“Chapter 18 A Matter of Justice: Legal Response to the Appalachian Opioid Crisis” in “Accessible Appalachia”
A Matter of Justice:
Legal Response to the Appalachian Opioid Crisis
Thomas Parker and Lynnette Noblitt
The opioid epidemic escalated in the 1990s after the introduction of OxyContin, an extended-release version of the pain medication oxycodone, into the prescription pain-relief market. OxyContin was initially approved by the United States Food and Drug Administration (FDA) specifically for the management of breakthrough pain in advanced cancer patients,[1] but through marketing of the drug for off-label use by a much wider population, its distribution became widespread and its abuse spiraled into a massive public-health crisis.
While no community has been left untouched, areas of persistent distress and poverty have been hit hardest by this opioid crisis. Appalachia—particularly areas of Kentucky, Ohio, and West Virginia—has suffered overwhelming consequences which threaten every aspect of its communities. As state and federal governments have attempted to reduce the proliferation of OxyContin use and abuse, those addicted to OxyContin have turned to more readily available substitutes such as heroin and fentanyl. Frustration has grown over the mounting costs of combating the epidemic, and legislative and regulatory efforts have proven slow and ineffective. As a result, the public has increasingly turned to the courts for solutions, with Appalachian states and communities filing multiple lawsuits in state and federal courts to seek relief and compensation.
State and federal courts play an immeasurable role in addressing the opioid epidemic and the current state of opioid litigation. While opioid lawsuits have garnered much attention from the public, such litigation may ultimately be both ineffective and inappropriate. Even if government lawsuits prevail and communities receive the relief requested, litigation is unlikely to provide sufficient resources to address the epidemic fully. Furthermore, using the courts to supplant the legislative and executive branches of government will lead to ineffective and incomplete resolutions, as the judiciary is not well-suited for public-policy development and implementation.
The Cost of the Opioid Epidemic in Appalachia
The overall cost of the opioid epidemic in Appalachia is incalculable, but local and state governments tasked with addressing the effects of the epidemic have quickly realized that the total bill is enormous. Costs of the opioid epidemic affect the budget of nearly every service that the government provides. The most immediately quantifiable, direct cost of the opioid epidemic is that of healthcare associated with the treatment of overdose, addiction, and drug-related health problems. Medicaid spending on opioid-addiction medication and related treatment costs has skyrocketed in response to the epidemic,[2] and the health costs extend beyond just those abusing prescription opioids. Although in decline, Appalachia has had the highest rate of babies born to opioid-addicted mothers in the country for decades.[3] The area has also experienced Hepatitis C and HIV outbreaks in several communities, as individuals taking opioid pills often switch to heroin (an illegal opioid that is often injected in unsanitary conditions, resulting in the spread of infectious disease) over the course of their addiction due to the relative availability and cost of the drug compared to OxyContin.[4] Finally, the widespread availability of fentanyl, an extremely potent synthetic opioid, has worsened addictions and resulted in a significant increase in overdose deaths.
The costs of the opioid epidemic extend well past the hospital clinic walls. For example, crime in areas plagued by opioid use has skyrocketed. Once-quiet communities note that nearly all crime in their area is now due to prescription-drug misuse and related addiction; nationwide, nearly two-thirds of incarcerated individuals have a substance use disorder.[5] As a result, state and local governments have experienced massive overcrowding of jails and prisons. Growing inmate populations have exhausted local budgets, leaving officials to seek tax increases at significant political peril.
Opioid addiction has also exhausted existing social services in many communities. Much of this increase can be directly linked to opioid use, with multiple generations of families often becoming addicted to opioids, leaving limited options for placing a child with another family member. As a result, Appalachian communities have experienced increased demand for foster-care services over the past decade.[6] In addition, schools throughout the area have also noted educational interruptions for students due to suspensions related to their parents’ opioid use. Finally, veterans are another vulnerable population with a higher rate of overdoses than that of the average population.[7]
As Appalachian communities struggle to pay the immense costs of the opioid epidemic, they find that the economic productivity of their communities also suffers, reducing their tax base to pay for needed services. While losses in economic productivity and resulting tax income are difficult to quantify, many of the areas hardest hit by the opioid epidemic note serious labor shortages. Local employers describe an inability to find employees who can pass drug screening to qualify to operate heavy machinery or complete other required tasks for unfilled labor positions.[8]
Corporate Causes of the Opioid Epidemic
The opioid epidemic did not occur overnight. It also did not occur by chance. It has been in significant part the result of corporate strategy, much of which has been revealed through whistleblowers and court filings. While much of the pharmaceutical industry continues to deny any wrongdoing, evidence is mounting that pharmaceutical companies actively promoted the off-label use of opioids, purposefully misled medical professionals, manipulated regulatory authorities, and promoted a disregard of the addictive nature of opioid pain medications in the pursuit of profit.
Litigation discovery—the legal process by which parties are able to obtain documents and other evidence from opposing parties under the supervision and power of a court—has revealed that pharmaceutical manufacturers targeted traditional sources of information available to medical professionals, engaging in massive marketing campaigns that touted benefits and dismissed concerns about opioid medications. For decades, the medical community had been warned of the risks of drug-seeking behavior and opioid addiction. Pharmaceutical manufacturers set out to overcome these fears by arming sales representatives with marketing materials containing unsubstantiated claims about the safety of long-term opioid use. These manufacturers also launched websites full of misleading surveys on opioid safety while stoking fears about NSAIDs (non-steroidal anti-inflammatory drugs), which are common alternatives to opioids with a much lower risk of addiction or abuse.[9]
Additionally, opioid manufacturers paid influential doctors identified as “key opinion leaders” to conduct continuing-education events for medical professionals that promoted the safety and efficacy of opioids. These key opinion leaders also promoted to physicians claims of “pseudo-addiction”—the idea that patients labeled as opioid addicts were actually not addicts but individuals being under-treated for pain who should receive more opioids, not fewer—and “opiophobia,” which openly attacked as irrational the medical community’s concerns about long-term opioid use and attempts to monitor opioid prescriptions.[10]
Opioid manufacturers also used financial donations to influence patient groups and professional organizations such as the American Pain Foundation and the American Pain Society. The goal was to promote peer-to-peer marketing among internal medicine and primary-care physicians who typically did not prescribe opioids and who had limited medical education or experience related to long-term opioid treatment. Manufacturers promoted a series of false claims related to opioid use, even presenting and publishing research studies using false data to bolster their claims of opioid efficacy and safety.[11]
In addition to systematically marketing false information to medical professionals, pharmaceutical manufacturers and distributors engaged in a variety of other behaviors designed to thwart traditional regulation of the pharmaceutical industry and to maximize company profits. Litigation discovery has revealed evidence that manufacturers required sales representatives to meet aggressive sales quotas for the number and concentration of opioid prescriptions written; this profit motive, in turn, encouraged sales representatives to identify and target doctors with high concentrations of opioid prescriptions.[12] Opioid sales representatives even provided phone scripts to doctors designed to mislead insurance companies into believing that patients had cancer in an effort to persuade the insurers to cover long-term opioid prescriptions.[13]
Pharmaceutical distributors and retail pharmacies compounded the consequences of corporate corruption of pharmaceutical manufacturers with corrupt practices of their own. Distributors systematically failed to report obviously suspicious orders of opioids placed over a period of years. Retail pharmacies also failed to counsel patients on the dangers of addiction despite being aware of overdoses and criminal activity taking place in their own parking lots.[14]
Despite the obvious harm of these corporate actions on public health, many of these strategies did not violate any laws or regulations at the time. Regulatory capture—the co-opting of a regulatory authority for the benefit of a special interest—appears to have played a significant role. Despite science to the contrary, pharmaceutical manufacturers and distributors successfully lobbied a variety of governmental agencies to act to their benefit, including limiting the authority of the Drug Enforcement Agency (DEA) to regulate “pill mills” (doctors, clinics, or pharmacies that dispense prescription drugs readily and inappropriately)[15] and convincing the Department of Veterans Affairs to increase opioid prescriptions despite high levels of addiction among military veterans.[16]
The Legal Response to the Opioid Epidemic: First Wave Litigation
At the turn of the 21st century, individuals suffering from opioid addiction—and eventually states and local communities—started turning to the court system, filing lawsuits against opioid manufacturers and other participants in the prescription-opioid market to seek monetary damages and injunctive relief (e.g., court orders to stop companies from marketing prescription opioids in harmful ways). Opioid-related litigation formed in two waves. First-wave litigation targeted individual doctors for prescribing medications inappropriately and manufacturers for producing harmful prescription drugs. Second-wave litigation framed the proliferation of opioids as a widespread public-health epidemic resulting from the actions of drug companies, distributors, and sales representatives working together to mislead doctors and patients alike into believing that opioid medications could be widely prescribed and used with a manageable, perhaps even minimal, risk of addiction.[17]
First-wave opioid litigation largely focused on doctors who prescribed opioid medications and the manufacturer of the time-release opioid medication OxyContin, made by Purdue Pharma. These early civil lawsuits were largely unsuccessful. Individual patients and their family members filed individual tort claims against both specific physicians and Purdue Pharma. While some patients won limited malpractice claims against physicians, they generally did not prevail against the manufacturer. Some courts dismissed claims against pharmaceutical companies based on the “learned intermediary doctrine,” which in some states prevents pharmaceutical manufacturers from being held liable when such entities provide information to learned intermediaries—in these cases, physicians—who interact directly with the patient and ultimately make the decision to prescribe a particular medication based on their medical education, knowledge, experience, and expertise.[18]
Courts also dismissed some plaintiffs’ claims based on illegal acts committed by the plaintiffs themselves. In a case filed against Purdue Pharma and decided in 2006, the Supreme Court of Mississippi held that “[t]his 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.”[19] This stigmatization of opioid users continues in many facets of the legal system, viewing addiction not as a disease but a moral failing worthy of criminal punishment. The first wave of opioid litigation came to an end in 2007 when individual plaintiffs prevailed on state false-advertising and consumer-protection claims in addition to malpractice claims, providing a new and perhaps more promising path for seeking judicial relief. These early, relatively modest victories set the stage for a much larger second wave of opioid litigation.[20]
The Legal Response to the Opioid Epidemic: Second-Wave Litigation
In the second wave of opioid litigation, plaintiffs are no longer focused on filing lawsuits against individual doctors or a single pharmaceutical company. Once major segments of American society began to recognize the systemic nature of the opioid epidemic, the legal community began to seek recovery from far deeper pockets. Instead of filing lawsuits on behalf of individuals based on their personally-suffered injuries, governments sued to recover costs directly suffered by the governmental entity and in their capacity to act as legal representatives for the public. Defendants now include representatives up and down the supply chain such as drug manufacturers, distributors, pharmacy retailers, and organizations responsible for defining appropriate standards for opioid prescription and treatment.
The causes of action or basis for claims in second-wave litigation are significantly different as well. Government entities have filed lawsuits based upon violations of consumer-protection laws.[21] Traditionally, consumer protection laws are designed to protect individuals from product hazards, particularly those for which information is unavailable to the general public. These suits allege that opioid manufacturers, distributors, and retail pharmacies knowingly mischaracterized the risk of opioid addiction to doctors and patients through marketing materials and statements. The suits also claim that these same actions defrauded Medicaid and Medicare as well as a variety of related state-assistance and insurance programs, since the defendants’ making repeatedly untrue statements to doctors and payment agencies resulted in pharmaceutical manufacturers and pharmacies receiving fraudulent payments from those programs.
Government entities also filed suit based upon traditional tort claims of negligence.[22] A tort claim asserts wrongdoing against another that results in civil or financial liability rather than criminal liability. A negligence claim specifically asserts that someone failed to take proper care when doing something. In a negligence lawsuit, the plaintiff must prove that the defendant owed the plaintiff a duty of care and breached (or failed to meet) that duty of care. This duty of care is the societal norm of how individuals or corporations are expected to treat each other. Once the duty of care is defined, tortfeasors (those who commit torts) are held responsible for the foreseeable consequences of their failure to fulfill obligations and expectations.
Governments allege that pharmaceutical manufacturers, distributors, and retail pharmacies all failed to meet their duty of care to the public, and that pharmaceutical distributors and retail pharmacies failed to create a system for reporting suspicious opioid orders to the Drug Enforcement Agency and local law enforcement agencies.[23] Furthermore, governments claim that pharmaceutical manufacturers breached their duty of care owed to the public by their aggressive, unregulated, and off-label marketing of opioids. Governments further urge the courts that this off-label marketing resulted in negligence per se,[24] a legal doctrine which allows plaintiffs to establish the first two elements of a tort claim—duty and breach of duty—by showing simply that a defendant violated a law or regulation designed to promote public safety.[25]
Most recently, governmental entities have also filed suit alleging the creation of a public nuisance.[26] This cause of action is the most novel and likely most fraught with legal complications. Public nuisance claims traditionally focus on environmental factors such as noise or air pollution and are filed both to stop future pollution and to obtain damages for the consequences of past pollution. In opioid litigation, however, the plaintiffs focus on language in public-nuisance statutes that protects the public from unreasonable interference with rights of the general public, including public health, safety, and peace. The plaintiffs argue that prevalent crime, infectious outbreaks, and the increased need for social services are direct and foreseeable results of widespread opioid addiction, fulfilling the requirements of the public-nuisance statutes. This legal strategy aims to recover not only past damages but the costs of abatement (i.e., paying to fix the societal problems that the defendants’ actions have allegedly created).
Based upon these causes of action, governmental entities have sought a wide variety of monetary damages and other forms of relief. In addition to civil penalties for individual violations of consumer-protection and Medicaid/Medicare fraud laws and regulations, plaintiffs have sought injunctive relief (court orders) to prohibit the defendants from future deceptive marketing as well as compensatory and punitive damages.[27] Although governmental entities know that courts are typically hesitant to grant relief other than carefully defined and demonstrated monetary damages, the additional injunctive remedies sought by the justice system demonstrate the plaintiffs’ desire not only to recover monetary damages for past offenses, but to enact policy changes designed to reduce or eliminate future injury to the public.
Pharmaceutical Industry Response to Government Legal Action
The consistent response of the pharmaceutical industry to these second-wave lawsuits has been to deny responsibility for all causes of action and damages. The bases for this denial are even more varied than the claims themselves; however, all companies argue that the plaintiffs cannot establish both direct and proximate cause for their tort (negligence and negligence per se) claims.[28] The defendant companies argue that the government cannot prove direct causation because it cannot prove that each individual would not have become addicted to opioids “but for” the defendants’ distribution of misleading marketing materials and information to doctors and consumers. The defendants further assert that the government cannot prove proximate causation because it cannot show that the financial consequences of opioid addiction stemming from the defendant companies’ misleading marketing were reasonably foreseeable or predictable to the defendants.
Defendants have also relied upon the doctrine of superseding cause to break the causal link between opioid addiction and damages such as those resulting in criminal activity or the need for enhanced social services such as foster care.[29] The doctrine of superseding cause relieves defendants from liability even when the defendants have started the chain of events leading to the injury, if the defendants can prove that an independent and unforeseen event or cause, rather than their own initial action, produced a harmful result that the defendant could not have reasonably foreseen when it acted initially.[30] Defendants argue that the later actions of third parties such as consumers, their family members, or others that result in criminal acts (e.g., illegal drug use, drug trafficking) were not reasonably foreseeable or predictable consequences of the actions of the pharmaceutical industry. Similarly, the defendants rely upon the derivative injury rule, under which some (but not all) states bar recovery of damages by a third party (here, the governmental entity that is suing) if that party is too far removed from the fraudulent or misleading communication by the defendant to consumers.
The pharmaceutical industry vehemently argues that public-nuisance law does not apply to the opioid epidemic.[31] The companies argue that public-nuisance law is a private rather than a public right so the state cannot bring such a suit on behalf of its citizens. In other words, private individuals directly suffering harm are allowed to sue under nuisance laws, not public entities suing on their behalf. Governmental entities, however, maintain that significant interference with public health and safety can form the basis for a nuisance claim. The companies once again respond that there is a lack of foreseeability or proximate causation and that illegal diversion and other activities constituted superseding and intervening acts that broke a causal link required for liability. Governments respond that the illegal actions were foreseeable and there is sufficient proximate causation to assign liability to the resultant harms from diversion.
Other arguments made by the pharmaceutical industry demonstrate that its members view—or at least portray—the opioid epidemic as an inevitable public-health problem for which they bear no responsibility. Companies argue that all cases should be dropped under the free public services doctrine, which in some states bars the government from seeking reimbursement for services funded by the general public even if the need for those public services has been created by the negligent actions of an individual or company.[32] Successful application of this doctrine could allow the pharmaceutical industry to escape litigation with no liability at all to government entities.[33]
Perhaps even more boldly, pharmaceutical companies present estoppel-like arguments. Estoppel arises when an entity makes a legal claim and then attempts to reverse this claim. Courts will rule that the entity is “estopped” from reversing their claim. The companies argue that governmental entities cannot recover damages for opioid misuse since they knew about the risks of prescription medications for a long time and did nothing to prevent their widespread misuse.[34] The governments predictably argue that their inability to combat opioid misuse successfully is not acquiescence. Indeed, since approximately 2010, state and local governments have tried in various ways to combat opioid abuse and, in the course of doing so, learned of the defendants’ conduct that led to individuals becoming addicted and opioids being readily available to them.[35] The governments further argue that the limited timeframe for filing suit due to statutes of limitations should be counted only from the time that the government entity learned of the defendant’s malfeasance, preventing defendants from avoiding liability based simply on the passage of time since their initial rollout of opioid medications onto the market.[36]
Second-Wave Litigation Outcomes
The large-scale outcome of second-wave opioid litigation remains unclear. The cases filed in this period are far more complex and massive than those filed in the first wave. Discovery in many of these cases may take years to complete and the full extent of damages may never be fully demonstrated. Decisions hailed as bellwether cases may serve as a roadmap for future litigation.
A 2021 decision in Oklahoma against Johnson & Johnson may serve as a warning to both future plaintiffs and defendants.[37] The state of Oklahoma filed suit requesting $17.5 billion for damages allegedly caused when Johnson & Johnson engaged in dangerous false marketing which flooded the state with opioids and resulted in a public nuisance.[38] The case, heard before a judge only rather than a jury, ultimately awarded the state $465 million in damages—the amount required to provide a single year of services needed to combat the opioid epidemic in the state.[39] Although state experts testified that the opioid epidemic would likely require twenty years of such services to resolve the public health crisis, the judge found that the state had not proven damages past a single year.[40] The state of Oklahoma vowed to produce evidence of ongoing public nuisance and to seek future damages. Johnson & Johnson has already filed an appeal of the decision.[41]
The full implications of the Johnson & Johnson decision are even less clear since it was decided in an Oklahoma state court applying Oklahoma state law.[42] While many second-wave lawsuits allege public-nuisance claims, every state has a different body of public-nuisance law, and other states are not obligated to follow an Oklahoma state court’s decision. Furthermore, Oklahoma has a uniquely broad public-nuisance law which may be the only reason that this lawsuit was successful.[43] The implication of the Oklahoma decision for cases that other states and local entities have filed since approximately 2015 is entirely unclear regardless of the ultimate outcome of the appeal.
A second opioid case was settled in 2019 just hours before going to trial in federal court in the Northern District of Ohio. Two Ohio counties, Summit and Cuyahoga, had filed suit against opioid distributors AmerisourceBergen, Cardinal Health, and McKesson as well as opioid manufacturer Teva Pharmaceuticals.[44] Instead of going forward with the trial, the distributors settled the case, pledging to pay a total of $215 million to the counties. Teva Pharmaceuticals agreed to provide $20 million in cash and an additional $25 million in medications to treat addiction and overdose. Since this case settled rather than going to trial, it does nothing to clarify questions of law for future litigants.[45] Furthermore, all four companies agreed to the settlement on the condition that they did not have to admit any wrongdoing.[46]
Although this federal settlement will provide badly needed funds for social services and medical costs to deal with the opioid crisis, it does little to shed light on the broader legal situation forming between the pharmaceutical industry and local governments. There are currently over 3,000 lawsuits filed in federal court by county, city, and tribal governments regarding prescription opioids.[47] The lawsuits have been consolidated into one massive lawsuit referred to the National Prescription Opioid Litigation (NPOL), which is situated in the Northern District of Ohio with Judge Dan Polster presiding. Judge Polster has publicly acknowledged that he would prefer that the parties actively work toward settlement and has rebuked the legislative and executive branches of the various governments involved in the lawsuits for failing to address the opioid epidemic earlier.[48]
The Competency of the Courts in Addressing the Opioid Epidemic
There are downsides to having the courts play such a prominent role in problems as complex and deep-rooted as the opioid epidemic, however. The tremendous scope and size of opioid-epidemic litigation have forced judges and the courts to resolve disputes that affect many parties beyond the listed litigants. In particular, the NPOL is of such a scale that a single court decision could drastically change the course of the entire pharmaceutical industry. In tort lawsuits, courts generally have two types of remedies available—monetary damages paid by defendants to plaintiffs along with injunctions (orders) issued by the court telling the defendant not to engage in certain activities (e.g., restrictions on marketing of opioids to medical professionals and/or consumers). State and federal legislatures have a much broader range of options such as creating and funding specific programs to assist the victims of opioid addiction, and these may be much more targeted and effective than the blunt instruments of monetary damages and injunctions. In addition, some remedies ordered by courts may have unintended consequences, such as limiting availability of potent palliative-care medications to individuals who actually need them or deterring (due to liability concerns) pharmaceutical companies from investing in further research that might yield more effective and/or less addictive alternatives to the prescription opioid medications currently on the market.
While courts are limited in their available remedies, plaintiffs’ attorneys also face limitations due to ethical rules that govern their conduct during litigation. Attorneys are required to zealously represent and seek the best results for the specific client or clients that they represent, rather than the best interests of others or society as a whole. In addition, when employed on a contingency-fee basis, an attorney’s compensation is determined by a set percentage of monetary damages obtained. This requirement means that non-monetary remedies such as injunctions against the industry to prevent future harm to others may not be in the interest of the attorney’s client, and settlements for monetary damages that directly benefit the attorney’s client are incentivized. These settlements are often reached before trial begins, preventing the public and the media from obtaining information on the industry’s practices through court proceedings. Settlements also often have conditions including non-disclosure agreements (in which the plaintiffs agree not to discuss any of the subject matter of the case with anyone as a condition for receiving payment) and non-disparagement clauses (in which the plaintiffs agree not to make any negative public statements about the defendants in the future as a condition for receiving payment). These conditions effectively prevent litigation from making information public, which limits opportunities to spur legislative or regulatory action through public airing of the defendants’ conduct and business practices.
The adversarial nature of the litigation process also prevents any reasonable possibility for consensus building. By its very nature, litigation is coercive. One party files a lawsuit, and the other party is forced to appear in court. At the end of litigation, there are winners and losers. Even alternative dispute resolution techniques such as mediation fail to reach the same type of consensus as the legislative process. Litigation does not allow for solutions where all parties can benefit in the same way that the legislative or rulemaking process can.
Where governments have filed large-scale suits against the opioid industry, they have done so in the hope that litigation will result in large-scale monetary awards that will fund court-ordered remedies that effectively mimic legislative action paid for by placing costs (through court-awarded damages) on businesses that allegedly caused the opioid epidemic rather than taxpayers in general. But imposing a “litigation tax” upon these corporations will likely cause them to simply pass these costs back to consumers, as the companies continue to provide products and services that consumers value. This transactional cost will ultimately raise the price of pharmaceuticals, as settling lawsuits or paying for damages simply becomes a cost of doing business for drug companies and distributors.
In addition to damage awards themselves, the litigation process—including the hiring of attorneys and scientific experts, discovery expenses, and other court fees and costs—is expensive for both the industry members already named in litigation and those expecting later filings. Once again, this cost imposed upon such corporations can be simply passed onto the consumers—often the same consumers that the litigation was filed to protect and defend. Unless the lawsuits result in long-term changes in corporate practices, they may ultimately only pass the costs from one set of injured parties to the next.
In addition to the expense of the litigation process, the judiciary may not be competent to provide long-term public funding to address public health and safety issues. Damages must be proven in court with evidence, and mere speculation as to future costs may not be enough to support a verdict on appeal. Furthermore, courts are reluctant to commit themselves to overseeing long-term remedies, preferring to bring a matter to closure with a single monetary award.
Finally, courts typically do not oversee how a plaintiff uses the funds after a court has ordered a monetary award. In the case of government-filed lawsuits against the opioid industry, there is little guarantee that cash-strapped governments will use the money received through a damage award or settlement for opioid relief at all, let alone use it in an effective manner to combat and ultimately end the opioid epidemic. Public class-action settlements or damage awards distributed to federal or state entities can easily be diverted in the budgeting process. If funds are not clearly earmarked for use in programs addressing the specific public-health concerns at issue in the litigation, the funds can be used to fill completely unrelated budget needs. Misdirection of such funds can occur years after the original award when parties and the public no longer have the time and attention to guard against such actions. In this sense, courts are limited in their ability to fashion effective relief and may simply end up shifting costs in a way that at best does little good for society, and at worst may actually increase costs to consumers and taxpayers.
The Appropriate Role of the Judiciary in Opioid-Addiction Policy Development
Although the judiciary may not be designed for public-policy development, some functions of the litigation process may ultimately aid in promoting the development of public policy through traditional legislative institutions. For instance, the judiciary is a competent body for the rigorous collection and examination of facts relevant to the litigation which can later be used in the legislative process. Rules of civil litigation, both in state and federal courts, provide for opportunities to gather information about problems otherwise hidden from the public. The discovery process allows for parties to demand that documents and other evidence be exchanged between the parties. It also requires that each party identify witnesses to provide depositions and other forms of testimony admitting facts and providing explanations. But judges can limit transparency through sealing documents (allowing them to be viewed only by the parties and the judge rather than the public), redactions (in which documents themselves may be exchanged but some information is blacked out or withheld), and other methods to maintain attorney-client privilege and litigant privacy. Rules of civil procedure limit discoverable information, and rules of evidence can prevent facts, even if unearthed and exchanged through the discovery process, from being introduced in court proceedings. Due to these rules, judicial proceedings are often decided using incomplete information that would be allowed in a legislative setting not bound by the rules governing trials.
The limitations of litigation discovery may be overcome when public scrutiny of an issue attracts media attention. Media investigation is not limited by the litigation filings and can allow broader discovery. Furthermore, the discovery process and media attention can embolden whistleblowers to emerge from the corporate shadows, providing even further information about hidden practices. The combination of judicial and media investigation can provide powerful tools that lead to increased transparency that are not available through either tactic alone.
State and federal opioid epidemic litigation has already resulted in substantial disclosures of corporate documents and testimony that have highlighted damaging practices in the pharmaceutical industry. The cases have also inspired whistleblowers and industry members to denounce past actions. This encouragement to disclose wrongdoings in turn fuels continued public outcry and ultimately can force legislators to take positive action.
In addition to rigorously collecting and examining facts, litigation requires that parties specifically identify causes of action and form arguments that can be tested through the adversarial process. Legal trials require disciplined thinking, exacting arguments, and ultimately proof that reaches the legal threshold for liability. In contrast, public legislative hearings increasingly have become venues for politicians to pontificate or provide “sound bites” for television and social media rather than effective questioning of witnesses or reasoned debate.
Opioid-epidemic litigation has forced the judiciary to engage in a rigorous analysis of both the causes and effects of the epidemic. Claims filed under tort law require the judiciary to examine carefully both the foreseeability of the epidemic due to corporate actions and the full scope of damages that result. This analysis can serve to educate the public on the relative culpability of corporate actors as well as to change public attitudes toward the victims of opioid addiction.
Next Steps in the Search for Justice
The search for justice for communities ravaged by the opioid epidemic continues as the COVID-19 pandemic complicated matters even further. Since the onset of COVID-19 in the United States, communities most vulnerable to opioid addiction have suffered massive disruption to their daily lives and economic livelihoods. In turn, there has been a significant increase in deaths from opioid overdose.[49] While the consequences of corporate action have intensified under pandemic conditions, the legal system dramatically slowed. Many court systems closed to the public, leaving them unable to docket civil cases for months and delaying access to justice and compensation for victims and communities impacted by the opioid crisis. Actions and orders in federal multidistrict litigation became sparse and inconsequential for over a year. As governmental entities focus on pandemic-related crises, there is simply less time and public attention available to demand justice for opioid victims and their communities. Even years after the courts reopened to the public, judges still struggle to clear backlogged dockets. The next steps are uncertain at this time; however, continuing to seek legal remedy seems inevitable in light of record-breaking opioid deaths, dwindling governmental resources, and an absence of legislative action.
Bibliography
Aliprantis, Dionisis, and Anne Chen. “The Opioid Epidemic and the Labor Market.” Federal Reserve Bank of Cleveland Economic Commentary, September 29, 2017.
Bennett, Alex S., et al. “Veterans' Health and Opioid Safety-Contexts, Risks, and Outreach Implications.” Federal Practitioner 32 (2015): 4-7. https://www.mdedge.com/fedprac/article/100225/addiction-medicine/veterans-health-and-opioid-safety-contexts-risks-and
Cavanagh, Ralph, and Austin Sarat. “Thinking about Courts: Toward and Beyond a Jurisprudence of Judicial Competence.” Law & Society Review 14 (1980): 371-420.
“Civil Law Torts.” The Law Dictionary. https://thelawdictionary.org/civil-law-torts-2/
Commonwealth of Kentucky v. Amerisource Bergen Drug Co., No. 18-CI-00167 (Floyd County Circuit Court, March 8, 2018).
Commonwealth of Kentucky v. Cardinal Health LLC, et al., Complaint, Jefferson County Circuit Court, February 19, 2018).
Commonwealth of Kentucky v. Endo Health Solutions, Inc., No. 17-CI-1147 (Franklin County Circuit Court, Nov. 6, 2017).
Commonwealth of Kentucky v. Insys Therapeutics, Inc. (Hardin County Circuit Court, November 19, 2018).
Commonwealth of Kentucky v. Johnson & Johnson, Inc. (McCracken County Circuit Court, April 18, 2018).
Commonwealth of Kentucky v. Mallinckrodt PLC, No. 18-CI-00381 (Madison County Circuit Court, April 18, 2018).
Commonwealth of Kentucky v. McKesson Corp., No. 18-CI-56 (Franklin County Circuit Court, May 23, 2019).
Commonwealth of Kentucky v. Teva Pharmaceuticals, USA, Inc., No. 18-CI-3767 (Fayette County Circuit Court, October 25, 2018).
Commonwealth of Kentucky v. Walgreens Boots Alliance, Inc., No. 18-CI-00846 (Boone County Circuit Court, June 14, 2018).
Douglas, Leslie L., Ba M. Djibril, Agbese Edeanya, Xing Xueyi, and Guodong Liu. “The Economic Burden of the Opioid Epidemic on States: The Case of Medicaid.” American Journal of Managed Care 25 (2019): 243-49.
Dowell, Deborah, Tom Haegerich, and Roger Chou. “CDC Guideline for Prescribing Opioids for Chronic Pain—United States.” MMWR Recommendations and Reports 65 (RR-1). March 18, 2016. https://www.cdc.gov/mmwr/volumes/65/rr/rr6501e1.htm
Dwyer, Colin. “Your Guide to the Massive (and Massively Complex) Opioid Litigation.” NPR. October 15, 2019. https://www.npr.org/sections/health-shots/2019/10/15/761537367/your-guide-to-the-massive-and-massively-complex-opioid-litigation
Erwin, Paul C., et al. “Neonatal Abstinence Syndrome in East Tennessee: Characteristics and Risk Factors among Mothers and Infants in One Area of Appalachia.” Journal
of Health Care for the Poor and Underserved 28 (2017): 1393-408.
Gluck, Abe R., Ashley Hall, and Gregory Curfman. “Civil Litigation and the Opioid Epidemic: The Role of Courts in a National Health Crisis.” Journal of Law, Medicine & Ethics 46 (2018): 351-66. https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3135410
Hoffman, Jan. “Johnson & Johnson Ordered to Pay $572 Million in Landmark Opioid Trial.” New York Times, August 26, 2019.
Hensler, Deborah R. “The New Social Policy Torts: Litigation as a Legislative Strategy—Some Preliminary Thoughts on a New Research Project.” DePaul Law Review 51 (2001): 493-510.
Leslie, Douglas L., Djibril M. Ba, Edeanya Agbese, Xueyi Xing, and Guodong Liu. “The Economic Burden of the Opioid Epidemic on States: The Case of Medicaid.” American Journal of Managed Care 25 (2019): 243-49.
Levasseur, A.A. “Legitimacy of Judges.” American Journal of Comparative Law 50 (2002): 43-85.
Lytton, Timothy D. “Should Government Be Allowed to Recover the Costs of Public Services from Tortfeasors? Tort Subsidies, the Limits of Cost Spreading, and the Free Public Services Doctrine.” SSRN, 10 July 2002. papers.ssrn.com/sol3/papers.cfm?abstract_id=314762
“Negligence Per Se Definition & Legal Meaning.” The Law Dictionary, n.d.https://thelawdictionary.org/negligence-per-se/
“Opioids in Appalachia: The Role of Counties in Reversing a Regional Epidemic.” National Association of Counties and the Appalachian Regional Commission, May 2019https://www.naco.org/sites/default/files/documents/Opioids-Full.pdf
Order Denying Motion to Dismiss, Commonwealth of Kentucky v. Cardinal Health LLC, No. 18-CI-001013 (Jefferson County Circuit Court, Sept. 12, 2019).
Order Denying Motion to Dismiss, Commonwealth of Kentucky v. Endo Health Solutions, Inc., No. 17-CI-1147 (Franklin County Circuit Court, July 10, 2018).
Order Denying Motion to Dismiss, Commonwealth of Kentucky v. Insys Therapeutics, Inc. (Hardin County Circuit Court, June 18, 2019).
Order Denying Motion to Dismiss, Commonwealth of Kentucky v. Johnson & Johnson, Inc. (McCracken County Circuit Court, Nov. 20, 2018).
Order Denying Motion to Dismiss, Commonwealth of Kentucky v. Teva Pharmaceuticals, USA, Inc. No. 18-CI-3767 (Fayette County Circuit Court, July 19, 2019).
Order Denying Motion to Dismiss, Commonwealth of Kentucky v. Walgreens Boots Alliance, Inc., No. 18-CI-00846 (Boone County Circuit Court, July 22, 2019).
“Overdose Deaths Accelerating During COVID-19.” Centers for Disease Control and Prevention, Centers for Disease Control and Prevention, 18 Dec. 2020, https://archive.cdc.gov/www_cdc_gov/media/releases/2020/p1218-overdose-deaths-covid-19.html
Price v. Purdue Pharma Co., 920 So. 2d 479, 486 (Miss. 2006).
Purcell, Michael J. “Settling High: A Common Law Public Nuisance Response to the Opioid Epidemic.” Columbia Journal of Law and Social Problems 52 (2018): 135-77.
Rigg, Khary K., et al. “Prescription Drug Abuse & Diversion: Role of the Pain Clinic.” Journal of Drug Issues 40 (2010): 681-702.
Shen, W. S. “Overview of the Opioid Litigation and Related Settlements and Settlement Proposals.” Congressional Research Service Legal Sidebar, November 25, 2019. https://crsreports.congress.gov/product/pdf/LSB/LSB10365
“Substance Use Disorders Among Military Populations.” Hazelden Betty Ford Foundation, n.d. https://www.hazeldenbettyford.org/education/bcr/addiction-research/substance-abuse-military-ru-518
Syrett, Keith. “Courts, Expertise and Resource Allocation: Is There a Judicial ‘Legitimacy Problem’?” Public Health Ethics 7 (2014): 112-22.
Van Zee, Art. “The Promotion and Marketing of Oxycontin: Commercial Triumph, Public Health Tragedy.” American Journal of Public Health 99 (2009): 221-27.
Weiss, Debra C. “$572M Verdict against Johnson & Johnson in Opioid Suit Is Based on Oklahoma's Unusual Public Nuisance Law.” ABA Journal, August 27, 2019.
Wiltz, Theresa. “Drug-Addiction Epidemic Creates Crisis in Foster Care.” PEW Charitable Trusts, October 7, 2016. www.pewtrusts.org/en/research-and-analysis/blogs/stateline/2016/10/07/drug-addiction-epidemic-creates-crisis-in-foster-care
[1] Dwyer, “Your Guide to the Massive Opioid Litigation.”
[2] Douglas et al., “The Economic Burden of the Opioid Epidemic.”
[3] Erwin et al., “Neonatal Abstinence Syndrome.”
[4] Ibid.
[5] National Association of Counties and ARC, “Opioids in Appalachia.”
[6] Wiltz, “Drug Addiction Epidemic.”
[7] Bennett, “Veterans' Health and Opioid Safety-Contexts,” 4.
[8] Aliprantis, “The Opioid Epidemic.”
[9] Commonwealth of Kentucky v. Endo Health Solutions, Inc., Complaint; Commonwealth of Kentucky v. Johnson & Johnson, Inc. et al., Complaint; Commonwealth of Kentucky v. Teva Pharmaceuticals, USA, Inc., Complaint.
[10] Ibid; Commonwealth of Kentucky v. Mallinckrodt PLC, Complaint.; Commonwealth of Kentucky v. Insys Therapeutics, Inc., Complaint.
[11] Ibid.
[12] Commonwealth of Kentucky v. Cardinal Health LLC, et al., Complaint.; Commonwealth of Kentucky v. Insys Therapeutics, Inc., Complaint.; Van Zee, "The Promotion and Marketing of OxyContin.”
[13] Commonwealth of Kentucky v. Cardinal Health LLC, et al., Complaint.; Commonwealth of Kentucky v. Walgreens Boots Alliance, Inc., Complaint.; Commonwealth of Kentucky v. AmerisourceBergen Drug Company, Complaint.
[14] Commonwealth of Kentucky v. Walgreens Boots Alliance, Inc., Complaint.
[15] Rigg, “Prescription Drug Abuse & Diversion,” 682.
[16] Hazelden Betty Ford Foundation, “Substance Use Disorders Among Military Populations.”
[17] Gluck, Hall, and Curfman, “Civil Litigation and the Opioid Epidemic,” 352.
[18] Ibid, 353.
[19] Price v. Purdue Pharma Co.
[20] Gluck, A. R.. “Civil Litigation and the Opioid Epidemic.”
[21] Commonwealth of Kentucky v. Insys Therapeutics, Inc., Complaint; Commonwealth of Kentucky v. Teva Pharmaceuticals, USA, Inc., Complaint.
[22] Ibid.
[23] Commonwealth of Kentucky v. Cardinal Health LLC, et al., Complaint; Commonwealth of Kentucky v. Walgreens Boots Alliance, Inc., Complaint.
[24] Ibid.
[25] The Law Dictionary, “Negligence Per Se.”
[26] Commonwealth of Kentucky v. Endo Health Solutions, Inc., Complaint; Commonwealth of Kentucky v. Johnson & Johnson, Inc. et al., Complaint; Commonwealth of Kentucky v. Teva Pharmaceuticals, USA, Inc., Complaint.
[27] Ibid.
[28] Commonwealth of Kentucky v. Insys Therapeutics, Inc., Order Denying Motion to Dismiss; Commonwealth of Kentucky v. Teva Pharmaceuticals, USA, Inc., Order Denying Motion to Dismiss; Commonwealth of Kentucky v. Walgreens Boots Alliance, Inc., Order Denying Motion to Dismiss.
[29] Commonwealth of Kentucky v. Cardinal Health LLC, et al., Order Denying Motion to Dismiss;
Commonwealth of Kentucky v. Endo Health Solutions, Inc., Order Denying Motion to Dismiss; Commonwealth of Kentucky v. Johnson & Johnson, Inc. et al., Order Denying Motion to Dismiss; Commonwealth of Kentucky v. Walgreens Boots Alliance, Inc., Order Denying Motion to Dismiss.
[30] The Law Dictionary, “Civil Law Torts.”
[31] Commonwealth of Kentucky v. Insys Therapeutics, Inc., Order Denying Motion to Dismiss; Commonwealth of Kentucky v. Teva Pharmaceuticals, USA, Inc., Order Denying Motion to Dismiss; Commonwealth of Kentucky v. Walgreens Boots Alliance, Inc., Order Denying Motion to Dismiss; Commonwealth of Kentucky v. Cardinal Health LLC, et al., Order Denying Motion to Dismiss; Commonwealth of Kentucky v. Endo Health Solutions, Inc., Order Denying Motion to Dismiss.
[32] Commonwealth of Kentucky v. Johnson & Johnson, Inc. et al., Order Denying Motion to Dismiss; Commonwealth of Kentucky v. McKesson Corporation, Order Denying Motion to Dismiss; Commonwealth of Kentucky v. Walgreens Boots Alliance, Inc., Order Denying Motion to Dismiss.
[33] Lytton, “Should Government Be Allowed to Recover Costs.”
[34] Commonwealth of Kentucky v. Endo Health Solutions, Inc., Order Denying Motion to Dismiss.
[35] Commonwealth of Kentucky v. Endo Health Solutions, Inc., Complaint.
[36] Ibid.
[37] Hoffman, “Johnson & Johnson Ordered to Pay.”
[38] Ibid.
[39] Ibid.
[40] Ibid.
[41] Ibid.
[42] Weiss, “$572M Verdict against Johnson & Johnson.”
[43] Ibid.
[44] Dwyer, “Your Guide to the Massive Opioid Litigation.”
[45] Ibid.
[46] Ibid.
[47] Ibid.
[48] Ibid.
[49] CDC, "Overdose Deaths Accelerating During COVID-19."
We use cookies to analyze our traffic. Please decide if you are willing to accept cookies from our website. You can change this setting anytime in Privacy Settings.