At 54 years old, the unnamed subject of a Purdue Pharma ad, a writer, suffered from osteoarthritis of the hands, a degenerative joint disease that guitarists and other musicians dread. Purdue claimed in its 2012 ad, which it called a “pain vignette,” that OxyContin was the key to the writer's chronic pain relief and his return to the computer to write; it failed to mention the trail of dependence and destruction the opioid often left in its wake.
Before the 1990s, opioids were mostly prescribed for short-term acute pain related to surgery or cancer or for end-of-life care. Using the class of drugs for chronic pain was discouraged and, in some cases, prohibited. Evidence showed that patients often developed opioid tolerance over time, increasing the risk of addiction and other side effects.
In 2016, doctors wrote more than 289 million prescriptions for opioids, “enough for every adult in the United States to have more than one bottle of pills,” according to Sept. 29 lawsuit filed in the Eastern District Court of Texas against a host of drug manufacturers.
Dallas-based litigation firm Simon Greenstone Panatier & Bartlett filed the lawsuit on behalf of Upshur County, 125 miles east of Dallas. Cases in other counties may soon follow.The lawsuit lists six causes of action: public nuisance, common law fraud, negligence, gross negligence, and violations of the Texas Controlled Substances Act and federal racketeering law.
“The goal is to try to recoup the cost of the opioid epidemic,” Upshur County Judge Dean Fowler told the Longview News-Journal. “It costs our taxpayers to take care of people who are addicted to opioids, and the cost to the public is very high.”
Although drugmakers have been hit by a tide of lawsuits from states, cities and other agencies nationwide, Upshur County's suit is the first of its kind filed by a Texas county to hold pharmaceutical companies responsible for an epidemic that has led to an increase in opioid addictions, drug overdose deaths and economic burden estimated to total $78.5 billion nationally.
“This epidemic did not occur by chance,” Dallas attorney Jeffrey B. Simon claims in the lawsuit.
The lawsuit has more than 20 defendants, including drugmakers and their subsidiaries. Among them are Abbott Laboratories, Johnson & Johnson, Pfizer, Inc. and Purdue Pharma Inc.
Both sales and overdose deaths involving prescription opioids quadrupled between 1999 and 2015, according to the Centers for Disease Control and Prevention. In that period, more than 183,000 people have died in the U.S. from overdoses related to prescription opioids.
The defendants manufacture brand-name drugs like OxyContin, Vicodin, Opana, Percocet, Percodan, Roxicodone and Avinza (which is no longer on the market), as well as generics like oxymorphone and hydrocodone. Some of the defendants also manufacture, market, distribute and sell prescription opioids, including fentanyl, Fentora, Duragesic, Ultram and Ultracet.
Each defendant listed in the lawsuit is accused of using direct marketing and unbranded advertising “disseminated by seemingly independent third parties to spread false and deceptive statements about the risks and benefits of long-term opioid use.”
The lawsuit claims drug manufacturers began changing doctors’ views of opioids in the late 1990s and early 2000s “through a well-funded deceptive marketing scheme.” They used sales representatives and physicians whom they called “key opinion leaders” to support their message to promote, according to the lawsuit, “highly addictive opioids through souvenirs and toys, including but not limited to, opioid brand-bearing stuffed plush toys, dolls, coffee cups, fanny packs, water bottles, notepads, pens, refrigerator magnets, clocks, letter openers, rulers, daytime planners, bags, puzzles, posters, clipboards, highlighters, flashlights, key chains, clothing, reflex mallets and mock-ups of the United States Constitution.”
They also implemented what the lawsuit calls “front groups” to help the key opinion leaders taint the sources that doctors and patients relied on for what they thought was neutral guidance: treatment guidelines, continuing medical education programs, medical conferences and seminars, and scientific articles.
“After their individual and concerted efforts, defendants convinced doctors that instead of being addictive and unsafe for long-term use in most circumstances, opioids were required in the compassionate treatment of chronic pain,” Simon wrote.
The drug manufacturers increased their advertising costs, in some cases tripling what they spent the previous decade, the lawsuit claims. Where Purdue had used a 54-year-old writer with osteoarthritis in one of its ads, Endo Health Solutions created a pamphlet with photographs of patients with physically demanding jobs, like a construction worker or a chef, benefiting from opioid use for chronic pain.
In a statement reported by the Longview News-Journal, Purdue Pharma said: "We are deeply troubled by the opioid crisis and we are dedicated to being part of the solution. ... We vigorously deny these allegations and look forward to the opportunity to present our defense."
The companies claim that if taken properly, opioids can be beneficial in combating chronic pain, but the lawsuit points out that, contrary to what drug labels indicated, companies also “downplayed the serious risk of addiction, promoted the concept of ‘pseudoaddiction’ thereby advocating that the signs of addiction should be treated with more opioids, exaggerated the effectiveness of screening tools in preventing addiction, claimed that opioid dependence and withdrawal are easily managed, denied the risks of higher opioid dosages and exaggerated the effectiveness of ‘abuse-deterrent’ opioid formulations to prevent abuse and addiction.”
In 2007, Purdue pleaded guilty to a federal criminal count of misbranding the drug OxyContin with the intent of defrauding and misleading the public and paid $636 million in penalties, according to a November 2011 Fortune article. Purdue told Fortune that it was spending large sums of money on programs to fight abuse and lawbreaking.
But multiple news reports claim that the marketing of opioids for chronic pain relief by drug companies like Purdue led to America’s heroin problem. In 2014, opioids generated $11 billion in revenue for drug companies as overdose deaths increased and two million people reported abusing heroin.
“Essentially, each defendant ignored science and consumer health for profits,” according to the Sept. 29 lawsuit.
“There is no denying that we have an opioid crisis in America, and that the human misery and financial damage it causes is enormous,” Simon wrote in a press release. “Although accidental overdoses have become the leading cause of death for Americans under the age of 50, the pharmaceutical industry has not been fully held accountable for its role in creating this epidemic.”
Purdue alone spent $108 million in 2014 pitching branded opioids to doctors, twice as much as it spent in 2000 and far more than the $57 million spent by drug companies Janssen, Cephalon and Endo combined. It relied on what the lawsuit calls “key opinion personal” or “pro-opioid doctors” to persuade other doctors to start prescribing opioids for chronic pain and, in turn, increase demand for the drug.
The lawsuit points out that Dr. Russell Portenoy, former chairman of the Department of Pain Medicine and Palliative Care at Beth Israel Medical Center in New York, is one example of a key opinion leader who was instrumental in normalizing opioids as a treatment option for chronic pain.
Portenoy was a paid consultant for Cephalon and Purdue. He received research support, consulting fees and honoraria from Cephalon, Endo, Janssen and Purdue. He served on the American Pain Society and American Academy of Pain Medicine guidelines committees and endorsed opioid use for chronic pain in 1997 and 2009. He also sat on the board of the American Pain Foundation, an advocacy organization funded by the defendants from 2007 until it folded in 2012, according to the lawsuit.
“Addiction, when treating pain, is distinctly uncommon,” Portenoy told Good Morning America in 2010. “If a person does not have a history, a personal history, of substance abuse, and does not have a history in the family of substance abuse, and does not have a very major psychiatric disorder, most doctors can feel very assured that that person is not going to become addicted.”
Portenoy later admitted to giving “innumerable lectures in the late 1980s and ’90s about addiction that weren’t true,” according to the lawsuit. In those lectures, he claimed that less than 1 percent of patients would become opioid addicts.
“Did I teach about pain management, specifically about opioid therapy, in a way that reflects misinformation?” Portenoy is reported saying. “Well … I guess I did.”
Another key opinion leader — Dr. Lynn Webster, the co-founder and chief medical director of Lifetree Clinical Research — was a leading proponent of the pseudoaddiction concept that claims addictive behaviors should not be seen as warning signs but simply indications of undertreated pain. In Avoiding Opioid Abuse While Managing Pain, Webster says increasing the opioid dose “in most cases … should be the clinician’s first response.”
Purdue also sponsored a program called "Path of the Patient, Managing Chronic Pain in Younger Adults at Risk for Abuse" that, according to the lawsuit, furthered the idea of pseudoaddiction. In a role play, a narrator notes that a doctor should not assume a patient is addicted to opioids even if he is persistently asking for the drug, seems desperate and hoards medicine “or overindulges in unapproved escalating doses.”
In fact, several of the defendants named in the lawsuit produced or supported materials that reassured patients that escalating doses weren't such a bad thing.
Published in 2007 and sponsored by Cephalon and Purdue, American Pain Foundation’s "Treatment Options: A Guide for People Living with Pain," claims patients need larger opioid doses and states that because opioids have “no ceiling dose,” they’re appropriate treatment for severe pain. In 2009, Janssen sponsored a patient education guide called "Finding Relief: Pain Management for Older Adults" that listed other pain medicines' dosage limitations as “disadvantages” yet failed to mention the risks of increased opioid dosages.
The lawsuit cites a 2013 letter from Dr. Janet Woodcock, director of Center for Drug Evaluation & Research, to Dr. Andrew Kolodny, president of Physicians for Responsible Opioid Prescribing, in which she claimed that the Food and Drug Administration was unaware of any studies showing the safety and efficacy of long-term opioid use.
A 2016 CDC guideline endorsed by the FDA declared that extensive evidence exists about the possible harm of opioids and pointed out that “opioid pain medication use presents serious risks, including opioid use disorder” and warned that “continuing opioid therapy for three months substantially increases risk for opioid use disorder.”
Upshur County's lawsuit notes this discrepancy.
“Defendants falsely claimed that doctors and patients could increase opioid dosages indefinitely without added risk and failed to disclose the greater risks to patients at higher dosages,” Simon wrote.
The lawsuit indicates that in late 2015 and 2016 Endo and Purdue agreed to quit advertising misleading representations of opioids in New York as part of a settlement agreement, but they continued to advertise opioid use for chronic pain relief in Texas.
At this point, some of the drug companies Upshur County is suing were busy engaging in what the lawsuit calls unlawful, unfair and fraudulent misconduct. For example, Cephalon was marketing its fentanyl-based drugs Actiq and Fentora for chronic pain although the FDA had limited their use to cancer treatment in people who were opioid tolerant. The drug company Insys had its employees pose as employees for prescribing physicians, who then contacted insurance companies to obtain prior authorization for Subsys, an expensive opioid intended for cancer pain.
“Insys intended to deceive prescribing physicians into believing Subsys was safe and effective for chronic pain and deliberately lied to insurance companies to ensure payment for its drug,” according to the lawsuit.
In Texas, the pharmaceutical companies often targeted susceptible prescribers and vulnerable patient populations like the elderly and veterans, including those in Upshur County. The lawsuit claims they would find primary care doctors who treated patients with chronic pain but were not as educated about the risks and benefits of opioids.
As opioid prescriptions increased in Upshur County, parental drug addiction led to an increase in the number of children in the county’s child protection agencies. Opioid addiction became one of the primary reasons county residents sought substance abuse treatment. The National Institute on Drug Abuse reports that every day, more than 90 people in the U.S. overdose on opioids.
The lawsuit claims the drugmakers' deceptive practices have created a lucrative, illicit marketplace in which doctor shopping, forged prescriptions and falsified pharmacy records occur more frequently. It also claims that the widespread use of opioids has led to an explosion in heroin use, which addicted users often turn to when prescription drugs aren't available. It has also led to higher health care costs for residents in places like Upshur County.
Upshur County Judge Dean Fowler wasn’t available when the Dallas Observer reached out, but he told the Longview News-Journal a couple of days before the lawsuit was filed that the goal was to try to recoup the cost of the opioid epidemic.
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Some of those costs include treating people who abuse opioids while on the county’s indigent health program and jail inmates who are addicted to the drug.
“It costs our taxpayers to take care of people who are addicted to opioids, and the cost to the public is very high,” he said in the Sept. 26 article.
“I want to make very clear that we are not talking about suing any local doctors or health care providers,” he added. “We are merely targeting the manufacturers, marketers and distributors that mislead them.”
Jack Walker of the Martin Walker law firm, Simon's co-counsel, said they plan to file comparable lawsuits in each county they represent.