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Sunday, May 5, 2024

Defense lawyers attempt to display due diligence in Washington State trial against opioid drug distributors

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SEATTLE (Legal Newsline) - Defense attorneys for three of the country’s top distributors of opioid drugs accused of starting an overdose epidemic in Washington State attempted on Tuesday to show the companies had done everything possible to prevent illegal drug diversion.

Paul Schmidt, attorney for McKesson Corp., displayed a document showing the company had okayed a customer drug limit increase for one customer, but declined two other requests.

“Is that good?” Schmidt asked.


Carter (right) | Facebook

“Yes,” Ruth Carter responded.

The trial 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 doctor’s offices that led to multiple overdose deaths in the state. The Washington State Department of Health estimated 1,200 in 2020.

The distributors take the 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.

Carter, a key witness called by the state formerly was an anti-drug diversion officer for the U.S. Drug Enforcement Administration (DEA) before retiring in 2019. She has served as an expert witness for plaintiffs suing the drug companies including state attorneys general.

The bench trial in the King County Superior Court began in mid-November as is expected to extend through February. The government is asking for $32.8 billion in damages initially to fund anti-drug programs, but the total with a court victory could go much higher when penalties and surrendered profits are added in.

In previous testimony under questioning by attorneys for the Washington Attorney General’s Office, Carter portrayed an opioid drug dispensing system spiraling out of control by the year 2008. She said red-flagged suspicious orders in which pharmacies ordered more than normal or more frequently continued to be shipped anyway. Under DEA regulations, the drug companies installed anti-diversion programs, but Carter said these were understaffed and unable to check on the number of suspicious orders.

She accused the companies of failing to seek “due diligence,” to know the buying habits of their customers including site visits to pharmacies and the use of questionnaires. Defense attorneys have argued that the companies acted in good faith, that each company anti-diversion program was a “business decision” and that the DEA had offered only vague and unspecific guidelines for compliance.

Carter also said the dosages of the drugs including OxyContin, Hydrocodone, fentanyl and methadone had increased from the years prior to the epidemic, which state documents indicated started to take off in about the year 2008.

“You identified 10 milligrams as a high dose,” Schmidt said. “What percentage (orders shipped) were high dose?”

Carter said she didn’t know.

Carter agreed that Jim’s Pharmacy in Port Angeles had been identified as receiving high dosages of opioid drugs.

“Were there any others with an unusually high level?” Schmidt asked.

“I don’t remember, but that’s not to say there were none,” Carter said.

Schmidt produced a document from 2021 in which Joe Rannazzisi, former head of the office of diversion control for the DEA, called the flagging of suspicious orders a “business decision.” Rannazzisi, who testified in November, oversaw a big increase in quotas in the amount of opioids manufacturers could sell. He became a celebrity of sorts after appearing on an installment of 60 Minutes in which he criticized federal opioid policy as “too lax.”

The document stated the type of anti-diversion system a company uses is a “business decision as long as the company identifies suspicious orders---that’s what the requirement is.”

“Do you agree?” Schmidt asked.

“Yes,” Carter said. “The registrant (company) must create the system. The (DEA) requirement is to not ship suspicious orders” 

Schmidt asked Carter if she had seen documents where McKesson had denied requests for drug threshold increases from customers.

“Occasionally, yes,” Carter said.

“Do you know how many orders McKesson blocked to Tick Klock Pharmacy (Colfax)?” Schmidt asked.

“No.”

“You didn’t attempt to calculate the blocked orders?”

“No.”

Carter said she reviewed the documents submitted to her.

“I did not do a comparison of threshold (drug limit) changes,” she said. “My focus was on what was distributed to the customer.”

Schmidt displayed a document that showed a site visit had been made to Tick Klock Pharmacy by a McKesson official in which it was noted, “I spoke to Bob in the pharmacy."

“Is that outreach?” Schmidt asked.

“Yes,” Carter agreed.

Another document concerning Tick Klock noted that the pharmacy was running 4,000 units short of the drug Hydrocodone, that the drug was needed so the pharmacy could “get through the month,” and to take advantage of rebates offered by McKesson.

The 4,000 units were shipped and the DEA renewed the pharmacy’s licensing.

Schmidt said for different reasons businesses sometimes legitimately needed more supply.

“It (document) said they were not able to currently service existing customers, it happens sometimes,” Schmidt said.

Later in the day the state called as a witness Dr. Caleb Banta-Green, a University of Washington Addiction, Drug and Alcohol Institute director. Green, who studies drug substance abuse impacts and interventions, displayed a chart that showed the rise in drug deaths in Washington State in the years 2003-2020. The chart showed a steady, gradual rise in the numbers of opioid deaths in the state from 2008, and a sharp increase in 2018.    

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