In a trial accusing Walgreens pharmacies of causing an opioid epidemic in Florida, defense attorneys on April 26 attempted to undermine the testimony of a former professor of pharmacy, questioning his methodology in a study that alleged the pharmacies had ignored red flagged suspicious prescription orders.
“A red flag doesn’t mean a prescription is invalid,” Steve Derringer, attorney for Walgreens, said.
“Yes,” Paul Doering agreed.
Doering had said he hoped the defense attorney was not going to “cherry pick” the evidence.
The trial in Pasco County in Port Richey is being streamed live courtesy of Courtroom View Network.
The company was sued in 2018 by then-Attorney General Pam Bondi and then inherited by the current Attorney General Ashley Moody. Walgreens is accused of flooding the state with pills engaging in irresponsible prescribing even to include ignoring drug transactions in its parking lots.
In 2013, Walgreens agreed to pay $80 million for violating the Controlled Substances Act and negligently allowing drugs to be diverted for abuse and black market sales. The U.S. Drug Enforcement Administration served Walgreens with suspension orders because of drugs being diverted. Walgreens at the time was the largest provider of the drug OxyContin in the state.
Florida, along with West Virginia and Alabama, has had one of the highest rates of opioid addiction in the country.
Plaintiff attorneys said the epidemic resulted, starting in the 1990s when the medical community, misled in the beginning by a few “opioid revisionist doctors” and later by drug manufacturers and distributors, eased what had been a tight policy of prescribing opioids mostly for end-of-life and cancer treatments. Instead, they argued, doctors began recklessly prescribing opioid drugs for less serious non-cancer conditions. In addition, anti-drug diversion in-house programs required of the companies by the DEA were ineffective, too many suspicious orders and too few checkers, plaintiff attorneys contended.
Defense attorneys blamed the DEA for setting a maximum quota system that allowed too many drugs to be manufactured. They also argued 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.”
Officials of Purdue reached an $8.3 billion settlement agreement with the government in 2020 after admitting the company had knowingly conspired to aid doctors who were dispensing the drugs without a legitimate medical purpose.
The original Florida lawsuit included as defendants CVS Pharmacy, Teva Pharmaceutical, Allergan and Endo International. Those companies settled with the state for more than $878 million last month.
Doering, a retired professor from the University of Florida Department of Pharmacotherapy, testified for a second day. He defended his findings that between the years 2006 and 2020 Walgreens pharmacies ignored 89 percent of suspicious orders that had been red-flagged, and filled the prescriptions.
Derringer displayed exhibits intended to show the need to prevent patients from suffering with chronic pain (non-cancer) conditions, a policy backed up he indicated by the Centers for Disease Control. A chart said, “CDC policy in 2016 was intended to be flexible, but had been inconsistent, misapplications to include a rigid application of dose thresholds.”
This was intended to counter Doering’s opinion that too many pills were being prescribed but also in dosages that were too high, for example 200 milligram pills.
The 2016 CDC policies are being updated for 2022, but the new guidelines are still in draft form.
Rigid limits on treatment could harm a patient, the document said, and result in untreated or undertreated pain.
“The benefits and risks to patients might differ,” the document further stated, “if a clinician is a pain management specialist.”
Derringer took issue with Doering’s earlier testimony that dangerous mixing of drugs was taking place called “cocktails,” an opioid prescribed for use with another drug, resulting in cascading side effects. One such secondary drug is benzodiazepine, sometimes referred to as “benzos,” used to treat anxiety.
“There are legitimate reasons why a patient might receive an opioid and a muscle relaxer (drug),” Derringer said.
“Yes sir,” Doering said.
“You agree that sometimes it (high dose) is needed to treat chronic pain conditions.”
“Yes.”
One such strong drug used for opioid-tolerant patients was a fentanyl-based product that comes in a patch called Duragesic. A graphic said such drugs can be used, “for an extended period of time with a patient who cannot be managed by other means.”
Derringer also called attention to an article in the New England Journal of Medicine that said a patient with non-cancer pain could be treated with a “minimal” risk of addiction, and in most cases doses of opioids up to 195 milligrams are considered moderate.
“That’s what she (Journal author) said,” Doering agreed.
“The New England Journal of Medicine is one of the most prestigious (medical publications) in the world,” Derringer said.
“I would agree with that, unless an article is retracted and some are,” Doering commented.
“You have no idea how many prescriptions were refused (by Walgreens pharmacists)," Derringer said. "If it wasn’t documented (noted), it didn’t happen.”
“Yeah, we can settle on that,” Doering responded.
“Simply because a pharmacist didn’t write it down.”
“That’s right.”
A testy rebuttal came when Derringer questioned Doering’s earlier testimony that he had spent approximately eight minutes reviewing each of 1,977 prescriptions. Using a hand calculator (while Doering used his own), Derringer arrived at a lesser figure, an estimation of perhaps 45 seconds to two minutes per prescription.
“You’re asking about failure to account for every hour of the day,” Doering said. “This is my honest testimony.”
Under redirect examination by state attorneys, Doering was asked if red-flagged orders were ever unclear to Walgreens pharmacists.
“Not in my opinion,” he said. These (red flags) are things that should wake a pharmacist up, (cause him to say), ‘say what?’ They are over-prescribers.”