RICHMOND, Va. (CN) — The Fourth Circuit on Thursday heard arguments on whether drug distributors are liable for public nuisance in the self-described ground zero for the opioid epidemic.
In separate, now consolidated cases, Huntington, West Virginia, and surrounding Cabell County filed a public nuisance suit against prescription opioid distributors AmerisourceBergen Drug Corporation, Cardinal Health, Inc., and McKesson Corporation, which hold a 90% market share of opioid distribution.
Drug manufacturers like Perdue and Johnson & Johnson sell their products to distributors supplying pharmacies. The localities settled cases involving manufacturers and pharmacies.
Due to the high potential for abuse, the legal opioid supply chain has safeguards to prevent the diversion or the distribution and use of opioids for reasons other than legitimate medical, scientific and industrial channels.
According to the localities' brief, diversions include excessive prescribing, consumers "doctor shopping" for multiple prescriptions, forging prescriptions, consumers selling or giving away their medications, acquaintances stealing drugs (so-called "medicine cabinet" diversion) and illegal trafficking.
The D.C. Circuit held in Masters Pharm., Inc. v. DEA that the 1970 Controlled Substance Act and federal regulations tasked distributors with identifying, reporting, investigating, or otherwise declining to ship suspicious orders placed by pharmacies.
A federal court in West Virginia saw the act differently, instead viewing it narrowly as only requiring distributors to decline to ship to rogue or illegitimate pharmacies rather than requiring them to decline service to legitimate pharmacies like a CVS or Walgreens that orders a suspiciously large quantity of opioids.
The localities claim that to avoid responsibility, the distributors continuously raised the threshold of opioids a pharmacy could order without being considered suspicious. The localities claim the distributors supplied the area that shares roughly 100,000 people with 80 billion units of opioids over 20 years, totaling 40 units per resident.
"One or more of the pharmacies were getting 10 times the national average," attorney David Frederick of Figel & Frederick, representing the localities, told the three-judge panel. "
U.S. Circuit Judge Robert King, a West Virginia native and Bill Clinton appointee, let Fredrick know that he believed the proper avenue for determining the applicability of West Virginia's state public nuisance law would be in the state's Supreme Court. Senior U.S. Circuit Judge Barbara Milano Keenan agreed.
"The opioid crisis has affected everybody in West Virginia," Keenan, a Barack Obama appointee said. "I don't understand why it's not more appropriate to have the Supreme Court of Appeals weigh in on this issue?"
King asked whether the U.S. Drug Enforcement Agency is to blame for not enforcing its requirement that distributors look out for suspicious orders. Frederick said the DEA could enforce requirements by receiving accurate information from distributors.
Paul Schmidt of Covington and Burling, representing McKesson, told the panel his clients proved in the nearly three-month bench trial that they were not responsible for diversion. In their brief, the distributors argue any oversupply issues can be traced to the doctors liberally prescribing large quantities to their patients.
"This was driven by doctors' decisions," Schmidt said. "There is no admissible evidence in this case that defendants caused diversion."
In response to a question from Keenan about why the number of opioids being distributed was so disproportionate compared to other places, Schmidt pointed to trial court findings that West Virginia has higher rates of all medication prescription than the national average due to a greater prevalence of health issues.
Nearly 645,000 people died from overdoses involving any opioid, including prescription and illicit opioids, from 1999-2021, according to the U.S. Centers for Disease Control and Prevention. Opioids are substances that work in the nervous system of the body or in specific receptors in the brain to reduce pain.
Types of opioids include prescription opioids like oxycodone and morphine, often prescribed following surgery or injury or for health conditions such as cancer. Synthetic opioids derived from chemicals rather than opium poppy plants include methadone and fentanyl.
All opioids, including heroin, are chemically similar, with the same biological mechanism and similar effects. Often, people turn to illegal opioids like heroin after running out of their prescription opioids following surgery or injury.
U.S. Circuit Judge DeAndrea Gist Benjamin, a Joe Biden appointee, completed the panel. Attorneys representing both parties did not respond to requests for comment.
"The distributors have an obligation to do due diligence," Frederick said. "It was on the distributors not to just willy-nilly provide it but to ask the question 'Why do you need it?'"
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