While the COVID-19 pandemic has consumed the field of public health since its onset in 2020, substance use disorder and the opioid crisis have continually plagued the United States for many years. Substance use disorder is a disease that “leads to an inability to control the use of a legal or illegal drug or medication.”[1] Since 1999, nearly 841,000 people have died from drug overdose, and as of 2019, 72.9% were opioid-related drug overdose deaths.[2]
Within this national health crisis, West Virginia leads the country in opioid-involved overdose deaths, with a rate of 42.4 deaths per 100,000 people in 2018.[3] Additionally, compared to the average national rate of 51.4 prescriptions per 100 people, West Virginia providers wrote 69.3 opioid prescriptions per 100 people, once again ranking the state as the highest rate in the country for 2018.[4] Researchers have cited “sociocultural factors, a depressed economy, lack of education, and a high rate of prescribing and dispensing of prescription opioids” as various reasons for the ongoing opioid epidemic in West Virginia.[5] To combat the opioid crisis in West Virginia, state legislators recently passed Senate Bill 334[6] to regulate Syringe Service Programs.[7] However, this bill will likely exacerbate the epidemic in the state.
In general, syringe service programs provide sterile injection equipment to reduce the spread of needle transmitted diseases, such as hepatitis C (“HCV”) and human immunodeficiency virus (“HIV”), amongst those who engage in improper injection techniques.[8] Syringe service programs also provide participants access to other resources, such as “vaccination, testing, linkage to infectious disease care and substance use treatment, and access to and disposal of syringes and injection equipment.”[9] These programs have successfully prevented the spread of infection throughout the country, leading to an estimated 50% reduction in HIV and HCV, and a two-thirds transmission reduction when combined with medication-assisted treatment.[10]
Regardless of such promising evidence about transmission reduction, West Virginia legislators proceeded to implement more restrictions on the state’s syringe service programs,[11] which will likely exacerbate the opioid epidemic in the state. Specifically, Senate Bill 334 requires participants to provide West Virginia identification before using any of the services from these programs in the state.[12] Identification requirements not only create a barrier between the in-state participants and providers, but they also create a barrier between out-of-state participants who also seek the help of the program providers.[13] Senate Bill 334 also requires existing syringe service providers to offer a “full array of harm reduction services,”—including “wellness checks, wound treatment from needle sticks, screening from communicable diseases, vaccination ability and counseling”—and if they do not offer the full range of these services, the providers are required to shut down their exchange service program altogether.[14] Lastly, the bill requires that syringe service programs must receive a license from the Office of Health Facility Licensure and Certification in West Virginia before they can provide assistance to those participants with substance use disorder.[15] All of these restrictions discourage participation in the programs, threaten to cut off avenues through which participants could access clean injection equipment, and further stymie the programs’ ability to timely respond to the participants’ needs. As a result, Senate Bill 334 will likely foster the improper exchange of syringes, exacerbate the spread of infectious diseases like HIV or HCV, and lead to more opioid-involved deaths in a state that is already deeply wounded from such realities.
The bill’s restrictions on syringe service programs not only present the aforementioned public health concerns, but the restrictions also present various legal concerns that must be addressed in turn. In Milan Puskar Health Right v. Crouch,[16] program providers claimed Senate Bill 334 violated their procedural due process rights, equal protection rights, and violated the constitution of West Virginia.[17] The providers also raised policy concerns, arguing that the bill would “result in fewer people accessing health services and fewer opportunities to prevent the spread of diseases including HIV, endocarditis, and Hepatitis C.”[18] However, the court determined the providers could only succeed on their equal protection claim.[19]
Regarding the equal protection claim, the providers argued that Senate Bill 334 was discriminatory in nature because it required existing providers to “cease and desist all operations unless it offers a ‘full array of harm reduction services,’”[20] while the bill exempted “new providers from ‘compliance with the provisions’ . . . until January 1, 2022” [21] and did not mention new providers having “harm reduction services or a license.”[22] The court held that the bill may be read to discriminate between new and existing providers.”[23] Because the state legislators did not offer a “rational basis” to justify such discrimination, the court concluded that the bill might violate the equal protection rights of the existing providers.[24] The potential discrimination between new and existing providers exemplifies how the bill overregulates syringe service programs in West Virginia. The different standards that new and existing providers must meet creates confusion within the functionality of such programs and may undermine the mission to prevent the spread of HIV or HCV by providing resources to those who suffer from substance use disorder. Therefore, Milan Puskar Health Right v. Crouch highlights another reason why Senate Bill 334 will likely worsen the opioid crisis in West Virginia.
Ultimately, the overregulation of syringe service programs in West Virginia establishes divergent standards that different programs must meet to provide services to its participants. Without a uniform approach to follow, these programs may become more chaotic and unable to effectively provide services to participants with substance use disorder. Therefore, Senate Bill 334 will likely exacerbate opioid-involved deaths and simultaneously increase the spread of opioid related infectious diseases, such as HIV or HCV. As the battleground for the opioid crisis, West Virginia must do better to implement effective solutions to eradicate the epidemic that has plagued the nation for far too many years.
In 2018, 128 people died every day from an opioid overdose, twenty-five percent of patients misused opioids prescribed for chronic pain, and approximately 1.7 million people developed a substance use disorder directly from prescription opioid use.[1] The effects were so devastating that the opioid epidemic was declared a national emergency.[2] In response, government officials and courts sought criminal and civil retribution to hold pharmaceutical executives responsible for their roles in the epidemic, most recently with the Racketeer Influenced and Corrupt Organizations Act (“RICO”).[3] When applied in the civil context, however, courts disagree on whether a fraudulent misrepresentation can satisfy the proximate cause requirements under RICO.[4] This Comment seeks to identify whether a misrepresentation of the addictive qualities of opioids would be a sufficient showing of proximate cause for a civil RICO claim to succeed and argues that such misrepresentations would be sufficient.
This Comment proceeds in five parts. Part I explains the progression of the opioid epidemic, pharmaceutical companies’ fraudulent misrepresentations, and the recovery options available to combat the epidemic—particularly RICO. Part II discusses RICO’s role in addressing fraudulent misrepresentations in the pharmaceutical industry. Part III describes the circuit split regarding fraudulent misrepresentations in civil RICO causation. Part IV analyzes the fraudulent misrepresentations that led to the opioid epidemic and argues that those misrepresentations are sufficient to establish proximate cause in a civil RICO claim. Part V recommends that the Supreme Court should grant certiorari on this issue and hold that misrepresentations of a drug’s harmful side effects are sufficient to show proximate cause in civil RICO cases.
I. Background
A. The United States Opioid Epidemic
The United States opioid epidemic is a major public health issue that has devastated the country’s social and economic welfare.[5] The epidemic began in the late 1990s when pharmaceutical companies began encouraging the medical community to prescribe prescription opioids to their patients.[6] During this time, pharmaceutical companies paid physicians to host informational seminars on drugs for their peers.[7] While hosting these events can be a positive source of information in the medical community, the speakers of these programs often received kickbacks to prescribe the drugs they were promoting.[8] The more prescriptions the physicians wrote, the more kickbacks they received.[9] By 2015, nearly fifty percent of physicians received kickbacks for prescribing pharmaceutical drugs.[10]
Often, physicians knew little about the drugs they were prescribing.[11] Pharmaceutical companies assured physicians of opioid safety, guaranteeing that patients would not become addicted.[12] As a result, physicians prescribed the drugs at high rates and quantities, leading to widespread addiction.[13] Newly addicted and reliant, patients soon turned to more potent drugs—like cocaine and heroin—culminating in the opioid epidemic now overtaking the United States.[14]
B. The History of Fraudulent Misrepresentations in the Pharmaceutical Industry
The pharmaceutical industry has a long history of systemic fraud related to the “testing, marketing, and distribution of dangerous pharmaceutical drugs.”[15] Throughout this history, pharmaceutical representatives have routinely concealed harmful side effects from physicians to convince them to prescribe dangerous drugs using “lies, bribes, and kickbacks.”[16] In fact, in the pharmaceutical industry, it is so common for physicians to be deceived about dangerous products “that it’s often dismissed as the equivalent of driving slightly over the speed limit.”[17]
Drug representatives are also targeted as these individuals are often offered large bonuses for selling harmful drugs.[18] For example, to increase sales of OxyContin, Purdue Pharma developed a “bonus system [that] encouraged sales representatives”[19] to use “any means necessary” to increase sales rates, even if it meant downplaying OxyContin’s addictive tendencies.[20] In this way, pharmaceutical manufacturers frequently engage in a “coordinated conspiracy to deceive the American public and the medical profession about the efficacy and safety of opioids.”[21]
C. RICO
In 2017, the federal government and state governments began to pursue criminal and civil retribution against pharmaceutical companies for their role in the opioid epidemic.[22] These entities often sought to recover for the economic harm they incurred due to increased rates of addiction in their communities.[23] While civil lawsuits were routinely unsuccessful early on, settlements have begun to increase in recent years, indicating their growing success.[24] For example, in 2007, Purdue Pharma settled in a civil suit with twenty-six states for $19.5 million.[25] In 2016, Cardinal Health and AmerisourceBergen, distributors of prescription opioids, did the same, settling with the State of West Virginia for $34 million.[26]
Generally, individual plaintiffs seeking damages for personalized injuries have also sought to recover via direct-injury lawsuits.[27] In the pharmaceutical context, direct-injury lawsuits “generally target opioid manufacturers for alleged misrepresentations during advertisement or opioid distributors for an alleged failure to monitor illicit distribution.”[28] When asserting direct-injury claims, plaintiffs generally rely on tort-based theories, one of which is RICO.[29]
RICO makes it “unlawful for any person employed by or associated with any enterprise . . . to conduct or participate, directly or indirectly, in the conduct of such [an] enterprise’s affairs through a pattern of racketeering activity” that affects interstate commerce.[30] To assert a RICO violation, a claimant must establish an “association-in-fact” enterprise, defined as a “group of persons associated together for a common purpose.”[31]To be a part of such an enterprise, a defendant must have either made decisions or intentionally performed acts that furthered the enterprise’s common purpose.[32]The enterprise’s common purpose must be “separate from the pattern of racketeering activity” that the enterprise is engaging in; otherwise, it will not amount to a RICO violation, only a general conspiracy to commit a crime.[33]
To establish a pattern of racketeering activity, there must be two or more acts that are “‘chargeable’ . . . under a host of state and federal laws,”[34] as well as interrelated, continuous, and occurring within a ten-year period.[35] Otherwise, the acts will be deemed “isolated” and will fail to constitute a pattern.[36] Furthermore, either the enterprise itself or the predicate acts of the enterprise must have a de minimis impact on interstate commerce.[37] This is generally a low threshold, as courts routinely find that most, if not all, economic behavior impacts interstate commerce.[38] Thus, to prosecute a defendant under RICO, a plaintiff must show that (i) a defendant performed two or more acts, (ii) those activities together formed a pattern of racketeering activity, (iii) the defendant benefitted from or participated in an enterprise, and (iv) the activities of that enterprise affected interstate commerce.[39]
II. RICO and the Pharmaceutical Industry
In the pharmaceutical context, defendants participate in a RICO enterprise when they give or follow a directive to engage in fraud or when they exert influence or control in a scheme to fraudulently profit from the sale of prescription drugs.[40] Thus, a RICO enterprise is formed when pharmaceutical companies conspire to misrepresent the efficacy and risks of opioids and opioid addiction.[41] While pharmaceutical executives are typically the easiest to implicate in such an enterprise, any person engaged in “false claims, kickback schemes, and acts of clinical and publication bias” are potential defendants for inclusion.[42]
A. Proving Causation in Civil RICO Claims
Standing to bring a civil RICO claim is stated under 18 U.S.C. § 1964(c).[43] Under the statute, a plaintiff has standing for a civil RICO claim when their injury (i) is to their business or property, and (ii) was caused “by reason of” the RICO violation.[44] The Supreme Court’s interpretation of “by reason of” requires the plaintiff to prove both proximate and but-for causation.[45] But-for causation asks whether the plaintiff’s injury would have occurred but for the defendant’s conduct.[46] Proximate causation serves to prevent liability when the link between the defendant’s conduct and the plaintiff’s injury has been severed.[47] Thus, proximate causation requires a plaintiff to show some sort of direct relationship between the defendant’s actions and the plaintiff’s injury.[48]
Holmes v. Securities Investor Protection Corp.[49] sets out three principles to guide the causation analysis[50]:
First, the less direct an injury is, the more difficult it becomes to ascertain the amount of a plaintiff’s damages attributable to the violation, as distinct from other, independent, factors. Second, . . . recognizing claims of the indirectly injured would force courts to adopt complicated rules apportioning damages among plaintiffs removed at different levels of injury from the violative acts, to obviate the risk of multiple recoveries. And, finally, the need to grapple with these problems is simply unjustified by the general interest in deterring injurious conduct, since directly injured victims can generally be counted on to vindicate the law as private attorneys general . . . .[51]
The first Holmes principle asserts that an injured party must be readily identifiable with readily apparent damages.[52] Damages are considered to be readily apparent when the action that caused the plaintiff’s injury has already occurred, because this negates the need for factual speculation.[53] The second principle requires damages to be awarded to the plaintiffs without fear that multiple parties will receive overlapping damages.[54] To conform with this principle, a court can award damages when only one party is seeking recovery for their payments towards a drug or when each individual plaintiff seeks only to recover for the damages they individually paid for a prescription drug.[55] Finally, the third principle requires that those most directly injured are bringing the suit; thus, the parties bringing the suit must be those best suited to do so.[56]
Since Holmes, however, the Supreme Court has eased the proximate cause standard for plaintiffs bringing RICO claims on mail and wire fraud.[57] In Bridge v. Phoenix Bond & Indemnity Co.,[58] the Court held that a plaintiff asserting a RICO claim on mail or wire fraud does not need to show that they relied on the defendant’s alleged misrepresentations to establish proximate cause.[59] As such, the plaintiff may recover whether or not they are the direct recipient of the false statements made.[60] But because a plaintiff must establish both but-for and proximate causation, they often still must show that someone relied on the defendant’s misrepresentation.[61]
B. Criminal RICO Application
In 2019, a Massachusetts court found John Kapoor (“Kapoor”), former executive of pharmaceutical company Insys, guilty of conducting a national scheme to pay physicians to prescribe a highly potent and addictive fentanyl-spray.[62] In Kapoor’s case, United States v. Michael Babich,[63] the Insys executives knowingly instructed physicians to prescribe the fentanyl-spray at six times the FDA-approved limit to guarantee patient reliance.[64] To ensure compliance, the executives held speaker programs disguised as “educational lunches and dinners,” which they used to pay bribes and kickbacks to high-prescribing physicians.[65] The Insys executives also targeted third-party payors (“TPPs”) using fake call centers to trick insurance companies into covering the spray at higher rates than they otherwise would have if they had known of the spray’s addictive tendencies.[66]
Kapoor and six other Insys executives were found guilty of racketeering, wire fraud, and mail fraud conspiracy, marking the “first successful prosecution of top pharmaceutical executives for crimes related to the illicit marketing and prescribing of opioids.”[67] As such, this case serves as the beginning of a new era in civil litigation to hold executives responsible for their role in the opioid epidemic.[68]
III. Conflicting Interpretations of Misrepresentations Under RICO
Several federal circuit courts have addressed the question of whether, in the civil context, fraudulent misrepresentation can satisfy the direct-injury requirements necessary to establish proximate cause under RICO.[69] The First, Third, and recently the Ninth Circuit have held that fraudulent misrepresentations can satisfy the direct-injury requirement, while the Second and Seventh Circuit have held that they cannot.[70] To date, the Supreme Court has not granted certiorari to resolve this issue.[71]
A. Fraudulent Misrepresentation as a Sufficient Assertion of Proximate Cause
Ninth Circuit
In Painters & Allied Trades District Council 82 Health Care Fund v. Takeda Pharmaceuticals,[72] the Ninth Circuit reviewed whether patients and TPPs can sufficiently meet the proximate cause requirements in a civil RICO claim when a pharmaceutical manufacturer fraudulently misrepresents a drug’s allegedly known safety risks.[73] There the defendants allegedly knew of and concealed that Actos, a drug prescribed to regulate blood sugar for Type II diabetics, increased a patient’s risk of developing bladder cancer.[74] The plaintiffs alleged that they would never have paid for or taken the drug if they had known of the risk of bladder cancer.[75]
The court concluded that the plaintiffs were the direct victims of the defendants’ alleged misrepresentations and therefore that the defendants’ fraudulent misrepresentations were directly related to the plaintiff’s harm.[76] Thus, the Ninth Circuit held that both patients and TPPs who paid for Actos could successfully meet the proximate cause requirements.[77] In so holding, the Ninth Circuit noted that because physicians commonly prescribe prescription drugs—like Actos—it is foreseeable that physicians would prescribe such a drug and therefore “play a causative role” in the defendant’s fraudulent scheme.[78] Accordingly, physician actions do not sever proximate cause.[79]
The Painters decision marked an express change of opinion for the Ninth Circuit.[80] Ten years prior, in 2009, the Ninth Circuit conversely found that misrepresentation claims could not successfully assert proximate cause in civil RICO claims.[81] Now, with the Ninth Circuit basing its decision on policy implications and societal interest, Painters introduces new considerations on the issue that cannot be ignored.[82]
First Circuit
In In re Neurontin,[83] the First Circuit considered whether the Kaiser Foundation (“Kaiser”) could recover for an alleged injury arising from Pfizer’s alleged fraudulent marketing of Neurontin for off-label uses.[84] Kaiser argued that Pfizer’s campaign explicitly targeted TPPs to influence formulary and prescribing decisions and encouraged physicians to serve on speaker’s bureaus and sponsor informational sessions to promote Pfizer drugs, while disguising bribe and kickback payments.[85] Through expert witness testimony, the court found that three out of ten Neurontin prescriptions made for such off-label uses would not have been written but for Pfizer’s fraudulent marketing scheme.[86] As such, the court held that Kaiser was a primary, intended, and direct victim that successfully met the proximate cause requirements under RICO.[87]
Third Circuit
In In re Avandia,[88] GlaxoSmithKline (“GSK”) marketed Avandia as a safer and more effective alternative to existing medications currently available for Type II diabetes treatment.[89] As a result, TPPs added Avandia to their formularies and covered Avandia prescriptions at preferred rates.[90] Soon after, however, risks arose regarding heart-related side effects, which GSK actively denied and countered despite knowledge to the contrary.[91]
The Third Circuit held that the presence of intermediaries did not sever proximate cause because the TPPs’ injury was a foreseeable result of GSK’s scheme.[92] Since TPPs covered the costs of Avandia directly because of GSK’s misrepresentations of Avandia’s risks, the TPPs were held to be intended and direct victims.[93] Thus, the court concluded that reliance on GSK’s misrepresentations was sufficient to allege proximate cause.[94]
B. Fraudulent Misrepresentation as an Insufficient Assertion of Proximate Cause
In a Seventh Circuit case, Sidney Hillman Health Center of Rochester v. Abbott Labs.,[95] Abbott Labs allegedly solicited physicians to prescribe Depakote, a drug approved to treat seizures and migraines, for off-label uses.[96] There the Seventh Circuit reasoned that because it would be too difficult to calculate the plaintiff’s damages due to unknown factors—some patients likely benefitted from taking Depakote for an off-label use, and some physicians would undoubtedly have prescribed Depakote for off-label uses regardless of solicitation—misrepresentations made to physicians fail the first Holmes factor and do not constitute a direct injury.[97] As such, the Seventh Circuit held that such misrepresentations cannot meet the proximate cause requirements of civil RICO claims.[98] Similarly, in UFCW Local 1776 v. Eli Lilly & Co.,[99] the Second Circuit concluded that a physicians’ reliance on misrepresentations is not a but-for cause of a drug’s higher price because physicians do not consider a drug’s price when they order prescriptions.[100] Thus, the Second Circuit held that fraudulent misrepresentations do not sufficiently establish proximate cause for a civil RICO claim.[101]
IV. Analysis
Painters, In re Avandia, and In re Neurontin discuss the issue of recovery for TPPs (and patients as well in the case of Painters) when dealing with fraudulent misrepresentations of a prescription drug’s harmful side effects.[102] These cases more closely align with the issues arising out of the opioid epidemic—as seen in Michael Babich—where pharmaceutical manufacturers and their executives fraudulently misrepresented the addictive qualities of opioids, in the form of a fentanyl-spray, resulting in economic injury to both patients and TPPs.[103]
A. The Opioid Epidemic Compared to Other Civil Applications
Like the pharmaceutical manufacturers in In re Avandia who falsely promoted Avandia as safe for use, the Insys executives in Michael Babich misrepresented the risks of the addictive qualities of their fentanyl-spray to ensure its coverage and use.[104] In In re Avandia, the pharmaceutical manufacturer knew of Avandia’s increased cardiac complications; in Michael Babich, the pharmaceutical manufacturer knew their fentanyl-spray risked addiction and misuse.[105] Like the pharmaceutical manufacturer in In re Avandia who promoted Avandia knowing its cardiac risks, the pharmaceutical executives in Painters also actively misled physicians, consumers, and TPPs to prescribe and use Actos despite knowing its risk for bladder cancer.[106] Thus, in all three cases, pharmaceutical manufacturers formulated schemes to misrepresent the harmful side effects of their touted drugs to increase prescription rates at the expense of patients and TPPs.
Michael Babich also mimicked these cases’ use of speakers’ bureaus and physician targeting. Both Michael Babich and In re Neurontin used speaker programs to target physicians with high prescription numbers and pay bribes and kickbacks to these physicians in exchange for increased prescription orders and dosages.[107] Furthermore, like Pfizer’s marketing scheme in In re Neurontin that actively targeted TPPs to add drugs to their formularies and influence prescribing decisions, Insys’ marketing scheme in Michael Babich targeted TPPs through the use of a fake call center that was used to guarantee insurance coverage of their fentanyl-spray.[108] In both cases, the use of these schemes directly targeted TPPs, causing them to prescribe more opioids than they otherwise would have prescribed.[109] In these ways, the facts of Michael Babich reflect those of Painters, In re Avandia, and In re Neurontin.
Thus, as the fraudulent misrepresentations presented in the aforementioned cases all constituted a direct injury,[110] it is likely that a civil RICO claim based on the fraudulent misrepresentations of the opioid epidemic would be successful. Therefore, opioid epidemic plaintiffs should bring civil—as well as criminal—suits when seeking retribution for their injuries caused by pharmaceutical companies’ fraudulent misrepresentations of the addictive qualities of opioids.
B. Analyzing the Proximate Cause Requirements of Civil RICO Claims
How Opioid Epidemic Plaintiffs Can Meet the Damages Attributable Requirement
In situations where plaintiffs can allege damages due to the failure to warn of a drug’s harmful side effects, damages are not based on factual speculation and are thus readily apparent.[111] In these situations, plaintiffs bring suit because they incurred an injury from taking a drug. To have such an injury, a plaintiff must have already taken the drug, meaning that their injury has already occurred and cannot be based on factual speculation. In the context of the opioid epidemic, a plaintiff brings suit asserting injury for the harm incurred from taking a drug with addictive characteristics. Because the factual scenario seen in the opioid epidemic falls squarely into this context, a plaintiff’s damages will be readily apparent and meet the damages attributable requirement.
Damages in these cases will also be readily determinable.[112] When a plaintiff’s injury is based on a fraudulent misrepresentation of a drug’s harmful side effects, the amount of damages attributable would amount to the difference between the cost of the injurious drug and the cost of a cheaper, alternative drug.[113] Thus, in the context of the opioid epidemic, the damages alleged would amount to the cost between what a patient, or TPPs, would have paid for an alternative drug and what they paid for the harmful drug prescribed. Because this amount is easily determinable, patients and TPPs would likely meet this requirement in any civil litigation arising from the opioid epidemic.
How Opioid Epidemic Plaintiffs Can Avoid Duplicative Recovery
In opioid epidemic cases, multiple parties, including patients and TPPs, will likely look to recover damages. In these cases, each individual plaintiff will be limited in what they can recover while still conforming with the second Holmes principle.[114] To ensure that there is no duplicative recovery, and thus no violation of the second principle, each plaintiff will only be able to recover damages for what they individually paid for a prescription drug.[115] Because both TPPs and patients will have incurred economic injury in a civil litigation suit, such a limitation is the only way to ensure compliance with the second Holmes principle and sufficiently assert proximate cause.[116]
How Opioid Epidemic Plaintiffs Can Meet the Direct-Injury Requirement
In civil opioid epidemic litigation, patients are directly injured parties because they incur financial and personal injury when they suffer harmful effects from using dangerous drugs.[117] Patients suffer financial injury in paying out-of-pocket for expensive, harmful drugs that often lead to complications and further health problems, including addiction and drug misuse. TPPs are directly injured parties that incur financial loss when they are targeted to add drugs to their formularies at preferred rates.[118] For the preceding reasons, TPPs and patients are the most directly injured parties of pharmaceutical companies’ fraudulent schemes to market and promote harmful drugs; thus, they are the best suited plaintiffs to bring suits against pharmaceutical companies. As such, both patients and TPPs would meet this third and final requirement in any future civil litigation related to the opioid epidemic.
C. Policy Considerations
Policy considerations further drive the argument in favor of allowing pharmaceutical companies’ fraudulent misrepresentations to sufficiently constitute proximate cause for patients and TPPs in civil RICO claims. For one, if courts hold that the causal chain is too attenuated to constitute proximate cause for TPPs and patients—like the Second and Seventh Circuits do—the implications would effectively allow pharmaceutical companies to avoid liability for their fraudulent marketing schemes.[119] In this way, pharmaceutical companies would be shielded from liability and permitted to hide behind the physicians who prescribed their drugs.[120]
For example, in the context of the opioid epidemic, such a holding would allow pharmaceutical companies to go unpunished for encouraging physicians to prescribe opioids at dangerous doses and rates. While arguably physicians should still be held liable for their own roles in the opioid epidemic, by not extending this same liability to pharmaceutical companies there would be no deterrence to stop pharmaceutical companies from engaging in these fraudulent schemes too. As such, pharmaceutical companies are likely to continue utilizing these harmful and fraudulent methods and will undoubtedly continue to use physicians as a proxy for engaging in such methods in the future if such actions are not met with liability.
Fraudulent misrepresentations should also be held to constitute proximate cause in civil RICO claims to allow plaintiffs to recover for their injuries. Patients and TPPs routinely incur economic injury in paying for expensive drugs.[121] Patients often incur additional financial harm when forced to sustain their habits.[122] For example, following the onset of addiction, patients must often pay to continue to use prescription opioids, or when prescription opioids are unavailable, they must pay for other drugs, such as heroin and cocaine.[123] When the financial harm stems from the patients’ continued use of prescription opioids, TPPs are also financially affected.[124] Since addiction to these drugs results in the need for continued use, permitting such recovery would allow patients and TPPs to obtain some compensation for the harms wrongfully inflicted upon them.[125] Therefore, pharmaceutical companies should not be allowed to cause such extreme harm and avoid responsibility,[126] especially when the societal harm caused by these misrepresentations far outweighs the corporate gains. Thus, for society to fully recover, adequate recovery must be allowed.
Ensuring liability would also allow trust to be restored in the medical system. Patients need to feel comfortable seeking care from their physicians. For this to occur, patients and other medical consumers must maintain a certain level of trust in the field of science and medicine. Patients need to feel that their physicians are prescribing them medications for their own betterment, not for the personal gain or profit of the prescribing physician. Thus, if pharmaceutical schemes, aimed to profit to the detriment of patients and TPPs, are ensured to be met with litigation, then pharmaceutical companies’ wrongful conduct will be deterred while increasing societal trust in the medical system.
Pharmaceutical executives must be held accountable before progress can be efficiently made. Allowing plaintiffs to satisfy the requirements of proximate cause in civil RICO claims will allow the largest societal benefit. Therefore, this position should be upheld in future civil litigation surrounding the opioid epidemic.
V. Recommendation
While pharmaceutical companies misrepresenting drugs to consumers and insurers to increase profits is certainly not a new occurrence, the opioid epidemic has arguably been the most widespread incidence of such an event. Because the opioid epidemic can affect anyone and everyone, the opioid epidemic is arguably one of the most transcendent public health issues that the United States has ever encountered. For this reason, the Supreme Court should grant certiorari on the issue of whether a fraudulent misrepresentation can constitute proximate cause in a civil RICO claim, especially regarding recovery for cases dealing with the opioid epidemic and the addictive tendencies of opioids.
The Supreme Court should grant certiorari on this issue because it is crucial for a uniform approach to be created and adhered to in the United States. If the Supreme Court denies certiorari and allows this issue to remain with the various circuits, then pharmaceutical companies could continue to avoid liability. Without a uniform approach, pharmaceutical companies can continue to bypass responsibility, establishing their companies in circuits that do not regard fraudulent misrepresentations as a sufficient means of causation in civil RICO claims. Thus, by failing to grant certiorari on this issue, the Supreme Court would be allowing pharmaceutical companies, and their executives, to avoid prosecution for their wrongful acts by allowing them the opportunity to reside in circuits with favorable precedent. Since the opioid epidemic affects every state on a national level, this sort of piecemeal approach across the circuits is not a suitable option; instead, the only way to truly curb these immense harms is with a uniform, national standard guaranteed to be consistently applied.
Should the Supreme Court grant certiorari to hear this issue of fraudulent misrepresentation as sufficient for proximate cause, the Court should follow the approach taken by the First, Third, and Ninth Circuits. Victims of the opioid epidemic have suffered. Not only have patients suffered physical injury, dealing with increased risk of disease or a newfound lifelong addiction, but patients have incurred financial injury in paying for drugs that not only did not ease their existing medical ailments, but also created new conditions that have further exacerbated their financial situations. States and local communities have also suffered economic injury. These communities have seen spikes in crime rates as consumers seek to maintain their habits and incur increased costs stemming from the need to provide treatment for their constituents. As such, if the Court grants certiorari on the issue, not only should it hold that fraudulent misrepresentations are enough to assert proximate cause, but it should also hold that patients, TPPs, state governments, and municipal communities are all victims of such misrepresentations, and thus, are entitled to recovery.
The Supreme Court should also hold that fraudulent misrepresentations should be sufficient allegations of proximate cause because of the effect that such a holding would have on the legal system moving forward. Allowing pharmaceutical companies to fraudulently misrepresent drugs at the peril of consumers and TPPs effectively contributes to the overburdening of the legal system. With fewer persons addicted to drugs that often lead to addiction of more potent drugs, such as heroin and cocaine, the crime rates in local communities would arguably decrease. With fewer crimes being committed by addicts attempting to maintain their habits, heavily impacted communities and the legal system would become less strained. As such, the deterrence of fraudulent misrepresentations of a harmful drug’s side effects, especially opioids, would have immense societal benefit. Thus, not only should the Court grant certiorari on this issue, but it should also hold that fraudulent misrepresentations of the addictive qualities of opioids are sufficient to allege proximate cause in civil RICO claims.
Conclusion
The opioid epidemic has recently subjected pharmaceutical companies to increased scrutiny, which will likely result in an uproar of future opioid epidemic litigation. Should this litigation arise, the Supreme Court should grant certiorari on the issue of whether fraudulent misrepresentations of the addictive qualities of opioids are sufficient to show proximate cause for civil RICO claims. Due to the policy considerations and societal implications the opioid epidemic has created, the Supreme Court should hold—as the First, Third, and Ninth Circuits have held—that misrepresentations of the addictive qualities of opioids are sufficient to show proximate cause for a civil RICO claim.
[2]. See Edgar Aliferov, Note, The Role of Direct-Injury Government-Entity Lawsuits in the Opioid Litigation, 87 Fordham L. Rev. 1141, 1142 (2018).
[3]. See 18 U.S.C. §§ 1961–1968.
[4]. Seeinfra Part III.
[5]. Societal costs soared in recent years, rising from roughly $55.7 billion in 2011 to $78.5 billion in 2016. Aliferov, supra note 2, at 1144; see also Nat’l Inst. on Drug Abuse, supra note 1.
[8]. Id. Hosting such events is not illegal until and unless physicians receive kickbacks in exchange for prescribing the drugs. Id. A kickback is any form of payment provided in exchange for an action or transaction that is usually illegal or improper. See What Is Kickback?, The Law Dictionary, https://thelawdictionary.org/kickback/#:~:text=Black’s%20Law%20Dictionary)-,What%20is%20KICKBACK%3F,job%2C%20contract%2C%20or%20order (last visited Aug. 24, 2021) (defining kickback as “a bribe for routing a job, contract, or order.”).
[15]. Eugene McCarthy, A Call to Prosecute Drug Company Fraud as Organized Crime, 69 Syracuse L. Rev. 439, 442 (2019).
[16]. Id.
[17]. Id. at 478 (quoting Stephanie M. Greene, After Caronia: First Amendment Concerns in Off-Label Promotion, 51 San Diego L. Rev. 645, 648 (2014) (internal citation omitted)).
[18]. McCarthy, supra note 15, at 478.
[19]. Id. (brackets in original source) (quoting Art Van Zee, The Promotion and Marketing of OxyContin: Commercial Triumph, Public Health Tragedy, 99 Am. J. Pub. Health 221, 222 (2009)).
[20]. Id. (quoting Zee, supra note 19, at 222).
[21]. Richard Ausness, The Current State of Opioid Litigation, 70 S.C. L. Rev. 565, 586 (2019) (quoting Complaint and Demand for Jury Trial at 135, City of Lansing v. Purdue Pharma L.P., No. 1:17-CV-01114 (W.D. Mich. Dec. 19, 2017)).
[22]. See Aliferov, supra note 2, at 1152–53, 1155.
[23]. Id. at 1144.
[24]. Id. at 1152.
[25]. Id.
[26]. Id. at 1153–54 (noting that Cardinal Health was sued for its failure to monitor suspicious orders for opioids, which West Virginia argued “facilitated the operation of pill mills throughout the state”). Cardinal Health agreed to pay $20 million of the $36 million settlement. Id. at 1154 n.94.
[27]. See, e.g., id. at 1156–57 (“When initiated by a party other than the government, a direct-injury claim is simple: a plaintiff’s personal interests (e.g., health or property) have been injured by a third party and the plaintiff seeks to recover damages flowing from that injury.”).
[28]. Id. at 1156.
[29]. See generally id. at 1160 (noting that “plaintiffs employ either a tort-based theory or equitable theory to complete the direct-injury claim” and subsequently referencing the various tort theories, including RICO). While RICO was enacted primarily to combat organized crime, its use in other contexts—including the opioid epidemic—has grown substantially, particularly because of its ability to “prosecute an entire criminal enterprise and its constituent members at once.” McCarthy, supra note 15, at 471, 441.
[30]. 18 U.S.C. § 1962(c).
[31]. In re Nat’l Prescription Opiate Litig., No. 1:17-md-2804, 2019 WL 4279233, at *2 (N.D. Ohio Sept. 10, 2019) (quoting Boyle v. United States, 556 U.S. 938, 946 (2009)).
[32]. Id. at *3; see also 18 U.S.C. § 1962(c) (stating that defendants must participate “directly or indirectly”).
[33]. In reNat’l Prescription Opiate Litig., 2019 WL 4279233, at *2 (quoting Frank v. D’Ambrosi, 4 F.3d 1378, 1386 (6th Cir. 1993)).
[34]. David Farve et al., Racketeer Influenced and Corrupt Organizations, 57 Am. Crim. L. Rev. 1191, 1195, 1197 (2020) (quoting Nat’l Org. for Women, Inc. v. Scheidler, 510 U.S. 249, 256–57 (1994)).
[35]. Id. at 1197. Such acts could include murder, robbery, bribery, extortion, or federal offenses involving bankruptcy or securities fraud. Id. at 1195–96. In the criminal context, the required acts that amount to racketeering activity can also include “mail fraud, wire fraud, insurance fraud, false claims, and honest services fraud.” McCarthy, supra note 15, at 465.
[36]. Farve et al., supra note 34, at 1197–98.
[37]. Id. at 1207.
[38]. McCarthy, supra note 15, at 466.
[39]. Farve et al., supra note 34, at 1194.
[40]. McCarthy, supra note 15, at 476. In the pharmaceutical context, “[pharmaceutical] [e]xecutives, sales representatives, doctors, lawyers, and politicians” often make up such enterprises. Id.
[41]. See, e.g., In re Nat’l Prescription Opiate Litig., No. 1:17-md-2804, 2019 WL 4279233, at *3 (N.D. Ohio Sept. 10, 2019) (holding that the plaintiffs “produced sufficient evidence for a reasonable jury to conclude that all [d]efendants . . . associated together for the common purpose of expanding the prescription opioid market,” thereby forming a RICO enterprise).
[42]. McCarthy, supra note 15, at 477–78.
[43]. 18 U.S.C. § 1964(c); Painters & Allied Trades Dist. Council 82 Health Care Fund v. Takeda Pharmas., 943 F.3d 1243, 1248 (9th Cir. 2019).
[44]. 18 U.S.C. § 1964(c); Painters, 943 F.3d at 1248.
[45]. Painters, 943 F.3d at 1248 (citing Holmes v. Sec. Inv. Prot. Corp., 503 U.S. 258, 268 (1992)).
[46]. Ausness, supra note 21, at 595 (asking “whether the injury would have occurred in the absence of the defendant’s conduct”).
[47]. Id. at 599. In Ashley County v. Pfizer, Inc., drug companies selling over-the-counter cold medicines used to produce methamphetamine were said not to have proximately caused the counties’ increased costs even though they knew the medicine would be used to make methamphetamine. 552 F.3d 659, 662–73 (8th Cir. 2009). The court held that the act of selling cold medicine was “totally independent” from the defendant’s production of methamphetamine. Id. at 670; see also Ausness, supra note 21, at 599–600 (discussing the Ashley County opinion).
[48]. Holmes, 503 U.S. at 268.
[49]. 503 U.S. 258.
[50]. See id. at 269.
[51]. Id. at 269–70 (citations omitted).
[52]. Id. at 269.
[53]. In re Avandia Mktg., Sales, Pracs. & Prod. Liab. Litig., 804 F.3d 633, 640 (3d. Cir. 2015); see also Sidney Hillman Health Ctr. of Rochester v. Abbott Labs, 873 F.3d 574, 577 (7th Cir. 2017). In Sidney Hillman, the plaintiffs’ claim was too speculative to meet the first Holmes requirement. 873 F.3d at 577. The court held that it was too difficult for the court to determine whether TPPs would have incurred costs from paying for another medication or whether physicians would have prescribed the drug for off-label uses without solicitation; thus, there was too much speculation for the damages to be readily apparent. Id.
[54]. Holmes, 503 U.S. at 269.
[55]. In re Neurontin Mktg. & Sales Pracs. Litig., 712 F.3d 21, 37 (1st Cir. 2013); Painters & Allied Trades Dist. Council 82 Health Care Fund v. Takeda Pharms., 943 F.3d 1243, 1251 (9th Cir. 2019).
[56]. In re Neurontin, 712 F.3d at 38.
[57]. Farve et al., supra note 34, at 1235.
[58]. 553 U.S. 639 (2008).
[59]. Id. at 649 (citing Anza v. Ideal Steel Supply Corp., 547 U.S. 451, 476 (2006) (“Because an individual can commit an indictable act of mail or wire fraud even if no on relies on his fraud, he can engage in a pattern of racketeering activity . . . without proof of reliance.”)).
[60]. See id. at 656. The RICO statute “provides no basis for imposing a first-party reliance requirement.” Id. at 660.
[63]. First Superseding Indictment, supra note 62 at 16.
[64]. Id. at 25–26. This was especially dangerous due to the potency of the fentanyl-spray; if the fentanyl-spray was prescribed at the same dosage as other fentanyl-based products on the market, then the patient could risk a fatal overdose. Id. at 10.
[71]. See Sergeants Benevolent Assoc. Health & Welfare Fund v. Sanofi-Aventis U.S. LLP, 137 S. Ct. 140 (2016).
[72]. 943 F.3d 1243 (9th Cir. 2019).
[73]. Id. at 1252–53.
[74]. Id. at 1246 (alleging that defendants misrepresented the risk of bladder cancer to increase sales of Actos).
[75]. Id. at 1247, 1251.
[76]. Id. at 1251.
[77]. Id. at 1252 (reasoning that “all patients and TPPs who paid for Actos on the premise that it did not cause an increased risk of bladder cancer were allegedly defrauded by Defendants and suffered the same direct, economic injury: payments for a drug which would not have been purchased if suitably described”).
[78]. Id. at 1257.
[79]. Id.
[80]. See generallyIn re Epogen & Aranesp Off-Label Mktg. & Sales Pracs. Litig., No. MDL 08-1934 PSG, 2009 WL 1703285 (Cal. June 17, 2009) (detailing the contrary holding).
[81]. See In re Epogen, 2009 WL 1703285, at *7–8.
[82]. See Painters, 943 F.3d at 1257–59 (discussing the benefits of deterring wrongful conduct and allowing economic recovery for victims).
[83]. 712 F.3d 21 (1st Cir. 2013).
[84]. Id. at 25–26.
[85]. Id. at 28.
[86]. Id. at 30.
[87]. Id. at 37–38.
[88]. 804 F.3d 633 (3d Cir. 2015).
[89]. Id. at 635.
[90]. Id.
[91]. Id. at 635–36.
[92]. Id. at 645.
[93]. Id.
[94]. Id.
[95]. 873 F.3d 574 (7th Cir. 2017).
[96]. Id. at 575. While physicians can prescribe medications to their patients to treat off-label conditions, drug manufacturers are prohibited from promoting drugs for such purposes. Id.
[97]. Id. at 577; see also Holmes v. Sec. Inv. Prot. Corp., 503 U.S. 258, 269 (1992).
[98]. Sidney Hillman, 873 F.3d at 578.
[99]. 620 F.3d 121 (2d Cir. 2010).
[100]. Id. at 133–34.
[101]. Id. at 134.
[102]. See supra Part III.A. Sidney Hillman and UFCW deal with fraudulent promotions of “off-label” uses and pricing decisions rather than a fraudulent failure to warn of a drug’s known risk of harmful side effects. See supra Part III.B.
[103]. See First Superseding Indictment, supra note 62, at 7–8.
[104]. See id. at 26–27; see also Kuchler et al., supra note 67; Emanuel, supra note 62; In re Avandia Mktg., Sales, Prac. & Prod. Liab. Litig., 804 F.3d 633, 635 (3d Cir. 2015).
[105]. See First Superseding Indictment, supra note 62, at 7–8, 26–27; In re Avandia, 804 F.3d at 635.
[106]. See Painters & Allied Trades Dist. Council 82 Health Care Fund v. Takeda Pharmas., 943 F.3d 1243, 1246 (9th Cir. 2019).
[107]. See First Superseding Indictment, supra note 62, at 17–18, 20 (quoting Burlakoff telling a sales representative “[t]hey do not need to be good speakers, they need to write a lot of . . . [prescriptions for the Fentanyl-Spray]”); In re Neurontin Mktg. & Sales Prac. Litig., 712 F.3d 21, 28 (1st Cir. 2013).
[108]. SeeIn re Neurontin, 712 F.3d at 40; Emanuel, supra note 62; seealso First Superseding Indictment, supra note 62, at 32–33 (misleading insurers as to their employment, patient diagnoses, and past medications used).
[109]. In re Neurontin, 712 F.3d at 40; First Superseding Indictment, supra note 62, at 20–22, 27, 30–31.
[110]. See supra Part III.A.
[111]. See In re Avandia Mktg., Sales, Prac. & Prod. Liab. Litig., 804 F.3d 633, 640 (3d Cir. 2015).
[112]. See supra notes 52–53 and accompanying text.
[113]. In reAvandia, 804 F.3d at 644.
[114]. See Holmes v. Sec. Inv. Prot. Corp., 503 U.S. 258, 269–70 (1992); see alsosupra notes 54–55 and accompanying text.
[115]. Painters, 943 F.3d at 1251–52; see also In reNeurontin, 712 F.3d at 37.
[116]. In re Avandia, 804 F.3d at 645–46; Painters, 943 F.3d at 1251–52.
[117]. See, e.g., Painters, 943 F.3d at 1251–52. It does not matter if some plaintiffs incurred extra or less harm from taking a drug that has harmful benefits; all patients are held to suffer the same direct economic injury. Id.
[118]. In In re Avandia, the court noted that TPPs are held to “suffer[] direct economic harm when, as a result of [a pharmaceutical company’s] alleged misrepresentations, they pa[y] supracompetitive prices for [brand drugs] instead of purchasing lower-priced generic [drugs].” In reAvandia, 804 F.3d at 639–40 (citing In re Warfarin Sodium Antitrust Litig., 391 F.3d 516, 531 (3d Cir. 2004)).
[119]. Painters, 943 F.3d at 1257.
[120]. Id.
[121]. See, e.g., id. at 1252 (discussing how patients and TPPs suffered economic injury paying for the drug Actos, which they would not have purchased if not for the fraudulent misrepresentation).
[122]. See generally Nat’l Inst. on Drug Abuse, supra note 1 (discussing the “total ‘economic burden’ of prescription opioid misuse . . . including the costs of healthcare, lost productivity, addiction treatment, and criminal justice involvement”).
[123]. See id. (stating that roughly five percent of those who developed an opioid addiction transitioned to heroin and roughly eighty percent of those who use heroin misused opioids before using heroin).
[124]. See, e.g., In re Neurontin Mktg. & Sales Prac. Litig., 712 F.3d 21, 38–39 (1st Cir. 2013) (showing that TPPs incur injury from paying for additional prescriptions due to fraudulent marketing schemes).
[125]. Id.
[126]. Id. at 38–39.
*. J.D. Candidate 2022, Wake Forest University School of Law. Shannon would like to thank the Wake Forest Law Review Board and Staff for their hard work and time on this Comment. She would also like to thank her family and friends for their unyielding support and encouragement.
According to the National Institute on Drug Abuse (“NIDA”), more than 130 people in the United States die every day from overdosing on an opioid drug.[1] The Centers for Disease Control and Prevention (“CDC”) reports that 68% of the over 70,200 deaths by drug overdose in 2017 were from an opioid.[2] Additionally, the CDC estimates the total economic burden per year in the United States is to the tune of $78.5 billion on just prescription opioid abuse.[3] In 2017, the US Department of Health and Human Services (“HHS”) declared that the opioid epidemic was a public health emergency.[4] Since then, over a billion dollars have been granted to community health centers to treat and research opioid addiction through the HHS.[5]
The alphabet soup of federal agencies are not the only actors on this stage attempting to treat the problem; states have also tried to prescribe their own remedies to societies’ new addiction.[6] As states scramble to find ways to staunch the hemorrhage of avoidable deaths via opioid abuse, North Carolina has breathed new life into a specter of the 1980s, leftover from the War on Drugs.[7] On December 1, 2019, North Carolina’s “death by distribution” law went into effect, which attempts to help fix the crisis by imposing felony convictions on illegal distributors of certain categories of drugs, when those drugs result in the death of their user.[8] Unfortunately, this new “death by distribution” law looks to be a very small solution for a very large problem.
To understand why this fix is so small, consider the cause of the epidemic. It has been widely reported and accepted that the opioid epidemic’s “patient zero” was over-prescription of opioid painkillers in the late 1990s, which led to rampant misuse by patients due to the extremely addictive properties of these painkillers.[9] NIDA reports that between 21% and 29% of patients prescribed opioids for pain relief misuse them, and 8% to 12% of that pool of patients develop a “use disorder.”[10] Out of the original 21% to 29% of people who misuse prescription opioids and ostensibly included in the 8% to 12% of “use disorder” cases, 4% to 6% transition to heroin abuse.[11] Roughly 80% of heroin users initially were misusing prescription opioids.[12]
Now consider what this “death by distribution” law criminalizes. First, while one might intuit “distribution,” the elements of both death by distribution[13] and aggravated death by distribution[14] explicitly state “[t]he person unlawfully sells at least one certain controlled substance.” Not any kind of distribution is criminalized, only sales of certain controlled substances.[15] The statute later defines what kinds of drugs are included as “certain controlled substances,”[16] as well as “lawful distribution” in a way to allow medical professionals to issue valid prescriptions for a legitimate medical purpose, and to allow for pharmacies to dispense, deliver, or administer controlled substances.[17]
Second, both regular and aggravated charges require
that “ingestion of the certain controlled substance causes the death of
the user.”[18]
Third, the sale of the certain controlled substance has to be the proximate
cause of the victim’s death.[19]
Fourth, the seller must not have acted with malice.[20]
The aggravated flavor of the charge includes an additional fifth element that
essentially requires the seller to have a previous conviction of this or
another drug distribution or trafficking crime.[21]
What this law does, in essence, is push the illegal sale of certain categories
of drugs from a Class I, H, or G felony[22]
to a Class C or B2[23]
felony if a person dies from overdose. Two questions arise after a review of
this law: will North Carolina’s flavor of drug-induced homicide statute have
any meaningful impact on the opioid epidemic,[24]
and how does a prosecutor even go about proving all the elements of the crime?
Drug-induced homicide statutes began creeping into the criminal codes of various states in the 1980s to combat the growing use of crack cocaine;[25] North Carolina’s death by distribution law even covers cocaine and its derivatives as the sole stimulant in a long list of depressants.[26] The idea behind these statutes was that big distributors and traffickers would be able to be charged for the deaths of their customers.[27] In reality, the people often caught by these drug-induced homicide statutes were friends, family members, or caretakers sharing drugs with one another.[28] The North Carolina statute is thus very clever in specifying a sale of a drug instead of mere distribution, as it ostensibly will avoid this unfortunate outcome. Unfortunately, clever avoidance of an overbreadth problem doesn’t speak to its efficacy as a solution to the opioid epidemic. Remember that the cause is over-prescription and subsequent abuse of painkillers.[29] While this law may help the people who’ve moved on to heroin or other illegal opioids by virtue of closing down the avenues for its distribution, it does nothing to address the problem of abuse with legally obtained opioids.[30]
The bigger issue with drug-induced homicide laws is proving the actual offense.[31] Drug-induced homicide laws do have two distinct advantages in that category; they do not have a mens rea requirement and operate as a strict liability offense, and they often do not have a proximate cause or foreseeability element.[32] North Carolina’s death by distribution law is similar in that it has no mens rea element in either the standard nor the aggravated offense, but both offenses explicitly incorporate a proximate cause requirement.[33] This introduces concepts of foreseeability and/or intervening or superseding causation into the statute,[34] which can significantly muddy an otherwise straightforward case. What if the buyer of a drug intentionally overdoses as a form of suicide?[35] What if the victim overdosed by taking a mixture of Vicodin and LSD?[36] The explicit statutory language requires that “[t]he ingestion of the certain controlled substance or substances cause[] the death of the user;”[37] what if a drug dealer sells oxycontin to a driver who dies in a car accident while high? This is ignoring the difficulty in locating and proving that a specific dealer sold the specific drug to a specific person who overdosed on that specific drug: what if the victim has more than one dealer of the same product? Ultimately, these are all fact-intensive inquiries for a jury to resolve, which introduces a large degree of unpredictability into any death by distribution case.
Besides unpredictability, there are other factors that
make the death by distribution law unworkable. The administrative costs to
secure toxicology reports and get experts to testify as to the drugs within the
victim’s systems brings with it a higher administrative cost to prosecute.[38]
There is also the greater financial burden on the state to incarcerate dealers
for four to fifteen years instead of less-than-one to three years. All these
costs go to remedy a symptom, not the actual disease underlying the opioid
epidemic. People affected by the opioid epidemic deserve better solutions than
a stopgap relic from the 1980s. The death by distribution law will be simply ineffective.
[7]
Valena E. Beety, Drug Enforcement & Health Policy in Today’s Epidemic:
Prosecuting Opioid Use, Punishing Rurality,
80 Ohio St. L.J. 741, 757–58 (2019).
[13]
N.C. Gen. Stat. § 14-18.4(b)(1)
(2019) (“Death by Distribution of Certain Controlled Substances”) (emphasis
added).
[14]
N.C. Gen. Stat. § 14-18.4(c)(1)
(2019) (“Aggravated Death by Distribution of Certain Controlled Substances”)
(emphasis added).
[15]
N.C. Gen. Stat. § 14-18.4(b)(1),
(c)(1) (2019).
[16]
N.C. Gen. Stat. § 14-18.4(d)
(2019) (“ . . . [A]ny opium, opiate, or opioid; any synthetic or natural salt,
compound derivative, or preparation of opium, opiate, or opioid; cocaine or any
other substance described in [the list of cocaine derivatives]; methamphetamine;
a depressant described in [the list of Schedule IV depressants]; or a mixture
of one or more of these substances.”)
[22]
N.C. Gen. Stat. § 90-95(b) (2019)
(depending on what schedule the drug is on).
[23]
N.C. Gen. Stat. § 14-18.4(h)
(2019) (criminalizing death by distribution as a Class C felony and aggravated death
by distribution as a Class B2 felony).
[30]
This may be intentional, however, as the STOP Act of 2017 explicitly targeted
legally prescribed opioids and tightened how they are to be prescribed by
pharmacists and physicians; the electronic prescription requirement of the act
came into effect just this year. Bill Summary, N.C. Medical Board, https://www.ncmedboard.org/images/uploads/article_images/The_STOP_Act_summary-OnLetterhead.pdf
(last revised June 30, 2017).
[31]
Hailey Varner, Note, Chasing the Deadly Dragon: How the Opioid Crisis in the
United States Is Impacting the Enforcement of Drug-Induced Homicide Statutes,
19 U. Ill. L. Rev. 1799, 1824
(2019).
[32]
Alex Kreit, Drug Enforcement & Health Policy in Today’s Epidemic: The
Opioid Crisis and the Drug War at the Crossroads, 80 Ohio St. L.J. 887, 896–97 (2019).
[33]
N.C. Gen. Stat. § 14-18.4(b)(3),
(c)(3) (2019).
[34]
Beety et al., supra note 25, at 725–27 (explaining the effect of proximate
cause and intervening cause doctrine on drug-induced homicide charges).
[35]
Kreit, supra note 32, at 897 (noting that at least one federal district
court judge stated that suicide through heroin overdose met a death by homicide
statute’s terms, which did not have a proximate cause element).
[36]
LSD is not covered by the Death by distribution statute.
[37]
N.C. Gen. Stat. § 14-18.4(b)(2),
(c)(2) (2019).
[38]
According to some commentators, the point of these kinds of laws isn’t even to
prosecute them; they’re just a scare tactic to force caught dealers into a plea
agreement. Beety, supra note 7, at 758–59.
As
Walter Bender, Deputy Sheriff in Montgomery County, Ohio stated: “[O]pioids
reach every part of society: blue collar, white collar, everybody. It’s
nonstop. It’s every day. And it doesn’t seem like it’s getting any better.”[1] It
is estimated that forty-six people die from opioid overdoses involving
prescription opioids every day, with methadone, oxycodone, and hydrocodone
being the most common drugs involved in these deaths.[2] It
is further estimated that 4-6% of people who misuse prescription opioids switch
to using heroin.[3]
These few statistics[4]
paint a dire picture: there is an opioid epidemic and we need help.
To that
end, states, counties, and towns have filed lawsuits against big pharmaceutical
companies, seeking to hold them responsible for the opioid epidemic and receive
financial assistance to help pay for some of the astronomical costs inflicted
by the scale of the opioid crisis.[5]
One such case involved the State of Oklahoma suing major pharmaceutical
companies (including Purdue, Teva, and Johnson & Johnson) under a public
nuisance theory.[6]
Purdue and Teva both settled prior to trial for $270 and $85 million,
respectively.[7]
However, Johnson & Johnson proceeded to trial, where they were handed a
$572 million verdict on 26 August 2019 for deceptively marketing opioids and
contributing to the opioid crisis.[8]
This
verdict was splashed across television screens and newspapers when it was first
rendered, with the underlying facts and findings of the case interestingly providing
a bird’s eye view of how involved the pharmaceutical companies were in
manufacturing this crisis. In seeking relief in state court, Oklahoma’s sole
claim was that the pharmaceutical companies caused a public nuisance and the
State sought abatement of that nuisance.[9] It
was undisputed that in 2015, there were enough opioids prescribed in Oklahoma
for each adult to have 110 pills.[10]
Further, “[i]n 2017, 4.2% of babies born covered by SoonerCare [Oklahoma’s
state Medicaid] were born with Neonatal Abstinence Syndrome . . . a group of
conditions caused when a baby withdraws from certain drugs [that] it’s exposed
to in the womb before birth.”[11]
Oklahoma is a microcosm of the epidemic ravaging the United States.
In
finding Johnson & Johnson caused a public nuisance, Judge Thad Balkman ruled
that Johnson & Johnson “marketed, promoted and sold opioid drugs in Oklahoma”
since the mid-1990s.[12] The
judgment devotes a few pages to discussing Johnson & Johnson’s subsidiary
companies. As part of a “pain management franchise,” Johnson & Johnson was owned
two subsidiary companies, Tasmanian Alkaloids Limited and Noramco, Inc., from
the 1990s through at least 2016.[13]
Tasmanian Alkaloids, based in Tasmania (a province of Australia), “cultivated
and processed opium poppy plants to manufacture narcotic raw materials” that
were imported into the United States and processed by Noramco.[14] Anticipating
demand for opioids, in 1994, Tasmanian Alkaloids developed a “high thebaine”
opium poppy plant to “enable[] the growth of oxycodone.”[15] Noramco
subsequently processed these raw materials into the active pharmaceutical
ingredients used in opioids and supplied both Johnson & Johnson and other
pharmaceutical companies with these active ingredients.[16]
Johnson & Johnson maintained these subsidiaries to “ensure a reliable
source of [narcotic] raw materials” and “security of supply.”[17]
Shrouded
behind a positive public image as the maker of familiar products like Band-Aids
and baby powder, Johnson & Johnson was, and still is, a major player in the
opioid supply business. Judge Balkman found that Noramco was used by Johnson
& Johnson to supply the top seven generic drug companies with active
pharmaceutical ingredients used in opioid manufacturing.[18]
Specifically, Noramco provided other manufacturers with “oxycodone,
hydrocodone, morphine, codeine, buprenorphine, hydromorphone, and naloxone.”[19]
Eventually, Noramco “grew to become the No. 1 narcotic [active pharmaceutical
ingredient] supplier of oxycodone, hydrocodone, codeine, and morphine in the
United States.”[20]
The
judgment then spends several pages detailing exactly how Johnson & Johnson
“embarked on a major campaign in which they used branded and unbranded
marketing to disseminate the messages that pain was being undertreated and
there was a low risk of abuse and a low danger of prescribing opioids to treat
chronic, non-malignant pain and overstating the efficacy of opioids.”[21]
Specifically, Johnson & Johnson promoted that pain was undertreated in an
effort to encourage providers to prescribe opioids as the solution.[22] The
Court found that Johnson & Johnson utilized the term “pseudoaddiction” to
“convince doctors that patients who exhibited signs of addiction . . . were not
actually suffering from addiction, but from the undertreatment of pain; and the
solution, according to Defendants’ marketing, was to prescribe the patient more
opioids.”[23]
Further,
in 2004, the FDA sent Johnson & Johnson a letter noting that a file card
used to promote their product Duragesic (a skin patch containing fentanyl, a
highly addictive opioid) was false or
misleading because the card suggested that “Duragesic has a lower potential for
abuse compared to other opioid products” and could “encourage the unsafe use of
the drug.”[24]
In conjunction with these instances, Johnson & Johnson used “education from
Defendants’ sales representatives, literature funded by Defendants in medical
journals and publications, materials from professional societies/patient
advocacy groups, continuing medical education funded by Defendants, unbranded
marketing materials, and Defendants’ paid speakers” to influence doctors’
prescribing habits and encourage them to utilize opioids to treat pain.[25]
In
finding that Johnson & Johnson committed a public nuisance, the Court
relied on the statutory definition of a nuisance as “unlawfully doing an act,
or omitting to perform a duty, which act or omission either: [f]irst, [a]nnoys,
injures, or endangers the comfort, repose, health, or safety of others . . . .”[26] While
some states require the use of property to commit a nuisance, Oklahoma has
interpreted their public nuisance statute to exclude the use of property, and
instead, only requires “unlawfully doing an act, or omitting to perform a
duty.”[27] Alternatively,
the Court found that if Oklahoma law does require the use of property in
committing a nuisance, the State still satisfied its burden by demonstrating
that “Defendants pervasively, systematically and substantially used real and
personal property, private and public, as well as the public roads, buildings
and land of the State of Oklahoma, to create this nuisance.”[28]
Ultimately, the Court concluded that “Defendants’ false, misleading, and
dangerous marketing campaigns have caused exponentially increasing rates of
addiction, overdose deaths, and Neonatal Abstinence Syndrome,” which are
“unlawful acts which annoys, injures, or endangers [sic] the comfort, repose,
health or safety of others.”[29]
The
Court also found that there were no supervening or intervening causes that
“supervened or superseded Defendants’ acts and omissions as a direct cause of
the State’s injuries.”[30]
Thus, the Court found that Johnson & Johnson created a public nuisance that
should be remedied by equitable abatement.[31]
After detailing Oklahoma’s Abatement plan (described in the table below), the
Court found that Oklahoma needed $572,102,028 to carry out the plan in its first
year.[32]
Even though several of Oklahoma’s witnesses testified that the abatement plan
required at least 20 years to be effective, the Court found that the State did
not provide sufficient evidence to establish the costs necessary for that
timeframe, and thus, were not awarded damages past the first year.[33]
Table
1: Overview of Oklahoma’s Abatement Plan[34]
So, why
does all of this matter? Not only is the Oklahoma case the first national civil
litigation suit for the opioid epidemic that went to trial,[35] it
seriously holds a major pharmaceutical company accountable for catalyzing the
opioid epidemic. Johnson & Johnson, along with the other major
pharmaceutical companies, aggressively marketed opioids as a low-risk solution
to pain, when they were anything but. As Gary Mendell, founder and CEO of the
advocacy group Shatterproof, stated: “Today’s monumental decision in Oklahoma
is a critical step in setting a precedent for the largest public health crisis
facing our country, bringing justice to the lives lost, and reversing the
course of addiction crisis for future generations.”[36]
[1] James
Nachtwey, The Opioid Diaries, Time,
Mar. 5, 2018, at 1.
[4] As with many
subjects, statistics don’t tell the whole story. No one wants to be an addict
and I would be remiss if I did not point readers to an article sharing
individual quotes and perspectives on this crisis. See Nachtwey, supra
note 1; see alsoFamilies Impacted By The Opioid Crisis Testified at
Johnson & Johnson Trial, NPR
(Aug. 28, 2019), https://www.npr.org/2019/08/28/754962728/families-impacted-by-the-opioid-crisis-testified-at-johnson-johnson-trial (“I wish that
someday people would realize I’m not a bad person. I’m a good person with a bad
disease.”).
[22]Id. at *10. At the time,
pain was sometimes referred to as the “fifth vital sign” in a push to have
providers respond to patient complaints of pain. See Natalia E. Morone
& Debra K. Weiner, Pain As the Fifth Vital Sign: Exposing the Vital Need
for Pain Education, 35 Clinical
Therapeutics 1728 (2013).
[26]Id. at *22. (citing Okla. Stat. Ann. tit. 50, § 1 (West
2017))
[27]Id.; see also
Paul L. Keenan, Note, Death by 1000 Lawsuits: The Public Litigation in Response
to the Opioid Crisis Will Mirror the Global Tobacco Settlement of the 1990s,
52 New Eng. L. Rev. 69, 75-77
(2017) (detailing the various theories of liability that communities are using
in their lawsuits against pharmaceutical companies).
