Pharmacy Law: Expert Witness Needed for Misdispensing Case?

Author: Joseph L. Fink III, BSPharm, JD

Joseph L. Fink III

Expert Witness Needed for Misdispensing Case?

Issue of the Case
In a case alleging a dispensing error by a pharmacist, is there a need to have an affidavit or certificate from an expert who has reviewed the claim and concluded that the claim has merit? Or is this factual scenario such an open-and-shut obvious matter that no such certification is required before the case can proceed to trial?

Facts of the Case
This is one of those unfortunately all-too-familiar cases apparently rooted in misinterpretation of the prescriber’s handwriting. The pharmacist received a prescription for the anticonvulsant primidone but dispensed prednisone. The patient filed suit against the pharmacist and the pharmacy alleging negligence.

The eastern state where this case arose is among some 25 states that have statutes requiring that plaintiffs, with the initial filing of a malpractice lawsuit, include a certification from a qualified expert showing that there is merit to the claim. This is called a certificate or affidavit of merit. Such a requirement is an example of “tort reform” designed to screen out from the judicial system those claims deemed frivolous or unworthy of consuming the courts’ resources. In the state involved here, the requirement is that the expert filing the assessment must be in the same specialty as the defendant, so a pharmacist would be required.

The patient/plaintiff’s attorney did not present such a certificate when filing the paperwork required to initiate the suit. When questioned about this, he argued that this was a common knowledge case, referring to an exception to the mandate in the state statute. The plaintiff subsequently filed an affidavit of merit, but the trial court judge found it lacking because it did not establish each of the deviations from the applicable standard of care the expert identified. Consequently, the trial court judge dismissed the case.

The Court’s Ruling
When the plaintiff appealed the dismissal of his claim to the court of appeals, the 3-judge panel there was swayed by his argument that this was in fact a common knowledge case not requiring a certification from an expert. As a result, the appellate court reversed or overturned the trial court’s decision of dismissal and sent the matter back to that level for further proceedings.

The Court’s Reasoning
The common knowledge exception specifies that a certification is not required if the case is one where expert opinion is not essential to establish the legal duty or its breach. If the factual situation is one where jurors’ common knowledge would be sufficient to enable them, using ordinary understanding and experience, to determine a defendant’s negligence without hearing from experts and their specialized knowledge about the field or specialty, then no affidavit is required.

The court said that this exception is appropriate when the “carelessness of the defendant is readily apparent to anyone of average intelligence and ordinary experience.” In this matter, the court concluded that the members of the jury would not need expert testimony to determine whether a pharmacist who dispensed an incorrect medication deviated from acceptable professional standards. Thus, because an expert would not be called at trial to testify that the care, skill, or knowledge of the defendant pharmacist in this instance fell below acceptable professional standards, an affidavit need not be provided. The appellate judges in this eastern state cited decisions from courts in 2 other states with similar statutory requirements, which had concluded that “it does not take an expert to know that filling (sic) a prescription with the wrong drug is negligence.”

Other claims were included in the lawsuit, however—whether inadequate information was presented to the patient by the pharmacist and whether the pharmacist should have recognized the “impropriety of the dosage” of the prednisone being dispensed. Those claims by the patient/plaintiff would require the testimony of experts to inform the jurors about professional practices and standards. Because of that, the affidavit or certificate of merit requirement would apply to those arguments and, because one was not supplied when the case was initiated, those claims were barred and could not be considered when the case went back to the trial court for further proceedings.

Accordingly, the appellate court judges pointed out the potential danger associated with relying on the common knowledge exception to the mandates of the statute. “Claims… that do not fall within the scope of the common knowledge doctrine and its narrow exception” to the requirements of the statute and which lack a supporting affidavit or certificate by an expert will not be preserved for consideration at trial.