SEATTLE (Legal Newsline) - A former officer of the U.S. Drug Enforcement Administration (DEA) during testimony on Monday through Wednesday told a courtroom in Seattle three of the country’s biggest distributors of opioid drugs made an insufficient effort to stop recklessly selling the drugs that led to an overdose epidemic.
“Were drug orders flagged in the system, was the compliance system adequately staffed?” Elizabeth Smith, the attorney for Washington State asked.
“No,” former DEA diversion program manager Ruth Carter said.
Schmidt
Carter today is a consultant and a star witness for plaintiffs suing the drug companies.
“Did Cardinal maintain sufficient control against (drug) diversion?”
“No.”
In a bench trial (no jury) in the King County Superior Court before Judge Michael Scott, opioid drug distributors McKesson Corp., Cardinal Health Inc. and AmerisourceBergen Corp are accused of causing an overdose crisis in Washington State that has claimed numerous lives by irresponsibly promoting drugs for profits.
The trial is being streamed by Courtroom View Network.
The distributors take the pills from the manufacturers and supply them to hospitals, doctor’s offices and pharmacies.
Last week, attorneys for the state presented evidence that alleged the big jump in highly addictive opioid pills really took off in about the year 2007.
Carter’s testimony painted a picture of the three companies having in-house anti-diversion drug programs in which checkers were faced with numerous red-flag orders they had neither the time, resources nor staffers to check, and continued shipping suspicious orders (unusually large or more frequent) anyway.
Attorneys for the defense sought to portray Carter as a high-paid hireling for lawsuit litigants, contending the companies are the unfair targets of wrongful litigation that is asking for wildly inflated damages.
The state is asking for damages of $32.8 billion initially to fund treatment and related programs, but with more coming from penalties and surrendered profits the total could reach $95 billion.
According to the Washington State Department of Health, 1,200 people died of opioid overdose in the state in 2020.
In testimony and presented documents, Carter alleged the three companies did not maintain effective controls against drug diversion (into the wrong hands), that they relied on artificially high thresholds (supply limits), and that they failed to generate customer information.
Inadequate staffing with insufficient training at the companies to check suspicious orders was also a reason, the state maintained.
As a result, the companies allegedly failed to identify and report suspicious orders.
“They were shipping suspicious orders,” Carter told Smith. “Prior to 2007 they shipped all of them.”
Carter conceded that some suspicious orders were stopped.
She said one red flag was a customer who paid for drugs in cash. Ordering by internet was also listed as an alleged culprit in the drug increase as were chain pharmacies.
Carter said orders of unusual size from pharmacies such as Jim’s Pharmacy in Port Angeles (Clallam County) a city of 20,000 in population; from 2007 to 2009 showed a big increase.
“We see a large volume (to Jim’s) and we didn’t see any due diligence (from McKesson),” Carter said.
She added there was a spike in the supply of the drug oxycodone.
“The purchases from McKesson of oxycodone were of unusual size and deviated from the usual (ordering) pattern,” Carter said.
“Is it appropriate for a distributor to defer to a customer on due diligence?” Smith asked.
“No,” Carter said.
In addition. Carter said threshold limits for supplies of drugs were increased in some cases by 50%.
“Was this consistent with control of (drug) diversion?” Smith asked.
“Absolutely not,” Carter replied. “The ordering defies any semblance of justification.”
Carter indicated the shipment of higher dose pills, the 10 milligram instead of 5 milligram of drugs like hydrocodone, had exacerbated the problem.
In 2007, Horen’s Pharmacy in Burlington, Wash. had received from Cardinal Health 22,712 units (pills).
“Why is that significant?” Smith asked.
“Becausae it’s 62 times more than the average,” Carter said.
“Is that a significant red flag?”
“Yes.”
Under cross examination Paul Schmidt, the attorney for McKesson Corp., called Carter an expert witness for plaintiffs pursuing litigation against drug companies.
“Since your being recruited by plaintiff lawyers, you’ve been in seven (court) cases. How much have you been paid?” Schmidt asked.
Carter said $1.9 million.
Schmidt said that was more than her DEA yearly salary in the range of $200,000.
Schmidt asked Carter if drug companies had a right to expect guidance from the DEA?
“Of course,” Carter answered. “I don’t know if it’s a right, but they could expect it.”
“You didn’t conduct an investigation of orders flagged or non-flagged?” Schmidt asked.
“I looked at the due diligence documents,” Carter said.
Schmidt took issue with Carter's portrayal of Jim's Pharmacy in Port Angeles as a heavy over-user of opioids.
"Jim's serves a much larger area than Port Angeles," he said.
"The entire (Olympic) Peninsula," Carter agreed.
"It's a large area."
"It includes Seattle, yes," Carter said.
Schmidt displayed a document that showed McKesson officials were looking at the elevated ordering (Jim's) and trying to understand why.
"They (Jim's) serve two major pain clinics, one hospital and one from an Indian tribe," Schmidt said.
"Yes," Carter said.
The pharmacy also served nursing care, hospice and long-term care facilities.
"It's a high-volume pharmacy, correct?" Schmidt asked.
'Yes," Carter responded.
Schmidt said rural patients often received non-controlled substances by mail, but went into a pharmacy to get controlled substances.
He displayed documents asserting that patients were drug-screened before receiving medications, that new patients were checked for their IDs and that McKesson had reduced threshold ordering limits requested by customers, in one case down from 29,000 units to 25,000, from 16,500 to 13,000 in another.
“Is it the prescribing doctors' responsibility when they prescribe for a medical need? Are doctors supposed to have a doctor/patient relationship and make a judgment?” Schmidt asked.
“Yes,” Carter agreed.
“Did the DEA ever announce a level of supply appropriate for Washington, yes or no?”
“Not to my knowledge,” Carter said.
Schmidt exhibited a document that said the DEA recognized that the overwhelming majority of distributors had acted lawfully and took appropriate measures to prevent drug diversion.
He added that the DEA changed its policy in 2006 and 2007. Formerly, distributors issuing suspicious order reports continued to ship orders. That was changed to where if a suspicious order could not be resolved satisfactorily, the order was suspended. However, the DEA did not formally approve the new provision.
Schmidt said McKesson, during the 2007 time period, issued daily suspicious reports including a Rite Aid Pharmacy in Vancouver to the DEA, faxing them to the agency and issuing bigger reports monthly.
“Were you aware they (McKesson) actually called (February 2008) the DEA over an order that was suspicious?” Schmidt asked.
“That was after the fact, something that had already been shipped,” Carter said.
“Are you aware that before 2008, if McKesson was suspicious of an order, they would do a manual block?”
“I don’t know if orders were blocked,” Carter said.
Schmidt said officials at McKesson were notifying customers they were getting close to their threshold limit of supply.
“See that? (threshold warning). It's on an invoice,” Schmidt said.
“Yes,” Carter responded.