Nearly 19,000 people lost their lives to opioid overdoses in 2014, a quadrupling of these deaths in just 15 years. The devastation wrought by the prescription opioid crisis, and the subsequent related epidemic of addiction to chemically similar heroin, is spreading anguish across America.
Fundamental change might be on the way, however, depending on what happens during the coming weeks in an unlikely locale: the Hinds County courthouse in Jackson, Miss.
A state judge there will decide whether Mississippi Attorney General Jim Hood — aided by a phalanx of private plaintiffs' attorneys — can proceed with a suit against opioid manufacturers in which the companies stand accused of promoting the drugs by allegedly systematically understating their health risks and exaggerating their benefits, violating state law.
The potential exists for a mega-case like the one that ultimately brought Big Tobacco to heel. At a minimum, pretrial discovery might force drug companies to do something they have heretofore fiercely resisted: produce their internal records, including any that show discrepancies between what they told doctors, regulators and the public about opioids, and what they knew or suspected privately.
To be sure, state attorneys general and trial lawyers, the former notoriously motivated by political ambition, the latter by whopping contingency fees, are not optimal redeemers of the public interest, in the health-care context or any other.
For reasons of accountability, efficiency and consistency, elected officials, acting with or through independent, expert regulatory bodies, should be the first choice for that job, not state courts.
Yet the opioid epidemic is a crisis in large part because the responsible institutions failed; indeed, they fell under the influence of the very interest groups — especially the drugmakers — they were supposed to regulate.
Eyeing billions in profits, opioid companies bombarded the marketplace’s gatekeepers — medical societies, academics, state legislatures, Congress and, crucially, the Food and Drug Administration — with a consistent, seductive message: Chronic pain affects tens of millions of adults and is woefully undertreated; and it can be safely and effectively eased, on a continuous basis, with opioids, contrary to long-standing medical wisdom.
To read the allegations in the 250-page Mississippi lawsuit is to marvel at the sophistication of a marketing campaign that recast a handful of debatable scientific studies as pro-opioid conventional wisdom, then fed it to everyone from selected opinion leaders in the medical elite to small-town family practitioners.
Audaciously, drugmakers — or ostensibly objective “pain management” experts and organizations funded by industry — labeled patient behaviors suggestive of opioid addiction, such as hoarding medication or doctor-shopping, as “pseudoaddiction,” and then instructed doctors that it was indicative of pain that should be treated with more opioids, the suit alleges.
The FDA went along. Among its many opioid approvals, it greenlighted OxyContin for chronic pain, based in part on the manufacturer's claim that it was less addictive because a dose lasts 12 hours. As the Mississippi lawsuit argues, and investigative journalists have documented, that claim proved dangerously invalid for many patients.
Over the past decade, the opioid makers and their allies spent more than $880 million to lobby against tougher regulations, state and federal, according to a recent report by the Associated Press and the Center for Public Integrity. Groups favoring regulation, by contrast, spent $4 million. The industry's money supported 7,100 candidates for state-level offices and funded an average of 1,350 lobbyists nationwide.
They also have excellent lawyers that have urged the Mississippi court to dismiss the attorney general’s lawsuit in deference to the FDA’s “primary jurisdiction” over drug regulation.
The seasoned, expert regulators in Washington are in the best position to decide these technical matters and are already conducting an evidence-based review, the industry lawyers note. (This year a new FDA commissioner, chastened by congressional criticism of the agency's record on opioids, promised to "fundamentally re-examine the risk-benefit paradigm for opioids.")
Given the past coziness between the drug industry and government, the companies’ contention is both predictable, and convenient.
There is legal precedent for it, though. A California state judge threw out a lawsuit against the opioid makers last year on the grounds that it would have usurped the FDA.
On Sept. 29, however, plaintiffs got a boost when a federal judge in Chicago rejected the "primary jurisdiction" argument and allowed that city to go ahead with a similar case.
The conflicting rulings in California and Chicago make the Mississippi case a tie-breaker of sorts, which could spawn many new lawsuits if it goes against the opioid makers.
At stake is whether they may continue being held accountable primarily by institutions where their clout is well established — or whether, for the first time, they will have to answer charges before impartial judges, as well as juries drawn from the very communities their products have ravaged.
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