Pharmacist Testifies as an Expert Witness on Medical Certainty

Both the prescriber and the pharmacy where the medication was dispensed were accused of negligence in a case of apparent suicide.

Issue of the Case

In a case of apparent suicide where it was alleged that there was negligence, both on the part of the prescriber and the pharmacy where the medication was dispensed, may a pharmacist testify as an expert witness on the issue of cause of death and “reasonable medical certainty,” issues usually addressed by a physician?

Facts of the Case

A woman was found unresponsive in bed with a plastic bag over her head. The resulting investigation found a suicide note and a collection of medication containers for both prescription and nonprescription products. Included among the former category were dosage forms of alprazolam and citalopram. All of the prescription medications had been obtained at the same pharmacy. The coroner’s report of the autopsy listed the cause of death as “multiple drugs toxicity.”

A lawsuit was filed by the mother of the deceased woman. The defendant pharmacy submitted a declaration by an expert witness who held a doctor of pharmacy degree as well as a doctor of philosophy in psychobiology. The expert witness stated that the levels of prescription medication found in the tissues of the deceased woman were high, but not sufficiently high to be lethal to a human being. As might be expected, expert witnesses for the plaintiff had a different view—the levels of the medications found during post-mortem examination were reflective of an amount of medication sufficient to be lethal.

Also at issue was the amount of diphenhydramine found in the deceased woman’s tissues from an OTC product found at the scene. The expert witness for the defendant pharmacy stated that this amount was well above the minimum level that would be fatal to a human being. Thus, the pharmacist/expert witness declared his opinion that within a reasonable degree of medical certainty it was the diphenhydramine from the nonprescription medication that caused the death, not the prescription medications. Further, based on the tissue levels of that medication, the expert witness concluded that the deceased woman would have had to ingest a minimum of 100 tablets of the OTC product in a short period of time to attain the lethal blood level.

To respond to the wrongful death lawsuit alleging medical negligence by the physician and pharmaceutical negligence by the staff at the pharmacy, the defendants filed a motion for summary judgment. This in effect asked the judge to rule that there were no genuine issues of material fact to be considered at a trial and that a judgment should be entered in their favor. The trial court judge concluded that was indeed the situation and entered a judgment for the defendants. The plaintiff felt the trial court judge had made an error when deciding the case that way and filed an appeal with the state appellate court.

The Court’s Ruling

The appellate court ruled that the trial court judge had indeed erred in entering the summary judgment in favor of the defendants. The case did present a triable issue of fact to be presented to a jury, and the process for handling the dispute should not have been short circuited by entering the summary judgment.

The Court’s Reasoning

In the course of reaching this conclusion, the appellate court was presented with an opportunity to address the issue of using a pharmacist in the expert role as had been done. The plaintiff had objected to a number of opinions offered by the pharmacist expert witness because he “was a pharmacist and not a licensed physician, and lacked the training, education, experience, and stated expertise to render an opinion as to cause of death.” Further, the argument had been advanced that when he offered opinions “within a reasonable degree of medical certainty” that was inappropriate because he was not a licensed physician and “any opinion about what did or did not cause decedent’s death was beyond his training, education, experience, and expertise.”

The court noted that he was a licensed pharmacist and the legislature had declared the practice of pharmacy to be a profession, defining it to be a “patientoriented health service that applies a scientific body of knowledge to improve and promote patient health by means of appropriate drug use, drug-related therapy, and communication for clinical and consultative purposes.” Moreover, during his 30-year career he had been involved with “toxicological analysis of individuals from a pharmacological standpoint.” This led the appellate court to conclude that his “training, education, experience, and expertise provided him with a basis for stating the effects of those medications ‘within a reasonable degree of medical certainty.’”

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