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November 1, 2019

The Opioid Crisis, Corporate Responsibility, and Lessons From the Tobacco Master Settlement Agreement

Author Affiliations
  • 1New York University College of Global Public Health, New York, New York
  • 2ASPPH Task Force on Public Health Initiatives to Address the Opioid Crisis, Washington, DC
  • 3East Tennessee State University College of Public Health, Johnson City
  • 4Boston University School of Public Health, Boston, Massachusetts
JAMA. Published online November 1, 2019. doi:https://doi.org/10.1001/jama.2019.17144

The opioid crisis has accounted for 770 000 deaths in the United States over the past 20 years, a number approximately equal to the first 20 years of the AIDS epidemic.1 A substantial portion of these deaths were the direct result of overprescription of opioids, and many others were caused by former prescription opioid users migrating to less expensive and easier to obtain heroin and synthetic opioids, such as fentanyl and its analogues. The opioid crisis has contributed to the decline in US overall life expectancy for 3 consecutive years; the first 3 year-on-year decline in US life expectancy since the 1918 flu pandemic.

A New Road Map to Address the Crisis Through Public Health and Legal Approaches

The Association of Schools and Programs of Public Health (ASPPH) Task Force on Public Health Initiatives to Address the Opioid Crisis has just released its comprehensive report and recommendations,2 which present a road map for addressing the broad dimensions of the opioid epidemic. The report calls for public and professional education to reduce the stigma of addiction; a focus on use of funds to prevent addiction; provision of services for those directly affected by addiction; and mounting programs for affected families, communities, and professions, including relief for the burden on the criminal justice systems and social service systems. The report also proposes funding broad research and evaluation with regard to the causes of the opioid epidemic and ultimate solutions.

Implementation of these recommendations will require considerable resources, certainly in the tens of billions of dollars, to reverse an epidemic that has unfolded over the past few decades. Responsibility for addressing this public health crisis is a shared one that includes units of government at the local, state, and federal level and the corporations that contributed to this epidemic.

Holding Corporations Accountable for the Opioid Epidemic

Responsibility for holding corporations accountable for their role in the opioid epidemic—and ensuring they contribute to solutions—falls primarily to state attorneys general. Attorneys general are responsible for protecting the public and can act individually or as a group through lawsuits or negotiations when public health is threatened. The strength of their negotiating ability is greatest when a strong legal case exists, as it now does with regard to liability for the opioid crisis. Attorneys general have available to them a range of laws with which to prosecute corporations that undermine public health, including consumer protection laws, public nuisance laws, antitrust, and state versions of the Racketeer Influenced and Corrupt Organization (RICO) Act. Settlements can achieve concessions from corporations, including marketing and lobbying restrictions that cannot otherwise be legally mandated under the First Amendment.

State attorneys general and other attorneys have filed suit on behalf of municipalities and states, which claim that substantial responsibility for the opioid epidemic lies with corporations that marketed, distributed, and sold prescription opioids that were overprescribed and overused. The evidence purportedly shows that some corporations promoted the products through misleading claims about likelihood of addiction to and safe dosing levels of opioids. Some corporations allegedly diverted drugs and failed to report excessive deliveries to individual distributors and retailers as well as allowing fraudulent prescriptions to be filled. Clinicians were advised that no ceiling on dosing levels was required and that signs of addiction were instead “pseudoaddiction,” a condition that has not been empirically validated.3 Opioid manufacturers promoted pain as the fifth vital sign and created pain advocacy groups to advance the industry’s corporate agenda.4,5 This suggests that sources of revenue the various involved companies receive through other product lines in addition to opioids can legitimately be accessed to address the epidemic.

In March 2019, the state of Oklahoma settled a suit against Purdue Pharma for $270 million, while separately, an Oklahoma judge ordered Johnson & Johnson to pay $572 million in damages associated with the opioid crisis and specified where the funds should go. These data are noteworthy in a state with just over 1% of the US population and could predict significant future settlements and judgments. The Oklahoma judge’s plan set forth specific allocation of the resources, as had the separate Oklahoma settlement with Purdue Pharma. The state legislature balked over the Purdue settlement and quickly passed a unanimous bill reasserting its appropriations jurisdiction over attorney general settlements. This implies that the attorney general and Purdue Pharma will need to negotiate.

The Oklahoma decisions appear to be a bellwether of future legal actions. Soon after the Oklahoma decisions, a framework for a settlement was announced with Purdue Pharma in an Ohio federal court in September 2019, which involved more than 2000 smaller government plaintiffs nationwide and 24 states. This was swiftly followed by the filing for Chapter 11 bankruptcy protection by the corporation, owned by the Sackler family. The proposed deal, worth an estimated $10 billion or more, could provide funds to address the opioid epidemic, provided, of course, that state and local forces do not divert current and future settlement funds for other purposes. Ironically, the funds would come from future sales of the drug.

To date, however, more than 20 state attorneys general have rejected the proposed settlement, strongly suggesting that key states leading the effort to bring the opioid industry to justice do not view the settlement as sufficient to meet the public interest needs brought about by the opioid crisis. Perhaps by way of understanding the reluctance to accept this settlement, global annual revenues of the opioid industry alone exceed $25 billion annually. The majority of this revenue, approximately 55%, has accrued to North American corporations.6

A Framework for a Potential Opioid Master Settlement Agreement

How can a settlement on opioids with the key pharmaceutical companies be implemented most effectively to help end the crisis? The 1998 tobacco Master Settlement Agreement (MSA) between 46 attorneys general and multiple territories offers key lessons from which much can be learned. The $206 billion tobacco MSA provided for payments to the states over an initial 25-year period, with only 1 financially designated effort: the establishment of a public health foundation supported over a decade with $1.7 billion in funding. Initially known as the American Legacy Foundation (now the Truth Initiative), this foundation mounted multiple programs supporting state initiatives for youth smoking prevention, national cessation efforts for adults, a bold and highly effective national youth public education campaign known as “truth,” and a range of research and evaluation efforts.7

Although there was some public benefit from the tobacco MSA, the limitations of the settlement are instructive and should be avoided in the context of an opioid MSA.8 According to the Campaign for Tobacco-Free Kids, over the past 19 years states received $156.7 billion in tobacco settlement revenues and an additional $296.7 billion in tobacco tax revenues. Of this, only $11.8 billion, or 2.6%, was spent on tobacco prevention programs.9 This minimizes the potential effect of the MSA on morbidity and mortality within the settling states. Appropriations are almost always made by a governmental body (eg, legislature), and subsequent funding allocations for public health initiatives are difficult to implement, both politically and procedurally. By way of illustrating the consequences of this MSA structure, at present no states are spending even the recommended minimum allocation for tobacco control proposed by the Centers for Disease Control and Prevention.

This suggests that opioid settlement and judgment resources should be dedicated, virtually in their entirety, to ameliorate the opioid epidemic. The creation of a foundation both to direct these funds efficiently and proportionate to the scope of the epidemic to the affected communities in ways that successfully fill gaps and to complement key local and national efforts to educate the public, reduce initiation, and reduce the stigma of addiction is an urgently needed action. Special efforts should be undertaken by attorneys general, legislative bodies, and judges who execute court orders in cases. Judges can and should make their order contingent on accepting the terms established by the judge or attorneys general to protect such a foundation from attempts to “claw back” resources, as happened with some state-sponsored nonprofit foundations created with state tobacco settlement dollars. Settlements should be structured such that funds are released by the settlement overseers only once irrevocably allocated by respective legislative units.

This perspective is shared by an amicus curiae brief submitted in May 2019 to the Ohio court overseeing the consolidated case associated with this proposed settlement.10 A coalition of public health, legal, research and advocacy groups recommended the formation of a similar foundation through which settlement proceeds would flow to ameliorate the opioid epidemic, with an emphasis on affected communities.8 This coalition highlighted the advantage of such a nonprofit organization, including that it relieved the plaintiffs of responsibility for allocating funds and protected funds from current or future diversion. The amicus brief suggests that a foundation-creation model should be used, such as the one that created the American Legacy Foundation, but to ensure that all settlement funds associated with the opioid epidemic be dedicated to the problem for which they were sought.

While state and local legislatures normally allocate settlement funds, they have the option to accept a settlement that directs the funds elsewhere or, once received, to direct them to an entity other than the governmental unit.

Conclusions

The opioid epidemic is one of the sentinel epidemics in recent history. It has affected millions of individuals in the United States, matching in scope some of the worst epidemics of the past century. The scale of corporate responsibility for the epidemic will be determined by the legal processes currently in play. Many proven public health strategies can help redress the epidemic. Should an MSA be reached or court-ordered damages received, the ultimate agreement should create funds that are used exclusively for proven public health approaches to directly address the opioid epidemic, avoiding some of the pitfalls that befell the tobacco MSA.

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Article Information

Corresponding Author: Cheryl Healton, DrPH, New York University College of Global Public Health, 665 Broadway, New York, NY 10012 (ch119@nyu.edu).

Published Online: November 1, 2019. doi:10.1001/jama.2019.17144

Conflict of Interest Disclosures: Dr Galea reported receipt of consulting fees from Sharecare and Tivity. No other disclosures were reported.

Additional Information: Dr Healton was previously chief executive officer of Legacy (1999-2014).

References
1.
Hedegaard H, Miniño AM, Warner M. Drug Overdose Deaths in the United States, 1999-2017. National Center for Health Statistics data brief 329. https://www.cdc.gov/nchs/data/databriefs/db329-h.pdf. Accessed October 22, 2019.
2.
Association of Schools and Programs of Public Health. Combatting the Opioid Epidemic: Bringing Science to Bear to Save Lives and Reduce Harm: Findings and Recommendations of the ASPPH Task Force on Public Health Initiatives to Address the Opioid Crisis. https://www.aspph.org/opioids/. Published October 2019.
3.
Greene  MS, Chambers  RA.  Pseudoaddiction: fact or fiction? an investigation of the medical literature.  Curr Addict Rep. 2015;2(4):310-317. doi:10.1007/s40429-015-0074-7PubMedGoogle ScholarCrossref
4.
Delaware, ex rel Matthew P. Denn v Purdue Pharma LP (Del Super Ct 2018).
5.
Scalpel  S.  The Joint Commission deserves some blame for the opioid crisis.  Mo Med. 2016;113(6):449.PubMedGoogle Scholar
6.
Grand View Research. Opioids Market Size, Share & Trends Analysis Report by Product (IR/Short-Acting, ER/Long-Acting), by Application (Pain Relief, Anesthesia), by Region, and Segment Forecasts, 2019-2026. https://www.grandviewresearch.com/industry-analysis/opioids-market. Published April 2019. Accessed October 22, 2019.
7.
Farrelly  MC, Davis  KC, Haviland  ML, Messeri  P, Healton  CG.  Evidence of a dose-response relationship between “truth” antismoking ads and youth smoking prevalence.  Am J Public Health. 2005;95(3):425-431. doi:10.2105/AJPH.2004.049692PubMedGoogle ScholarCrossref
8.
Schroeder  SA.  Tobacco control in the wake of the 1998 Master Settlement Agreement.  N Engl J Med. 2004;350(3):293-301. doi:10.1056/NEJMsr031421PubMedGoogle ScholarCrossref
9.
Campaign for Tobacco-Free Kids. Broken Promises to Our Children: A State-by-State Look at the 1998 Tobacco Settlement 20 Years Later. https://www.tobaccofreekids.org/assets/content/what_we_do/state_local_issues/settlement/FY2019/2018_State_Report.pdf. Published December 2018. Accessed October 22, 2019.
10.
Brief of amici curiae in support of a settlement with favorable public health outcomes (ND Ohio 2019) (No. 1:17-MD-2804).
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