Phenobarbital Dispensed Instead of Phentermine

Pharmacy Times, Volume 0, 0

Issue of the Case:

In this month's case, the GeorgiaCourt of Appeals was presented withthe often-asked question of whether apharmacist who made a dispensingerror could be held negligent if therewas no proof that he caused the injury.More particularly, the issue centeredon whether the court could withholdevidence of the pharmacist's misconductfor a later phase of the trial, andfirst require the jury to determine thatthe error even caused the harm.

Facts of the Case:

The plaintiff began taking fenfluramineand phentermine in 1997 totreat obesity. Approximately 3 monthsafter beginning the therapy, the dispensingpharmacist erroneously filledthe phentermine prescription with 30-mg phenobarbital tablets. Over thenext several days, the plaintiff took 4tablets of phenobarbital. She began tocomplain of fatigue, dizziness, headaches,lethargy, emotional instability,and nightmares.

Later the plaintiff "blacked out"while taking a bath. She called a pharmacy(not the dispensing pharmacy)and described the medication she hadtaken and her subsequent symptoms.The plaintiff's conversation with thepharmacist led her to believe that shehad ingested phenobarbital. She calledher husband, who rushed home andtook her to an urgent care center.

The plaintiff was diagnosed with anadverse reaction to the drug. She wasgiven intravenous fluids and activatedcharcoal, even though the level of phenobarbitalin her blood was described as"barely detectable. Certainly not toxic."

The plaintiff later returned to theurgent care center, complaining thather right leg had become swollen andknotty and that she was having difficultyurinating. Although there wassome disagreement among the experts,it was generally concluded thatthe problems in her leg were notcaused by the phenobarbital, but wereprobably related to the varicose veinsshe suffered during pregnancy.

The defense also presented evidencethat the plaintiff had a history of urinarytract infections and had soughttreatment on at least 2 occasions priorto ingesting the phenobarbital. Furthermore,in response to her claims offatigue and lethargy, the defense elicitedtestimony that she was up in themiddle of the night giving bottles toher twin infants. Her husband worked60 hours a week, and he stated thatshe had to take care of their 3 childrenand was often exhausted.

The Court's Ruling:

The trial judge ruled, as a matter oflaw, that the pharmacist and the pharmacyhad breached their duty of carewhen the wrong drug was dispensed.Thus, there was no need to litigate theissue of negligence, but the question ofcausation and damages remained. Thecourt split the issues and first asked thejury to determine whether the negligentact was the direct cause of theplaintiff's complaints. The jury foundno causation and ruled in favor of thedefendants. The plaintiff appealed,claiming that it was a mistake for thecourt to separate the issues. The appellatecourt affirmed the jury verdict.

The Court's Reasoning:

Appellate courts prefer not to separatea case into different phases, butwide discretion is given to the trialcourt on how to handle the situation.In this case, there was evidence thatthe dispensing pharmacist had a priordisciplinary action, but the court recognizedthat this fact might haveimproperly influenced the jury indetermining causation. Instead, suchevidence would be admissible only inthe punitive damages phase of thetrial, if the case went that far.

Additionally, the trial court orderedthat the testimony of the plaintiff'sexpert witness, another pharmacist,regarding the applicable standard ofcare also would be admissible only ina later phase, because the question ofstandard of care was not at issue duringthe causation phase of the trial.

The court's instructions to the jurymay be helpful in understanding whythe court split the decision-makingprocess: "Ladies and Gentlemen: Inany negligence case, there are generallyfour elements that generally mustbe proven?One is a duty owed by thedefendant to the plaintiff; numbertwo would be a breach of that duty;three would be what is known as proximatecause or a causal relationshipfrom the duty and the breach; and thefourth element would be damages. Inthis case, the first two issues havealready been resolved . . . in favor ofthe plaintiff. So the only issues left foryour consideration would be whetherthere is some causal connection betweenthe defendant's conduct andthe resulting injury, and whether thereis some loss or damage."

Larry M. Simonsmeier is Emeritus Professor of Pharmacy Law at Washington State University College of Pharmacy.