Millions of states and local governments sued pharmaceutical companies in 2014 for creating the opioid crisis. They claimed that they exaggerated the benefits of pain medications and minimized the risk. You might conclude that this allegation is true, given the number of lawsuits against four pharmaceutical companies and the $26 billion multijurisdictional settlement. To find out more, read yesterday’s 42-page Orange County Superior Court Judge Peter J. Wilson ruling in the wake of the lawsuit.
Although the details can be quite damning, they are not as severe as you would think. Wilson’s harsh rejection of four of the drug manufacturer cases highlights the myths that underlie the narrative that pain treatment is responsible for an increase in opioid-related deaths. This can be better understood by understanding the war against drugs.
Orange, Los Angeles and Santa Clara counties filed a seven-year-old complaint claiming that they created a public nuisance by encouraging greater use of their products via a misleading or false marketing campaign. Wilson concluded after the bench trial, which started on April 19th and was completed at the beginning last month. AnyThey are denying these claims.
Wilson points out that both California and the federal governments have determined that opioids can be prescribed for medically necessary purposes. The plaintiffs countered that it was not necessary to demonstrate harm done by the drug companies through encouraging prescriptions for medically inadequacies. Wilson asserts that this is clearly false.
Even if marketing led to an increase of prescriptions for opioids in quantity, dosage or length DidFalse or misleading marketing. Any adverse downstream consequences Medically acceptablePrescriptions can’t be considered an actionable 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….
A rise in opioid prescriptions is not enough to prove that there was an increase in other medications. Medically inadvisablePrescriptions for opioids. The plaintiffs did not distinguish between medically prescribed and non-medically prescribed opioids. There is simply Please enter 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 noThere is evidence to show that the false and misleading marketing of Defendants led to the writing medically incorrect prescriptions.
Wilson also found no support for the plaintiffs’ “false advertisement” claims. These were based mostly on statements made by the companies in sales training material and literature targeted 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. Wilson concludes that the plaintiffs misrepresented the statements of the companies, took them out of context or claimed truthful statements were misleading or inaccurate. These are just a few of the examples that Wilson uses to illustrate how ridiculous and frivolous plaintiffs’ accusations were.
In a 192-page manual Allergan wrote that doctors who were incorrectly taught that opioids would lead to addiction never saw any symptoms. The plaintiffs called that false and misleading. This is not the case.
Wilson points out that Anna Lembke was one of plaintiffs’ expert witnesses and “told that 1 in 4 patients who were prescribed opioids would get addicted to them.” However, “Defendants” point out that Dr. Lembke relied on in support of this conclusion. Wilson claims that the more reliable data suggests a lower than 5% rate, and not 25%. Wilson says that “most patients do not develop addiction if they have been given opioids.”
In the same document, “pseudoaddiction” is discussed. This concept was misrepresented by plaintiffs. Wilson points out, however, that this is a medically accepted term. It describes a condition in which patients seek more or stronger opioids because of pain, but not because they are suffering from an abuse disorder. California’s Legislature “itself recognized the condition without using the term pseudoaddiction in Health and Safety Code section 18.11156(b).(2):[A]A person whose addiction is caused by the inability to manage pain is not an addict.
Janssen’s Nucynta ER (an extended-release tapentadol version) is a prescription for managing moderate-to-severe chronic pain. The document contains 31 pages of sales training. Even though “that was an FDA approved use”, the plaintiffs maintained that this claim was inaccurate or misleading.
Wilson refers to another Janssen training manual and says that Plaintiffs consider false or misleading any statements that could be misinterpreted as suggesting that certain opioid products improve 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.”
Even Endo’s balanced statement was disputed by the plaintiffs Responsible Opioid prescribing: A Physician’s guide“Patients suffering from pain and who depend on opioids for pain management and better function deserve safe, effective medications; to deny them pain relief does great harm.” These life-saving medications can cause serious harm to those who are at high risk of addiction or abuse. Wilson points out that there are “numerous other references in the handbook to the “critical need” of “balancing pain relief and the associated risks of medication.”
Plaintiffs claimed that Janssen’s Duragesic, Janssen’s fentanyl patches, journal advertising was misleading or false. 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.”
You can go on and 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….
According to the Court, there is nothing misleading or falsifiable in these statements.
The Court finds nothing false or misleading in this document….
The Court has found nothing in the statement that was cited from this document to be false or misleading.
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. Similar evidence was presented in the other case.
Cleveland County District Court Judge Thad Balkman faulted Johnson & Johnson for suggesting that prescription analgesics 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. Wilson noted that the company had also wrongly stated that opioids can be used to treat chronic pain, something that California law allows. He was also wrong to suggest that patients who are suffering from addiction might appear like they’re seeking relief. Wilson also pointed out that California recognizes “pseudoaddiction”.
Johnson & Johnson said Wilson’s ruling shows that its marketing has been “appropriate and responsible.” The company wants to finalize the $26 billion settlement that I mentioned. While its products make up less than 1% of all prescription opioids in the United States, their share in this settlement is larger: $5 billion or 19%.
This fact is enough to suggest that these payouts don’t have much to do with fair blame sharing. 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. Similar reasoning applies to the argument against pain treatment being the primary cause of opioid-related fatalities. This includes fentanyl, which is overwhelmingly used in pain treatments.