and AmerisourceBergen Corp., are accused by the Washington State Attorney General’s Office of irresponsibly over-promoting and distributing opioid drugs to pharmacies and doctor’s offices for profit.
The trial, which resumed on Wednesday after a holiday break, began in mid-November and is expected to last into February.
In previous testimony, Carter told the court the three companies had continued to ship highly addictive opioids with insufficient anti-diversion programs (preventing drugs from getting into the wrong hands), progtams that lacked enough checkers to investigate red-flagged suspect orders, orders that were higher in volume than normal or more frequent orders.
In response, defense attorneys portrayed Carter as a well-paid hireling of plaintiff lawyers filing litigation against drug companies across the country. They maintained the companies had done everything possible to responsibly distribute the drugs and had received little or no guidance from the DEA.
Wednesday’s discussion centered on the period 2007-2008, a time opioid use and abuse had taken a big leap in the country, according to evidence presented by the state. Culprits responsibe for the rise were identified as online pharmacies (not brick and mortar) and clinics or doctors irresponsibly prescribing opioids in what were called “pill mills.”
Mainigi exhibited a document that referred to a new set of DEA standards and a response from a Cardinal anti-diversion official (Stephen Rearden) that stated “We must comply.” She said Rearden had written the statement within a week after a meeting with DEA officials in December of 2007.
“I have no reason to disagree he (Rearden) wrote the email,” Carter said.
Evidence presented said the process of inquiry before 2008 was to ship drugs and then report suspicious orders afterward to the DEA. This was followed by a system where the companies were directed to identify, investigate and report suspicious orders.
“Cardinal set about to reflect this,” Mainigi said.
“I understand they (Cardinal) made changes,” Carter answered.
The companies adopted drug monitoring and training programs including one entitled “Know Your Customer.”
Carter indicated the training was insufficient.
Mainigi said distributors had to make a “business decision” how to implement their drug anti-diversion monitoring programs. Carter agreed.
“No one size (type of program) fits all,” Mainigi said.
“The DEA doesn’t know the customer,” Carter explained. “The registrant (company) does. The registrant knows what was shipped in the past. That’s why it’s a business decision.”
“The DEA never put out specific guidelines,” Mainigi said.
“They did put out guidance,” Carter responded. “Every business is different. That’s why there were no lists (same specific guidelines). The registrant knows the customers.”
Mainigi asked Carter if Cardinal had developed a program to look at potentially problematic patterns of ordering drugs.
“The only patterns that were reviewed were after an order had been flagged (suspicious),” Carter said.
Mainigi exhibited a document that said every month officials at Cardinal evaluated pharmacy customers against their anti-diversion model. In one report by the Department of Justice in 2009 no deficiencies or violations were uncovered.
“See that?” Mainigi said of the report.
“Yes,” Carter answered.
“How a business creates a system (anti-diversion) is a business decision,” Mainigi said.
“Definitely,” Carter said.
“Would you agree Cardinal would red-flag orders that hit threshold (limit)? Mainigi asked.
“Yes.”
“They did not have enough checkers you said?”
“Yes.”
“Orders (to check), 150 a day was too much?”
“That’s a lot,” Carter agreed.
Mainigi exhibited documentation from a company official saying that his anti-diversion program had been provided with enough resources (2009) and that his staff (checkers) had grown.
“You have not identified a single suspicious order shipped by Cardinal since 2013?” Mainigi asked.
Carter agreed.
“You haven’t identified a single pharmacy that diverted opioids (since 2013)?”
“Correct.”
“A single diversion tied to Cardinal?”
“Yeah, I didn’t identify a specific diversion.”
Under cross examination later in the day Washington State attorneys had Carter read a passage from a document that stated, “Reporting the (suspicious) order (to the DEA) does not relieve the company from responsibility for the (drug) shipment.”
Carter agreed that McKesson officials reporting suspicious orders to the DEA after the orders had been shipped to customers did not satisfy the requirements of the DEA.