Since 2014, thousands of state and local governments have sued pharmaceutical companies they blamed for causing the "opioid crisis" by exaggerating the benefits and minimizing the risks of prescription pain medication. Given the enormous volume of lawsuits and a pending $26 billion multi-jurisdictional settlement involving four of those companies, you might surmise that there must be something to this accusation. If so, you should read the 42-page ruling that a California judge issued yesterday in response to the lawsuit that started this flood of litigation.
The details are indeed damning, but not in the way you might expect. Orange County Superior Court Judge Peter J. Wilson's scathing rejection of the case against four drug manufacturers highlights some of the misconceptions underlying the false narrative that blames pain treatment for a surge in opioid-related deaths that is better understood as a predictable result of the war on drugs.
In a complaint that was originally filed seven years ago, Orange, Los Angeles, and Santa Clara counties, joined by the city of Oakland, argued that the companies they sued created a "public nuisance" by encouraging increased use of their products through a false or misleading marketing campaign. The four jurisdictions sought more than $50 billion in damages. Following a bench trial that began on April 19 and wrapped up at the beginning of last month, Wilson concluded that the plaintiffs had failed to prove any of their allegations.
Regarding the public nuisance claim, Wilson notes that both the federal government and the state of California have determined that the benefits of prescribing opioids for medically appropriate uses outweigh the attendant risks. Yet the plaintiffs argued that they did not need to show the defendants had caused harm by encouraging medically inappropriate prescriptions. That is clearly wrong, Wilson says:
Even if any of the marketing which caused an increase in the number, dose or duration of opioid prescriptions did include false or misleading marketing, any adverse downstream consequences flowing from medically appropriate prescriptions cannot constitute an actionable public nuisance. This is so because, as the Federal government and the California Legislature have already determined, and as this Court finds, the social utility of medically appropriate prescriptions outweighs the gravity of the harm inflicted by them and so is not "unreasonable" or, therefore, enjoinable….
The mere proof of a rise in opioid prescriptions does not, without more, prove there was also a rise in medically inappropriate opioid prescriptions. Plaintiffs made no effort to distinguish between medically appropriate and medically inappropriate prescriptions. There is simply no evidence to show that the rise in prescriptions was not the result of the medically appropriate provision of pain medications to patients in need….
Plaintiffs proffered no evidence that the allegedly false or misleading marketing by Defendants caused the writing of medically inappropriate prescriptions.
Wilson likewise found no evidence to support the plaintiffs' "false advertising" claims, which were based mainly on statements the companies made in training materials for sales representatives and literature aimed at doctors. He goes through the allegations against each of five companies: Endo, Teva USA, Cephalon (which Teva acquired in 2011), the AbbVie subsidiary Allergan, and the Johnson & Johnson subsidiary Janssen. Again and again, Wilson concludes, the plaintiffs misrepresented what the companies had said, took it out of context, or falsely asserted that truthful statements were inaccurate or deceptive. A few examples give you a sense of how frivolous the plaintiffs' charges were.
"Clinicians who had been incorrectly trained to believe that taking opioids for a prolonged period would always result in addiction were surprised that most of these patients never exhibited any signs or symptoms of addictive disease," Allergan said in a 192-page training manual for sales reps who handled Kadian, an extended-release version of morphine. The plaintiffs flagged that statement as false or misleading. It is neither.
Wilson notes that one of the plaintiffs' experts, Anna Lembke, "testified that one in four patients prescribed opioids would become addicted." But "as Defendants point out, the studies relied upon by Dr. Lembke for that conclusion are inadequate to support it." Wilson says "the more reliable data would suggest less than 5%, rather than 25%." But either way, "addiction based solely on the patient having been prescribed opioids does not occur in 'most of these patients.'"
The same document discusses "pseudo-addiction," a concept that the plaintiffs portrayed as false or misleading. But as Wilson notes, "this is a medically recognized term, describing a condition where a patient seeking more or stronger opioid medication might be doing so because their pain is undertreated, and not because they have or are developing an abuse disorder." California's legislature "itself recognized this condition, without using the term 'pseudoaddiction,' in Health and Safety Code section 18 11156(b)(2): '[A] person whose drug-seeking behavior is primarily due to the inadequate control of pain is not an addict within the meaning of this section.'"
According to a 31-page sales training document, Janssen's Nucynta ER, an extended-release version of tapentadol, "is indicated for the management of moderate to severe chronic pain in adults when a continuous, around-the-clock opioid analgesic is needed for an extended period of time." Although "that was the FDA approved use," the plaintiffs still claimed this statement was false or misleading.
Regarding another Janssen training document, Wilson notes that "Plaintiffs identify as false or misleading any statement that can be interpreted as saying that a particular opioid product improves function." Yet "it seems beyond debate that for a patient whose pain has been sufficiently controlled that they are able to resume some of the basic functions of life—shopping, cooking, cleaning, and so on—that patient's function has improved."
The plaintiffs even took issue with this balanced statement from Endo's Responsible Opioid Prescribing, a Physician's Guide: "Patients in pain who rely on opioids for analgesia and improved function deserve access to safe and effective medication; to deprive them of optimal pain relief certainly does them harm. Yet these same life-restoring medications carry the potential to do grave harm to patients who may be at risk for addiction and abuse." Wilson notes that the handbook includes "numerous" other mentions of "the critical need to balance pain relief on the one hand with the attendant risks of the medication."
The plaintiffs said journal advertising for Duragesic, Janssen's fentanyl patch, was false or misleading. Yet the plaintiffs' own expert witness, Matthew Perri, "found that the claims in Janssen's marketing materials track the FDA-approved labels fairly consistently" and said he "did not see any indication of Janssen failing to include important safety information in its marketing pieces."
And so on:
- Plaintiffs' characterization of the statements is inconsistent with the statements themselves, and again ignores context….
- The Court finds none of the identified statements to be false or misleading….
- Read in the context of the entire document, the Court finds none of the identified statements to be false or misleading….
- Nothing in the challenged statement is shown to be inaccurate….
- The Court finds nothing false or misleading in the statements cited from these documents….
- The Court finds nothing false or misleading in this document….
- The Court finds nothing false or misleading in the statement cited from this document.
You get the idea.
One of the prevailing defendants in this lawsuit, Johnson & Johnson, is appealing a 2019 decision in which an Oklahoma judge said it should pay $572 million for its part in that state's opioid-related problems. The evidence in that case was similarly flimsy.
Cleveland County District Court Judge Thad Balkman faulted Johnson & Johnson for suggesting that prescription opioids pose a "low danger" when used for legitimate medical purposes, even though there is plenty of evidence to support that claim, whether we are talking about the risk of addiction or the risk of a fatal overdose. He also thought the company was wrong to say opioids could be appropriate for treating chronic pain (something that California law explicitly allows, as Wilson notes) and wrong to suggest that undertreated patients might look like addicts as they desperately sought relief (the "pseudo-addiction" concept that California likewise recognizes, as Wilson also points out).
Johnson & Johnson said Wilson's ruling shows that its marketing has been "appropriate and responsible." Yet the company is keen to put the final touches on that $26 billion settlement I mentioned. Although its products account for less than 1 percent of prescription opioids, its share of the settlement is much bigger: $5 billion, or 19 percent.
That fact alone suggests such payouts have little to do with a fair allocation of blame. And as Wilson's ruling shows, Johnson & Johnson's eagerness to eliminate this liability risk should not be interpreted as evidence that the case against the company is strong. The same goes more generally for the case against pain treatment as the main cause of opioid-related deaths, which overwhelmingly involve illicit fentanyl.