Suit alleges that JCAHO’s misrepresentation of opioid risks contributed to West Virginia’s opioid crisis.
On November 2, 2017, four cities in West Virginia teamed up to file suit against The Joint Commission over the organization’s handling of pain management standards. The move follows more than a decade of public sparring over the role that the organization may have played in the worsening opioid epidemic.
The lawsuit details a laundry list of allegations. It claims that The Joint Commission, formerly known as JCAHO – partnered with Purdue Pharma, manufacturer of Oxycontin, to set pain management standards that “grossly misrepresented the addictive qualities of opioids and fostered dangerous pain control practices” which fostered a culture of providing inappropriate prescriptions of opioids to patients and resulted in “disastrous adverse consequences” for patients and families.
According to the claim, JCAHO ignored the CDC recommendations on opioid prescribing and its policies continue to spread a “misinformation campaign” about the safety of opioids. Because The Joint Commission certifies 99% of health care organizations in the Unites States, and because its certifications are “critical” to healthcare organization operations, the lawsuit alleges that healthcare organizations are highly influenced by these standards.
The lawsuit goes on to detail the development of JCAHO’s pain management standards, beginning with policies in 2001 stating that patients “have the right to appropriate assessment and management of pain” and that pain must be “considered the ‘fifth’ vital sign in the hospital’s care of patients.” The lawsuit notes how JCAHO partnered with the National Pharmaceutical Council, and how JCAHO continued collaborating with Purdue Pharma even after Purdue had been issued a warning from the FDA that Purdue’s advertisements were minimizing risks associated with OxyContin. Even after Purdue Pharma pled guilty to criminal allegations of misleading the public about OxyContin’s addictive properties, the lawsuit noted how JCAHO – which changed its name to The Joint Commission – continued to push the requirement that pain be considered “The Fifth Vital Sign.” The lawsuit even included a picture of the front page of the November 2011 edition of “The Source” – a Joint Commission publication – with a headline stating “The Fifth ‘Vital Sign’”.
Rather than creating standards to prevent or curtail the opioid crisis, the lawsuit alleges that JCAHO added to the problems.
The lawsuit seeks compensation for the funding that the West Virginia towns have had to spend to combat the opioid crisis. It cited West Virginia court opinions noting that West Virginia has the highest rate of fatal drug overdoses in the nation – of which 86% involved opioids. While JCAHO has reported income of $60 million per year, the lawsuit alleges that JCAHO has continued to prosper while the West Virginia communities are floundering because of economic damages related to increased costs associated with health care, insurance, first responders, crimes, criminal vagrancy, and public safety. Had JCAHO not issued and enforced inappropriate pain management standards, the lawsuit alleges that the towns would not have had to incur these costs.
The lawsuit seeks more than $75,000 in damages and also seeks class action status.
The West Virginia lawsuit comes after years of similar clashes and critique within healthcare. So much so that The Joint Commission issued a written policy statement in April of 2016 in which David W. Baker, MD, MPH, Executive Vice President of Healthcare Quality Evaluation at The Joint Commission, attempted to address the controversy head on.
“In the environment of today’s prescription opioid epidemic, everyone is looking for someone to blame,” The Joint Commission’s statement begins. “Often, The Joint Commission’s pain standards take that blame. We are encouraging our critics to look at our exact standards, along with the historical context of our standards, to fully understand what our accredited organizations are required to do with regard to pain.”
Baker goes on to synopsize the Pain Management Standards in a way that is both simple and non specific. The foundational principles of The Joint Commission’s pain standards, says Baker, are that hospitals (1) educate all licensed independent practitioners on assessing and managing pain, (2) respect the patient’s right to pain management and (3) assess and manage the patient’s pain.
In the 2016 statement, Baker sought to distance The Joint Commission from the claim that pain should be treated as the fifth vital sign. “The original 2001 Joint Commission standards did not state that pain needed to be treated like a vital sign,” writes Baker. “The only time that The Joint Commission standards referenced the fifth vital sign was when The Joint Commission provided examples of what some organizations were doing to assess patient pain. In 2002, The Joint Commission addressed the problems in the use of the 5th vital sign concept by describing the unintended consequences of this approach to pain management and described how organizations had subsequently modified their processes.”
According to Baker, the idea that these standards in any way caused a sharp uptick in opioid prescriptions is “completely contradicted by data.” As evidence he points to statistics from The National Institute on Drug Abuse. One chart in particular shows the number of opioid prescriptions filled at commercial pharmacies in the United States from 1991 to 2013. While the graph shows a disconcerting increase in prescriptions over time, the curve doesn’t show a sharp uptick after 2001. “If there was an uptick in the rate of increase in opioid use, it appears to have occurred around 1997-1998,” writes Baker. That would have been two years prior to release of the pain care standards.
These statistics will doubtless be critical to the West Virginia case as they are central to the plantiff’s claims. “The [opioid]epidemic is not a coincidence,” states the complaint. “It is in part the result of Pain Management Standards issued in 2001 and recklessly maintained and enforced to this day by Defendant JCAHO that led to a sharp increase in prescriptions for opioids.”
In a JAMA letter from July, 2017, Dr. David Baker was more sanguine, writing: “The Joint Commission should have examined ways to address the opioid epidemic earlier, and the organization should learn from this experience. Past criticism of the pain standards may have caused some reluctance to tackle the emerging opioid epidemic.”
The plaintiff’s claim that The Joint Commission teamed up with Oxycontin manufacturer Purdue Pharma on educational strategies has a more complicated history, and the lines have been drawn for years. In a July 2017 letter to JAMA, Drs. Neeraj Chhabra, MD and Jerrold B. Leikin made the claim that Purdue Pharma was one of two companies that provided funding for The Joint Commission’s pain management educational programs. Baker’s response in JAMA that same month unequivocally denied this claim, stating that the only organization to provide funding for The Joint Commission’s pain standards was the Robert Wood Johnson Foundation.
However, according to reporting by The New Yorker in 2013, “Purdue helped fund a ‘pain-management educational program’ organized by The Joint Commission; a related agreement allowed Purdue to disseminate educational materials on pain management, and this, in the words of the report, “may have facilitated its access to hospitals to promote OxyContin.” This finding dates back to a 2003 investigation by The U.S. Government Accountability Office called OxyContin Abuse and Diversion and Efforts to Address the Problem.
This suit summary doesn’t mince words, calling out The Joint Commission’s “reckless and negligent indifference to the horrors of addiction,” their “profitable co-option by the opioid industry,” and finally their “arrogant and intransigent refusal, despite an epidemic of human suffering, to modify or enforce its Pain Management Standards in a way that would reduce the risks of addiction.”
Doubtless this 15-year history will resurface as this case progresses. And if it appears before a jury, the results could be unprecedented.