Litigation is critical to opioid crisis response

The opioid problem is monstrous and tentacular. Its sprawling arms have claimed 300,000 American lives, including nearly 49,000 last year alone, dwarfing both car crashes and gun violence. In inner cities and rural counties alike, it continues to sweep in victims -- an expected half-million more within the next decade. That's like wiping out all the men, women and children in Sacramento in one fell swoop.

Efforts to combat the problem, too, are multi-pronged. Initiatives within the medical profession have begun to change how and when physicians prescribe these potent painkillers. Police in many localities have shifted away from hardline law enforcement toward approaches that connect opioid users with treatment. The Food and Drug Administration is spearheading a range of initiatives, including working to stem the flow of illegal opioid shipments, preventing illicit internet sales, clamping down on reckless distributors, issuing new guidance on the risks and benefits of opioid use, and speeding the overdose reversal drug, naloxone, to over-the-counter status. Even the conflict-riddled Congress has responded with surprising vigor, as the SUPPORT for Patients and Communities Act was signed into law in 2018. Among other things, the act supports research into new pain therapies, funds medical continuing education programs, and enhances the interoperability and quality of state prescription monitoring programs.

The courts, too, are playing a role. Indeed, we believe they may be the most important stage on which the fight against the epidemic will play out. Litigation against opioid manufacturers and sellers is in full swing and, as the New York Times recently observed, is already becoming "one of the most complicated and gargantuan legal battles in American history." Scores of public and private plaintiffs have filed thousands of lawsuits. This litigation uses an array of tools, seeks a range of penalties, and is pending in courts throughout the country. But a federal courtroom in Cleveland, Ohio, is seeing the lion's share of the action. There, over 1,500 federal lawsuits have been consolidated into a massive multidistrict litigation, or MDL, overseen by "transferee" Judge Dan Polster.

Most of the MDL plaintiffs are cities, counties and tribal governments, and these plaintiffs are seeking compensation for their additional public spending traceable to the opioid epidemic. Their claims largely boil down to the assertion that they have been injured because the defendants pumped opioids into the hands of their citizens and, in so doing, increased spending for governmental services. Everything from policing, education, foster care, the provision of health care, even the operation of coroner's officers, have all been made more expensive because an opioid-dependent population is far less productive and needs far more by way of government help.

For three reasons, the litigation is a critically important component of the response to the opioid crisis. First is its potential as a discovery mechanism. Much like the crusading tobacco plaintiffs from the 1990s, plaintiffs in the opioid suits want opioid makers and sellers to cough up their internal documents so we can all better understand what the defendants knew about the dangers of the products they were peddling. Massachusetts' suit against Purdue Pharma has already surfaced stunning allegations about how the company penetrated medical practice and encouraged the reckless overprescription of their marquee painkiller, OxyContin. Likewise, Judge Polster recently compelled the release of Drug Enforcement Administration data on opioid sales. Much of the information isn't yet public, but the little we do have shows, for example, that during one 10-month period in 2007, the behemoth distributor McKesson shipped nearly 10,000 opioid pills a day to a single drugstore in Kermit, West Virginia (population: 400).

As the litigation progresses, we imagine similar facts will come to light implicating other defendants. This information is important in its own right, and it may, in time, build momentum to curb drug companies' promotion of brand-name drugs to physicians, which has not only driven the opioid epidemic but also fueled the continued rise in healthcare costs.

Second, the litigation has obvious importance for establishing accountability. As the epidemic unfolded, opioid abusers initially were portrayed as the culpable parties. Later, as the role of excessive prescribing in getting people started using opioids became clearer, physicians moved into the bullseye. Unquestionably, "pill mills" and other high-volume prescribers were important contributors to the growth of the epidemic in some parts of the country. Most prescribing, however, did not emerge from those sources, but from rank-and-file physicians responding to two powerful messages about their clinical practice. National expert groups emphasized that patients' pain needed to be treated more aggressively, and drug company sales representatives jumped in with the message that highly effective, very safe, non-habit-forming opioid therapies could fill that need. As the epidemic has matured, public focus has now shifted to that latter message and its palpable falsity. The time has come for sellers of these highly addictive products to accept their share of the financial, legal, and moral responsibility for the epidemic. The litigation, if successful, will be the primary forcing mechanism.

Third, the litigation is crucially important because of its potential economic consequences. The opioid epidemic is not only a public health disaster, it is also an economic bomb detonated in areas of the country where healthcare and social systems are already overstressed. Particularly in states that declined to expand their Medicaid programs when funds were made available under the Affordable Care Act, the size of the population of low-income individuals with addiction problems dwarfs the scant resources available for treatment. Hence the refrain of cities and counties suing opioid makers: while you have profited, we have sunk as we have had to shoulder the costs of addiction. The suits could help to replenish governmental coffers and support a range of programs to treat, house, and otherwise support those in need.

All that said, the plaintiffs' path forward is studded with obstacles. The civil suits could be thwarted, or at least significantly complicated, if defendants file for bankruptcy, as many asbestos defendants did in the 1980s and 1990s as their liability mounted. Ominously, as we write, there are reports that Purdue Pharma is considering seeking bankruptcy protection.

Further, on the merits, the plaintiffs' claims raise a thicket of legal questions. How can jurors be convinced that an FDA-approved product is defective? Can plaintiffs prevail in states that apply the learned intermediary doctrine? Will they be able to characterize users' abuse of prescribed drugs as foreseeable by the defendants, in order to defeat a misuse defense? What about the fact that many individuals who have died from drug overdoses weren't taking prescribed medication but, rather, black-market alternatives? Finally, how should juries untangle the relative responsibility of the many alleged tortfeasors?

On May 28, trial will begin in the first of the opioid suits, brought by the Oklahoma attorney general. The eyes of a pained and hopeful nation will be watching.