SANTA ANA - A California judge eviscerated legal arguments that opioid manufacturers caused a public nuisance by selling their products, dismissing a vanguard lawsuit by Santa Clara County and other municipal plaintiffs because they failed to provide any evidence the companies caused doctors to write medically inappropriate prescriptions.
Acknowledging that opioid addiction and overdose deaths are a significant social problem, Orange County Judge Peter J. Wilson nevertheless concluded that the plaintiffs, which included Los Angeles County and the City of Oakland, failed to explain how sales of legal narcotics met the legal definition of a public nuisance. The decision, if upheld, could assist defendants Johnson & Johnson, Endo Pharmaceuticals and others defend against lawsuits based entirely upon statistical evidence purporting to show an increase in opioid sales caused related addictions and deaths.
“Mere proof of a rise in opioid prescriptions does not, without more, prove there was also a rise in medically inappropriate prescriptions,” the judge wrote.
Santa Clara was the first municipality to sue the opioid industry in 2014, kicking off a land rush as private lawyers recruited thousands of cities and counties nationwide to sue manufacturers, distributors, pharmacy chains and even consultants McKinsey & Co. under novel theories of public nuisance, false advertising and unfair competition. More than 2,000 federal lawsuits were gathered under the supervision of U.S. District Judge Dan Aaron Polster in Cleveland, whose pro-plaintiff rulings – most in direct contradiction to Judge Wilson’s decision – helped propel J&J and the nation’s three largest drug distributors to negotiate a proposed $26 billion settlement of claims this year.
Central to the plaintiffs’ legal theory is that opioid manufacturers and distributors convinced doctors to prescribe too many narcotics, or willfully closed their eyes to “red flags” indicating prescriptions that shouldn’t be filled. Those theories have only been fully tested in court a few times and the California ruling adds to a number of dismissals where judges have determined that public nuisance law can’t be stretched to include legal sales of a government-approved product.
Judge Wilson also rejected plaintiff claims the drug companies made false marketing claims, including claims that opioids weren’t tremendously addictive, citing studies even plaintiff experts relied upon that suggest fewer than 5% of opioid patients become addicted.
California’s public nuisance law covers “anything which is injurious to health” including “the illegal sale of controlled substances.” But it also says “nothing which is done or maintained under the express authority of a statute can be deemed a nuisance.”
Another essential element of any public nuisance claim is that the conduct is “unreasonable,” the judge wrote. But opioids were approved by the Food and Drug Administration for treating chronic pain, the judge wrote, undermining plaintiff arguments that the risks of selling opioids outweighed the benefits.
“The Federal government made a determination that the `social utility’ of appropriately prescribed opioids outweighed the `gravity of the harm inflicted’ by them,” he wrote.
The California Legislature also passed laws explicitly approving the sale of opioids, including the Pain Patients’ Bill of Rights in 1997 ensuring physicians could prescribe narcotics for chronic pain without risking discipline.
The plaintiffs tried to get around the express prohibition of nuisance lawsuits over legal activities by arguing they were suing over misleading marketing practices that led doctors to prescribe too many pills. They also argued they only had to prove that prescriptions increased, without distinguishing between appropriate and inappropriate scrips.
The judge disagreed. The plaintiffs didn’t present any evidence of specific improper prescriptions, he ruled. It would be “rank speculation” to assign liability to the manufacturers when there were any number of other factors from the FDA to illegal drug dealers, that contributed to the opioid crisis, the judge concluded. The plaintiffs failed to prove any of the defendants made a more than “negligible or theoretical” contribution to the harm, he wrote.
It wasn’t enough to state what “everybody knew,” he wrote, which is that opioid-related injuries increase with the number of prescriptions. That actually undermines the plaintiffs’ case, he continued, since that is why the FDA placed opioids under Schedule II with tight prescribing rules.
Under the plaintiffs’ own theory, he wrote, “adverse downstream consequences will inevitably continue to occur, as the entirely foreseeable consequence of the continued approval of opioids by both the Federal government and the California Legislature.”
The judge cited a landmark nuisance case holding lead-paint manufacturers liable for selling otherwise legal paint for interior use, saying it can be distinguished because there was no appropriate use for the lead paint indoors. Manufacturers paid $305 million to settle that case, disputing liability, after the California Supreme Court refused to hear their appeal.
Judge Wilson also attacked “aggregate proof,” the method Judge Polster approved for federal multidistrict litigation over the fierce objections of defendants. Citing a 2004 decision by another California appeals court, the judge said plaintiffs can prove their case by showing statistical probability but only if they include actual evidence that inappropriate prescriptions were written. The plaintiffs chose not to do that, the judge concluded.
The judge stated that he didn’t intend to suggest that false or misleading promotion couldn't result in inappropriate prescriptions, “but that is not the evidence before the court.”
The judge also rejected false advertising claims based on marketing statements that were in line with FDA guidance, such as J&J’s claim that its Nucynta extended-release opioid was appropriate for chronic pain.
“That was the FDA approved use,” the judge wrote. The plaintiffs also challenged as false a statement “addiction is rare,” citing an opinion by their expert, Dr. Anna Lembke, that a quarter of opioid patients will become addicted.
The studies Dr. Lembke relied upon don’t support her conclusion, however, the judge ruled. More reliable data suggest less than 5% of patients become addicted, he wrote.
The court held the first phase of the trial, to determine liability, between April and July of this year. The defendants moved for judgment at the close of the plaintiffs’ case in June but the judge declined to rule until the defense closed their case.