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Saturday, April 27, 2024

Drug distributors slam plaintiff’s causation and misconduct argument

Federal Court
Byrdcourthousewv

CHARLESTON – Three of the nation’s largest pharmaceutical distribution companies pushed for a trial dismissal as the plaintiffs wrapped up their case at the bellwether federal opioid trial.

During a day of motions July 1, the drug distributors maintained the plaintiffs continuously have failed to give substantial evidence of misconduct. 

The City of Huntington and Cabell County sued the distribution companies –AmerisourceBergen, Cardinal Health and McKesson Corp – in 2017, seeking the parties be held responsible for their part in the opioid epidemic. Five of 77 pharmacies in Cabell County and Huntington, received over 23.2 million pills between 2006 and 2014 according to DEA data. 


Majestro

On behalf of Cabell County and the City of Huntington, Paul Farrell Jr. motioned to rest the plaintiff’s case, entering a day of motions. 

“We are not arguing the defendants are the only ones responsible,” attorney Anthony Majestro, representing Cabell County, told U.S. District Judge David Faber, who is conducting the bench trial. “We are arguing we have provided enough evidence [showing] they are a substantial factor in this opioid epidemic”

Attorney Timothy Hester, representing McKesson, asked for a Rule 52(c) motion, on behalf of all three defendants, to dismiss the case based on lack of foundation. 

Hester argued the plaintiff’s failed to show proximate causation to the “flood of pills” claim being used. 

“The evidence is overwhelming and incontrovertibly,” Hester said. “The flood of pills, if there was one, was due to overprescribing.”

Hester pointed out several testimonies where witnesses said the increase of prescriptions and a change in standard care kicked off the epidemic.

“The increased volume was caused by doctor prescribing,” Hester said. “The opioid crisis would not have occurred if prescribing opioids had not become standard practice.”

Referencing testimonies from James Rafalski, a former DEA official, and Joe Rannazzisi, who retired from the DEA as Deputy Assistant Administration Office of Diversion Control in 2015, Hester said “distributors can’t second-guess prescribers.” The other defendants supported this argument. 

“This increased prescribing was undertaken in good faith in their best medical judgement based on what was needed to treat pain,” Hester said. 

Hester argued that once pills leave the pharmacy and are in the community, the distributors no longer have control of the drugs – usually becoming medicine cabinet diversion.

Hester presented a previous statement from Sheriff Chuck Zerkle in which he referred to Huntington as “Little Detroit” due to the large Detroit-based heroin traffickers. 

Defendants continue to claim two separate epidemics are occurring – prescription opioids and illicit opioids. 

Attorney Robert Nicholas, representing AmerisourceBergen, argued the plaintiff’s case had a “total absence of any proof of wrongful conduct.”

“Isn’t wrongful conduct under the nuisance theory,” Faber asked. 

“I believed unreasonable conduct has to be established,” Nicholas said. 

Nicholas argued that there was little cross-examination of the four AmerisourceBergen company witnesses and there was no negative testimony. He said Mike Perry, ABDC sales rep, spoke with great emotion and pride about Huntington. Perry knew the pharmacies in "great detail" and Nicholas said if there was any evidence of missed diversion, Perry was the one to ask, but the plaintiffs failed to do so. 

Nicholas said every ABDC customer was licensed and registered by the DEA. He also said no one disputed the company reported suspicious orders for pharmacies and not one single order that should have been reported went unnoticed. 

Faber questioned the evidence of a failure of a suspicious order reporting system and the responsibility the defendants should have if they recognized it as the plaintiffs claim. 

“Was there any evidence of misconduct in Cabell or Huntington? The answer is no,” Nicholas said. “I think the plaintiffs are faulting to Plan B, that there’s some systematic failure. Evidence is to the contrary.”

Nicholas argued the plaintiff’s only argument is the volume of pills. 

“The evidence of volume is not new, it isn’t uncovered, it isn’t discovered. The DEA had this,” Nicholas said. “The number of pills distributed match the number of pills prescribed. One to one. They were mirror images. Witness after witness said that.” 

Attorney F. Lane Heard III, representing Cardinal Health, said the company supported everything Hester said. 

“There’s a failure to prove cause and effect in this case,” Heard said. “There is no proof in this case if Cardinal Health [had] done more due diligence, had it blocked more orders… [it] would have diminished one pill coming into Cabell/Huntington.”

Heard said 99.9 percent of doctors were prescribing appropriately and that “cutting off a customer would not cut off a supply, only the DEA [can], as Mr. Rannazzisi testified.” He said the DEA knew the total volume of pills in every pharmacy across the nation. 

Heard argued the plaintiffs also failed to support or show where the federal court has done what is being asked in this trial. 

Faber mentioned he had wondered if the “law was broad enough to cover this cause of action.”

Hester argued the plaintiffs were seeking damages, not abatement and that abatement “does not include downstream harms of public nuisance.”

Heard said everything was lumped together and the legal remedy was not tailored to the defendant’s wrongful conduct or period the wrongful conduct occurred. 

“You got addicted to opioids before 1990 and you’re still alive today, you’re in the abatement plan. You became addicted in Vegas and moved to West Virginia, you’re under the plan. You are not born today, you’re under the plan,” Heard said. 

Majestro said the epidemic is not limited to those fallen to opioid use disorder. 

“[The] opioid epidemic is made up of different parts, but it’s one epidemic,” Majestro said. 

Attorney Christian Pistilli, representing McKesson, argued the plaintiffs failed to “prove unreasonable conduct and substantial factor in bringing about the present-day opioid abuse problem in Huntington and Cabell County.”

Pistilli said McKesson’s shipment volumes into Cabell/Huntington were relatively small at less than 6% and there was no evidence of diversion into the area. He also said McKesson was blocking all suspicious orders at the time. 

Hester said “case law recognized a claim should be dismissed if plaintiff fails to give the court guidance along relief seeking.”

“They have not given enough, they’ve thrown it up to the court and said, ‘you figure it out,’” Hester said. 

Hester said the plaintiffs have waived all damage claims, including punitive, which is what he feels plaintiffs are seeking. 

Hester argued that settlement the plaintiffs are seeking is heavily based in the future and it would lead to an improper windfall.

“Lead to fundamentally unfair windfall in two respects,” Hester said. “The city and county do not pay for or run the programs. No analysis of needs was done.”

Hester said the community may be doing enough. 

“Evidence is quite strong there is a set of powerful programs in this community,” Hester said. “In fact, they may have done everything that is needed. It may take some time, but as we heard over and over again from the community leaders, they’re doing a lot already.”  

Majestro argued this was a plus for the defendants. 

“They [defendants] have the advantage of being sued by somebody who actually did their best to solve this problem. There’s still an opioid epidemic in Cabell County so they’re obviously not doing enough,” Majestro said. “What’s being done now is not being done by the defendants. The fact that other people are paying for it and not the people who caused the problem should be what concerns us”

Majestro argued this was not a novel cause of action and the plaintiffs believed motion 52(c) should be denied. 

Majestro said there are 41 similar cases rejecting the defendant’s argument across 23 states. 

“This claim is not a stretch anymore," Majestro said. "It’s substantial." 

Faber shared his concerns throughout the day. 

“The subject that has troubled me in this case, that’s whether this is really a nuisance case at all,” Faber said. 

Majestro referenced different cases and said, “The nuisance standard that they’re willing to accept is that the conduct just needs to be unreasonable.”

Farrell later said, “a public nuisance is an act, not a condition. The condition left behind are the people.”

Majestro argued the defendants are registrants under the Controlled Substance Act and make money through the delivery of prescriptions. He said there is no suggestion on record that the defendants flooded the market with 80,000 pills accidently. 

“Four out of five heroin users began as prescription opioid users,” Farrell said. “The medical literature is as strong as it has ever been.”

Majestro argued this case was “entirely foreseeable,” citing cases where Congress was concerned of diversion from legitimate sources. 

“The evidence shows the transition of pills to heroin, when the pills started shutting down, that’s when heroin became evident,” Majestro said.

Majestro said the defendants failed to fulfill duties under the CSA. 

“When you don’t meet the duties under the CSA. Shipments are shipped that are likely to be diverted,” Majestro said. “No evidence defendants policies were any different here than they were anywhere else. They didn’t produce any evidence of that due diligence. But certainly, something as important as that, they could give us something”

Defendants presented briefs at the end of the day that plaintiffs said would be responded to accordingly with a case. Defendants will start presenting witnesses July 2. 

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)

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