An expert witness and former Drug Enforcement Administration agent testified Wednesday that, out of thousands of drug transactions, the three drug firms accused of fueling the region’s opioid crisis reported only a handful, despite data showing thousands more should have been flagged.
The city of Huntington and Cabell County are accusing the “Big Three” drug wholesalers — AmerisourceBergen, Cardinal Health and McKesson — of sending excessive shipments of opioids into the area for eight years, before a reduction in the number of pills shipped made users turn to illicit drugs.
The defendants say the DEA, doctors and West Virginians’ poor health are the culprits.
Testimony opened Wednesday with Cabell County attorney Paul Farrell Jr. calling James “Ralf” Rafalski, a retired diversion investigator at the DEA, to the stand as an expert witness. Rafalski had been asked by plaintiffs to review transactional and other data to conclude if the defendants were culpable in the opioid crisis.
The defense objected to his testimony and Senior U.S. District Judge David Faber, who will decide the case in the bench trial, elected to conditionally allow it and rule if Rafalski would be considered an expert at a later time.
Rafalski said he found that the defendants were a substantial factor in the diversion of pills into the illicit market in Huntington and that they should have known, or at least been suspicious, that it was occurring. He added that it was a systemic, widespread problem.
From 2002-18, AmerisourceBergen shipped 35.4 million dosage units of hydrocodone and oxycodone to Cabell County. From 1996 to 2018, Cardinal Health shipped 35.1 million dosage units and, from 2004-18, McKesson shipped 7.6 million dosage units into the county.
Rafalski’s testimony showed that, at the time those dosage units were being shipped, there were six main systems to calculate opioid pill shipment thresholds since the late 1990s. He said that, no matter which system you input the defendants’ shipment data into, anywhere from 20% to 99.8%, most categories showing more than 50%, of their shipments — amounting to millions of pills — should have been flagged and reported to the DEA.
But, of 77,398 transactions from 2007-18, AmerisourceBergen flagged just 45 cases and reported them to the DEA. Cardinal Health reported 291 of its 92,915 transactions from 1997 to 2018. McKesson reported 79 of its 18,862 transactions during that same time period.
Combined, it amounts to 415 of 189,175 transactions.
As an example, Rafalski pointed to specific April 2007 transactional data from Cardinal Health to The Medicine Shoppe, in West Huntington.
For The Medicine Shoppe, Cardinal Health took the average retail pharmacies from that distribution center and multiplied it by four, creating a threshold limit of 104 grams per month of opioid orders. If it hit that limit, it didn’t stop the shipment, Rafalski said, it just meant it was reported to the DEA in the next month.
He said that, in April 2007, for example, The Medicine Shoppe purchased 157 grams worth of oxycodone, about 150% above its original threshold.
Farrell said this is what happened when the fire alarm went off and no one responded.
Taking over questioning Wednesday afternoon, McKesson attorney Paul Schmidt spent most of the examination attempting to impeach Rafalski’s testimony as false, pointing to differences in his questioning Wednesday to a deposition taken in 2020.
Rafalski’s findings are based on data analysis of another person, Craig McCann, which left room for human error, Schmidt said.
The DEA has worked to come up with an estimation of how many pills have been diverted into the illegal market in the past two years. Using its method, the DEA believes just .01% of opioid pills have been diverted. Rafalski said he does not agree with the DEA’s methods.
Schmidt said Rafalski’s findings did not include prescription data from doctors. Schmidt said they have no duty to determine if those prescriptions are legitimate and quoted DEA leaders in saying 99.9% of doctors act in good faith when prescribing opioids.
The DEA also is to blame, Schmidt said, stating that, from 2003-13, the DEA authorized higher pill production quotas, increasing more than 400%, and was slow to respond to the dramatic increase of opioid abuse.
“I believe everybody probably bears some responsibility in the opioid crisis,” Rafalski said, later adding, “I don’t think there’s anyone in America that could say, ‘I did everything perfect.’”
Rafalski was asked to focus on the distributors and not the possible fault to the DEA, pill manufacturers or others, Schmidt said, despite him being hired by the plaintiffs to research those areas in other cases.
“Are there any opinions in the case that the lawyers did not ask you to give?” Schmidt asked.
While drug distributors are the focus of this trial, the governments have active cases against manufacturers, pharmacies and others that have not yet gone to trial.