Pharmacy Law: Role of an Expert Witness in a Pharmacy Lawsuit

Dr. Fink is professor of pharmacy law and policy at the University of Kentucky College of Pharmacy, Lexington.

Issue of the Case

In a case alleging that a dispensing error caused “severe and excruciating” damages for the patient, could the report filed by a pharmacist serving as an expert witness address the legal issue of causation of the damages, or was a physician required to provide that information? Also, was the report from the physician sufficiently direct on the issue of causation to be used in the case?

Facts of the Case

A patient received a prescription requesting dispensing of Paxil CR and presented it at a pharmacy in a southern state. When she returned for a refill, a dispensing error occurred, because an employee in the pharmacy placed the label for the Paxil product over the label on a container bearing Ambien. The patient alleged that this erroneous interchange of medications caused her to suffer “severe and excruciating pain, migraines, nausea, irritability, supersensitivity to light and sound, anxiety, fear, nightmares, inability to perform household functions, inability to stand up, irrational behavior, and to suffer very severe depression.”

To support her claim, the plaintiff filed an expert report prepared by a pharmacist who held faculty and academic administrator positions at a college of pharmacy. The defendant pharmacy made a motion with the trial court judge to dismiss the case because of what it viewed as 2 defects in the report: (1) the report did not address the issue of whether the dispensing error caused the offensive symptoms; and (2) as a pharmacist, the expert witness was not qualified to render an opinion on causation. The argument was that only a physician was qualified to address that key element of the lawsuit.

The plaintiff/patient requested an extension to secure a report from a physician in order to comply with the relevant state statute governing such cases. The additional time was approved, and the plaintiff submitted an expert report from a physician who had medical specialty board certification in adult neurology and sleep medicine. Upon reviewing that additional report, representatives from the defendant pharmacy again moved to have the lawsuit dismissed, because in their view, the report did not adequately address the issue of causation. The report was worded in terms of the damages being “consistent with” the dispensing error and the medication the patient actually did receive. The trial court denied the defendant’s motion to dismiss the case, and the pharmacy appealed to the state court of appeals, arguing that the trial court judge had erred in not dismissing the case.

The Court’s Ruling

The appellate court ruled that the trial court judge abused his discretion when ruling that the report from the physician was sufficient to support the claim, and it sent the case back to the trial court to be dismissed.

The Court’s Reasoning

The appellate court focused on the relevant state statute, which requires that such a claim be supported by a “written report by an expert that provides a fair summary of the expert’s opinions as of the date of the report regarding the applicable standard of care, the manner in which that standard was breached, and the causal relationship between that breach and the injury, harm, or damages claimed.”

The report filed by the physician with the trial court stated that when the patient/plaintiff suddenly ceased taking the Paxil and began taking Ambien for daytime use, the symptoms she suffered were “consistent with the known side effects of each medication.” The pharmacy/defendant argued to the appellate court that using wording such as “consistent with” does not demonstrate a causal connection, because language indicating that her symptoms are “consistent with” the known side effects of the medications is not the same as stating that the symptoms were in fact caused by the medication interchange.

The judges pointed to prior cases where wording directed at the issue of causation had been found lacking— “possibility of a better outcome,” “more likely,” “could have contributed,” “injury may have been avoided,” and even one directly on point—“consistent with.” In the view of the higher court, the wording selected by the physician expressed an opinion on a possibility, not an ultimate opinion on causation.

The expert opinion filed by the pharmacist was deemed acceptable on a number of issues other than causation, including the other 2 specified in the statute—the applicable standard of care and the manner in which that standard was breached. The insights of the pharmacist about how activities flow when preparing medication for dispensing in the prescription department could have been used had the matter proceeded to trial. â–