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SANTA ANA (CNS) - Orange County supervisors voted to approve settlements with pharmaceutical companies that won a tentative ruling from an Orange County Superior Court judge who rejected claims from prosecutors in Orange and Santa Clara counties as well as Los Angeles and Oakland blaming the drug-makers for the opioid crisis.
The supervisors voted unanimously to approve settlements with opioid distributors McKeon, Bergen and Cardinal Health as well as Janssen Pharmaceuticals. The move will help the county recover some of the costs of the litigation, which unfolded over seven years. The amount has yet to be determined.
Orange County Superior Court Judge Peter Wilson on Nov. 1 handed down a tentative ruling that concluded that prosecutors failed to provide enough evidence linking the pharmaceutical companies to the crisis that would amount to a public nuisance claim.
The trial began in April and was conducted entirely on Zoom with weeks of testimony and two days of closing arguments.
The first lawsuit was filed May 21, 2014, but the sixth amended complaint that was ruled on was filed June 8, 2018.
``In summary, plaintiffs contend that each defendant engaged in an aggressive false and/or misleading marketing scheme designed to increase, and which succeeded in increasing, the writing of prescriptions for defendants' opioid medications, and that the increased prescriptions have caused or contributed to the opioid crisis ... being experienced in California,'' Wilson wrote.
The prosecutors alleged the opioid crisis is the public nuisance and that false and/or misleading marketing caused it.
The defendants include Johnson & Johnson, Janssen, Endo Pharmaceuticals Inc., Allergan, Cephalon Inc., Teva Pharmaceuticals USA, Actavis and Watson Laboratories, among others associated with those companies.
Wilson said it was not in dispute by anyone involved in the litigation that there is an opioid crisis.
``Drug abuse, including opioid abuse, affects not only the individuals directly involved, but their family and friends, doctors and other medical care providers, emergency rooms, law enforcement, and indeed all those impacted at each step of the drug-abuse cycle,'' Wilson wrote.
``Opioid-related hospitalization rates and opioid-related deaths starkly demonstrate the enormity of the ongoing problem.''
However, Wilson added the pharmaceutical companies disputed whether the prosecutors had ``proven that the opioid crisis constitutes an actionable public nuisance for which defendants, or any of them, are legally liable.''
Wilson emphasized that his ruling should not be seen as an effort to ``minimize the existence and extent of the ongoing opioid crisis.''
The prosecutors alleged false advertising, unlawful business practices and public nuisance.
Wilson noted that the Food and Drug Administration and Drug Enforcement Administration have approved the Schedule II narcotics at issue in the complaint despite the risks because the medicines have benefits that outweigh those drawbacks.
Wilson also found that ``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.
``That 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.''
Wilson said the significant increase in volume of opioid prescriptions does not, ``without more, prove there was also a rise in medical inappropriate opioid prescriptions.''
Wilson said prosecutors ``made no effort to distinguish between medically appropriate and medically inappropriate prescriptions.''
Wilson also said prosecutors failed to provide evidence that false or misleading marketing spurred the issuing of medically inappropriate prescriptions.
``Instead, plaintiffs ask the court to inter that the rise in prescriptions generally must logically also have resulted in the rise of medically inappropriate prescriptions,'' Wilson wrote. ``But there is no evidence, other than the rise itself, from which this court can reasonably draw such an inference.''
Furthermore, even if they could prove the marketing caused some inappropriate prescriptions to be written there is not evidence that could lead him to conclude ``without rank speculation'' that they ``contributed to the alleged public nuisance, and, if so, to what extent,'' Wilson said.
Even the expert witness for the prosecutors said the opioid crisis was ``multifaceted, with contributing actors including manufacturers, distributors, pharmacies, doctors, the illegal drug trade, the FDA, the DEA, and the state of California,'' Wilson said.
Wilson said the FDA designated opioids as Schedule II drugs because the agency understood the risks of abuse. And when the agency was asked in 2013 ``when the opioid crisis was already full blown, to impose dose or duration limits, the FDA declined to do so, leaving such decisions instead to the healthcare practitioner in consultation with his or her patient.''
Wilson noted that the prosecutors relied on precedent involving the continued use of lead paint, but the difference being that lead paint had no ``appropriate'' use.