Pharmacy Law: Duty to Warn Waived When Patient Refuses Counseling

Issue of the CaseA California appellate court wasasked in this month's case whether apharmacist has a duty to warn of amedication's side effects when thepatient refuses to be counseled.

Facts of the Case

The plaintiff presented 2 prescriptionsto the defendant pharmacy. Onewas a new prescription for trazodone(Desyrel) as a sleep aid, and the otherwas for an increased dosage of sertraline(Zoloft). When the pharmacyclerk noted that the patient hadalready been taking Zoloft, she asked ifhe wished to speak to the pharmacistabout the trazodone.

The patient admitted in his depositionthat he responded, "Oh, I don'tneed to talk to him about a sleepingpill." He also testified that he thoughtthat the sleep aid was not a powerfuldrug. The plaintiff also signed a formthat stated, "I do not wish to be counseledby the pharmacist and do nothave any questions."

Although not a corporate requirement,the pharmacy typically providesa printed handout that includes warningsof any side effects with each newprescription. The plaintiff did not getsuch a handout.

After the plaintiff took the trazodoneat bedtime for several days, hedeveloped priapism, which occurs inless than 1% of men taking the drug.The pharmacy's printed handoutwarns male patients to contact theirphysician immediately, should thecondition develop. The plaintiff wasnot treated for 3 days and sustainedpermanent injury. The plaintiff suedboth the prescribing psychiatrist andthe pharmacy.

The Court's Ruling

The trial court awarded summaryjudgment in favor of the pharmacy. Theappellate court affirmed. (Note: In a separateaction, a jury returned a $3-millionverdict against the psychiatrist.)

The Court's Reasoning

The trial court concluded that thepharmacy had complied with its regulatoryrequirement because the plaintiffhad been offered the opportunityto speak to a pharmacist. The appellatecourt went on to note that the stateregulation and the federal statute uponwhich it was based expressly contemplatedthe possibility of a waiver by thepatient, in which case a pharmacist hasno duty to provide a consultation.

Even though the record was clear thatthe plaintiff refused any consultation,he argued that the pharmacy's offer toconsult was ineffective. He claimed thatthe pharmacist was busy at the time ofdispensing the medication, that he hadwaited for some time to get the prescriptionfilled, and that there were peoplein line in front of and behind him.

The court did not accept this argument,because there was nothing in theexchange between the pharmacy clerkand the plaintiff that indicated thatthere would be any delay.

Next, the plaintiff contended that hisrefusal was invalid because "no actualpharmacist" ever spoke to him, as heclaimed was promised in a Board ofPharmacy newsletter. The court foundno evidence that the board had everdisciplined pharmacies in which anemployee other than the pharmacistmade the offer to consult. The courtconcluded that any interpretation ofthe regulation must comply with commonsense. In the court's opinion, itserved no purpose and was unrealisticto expect a pharmacist to greet everypatient, and to interpret the regulationto require the pharmacist to do sowould delay the filling of prescriptionsand result in more impatient customers.

Not giving up, the plaintiff thentook the position that a mere offer toconsult was not enough and that thepharmacist must provide consultation,no matter what. The court recognizedthat no one could physicallyrequire a patient to listen to an oralconsultation. The court went on tostate that it would be absurd to suggestthat a pharmacist or clerk could notfirst ask the patient whether he or shewould like the consultation.

Finally, the court looked at the effectivenessof the plaintiff's waiver.Whether there has been a waiver generallyis a question of fact, exceptwhere the underlying facts are undisputedand only one inference may reasonablybe drawn. In a somewhat circuitousargument, the plaintiffmaintained that someone should havetold him that the sleeping medicationhad serious side effects so that he knewwhat he was waiving.

The court concluded that waiver ofconsultation does not require notice ofthe substance or dangers of what waswaived. Otherwise, no waiver would beeffective until the relinquishing partieslearned in whole or in part what theywere relinquishing, which, wouldobviate the need for the waiver.

Larry M. Simonsmeier isEmeritus Professor ofPharmacy Law atWashington State UniversityCollege of Pharmacy.