CHARLESTON — Fingers were pointed and blame was thrown all around a federal courtroom as a retired Drug Enforcement Administration official and attorneys for three drug distributors butted heads for a second full day of testimony.
Joe Rannazzisi, the former director of the DEA’s Office of Diversion Control, was under cross-examination for the entirety of June 9’s testimony by attorneys for AmerisourceBergen, Cardinal Health and McKesson.
Huntington and Cabell County sued the nation's three largest pharmaceutical distribution companies in 2017 seeking to hold the companies accountable for their alleged part in the opioid epidemic by sending more than 540,000 opioids each month to independent and chain pharmacies – excluding hospitals and/or hospital pharmacies – located in Cabell County.
Rannazzisi is under a Touhy authorization that limits his testimony to protect the inner workings of a federal program. Like they did the day before, the defendants objected several times on various grounds –including hearsay, relevance and saying Rannazzisi’s testimony should not sound as if he is speaking on behalf of the DEA.
When he did answer questions, Rannazzisi often was limited to yes or no answers.
Paul Schmidt, representing McKesson, resumed his cross-examination when court resumed Wednesday. His questions tried to pin changes made when Rannazzisi stepped into his role led and vagueness from DEA directives and Rannazzisi for issues that led to opioids being diverted into Huntington and Cabell County as well as other communities across the country.
“The DEA cannot tell a registrant if an order is suspicious,” Rannazzisi testified. “I don’t think we’ve even taken action against a registration for shipping one suspicious order.”
While he said the overwhelming majority of distributors – as well as doctors, pharmacies, hospitals and drug manufacturers – act responsibly, Rannazzisi, did say drug distributors were at least partly to blame for the epidemic.
“It was up to a distributor to determine if an order was suspicious,” Rannazzisi said. “The DEA had no internal guidance about suspicious orders.”
In letters sent by Rannazzisi shortly after he stepped into his position, the DEA told the distributors they had a duty to do due diligence regarding suspicious orders to keep them from being diverted. He said DEA officials also conducted meetings and seminars with distributors to provide guidance.
While questioning Rannazzisi, Schmidt said before 2008, the drug distributors shipped suspicious orders and reported them to the DEA. In 2009, policy was changed to make it so suspicious orders weren’t filled before being reported it the DEA.
Several times during questioning, Rannazzisi said simple numbers don’t make an order suspicious.
“It’s not just that it reached a certain threshold,” he said. “Explain why this pharmacy is doing something suspicious. Don’t just say that they’re above a threshold. That means nothing to us. Just being over a threshold is not suspicious.
“Identify what the issue was with a suspicious order. They (the distributors) were supposed to explain the reason it was a suspicious order.”
Schmidt asked about DEA changes in 2006 to allow physicians to prescribe opioids to patients with less frequent visits, such as by allowing a doctor to write three 30-day prescriptions to keep patients from having to come in every month.
Rannazzisi cited the example of a student away for college needing an ADHD drug but not being able to return home every month to get a refill.
“Doctors should not hesitate to provide patients with whatever treatment they feel necessary,” Rannazzisi said. “We made numerous statements about how patients should get appropriate medical care to relieve pain.
“But, a college student four states away isn’t the only reason. It’s palliative care, hospice care, end of life care. We thought it wouldn’t be prudent, if that patient passed, to have those pills in someone’s medicine cabinets. There’s no quantity limit on a Schedule 2 prescription.
“This ruling was supported by a wide variety of individuals and groups. Believe this final rule would be beneficial for both physical and financial … less frequent visits to physician.”
Schmidt asked him if he supported the rule.
“Yes, I did,” Rannazzisi said. “I reviewed the rule and gave my input. Then it subsequently went through the ruling process.”
Schmidt also asked Rannazzisi several times if he ever pushed or followed DEA guidelines he didn’t agree with. One example was Congressional testimony when he said the most frequent way of people obtaining pills for non-medical use was via friends and family.
“I was the government vehicle to get that message to Congress,” Rannazzisi said. “I presented views that I didn’t agree with, but I don’t know or can’t say that they were false.
“Again, that is the view of the administration. When I testify before Congress, I’m not testifying as Joe Rannazzisi. I’m presenting as the administration.
“In my opinion, I didn’t agree with that statement. But I don’t know if it’s false.”
Schmidt asked Rannazzisi if he told Congress he didn’t agree with the statement.
“That isn’t how Congressional testimony works,” Rannazzisi replied. “No, I never did. That’s the government’s position. I wouldn’t do that. It isn’t something we’d do.
“As I said before, I didn’t agree with it. But they had a survey to back it up, so I presented it.”
Schmidt asked if Rannazzisi had contrary data to that statement.
“Yes, our investigations,” he replied. “Once it’s in the patient’s hands, if it’s stolen, it’s stolen. It isn’t necessarily diversion.
“That form of theft can occur even if the distributor, pharmacy, prescriber, manufacturer does what they’re supposed to do. It still can be stolen or given away.”
Rannazzisi also said the DEA encouraged physicians to obtain guidance from their state medical boards.
“Distributors can’t second guess medical decisions, can’t prescribe, can’t see patients, don’t have access to individual medical records,” he said. “The state dictates the practice of medicine and pharmacy, so it’s what the state believes is appropriate.
“As long as it has the correct licensure requirements under the state, the DEA has no method to question it.”
Schmidt noted that Rannazzisi had “ultimate authority” for 10 years during the opioid crisis.
“You were the senior-most law enforcement official at the DEA for pharmaceutical diversion,” Schmidt said. “And you take no responsibility for the opioid crisis? Zero percent?”
“No,” Rannazzisi said. “Zero percent … in mind with what the law allowed us to do.”
“Did you execute those powers properly?”
“Yes, as we were allowed.”
“Do you believe you gave perfect guidance to distributors?”
“We gave them the guidance we were able to give in the confines of policies and procedures.”
Wednesday’s testimony ended with Jennifer Wicht, representing Cardinal Health, and then Robert Nichols, representing AmerisourceBergen, questioning Rannazzisi.
“There are pain clinics that are legitimate practice of medicine,” Rannazzisi told Wicht. “There are also prescribers who specialize in treatment of pain. Just because a doctor is a pain specialist doesn’t mean they’re prescribing in any sort of rogue fashion.
“We would not tell a registrant this is suspicious, don’t ship it.”
Nichols’ cross-examination of Rannazzisi will resume Thursday.
Huntington is represented by Anne Kearse, Joseph Rice, Linda Singer and David Ackerman of Motley Rice and Rusty Webb of Webb Law Centre. Cabell County is represented by Paul Farrell Jr. of Farrell Law, Anthony Majestro of Powell & Majestro and Michael Woelfel of Woelfel & Woelfel.
AmerisourceBergen is represented by Gretchen Callas of Jackson Kelly and Robert Nicholas and Shannon McClure of Reed Smith. Cardinal Health is represented by Enu Mainigi, F. Lane Heard III and Ashley Hardin of Williams & Connolly. McKesson is represented by Mark Lynch, Christian Pistilli, Laura Wu and Megan Crowley of Covington & Burling.
U.S. District Court for the Southern District of West Virginia case numbers 3:17-cv-01362 (Huntington) and 3:17-cv-01665 (Cabell)