Brian A. Gallagher, RPh, JD

Brief Synopsis of Tug Valley Pharmacy et al v All Plaintiffs

Prescription drug—addicted patients vs Prescribers and pharmacists who provided the medications to them.

The addicted patients sued the providers contending that the providers caused their addiction, and the court ruled that the suits could proceed.

2002-2010 time frame with the court ruling issued in 2015.

While the patients were at least partially responsible for their own addiction and committed illegal acts to obtain controlled substances, the providers also engaged in questionable activities that may have been a factor in causing their addiction.

The court allowed the patients to sue providers and task juries with allocating fault to both patients and providers for causing the addiction.

In the recent case of Tug Valley Pharmacy et al v All Plaintiffs (2015 W.Va. LEXIS 673 [May 13, 2015]), the West Virginia Supreme Court weighed in on public policy concerning the diversion of controlled substances. The ruling allowed substance abusers to sue the prescribers and pharmacists who supplied the medications, even though the patients acknowledged engaging in an array of illegal activities including criminally acquiring narcotics by misleading physicians and pharmacists, doctor shopping, and ingesting the medications in amounts greater than prescribed. In a split decision, the court refused to adopt the “wrongful conduct rule,” which prohibits individuals from suing for injuries that occur as a result of their own criminal acts (here, becoming addicted by obtaining controlled substances illegally). Instead, the ruling will allow similar suits to proceed and will require juries to allocate responsibility for the addiction through the concept of “comparative negligence.”

In cases involving comparative negligence, the jury, after hearing all of the evidence and being fully informed, allocates a percentage of negligence to each of the parties in the lawsuit: the prescriber, the pharmacist, and the patient who is suing. If the patient’s negligence is greater than 50%, then the patient cannot recover any money. 

The decision seems to reflect the court’s frustration with the proliferation of inappropriate prescribing practices and the pharmacies that turn a blind eye to such activities by filling these prescriptions with little concern about their legitimacy. The ruling seeks to add more accountability for “bad” prescribers and dispensers by allowing addicts to sue them in civil court for money. This new ruling adds to the criminal culpability that already exists for the illegal prescribing or dispensing of medications in violation of the corresponding responsibility doctrine.     

Presumably, the possibility of being sued by addicted patients would deter prescribers and pharmacists from bad acts such as overprescribing and filling illegitimate prescriptions. While these are laudable goals, this opinion is unlikely to make a meaningful impact on the “bad actors.” These individuals have already made the conscious decision to place their professional licenses in jeopardy and risk going to prison for illegal and inappropriate prescribing and dispensing. The prospect of getting sued for money (that may or may not be covered by insurance) pales into insignificance by comparison.

Conversely, the array of negative implications from this decision is quite substantial. Addicted individuals, both in and out of prison, will now have a significant incentive to file these suits and take their chances that juries will find them less at fault for their addiction than the prescribers and pharmacists who provided them with the medications. They have almost nothing to lose and virtually everything to gain by bringing these lawsuits.

In addition, malpractice insurance might not provide coverage or even a legal defense for health care providers because illegal acts (such as prescribing or dispensing opiates that are not for a legitimate medical purpose) are typically not covered by insurance. As a result, providers may be personally responsible for any verdict and for all of their own legal costs. With the burgeoning number of substance abusers, there could be a tsunami of these lawsuits burying an already overwhelmed court system and forcing either the defendants or their insurance companies to foot the bill.

To compound the problem, no insurance company or defendant will want to settle these cases because paying to settle will spark more cases. So, except for the most egregious situations, the courts and providers should expect that nearly all of these cases will go to trial, further increasing costs to defendants and consuming limited judicial resources.

Another significant obstacle exists for providers and their attorneys in defending these suits. Virtually all of the addicts in the Tug Valley case invoked the Fifth Amendment right to refuse to testify about their own illegal activities because they might have incriminated themselves. Because of this constitutional protection, health care providers will have a difficult time proving the extent of patients’ negligence and legal responsibility for their own addictions. Thus, juries will not be fully informed and equipped to allocate fault as required under comparative negligence.

While all of this is bad for responsible prescribers and pharmacists, the individuals who stand to lose the most are patients who truly need pain medication. This decision will clearly have a chilling effect on legitimate prescribing and dispensing for fear of inadvertently inducing addiction and subsequent lawsuits. Some responsible practitioners will take a conservative approach and curtail opiate prescriptions, even for patients who are suffering, and some pharmacists will stop dispensing them altogether.

Because some of the activities of the providers in the Tug Valley case were dubious at best, the court attempted to resolve the inherent tension that exists between two very compelling but competing public policy goals: (1) deterring inappropriate prescribing and dispensing and (2) not inadvertently deterring providers who try to do the right thing and provide pain medications to patients who legitimately and desperately need them. Courts are often not adequately prepared or informed to make such complex public policy decisions, and these opinions result in significant unintended consequences. This decision is no exception.

Since this ruling, West Virginia providers have experienced considerable trepidation over writing or filling opiate prescriptions, even for patients who legitimately need them. The initial reaction of legitimate providers was to ask policy makers to adopt the wrongful conduct rule during the next legislative session. Some policy makers, patients, and even providers, however, believe that the wrongful conduct rule goes too far because it would protect and perhaps even embolden and incentivize “bad” prescribers and pharmacists.

Therefore, resolving this dilemma in a balanced, just, and fair way involves delicate line drawing to distinguish between acceptable and unacceptable prescribing and dispensing behaviors. A workable resolution is not simple because, when it comes to health care in general and prescribing opiates in particular, a lot of judgment is involved and there are simply no bright lines between appropriate and inappropriate behavior. The conundrum created by this case will be addressed when the West Virginia legislature convenes in January. If policy makers choose not to adopt the wrongful conduct rule into state code, as has been done in seven other states, they are going to have a difficult time drawing a line that protects providers and patients while also deterring individuals from contributing to the addictions of many more people.

Brian A. Gallagher is Director of Pharmacy Services for Marshall Health and Assistant Professor in both the Schools of Pharmacy and Medicine.  Prior to joining Marshall, he served as Senior Vice President of Government Affairs at the American Pharmacists Association (APhA).  Brian graduated from West Virginia University School of Pharmacy and Wake Forest University School of Law. He previously served as Rite Aid’s Vice President for Regulatory Compliance, Vice President of Risk Management and Governance for NDCHealth, General Counsel for TechRx, Inc. and Director of Pharmacy Regulatory Affairs for the National Association of Chain Drug Stores (NACDS). He served in the West Virginia Legislature for eight years in a variety of leadership positions where, among other legislation, he authored the WV Pharmacy Practice Act and several progressive statutes on medical ethics.  Brian was General Counsel for West Virginia University Hospitals and has practiced hospital, chain, and independent pharmacy.

Articles

In the recent case of Tug Valley Pharmacy et al v All Plaintiffs, the West Virginia Supreme Court weighed in on public policy concerning the diversion of controlled substances.