Glyburide-Metformin Causes Multiple Fatalities in Car Accident

Pharmacy Times, July 2021, Volume 87, Issue 7
Pages: 53

When a medication, intended for another patient, is dispensed in error, is the pharmacy liable?

Issue of the Case

A patient received an incorrect medication at the pharmacy. Taking that product impaired his driving ability, resulting in the death of 2 other people. Can the surviving relatives of the deceased individuals maintain a lawsuit against the pharmacy for the deaths?

Facts of the Case

A patient picked up a prescription at a chain pharmacy in a Southern state but was given medication intended for someone else. He mistakenly consumed the glyburide-metformin the pharmacy had prepared for that other patient, and allegedly experienced severe hypoglycemia that resulted in erratic driving. He first rear-ended a car carrying a husband and wife, then crossed the center lane and crashed head on into another car, killing the female driver. He then collided with 3 vehicles in an intersection, causing his own car to burst into flames.

The driver who had taken the medication perished, and an autopsy revealed detectable levels of glyburide-metformin in his system at the time of the accident. The lawsuit alleged that the medication he had consumed can cause hypoglycemia in individuals who do not have diabetes.

Symptoms that can result “include cognitive impairment, behavioral changes, and psychomotor abnormalities,” according to the lawsuit.

The son of the deceased driver reached an out-of-court settlement with the pharmacy chain after having filed suit in federal court, due to the parties’ diversity of citizenship. The suit continued with the plaintiffs being the husband and wife who had been rear-ended, along with the daughter of the woman killed when the driver’s car hit her head-on, killing her.

The pharmacy chain made a motion with the federal trial court that it be granted summary judgment; that is, judgment in its favor without going through a complete trial. Such a ruling is appropriate when the judge has concluded that there is no genuine dispute regarding any material fact in the case, so no trial is needed. The US District Court judge granted that motion, concluding the case at that level, and the plaintiffs took the case to the relevant US Court of Appeals, focusing on the issue of whether the trial court judge erred with that ruling.

The Ruling

The appellate court framed the issue as whether the pharmacy chain had a duty of due care under tort law that extended to the third-party plaintiffs in this case. It concluded that there was no such duty.

The Court's Reasoning

The appellate court began by emphasizing that its role was to review the granting of summary judgment by “viewing the evidence in the light most favorable to the non-moving parties and drawing all reasonable inferences in favor of the non-movants.”

In a diversity of citizenship matter such as this where there is no case law precedent from the state supreme court to declare the law of the state relevant to the issue, the federal court is put in the position of having to decide “as best we can what the state supreme court would decide.”

The federal court emphasized that the state supreme court “has repeatedly recognized that any duty of reasonable care on the part of the health care provider to avoid negligence originates solely through the relationship with, and flows only to, the patient.”

The state’s highest court had also stated in the past that “there is generally no relationship between [a health care professional and a patient] that would provide the type of control necessary to create a duty to third persons.”

The court continued, “The plaintiffs do not contend that the medication given to [the driver] was unaccompanied by proper warnings and directions for its use. Foreseeability is paramount to the duty analysis, and there are relevant differences between failing to warn a patient of the risks of medication that the health care professional knows the patient will take, on the one hand, and giving a patient a bottle of prescription medication intended for someone else, on the other.”

Further, “we have little difficulty concluding that the [state supreme court] would not impose a tort duty between pharmacies and third parties of the type the plaintiffs here advocate. We agree with [the pharmacy chain] that the harm caused to the injured parties was not a foreseeable consequence of the pharmacy staff’s alleged conduct. Most importantly, it was not sufficiently foreseeable that a pharmacy customer would take the medication in a bottle intended for someone else, notwithstanding that the label listed someone else’s name and a different medication.”

The appellate court also addressed whether state legislation could be used as the source of a legal duty to act with regard to third parties in this case. This deriving a duty from legislation is known as the doctrine of negligence per se. The court pointed to numerous legal expectations under which pharmacists operate that are designed to protect the public.

However, it concluded that none of those were “intended to prevent the type of harm that the plaintiffs experienced.”

Joseph L. Fink III, JD, DSC (Hon.), BSPHARM, FAPhA, is a professor of pharmacy law and policy and the Kentucky Pharmacists Association Professor of Leadership at the University of Kentucky College of Pharmacy in Lexington.

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