Pharmacy Fails to Warn Aspirin-Sensitive Patient

JANUARY 01, 2005
Larry M. Simonsmeier, JD, RPh

Issue of the Case:

The central issue in this month's Illinois case is whether a pharmacy has a duty to warn when it is aware of a patient's drug allergies and knows that the prescribed medication is contraindicated for a person with those allergies. Upon removal of the case to the federal court system, the issue became whether the plaintiffs could pursue claims of willful misconduct on the part of the defendant pharmacy.

Facts of the Case:

The plaintiff's husband went to the defendant pharmacy and picked up a prescription of Toradol (ketorolac tromethamine) for his wife. The pharmacy allegedly kept a patient profile and knew that the plaintiff was allergic to aspirin and other nonsteroidal antiinflammatory drugs (NSAIDs). When the prescription was called into the pharmacy and entered into its computer system, a warning appeared showing that Toradol was an NSAID and that the plaintiff was allergic to the medication.

According to the complaint, the prescription label and bill cannot be printed when there is a computer warning, such as the one in this case, unless a pharmacist overrides the system. The pharmacy's policy required the pharmacist to call the prescribing physician before taking this step. This protocol was allegedly not followed in this case.

After taking the medication, the plaintiff called the pharmacy and informed the staff that she was experiencing breathing problems. She also reminded them that she was allergic to NSAIDs. She was allegedly assured by the pharmacist that her breathing problems were not related to taking the prescription medication. The plaintiff alleges that she suffered long-term medical problems as a result of taking the Toradol.

The plaintiff and her husband first filed a negligence lawsuit in the state of Illinois court system, but the case was later removed to the federal courts because the defendant pharmacy was a national chain with headquarters in another state.

The Court's Ruling:

The state trial court granted summary judgment in favor of the defendant on the claims of duty to warn. A court of appeals reversed this decision and the Illinois Supreme Court affirmed the reversal, but it did deny the plaintiff's request to amend the complaint to include charges of intentional misconduct. The case was then removed to a federal court, where the judges are bound to follow the law of the state in which the case arose. Because it was not clear which intentional torts the plaintiffs were alleging, the federal case was dismissed but the door was left open for them to refile the complaint.

The Court's Reasoning:

The state court found that it was reasonably foreseeable that a failure to convey the Toradol contraindication to the plaintiff could result in her injury. It also concluded that the burden on the defendant was minimal because it simply required the pharmacist to provide the information to the patient or telephone the physician.

The pharmacy contended that imposing such a duty would have a "chilling effect"on all pharmacies and how they interact with their customers. The court disagreed. It felt that by accepting the pharmacy's argument, it would be sanctioning the status— something it was not willing to do. By asking patients about their drug allergies, the court determined that the pharmacy engendered reliance that it would take the necessary steps to ensure that patients would not receive a drug to which they were allergic. In the eyes of the court, any negative consequences of recognizing a duty to warn, as suggested by the defendant, were far outweighed by the substantial reasons favoring such a duty.

The court concluded that a narrow duty to warn exists where a pharmacy has patient-specific information about drug allergies and knows that the drug being prescribed is contraindicated for the individual patient. In such instances, a pharmacy has a duty to warn either the prescribing physician or the patient of the potential danger. Because the pharmacy did not satisfy this duty, the courts reversed the pharmacy's motion for summary judgment.

At the federal level, the judge wrestled with the claim of intentional misconduct. A complaint may contain both a negligence claim for duty to warn (described above) and an intentional tort claim for which punitive damages are recoverable. While there were hints of allegations of battery and fraud, it was not clear which torts the plaintiffs were trying to plead. The federal court dismissed these claims and told the plaintiffs they could clarify the issues and refile the lawsuit.

However, the federal court went on to warn the plaintiffs that if they came back, they would need to be prepared to meet a very high threshold under Illinois law. It would not be enough to simply show a systems error or inattentiveness on the part of the pharmacist. "Someone dispensing the prescription must have been aware that Toradol would cause or was likely to cause harm to the plaintiff and, nevertheless, dispensed the prescription with the intent to cause her harm."

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