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After four years of contentious litigation, three of the nation’s largest pharmacies faced a jury trial for their role in the opioid epidemic in the United States. The trial, heard by the Judicial Panel on Multidistrict Litigation, and more specifically, Judge Dan Polster of the Northern District of Ohio, serves as a bellwether case. The plaintiffs in the case, Lake County and Trumbull County, sought up to $2 billion in costs and contended that CVS, Walgreens, and Walmart created a public nuisance by failing to prevent excessive amounts of pain pills from flooding their counties, and/or by stopping bogus prescriptions from being filled[1]. The pharmacy defendants contended their companies took steps to guard against diversion of pills and also pointed to the many other actors who played a role in the opioid crisis, including manufacturers, distributors, government agencies, physicians, and drug cartels. After a six-week trial and five and a half days of deliberation, the jury returned their verdict on November 23, 2021, and found that the three defendant pharmacies failed to properly monitor opioid prescriptions, thus contributing to a public health crisis.
Taking a step back from the trial, one might wonder what exactly is an opioid, what is the opioid crisis, and why are there so many opioid cases being filed all across the United States? The Johns Hopkins Medicine website[2] defines opioids as a class of drugs naturally found in the opium poppy plant that work in the brain to produce a variety of effects, including the relief of pain. Opioids are typically prescribed to treat moderate to severe pain, and work by blocking pain signals between the brain and the body. While blocking pain post-surgery and in certain circumstances where other pain medications may not sufficiently relieve one’s pain is a desirable result, opioids can make some people feel “high” and can be addictive. Other less desirable side effects can include slowed breathing, constipation, nausea, confusion, and drowsiness. Opioids can restrict one’s ability to breathe when taken at higher dose, and opioid misuse can lead to fatal overdose.
According to the Johns Hopkins website, the most common opioids, also referred to as narcotics, include prescription opioids (i.e., OxyContin, Hydrocodone, Vicodin); fentanyl (a synthetic opioid 50-100 times more powerful than morphine), and heroin (an illegal drug).
Arguably, any prescription medication that is not used correctly or is abused by a patient who is informed of the risks and side effects that medication can lead to a dangerous situation for the patient. So why all of the opioid litigation?
In the last several years, opioid deaths have skyrocketed around the United States. Certain counties claim increased costs for emergency responder services, increased crime, and other costs associated with drug use. In 2017, then President Donald Trump declared opioid abuse by millions of Americans a national emergency.
The opioid epidemic has also garnered more media attention. HBO’s Last Week Tonight with John Oliver has aired three episodes about opioids, HBO’s The Crime of the Century is a two-part documentary about opioids, and more recently, Hulu has released a fictionalized series called Dopesick. These series explore the manufacture, marketing, and distribution of Oxycontin, which was developed by Richard Sackler of Purdue Pharmacy. These series also cover the narrative that the addiction risks of Oxycontin were downplayed, and the drug was very aggressively marketed to physicians as a way to treat chronic pain. In addition, the FDA labeled a class II narcotic as a less addictive drug for the first time.
In Dopesick, the series portrays a coal mining town where a woman becomes addicted to opioids to treat her chronic back pain. However, the show also depicts teenagers, and at one point even a physician, licking and rubbing off the controlled release coating on the Oxycontin tablets and then crushing up the pills and snorting them for an immediate effect. The show then follows a narrative of one becoming “dopesick” when the addiction and cravings begin. A narrative follows that an addict then may visit multiple physicians or be dishonest about symptoms in an effort to obtain additional pain pills. However, prescription pain medication may be very costly for certain individuals who then opt for cheaper drugs on the black market such as heroin (a “cousin” to Oxycontin also derived from the opium plant) or fentanyl. Unregulated street drugs run a higher risk of overdose and death.
To be sure, the drug manufacturers and distributors benefit from high profits from prescription opioid medications such as Oxycontin, Oxycodone, Hydrocodone, and others. In many states, pharmacies are typically shielded from liability under what is known as the Learned Intermediary Doctrine. Generally speaking, this doctrine provides that a manufacturer’s or pharmacy’s duty to warn runs to the physician who prescribed the medication.
The Seventh Circuit affirmed the applicability of the learned intermediary doctrine in Walton v. Bayer Crop., 643 F.3d 994, 1000 (7th Cir. 2011) (a pharmacy “can’t be expected to warn their customers of the possible defects and dangers of the prescription drugs they sell”; 48 states follow this doctrine). Other states have also adopted the learned intermediary doctrine to ensure doctors make medical decisions as to the appropriateness of a given medication for a specific patient, not pharmacists. Happel v. Wal-Mart Stores, 316 Ill. App. 3d 621, 627 (2d Dist. 2000). In Illinois, the courts have repeatedly and “consistently declined to impose upon a pharmacy any duty to monitor patients, make medical decisions, or to warn a physician or a patient of ‘excessive’ prescribed doses.” Hernandez v. Walgreen Co., 2015 IL App (1st) 142990, ¶ 24. Other states have also failed to impose a “duty on a pharmacist to warn the customer or notify the physician that drugs are being prescribed in dangerous amounts, that the customer is being overmedicated, or that various drugs in the prescribed quantities could have an adverse effect.” Id. at ¶ 25.
So, where do we go from here? There are many Americans with pain conditions helped by needed opioid medication who do not face addiction concerns, and whose prescriptions are legitimate and far from nefarious. Eliminating opioids entirely is not a viable option. However, for those Americans struggling with addition, the focus will need to be on recovery. Of course, policies and procedures to safeguard against diversion and misuse must be implemented. But at what point does criminal drug use become a matter of liability for professionals such as physicians and pharmacists?
Of course, a patient should review current medications and disclose any past or present drug use with their physician when discussing the appropriateness of an opioid prescription. Patients with a personal or family history of substance abuse may face a higher risk of addition. Moreover, a patient should follow all treatment instructions whenever provided any treatment, including prescription opioids.
Friends, family, and physicians should also be cognizant of the signs of opioid use disorder. Per the Johns Hopkins’ website, common signs of opioid addiction include the inability to control opioid use; uncontrollable cravings; drowsiness; changes in sleep habits; weight loss; frequent flu-like symptoms; decreased libido; lack of hygiene; changes in exercise habits; isolation from family or friends; stealing from family, friends or businesses; and new financial difficulties.
Not surprisingly, the pharmacy defendants have vowed to appeal the recent trial verdict and maintain they filled legal prescriptions written by licensed physicians who prescribed FDA-approved substances to treat actual patients in need. The ultimate outcome of this landmark trial against pharmacies will have major implications on how prescription opioids are prescribed and dispensed across the United States. While pharmacies may ultimately be on the hook for large settlements or verdicts, a clearer delineation of duties may create fewer ambiguities in the law in the future.
[1] Giant Eagle Inc. had also been a named pharmacy chain defendant. Giant Eagle Inc. reached settlement with plaintiffs for an undisclosed amount during the fourth week of trial.
[2] https://www.hopkinsmedicine.org/opioids/what-are-opioids.html
