Pursuing Public Health Through Litigation.

• Author: Engstrom, Nora Freeman

Table of Contents Introduction I. Tobacco: A Retrospective A. The Early Days: Health Risks Rising, Then Unmasked B. Individual Lawsuits: The First Two Waves C. Aggregating Claims D. Individual Claims Revived II. Opioid Litigation A. The Early Days: "OxyContin Is Our Ticket to the Moon" B. The First Wave: 2001 Through 2013 1. Individual claims 2. Public litigation C. The Second Wave: 2014 to the Present III. A Tale of Two Products and Two Litigations A. Product Attributes 1. Product substitution 2. Social utility 3. Price sensitivity B. Regulatory Environments C. Litigants and Litigation IV. Larger Lessons A. What the MSA Got Wrong and Right B. Aggregation's Impact 1. Whether in tobacco or opioids, individual claims have mostly faltered 2. Aggregation and the implications of proceeding with surrogates and en masse C. Value of Public-Health Litigation Conclusion Introduction

As a public health concern, tobacco-related disease has surrendered the limelight to the opioid crisis. And one can well understand the sense of urgency associated with the catastrophic death and disease toll attributable to the abuse of prescription painkillers. Since 1999, opioids have claimed nearly 450,000 American lives, including nearly 50,000 in 2019 alone, dwarfing the carnage caused by either car crashes or gun violence. (1) If the problem is not promptly and adequately addressed, death tolls will rise: Opioids are on track to claim the lives of another half-million Americans within the next decade. That's like wiping out all the men, women, and children in Atlanta in one fell swoop. (2)

And fatalities, of course, only tell a sliver of the story. Beyond the hundreds of thousands of lives lost, the lives of millions more are diminished and upended. Roughly 2.1 million Americans suffer from an opioid-use disorder, (3) over 4 million Americans misuse opioids each month, (4) and an opiate-dependent American child is born every fifteen minutes. (5) The resulting economic costs are astronomical. A 2017 report from the Council of Economic Advisers estimated that the economic cost of the opioid crisis exceeds $500 billion annually, which works out to nearly 396 of U.S. gross domestic product. (6)

At the same time, the ravages of smoking-related disease remain at a historic level. Over the past half-century, Americans have consumed nearly 25 trillion cigarettes, which have, in turn, killed more than 20 million Americans--that's more than ten times the number of U.S. citizens who have died in all wars fought by the United States, combined. (7) Further, though smoking rates are down sharply from their mid-twentieth-century peak, the habit continues to devastate the American population. (8) Based on the most recently published Centers for Disease Control and Prevention (CDC) figures, cigarette smoking in the United States accounts for more than 480,000 premature deaths per year. (9) That is roughly ten times the number of opioid-overdose deaths and accounts for about one in every five U.S. fatalities--including the deaths of an estimated 41,000 nonsmokers from exposure to secondhand smoke. (10) An estimated 14% of adults--one in seven--are current cigarette smokers, with usage concentrated among those of lower educational attainment and socioeconomic status. (11) Economic costs associated with tobacco-related disease were recently estimated to be more than $300 billion, including nearly $170 billion in direct medical costs and another $156 billion in lost productivity. (12) If the value of lives lost is factored in, the economic toll rises dramatically--to more than $4.5 trillion per year. (13)

As might be expected, the massive human and economic toll of these two health-based crises has struck a chord in the tort system. Further, the tobacco-litigation experience--which dates back to 1954 and, in 1998, culminated in the largest settlement in the history of American civil litigation--offers an array of insights into how one might expect the opioid litigation to unfold, including tactics that might be employed, obstacles that might be confronted, and cautionary notes all actors would be wise to heed. (14)

Many have remarked on the myriad similarities between tobacco and opioids. (15) Both are highly addictive products that were sold in stunningly high volumes to a mostly unwitting public. Both were marketed by well-resourced manufacturers who resolutely exaggerated the products' benefits and downplayed their risks. And of course, both products were utilized (by some measure, ingested) by millions of Americans, to devastating effect.

Many, too, have remarked on the obvious similarities between the litigation that both episodes spawned. (16) These include that the litigation came to be aggregated, rather than individualized; that it's being quarterbacked by public, rather than private, actors (though, in both, the public actors are assisted by highly specialized private litigators); and that, like the tobacco litigation before it, the opioid litigation seems destined to involve the payment of eye-popping sums.

Here, we reassess these surface-level similarities. But our analysis proceeds to deeper depths and canvasses a wider terrain. From this broader perspective, we also identify critical differences between the two products, and the respective litigation responses. In our view, these crucial differences--chiefly, the products' differential susceptibility to substitution (particularly via black-market alternatives); their divergent social utility; the fact that, for opioids (unlike cigarettes), price is not a potent policy lever; and the opioid litigation's crowded roster of players on both the plaintiff and defendant sides--stand to complicate the resolution of the opioid litigation, as well as effective policy responses to this public-health catastrophe.

The Article unfolds as follows. Drawing on a broad mix of primary-source material, including interviews, contemporaneous news reports, and trial court documents, Parts I and II set the stage. In particular, Part I provides a retrospective look at tobacco use in the United States alongside a short history of tobacco tort litigation. This Part shows that, starting in 1954 and continuing for four decades, hundreds of personal injury suits were filed against the cigarette industry, but the industry's dominance was so complete that no individual plaintiff prevailed. But then, in the early 1990s, something unexpected happened: Tactics changed, and the tide turned. The tide turned so completely, in fact, that in 1998 plaintiffs forced the tobacco industry to the negotiating table and entered into a $206 billion "master settlement agreement" (MSA)--the largest tort payment, by far, in American history, which was heralded as a bonanza for the anti-tobacco movement. (17)

Part II pivots to opioids. Starting with OxyContin's 1995 approval, this Part charts the rapid rise of opioid use. It offers a detailed review of the early (and unsuccessful) first wave of opioid litigation, which involved at least 5,000 plaintiffs and 1,400 private suits--far more than previously recognized. And it canvasses the second wave of litigation, initiated by over 2,700 states, counties, cities, municipalities, and tribes, which dates back to 2014 and continues to this day.

Part III then compares and contrasts the two products, as well as the litigation each has generated. In particular, Part III surveys the many ways in which cigarettes and opioids are and are not alike. It maps the widely divergent regulatory environments the products inhabit. And it considers the different ways in which the two litigations have unfolded, and seem destined to unfold, going forward.

A final Part IV steps back to offer larger lessons, mining insights that ought to inform not just litigants', judges', and policymakers' responses to the opioid crisis or the tobacco problem, but also to future (as-yet-unidentified) public-health calamities. In particular, with more than two decades of distance, Part IV evaluates what the MSA--which (mostly) closed the book on tobacco litigation--got right and wrong. It analyzes the power of aggregation in addressing individual injuries, in part by exploring the financial and cultural challenges that continue to confront individual plaintiffs, especially when those plaintiffs bear some responsibility (however tenuous) for their current plight. Lastly, it confronts the following hotly contested question: What is the role of tort litigation in protecting the public health? Addressing that question head on, this Part amasses new support for what we dub a "catalyst" theory of litigation. Drawing on both the tobacco and opioid episodes, we show that litigation can, at least some of the time: (1) draw attention to the problem's existence; (2) unearth otherwise concealed information that clarifies the problem's origin, scope, and character; and, in so doing, (3) affect public opinion in such a way as to spur private actors to address the problem and also make political action against a powerful industry more palatable. In this way litigation can, at least some of the time, serve not as a substitute to governmental action, but as a spark to generate broader governmental and private reform.

1. Tobacco: A Retrospective

   1. The Early Days: Health Risks Rising, Then Unmasked

      Tobacco use in the United States predates Christopher Columbus's arrival. (18) But cigarette smoking didn't really take off until the middle years of the last century. (19) When smoking did grab hold, however, its grasp was firm: In 1900, Americans over the age of eighteen smoked an average of only 49 cigarettes per year. (20) By 1920, that figure ticked upward to roughly 600. (21) By 1940, it was up to 2,558. (22) Then, by 1955--by which time nearly half of Americans (68% of men and 32% of women) had acquired the habit (23)--per capita consumption skyrocketed to over 3,500 cigarettes per person, per year--approximately half a pack a day for...