Pain Society's Expected Bankruptcy
What Does It Mean for Other Medical Associations?
By Gina Shaw
July 11, 2019
Article In Brief
The proposed dissolution of the American Pain Society, due to bankruptcy from lawsuits related to opioid practices, prompts discussion from health care attorneys about the ways in which medical societies are vulnerable to legal action and the policies they put into place to prevent that.
In May 2019, struggling under a heavy burden of opioid-related lawsuits, the board of directors of the American Pain Society (APS) recommended that its membership vote to approve the filing of a Chapter 7 bankruptcy petition, dissolving the Society with an independent trustee disposing of its assets. If a majority of the members vote to approve the recommendation (an announcement was still pending at press time), the 42-year-old Society would become the second pain-related association to cease operations in less than a year. (The Academy of Integrative Pain Management shut down in late January.)
The APS has been named, along with drug manufacturers like Purdue Pharma, in a number of the lawsuits filed by state and city governments over the opioid crisis. The cost of defending against these suits, and responding to multiple subpoenas even in cases in which the Society was not a defendant, pushed the organization to the brink.
“Despite our best efforts, APS was unsuccessful in its attempts to resolve these lawsuits without the need for what will no doubt be lengthy and expensive litigation,” they wrote. “The anticipated time-consuming and costly litigation combined with the declining membership and meeting attendance has created the perfect storm placing APS in a precarious financial position. Constrained by these unfortunate circumstances, we do not believe APS can continue to fulfill its mission and meet the needs and expectations of our members and community.”
Other Lawsuits, Medical Specialty Societies
It's not the first time that a medical specialty society has been subjected to significant costs related to lawsuits. In the mid-1990s, the American Academy of Orthopedic Surgeons, American Association of Neurologic Surgeons, North American Spine Society (NASS), and Scoliosis Research Society faced thousands of product-liability suits over the pedicle screw—a metal implant used in spinal surgery. The suits claimed a conspiracy by the associations and a host of other defendants, claiming that they had acted as “promotional centers” for the implants and inappropriately pushed their off-label use.
And today, the Infectious Disease Society of America (IDSA)—along with multiple insurance companies and individual physicians–is defending itself against a federal antitrust lawsuit filed in Texas, alleging that they have denied the plaintiffs treatment for chronic Lyme disease. The patients assert that the IDSA guidelines were created by consultants who were paid handsomely by the named insurance companies.
An organization need not lose a lawsuit or be found liable to incur enormous expenses. “Even if you aren't a defendant in a suit, you may be a party to it and receive subpoenas that require you to respond at great expense,” says Rob Portman, a principal with the Powers law firm in Washington, DC.
Claims of Special Interests
One thing all three cases have in common is claims that the medical specialty societies were unduly influenced by funding from special interests—drug manufacturers, device manufacturers, or insurance companies—as they developed guidelines or made other clinical recommendations. It's a rare specialty society today that takes no corporate funding to support CME courses or medical meetings, or allows no advertising by drug or device manufacturers in its publications. Does that mean everyone is potentially liable?
“There are always going to be individuals who feel as though associations shouldn't be receiving any external support from these companies, that any corporate funding biases the organization in some way,” says AAN General Counsel John Hutchins. “Others appreciate the truism ‘no money, no mission,’ and believe that the ways that you support your mission financially can be diversified in such a way that you are not overly reliant on one particular source of funding, or category of funding.”
“The mere fact you receive sponsorship money from a company should not mean guilt by association,” agrees Portman. “It's what that sponsorship goes to. For example, if an organization sponsors a guideline, a study or symposium that appears to be favorable toward a particular product—rather than just sponsorship of a general meeting—that could present a risk of legal challenge.”
How can other medical specialty and subspecialty associations protect themselves against such lawsuits? Although there are no guarantees, experts agree that organizations can take several key steps to limit their exposure, particularly with regard to the development of clinical practice guidelines.
Appropriate firewalls should be maintained between industry and the association's core activities, Hutchins said. “This can include transparent principles governing relationships with external supporters, prohibited funding of guideline and measure development, extensive conflict of interest policies and procedures for education programming, guidelines and quality measures, and association leadership, and prohibited relationships for key leaders during their term of service. It is also critical for associations to have a comprehensive insurance plan, reviewed annually or as activities evolve.”
He noted that the AAN abides by recommendations set by the American Society of Association Executives (ASAE), suggesting that nonprofits keep 50 percent of their annual operating budget in reserve as a “rainy day fund.”
The standards for guideline development have evolved significantly over the past 10-15 years, experts told Neurology Today. Newer guidelines often use the widely accepted GRADE (Grading of Recommendations Assessment, Development and Evaluation methodology), which is what a large coalition of specialty societies—including the IDSA, AAN, and the American College of Rheumatology, as well as nearly a dozen others—is following to develop revised Lyme disease guidelines.
Experts suggest that following these rigorous standards, which are designed to ensure objective, transparent, and scientifically valid systematic reviews and clinical practice guidelines, should help organizations reduce their legal risk as well as help increase acceptance of their guidelines.
In addition, the Council of Medical Specialty Societies in 2010 published its Code for Interactions with Companies (revised and updated in 2015), which has an entire section focused on how to appropriately assemble a guideline panel. “They recommend that the majority of the panel be considered ‘non-conflicted’ with no topic-relevant conflict of interest, and that at least one chair of the panel be non-conflicted,” said Hutchins. “They also recommend prohibitions about panel members speaking on behalf of a company that might be affected by a guideline for at least a year after that guideline is published. The AAN was one of the original signatory organizations to that code.”
“All medical specialty organizations should have clear conflict of interest policies, enforced religiously,” Portman said. “But in reality, you can't prevent someone from suing you or issuing a third-party subpoena. You could get dragged into a suit just because you have a relationship with a company, but that doesn't always mean a serious liability risk. I tell my clients that if your organization is putting out guidelines in order to do the right thing and promote high quality patient care, don't let perception of legal risk deter you from doing that; just make sure they are completely objective and based on sound medical and scientific evidence.”