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.” The Oklahoma Supreme Court reversed that ruling yesterday, stating that Thad Balkman, Cleveland County District Court judge, “erred” in expanding the public nuisance statute to include the marketing and manufacturing of prescription pain medications.
Opioids
This ruling comes just one week after another California judge dismissed similar claims against the company. It casts doubt further on the validity of lawsuits seeking to blame the pharmaceutical sector for opioid addiction. It also highlights some common myths surrounding the relation between pain treatment and these issues.
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. This ruling relied upon a broad notion of public nuisance that was not compatible with either the Oklahoma Supreme Court’s century-old judicial decisions or the statute.
According to the court, “Oklahoma’s nuisance statute codifies and applies the common law.” According to common law, the Restatement of Torts (Second), 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.”
Examples include: “Interference with the Public Health, such as the keeping of diseased animals or the maintenance a pond breeding mosquitol malarials. Also, with safety and security, like the storage and firing of fireworks in public places. [and]With the public convenience.
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.”
This invitation was rejected by the court for several reasons. It states that “public nuisance and product liability are distinct causes of action with different boundaries, which are not meant to overlap.” It states that product-related claims can only be settled by public nuisance.
The U.S. Court of Appeals 8th Circuit stated in 1993 that “regardless of defendant’s level of culpability and the availability of traditional tort law theories of recovering,” public nuisance claims could have been used against any manufacturer. The result would be that nuisance claims could “become a giant which will consume in one swallow the whole 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.'”
The court noted that, in addition to this general concern, “the manufacturing and distribution of goods rarely causes a violation of any public right.” In this case, the state argued that Johnson & Johnson’s actions violated “the public right of health.” The damages sought by the state are not intended to compensate for communal injuries, but rather for individuals who have suffered from injury due to use of legal products.
This is a vast improvement on the danger posed by nuisances like “diseased animal, water pollution, and the release of [sewage]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.”
It is not reasonable or just, considering that a manufacturer doesn’t have any control over the product once it has been 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.” The sale of these products was approved by government regulators. They are distributed to hospitals and pharmacies via distributors. You cannot legally obtain the drug without a doctor’s prescription. Once the prescription has been filled, it is out of the control of the pharmacist to determine what patients do or who else might get the drug.
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. Duragesic was responsible for the manufacture of Duragesic fentanyl pills, Nucynta’s brand tapentadol tablets and a number of medications containing tramadol (a Schedule IV narcotic). They accounted for only 3 percent of Oklahoma’s prescription opioid sales. According to the court, “Other pharmacies were responsible for marketing 97% prescription opioids.” “Yet the district court held J&J responsible for those alleged losses caused by other pharmaceutical companies’ opioids.”
Balkman approved the expansion of public nuisance law. The court is concerned that manufacturers could become “permanently liable” because nuisance claims “evade any limitation statute.” 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.
This ruling not only clarifies what public nuisance law is, but also highlights other important issues that lawsuits like these tend to miss. Many of these were caused by the “improper use” of prescription opioids. [opioid-related]Deaths,” noted the court, “Related to individuals who used prescribed opioids.”
Not to be forgotten, these prescriptions met a legitimate medical need. “We cannot ignore the fact that chronic pain impacts millions of Americans. Chronic pain is expensive, and opioids can help. 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.”
This isn’t the impression that the thousands upon thousands of lawsuits seeking to blame drug companies on an “opioid epidemic” which overwhelmingly involves illegal fentanyl, does not give. While prescription opioids are legally legal, they can also be dangerous if misused. It is morally questionable to hold manufacturers responsible for this kind of harm. This also hurts consumers who have benefited from potentially hazardous products.
Oklahoma complained that Johnson & Johnson “actively promoted the concept that physicians were undertreating pain,” a message the state viewed as misleading and dangerous. That message could not have been true if Oklahomans who were suffering from pain that can be relieved with opioids had received appropriate treatment. These patients shouldn’t have to suffer just because they can abuse the medications that they require.