Pharmacy not dismissed in drug-interaction case

On the Docket

The question of a pharmacist’s duty to a patient for whom two interacting drugs have been prescribed was recently addressed by the Superior Court of the District of Columbia. The court denied the defendant pharmacy’s motion to dismiss the case.

Background

A patient was prescribed duloxetine (Cymbalta—Lilly) and lisdexamfetamine simultaneously for several months, and he died of sudden heart failure. In a subsequent lawsuit, the patient’s wife alleged that the two drugs are known to cause serious adverse effects when taken together, and that a drug–drug interaction caused his death.

The wife alleged that the computer system at the pharmacy where the medications were dispensed alerted pharmacy personnel to the interaction and prompted that the prescriber should be notified. She further alleged that the pharmacy personnel never told the patient about the interaction, nor did they contact the prescriber.

The pharmacy contended that it was entitled to dismissal of the case because “(1) it had no duty to warn [the patient] of known contraindications, as its only duty was to accurately fill the prescription; and (2) relying on the learned intermediary doctrine, any other duty rested upon decedent’s physician.”

The plaintiff countered that dismissal was not warranted because “there was a duty to warn, particularly in the face of known contraindications, and that the learned intermediary doctrine does not apply for policy reasons.”

Analysis

The court first noted “the general rule is that pharmacists have no duty to warn a customer of the general side effects of her prescription. In many jurisdictions, however, the pharmacist’s duty to warn the patient or notify the prescribing physician may arise under certain circumstances.”

The court also referred to the learned intermediary doctrine that has insulated pharmacists from liability in some circumstances where the imposition of an expanded duty for pharmacists would “encourage pharmacists to ‘second-guess’ the prescribing physician’s decisions and would ‘place the pharmacist between the patient and the physician.’” In some prior pharmacy “duty to warn” cases, pharmacists have been held not liable under the rationale that it is the physician’s responsibility, not the pharmacist’s, to warn patients of potential adverse drug effects. Yet the court cited other prior pharmacy cases in which the learned intermediary doctrine was not applied because imposing a duty to warn would not have caused the pharmacist to interfere with the physician–patient relationship.

Applying these legal precedents to the facts of the case, the court explained that the defendant pharmacy’s computer system had alerted pharmacists to the serious interaction between duloxetine and lisdexamfetamine, and to the substantial potential threat this interaction posed to the patient. “Armed with this knowledge, [the pharmacy] had a duty to warn [the patient] himself or to notify his physician of the contraindication. At this stage, it may fairly be said that [the pharmacy] had a duty to warn because [the patient] was at risk of a specific, defined, and foreseeable harm about which the pharmacists knew or should have known,” the court said.

The court then recognized the applicability of the learned intermediary doctrine under some circumstances, but the court ruled that “the reasons underlying the doctrine do not appear to apply here.” The court explained that had the pharmacists warned the patient or notified the prescriber of the potential drug–drug interaction, they would not have obstructed the patient’s access to medical care, nor would they have placed themselves between the patient and the physician.

The pharmacy’s motion to dismiss the case was denied.

Discussion

Pharmacy computers provide frequent warnings to pharmacists regarding potential problems with drug therapy, including drug–drug interactions. This case suggests that such computer prompts can be deemed significant when they describe a risk of specific, defined, and foreseeable harm to a patient.

Significant risks to patients can be managed in one of two ways, according to this case. Either notifying the physician or educating the patient will suffice to meet the pharmacist’s duty to warn as described in this case. Following the precedent of previous cases, this case reiterates that pharmacists do not have a general duty to inform patients of every possible risk from taking a medication. Rather, the duty to warn depends on the identification of a specific risk that is well-defined and could cause the patient harm. Providing warnings under such circumstances, either to the patient or to the prescriber, supports the physician–patient relationship rather than threatening that relationship.

Based on: Keffer v Lorenz, 2012 D.C.Super. LEXIS 7 (July 19, 2012).