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

Pharmacy Times, Volume 0, 0

When a patient is harmed by a prescribing decision, who is most responsible for knowing the patient's medical history?

Dr. Fink is professor ofpharmacy law and policy atthe University of KentuckyCollege of Pharmacy,Lexington.

Issue of the Case

When a physician treating a patientasks the pharmacist for a dosing recommendationfor a medication he hadselectedas appropriate to treat thatpatient,implements that recommendationand thereby injures the patient,where does the liability lie—with theprescriber or with the pharmacist whogave the recommendation?

Facts of the Case

A patient entered a hospital emergencyroom complaining of knee pain. Thephysician there arrived at a diagnosisof gout and proceeded to prescribe colchicineto treat the disorder. He askeda pharmacist at the hospital about theproper oral dose. The physician did notprovide the pharmacist with informationabout the patient's other health history,which included several existing healthproblems.

The prescription issued by the physiciandid not indicate a maximum numberof dosage units that could be used. Thepatient suffered from a kidney condition,and the lawsuit filed following his deathalleged that he consumed an excessiveamount that caused his death.

The wrongful death lawsuit was filedagainst the physician and the hospitalthat employed the pharmacist. A wrongfuldeath action is a lawsuit initiated bythe survivors of the deceased individualfor the damages or diminished valueof their lives now that he or she is nolonger around. The legal theory of vicariousliability was used by the plaintiffs toattemptto hold the hospital employerliablefor the acts of the pharmacistemployeeperformed within the scopeof employment.

At trial, the jury returned a verdict infavor of the surviving family membersand added an award for punitive damagesin the amount of $4 million. Punitivedamages are assessed as punishment,not as compensation for loss, and anaward of punitive damages cannot bepaid by the insurance company; it mustbe paid directly by the defendant.

The hospital appealed the case tothe state Supreme Court, advancing theargumentthat it had no liability exposurebecause of the learned intermediarydoctrine. This legal principle is more frequentlyencountered in products liabilitycases against manufacturers of pharmaceuticalsor medical devices. It is basedon the fact that the intermediary—theprescriber—exists between the supplierof the product and the patient andexercises informed judgment to assessthe relative benefit and risk of using aparticular approach to treatment versusalternatives. The rule frequently works toinsulatea manufacturer from liability.

The Court's Ruling

The state Supreme Court ruled thatthe learned intermediary doctrine wasindeedapplicable to this situation, resultingin the pharmacist owing no legal dutyto the patient. The trial court erred whenit did not grant a judgment in favor of thehospital as a matter of law. The hospitalwon on appeal, and the survivors of thepatient lost.

The Court's Reasoning

The court ruled that application ofthe learned intermediary doctrine wasnot limited to products liability cases.It referredto a ruling in a prior case inthe same state by the Supreme Courtthat a pharmacist has no legal duty toalert patients to foreseeable injuries thatcould follow from use of medicationbeingdispensed by the pharmacist.

The court acknowledged there was afactual difference between the case itwas looking to as a precedent and thisone—the prior case involved a pharmacistconsulting with a patient, whereashere the pharmacist was consulting witha prescriber. Nonetheless, the justicesconcluded that the legal reasoning thatapplied to the physician-patient-manufacturertriad to make the learned intermediarydoctrine applicable in productsliability cases also was applicable toa physician-patient-pharmacist relationshipsuch as existed here. In the viewof the court, the physician is in the bestposition to convey to his or her patientsthe benefits and risks of using a particularmedication.

This quotation from the court's opinionis significant: "[T]he physician, not thepharmacist,has the medical educationand training and the knowledge of thepatient'sindividual medical history necessaryfor properly prescribing medication"(emphasis added). In this case, it arguablywas the failure of the physician to sharethe patient's health history with the pharmacistthat led to all the problems.