CHARLESTON – Attorneys for Cardinal Health and McKesson presented closing arguments in hope of convincing U.S. District Judge David Faber the distribution companies should not be held liable for any part in the opioid epidemic.
Faber is overseeing the bellwether federal bench trial where the City of Huntington and Cabell County filed suit against three pharmaceutical distribution companies – AmerisourceBergen, Cardinal Health and McKesson – 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.
“We’re not disputing the opioid problem,” said Enu Mainigi, representing Cardinal Health. “Over 32 trials days, the court heard very little from Cardinal Health’s conduct.”
Mainigi
Mainigi claims the plaintiffs completed failed to show any misconduct from Cardinal Health. While she does not deny Cardinal sent a high volume of opioid pills to Huntington/Cabell County, she argued that does not prove misconduct.
“Volume does not equal wrongdoing,” Mainigi said. “What caused the increase in volume was the change in standard of care.”
Mainigi argued that the plaintiffs failed to identify any orders shipped to the Cabell Huntington area that were deemed suspicious.
She pointed to several evidence pieces that showed the change in standard of care and the push to address pain treatment more resulted in the increase of opioid prescriptions, citing the push came from the American Pain Society, Drug Enforcement Agency (DEA), the Board of Medicine, the Joint Commission and even the Center of Disease Control (CDC).
“Supply does not drive demand,” Joe Rannazzisi, who retired from the DEA as Deputy Assistant Administration Office of Diversion Control in 2015, had testified.
“Their [plaintiffs] economists would disagree with that,” Faber said.
Mainigi argued Rannazzisi was “on the ground” and had firsthand knowledge.
“That demand is what drives the supply and that determines the volume,” Mainigi said. “What happens in healthcare – we reflect it, we don’t drive it.”
“Is there some point that number could be so great that it would be unreasonable,” Faber asked.
Mainigi was unsure there is a number for that.
“They have to provide a context for the particular volume,” she said. “I think in this case, your honor, when there is a complete matchup of the prescriptions distributed to the prescriptions being written, that is not a high up [number]."
She said Craig McCann, data consultant, said that prescriptions and distributors are “two sides of the same coin.”
Mainigi argued that distributors were responding to the need of prescription opioids being requested by pharmacies to fill prescriptions my licensed doctors who were following the change in standard of care and treating pain as the fifth vital sign, as well as the DEA’s statement that pain was undertreated in the United States and opioids were the best treatment for severe pain and the Attorney General citing there was “too much focus on anti-diversion and not enough on treatment of pain.”
“The distributor’s role is to make sure prescriptions are available for pharmacies for legitimate prescriptions,” Mainigi said.
Several witness testimonies were quoted that said, “virtually all of the prescriptions were legitimate” and the “vast majority of doctors in Cabell County and Huntington thought they were prescribing opioids appropriately.”
Mainigi referred to testimony from Kevin Yingling, former dean of Marshall’s School of Pharmacy, in which he said there is some debate on if opioid prescribing restrictions have gone too far and may be hurting patients in real pain.
Using data from McCann’s data graphs and charts, Mainigi said the increase of opioids in not only Cabell County and Huntington was appropriate and matched the magnitude of increases in West Virginia and the country.
A morbidity chart was presented showing West Virginia leading the country in overall health statistics and have the highest prescribing rates in not just opioids, but all prescription medications.
“Even in 1997, before any of the alleged misconduct, the numbers were higher in West Virginia and in particular Cabell/Huntington with higher rates of pain causing conditions,” Mainigi said.
Throughout the trial distributors have said ingredient limit reports were sent into the DEA regularly, something Rannazzisi testified did nothing. Mainigi shared a clip from DEA official, Michael Mapes’ deposition where he was asked if ingredient reports were compliant to the regulations and expectations.
“I view that as compliant with the regulation of suspicious orders,” Mapes said.
Mainigi said Cardinal Health complied with changes made by AmerisourceBergen’s monitoring systems and presented to distributors by the DEA in 2007.
West Virginia’s economic downturn and the invalidity of the gateway theory were always pointed as to as causation. Both things mentioned by multiple expert witnesses arguing the opposite of defendants.
“It is too much insinuated in a chain of events,” Mainigi said. “There is a vast disconnect between the evidence we’ve heard and what the plaintiffs claim.”
Mainigi closed her argument saying Huntington’s efforts are important, but nothing has shown Cardinal Health had one order shipped that should not have been shipped or diverted.
Finishing the closing arguments, Timothy Hester representing McKesson said the claims are unsupported.
“The plaintiffs' claim is foreclosed by the law, and it’s unsupported by the record evidence,” Hester said.
Hester said his argument can be summed up in five points – “distributors were not a proximate cause of the opioid crisis, distributor’s conduct was not a public nuisance, McKesson’s conduct in Huntington/Cabell was not wrongful, distributors are not responsible for illegal heroin and fentanyl and plaintiff’s abatement plan in unreasonable and unsupported.”
Hester said medicine cabinet diversion defeats any causation referencing testimony from James Ralfalski, a former DEA official where he said he agreed with the statement, “not reporting the suspicious order to the DEA is not what causes diversion, correct.”
He said all products come with risks and cannot be considered a public nuisance.
“Virtually all products have risks among the benefits, which is true for all medicines,” Hester said.
Hester referred to the State v. Lead Industries Association (lead paint case) that reads, “manufacture and distribution of products rarely, if ever, causes a violation of a public right as that term has been understood in the law of public nuisance.”
He argues it is “unfathomable distributors be expected to second-guess doctors” and public nuisance does not apply to products, a personal injury case would.
Hester said McKesson has limited customers in the Cabell/Huntington area, with one salesman saying he only had three at one point. Yet, he also said between 2006 to 2014, McKesson shipped 5.5 million prescription opioid pills to the area.
Addressing the plaintiff’s expert-made abatement plan, Hester said there were several huge flaws including unreliable numbers, future addiction built-in and that it is “simply unreasonable.”
“Treatment of harms is not a proper abatement remedy,” Hester said. “Treatment is from downstream harms of drug abuse.”
Hester argued the numbers from experts did not consider for programs currently in the Huntington/Cabell County area that can mostly be covered by insurance which witnesses have said a majority of West Virginians have and that economists did not get reliable numbers that matched other experts.
The biggest flaw, Hester claimed, is the abatement plan to reduce overdoses by 50 percent over a 15-year period, costing an estimated $2.4 billion, has already been achieved by the city and county which he said is down in overdoses by 52 percent and down 46.7 percent in overdose deaths between 2017 to 2019.
Between the first-ever county surplus and extra grant money, Hester’s argument is there is not a need for more money to fund recovery programs. He said there is no evidence supporting relief claims or evaluation of what is being done and what more is needed in the community.
Hester ended arguments that there are two undisputed facts: doctor prescribing drive volume and that harm based on medicine cabinet diversion- something that is a result of criminal actions by third parties.
Representing both Cabell County and the City of Huntington for the redirect, Paul Farrell Jr. immediately held back emotion, saying there was “disappointment in what feels like misrepresentation.”
Farrell did not hold back during the rebuttal, stating that the United States has recognized the potential dangers of narcotics going into the black market not controlled, for a “significant period of time.”
“To pretend that the supply of opium doesn’t create addiction and demand, totally ignores the entire premise of why we’ve regulated this drug as a drug two substance,” Farrell said. “Opium has been around since the Byzantine era. It has toppled governments. You can’t get opium supply without opium.”
Farrell reference a 1943 case where supply was helping fuel the demand and misuse of medications.
“The volume of pills sold is clearly deviant,” Farrell said. "The DEA has on record, testified that they were in violation of their regulatory obligations. The DEA told them so. The DEA warned them, provided notice, sanctioned them. The three companies are continuing to say the same thing – it’s not their duty. What that tells me, your honor, if it happens again, they would do it again.”
Farrell questioned the purpose of a closed system if it was not going to be regulated.
Comparing the opioid shipments from the defendant to the James Randolph Dam, where Farrell has fished, he said he would monitor the output “because little subtle differences can lead to big things.”
He then showed a picture of a blast of water from the upper Gauley.
“Judge, this isn’t a subtle change in the behavior, this is a blowout,” Farrell said.
Farrell presented the shipment levels graphs and compared them to water leaks.
“The defendants are the dam and they’re standing on top of the bridge and they’re looking down and the volume of the water that comes out is under their control,” Farrell said. “This isn’t an issue of the safety valve failing. This volume of water at the bottom of Summersville Lake, here, somebody turned it on. It’s not an accident they had to turn it on.
“This is what happened here. There are active participants charged by the US code to be responsible for the control valve. They are the ones supposed to see, not just the subtle changes in the water levels, they are supposed to prevent the blowouts and that’s what we had in this case, we had a blowout."
He argued that 81 million pills shipped into the small area of 100,000 residents was not an accident and the argument that the prescriptions were written by doctors does not give the companies immunity.
Farrell said distributions companies should get out of the business if they do not want to be responsible for opioid volumes.
“If the number of pills that came into Huntington/Cabell County, West Virginia isn’t suspicious, I don’t know what is.”
Farrell said the last witness, expert Stephanie Colston, who acknowledged “we don’t have to identify that the defendant, dam operators, as THE cause, we just have to show they have a part in it.”
“I have not lost faith that we can cleanse our community, judge, but faith alone may be insufficient," Farrell said. "What we need to do is a lot of work and after four years my work is done.
"And I truly believe in my heart that I have done all that I can."
Before adjourning, Faber thanked the lawyers for their quality and character of work, stating they could have made the long case more difficult without it.
Attorneys for both sides have been granted three weeks to finish all responses and motions. It is unclear when Faber will make a ruling.
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)