The courts are front and center in the national opioid crisis. Hundreds of lawsuits have been filed over the past several years by plaintiffs including individuals, states, cities, Native American tribes, and the federal government. These lawsuits have cast an extremely broad net, seeking to impose blame — and with it, enduring responsibility. The suits target not only the manufacturers of the pain-killing drugs themselves and the doctors who have prescribed them, but also the intermediary companies that distribute them, the pharmacies that sell them, and even the principal health-accrediting organization that has argued for more treatment of pain. More than 700 of these suits are now before the same single federal judge, who has vowed to resolve all the cases — the ones before him as well as those not — within the year, even if it means departing from traditional litigation to do so.
Precisely because of this wide scope of responsibility, victories in court will not be easy. Some courts, for instance, already have refused to impose liability on drug manufacturers for these products, which were approved by the Food and Drug Administration (FDA) and then prescribed by doctors, often for labeled indications. Although over-utilized, opioids are indispensable in medical practice, a fact which complicates theories of liability.Reference Frieden and Houry1 Further, even when court cases might succeed, the relief sought thus far has been vague and undirected, typically involving large sums of money without specific indication how the money ultimately will be spent.
Successful litigation by itself could not possibly solve a public health crisis as multi-dimensional and far-reaching as this. The question, rather, is whether litigation has a sufficiently productive role to justify the energy, attention, and resources already devoted to it. This is far from the first time that courts have been asked to tackle questions of public health. The tobacco litigation of the 1990s is the most salient example of a high-profile litigation effort that after settlement yielded vast sums. But that litigation also raised questions about how effective settlements were in changing behavior and public health outcomes. It also raised questions about also whether lawyers benefited more than those who had suffered.
Litigation also has been invoked to address other recent public health crises, including obesity, guns, and dirty water.Reference Schwartz and Appel2 Some of those cases, like the opioid lawsuits, involved very novel legal claims, and sparked concerns about excessive attorneys' fees.3 In many instances, the public exposure and pressure attendant to the litigation, despite the weaknesses of some legal theories presented, nevertheless pushed these cases toward settlement, or sometimes industry change even before court-driven resolution. McDonalds, for instance, began making substantive healthy changes to its menu during the early stages of litigation against it for its role in childhood obesity.4 That class action ultimately was not allowed to proceed,5 but the healthful changes endured and grew.6 Even in cases where novel legal claims have not produced settlements — gun litigation provides a prominent example — scholars have illustrated how litigation is still helpful in placing the issue on the national policymaking agenda, generating media coverage, and framing issues in terms of the nature of the harms suffered and the paths to improvement.Reference Lytton7
This article offers a snapshot of the current state of the opioid litigation, with the caveat that the terrain is constantly shifting. We focus primarily on what we call the “second wave” of lawsuits — the cases that began around 2014 and have continued to the present — which have helped to focus attention on this crisis and to make it one of the most salient national health issues in recent years. We detail the various legal claims, what may be novel about them, and what weaknesses they may have. We focus almost entirely on the civil cases. There have been a number of important criminal investigations brought by the federal government against the some of the same defendants discussed here — drug companies, doctors, distributors, and retailers, as well as other defendants including drug-dealers. Those cases are detailed elsewhere in this volume.
As this article went to press, evidence had begun to emerge documenting a reduction in opioid prescribing by physicians, largely attributable to the now widespread awareness of the risks and the medical profession's role in contributing to the crisis.8 Purdue Pharma, the largest manufacturer of opioids, also recently announced that it would no longer market OxyContin to doctors.Reference Wight9 It is impossible to draw casual links, but it is highly unlikely that the attention the litigation has drawn to the crisis combined with the threat of impeding resolution did not contribute.
Litigation, of course, may produce monetary awards, effectively imposing a “tax” on the responsible parties that deters future harmful conduct and, in the best circumstances, provide funds to directly address the health problems caused.10 It also has been helpful in revealing concealed information. In the tobacco cases, for instance, the litigation was instrumental in leading to the disclosure of damaging documents about the industry's knowledge of tobacco's addictive properties. In the context of the opioid crisis, a salient theme has been that information is wanting about the parts played by the various players. Government investigation and ordinary civil litigation may be the most effective way to elicit those materials.
This article offers a snapshot of the current state of the opioid litigation, with the caveat that the terrain is constantly shifting. We focus primarily on what we call the “second wave” of lawsuits — the cases that began around 2014 and have continued to the present — which have helped to focus attention on this crisis and to make it one of the most salient national health issues in recent years.Reference Ausness11 We detail the various legal claims, what may be novel about them, and what weaknesses they may have. We focus almost entirely on the civil cases. There have been a number of important criminal investigations brought by the federal government against the some of the same defendants discussed here — drug companies, doctors, distributors, and retailers, as well as other defendants including drug-dealers. Those cases are detailed elsewhere in this volume.Reference Rothberg and Stith12
The final Part of the article discusses the recent consolidation of more than 700 suits into the massive aggregated case noted above: a “multidistrict litigation” (MDL) that has moved all these suits into the federal district court of Northern Ohio. This MDL is the most important legal development yet and a game changer. That court has not only discounted potential weaknesses in the legal claims presented by plaintiffs, but also has chided legislatures for abdicating responsibility for the crisis and has promised to use untraditional means to bring about a fast and comprehensive settlement. The MDL is likely to be the focal point of any court-related resolution going forward.
I. The First Wave of Opioid Litigation
Thus far, there have been two waves of litigation. The first wave, in the early 2000s, was in response to the initial introduction of extended-release oxycodone (OxyContin) into the pharmaceutical drug market in 1996.Reference Van Zee13 The medication proved highly financially successful; between 1996 and 2000 sales grew from $48 million to $1.1 billion. The proliferation of this drug resulted in OxyContin and other opioids becoming some of the most abused prescriptions drugs in the nation.14
A. Manufacturers
The first wave was largely directed at the pharmaceutical industry, but doctors were also frequent defendants. The main target was Purdue Pharma, the creator of OxyContin (continuous-release oxycodone) and the early market leader of prescription opioids. There were individual suits, class actions, and suits brought by state attorneys general. Plaintiffs typically alleged a wide array of theories including strict products liability, fraud, negligence, breach of implied warranty, conspiracy, and violations of state consumer protection statutes.15 At the heart of most claims were allegations that drug makers fraudulently and negligently marketed their drugs as substantially less addictive, thus leading to addiction and overuse.Reference Moore16 Relatively low monetary damages were sought — for the costs to the states of numerous OxyContin prescriptions and, secondarily, for the “indirect expenses related to over-prescribing” including the costs to the state of treating addiction.Reference Prater17
The pharmaceutical defendants largely succeeded in batting back these suits. Taking a no-settlement approach, they avoided liability by placing blame on the individual plaintiffs who brought suit; by arguing that class actions largely ignored the individual medical records of patients who used their products; and by focusing on the physicians who “knew the risks … yet decided to prescribe [the medication] anyway.”18 In dismissing these cases, courts typically found that “intervening conduct” by patients and physicians broke any chain of causation from drug manufacturer to harm.
Stigma against addiction also played a key part in the success of drug manufacturers in defending themselves in these suits. During this era, stigmatization associated with illicit drug use was pervasive and bled into courtrooms. Individual plaintiffs suffering from addiction to prescription opioids were perceived to have made the choice to abuse their prescriptions.19 In language similar to that used by other courts, the Supreme Court of Mississippi held, in a case against Purdue, “This Court will not lend aid to a party whose cause of action directly results from an immoral or an illegal act committed by that party.”20 Courts often classified dependence on prescription opioids as a form of “illegal conduct” — rather than as a disease — that as a public policy matter, should bar legal recovery.21
In a similar vein, plaintiffs attempting to bring class action suits — aggregate litigation on behalf of large groups of consumers — were also unsuccessful. The problem was that each individual's circumstances, including each unique medical history, leading to addiction was too different from the next.22 In order for class actions to be brought, courts require common issues of law and fact among the claimants; in federal court those common issues must predominate.23 Health care cases, in general, have proved particularly difficult to satisfy this prerequisite because each comes into the health care arena with different pre-existing vulnerabilities and conditions and so each individual is harmed in a unique way. In addition, in the opioid context, courts have focused on the fact that prescriptions written to each patient are individualized to that person's particular pain management needs as another reason to defeat aggregation. Some courts also have held that the very fact that each patient has a different doctor as “intermediary” makes it impossible to treat the claims in aggregate fashion. As one federal court put it: [The] existence of individual Learned Intermediaries trumps any common marketing issues.” 24
Purdue Pharma mostly rode waves of victory until a major suit that marked the end of the first wave of litigation. In 2007, the company agreed to pay $600 million in criminal and civil fines to the federal government and nearly $20 million to 26 states and the District of Columbia after pleading guilty in a federal suit. Purdue and three of its executive officers were charged with violating the Federal Food, Drug and Cosmetic Act (“FDCA”) by introducing a misbranded drug into interstate commerce.25 The three executives pleaded guilty to criminal charges, and Purdue admitted to misbranding by falsely advertising OxyContin pills as “less addictive” and “less subject to abuse and diversion” than other pain medications.Reference Sarpatwari26 The settlement was viewed as relatively modest, especially when compared to the $250 billion payout received by states in the Tobacco Master Settlement.27
It is unclear what each state did with this settlement money, but press releases may be illustrative. One, from the Connecticut Attorney General, indicates that the state was to receive $719,000 as a result of the settlement and of that amount only $100,000, a minority of those funds, was to go towards prescription monitoring programs, with the remaining going toward attorneys' fees and the state's general fund.Reference Blumenthal28
B. Physicians
In a number of cases against opioid manufacturers in the first wave, defendants blamed physicians for overprescribing that in some cases led to lethal misuse and abuse.29 Doctors were sued across a spectrum that ranged from malpractice to criminal charges. With respect to malpractice, the lack of a clear standard on how to treat pain was a complicating factor. Doctors who overprescribe may be held liable for malpractice while doctors who underprescribe may be charged with not adequately responding to the pain management needs of their patients.Reference Rich and Webster30 Most physicians fall within the two extremes; a breach in the standard duty of medical care therefore often requires some egregious action on the part of the doctor. State medical boards also disciplined physicians who failed to meet the appropriate standard of care.Reference Dineen and DuBois31
Alleging a broader circle of responsibility, however, is a double-edged sword. On the one hand, it enlists more targets for litigation. On the other, as detailed below, a wider web of actors sufficiently complicates the legal chain of causation such that courtroom victories may be less likely.
The Drug Enforcement Agency (DEA), the federal agency tasked with regulating controlled substances, targeted some physicians as well. The hook was typically violation of the Controlled Substance Act (CSA) by knowingly prescribing a controlled substance without a legitimate medical purpose and outside the course of professional practice.32 So-called “pill mills” — where prescriptions were issued for money rather than for legitimate medical care — were a common target.33
During this time, the DEA also launched what was known as the “OxyContin Action Plan,” an effort to target doctors and pharmacists who engaged in improper opioid prescription practices.Reference Hoffmann34 This was the first DEA plan that targeted a particular brand of controlled substance.35 The result was a notable increase in the number of OxyContin prosecutions.36 DEA targeted both physicians and pharmacists; it is estimated that between 2001 and 2004 approximately 60% of arrests related to the distribution, dispensing, and possession of OxyContin were medical professionals, such as doctors and pharmacists.37 State prosecutors and medical boards also pursued analogous actions. The role of criminal enforcement in the opioid crisis is more fully detailed elsewhere in this volume.38
II. The Second (Current) Wave of Opioid Litigation
The second wave of litigation began in 2014, when the perception of a national crisis really began to take hold. The second-wave suits have largely been brought by state and local governments, but also include significant criminal prosecutions brought by the DEA and suits brought by Indian nations.39
The major difference between the two waves is the much wider net cast for defendants in the second wave. Plaintiffs and prosecutors have moved beyond just targeting major pharmaceutical manufacturers to include opioid distributors, pharmacy retailers, and even a major professional accreditation commission. Although some suits do still target individual doctors40, the current wave is largely focused on “deep pockets,” as plaintiffs have looked for entities with the ability to pay the multi-billion-dollar price tag associated with efforts to address the crisis.
The wider net of defendants — and the settlements some have already entered — also has sent a message about responsibility for the crisis. This message may have an impact that outlives the current moment. Lawsuits arguing that retail pharmacies, for instance, have an obligation to do their part to prevent addiction and diversion may change the way the industry and the public think about pharmacies' legal and social responsibilities. So, too, suits arguing that distributors have privately enforceable duties as “gate keepers” to monitor, detect, and report “suspicious” drug orders may change the operational model of those companies going forward.41
Alleging a broader circle of responsibility, however, is a double-edged sword. On the one hand, it enlists more targets for litigation. On the other, as detailed below, a wider web of actors sufficiently complicates the legal chain of causation such that courtroom victories may be less likely.
A. New Plaintiffs
State and local governments have emerged as new key players in the second wave. As of February 2018, more than 700 states, counties, and cities had filed suit against pharmaceutical companies, with numbers increasing weekly.42 At the time this piece went to press, 26 states had brought suit in the current wave of litigation — including Alabama,43 Alaska,44 Arizona,45 Delaware,46 Kentucky,47 Louisiana,48 Mississippi,49 Missouri,50 Montana,51 New Hampshire,52 New Jersey,53 New Mexico,54 New York,55 North Carolina,56 Ohio,57 Oklahoma,58 South Carolina,59 Washington,60 West Virginia,61 and nine other states. Hundreds of cities,62 counties,Reference Ban and Barton63 and other localities had sued. In addition, 41 state attorneys general were working together in a multistate investigation targeting manufactures and distributors, with six of those having already filed suit.Reference Lurie64
The number of suits brought by localities is increasing weekly and is a particularly noteworthy new development. A typical example of a recent filing is a suit brought by Summit County in Ohio.65 The County alleges that it has spent $66 million since 2012 on ramifications of the opioid crisis and is seeking to recoup that large monetary loss to address the ongoing opioid crisis in the County. New York City has filed its own suit alleging “hundreds of millions of dollars” in damages. Filings by localities stretch from coast to coast. The defendants and causes of action in these cases are similar to those in the cases brought by state attorneys general. Like the other cases, many are being handled by various law firms on a contingency basis. The repeat-player law firms involved in these cases have aggressively recruited clients, which has contributed to the rising number of cases and the similarities among them.
Local governments have been motivated to sue by a concern that financial settlements to states may not necessarily result in money being transferred directly to local communities. Many look to the tobacco litigation of the 1990s a cautionary example. There, the large financial payouts made by the tobacco companies to the federal and state governments were often used by state governments for health care purposes not directly related to tobacco cessation and were not necessarily directed to particular localities.Reference Jones and Silvestri66 Even so, current complaints remain rather nonspecific except insofar as they wish to direct funds right to the county. The complaint in the Summit County case, for instance, seeks relief in the form of injunctions against actions of the defendants “engaging in the acts and practices” that violate the various laws under which the county is suing seeks punitive damages, actual damages and disgorgement of ill-gotten benefits.
In another novel development, the Cherokee Nation also filed first-of-their-kind legal claims asserting jurisdiction in its own tribal court over those companies that helped bring opioids into Indian country. A federal court recent enjoined that case, holding tribal courts did not have jurisdiction over the companies, and the Cherokee Nation has refiled in Oklahoma state court.Reference Tipps, Buzzard and McDougall67 As detailed elsewhere in this volume, the effects of the crisis have been devastating for some tribes.68
B. The Defendants
1. manufacturers
Plaintiffs of all kinds continue to target manufacturers. Purdue Pharma remains a major target but other manufacturers also being sued now include Teva Pharmaceutical, Cephalon Inc, Johnson and Johnson, Janssen Pharmaceuticals Inc, Endo Health Solutions Inc, and Allergan PLC.69 These suits focus on misrepresentations in the marketing of the drugs.70 The complaints generally allege that the companies downplayed the risk of addiction; promoted a misleading “pseudoad-diction” concept71; denied the risks of higher dosages; and exaggerated the ease with which addiction in patients could be detected and managed.72 They also are alleged to have relied on well-respected medical professionals, including nationally known pain specialists (whom the complaints call “key opinion leaders”), and pain management groups to promote their products without disclosing that those spokespersons were being paid for their promotional statements.73 Causes of action include public nuisance, negligence, unjust enrichment; and violations of state consumer protection, racketeering, and Medicaid fraud statutes.
The prevalence of nuisance claims is another interesting legal development. A public nuisance is anything that interferes with rights that are held in common by the general public including public health and safety.74 This cause of action was one of the main claims alleged in the tobacco litigation of the 1990s. An additional cause of action against manufacturers is that of racketeering violations of both state and federal law. These claims are brought on the theory that defendants are profiting from illegal activity — here, fraud.75
2. distributors
As noted, in a major shift in strategy from the first wave, claimants have also chosen to pursue opioid distributors and pharmacy retailers. Some of the parties targeting distributors include New Mexico,76 Cherokee Nation,77 a number of West Virginia counties,78 and the Cities of Birmingham, Alabama, New York City, and New Haven, Connecticut. Three major distributors play a crucial role in getting opioid pills to consumers: Cardinal Health, AmerisourceBergen, and McKesson Corporation. Together, these “Big Three” are responsible for distributing 85% of prescription drugs in the United States and are major targets for suits in the current wave.79 Like manufacturers, distributors have made enormous profits from addictive pain pills.Reference Fein80 McKesson Corporation is reported to make about $4 billion in profits per year as a result of opioid sales.Reference Alexander81
The legal hook in these cases is novel, because plain-tiffs are asserting that they have individual rights of action derived from distributors' duties under federal and state law to “monitor, detect, investigate, refuse and report suspicious orders of prescription opioids.”82 Most of the cases rely on DEA regulations issued under the CSA that require any entity involved in the distribution of controlled substances to “design and operate” a system that enables them to detect suspicious orders and in turn report those orders to the DEA.83 In addition, plaintiffs are bringing state law claims that piggyback on this federal provision: they argue that violation of the DEA regulations gives rise to violations of state consumer and trade practice statutes. Further, some states have regulations similar to the CSA provisions, and distributors have been sued under those as well. At least one federal court has already held that the CSA does not likely create a private cause of action84—that is, that while the distributors may have rights owing to the government, only the government, not individuals, can enforce those rights. Such a ruling, if replicated by other courts, will be fatal to these types of claims.
As an example of kinds of facts typically being used to support these claims, the Charleston Gazette-Mail found that distributors shipped 780 million doses of opioids to West Virginia alone over a five-year period. In the West Virginia County of Cabell, nearly 40 million tablets were shipped in a five-year period, despite the community's population of only 96,000.Reference Barasch85 Although distributors are required to report suspicious orders, plaintiffs allege they failed to report any suspicious orders between 2007 and 2012 despite rises in opioid prescriptions and addictions.86
There has been some federal enforcement of the DEA regulations against distributors. For example, McKesson paid a $150 million federal penalty to settle federal claims in 2017. McKesson was previously held to be in violation of the CSA requirement to design and implement an effective system to detect and report suspicious orders of controlled substances in 2008 — a finding that resulted in a $13.25 million civil penalty. In the recent 2017 action, McKesson admitted to failing to report additional orders to the DEA that should have been deemed “suspicious” due in part to their continued lack of effective controls required under the CSA.87 Some civil parties are using those settlements as jumping off points for their derivative claims.
3. pharmacy retailers
Retail pharmacies are another new category of defendant introduced in the second wave. Major suits against pharmacies have been brought not only by Cherokee Nation, but also by a number of counties in West Virginia and Massachusetts.88 Pharmacies currently subject to suit include Rite Aid, Walgreens, Walmart, and CVS.89
The theory in the cases against pharmacies is that prescriptions that raised “red flags” were consistently filled when a “reasonably prudent pharmacy” would have recognized these high-risk prescriptions and refused to fill such orders.90 Here, too, the claim derives from duties of pharmacies under the CSA, the relevant section of which states that practitioners have a “responsibility for the proper prescribing and dispensing of controlled substances,” and that the pharmacists who fill prescriptions also have a “corresponding responsibility.”91 As in the suits against distributors, plaintiffs suing pharmacists point to past federal settlements in which defendants had admitted to breaching this legal duty.92 For example, in 2013, Walgreens agreed to pay $80 million in civil penalties to resolve DEA allegations that it committed a large number of “record-keeping and dispensing violations” under the CSA.93 In early 2016, CVS agreed to an $8 million settlement to resolve federal allegations that it violated the CSA by issuing opioid prescriptions that were not for a “legitimate medical purpose.”94
4. the joint commission on accreditation of health care organizations and other novel claims
One of the newest suits extends the range of defendants to include the Joint Commission On Accreditation of Health Care Organizations (The Joint Commission), the half-century old non-profit organization that certifies 21,000 health care organizations nationwide, including most major hospitals.95 To achieve and maintain certification, health care organizations must adhere to the standards set by The Joint Commission. As relevant to the opioid crisis, The Joint Commission issued an infamous 2001 report that developed new standards related to pain management. This campaign, which ultimately became known as “pain as the fifth vital sign,” and as detailed elsewhere in this volume,Reference Schottenfeld, Waldman, Gluck and Tobin96 is viewed as largely responsible for bringing questions about pain into every routine patient encounter.
The new litigation, a putative class action filed on November 2, 2017, in federal district court in West Virginia, blames The Joint Commission's standards for contributing to the epidemic. West Virginia has been hit especially hard by the opioid crisis, and the plaintiffs seek monetary damages to mitigate the large financial burden brought about by the crisis. Among other claims, plaintiffs allege The Joint Commission colluded with Purdue Pharma, the manufacturer of OxyContin, in producing its Pain Management Standards, and that Purdue and other companies funded the report. The Joint Commission recently promulgated new standards, effective in January 2018, to better emphasize the potentially addictive properties of opioid analgesics, but plaintiffs argue that this action was too late in coming,Reference Baker97
As this article went to press, another novel set of claims had been filed. Individuals in five class actions have sued drugmakers over allegations that the opioid crisis has caused insurance premiums to rise even for those not suffering from opioid use disorder.
C. Defendant Responses in the Second Wave
Defendants have largely responded by challenging both the legal theories of the second wave cases as well as the chain of causation. Examining some of the responses filed by Purdue in various cases provides a snapshot. In one case brought by the city of Everett, Washington, for example, Purdue rejects arguments that it has any duties under the CSA that give rise to private causes of action; it argues any violations of the CSA should be properly enforced by the corresponding regulatory agency, not a private party.98 Moreover, even if there were a breached duty, Purdue argues, illegal drug trafficking in the city of Everett is an intervening actor that breaks the chain of causation between Purdue's actions and the harms suffered by the community.99 Finally, Purdue argues that nuisance claims fail on the ground that local governments do not have a property interest in law enforcement and health care services, and consequently those costs cannot be recovered through litigation.100
In a case brought in California, Purdue has sought to have the case dismissed on the basis of the primary jurisdiction doctrine. Under that doctrine, considerations of claims in advertising alleged to be “unfounded” and “misleading” should be evaluated by the FDA, not by the court system, because the FDA is the regulatory body tasked with approving the manufacturing and sale of prescription drugs.101
In a joint motion to dismiss advanced by manufacturers in the Ohio suit, defendants assert the state is improperly attempting to blame an entire industry for the problems created by the opioid crisis.102 Their response points to the fact that the opioid medications sold by manufacturers were approved by the FDA itself; any state claims challenging that determination, they argue, are preempted by federal law.103 The manufacturers also focus on the failure of claimants to establish causation. They assert that the intervening actions of physicians and other criminal conduct break the causal link and therefore absolve manufacturers from liability.104
On the distributor side, recent McKesson responses are illustrative. In response to suits filed by West Virginia's Cabell and Kanawha Counties, McKesson has argued that no single wholesale distributor or group of distributors could have caused the prescription opioid problem.105 It argues that “criminal activity by others necessarily breaks any causal chain” and therefore they, along with other distributors, cannot be held liable for the ill effects of the opioid crisis.106 Like Purdue, McKesson also asserts that reliance on the CSA, or the corresponding state version of that law, to establish a legal duty is misplaced. Although the regulations do require distributors to monitor, detect, and ultimately refuse suspicious orders, the regulation does not create a private cause of action.107 In other words, although distributors may have breached their duty, that duty was owed to the government agencies that created those regulations, not private litigants.108 This defense held sway recently in one of the cases brought by Cherokee Nation.109
McKesson also asserts that plaintiffs place too much emphasis on the aggregate number of prescriptions distributed by all pharmaceutical distributors rather than disaggregating the particular shipments carried out by each distributor.110 It argues that distributors are not aware of the amounts of drugs shipped by their competitors at any given time and therefore aggregate data cannot constitute a “red flag.” 111
AmerisourceBergen (ABDC), an additional defendant in the suits brought by West Virginia counties, makes similar arguments and also adds that since plaintiffs cannot demonstrate that a pill distributed specifically by ABDC has been diverted into illicit drug markets, they have failed plausibly to plead that ABDC in any way contributed to diversion in West Virginia.112
Finally, pharmacy retailers have offered defenses similar to those of the manufacturers and distributors. They also assert that their role in getting prescriptions to patients is too remote for them to be held liable for opioid overdoses that occur in the county. In some cases, defendants stress that plaintiffs have failed even to suggest that a “single pill” was delivered to any patient in their communities that was eventually used for an illegitimate purpose.113 Additionally, the pharmacies assert that plaintiffs have failed to establish just how many pills are too many and at what number does the dispensing of pills become “excessive.”114 In arguing this point, they draw comparisons to cases involving gun violence, in which courts have acknowledged there is difficulty in apportioning blame when various “gun manufacturers, distributors, dealers, resellers, and the shooter” are each alleged to be liable.115 The pharmacies likewise argue that complex chain of delivery of prescription opioids suggests that the role of a pharmacy is too far removed and speculative. For example, Walgreens, a defendant in the Kanawha and Cabell County cases points to the “gatekeeper role of physicians”, tasked with using independent judgment in prescribing opioids, by arguing such a role precludes pharmacies from being the proximate cause of injuries caused by physicians.116
In the Cherokee Nation case, pharmacies objected to tribal court jurisdiction in the first place. As noted previously, tribal court jurisdiction was recently denied, and Cherokee Nation is now pursuing its case in Oklahoma state court.
IV. The Comparison to Tobacco
It is impossible to evaluate the opioid lawsuits without seeing in many of them the playbook used against the tobacco industry in the major litigation effort of the 1990s. That litigation resulted in the Master Settlement Agreement of 1998 (MSA), which required that big tobacco companies pay $250 billion dollars over the course of 25 years to 46 states.117 As has been documented before, however, the MSA fell far short of ending tobacco use in the United States, and has been roundly criticized for the share of the funds that went to attorneys' fees and general state funds to compensate for budget shortfallsReference Patel118 and even to general state health funds, instead of specifically being directed toward smoking cessation and youth tobacco prevention programs.119 For instance, one group recently found that less than two percent of the settlement money to be paid out to states in 2014 was expected to be allocated to tobacco prevention programs.120
To be sure, some MSA funds did go to Medicaid-related services and educational programs to help address underage smoking, and some states did better than others in ensuring that most of the funds went towards public health and prevention. For instance, Pennsylvania dedicated all of the nearly $366.3 million received from the settlement to either healthcare costs or tobacco control.121 But many other states spent most of the money elsewhere, including on general purposes, economic development and infrastructure, and securitization of funds.122
Even so, similarities between the tobacco and opioid epidemics have made the tobacco litigation strategy a blueprint, especially for private lawyers eager for profits and state attorneys general seeking political glory. The opioid crisis has been embraced by Democratic and Republican lawmakers alike as a health care issue of national importance — and one the public wants elected officials to address.Reference Roubein123 The Attorney General of Ohio, Mike DeWine, for instance, is primed to run for governor, and his campaign is focused in part on the harms from opioids suffered by communities all over the country. On the private side, lawyers previously involved in tobacco litigation have signed up to translate the tobacco model into the opioid context. Perhaps most notably, Mike Moore, the former Mississippi Attorney General who was the pivotal private attorney in the tobacco Master Settlement Agreement, is now involved in opioid litigation in Mississippi — the first state to file suit against opioid manufacturers in the second wave of opioid litigation.
Nevertheless, the litigation strategy in the current wave differs from the tobacco litigation in one signifi-cant way: The plaintiffs, as we have shown, have cast a much broader net of responsibility beyond manufacturers. There is a far more complex chain involved in delivering opioid prescriptions to consumers than in the sale of tobacco products. For opioids, that chain includes doctors, distributors, pharmacies, and patients as well as the drug companies. This complexity may complicate efforts at litigation because of the difficulty of pinning blame on any single actor and thereby lessen plaintiffs' leverage, as compared with the tobacco context.
Another complicating factor is that opioids are approved as safe and effective by the FDA — and are indeed safe, effective, and necessary in many cases — and then, are prescribed by doctors, often for necessary medical use. Neither of those factors was present in tobacco, and this further complicates the chain of responsibility. In the first wave of opioid cases, defendants sometimes succeeded with a contributory negligence strategy, by arguing the individual plaintiffs themselves contributed to their own harm.124 It is possible that culpability of multiple parties will come into play in the second wave, e.g., at the damages stage, especially because so many other actors, such as the FDA, distributors, pharmacies, individuals, and doctors, are also implicated.Reference Beletsky125 But most of the second-wave claims involve purported statutory violations rather than negligence, so contributory negligence may be less relevant.
Attorney-fee arrangements also have been causes for concern. As in the case of tobacco, most state and local governments are being represented by private firms that are working on a contingency fee basis — a fee arrangement that some worry over-incentivizes early settlement without ensuring concrete public-health results.Reference Whalen126 Elected officials, with short time horizons, might likewise may have incentives to settle cases quickly for big headlines rather than pursuing remedies that might more positively affect health outcomes. On the other hand, as many localities have pointed out, having private firms involved shields the public from having to bear the costs of litigation in the event that cases do not yield high damages.
V. The New Federal Multidistrict Litigation as Game Changer
The most significant legal development thus far has been the consolidation of more than 700 opioid-related cases into a nationwide multidistrict (MDL) litigation, which occurred shortly before this article went going to press.127 Multidistrict courts are special creations of federal law. Under 28 U.S.C. §1407, a special panel of federal judges is authorized to consolidate cases that may have been filed in different courts across the country but that raise the same or related claims against the same defendant(s) before a single judge for efficient pretrial management.128 Importantly, cases can be aggregated in the MDL that may not meet the stricter criteria to be consolidated for class action.
Although the MDL court does not have authority to actually try all those cases — it only has the authority to conduct pre-trial discovery and motion practice — in reality, more than 97% of cases before MDL judges settle in the MDL, without returning to their original jurisdiction for a trial. The high rate of settlement is unsurprising, not only because most civil cases do not see trial anyway but also because large scale MDLs typically deal with complex problems with intractable numbers. Without a way to aggregate fact finding and resolution, it could take years for all the individual cases to be heard, much less resolved, and defendants are unlikely to reach meaningful settlement without the promise that more lawsuits will not be forthcoming. Recent high-profile matters that have been or are currently being resolved by MDLs include the BP oil spill, the NFL concussion litigation, and most modern mass prescription drug products liability cases.Reference Gluck129 Although MDL courts have jurisdiction only over cases filed in federal court, many MDLs coordinate with parallel state actions. In some cases, MDL judges have exerted pressure in the state cases themselves to achieve “global settlements” that include those state cases. Some defendants insist on such “total peace” across pending cases before settling.
The opioid MDL fits these descriptions but also has some unique features that have particular relevance to the questions posed by this article about the part that litigation may play in a public crisis of this scale. The opioid cases have been consolidated before Judge Dan Polster in the northern district of Ohio (a geographical decision made by the Judicial Panel on Multidistrict Litigation partially in light of how hard Ohio has been hit by the crisis).130 All the initial cases consolidated had been brought by state or local governments; since the initial consolidation order in December 2017, hundreds more cases have been added, some of which involve individual and other non-governmental entities.131
Not every plaintiff in the case was in favor of consolidation. West Virginia, for example, argued unsuccessfully that its case turned on state law claims and did not want its claims lumped in with the group. There are other actors that are purposefully eschewing federal court to avoid being pulled into the MDL. The Cherokee Nation, for instance, refiled its suit in state court for precisely that reason and appears to be trying to get out ahead of any MDL settlement.Reference Elfin132 Some defendants are trying to remove that case to federal court to benefit from consolidating it with the MDL.Reference Powell133 Oklahoma's case is most advanced, with a state court trial date set for May 2019,134 the earliest trial date set thus far. Several other tribal cases, which were filed in federal court, are now part of the MDL.Reference Horwitz135 Six attorney generals similarly filed state cases as this article went to print. Time will tell if they get pulled into the MDL too.
It is unusual that the transferring panel was willing to group so many different kinds of defendants into the single MDL. The consolidated defendants include not only the drug manufactures, but also distributors, retailers, and even individual physicians. Some defendants had protested consolidation on these grounds — i.e. that their role was different and far more limited from that of manufacturers, and so their claims should not be grouped together. The transferring court, however, seemed to prefer a comprehensive action to get at a comprehensive solution. In that vein, the MDL court has already contacted the 41 state attorneys general investigating the crisis to bring them in for discussions. It also made clear that it intends to find a way to coordinate with the state court cases as well with an eye toward as complete a resolution as possible of all pending litigation. That is an extraordinary goal. Eighteen principal attorneys have been designated thus far to represent the various stakeholders.
These features suggest the court is interested in dealing with the opioid crisis in a way that approximates a legislative approach more than a litigation approach. The judge himself announced at the first hearing his intention to resolve the cases within the year. He made clear his view that that “this is not a traditional MDL [which] generally focuses on something unfortunate that's happened in the past, and figuring out how it happened, why it happened, who might be responsible.” “The opioid crisis,” he said, “is present and ongoing” and creates an opportunity and an obligation for the court to try to do something sooner rather than later.
The judge also has stated that the federal and state governments have “punted” on legislative solutions, leaving the work to the courts. At the same, time, however, he has made clear his view that traditional litigation is not the way to solve the problem, even in court.
“People aren't interested in figuring out the answer to interesting legal questions like preemption and learned intermediary, or unraveling complicated conspiracy theories … So my objective is to do something meaningful to abate this crisis and to do it in 2018. What we've got to do is dramatically reduce the number of the pills that are out there and make sure that the pills that are out there are being used properly … We need a whole lot — some new systems in place, and we need some treatment. We don't need — we don't need a lot of briefs and we don't need trials. They're not going to — none of them are — none of those are going to solve what we've got.”
Earlier in this article, we discussed some of the potential legal obstacles to successful litigation. For instance, the question whether private rights of action derive from the companies' obligations to monitor opioids under the CSA is unresolved and might not be answered in plaintiffs' favor in a traditional legal proceeding. Similarly, we have emphasized that the many different actors involved complicates the chain of legal causation and so might prevent recovery at trial. The MDL, especially as Judge Polster has framed it, has the potential to smooth over some of these challenges. Moving away from a traditional legal proceeding into problem solving mode is likely to generate a settlement regardless of how individual cases might have come out had they been tried. For some, these aspects of the MDL — what one of us has previously called “unorthodox civil procedure” — is a benefit. For others, it raises serious legal and even constitutional concerns.136
Indeed, Judge Polster has already indicated his view that wide web of responsibility makes settlement more, not less, appropriate.
[I]n my humble opinion, everyone shares some of the responsibility, and no one has done enough to abate it. That includes the manufacturers, the distributors, the pharmacies, the doctors, the federal government and state government, local governments, hospitals, third-party payers, and individuals.
Attorneys' fees and incentive to settle are also an issue in the MDL context in general. Commentators have documented concerns about large fees, and a chummy small bar of plaintiffs and defense attorneys who have aligned interests in quick settlement.Reference Burch and Williams137
It should be clear the MDL is a game changer in the litigation. The judge already has expressed more interest in coming up with solutions rather than trying claims or even addressing the novel legal questions. He has set an aggressive schedule for settlement negotiations and ordered even those parties not before his court to participate. Defendants have an interest in a global settlement that resolves all their liability in one shot. Attorneys involved, including state Attorneys General, will be attracted to early settlement and quick gains, especially in light of some of the novelties and legal weaknesses in the causes of action themselves. Even then DEA has filed a statement of interest in Judge Polster's court, seeking some piece of the expected recovery.138
Some commentators have been extremely critical of Judge Polster's approach, even deeming it undemocratic.Reference Little139 Others applaud Judge Polster's creative and aggressive strategyReference Feeley140 as the best way to address the crisis with the urgency that it requires. Either way, settlement in the near future seems almost certain.
VI. Conclusion: What Role Litigation Can Play
Litigation has helped set the agenda and frame the issues in this crisis. The start of litigation, or in some cases the mere threat of it, has brought additional political, health, and educational attention to the opioid crisis and, arguably, changed the way actors at the edge of the web, including distributors, retailers, and accreditation entitles, conceive of their responsibilities. In addition, the pressure to rehabilitate a company reputation damaged by litigation and other publicity may prompt companies to contribute to the solution, perhaps even before court resolution.Reference Deprez and Barrett141 As just a few examples, Purdue already introduced a tamper-resistant OxyContin tablet (although some have argued that this was done more for marketing reasons and to protect its intellectual property than to address the crisisReference Curfman, Beletsky and Sarpatwari142). As noted, Purdue also recently announced that it has canceled further direct promotion of OxyContin to prescribers, and it has cut its detailing force by half. And The Joint Commission has revised its pain guidelines. Indeed, in the healthcare community, there is already evidence that prescribing of opioids has declined,Reference Stein143 so much so that some are now worried that needed care will not be available.Reference Kertesz144
Litigation also has a key investigatory function even if cases do not make it to court. Lawyers for Cherokee Nation, for example, have stated litigation is way to get the internal records of these companies, through discovery, to gather proof that they were in fact aware of the diversion that was taking place. That information, if found, may generate public pressure on the companies to change their behavior going forward.Reference Higham and Bernstein145 There is also an expressive and dignity component that cannot be overlooked, as those harmed by the crisis want to hold players accountable for the harm caused.
Money remains a paramount goal, of course. Money may be even more important in this crisis than in some others, given the overwhelming medical costs that have emerged from the epidemic of addiction. The challenge is to ensure that any recoveries are put towards the right programs. This was a major concern in the tobacco context, as noted,Reference Sloan and Chepke146 and there is little indication that opioid plaintiffs are being more specific with their damages claims.147 Many complaints simply focus on the profits made by manufacturers, distributors, and pharmacy retailers and on the costs taxpayers have simultaneously had to bear, and ask for money without more particulars. In the Ohio suit, for example, plaintiffs assert defendants have reaped “blockbuster profits,” whereas the state's “costs of opioid addiction are staggering.”148 Common among requests for monetary damages is the goal that funds be used to pay for expenses that include covering the costs of health care, addiction treatment, welfare support for children with parents incapacitated by substance abuse, law enforcement, and public safety.149 Only a handful of complaints call for the establishment of a specific “abatement fund” as part of their request for relief,150 but even those complaints describe that fund without details, simply asking for a fund “for the purposes of abating the opioid nuisance.151
Money remains a paramount goal, of course. Money may be even more important in this crisis than in some others, given the overwhelming medical costs that have emerged from the epidemic of addiction. The challenge is to ensure that any recoveries are put towards the right programs. This was a major concern in the tobacco context, as noted, and there is little indication that opioid plaintiffs are being more specific with their damages claims. Many complaints simply focus on the profits made by manufacturers, distributors, and pharmacy retailers and on the costs taxpayers have simultaneously had to bear, and ask for money without more particulars.
Some plaintiffs also have requested declarations that the actions of defendants were unlawful152 or sought injunctive relief. Those requests have included requirements to cease fraudulent or misleading marketing practices (such as the use of key opinion leaders to promote opioids), or to meet legal duties under the CSA. Some settlements have achieved more specific policy relief, and it is likely that any settlement by the state attorneys general or in the MDL will include some agreement to modify business practices. For example, in a July 2017 settlement, CVS Pharmacy paid $5 million to resolve violations of the CSA involving 9 of its pharmacies in the Eastern District of California. Accompanying the settlement payment was an agreement on the part of CVS to institute a compliance plan aimed at preventing further record-keeping infractions. Similarly, in 2016 Massachusetts Attorney
General Maura Healey announced a settlement with CVS Pharmacy that required every CVS pharmacist to check the state's prescription drug monitoring program before dispensing opioid drugs (in addition to paying $750,000 to the Commonwealth, $500,000 of which was allocated to address opioid dependence.) There is always a concern, especially in cases involving state attorneys general that seem headed for quick settlement, that these high-profile cases have major opportunity costs, in terms of shifting public attention to high profile but ineffective interventions to address the crisis.
Whether courts are the best venue in which to achieve these policy reforms is a different question. In the legislative arena, as detailed elsewhere in this volume, a plethora of policy responses to the crisis already have been suggested and in many cases enacted into law — ranging from public education, to state restrictions on physician prescribing, to good Samaritan laws, to laws requiring physicians and others to check state prescription databases before prescribing or filling orders.Reference Parker, Strunk and Fiellin153 Some scholars have argued that court-derived solutions to public health crises thus “threate[n] democratic norms of public policy-making” — supplanting legislative bodies with non-expert, entrepreneurial lawyers who are not generally accountable to the people (except for most state attorneys general).Reference Hensler154 The MDL court's view that the legislative branches have “punted” does not seem completely accurate on the state side, where there has indeed been a great deal of legislative activity. More accurate may be the conclusion that piecemeal efforts implemented unevenly by the states simply are not enough to address a crisis of this scale.
Other scholars have pointed out that litigation against powerful companies may also have the benefit of bringing about regulatory change that legislators often cannot accomplish due to the influence of industry lobbyists. One frequently cited example of this phenomenon is the litigation against the automotive manufacturers, which led to the installment of safety features that were eventually incorporated into law. The industry's influence in Congress had made this kind of regulation politically unattainable before the litigation.Reference Jacbson and Soliman155 The pharmaceutical industry likewise has a long history of successfully batting back congressional efforts to regulate it. Recent failed legislative attempts even to modestly address drug pricing have fallen apart for precisely this reason.Reference Lee, Gluck and Curfman156
Litigation, in the end, may be a second-best but necessary effort to catalyze broader change. It is too soon to evaluate the contribution that litigation may make or its failures in this context, but it is indisputable that it will remain front and center for the foreseeable future.
