Pharmacy Law: In Harm's Way: Sorting Out Prescribing Liability

JULY 01, 2008
Joseph L. Fink III, BSPharm, JD

Dr. Fink is professor of pharmacy law and policy at the University of Kentucky College of Pharmacy, Lexington.

Issue of the Case

When a physician treating a patient asks the pharmacist for a dosing recommendation for a medication he had selected as appropriate to treat that patient, implements that recommendation and thereby injures the patient, where does the liability lie—with the prescriber or with the pharmacist who gave the recommendation?

Facts of the Case

A patient entered a hospital emergency room complaining of knee pain. The physician there arrived at a diagnosis of gout and proceeded to prescribe colchicine to treat the disorder. He asked a pharmacist at the hospital about the proper oral dose. The physician did not provide the pharmacist with information about the patient's other health history, which included several existing health problems.

The prescription issued by the physician did not indicate a maximum number of dosage units that could be used. The patient suffered from a kidney condition, and the lawsuit filed following his death alleged that he consumed an excessive amount that caused his death.

The wrongful death lawsuit was filed against the physician and the hospital that employed the pharmacist. A wrongful death action is a lawsuit initiated by the survivors of the deceased individual for the damages or diminished value of their lives now that he or she is no longer around. The legal theory of vicarious liability was used by the plaintiffs to attempt to hold the hospital employer liable for the acts of the pharmacist employee performed within the scope of employment.

At trial, the jury returned a verdict in favor of the surviving family members and added an award for punitive damages in the amount of $4 million. Punitive damages are assessed as punishment, not as compensation for loss, and an award of punitive damages cannot be paid by the insurance company; it must be paid directly by the defendant.

The hospital appealed the case to the state Supreme Court, advancing the argument that it had no liability exposure because of the learned intermediary doctrine. This legal principle is more frequently encountered in products liability cases against manufacturers of pharmaceuticals or medical devices. It is based on the fact that the intermediary—the prescriber—exists between the supplier of the product and the patient and exercises informed judgment to assess the relative benefit and risk of using a particular approach to treatment versus alternatives. The rule frequently works to insulate a manufacturer from liability.

The Court's Ruling

The state Supreme Court ruled that the learned intermediary doctrine was indeed applicable to this situation, resulting in the pharmacist owing no legal duty to the patient. The trial court erred when it did not grant a judgment in favor of the hospital as a matter of law. The hospital won on appeal, and the survivors of the patient lost.

The Court's Reasoning

The court ruled that application of the learned intermediary doctrine was not limited to products liability cases. It referred to a ruling in a prior case in the same state by the Supreme Court that a pharmacist has no legal duty to alert patients to foreseeable injuries that could follow from use of medication being dispensed by the pharmacist.

The court acknowledged there was a factual difference between the case it was looking to as a precedent and this one—the prior case involved a pharmacist consulting with a patient, whereas here the pharmacist was consulting with a prescriber. Nonetheless, the justices concluded that the legal reasoning that applied to the physician-patient-manufacturer triad to make the learned intermediary doctrine applicable in products liability cases also was applicable to a physician-patient-pharmacist relationship such as existed here. In the view of the court, the physician is in the best position to convey to his or her patients the benefits and risks of using a particular medication.

This quotation from the court's opinion is significant: "[T]he physician, not the pharmacist, has the medical education and training and the knowledge of the patient's individual medical history necessary for properly prescribing medication" (emphasis added). In this case, it arguably was the failure of the physician to share the patient's health history with the pharmacist that led to all the problems.

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