CLEVELAND (Legal Newsline) - Pharmacists bear equal responsibility with doctors for allowing prescription painkillers to flood communities, triggering the opioid crisis, former Drug Enforcement Administration official Joe Rannazzisi testified in a landmark trial this week.
A star witness for lawyers representing two Ohio counties that are suing Walgreens, CVS and other pharmacy chains, Rannazzisi told jurors about an expansive and mostly unwritten set of “red flags” pharmacists are supposed to identify and resolve before filling prescriptions for opioids, even if that means calling physicians and questioning their medical judgment.
“You’ve got to examine the doctor,” said Rannazzisi. “You have to say: `Explain it to me. What are you doing here?’”
Rannazzisi ran the DEA’s Diversion Control Division until shortly before he retired in 2015, overseeing a massive 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. He has since become a $500-an-hour expert for private lawyers representing state and local governments suing the opioid industry.
He said he wasn’t being paid for his testimony in the case involving Lake and Trumbull counties, although he has earned the bulk of his income, more than $900,000, as a plaintiff expert since 2017 working with some of the same private lawyers. Those lawyers stand to earn more than $2 billion fees under settlements they have negotiated so far.
In testimony Tuesday and Wednesday, Rannazzisi helped attorney Mark Lanier navigate around what defendants say is a gaping hole in the plaintiffs’ case: They aren’t expected to identify a single improper prescription the defendants filled in Lake or Trumbull counties. Instead, they are trying to convince the jurors to equate violations of the rules – especially unwritten rules about documenting how pharmacists investigated and resolved red flags indicating suspicious prescriptions – with creating a public nuisance.
Rannazzisi’s testimony on Tuesday and Wednesday centered on a term the plaintiff lawyers have used throughout the trial: “Corresponding responsibility.” While the term appears in federal law, plaintiffs and defendants don’t agree on its exact meaning. Rannazzisi, who is a licensed pharmacist as well as a lawyer, said it encompasses a broad collection of duties that include investigating opioid prescriptions that have any of a number of red flags, from the prescribing practices of the doctor to whether the patient lives near the pharmacy. Unless each red flag is resolved and the resolution documented, Rannazzisi said, the pharmacist has violated his or her corresponding responsibility.
Over the objections of defense lawyers, Rannazzisi discussed a handful of enforcement actions the DEA took against individual pharmacies operated by three of the chains in Florida, California and Massachusetts. Those included the Holiday case where two CVS pharmacies in Florida were disciplined by the DEA. The case is important to the plaintiffs because the administrative law judge upheld the DEA’s legal theories that by ignoring red flags, the pharmacists increased the risk of diversion and harm to the community.
Rannazzisi also described how he approved several letters to DEA-licensed pharmacies nationwide during his tenure reminding them of their corresponding responsibilities to investigate suspicious prescriptions. This testimony supported plaintiffs’ legal case that the defendants, which include Walmart and Giant Eagle, a regional grocery chain, were on notice about their obligations and ran unreasonable risks by failing to adhere to them.
Most contentious was Rannazzisi’s claim pharmacists not only had a duty to investigate any prescription that had red flags, but to document how they were resolved, another rule that doesn’t appear in writing. Defense lawyers have challenged this assertion with Rannazzisi and other plaintiff witnesses to no avail, pointing out this requirement doesn’t appear in any written communications from the DEA.
Rannazzisi backed off from some of his statements under cross-examination by Jones Day attorney John Majoras for Walgreens. The DEA tripled quotas for opioid production while he was in charge of the division that set them, Rannazzisi conceded, undermining a central plaintiff claim that the opioid crisis was caused by excess supply in the system. If so, Rannazzisi confirmed, it happed under his direct authority as the official in charge of assessing the quantity of opioids needed to meet legitimate demand.
“We’ve always said legitimate patients should not be denied medication because of supply issues,” he said.
He also acknowledged the rules for opioid prescriptions were eased during his tenure to allow doctors to issue three sequential, 30-day scrips instead of limiting them to one. And in contrast to the idea that systematic failure to block improper prescriptions caused the opioid crisis, he acknowledged telling Congress in 2012 that “99% of doctors are perfect” and improper prescribing was limited to a small number of bad actors. DEA statistics show fewer than 1 in 10,000 prescribers lose their DEA license each year.
Asked directly if pharmacies had an obligation under federal law to call the doctor each time they are presented with an opioid prescription, Rannazzisi also said no.
“It doesn’t require a call for every controlled substance prescription,” he said, although he repeated that if there are any red flags they must do so. The defendants argue their individual pharmacists are in the best position to judge whether a prescription is suspicious, based upon their knowledge of patients and prescribers in their community.
Pharmacies complain the contours of “corresponding responsibility” are vague and don’t appear in any statutes or regulations. Rannazzasi said that is because pharmacies all serve different customers and that setting up systems to catch bad scrips is “a business decision.”
In earlier testimony, a plaintiff expert who once headed a major pharmacist group also said the pharmacy chains were guilty of failing to document how they resolved red flags. Carmen Catizone, the former chief executive of the National Association of Boards of Pharmacy, agreed the requirement isn’t in any federal regulations but said “everyone realized” it was a requirement.
Catizone, now working as an expert for plaintiff lawyers, was called to testify about a report he compiled with the help of a statistical expert based on nearly 8,000 randomly selected prescriptions from the two counties that the defendants turned over as evidence. Catizone and another expert found nearly all of them contained at least one red flag and said in each case the pharmacist should have documented how it was resolved.
On cross-examination, he acknowledged he only worked with materials the plaintiff lawyers gave him, and didn’t examine hundreds of thousands of pharmacist entries that the defendants also supplied. He also said he didn’t examine whether the prescriptions he flagged as suspicious were issued to cancer patients or people recovering from surgery, or whether patients he judged to live too far from the pharmacy had a job nearby that explained why they went there. He also had to walk back a statement that it was suspicious how few prescriptions were blocked in his database; a defense lawyer pointed out the plaintiffs only provided him with records for prescriptions that were filled.
Late Wednesday, a plaintiff lawyer questioned Brian Joyce, a retired former Walgreens district pharmacy manager overseeing pharmacies in Trumbull County who also served as president of the Ohio Board of Pharmacy, which disciplines pharmacists. The lawyer walked Joyce through statistics showing the five Walgreens stores in Trumbull County filled scrips for more than 26 million pills between 2006 and 2016 in a county with a population of 210,000, or a rate of 10 pills per person per year.
“Does that sound excessive to you?” the lawyer asked Joyce.
“It doesn’t seem to be a crazy number of pills,” Joyce responded, explaining that some patients may be consuming a dose every four hours, or 180 pills a month.
The lawyer then asked Joyce about his objection, while he ran the Board of Pharmacy, to a proposal to require pharmacists to use Ohio’s electronic system to check every prescription to make sure patients weren’t obtaining drugs from multiple prescribers or engaging in other misconduct. Joyce said it was because he believed the system “wasn’t ready for prime time” and would consume pharmacist time that was better spent interacting with patients.
“You were putting profits before public safety, weren’t you?” the lawyer asked.
“No,” Joyce responded.