Two years ago, when an Oklahoma judge ruled that Johnson & Johnson had created a "public nuisance" in that state by marketing prescription pain medications in a way that minimized their risks and exaggerated their benefits, it was the first time a U.S. court had held a pharmaceutical company liable for contributing to the "opioid epidemic." Yesterday the Oklahoma Supreme Court overturned that decision, saying Cleveland County District Court Judge Thad Balkman "erred in extending the public nuisance statute to the manufacturing, marketing, and selling of prescription
That ruling, which comes just a week after a California judge rejected similar claims against the same company and three others, casts further doubt on the merits of lawsuits that seek to blame the pharmaceutical industry for opioid addiction and opioid-related deaths. The decision also underscores common misconceptions about the relationship between those problems and pain treatment.
Balkman initially ordered Johnson & Johnson to pay the state $572 million to "abate" the public nuisance it supposedly had created, a sum he later reduced to $465 million. His ruling relied on a very broad concept of public nuisance, one that the Oklahoma Supreme Court says cannot be reconciled with the statute or a century of judicial decisions applying it.
"Oklahoma's nuisance statute codifies the common law," the court says. Under common law, according to the Restatement (Second) of Torts, a public nuisance involves "interference with the interests of the community at large—interests that were recognized as rights of the general public entitled to protection."
Classic examples include "interference with the public health, as in the case of keeping diseased animals or the maintenance of a pond breeding malarial mosquitoes; with the public safety, as in the case of the storage of explosives in the midst of a city or the shooting of fireworks in the public streets; with the public morals, as in the case of houses of prostitution or indecent exhibitions; with the public peace, as by loud and disturbing noises; with the public comfort, as in the case of widely disseminated bad odors, dust and smoke; [and] with the public convenience, as by the obstruction of a public highway or a navigable stream."
In the Oklahoma Supreme Court's view, Johnson & Johnson's manufacture, marketing, and sale of legally approved analgesics clearly does not fit this template. "For the past 100 years," the ruling says, "our Court, applying Oklahoma's nuisance statutes, has limited Oklahoma public nuisance liability to defendants (1) committing crimes constituting a nuisance, or (2) causing physical injury to property or participating in an offensive activity that rendered the property uninhabitable….This Court has not extended the public nuisance statute to the manufacturing, marketing, and selling of products, and we reject the State's invitation to expand Oklahoma's public nuisance law."
The court offers several reasons for rejecting that invitation. "Public nuisance and product-related liability are two distinct causes of action, each with boundaries that are not intended to overlap," it says. "Public nuisance is fundamentally ill-suited to resolve claims against product manufacturers."
If that distinction were ignored, the U.S. Court of Appeals for the 8th Circuit observed in 1993, public nuisance claims could be used to target nearly any manufacturer, "regardless of the defendant's degree of culpability or of the availability of other traditional tort law theories of recovery." As a result, nuisance claims "would become a monster that would devour in one gulp the entire law of tort." Among other things, the Oklahoma Supreme Court notes, "extending public nuisance law to the manufacturing, marketing, and selling of products—in this case, opioids—would allow consumers to 'convert almost every products liability action into a [public] nuisance claim.'"
In addition to that general concern, the court notes that "the manufacture and distribution of products rarely cause a violation of a public right." In this case, the state argued that Johnson & Johnson's actions violated "the public right of health." Yet "the damages the State seeks are not for a communal injury but are instead more in line with a private tort action for individual injuries sustained from use of a lawful product."
That's a far cry from the threat posed by nuisances such as "diseased animals, pollution in drinking water, or the discharge of [sewage] on property." The court notes that "a public right to be free from the threat that others may misuse or abuse prescription opioids—a lawful product—would hold manufacturers, distributors, and prescribers potentially liable for all types of use and misuse of prescription medications."
That hardly seems just or reasonable, since "a manufacturer does not have control of its product once it is sold." The court notes that "the alleged nuisance in this case is several times removed from the initial manufacture and distribution of opioids by J&J." Government regulators approved the sale of those products, which reach pharmacies and hospitals via distributors. The drugs cannot be legally obtained without a licensed and regulated doctor's prescription filled by a licensed and regulated pharmacist. And once the prescription is filled, the actions of patients or other people who might obtain the drugs from them are likewise beyond the manufacturer's control.
Even if you ignore this long causal chain and all the other people involved in it, the blame that Balkman apportioned to Johnson & Johnson makes little sense. The company made Duragesic fentanyl patches, the Nucynta brand of tapentadol tablets, and several medications containing tramadol, a Schedule IV narcotic. Altogether, these products accounted for just 3 percent of prescription opioids sold in Oklahoma. "Other pharmaceutical companies were responsible for marketing and selling 97% of the prescription opioids," the court notes. "Yet the district court held J&J responsible for those alleged losses caused by other pharmaceutical companies' opioids."
The court also worries that the extension of public nuisance law approved by Balkman would mean that a manufacturer could be "held perpetually liable for its products," because nuisance claims "sidestep any statute of limitations." In this case, Balkman "held J&J responsible for products that entered the stream of commerce more than 20 years ago, shifting the wrong from the manufacturing, marketing, or selling of a product to its continuing presence in the marketplace." It did not matter that Johnson & Johnson had stopped actively promoting Duragesic in 2007 or that it had sold its Nucynta line to another company in 2015.
In addition to clarifying the boundaries of public nuisance law, the ruling highlights some important considerations that lawsuits like this one tend to ignore. While "improper use of prescription opioids led to many of these [opioid-related] deaths," the court notes, "few deaths occurred when individuals used pharmaceutical opioids as prescribed."
And lest we forget, those prescriptions addressed a genuine medical need: "We also cannot disregard that chronic pain affects millions of Americans. It is a persistent and costly health condition, and opioids are currently a vital treatment option for pain. The U.S. Food and Drug Administration…has endorsed properly managed medical use of opioids (taken as prescribed) as safe, effective pain management, and rarely addictive."
That is not the impression left by the thousands of lawsuits that seek to blame drug companies for an "opioid crisis" that nowadays overwhelmingly involves illicit fentanyl. Prescription opioids, like firearms, are legal and beneficial products that can cause harm when they are misused. Holding manufacturers liable for that sort of harm is not only morally suspect; it hurts all of the consumers who benefit from potentially dangerous products.
Oklahoma complained that Johnson & Johnson "actively promoted the concept that physicians were undertreating pain," a message the state viewed as misleading and dangerous. But that message surely was accurate unless every Oklahoman whose pain could have been safely relieved by opioids was receiving appropriate treatment. Such patients should not have to suffer simply because the medication they need can be abused.