Courts are right to deny public-nuisance claims in opioid litigation.
Courts are right to deny public-nuisance claims in opioid litigation.
T he opioid crisis has spawned a rash of litigation, with thousands of pending state and federal cases threatening to penalize legitimate prescription opioid makers. But a welcome decision by the Oklahoma supreme court last week challenges the legal basis for nearly all of the lawsuits, which attempt to treat opioid marketing as a “public nuisance.”
Injured parties have a legal right to obtain redress from a public nuisance, which is defined as an “unreasonable interference with a right common to the general public.” Usually, public-nuisance actions are brought against alleged environmental wrongs such as noxious smells, loud noises, and pollution.
But in 2017, the state of Oklahoma claimed in state court that three prescription opioid manufacturers created a public nuisance through deceptive marketing that overstated opioids’ benefits and downplayed their dangers.
Two years later, two of the three companies settled with Oklahoma — Purdue Pharma for $270 million, and Teva for $85 million — leaving Janssen, a Johnson & Johnson subsidiary, as the sole defendant. But J&J only manufactured a mere 3 percent of all prescription opioids in Oklahoma. What’s more, only two of their products — Duragesic fentanyl patches and Nucynta pills — were designated by the Drug Enforcement Administration as Schedule II drugs with “high potential for abuse,” and they accounted for less than 1 percent of Oklahoma opioid prescriptions.
Yet, remarkably, the trial court assigned public-nuisance liability to J&J for the harms done by all the prescription opioids in Oklahoma, not just the small fraction that J&J sold, and awarded the state $465 million.
On appeal, the Oklahoma supreme court found that the trial court had expanded public-nuisance law “too far.” Nuisance statutes cannot be applied to manufacturers of lawful products such as prescription opioids because they do not control the product or how it is used once it is sold. J&J did not have the ability or duty to police its own or other manufacturers’ products or the people who use them.
According to the court, holding a manufacturer of a legal product that causes injury liable for creating a nuisance would “create unlimited and unprincipled liability for product manufacturers.” The court cited other states’ rulings rejecting nuisance claims against the makers of potentially harmful products such as guns, tobacco, and lead paint, finding that mass harms caused by legal products are better addressed through the more demanding law of products liability.
“However grave the problem of opioid addiction is in Oklahoma,” the court opined, “public nuisance law does not provide a remedy for this harm.”
A week earlier, a lower court in Orange County, Calif., rejected similar nuisance claims. Four jurisdictions sued four prescription opioid makers, including J&J, alleging that the companies had engaged in false advertising and unfair business practices that created a public nuisance.
Judge Peter Wilson noted that the FDA had approved the medications as safe and effective for their labeled indications and had found that the products presented an appropriate benefit–risk balance for the intended population and use. And California statutes — including the “Pain Patient’s Bill of Rights” — declared that inadequately treated pain “is a significant health problem” and that opioids can be a “safe” and “effective treatment.”
The judge concluded that “medically appropriate prescriptions cannot constitute an actionable public nuisance” and added that even if the companies’ promotional materials had been misleading — and the judge determined they were not — the plaintiffs failed to demonstrate that they led to an increase in medically inappropriate prescriptions.
True, some culprits have emerged. Purdue Pharma pled guilty to various felonies in 2007 and again last year, and Insys Therapeutics executives were convicted of bribing physicians to prescribe opioids and defraud insurers. Yet aside from these companies, proof of deliberate wrongdoing is scarce.
Nevertheless, companies are eager to mitigate litigation risk by settling. The nation’s three largest drug distributors, along with J&J, proposed a $26 billion settlement in the ongoing multidistrict litigation pending in an Ohio federal district court.
Still, multiple state and local governments are holding out for even more.
These plaintiffs, abetted by the private trial bar in search of large contingency fees, are targeting companies with deep pockets. And these legally dubious lawsuits are extracting huge sums because companies are reluctant to risk bad publicity and large trial judgments. Unfortunately, there is no guarantee that the monies will be used to combat opioid abuse — little of the tobacco-settlement money ever went to fight smoking.
With over 3,000 opioid cases pending, more courts should follow Oklahoma’s and California’s lead and put an end to this epidemic of litigation.
Joel Zinberg J.D., M.D. is a senior fellow at the Competitive Enterprise Institute, the director of Paragon Health Institute’s Public Health and American Well-being Initiative, and an associate clinical professor of surgery at the Icahn Mount Sinai School of Medicine. He was general counsel and a senior economist at the White House Council of Economic Advisers from 2017 to 2019. Sally Satel, M.D., is a senior fellow at the American Enterprise Institute and a visiting professor of psychiatry at Columbia University’s Vagelos College of Physicians and Surgeons.