Pharmacist Ignores “Hard Stop” in Computer

Issue of the Case

A pharmacist was presented with a dispensing situation that prompted a hard stop warning to appear in the pharmacy chain’s computer system.

When a lawsuit is filed alleging breach of the pharmacist’s standard of due care for proceeding with the dispensing, may a physician testify at trial regarding the legal standard of due care applicable to the pharmacist?

Facts of the Case

A patient presented a prescription at the pharmacy in a New England state for levofloxacin, and the pharmacist handling the transaction encountered a hard stop in the pharmacy’s computer system, indicating that the patient was allergic to quinolones.

The notification appeared despite the presence of a notation in the patient record system from 5 years earlier that the patient “states he has no quinolone allergy.”

Moreover, the patient’s records in the system reflected that he had received quinolones on 3 occasions around the time of the notation. Taking all that history into account, the pharmacist concluded that there was no contraindication for dispensing of the antibiotic and he prepared it for
the patient.

After consuming the medication, the patient developed a red circular rash with central blisters.

This was noted to be an “atypical appearance for an allergic reaction but may represent erythema multiforme/very mild Stevens-Johnson Syndrome (SJS).”

The patient initiated a lawsuit alleging negligence and also advancing claims for product liability and unfair business practices. His pretrial filing included mention that he would have an expert witness participating in the presentation of the case from his perspective. The proposed expert witness was a physician who specialized in allergy and immunology.
The pretrial affidavit filed by the physician expressed the opinion that the pharmacist’s act of dispensing the levofloxacin to the patient/plaintiff despite the hard stop alert appearing in the computer system “was a breach of the standard of care.”

The physician further expressed the opinion that the somewhat quick onset of symptoms following consumption of the levofloxacin was more rapid than typically seen with SJS stating: “SJS can occur rapidly in patients who have experienced reactions to that medication previously.”

The physician concluded that the levofloxacin was likely the cause of the injuries and damages that the plaintiff experienced.

The attorneys for the defendants took the deposition of the physician and during that proceeding he stated under oath that “he did not know the standard of care applicable to a pharmacist in this situation.”

The deposition also led to the physician’s testimony that he “did not know how the patient’s rashes appeared, and whether he had any other symptoms of SJS.”

The attorneys for the defendant pharmacy chain filed a motion with the court to exclude the expert testimony of the physician and also requested that the court grant summary judgment for the defen- dants. Summary judgment is appropriate when the judge concludes that there are no material issues to be addressed by a jury, so no full trial is warranted.

The Ruling

The court granted the motion for summary judgment for the defendants on the claim alleging negligence. The court reached the same decision regarding the product liability and unfair business practices allegations.

The Court's Reasoning

It was noted by the court when reviewing the pro- posed expert witness’ deposition (statement under oath as part of preparation for trial) that he had admitted that “he did not know ‘the standard of care applicable to a pharmacist in this situation.’”

Further, his testimony reflected that he “did not know how the patient’s rashes appeared and whether he had any other symptoms of SJS.”

The court observed that the physician’s “testimony revealed that he had only a limited understanding of the facts of the case and SJS generally.” The physician could not identify the criteria used to diagnose SJS and has neither diagnosed nor treated any patients with SJS. He was unaware that the patient had been prescribed quinolone antibiotics on multiple occasions prior to the dispensing that was the focus of this action. Finally, he had no understanding of the responsibilities of a pharmacist in general and specifically the standard of care when a pharmacist encounters hard stop or soft stop warnings.

On the other hand, the attorneys for the pharmacy chain had reports from 3 experts, a pharmacist and 2 physicians. The opinions there were that the pharmacist’s actions and decision-making met the standard of care and that the plaintiff did not have SJS.

The ruling of the court was that the plaintiff’s expert witness, the physician, “is not qualified to render the opinions at issue and his opinions are not based on adequate data.”

The result was that his testimony must be excluded based on the provisions in the Federal Rules of Evidence.

On occasion, pharmacists are asked to serve as expert witnesses at trial. This case decision is instructional for those who take on that role.

Joseph L. Fink III, JD, BSPharm, DSc (Hon), FAPhA, is a professor of pharmacy law and policy and the Kentucky Pharmacists Association Professor of Leadership at the University of Kentucky College of Pharmacy in Lexington.