Will the Law Treat Opioids More Like Cigarettes or Handguns?

Governments are suing pharmaceutical makers over the opioid epidemic. They'll need to prove that companies borrowed “a page from Big Tobacco’s playbook.”

In late May, Ohio followed Mississippi, the City of Chicago, and counties in New York and California, among others, in filing suit against drug makers for marketing powerful painkillers in allegedly misleading ways. The defendants—which include Purdue Pharma LP, Johnson & Johnson, and Teva Pharmaceutical Industries Ltd.—deny wrongdoing and say they’ve acted responsibly. Meanwhile, attorneys general of another group of states—Connecticut, Massachusetts, New York, and Vermont—have also been issuing opioid-related subpoenas without naming the companies they’re investigating or committing themselves to going to court.

The abuse of brand-name prescription opioids, such as Purdue’s OxyContin and generics like oxycodone, has become a public health crisis. Overdose deaths in the U.S., including from prescription drugs and heroin, exceeded 33,000 in 2015 (the most recent year for which data from the Centers for Disease Control and Prevention are available), up from 19,000 the year before. One study by Wolters Kluwer Health estimated that costs related to treatment, policing, and lost economic output reach into the tens of billions of dollars a year.

At issue in the current wave of litigation is who should pay those societal costs: taxpayers or drug companies? The public officials spearheading the suits compare their cases to those filed by states against major tobacco companies in the 1990s. In court papers, Ohio’s attorney general, Mike DeWine, accuses the drug companies of “borrowing a page from Big Tobacco’s playbook” by allegedly concealing addiction risks from physicians and patients, much as the tobacco industry for decades obscured the addictive quality of nicotine and the health dangers of smoking.

And much as state tobacco suits sought damages for public health costs related to treating smokers, opioid litigation seeks reimbursement for Medicaid payments and addiction treatment for prescription painkillers. It worked for tobacco litigation: In 1998, the cigarette companies agreed to a $246 billion settlement that would be divided among the states and paid out over decades.

But there are crucial differences between painkillers and cigarettes. Opioids, however potentially dangerous they may be, are regulated by the Food and Drug Administration, which tells manufacturers what warnings to put on pill bottles. If used as intended under a doctor’s supervision, opioids improve patients’ health. Where painkillers are misused, manufacturers can plausibly argue—and do—that blame should rest with the doctor who overprescribes or the consumer who knowingly takes too many pills. By contrast, cigarettes don’t have the FDA’s blessing, and they cause deadly diseases if used exactly as intended.

Legal experience may suggest, though, that the better analogy for opioids is firearms. In the wake of the tobacco litigation, in the late 1990s, dozens of municipalities tried the same strategy against the handgun industry’s biggest players, seeking to recover the public costs of firearm-related violence. The national price tag for municipal police and emergency-medical services was estimated to be in the tens of billions of dollars a year. 

Unlike the tobacco cases, though, the gun suits soon fizzled. One reason was that judges ruled that firearm manufacturers shouldn't be held liable for the misuse of the otherwise-lawful commercial articles they made and sold. Under this view, while guns are designed to fire bullets, they’re not designed to be used in crime. In order for a pistol to be used unlawfully, another actor—the criminal—has to intervene and pull the trigger. In legal terms, the criminal “breaks the chain of causation” between the manufacturer and the harm caused by the product. In the eyes of the law, a broken chain eliminates liability.

Opioid manufacturers might be inclined to argue that their product is more like guns in this regard. When used properly, both have legitimate purposes and don’t necessarily cause harm. While firearms are dangerous, the fact remains that they're widely and legally owned for target shooting, hunting, and home security. Likewise, opioids are widely and legally used to manage pain. Pharma lawyers might argue that, as with guns, when opioids are misused, there’s a break in the chain of causation: The negligent doctor or pill-abusing consumer is analogous to the criminal triggerman.

This may have been the reasoning, at least, when, back in 2004, West Virginia settled with Purdue for a mere $10 million. The relatively small size of the settlement (in which the company didn't admit wrongdoing) “suggests that the attorney general's lawyers realized that there was no assurance that the state would ultimately prevail if the case went to trial,” observed Professor Richard Ausness of the University of Kentucky College of Law in a 2014 article. "A particular concern was that a court would conclude that misuse of OxyContin by drug abusers was a superseding cause sufficient to break the chain of causation between Purdue's marketing activities and the costs the state incurred to treat the effects of such abuse." Ausness concluded: “The overall effectiveness of civil litigation in this area is highly questionable."

Circumstances have changed since 2014, and they’ve changed a lot since 2004. Opioid abuse has spread and intensified, possibly changing attitudes among potential jurors, especially in regions where the opioid toll is high. A skeptical jury pool could raise the settlement value of the new municipal and state suits. Moreover, Ohio and the other current government plaintiffs are seeking to prove that painkiller manufacturers continue to spread falsehoods about their products, using front groups and morally corrupt physicians as their messengers. Ohio blames the drug companies for unleashing a “flood of prescription opioids” that become “available for illicit use or sale,” creating “a population of patients physically and psychologically dependent” on the pills. If these allegations are substantiated—the manufacturers deny them—the alleged corporate malfeasance could trump any concerns about broken chains of causation. 

A final consideration is sheer numbers: If the opioid industry were faced with hundreds of coordinated suits, the cost of fighting them simultaneously could indeed force the drug companies to borrow a page from tobacco’s playbook and run up a very expensive white flag. 

    Paul Barrett
    Former Bloomberg Businessweek Columnist
    Before it's here, it's on the Bloomberg Terminal.