By Andrea Millard, JHBL Staff Member
In November 2021, pharmacy giants CVS Health, Walgreens, and Walmart were found liable in Trumbull County, Ohio, et al. v. Purdue Pharma LP et al. for contributing to the opioid abuse epidemic in two Ohio counties, marking the first time a jury has spoken out on this controversial issue. This appeal arose from a jury verdict holding the defendant pharmacies liable under state tort law for improperly filling large numbers of purported prescriptions for opioids. The pharmacies promptly appealed the $650 million judgment, arguing that this “unprecedented” award wrongly holds the pharmacies responsible for the opioid crisis.
The opioid epidemic is a national health crisis, with overdose deaths remaining a leading cause of injury-related death in the United States. The majority of overdose deaths involve opioids, and deaths involving synthetic opioids and stimulants have increased in recent years. The onset of the COVID-19 pandemic further accelerated overdose deaths in the United States and around the world. Street dealers and drug abusers obtain opioids from commercial pharmacies by using what they present as “valid” prescriptions. Some of these prescriptions are counterfeits and others are issued by practitioners for illegitimate reasons. Increasingly, invalid prescriptions are being issued by known “pill mills,” which are illegal facilities that regularly prescribe painkillers without sufficient medical history, physical examination, diagnosis, medical monitoring, or documentation. Some illicit prescriptions provide for unreasonably large dosages that are inconsistent with the physician’s area of practice. There is also significant concern over certain prescribed drug combinations that are medically dangerous or show no legitimate medical purpose, as well as duplicate prescriptions for the same patient. A key concern surrounding the dispensation of pain medication is being able to identify and stop illegal drug diversion, while still preserving legitimate prescriptions for those with serious medical conditions.
The Drug Enforcement Administration (DEA) implements regulations that govern the prescribing and dispensing of controlled substances in the United States. Namely, the DEA implements the Controlled Substances Act (CSA), which is at issue in this case. The CSA seeks to regulate “legitimate and illegitimate traffic in controlled substances,” including “diversion of drugs from legitimate to illicit channels.” The DEA imposes certain key regulations related to prescriptions, clarifying what should be considered a “lawful order” of a “practitioner” and describing that for a prescription to be “effective,” it must be issued by an authorized prescriber “for a legitimate medical purpose” in the “usual course” of the practitioner’s “professional practice.” This regulation also marks the practitioners’ responsibility “for the proper prescribing and dispensing of controlled substances,” and it recognizes a “corresponding responsibility,” on the part of pharmacists. The regulation confirms that a prescription order is not an actual “prescription” under the regulation if it is invalid. A person who knowingly fills such an invalid prescription is subject to penalties.”
This case, brought by two Ohio counties, asserts claims under Ohio law, alleging that the defendant pharmacies “created a public nuisance by improperly dispensing opioids in violation of its duties under the CSA and its implementing regulations.” The defendant pharmacies urge that this authorization entails minimal responsibilities. The pharmacies believe they have the right to fill any purported prescription, no matter how suspicious, unless the pharmacist has actual knowledge of its invalidity.
In March of this year the federal government stated that the pharmacies mistakenly argued in their appeal that they have minimal responsibilities to screen for suspicious prescriptions under the Controlled Substances Act. In their amicus brief, the Department of Justice states, “When there are recognizable indicia of a prescription’s invalidity — that it was not issued for a legitimate medical purpose or even that it is a counterfeit — a pharmacist is not authorized to fill the prescription unless or until he can confirm that the prescription is legitimate.” A lawyer representing the Ohio counties commented, “[The] DOJ is spot on; there are very clear obligations under the [Controlled Substances Act] that the chain pharmacies must comply with, and they didn’t in Lake and Trumbull Counties and the rest of the country, and no matter how much the chains deny this, they are simply wrong.”
At its core, this case is about taking responsibility for one’s actions. The opioid crisis has multiple sources of origin, ranging from discriminatory practices in the United States, to poverty, mental health issues, and, of course, the booming pharmaceutical industry. While researchers try to grapple with the roots of this epidemic, people are continuing to die. Although many consider the opioid crisis to be one that exists solely on the streets between so-called “junkies,” oftentimes street drugs originate from legitimate pharmacies. These pharmacies are the same ones that people go to every day to get their prescriptions filled. The same pharmacist that fills your diabetes medication may also be filling a suspiciously large dosage of oxycontin without even batting an eye. Thus, it is proper for the United States government to use all of its resources to regulate all channels of potential drug diversion. Since pharmacies are an obvious place in which these drugs are sourced, they need to be heavily regulated, and as such, pharmacists need to be held accountable for the prescriptions they are filing. None of these steps are meant to deny people with legitimate medical needs from accessing opioid painkillers, but there needs to be more responsibility placed on pharmacies that fill these prescriptions.
While it is understandable from a business standpoint why these pharmacies do not want to take on greater responsibility in checking for suspicious prescriptions, knowing it will mean fewer will be dispensed and paid for, they cannot overlook how they are contributing to this epidemic at large. It is disheartening to see these companies fail to step up and take action to counteract this crisis. Not only do they have the ability to do so, but they also hold all of the power. Feigning a lack of responsibility is not only unethical, but as a legal argument, it is unlikely to hold water.
Disclaimer: The views expressed in this blog are the views of the author alone and do not represent the views of JHBL or Suffolk University Law School.
Andrea Millard is a 2L interested in healthcare law. She is looking forward to starting as a Summer Associate at Ropes & Gray in their Boston office in May.
Source Links:
https://www.law360.com/health/articles/1588552/feds-tell-6th-circ-pharmacies-have-opioid-duties
https://www.law360.com/articles/1554528
https://www.law360.com/articles/1427792