The opioid epidemic is one that has garnered significant attention, warranting governmental efforts to reduce the substantial misuse of opioids and the addiction and overdose deaths that occur as a result thereof both nationally and locally. Such efforts should come as no surprise. The misuse of opioids continues to increase nationwide. The Centers for Disease Control and Prevention have attributed approximately 68 percent of the more than 70,200 overdose deaths that occurred in 2017 to the misuse of opioids, a statistic six times higher than that first documented in 1999. On average, approximately 130 Americans die every day from an opioid overdose.
The state and federal administrative and legislative apparatuses, however, are ill-equipped to alleviate the epidemic on their own, resulting in the snowballing of individuals seeking remedies against the multibillion-dollar manufacturers and marketers of opioids by means of the judiciary.
Indeed, last Monday, August 26, 2019, Judge Thad Balkman, of the District Court of Cleveland County, Oklahoma, held a manufacturer and marketer of opioids partially liable for the epidemic in the first ruling of its kind in American history.
In Oklahoma ex rel. Hunter v. Purdue Pharma L.P., Judge Balkman ruled that the state had met its burden of demonstrating that the misleading marketing of opioids by the defendants constitutes a public nuisance, endangering the health and safety of thousands of Oklahomans. The attorneys representing the defendants maintained that a theory resting upon a claim of public nuisance had previously been restricted to litigation concerning public and private property.
Nonetheless, Johnson and Johnson, as well as its subsidiary, Janssen, were held to have understated the risk of addiction posed by the misuse of opioid painkillers Duragesic, Nucynta, Tylenol with Codeine, Tylox, Ultracet, and Ultram, ignoring decades of scientific research on the risk and instructing their sales representatives to concentrate their efforts upon high-opioid-prescribing physicians and to inform them that the risk is drastically lower if the opioids are prescribed thereby.
Oklahoma Attorney General Mike Hunter Mike Hunter claimed that the defendants had “embarked on a cynical, deceitful, multibillion-dollar brainwashing campaign to establish opioid analgesics as the magic drug.” Judge Balkman thereby held the defendants liable for damages in the amount of $572 million, placating one year of costs expected to be assumed by the state of Oklahoma in its thirty-year, $17.5 billion-effort to reduce the misuse of opioids by Oklahomans and the addiction and overdose deaths that occur as a result.
Purdue Pharma, the manufacturer of OxyContin, and Teva Pharmaceutical, some of the other defendants named in Oklahoma ex rel. Hunter, each had reached $270 million and $85 million settlements with the state of Oklahoma prior to the commencement of trial, escaping any admission of liability that may have been imposed upon them by Judge Balkman as a result.
Oklahoma ex rel. Hunter is significant in its implications. Noramco, one of the other subsidiaries of Johnson and Johnson, is the largest manufacturer of codeine, hydrocodone, morphine, and oxycodone in the United States. The case has been thought of as the holy grail for the plaintiffs bringing the approximately two thousand pending cases against Johnson and Johnson, Purdue Pharma, Teva Pharmaceutical, and other manufacturers and marketers of opioids, each of which were recently consolidated and removed to the U.S. District Court for the Northern District of Ohio in what is likely to become one of the most complicated and consequential trials ever held. The trial is scheduled for October 21, 2019.
“Given the scale of the crisis,” noted the Financial Times Editorial Board, “addressing it effectively requires using far more tools than just the law courts.” One of the principal explanations as to the misuse of opioids is the lack of awareness by physicians of the addictive behaviors of their patients. Blockchain technology, wherein patient records may be securely shared across a network of healthcare providers, however, may increase such awareness, equipping providers with knowledge regarding the amount and types of opioids prescribed to patients by other sources.
Intel Corp., for instance, has collaborated with healthcare providers to track opioid prescriptions from the manufacturer to the patient, eventually to the point at which the patient ingests the opioid, thereby enabling providers to detect and prevent “double doctoring,” whereby a patient receives more than one prescription from multiple providers. The technology further enables the U.S. Food and Drug Administration to identify and raise regulatory violations against “pill mills,” those providers that prescribe more opioids than is necessary.
Under Title II of the Drug Supply Chain Security Act, for instance, all prescriptions are required to contain such traceable technology as a two-dimensional barcode. The Act, however, is continually being phased in through 2023. Some states, such as North Carolina, have grown impatient and taken matters into their hands. The University of North Carolina at Chapel Hill Healthcare System, for instance, recently announced plans to integrate its own, institutional prescription reporting system with that of the state, demonstrating the willingness of large healthcare providers to adopt technologies akin to blockchain. Whether attributable to the adoption of such technologies or not, the state of North Carolina has seen overdose deaths that occur as a result of the misuse of opioids decrease for the first time in five years.
Several states have adopted similar prescription reporting programs. However, in not incorporating blockchain technologies, such states have experienced a lag time anywhere between a few days and a few weeks in reporting prescriptions. “It’s fairly easy to game a national database of prescriptions, providers, and patients,” said computer programmer, systems analyst, and industry consultant Josh Greenbaum. “But making the drugs traceable provides a much more comprehensive view of what each party is doing with the opioids.”
Indeed, “one large, immutable, secure, trusted, decentralized, real-time, nationwide, cost-effective database that is HIPAA compliant could go a long way toward addressing the opioid epidemic,” writes Dr. Meda Raghavendra. “Blockchain does exactly that. Accordingly, startup BlockMedx has developed a blockchain-based prescription reporting system, claiming to be the “world’s first and only completely secure, HIPAA-compliant, end-to-end solution for transmitting DEA Controlled Drug prescriptions such as prescription opioid pain relievers and others, from physicians to pharmacies using the Ethereum blockchain.” Other startups have eagerly jumped on board. Deloitte found, in a survey conducted last year, that approximately 30 percent of life sciences organizations have already invested in blockchain technologies.
Thus, while Oklahoma ex rel. Hunter serves as an important victory in the opioid epidemic, litigation cannot be the only solution thereto, even when accompanied by legislation and regulation.
The adoption of technologies akin to blockchain by healthcare providers, opioid manufacturers and marketers, and state and federal governmental agencies may prove just as fruitful in winning the war, and not just the battle.
| Mousa A. Alshanteer |
September 2, 2019