Pharmacy Fails to Warn Aspirin-Sensitive Patient

Pharmacy Times, Volume 0, 0

Issue of the Case:

The central issue in this month's Illinoiscase is whether a pharmacy has aduty to warn when it is aware of apatient's drug allergies and knows thatthe prescribed medication is contraindicatedfor a person with thoseallergies. Upon removal of the case tothe federal court system, the issuebecame whether the plaintiffs couldpursue claims of willful misconduct onthe part of the defendant pharmacy.

Facts of the Case:

The plaintiff's husband went to thedefendant pharmacy and picked up aprescription of Toradol (ketorolactromethamine) for his wife. The pharmacyallegedly kept a patient profileand knew that the plaintiff was allergicto aspirin and other nonsteroidal antiinflammatorydrugs (NSAIDs). Whenthe prescription was called into thepharmacy and entered into its computersystem, a warning appeared showingthat Toradol was an NSAID and that theplaintiff was allergic to the medication.

According to the complaint, the prescriptionlabel and bill cannot be printedwhen there is a computer warning,such as the one in this case, unless apharmacist overrides the system. Thepharmacy's policy required the pharmacistto call the prescribing physicianbefore taking this step. This protocolwas allegedly not followed in this case.

After taking the medication, the plaintiffcalled the pharmacy and informedthe staff that she was experiencingbreathing problems. She also remindedthem that she was allergic to NSAIDs.She was allegedly assured by the pharmacistthat her breathing problems werenot related to taking the prescriptionmedication. The plaintiff alleges that shesuffered long-term medical problems asa result of taking the Toradol.

The plaintiff and her husband firstfiled a negligence lawsuit in the stateof Illinois court system, but the casewas later removed to the federal courtsbecause the defendant pharmacy wasa national chain with headquarters inanother state.

The Court's Ruling:

The state trial court granted summaryjudgment in favor of the defendanton the claims of duty to warn. A courtof appeals reversed this decision andthe Illinois Supreme Court affirmedthe reversal, but it did deny the plaintiff'srequest to amend the complaintto include charges of intentional misconduct.The case was then removedto a federal court, where the judges arebound to follow the law of the state inwhich the case arose. Because it wasnot clear which intentional torts theplaintiffs were alleging, the federal casewas dismissed but the door was leftopen for them to refile the complaint.

The Court's Reasoning:

The state court found that it was reasonablyforeseeable that a failure toconvey the Toradol contraindicationto the plaintiff could result in herinjury. It also concluded that the burdenon the defendant was minimalbecause it simply required the pharmacistto provide the information to thepatient or telephone the physician.

The pharmacy contended thatimposing such a duty would have a"chilling effect"on all pharmacies andhow they interact with their customers.The court disagreed. It felt thatby accepting the pharmacy's argument,it would be sanctioning the status—something it was not willing todo. By asking patients about their drugallergies, the court determined that thepharmacy engendered reliance that itwould take the necessary steps toensure that patients would not receivea drug to which they were allergic. Inthe eyes of the court, any negative consequencesof recognizing a duty towarn, as suggested by the defendant,were far outweighed by the substantialreasons favoring such a duty.

The court concluded that a narrowduty to warn exists where a pharmacyhas patient-specific information aboutdrug allergies and knows that the drugbeing prescribed is contraindicated forthe individual patient. In suchinstances, a pharmacy has a duty towarn either the prescribing physicianor the patient of the potential danger.Because the pharmacy did not satisfythis duty, the courts reversed the pharmacy'smotion for summary judgment.

At the federal level, the judge wrestledwith the claim of intentional misconduct.A complaint may containboth a negligence claim for duty towarn (described above) and an intentionaltort claim for which punitivedamages are recoverable. While therewere hints of allegations of batteryand fraud, it was not clear which tortsthe plaintiffs were trying to plead. Thefederal court dismissed these claimsand told the plaintiffs they could clarifythe issues and refile the lawsuit.

However, the federal court went onto warn the plaintiffs that if they cameback, they would need to be preparedto meet a very high threshold underIllinois law. It would not be enough tosimply show a systems error or inattentivenesson the part of the pharmacist."Someone dispensing the prescriptionmust have been aware that Toradolwould cause or was likely to cause harmto the plaintiff and, nevertheless, dispensedthe prescription with the intentto cause her harm."

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