Relevant Documents:ComplaintPlaintiffs’ Trial Brief
The parties made their opening statements today in the California state court opioid bench trial in Orange County Circuit Court, with plaintiffs Los Angeles, Orange and Santa Clara counties and the City of Oakland focusing on opioid manufacturers’ allegedly misleading marketing campaigns and defendants denying that the plaintiffs could prove any doctors were actually misled or patients harmed by their marketing.
The plaintiffs seek up to $50 billion to remediate
of an opioid crisis in California from affiliates of Teva Pharmaceuticals, Endo Pharmaceuticals
, Abbvie and Johnson & Johnson. The trial does not involve AmerisourceBergen, Cardinal Health or McKesson, the three distributors expected
to pay the bulk of any global settlement of more than 3,400 pending opioid claims. The plaintiffs originally sued Purdue
as well, but those claims have been stayed by that company’s chapter 11 filing. Mallinckrodt
has also filed chapter 11 to settle $2.2 trillion in governmental opioid claims, among other liabilities. The next trial to involve both manufacturer and distributor defendants is a jury trial currently scheduled
to begin on June 8 in New York state court.
According to Fidelma Fitzpatrick of Motley Rice, counsel for the plaintiffs, the defendants used misleading “unbranded marketing” pushed by “front groups” to “increase the total amount of opioids used generally,” and then used misleading branded marketing to “compete to see who could get the biggest share of the overall pie.” Fitzpatrick told Judge Peter Wilson that the defendants told doctors opioids would “improve the quality of life” for patients, when in reality they caused addiction, overdose and death. The defendants also developed the false concept of “pseudoaddiction,” Fitzpatrick said, to justify doctors giving patients with signs of drug-seeking behavior even more opioids, and suggested that “addiction is rare” and there is no “ceiling dose” for their opioids.
As a result of these marketing efforts, Fitzpatrick argued, the defendants have created a “serious threat to the health of all individuals” throughout California. Fitzpatrick asked the judge to force the defendants to “be a part of the solution to this public health crisis.”
Collie James of Morgan Lewis, counsel for the Teva entities, responded that his clients’ opioid products “remain legal, necessary and effective” pain management options in California. The plaintiffs, Collie argued, do a “disservice to every citizen” when they “reduce this trial to a simple flawed picture about prescription drug marketing.” James called Teva’s marketing practices “normal,” “legal,” “common” and “not nefarious,” and noted that both the drugs involved and the marketing materials were approved by the U.S. Food and Drug Administration. It is the FDA’s job, James suggested, to “strike the right balance” between reducing the risks of addiction from prescription drugs and protecting patients’ access to effective pain management medication.
James also maintained that the plaintiffs have failed to distinguish between the different Teva entities as marketers of opioids. For example, James said, Cephalon, one of the Teva defendants, only sold Actiq and Fentora, two drugs with very limited indications and sales - and Teva did not acquire Cephalon until 2011. Teva did not acquire the generic opioids manufacturers sued by the plaintiffs until 2016, James added, and generic opioids were a “small portion” of the businesses acquired. James flatly denied that Teva’s opioid sales “dominate” the market as alleged by the plaintiffs.
Michael Yoder of O’Melveny, counsel for Johnson & Johnson’s Janssen affiliates, focused on the distinction between Purdue’s Oxycontin and its own Duragesic, a fentanyl-based patch, and Nucynta, a pill based on a different molecule that includes tamper-resistant features to discourage misuse. Yoder further suggested that the four plaintiff jurisdictions may not in fact be oversupplied with opioids, noting that Los Angeles County is 1,549th in the country in per capita opioid supply and Orange County 1,183rd. The plaintiffs, Yoder argued, cannot tell the court what the appropriate amount of opioids prescribed in these jurisdictions should be, or by how much the actual amount exceeded that appropriate amount.
The court, Yoder asserted, is not a “public health administrator” that should decide the appropriate amount of opioid prescriptions in the plaintiff jurisdictions. That should be left to individual doctors making decisions for individual patients, Yoder suggested. “In the real world,” Yoder said, opioids are a key element of effective pain management, as recognized by the FDA, and physicians know the risks of prescribing these drugs and how to monitor patients for abuse.
John Hueston of Hueston Hennigan, counsel for the Endo entities, accused the plaintiffs of using the court as a “super-legislature” to overturn policy decisions by the FDA, the federal government and the State of California using arguments that have already been rejected by these policymakers. Hueston also stressed that the people “on the ground” have decided there “is no crisis” in the four plaintiff jurisdictions, and added that California is “near the bottom of the list” in many measures of opioid use and abuse. “These are not counties in Ohio,” Hueston declared.
Nor, Hueston asserted, is Endo equivalent to Purdue, whose conduct with respect to Oxycontin he called “reprehensible.” Endo’s “stand-up corporate conduct calls for praise and commendation,” not a civil suit, Hueston asserted. Hueston blamed illicit opioids, especially fentanyl, for any opioid abuse issues in California - and said the science shows prescription opioids are not a “gateway” to heroin use. The “gateway theory” is “bunk,” Hueston argued.
For the plaintiffs’ position on the evils of prescription opioids to be correct, Hueston concluded, virtually “all of the world’s” experts on opioids, including the FDA, the United Nations and the U.S. Drug Enforcement Administration, would have to be wrong. If these organizations are wrong, they can change course later, Hueston continued, but a litigation judgment cannot be revisited.
Counsel for Abbvie’s Allergan affiliates will present opening arguments when the trial continues on April 20 at 12 p.m. ET.