Court rules no presumed malice occurred in pharmacy error case

Abstract

The complexities of tapered dosing can lead to pharmacy liability if the directions given to patients are unclear or incomplete. Exposure to liability may increase when the error is not discovered at the time a prescription is refilled. This type of error was the basis of a lawsuit filed by a patient's estate against the patient's pharmacy, alleging that the patient died due to an amiodarone overdose. The patient was a 71-year-old male with chronic ischemic heart disease and atrial fibrillation. His cardiologist prescribed amiodarone 200-mg tablets. The signatura in the prescription stated: “1 TAB PO UD For Heart Rhythm 400mg 2x/day x 1 week, then 200mg 3x/day x 2 wks, then 200mg 2x/day x 2 wks, then 200mg daily” The pharmacist generated a label that read: “Take 2 tablets by mouth twice daily for 1 week – [800 mg]Then 1 tablet by mouth three times daily for two weeks – [600 mg]Then 1 tablet by mouth twice daily for 2 weeks – [400 mg]”The pharmacist omitted from the label the final part of the instructions to “then take 200 mg daily.” The pharmacist had only 60 tablets in stock, so he dispensed that number of tablets initially. He entered into the computer a quantity of 514 tablets for the prescription. Several days later, a different pharmacist dispensed the remainder of 454 tablets. The second pharmacist did not catch that the patient was to use only one tablet daily after the first 5 weeks. Six months later, a third pharmacist refilled the prescription for 514 tablets, without catching the original error. The patient died, allegedly due to “amiodarone-induced hepatotoxicity.” In the lawsuit that followed, the pharmacy did not contest liability but did move for dismissal of the plaintiff's claim for punitive damages. The court first noted that punitive damages can be awarded to a plaintiff only when there is either actual or presumed malice by the defendant. The plaintiff had not alleged actual malice by the pharmacists, so the court examined the allegation of presumed malice. Prior case law established that presumed malice requires a person to have acted “willfully or wantonly” in causing injury to another person. To prove willful or wanton misconduct, the plaintiff must prove that the defendant “knew or should have known of the substantial probability of serious physical harm and acted with a culpable mental state.” The plaintiff contended that since the pharmacists knew the adverse effects of amiodarone, the error they made was willful and wanton. The court ruled that while the pharmacists were aware of the risk of amiodarone toxicity, “awareness of the risk in and of itself does not constitute presumed malice or willful or wanton misconduct.” The court concluded that “none of the pharmacists—regardless of how irresponsibly neglectful they were or the seemingly dire consequences resulting—had the required culpable mental state by acting in some appreciable nature deliberately or intentionally.” The punitive damage allegations against the pharmacy were dismissed. Although the punitive damages claim has been dismissed, this case will continue based on the allegation of negligence and may result in an award of compensatory damages. Pharmacists can learn several important risk management lessons from the case: □When a complex tapered dose is prescribed, patient counseling can prevent misunderstandings by the patient and can correct errors by the pharmacy.□At the first refilling of prescriptions for a drug that is usually started with a loading dose, it's important to verify the maintenance dose.□Be sure to corroborate a large number of dosage units that would extend beyond a 90-day supply, particularly for a drug that is usually dosed once or twice daily.□To detect and prevent dosing errors, pay special attention to prescriptions for a drug that is labeled with a boxed warning.