American Pain Society Files for Bankruptcy

By Pat Anson, PNN Editor

The American Pain Society (APS) filed for bankruptcy Friday after an overwhelming vote by its members to dissolve the financially troubled medical organization. In a membership vote last month, 93% voted in favor of a recommendation by the APS board of directors to file a voluntary petition for Chapter 7 bankruptcy.

The APS is a non-profit, research-based organization that focuses on the causes and treatment of acute and chronic pain. Although many of its members are researchers and academics who are investigating non-opioid treatments for pain, the APS was targeted as a defendant by Simmons Hanly Conroy and several other law firms seeking to recover billions of dollars in damages in opioid litigation cases.

In a press release, APS said efforts to resolve the “meritless” lawsuits without lengthy and expensive litigation were unsuccessful.

“It’s the perfect storm and now pointless to continue operations just to defend against superfluous lawsuits.  Our resources are being diverted to paying staff to comply with subpoenas and other requests for information and for payment of legal fees instead of funding research grants, sponsoring pain education programs, and public policy advocacy,” APS President William Maixner, DDS, said in a statement.

“As a result, the Board of Directors no longer believes APS can continue to fulfill its mission and meet the needs of our members and the pain care community.”

Press coverage of the APS often parroted what the opioid lawsuits alleged. The Guardian, for example, called the APS a “pawn of big pharma” and claimed the organization “pushed doctors to prescribe painkillers.”

The Guardian’s coverage was based largely on a report by Sen. Claire McCaskill (D-MO), who accepted over $400,000 in campaign donations from Simmons Hanly in her failed bid for re-election in 2018. APS is named as a defendant in several opioid lawsuits filed by Simmons Hanly, which stands to make hundreds of millions of dollars in contingency fees if the lawsuits are successful. The Guardian failed to mention any connection between Simmons Hanly and McCaskill.

The APS’ bankruptcy filing likely brings an end to its monthly publication, The Journal of Pain, which has been rated among the top five scientific journals in pain science. The current issue features research articles on diverse topics such as meditation for low back pain, diagnostic codes for fibromyalgia, whether opioids are effective for chronic noncancer pain, and the use of virtual reality to relieve arm pain.

“APS has been advocating for increased investment in research for many years, and it is particularly ironic that APS’s voice will go silent at this critical time in our history, when increased investment in pain research has finally become a reality in an effort to combat the opioid crisis,” said Roger Fillingim, PhD, an APS past president and professor of psychology at the University of Florida School of Dentistry.  

“There is a sad irony that the professional organization best poised to provide the spectrum of science to improve the prevention and treatment of pain and related substance abuse is defunct,” said APS President-elect Gary Walco, PhD, director of pain medicine at Seattle Children’s Hospital.

“Now, more than ever, our nation needs the collective efforts of leading scientists and clinicians who hold patients’ well-being at the highest premium.  The principal focus on punishing those in industry that may have contributed to the problem is shortsighted and far from sufficient.”

The APS is the second professional pain management organization to cease operations this year. In February, the Academy of Integrative Pain Management (AIPM) also shutdown. Opioid litigation has not only been costly for APS and AIPM, it has contributed to steep declines in financial support from pharmaceutical companies for other pain organizations, medical conferences and patient advocacy groups.   

Liability Trial of Opioid Drug Maker Could Set Precedents

By Jackie Fortier, Kaiser Health News

All eyes will be on Oklahoma this week when the first case in a flood of litigation against opioid drug manufacturers begins. Oklahoma Attorney General Mike Hunter’s suit alleges Johnson & Johnson, the nation’s largest drugmaker, helped ignite a public health crisis that has killed thousands of state residents.

With just two days to go before the trial, one of the remaining defendants, Teva Pharmaceutical, announced an $85 million settlement with the state on Sunday. The money will be used for litigation costs and an undisclosed amount will be allocated “to abate the opioid crisis in Oklahoma,” according to a press release from Hunter’s office.

In its own statement, Teva said the settlement does not establish any wrongdoing on the part of the company, adding Teva “has not contributed to the abuse of opioids in Oklahoma in any way.”

That leaves Johnson & Johnson as the sole defendant.

Court filings accuse the company of overstating the benefits of opioids and understating their risks in marketing campaigns that duped doctors into prescribing the drugs for ailments not approved by regulators.

The bench trial — with a judge and no jury — is poised to be the first of its kind to play out in court.

Nora Freeman Engstrom, a professor at Stanford Law school, said lawyers in the other cases and the general public are eager to see what proof Hunter’s office offers the court.

“We’ll all be seeing what evidence is available, what evidence isn’t available and just how convincing that evidence is,” she said.

Most states and more than 1,600 local and tribal governments are suing drugmakers and distributors. They are trying to recoup billions of dollars spent on addressing the fallout tied to opioid addiction.

Initially, Hunter’s lawsuit included Purdue Pharma, the maker of OxyContin. In March, Purdue Pharma settled with the state for $270 million. Soon after, Hunter dropped all but one of the civil claims, including fraud, against the remaining defendants. Teva settled for $85 million in May, leaving Johnson & Johnson as the only opioid manufacturer willing to go to trial with the state.

But he still thinks the case is strong.

“We have looked at literally millions of documents, taken hundreds of depositions, and we are even more convinced that these companies are the proximate cause for the epidemic in our state and in our country,” Hunter said.

The companies involved have a broad concern about what their liability might be, said University of Kentucky law professor Richard Ausness.

“This case will set a precedent,” he said. “If Oklahoma loses, of course they’ll appeal if they lose, but the defendants may have to reconsider their strategy.”

With hundreds of similar cases pending — especially a mammoth case pending in Ohio — Oklahoma’s strategy will be closely watched.

“And of course lurking in the background is the multi-state litigation in Cleveland, where there will ultimately be a settlement in all likelihood, but the size of the settlement and the terms of the settlement may be influenced by Oklahoma,” Ausness said.

Rx Opioids ‘Useful Products’

The legal case is complicated. Unlike tobacco, where states won a landmark settlement, Ausness pointed out that opioids serve a medical purpose.

“There’s nothing wrong with producing opioids. It’s regulated and approved by the Food and Drug Administration, the sale is overseen by the Drug Enforcement Administration, so there’s a great deal of regulation in the production and distribution and sale of opioid products,” Ausness said. “They are useful products, so this is not a situation where the product is defective in some way.”

It’s an argument that has found some traction in court. Recently, a North Dakota judge dismissed all of that state’s claims against Purdue, a big court win for the company. In a written ruling that the state says it will appeal, Judge James Hill questioned the idea of blaming a company that makes a legal product for opioid-related deaths.

“Purdue cannot control how doctors prescribe its products and it certainly cannot control how individual patients use and respond to its products,” the judge wrote, “regardless of any warning or instruction Purdue may give.”

Now the Oklahoma case rests entirely on a claim of public nuisance, which refers to actions that harm members of the public, including injury to public health.

“It’s sexy you know, ‘public nuisance’ makes it sound like the defendants are really bad,” Ausness said.

If the state’s claim prevails, Big Pharma could be forced to spend billions of dollars in Oklahoma helping ease the epidemic. “It doesn’t diminish the amount of damages we believe we’ll be able to justify to the judge,” Hunter said, estimating a final payout could run into the “billions of dollars.”

Hunter’s decision to go it alone and not join with a larger consolidated case could mean a quicker resolution for the state, Ausness said.

“Particularly when we’re talking about [attorneys general], who are politicians, who want to be able to tell the people, ‘Gee this is what I’ve done for you.’ They are not interested in waiting two or three years [for a settlement], they want it now,” he said. “Of course, the risk of that is you may lose.”

Oklahoma has the second-highest uninsured rate in the nation and little money for public health. Of the $270 million Purdue settlement, $200 million is earmarked for an addiction research and treatment center in Tulsa, though no details have been released. An undisclosed amount of the $85 million Teva settlement will also go to abating the crisis.

This story is part of a partnership that includes StateImpact Oklahoma, NPR and Kaiser Health News. KHN is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

American Pain Society Likely to File for Bankruptcy

By Pat Anson, PNN Editor

The board of directors of the American Pain Society (APS) is recommending to its members that the organization cease operations and file for bankruptcy, PNN has learned.

The APS is a non-profit, research-based organization that focuses on the causes and treatment of acute and chronic pain. Although many of its members are researchers and academics who are investigating non-opioid treatments for pain, the APS has been named as a defendant in numerous “spurious lawsuits” involving opioid prescriptions.

“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. 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,” the board said in a letter sent to its members yesterday.

“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.”   

In order to proceed with a Chapter 7 bankruptcy filing, only 10% of the organization’s 1,173 active members need to approve the board’s recommendation. Assuming there are sufficient votes, an independent third party trustee would then be appointed by a bankruptcy judge and all lawsuits pending against APS will be subject to an automatic stay.

“This will allow APS to minimize legal expenses and maximize recoveries for its creditors, as opposed to future dissipation of assets in defending the lawsuits which have no end in sight,” the board wrote.

The APS membership vote will be tallied May 29th.

“Sad day for U.S. pain research, education, advocacy and patient care,” APS member and Stanford University psychologist Beth Darnall, PhD, tweeted to her followers.

In recent years, thousands of lawsuits have been filed by states, cities and counties seeking to recover billions of dollars in damages caused by the “overprescribing” of opioid pain medication. The lawsuits initially focused on Purdue Pharma and other opioid manufacturers, but have recently expanded to include opioid distributors, wholesalers, pharmacies and professional medical organizations like the APS as defendants.

If the APS files for bankruptcy, it would be the second pain management organization to cease operations in recent months. In February, the Academy of Integrative Pain Management (AIPM) shutdown, largely due to financial problems.  

“It's really sad that pain organizations are failing,” said Bob Twillman, PhD, the former Executive Director of AIPM. “I'm not clear about the extent to which this was an anticipated or desired outcome of the lawsuits against opioid manufacturers, but it strikes me that an effort to say that we've been harming people by treating pain the wrong way has now eliminated two organizations focused on treating pain the way every guideline now says it should be treated, and on discovering new treatments that might obviate the need for opioids.”

Twillman says the shutdown of APS and AIPM will cause “significant gaps in the field” of pain management.

“The unintended consequences here may end up being quite ironic," he added.

Guilt by Association 

Like other professional medical organizations, APS relied on corporate donors to help pay for its annual meetings and widely respected publication, The Journal of Pain. That meant accepting nearly $1 million in donations from Purdue Pharma, Janssen, Depomed and other opioid manufacturers.

It also meant being targeted by lawyers and politicians in a campaign of guilt by association.

In 2018, APS was one of the medical societies and patient advocacy groups singled out by Missouri Sen. Claire McCaskill (D) in a Senate report that accused the organizations of being mouthpieces for opioid manufacturers. 

“Initiatives from the groups in this report often echoed and amplified messages favorable to increased opioid use — and ultimately, the financial interests of opioid manufacturers,” the report found.

McCaskill’s report failed to mention that she accepted nearly $500,000 in campaign donations since 2005 from the national law firm of Simmons Hanly Conroy, which represents many of the plaintiffs involved in opioid litigation. It has named the APS as a defendant in several of those lawsuits, along with American Academy of Pain Medicine and American Geriatric Society “for working with the manufacturing defendants in promoting opioids to doctors and patients.”

Simmons Hanly Conroy was the third largest contributor to McKaskill during her losing bid for re-election last year, donating over $400,000, an amount seven times larger than it gave to any other candidate in 2018, according to OpenSecrets.org.

According to its website, Simmons Hanly Conroy currently represents governmental entities in Illinois, Louisiana, Texas, and eight New York counties in opioid lawsuits. The law firm reportedly stands to collect one-third of the proceeds from opioid settlements, which could potentially reach $50 billion, according to a Bloomberg analyst.

‘Corrupting Influence’

APS is also mentioned in a congressional report released this week by Reps. Katherine Clark (D-MA) and Hal Rogers (R-KY). The “Corrupting Influence: Purdue and the WHO” report accuses the World Health Organization of being unduly influenced by Purdue Pharma and other opioid makers when it developed guidelines in 2011 and 2012 to treat pain in adults and children.

“The web of influence we uncovered, combined with the WHO’s recommendations, paints a picture of a public health organization that has been manipulated by the opioid industry,” the report said. “The investigation revealed that multiple organizations that claimed to be independent patient advocacy groups, including the American Pain Society, received significant payments from opioid manufacturers.”

The report does not mention that Rep. Clark has also accepted significant payments from drug makers. According to OpenSecrets.com, Clark has received over $522,000 in campaign donations from the healthcare industry since 2013, including donations from Pfizer, Celgene, Takeda, Biogen, Vertex, AstraZeneca and Sanofi.

Rep. Rogers has received over $581,000 in campaign donations from the healthcare industry during his 30 years in Congress.