Author: Joseph L. Fink III, BSPharm, JD
Overriding a drug interaction warning can lead to deadly consequences.
Issue of the Case
Two medications that interacted with adverse consequences were dispensed and the pharmacy staff ignored a computer alert recommending that the prescribers be contacted, allegedly leading to the death of the patient. The surviving relatives filed a negligence lawsuit against the pharmacy chain, and the defendant corporation moved to have the lawsuit dismissed. Should the legal action be thrown out of court or allowed to proceed to trial?
Facts of the Case
A patient met his demise while consuming 2 prescription medications that when taken together are known to cause serious adverse effects in some patients. Both medications were dispensed at the same unit of a national pharmacy chain. The pharmacy computer system used by the pharmacists who dispensed the medications provided the patient’s medication use history and indicated that he had been prescribed both medications, reflecting that he was receiving both medications simultaneously.
The computer system posted an alert to the involved personnel, emphasizing that the 2 medications should not be dispensed together without first contacting the patient’s prescriber to confirm that both were indeed intended for the patient to use concurrently.
Personnel on duty at the pharmacy did not inform the patient about the potentially serious drug interaction nor did they contact his physician to discuss the matter. As a result, the patient used the 2 medications concomitantly for several months before he suffered a sudden heart attack, leading to his demise.
The surviving widow filed a lawsuit naming a number of defendants, including the physician and the pharmacy chain. The latter business entity filed a motion with the trial court seeking to have the lawsuit dismissed. In support of its request, the attorneys representing the pharmacy chain advanced 2 arguments: 1) there was no legal duty to warn the patient of the potentially serious drug interaction because the legal duty of the pharmacy was limited to accurately preparing and dispensing the prescription, and 2) based on a legal principle known as the learned intermediary doctrine, any obligation to alert the patient to the potential for harm when using the medications together rested with the prescriber. In rebuttal the attorneys representing the widow argued that there was a duty to warn, especially in light of the known contraindications and computer alert.
The Court's Ruling
The motion made by the pharmacy claim to dismiss the claim was denied by the trial court judge.
The Court’s ReasonIng
At the outset, the judge pointed out that the legal standard in this jurisdiction was that a complaint should not “be dismissed because a court does not believe that a plaintiff will prevail on the claim.” The court is to construe “all facts and inferences in favor of the plaintiff” at this stage of the legal proceedings.
The judge then turned her attention to issues surrounding a pharmacist’s duty to warn the patient of potential hazards or dangers when using medications. Starting from the point of examining prior decisions that addressed the standard of care expected of pharmacists, she pointed out that a pharmacist “has a duty to exercise the degree of care that a reasonable, prudent person in the same profession would exercise under similar conditions” and that “…a pharmacist will be held to the standard of care, skill, and intelligence which ordinarily characterizes the profession.” The law requires “only reasonable and ordinary care…which means the highest degree of prudence, thoughtfulness, and diligence, and is proportioned to the danger involved.” Finally, she quoted a decision in a prior case stating that “ordinary care” as applied to a pharmacist means “The highest practicable degree of prudence, thoughtfulness and vigilance commensurate with the dangers involved.”
Reviewing a number of case decisions from a variety of jurisdictions, the judge concluded that “The general rule is that pharmacists have no duty to warn a customer of The general side effects of her prescription.” Nonetheless, she continued by pointing out that “In many jurisdictions, however, the pharmacist’s duty to warn the patient or notify the prescribing physician may arise under certain circumstances.” Courts have imposed that duty to warn when the patient’s medical history or current medication regimen indicates that the prescribed medication is contraindicated.
The judge also addressed an argument known as the learned intermediary doctrine advanced by the defendant pharmacy. This principle holds that the prescriber stands in place of the manufacturer when a product’s liability claim is made based on a product sold by the company. This is based on the positioning of the prescriber between the manufacturer and the patient and assumes an informed or learned decision has been made by the prescriber. The doctrine has been applied in some cases to focus responsibility on the prescriber and insulate the pharmacist from liability. The jurisdiction where this case arose had applied that doctrine to lawsuits against manufacturers, but had never done so in “pharmacy-patient cases.” The judge ruled it was inapplicable to these circumstances.
Based on those factors, the judge concluded that the lawsuit should not be dismissed and should be scheduled for trial.
Dr. Fink is professor of pharmacy law and policy and Kentucky Pharmacists Association Endowed Professor of Leadership at the University of Kentucky College of Pharmacy, Lexington.