A former top officer with the U.S. Drug Enforcement Administration in a state-led case accusing Walgreens Pharmacy of causing an opioid epidemic in Florida, said the company failed to adequately check the drugs it dispensed.
“They (Walgreens) did not maintain effective controls,” former DEA official Joe Rannazzisi told a jury on Tuesday.
It's the second week of trial at Pasco County Florida Sixth Circuit Court in Port Richey, and is being streamed live courtesy of Courtroom View Network.
The case against Walgreens, the country’s largest drug chain, was originally filed by former Florida Attorney General Pam Bondi in 2018. She accused the company of flooding the state with opioid pills and creating an epidemic of addiction. The current Attorney General Ashley Moody now directs the lawsuit.
Defense attorneys have countered the state by arguing that the DEA in its maximum quota system allowed too many drugs to be manufactured. They also argue argue that others caused the epidemic - pharmaceutical companies like Purdue Pharma, distributors like McKesson Corp. and AmerisourceBergen, internet pharmacies and irresponsible clinics known as “pill mills.”
Purdue Pharma, owned by the Sackler family, reached an $8.3 billion settlement agreement in 2020 after admitting company officials had knowingly conspired to aid doctors dispensing the drugs without a legitimate medical purpose.
The original Florida lawsuit included as defendants opioid distributors CVS Pharmacy, Teva Pharmaceutical, Allergan and Endo International. Those companies settled with the state for more than $878 million last month.
Rannazzisi, former head of the Office for Diversion Control with the DEA serving 29 years, appeared for two days as an expert witness for the State. While at the DEA until shortly before he retired in 2015, Rannazzisi oversaw an increase in the quotas that set how many opioid pills manufacturers can sell. He came to national fame in 2018 after appearing on “60 Minutes” criticizing federal opioid policy as too lax.
Rannazzisi has since become a $500-an-hour expert for private lawyers representing state and local governments suing the opioid industry.
On April 19, he said that for the Florida case he was only receiving reimbursement for his hotel and expenses.
He was asked why he was appearing as a witness basically for free.
“Because it’s about accountability,” Rannazzisi said. “Taking ownership for what you did. It (epidemic) could have been solved if people had just complied (with the law).”
Tom Schultz, attorney representing Florida, showed a graphic that said the DEA had served Walgreens with suspension orders because of drugs being diverted from its area stores. Walgreens at the time was the largest provider of the drug OxyContin in the state.
Six Walgreens stores were suspended including stores in Jupiter, Port Richey, Hudson, Ovedo and Fort Pierce.
In 2013, the company settled with government officials agreeing to pay $80 million in civil penalties for violating the Controlled Substances Act and negligently allowing drugs to be diverted for abuse and black market sales.
“Every registrant (store) has an obligation to maintain control over diversion,” Rannazzisi said. “We’re dealing with things that can kill people. You must look for red flags (suspicious orders).”
“Did Walgreens maintain effective controls?” Schultz asked. “What was your conclusion?”
“They did not maintain effective controls,” Rannazzisi said.
Schultz referred to comments from defense attorneys that he said hinted that other factors were involved in creating the epidemic.
“It has nothing to do with other things,” Rannazzisi said. “You’re supposed to do what the law says.”
Rannazzisi explained that quotas set by the DEA were required by statute, and told manufactures the amount of drugs they could produce for different purposes including medical needs, exports, scientific studies and industrial use.
“The quotas were based on justification provided by the manufacturers,” Rannazzisi said. “I had to give them that choice based on the needs of the country. The (quota) increases were based on individual justifications. The statute told us what we had to do.”
Rannazzisi disagreed with the defense argument that he said portrayed the DEA as arbitrarily increasing quotas without reason.
“People talk about the quotas being at fault (for the epidemic),” he said. “That has nothing to do with it. If everyone had been doing their jobs, the quota (increased amounts of drugs) would just be sitting on (store) shelves.”
Rannazzisi said the DEA during his tenure had 1,700 field investigators.
“Does the DEA have enough (officers) to post at every Walgreens?” Schultz asked.
“No,” Rannazzisi responded.
“What was your budget?”
“Two billion.”
“If you had had more resources, would you have done more?”
“A heck of a lot more investigations,” Rannazzisi said.
‘Did you do everything in your power to stop diversions?”
“I did.”
“Are you proud of your work?”
“Absolutely.”
Under cross examination, Kaspar Stoffelmayr, attorney defending Walgreens, focused on the pay Rannazzisi customarily received as a plaintiff witness and the DEA’s increasing of drug quotas during his tenure.
“You’ve made about $1.1 million in multiple cases, correct?” Stoffelmayr asked.
“Yes.”
“That’s $500 an hour.”
“Yes.”
“You have a pharmacy degree?”
“Yes.”
Rannazzisi added that he last practiced pharmacy in 1987.
“You had the top job for diversion control.”
“Yes.”
“Is it fair to say that in the DEA the buck stopped with Joe Rannazzisi?”
“That’s true.”
“There was an opioid crisis the whole time you were there (DEA),” Stoffelmayr said.
“That’s correct.”
“It got worse and worse didn’t it?”
“Yes.”
“You were responsible for coming up with the (drug) quotas.”
“Yes sir.”
Rannazzisi explained the quota is a maximum amount that could be manufactured in the U.S. for each class of drug, for example Oxycodone.
“There are people who think you made the opioid crisis worse with your quotas,” Stoffelmayr said.
“I’m sure there are,” Rannazzisi responded. “We’ve explained why the increases many times. There is a perfectly logical reason for it.”
Stoffelmayr exhibited a document noting that the Office of the Inspector General (U.S. Department of Justice) had done a review of the DEA in 2019. The review stated, “The DEA was slow to respond to dramatic increases in opioid abuse and needs to more fully utilize its regulatory authority and enforcement resources to combat and detect diversions.”
“That was a conclusion,” Rannazzisi said. “But they (OIG) interviewed me and did not use any of the information I provided for them. It’s like half of the story.”
A chart displayed said opioid-related deaths in the U.S. grew 8 percent from 1999 to 2013, and 71 percent from 2013 to 2017.
“Yet from 2003-2013 the DEA was authorizing manufacturers to produce substantially larger amounts of opioids,” the OIG document read. "Oxycodone increased 400 percent.”
‘I’m not sure that percentage is right,” Rannazzisi said.
“You think the OIG got the math wrong?”
“Yes I do.”
Rannazzisi said his estimate was in the mid-300 percent range.
He noted that if a drug supplier is sent an order to show cause, a hearing is held before an administrative law judge that gives a registrant the chance to present their evidence. Rannazzisi added that the hearing review process is a formal requirement.
“We can’t just take a (drug dispensing) registration away,” he said. “I can’t just say, I don’t like what you’re doing.”