SEATTLE (Legal Newsline) - Defense attorneys on Tuesday sought to portray their clients, three of the biggest distributors of opioid drugs in the U.S., as taking appropriate steps in the early 2000s through 2014 to safeguard the public by establishing in-house systems to check suspicious drug orders.
A lead witness called by the State of Washington disagreed.
“The U.S. Drug Enforcement Agency (DEA) had the legal obligation to investigate the extremely small fraction of registrants,” Joe Rannazzisi, former head of the Office for Diversion Control with DEA told a courtroom. “They can cause enormous harm. It only takes a few to create large pockets of addicts.”
Rannazzisi said the total number of over-prescribing doctors was “extremely small.”
The companies, McKesson Corp., Cardinal Health and Amerisource Bergen Corp., are accused by the Washington State Attorney General’s Office of not properly monitoring suspicious orders which resulted in illicit diversions of drugs falling into the wrong hands, and causing an opioid epidemic.
A suspicious order is one that deviates from a normal pattern of size (number of pills) or a change in the frequency of orders. The distributors take the pills from the manufacturers and supply them to hospitals, doctor’s offices and pharmacies.
As on Monday the trial saw previous testimony given by Rannazzisi that was recorded from him last June. Attorneys for both sides sat in a witness box and read out Rennazzisi’s responses to the questions.
Later in the day a trial judge for the Coleville Native American Reservation in Eastern Washington called as a witness by the state recounted for the courtroom how opioid drugs had devastated her community.
Rannazzisi formerly served as a director of the DEA and was tasked with ensuring that distributors obeyed the guidelines of the Controlled Substances Act (CSA), a federal law passed in 1970.
He testified that in the early 2000s through 2014 the system had broken down and the market was flooding pills to the public causing a sharp rise in overdose deaths.
Before retiring in 2015, Rannazzisi oversaw a big increase in the quotas that set how many opioid pills manufacturers could sell. He came to national fame in 2018 after appearing on “60 Minutes” criticizing federal opioid policy as too lax. Since his retirement, beginning in 2017 he became a consultant expert paid an estimated $850,000 working for private lawyers representing state and local governments suing the opioid industry.
Paul W. Schmidt, the attorney for McKesson Corp., told the court government officials believed that more guidelines should have been provided to distributors by the DEA.
“Did you understand that?” Schmidt asked.
“Yes,” Rannazzisi replied.
“Do you agree that if a (drug) threshold is too low it can impact the patient and the pharmacy (negatively)?”
“I can’t agree or disagree,” Rannazzisi said.
“The opioid crisis worsened during your tenure,” Schmidt said.
Rannazzisi agreed.
“You take no responsibility?”
“I don’t take any, no,” Rannazzisi said.
He said the DEA had followed the letter of the law and had done the best they could under the circumstances.
Rannazzisi said he retired in 2015 after his job was discontinued and he was bound for a transfer that was unspecified.
Schmidt said Congress had opened an investigation on him.
“Two reps (Congress) claimed I attempted to intimidate them,” Rannazzisi said.
During questioning by Ashley Hardin, the attorney for Cardinal Health, Rannazzisi agreed that not all pain doctors prescribed medicines in a “rogue fashion.”
“You never told them (distributors) they should be collecting (drug) dispensing data from customers?” Hardin asked.
“I never said they should collect, I said they should review (orders) for anomalies,” Rannazzisi explained.
Rannazzisi said he had never personally studied in detail Cardinal’s in-place “Suspicious Order Monitoring System” during the early 2000s. He also said he could not remember if DEA officers had told Cardinal officials at the time concerning their order checking, that “You’re doing the right thing.”
Under questioning by Linda Singer, the attorney for the state, Rannazzisi said the obligation to make certain that orders were not getting into the wrong hands was on the distribution companies, not the DEA.
“Only the registrant can conform their (checking) system to their business plan,” Rannazzisi said.
Sophie Nomee is a trial judge with the Coleville Native American Reservation, a 1.4 million acre tract in Eastern Washington that is its own sovereign nation with its own set of laws. The reservation has 1,500 residents and 11,000 tribal members.
Called as a witness by the state, she said the most common opiates on the reservation were oxycodone and hydrocodone in addition to the hard drugs heroin and cocaine.
“What percent of criminal cases involve opioids?” David Ackerman, a state attorney asked.
“About 80%,” Nomee answered, "50% of civil cases.”
Nomee said tribal court caseloads concerning drug abuse had increased in recent years including rises in the drugs methamphetamine and fentanyl.
The impact of opiates on the reservation she said had produced an increase in crimes most commonly domestic violence and theft. It was also breaking up families as children had to be separated from addicted parents for their own safety.
“Do you believe there is an opioid epidemic at Coleville?” Ackerman asked.
“Yes,” Nomee responded.
Nomee said she had lost her own sister and sister-in-law to drug overdose and added that the damage included the cultural as well as physical.
“A parent is addicted and their children don’t participate in tribal functions, ceremonies and traditions,” she said. “They don’t speak the language. They feel lost.”
Nomee said most of those addicted are 20 to 40 years old.