Facts about the case

A patient picked up a prescription from a pharmacy chain in a southern state but was given medication intended for someone else. He mistakenly consumed the glyburide metformin that the pharmacy had prepared for this other patient and allegedly suffered severe hypoglycemia that resulted in irregular driving. He first crossed a car with a man and a woman, then crossed the center lane and crashed head-on into another car, killing the driver. He then collided with 3 vehicles at an intersection, causing his own car to go up in flames.

The driver taking the drug died and an autopsy showed detectable levels of glyburide-metformin in his system at the time of the accident. The lawsuit alleged that the drugs he was taking could cause hypoglycemia in people without diabetes.

Symptoms that can lead to this 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 a lawsuit before the federal court due to the different citizenship of the parties. The lawsuit continued, with plaintiffs being the husband and wife who were killed along with the woman’s daughter when the driver’s car hit her head-on, killing her.

The pharmacy chain applied to the Federal Supreme Court for a summary judgment; that is, a judgment in his favor without going through a full process. Such a decision is appropriate when the judge has concluded that there are no real disputes related to an essential fact of the case so that legal proceedings are not required. The U.S. District Court judge granted that motion and closed the case at that level, and plaintiffs took the case to the competent U.S. Court of Appeals, focusing on whether the judge in the court of first instance was wrong with this decision .

The regulation

The court of appeal summarized the question as to whether the pharmacy chain had a tortious duty of care, which in the present case extended to the third-party plaintiffs. It came to the conclusion that such an obligation did not exist.

Justification of the court

The appeals court first emphasized that its task is to review the issuance of a summary judgment by “considering the evidence in the light most favorable to the non-collectors and drawing all reasonable conclusions in favor of the non-collectors”.

In a variety of citizenship matters such as this where there is no state Supreme Court jurisdiction to explain the state law relevant to the issue, the federal court is empowered to “do the best we can” about what the Supreme Court is State Court of Justice would rule. “

The Federal Supreme Court emphasized that the state’s Supreme Court “has repeatedly recognized that any duty of care on the part of the service provider to avoid negligence arises solely from the relationship with the patient and flows only to him”.

The state’s highest court had also found in the past that “there is generally no relationship between” [a health care professional and a patient] this would provide the kind of control necessary to establish an obligation to a third party. “

The court continued, “Plaintiffs do not claim that the drugs are taking [the driver] was not accompanied by adequate warnings and instructions for use. Predictability is paramount to mandatory analysis, and there are relevant differences between not warning a patient about the risks of medications the doctor knows the patient is taking and giving a patient a bottle of prescription medication for someone others on the other hand. “

Further, “we have no difficulty in concluding that the [state supreme court] would not impose a tort obligation between pharmacies and third parties, as advocated here by the plaintiffs. We agree [the pharmacy chain] that the damage inflicted on the injured party was not a foreseeable consequence of the alleged behavior of the pharmacy staff. Above all, it was not foreseeable that a pharmacy customer would take the drug in a bottle intended for another person, even though the name of another person and a different drug were listed on the label. “

The appellate court also dealt with the question of whether, in this case, state legal provisions could be used as a source of a legal obligation to act towards third parties. This derivation of an obligation from legislation is known as the doctrine of negligence per se. The court pointed to numerous legal expectations under which pharmacists operate and which serve to protect the public.

However, it concluded that none of them were “designed to prevent the type of damage the plaintiffs have suffered”.

Joseph L. Fink III, JD, DSC (Hon.), BSPHARM, FAPhA, is Professor of Pharmaceutical Law and Policy and Professor of Leadership for the Kentucky Pharmacists Association at the University of Kentucky College of Pharmacy, Lexington.