Government officials grappling with the nationwide opioid crisis, from the sandy beaches of Florida to the far reaches of the Alaskan frontier, have filed lawsuits against drug companies at a steady clip this year. These suits seek to hold manufacturers and distributors financially responsible for the strain on public services that drug addiction has caused.
Now local officials in West Virginia — the state with the nation’s highest drug death rate — have taken aim at a different target: the medical experts who recommended their use. This past week the cities and towns of Huntington, Charleston, Kenova, and Ceredo filed a class-action lawsuit against the Joint Commission, the influential nonprofit that both inspects hospitals’ performance and sets practice standards for their physicians. Hospitals must abide by the group’s standards, on opioids or anything else, in order to get reimbursed for care provided to Medicaid and Medicare patients.
The lawsuit claims the nonprofit — responsible for accrediting more than 20,000 health organizations nationwide — has spread “misinformation” about the risks of opioid addiction dating back to the early 2000s, including in published materials underwritten by opioid manufacturers.
And experts say the lawsuit could pave the way for many other municipalities to follow in West Virginia’s footsteps.
“Opioids are killing a generation of West Virginians,” Ceredo Mayor Paul Billups told STAT. “It’s had a tremendous impact. It appears that a number of medical providers were relying on directives from the Joint Commission that caused an increase on the number of opioids on the market.”
The lawsuit centers on the Joint Commission’s pain management standards, first issued in 2001, and the alleged cozy financial ties the nonprofit had with pharmaceutical firms. According to the lawsuit, the nonprofit produced materials that downplayed the evidence “that addiction is a significant issue when persons are given opioids for pain control.” It also says that similar materials claimed that patients who used opioids rarely became addicted, even though that was underpinned by scant evidence.
And those standards were developed in collaboration with the very drug makers positioned to profit from them, the suit alleges. Dr. Gary Franklin, a neurology professor at the University of Washington and vice president of state regulatory affairs for the advocacy group Physicians for Responsible Opioid Prescribing, said the research supporting the original standards was “developed in collaboration with University of Wisconsin” pain researchers who accepted drug company funding while pushing the industry’s agenda.
Industry involvement also went beyond the standards. In the early 2000s, pharmaceutical firms — including Purdue Pharma, maker of OxyContin — underwrote educational Joint Commission programing and paid for its own events to train hospital physicians about the accreditation standards, the lawsuit said. Even after the Food and Drug Administration warned Purdue in 2003 about overstating OxyContin’s effectiveness in ads, the Joint Commission kept producing materials that urged doctors to treat patients until they were “free from pain.” According to the lawsuit, the pattern continued for years, leading to the promotion of pain as the “fifth vital sign” in articles, as well as published education materials funded by Janssen Pharmaceuticals, maker of Duragesic, a skin patch that contains fentanyl.
The Joint Commission declined STAT’s request for an interview, but a spokesperson said in a statement that the nonprofit is “deeply troubled by a lawsuit that contains blatantly false accusations that have been thoroughly debunked.”
‘It’s not a lawsuit I would’ve brought’
This latest tack signals a new chapter in the legal war brewing around the opioid crisis. Earlier this year, West Virginia settled suits against a pair of drug distributors for a combined $36 million; a collection of the state’s cities and counties have since taken wholesalers and pharmacy owners to court. Following West Virginia’s lead, a coalition of about three dozen state attorneys general have launched an opioid investigation that’s earned comparisons to the tobacco litigation of the ’90s.
“This is just the beginning,” said Dr. Andrew Kolodny, executive director of PROP, which is not involved in the lawsuit. “They’re going to start to get named more frequently. Other complaints are going to include the Joint Commission.”
But Paul Hanly, a New York-based attorney helping local governments sue opioid makers in five states, doesn’t think the lawsuit “advances the ball” beyond sending a symbolic message. He sees two key limitations of the legal strategy. First, he said the Joint Commission — which made nearly $13 million in 2015, leaving it with total assets of $147 million, according to nonprofit filings — lacks the deep pockets of pharmaceutical industry. He’s also skeptical that a judge will “substitute his or her non-expert opinion for what purportedly is the consensus of physician and hospital groups” involved with the Joint Commission.
“Let me put this way: I’ve been doing this for a very long time, and it’s not a lawsuit I would’ve brought,” Hanly said.
Former Mississippi Attorney General Mike Moore, a pioneer of the tobacco litigation who’s now advising states to sue drug companies, sizes up the accreditor suit as follows: “The state cases now in litigation — the strongest, most compelling cases — are the A-team; the city and county cases suing the manufacturers and distributors are the B-team; the C-team is the investigations from the other attorneys general. Cases like this one fall into rank after that.”
“Having said that,” Moore noted, “it’s important that innovative trial lawyers come up with new and novel ways to solve this problem. I don’t know if it’ll succeed or not — after all, I was told my tobacco suit wouldn’t succeed.”
A cautionary tale
The attorneys filing the class-action suit point to end goals beyond just financial ones. Ultimately, they say, they hope that nearly a dozen hospitals in their region — perhaps more depending on what other governments join the suit — will no longer be forced to choose between keeping their accreditation or prescribing fewer opioids. Two lawyers behind the suit, Scott Damron and Paul Ellis, the city attorneys with Huntington and Charleston respectively, told STAT in a statement that stronger control over prescribing practices would be a “choke point” for reducing future addiction.
“There hasn’t been a focus on The Joint Commission in part because few municipalities have the depth of understanding of the opioid problem that we do in West Virginia and in part because The Joint Commission is a not for profit entity,” they wrote. “But being not for profit does not allow you to overwhelm our communities with addiction.”
This past summer the Joint Commission announced it would issue new pain management standards. Those revisions – which urge hospitals to identify high-risk patients, embrace prescription drug monitoring programs, and help train doctors to refer at-risk patients to addiction treatment programs – won’t go into effect until 2018.
Gary Mendell, founder of Shatterproof, a national advocacy group pushing to improve substance use disorder treatment, believes that placing the spotlight on the Joint Commission through these lawsuits will remind the nation that drug companies aren’t the only groups potentially culpable in the opioid crisis. In his mind, the nonprofit offers a cautionary tale of what happens when the medical practice is influenced by giant drug companies.
“Accrediting agencies need to be held accountable to the families who’ve lost loved ones and the health care costs of those suffering from an opioid use disorder,” Mendell told STAT. “This will change behavior, not only for this situation with opioids, but for other drugs in the future.”