a) An Overview of the Opioid Litigation Landscape

What value has opioid litigation brought to addressing the public health crisis, and what is its future potential? As alluded to and much like the tobacco and other litigation domains discussed, opioid litigation has proceeded in several distinct but overlapping waves, culminating in a third wave characterized by mass tort suits alleging population harms. Table 2 provides an overview of these waves of litigation and includes for each: predominant suits, public perception of opioid analgesics, common claims, and usual winner. Opioid cases involve a diverse set of claimants: individuals harmed by opioid analgesics brought cases in the first wave; classes of injured individuals brought suit in the second wave; and governments (state, county, tribal, and federal) sued in the third wave that continues to present.⁴⁴ Fewer cases have been brought by hospital and health care organizations, suing for the costs they have borne from opioid prescribing-related harms. The most common defendant in early cases and to this day is Purdue Pharma, although other opioid analgesic manufacturers frequently named include Johnson and Johnson (and its subsidiaries), Janssen Pharmaceuticals Inc., Insys Therapeutics, Teva Pharmaceuticals, Endo Health Solutions Inc., and Allergan PLC.⁴⁵ Other common defendants include dominant opioid distributors — McKesson Corporation, Cardinal Health, AmerisourceBergen, Mallinckrodt, and Miami-Luken — as well as major pharmacies like Walgreens, RiteAid, and CVS.⁴⁶

Table 2.

Opioid Litigation Waves

Notes: FDCA, Food Drug and Control Act; CSA, Controlled Substances Act; RICO, The Racketeer Influenced and Corrupt Organizations Act.

Liability theories asserted in opioid litigation and their outcomes have varied depending on the parties to the suit. In the first wave of litigation, individual plaintiffs most typically asserted personal injury claims against manufacturers. Manufacturers were accused of fraudulently misrepresenting in advertising and detailing efforts opioid analgesic effectiveness for treating pain and non-addictive nature, failing to adequately warn consumers about their products' potentially addictive properties, and failing to include tamper resistant formulations for these drugs. These cases typically were dismissed in early stages of litigation, when defendants successfully asserted defenses such as: lack of causation (given the many contributors to addiction and ensuing harms); wrongful conduct on the part of some individual plaintiffs in illegally obtaining prescription opioids; and product misuse on the part of patients.⁴⁸ The second wave of opioid litigation involved attempts to aggregate individual defendants into classes. However, the classes typically were not certified for lack of commonality among class members because individuals had different trajectories of product use that contributed to their respective harms.⁴⁹

The third wave of opioid litigation has proven the most viable. Government plaintiffs, armed with greater resources and more robust population-level evidence that establishes patterns of violations and injuries, have asserted aggregate harms under state-based public nuisance, fraud, conspiracy, and unjust enrichment theories and/or federal statutes.⁵⁰ A significant development in this wave has been the consolidation of approximately 2700 cases into a federal MDL, overseen by Judge Dan Aaron Polster who is keen to achieve a productive, global settlement. As well, a spate of criminal charges against Purdue Pharma executives, which resulted in a $634 million settlement in 2007, and more recently owners (i.e., the Sackler family) have elevated potential liabilities of and spurred a bankruptcy settlement proposal with this closely-held company.^{Reference Belmonte and Mann51} Recent settlements in a number of state cases are likely to be an indicator of additional settlements or jury awards to come. However, there are significant challenges to achieving an equitable global settlement, including important structural barriers like: contingency fees paid to private firms (working on behalf of governments) who may have ulterior motives to settle quickly; loss of control over the course of the litigation for those plaintiffs not part of the negotiating lead counsel teams; complexity of settling among so many parties with diverse and sometimes competing interests in state and federal courts; and limited engagement of the public health community in the negotiating process.^{Reference Ausness52}

b) Public Health and Civil Tort Objectives of Opioid Litigation

The goals of the current opioid litigation are widespread and ambitious. This discussion will focus on the third wave of litigation and what governments can and have achieved through litigation, rather than the goals of private party litigation. In terms of public health objectives, Judge Polster said the following in the first of many MDL settlement hearings:

As Judge Polster's comments suggest, other branches of government were slow to respond to the opioid crisis. State policymakers acted before the federal government, but even state responses did not start in earnest until well over a decade after prescribing and deaths began their precipitous climb.^{Reference Haffajee, Frank, Haffajee and French54}

Several high profile examples demonstrate signifi-cant federal regulatory failures and gaps in prescription opioid oversight. For instance, a Drug Enforcement Agency (DEA) whistleblower disclosed that members of Congress close to the pharmaceutical lobby pushed for policies directly requested by the industry. Specifically, Congress passed a 2016 law that stripped the DEA of certain monitoring and enforcement powers, including the ability to freeze suspicious pharmaceutical shipments, at the height of the opioid crisis and following a $102 million lobbying campaign by the industry.^{Reference Whitaker, Higham and Bernstein55} Federal civil case filings against drug wholesalers fell from 131 in 2011 to 40 in 2014, rebounding somewhat to 64 in 2016 — perhaps providing evidence that the pharmaceutical industry had captured the Department of Justice and affected it's behavior around charges and intervening into DEA enforcement activities.⁵⁶

The FDA has long been critiqued for its lax response in regulating prescription opioid harms.^{Reference Bonnie, Zettler and Frydl57} Noted oversights include: passive post-marketing surveillance of these drugs even when they are subject to a Risk Evaluation and Mitigation Strategy (REMS) program;⁵⁸ approval of potent opioids such as Zohydro (2013) and Dsuvia (2018), despite a panoply of opioid analgesics already on the market and these products' potential for misuse amidst the height of the opioid crisis;^{Reference Manchikanti, Gottlieb, Sarpatwari, Sinha and Kesselheim59} and lack of incentives to spur innovation in the addiction treatment space (at least until recently). More generally, pharmaceutical companies exert influence over the FDA, calling into question the agency's independence in decision-making. Evidence of this includes: that a large proportion of the FDA's budget has been paid for by the pharmaceutical industry since the 1990s associated with drug application and approval fees;^{Reference Sekerka and Benishek60} a revolving door between the agency and pharmaceutical industry employees;^{Reference Silverman61} and “pay-for-play” type deals whereby pharmaceutical executives have paid to meet privately with FDA executives and influence analgesic division recommendations.^{Reference Whoriskey62}

The pharmaceutical industry also has exhibited substantial self-regulation failures when it comes to ensuring the safe use of their opioid products. Drug suppliers should be motivated to protect consumers from harms related to their products: if these products prove dangerous, then consumer demand and company profits will decrease and the image of the company will be tarnished. Nevertheless, firms repeatedly seem to favor short-term profits over long-term product safety, as occurred in the opioid space. Purdue Pharma's sophisticated marketing plan for OxyContin has been documented extensively, and other defendants to the litigation are alleged to have engaged in similar conduct. In its OxyContin detailing efforts, Purdue profiled individual providers, detailing their prescribing patterns, and targeted those who prescribed large quantities of opioids and those with large numbers of patients with chronic pain.^{Reference Van Zee63} Purdue also created a generous incentive structure for its sales representatives to increase OxyContin sales in their regions and more than doubled the size of its sales force from 1996-2000.⁶⁴ Sales representatives provided free samples and coupon programs, along with branded gifts, to prescribers to promote the drug.⁶⁵ Despite a lack of clinical evidence to support its claims, Purdue pushed the message, including through physician front-men, that opioids were non-addictive and could be prescribed liberally to treat non-malignant pain.^{Reference Haffajee66} The result was a nearly tenfold increase in OxyContin prescriptions for non-malignant pain, from 670,000 in 1997 to 6.2 million in 2002.⁶⁷ Other companies engaged in similar behaviors. For example, Insys Therapeutics' aggressively targeted non-cancer patient populations (via prescribers) for its powerful fentanyl product approved for the treatment of cancer, Subsys^®, to increase market share. Insys did this by conveying misleading marketing messages to its sales force and, by extension, the prescribers they detailed.⁶⁸

In summary, litigation is bringing to light growing evidence to support allegations that opioid companies failed to self-regulate in the interest of public health, and liability may attach to some of these failures. Certain opioid manufacturers deliberately misrepresented and fraudulently marketed their drugs, despite some known risks and even REMS programs in place for post-marketing surveillance. Certain distributors appear to have supplied opioids in quantities beyond what seemed plausibly medically necessary and colluded with other distributors in neglecting to report suspicious order. Some pharmacies dispensed opioids in alarmingly high dosages. Evidence of these practices and agreements to change behavior have served as the basis for new government regulatory oversight and past settlements with key defendants, as detailed below. Public health litigation thus can and has played a role in addressing serious opioid market failures.

Past opioid litigation settlements also have achieved certain civil tort litigation objectives, a trend poised to continue into the future. Table 3 sets forth key opioid settlement terms among government plaintiffs (states and federal) and various defendants (manufacturers, distributors, and pharmacies) to illustrate satisfied tort litigation objectives. This is not to suggest that all opioid suits have arrived at productive outcomes; many have not settled or have done so on less than ideal terms. For instance, the first settlement included in Table 3 of 2007 between 27 states Attorneys General and Purdue settled for a paltry amount ($19.5 million) given the many plaintiffs involved and failed to attribute much accountability to Purdue Pharma.⁶⁹ The opioid crisis in states party to this deal only accelerated after the settlement, and Purdue has been accused in subsequent litigation of continuing the very behaviors forbidden in the settlement — namely, making misrepresentations about its opioid product's addictiveness.⁷⁰ On a whole, however, these settlements largely represent positive developments that are likely to be replicated and built upon in settlements and perhaps judgments to come.

Table 3.

Civil Tort Objectives Achieved in Representative Opioid Settlements

First, in terms of compensation, opioid cases have garnered increasing sums over time, ranging from the $19.5 million in the aforementioned settlement between the states Attorneys General and Purdue Pharma, to $270 million in the 2019 settlement between the State of Oklahoma and Purdue, to almost $500 million in the Oklahoma judgment against Johnson & Johnson.⁷¹ More recent compensation amounts reflect a growing understanding of the costs of the crisis, estimated to range nationally from $75 million in 2013 up to $500 billion per year — for a total cost of the epidemic since 2001 of $1 trillion.^{Reference Rhyan, Manchikanti and Florence72} Governments bear about half of these cumulative costs.^{Reference Rhyan73} Future opioid litigation could garner much more substantial sums, particularly if parties to the MDL settle as is under discussion with many. Assuming opioid companies do not routinely file for bankruptcy, an MDL global settlement reasonably could be on the order of tens of billions if all parties come to the negotiating table, given the tobacco MSA precedent, extraordinary costs of the crisis, and current settlement talks.⁷⁴ Although suppliers of opioid analgesics cannot reasonably be expected to bear all opioid-related costs borne by governments or other parties, their pivotal role in fostering addiction by alleged deceitful, misleading, and unlawful means to achieve tremendous profits appears to justify some compensation to ameliorate civil harms.

Another positive compensation development is the earmarking of funds, as we have seen in many state cases (e.g., Kentucky and Oklahoma settlements, Table 3). The Oklahoma settlement, negotiated by the Attorney General with Purdue, was particularly encouraging because it specifically allocated funds to the Center for Wellness and Recovery at Oklahoma State University ($102.5 million).⁷⁵ This center is focused on addiction treatment — both providing care and also developing new research — across the state and will use the money to further these goals.⁷⁶ Another $12.5 million was allocated to cities and counties to abate their opioid crisis nuisances.⁷⁷ While this money can be spent in various ways by local governments, the uses must abate opioid harms and cannot be diverted to unrelated purposes, unlike with tobacco MSA funds. (Of note, however, after the Oklahoma settlement was announced the disgruntled legislature passed a law to require that they oversee the allocations of future settlements, as occurred with the MSA.^{Reference Bernstein78})

Opioid litigation moreover appears to have had a deterrent effect on the companies that historically supplied and continue to supply prescription opioids. This stands in contrast to the lead paint litigation, wherein companies were out of business by the time litigation penalties or behavior change requirements could have any deterrent effect. In the case of opioids, the monetary damages may not have deterred some companies, they do seem to have deterred others. For instance, Purdue Pharma is on the verge of bankruptcy arrangements and Insys Therapeutics, which has paid penalties in both civil and criminal cases totaling at least $230 million, recently filed for bankruptcy.^{Reference Silverman, Spector, DiNapoli and Raymond79} Bankruptcy filings may prevent these companies from operating in the future, or at a minimum, could make them recalibrate the risks of pursuing profits over public health concerns. On the other hand, bankruptcy filings could limit the financial resources available in future settlements (as happened in the case of asbestos) and thus may act a as a “shield” from public health accountability.⁸⁰

Beyond monetary penalties, various settlements have included behavior change requirements that specifically deter opioid suppliers from engaging in unlawful acts, as shown in Table 3. For manufacturers, settlements increasingly include terms that forbid prescription opioid marketing or promotion altogether or for a period of time within jurisdictions party to the litigation (e.g., Illinois and Massachusetts for Insys Therapeutics, and Oklahoma and 27 other states for Purdue Pharma).⁸¹ For distributors and pharmacies, behavior change requirements often involve suspension of opioid analgesic distribution or sales to jurisdictions where they were excessively supplied, strict reporting of suspicious shipments or sales to the DEA as required under the CSA, and heightened internal monitoring systems that track shipments and flag outliers (Table 3). On the other hand, the litigation could serve to over-deter many drug companies from innovating, manufacturing, and supplying opioid analgesics, which could exacerbate pain suffering for some patients. Evidence of opioid analgesic shortages (let alone relating to the litigation) is so far scant, but this potential unintended consequence is one to carefully monitor.

Opioid litigation has changed the behavior of at least some opioid companies that are taking voluntary steps to address the crisis. For instance, several opioid suppliers are donating profits to abate the crisis and seeking to innovate new products that deter abuse, treat pain non-addictively, or manage addiction.⁸² Purdue Pharma introduced an abuse-deterrent formulation of OxyContin, the first of its kind to be approved by the FDA, in 2010. Purdue also financially supports prescription drug monitoring program development across the states to help prevent diversion, problematic polypharmacy, and “doctor or pharmacy shopping” for opioids and donates to naloxone access and medication for opioid use disorder expansion efforts.⁸³ Purdue Pharma also volunteered to stop marketing prescription opioids to physicians.⁸⁴ These steps appear to be directly or indirectly tied to the litigation efforts, which changed public perception of opioid analgesics and the companies making them and pressured suppliers to modify any questionable practices that arguably contributed to the crisis.

Finally, the litigation has succeeded in holding opioid suppliers accountable for their alleged wrongdoings, at least to a degree. One of the drawbacks to settlements, as compared to a judge or jury trial verdict in a plaintiff's favor, is the frequent lack of admission of fault on the part of defendants (Table 3). For instance, Purdue Pharma and Johnson & Johnson have yet to admit responsibility in any of the opioid litigation settlements to which either has been a party. Distributor and pharmacy defendants more frequently have admitted fault (Table 3). Admission of responsibility is important as it documents, on the record, that a defendant engaged in legal wrongdoing, and forms the basis of their penalties or behavior change requirements. Even without admission, however, the publicity garnered from the litigation and implied responsibility arising from a settlement agreement or actual liability demonstrated in a judgment serve to hold companies accountable. Evidence divulged in litigation also can induce policymakers to act and start to fill regulatory gaps. For instance, Senator Claire McCaskill's investigations of various opioid distributors and significant opioid legislation have followed on the heals of litigation.⁸⁵

Future behavior change induced by and initiatives that can be funded by damages arising from the litigation can augment existing abatement efforts and serve to further hold opioid companies accountable for their actions. Settlements or judgments could require opioid suppliers to engage in counter-advertising campaigns, much like in the “Truth” campaign generated from the tobacco MSA, and to fund educational efforts (though not be involved in generating their content) geared towards prescribers, pain specialists, and addiction treatment specialists. Companies could be required to invest in and innovate new (non-addictive) pain and opioid addiction therapies, along with fund research into initiatives with proven effectiveness to triage opioid harms (e.g., robust prescription drug monitoring programs often paired with pain clinic regulation, naloxone distribution, needle exchange programs, provision of medications to treat opioid use disorder and counseling).^{Reference Mauri, Townsend, Haffajee and Haffajee86} Strict compliance with federal laws (including the CSA's reporting requirements and the FDCA's marketing requirements) and state laws, and limits on marketing and lobbying tactics around prescription opioids (both direct-to-consumer and to professionals) should also be required. Finally, assistance with funding and programming targeted at structural determinants of disease (e.g., housing and employment services for those in recovery) could also be incumbent upon opioid suppliers to hold them accountable for the prescription opioid-related outcomes among vulnerable sectors of the population.