Dr. Fink is professor of pharmacy law and policy at the University of Kentucky College of Pharmacy, Lexington.
In a case alleging damages to a patient arguably due to off-label promotion of a federal legend medication, does a pharmacist serving as an expert witness possess the specialized knowledge necessary to aid the jury in determining legal causation of the injuries?
The patient suffered recurring back pain and underwent 2 surgical procedures to address the problem. Reporting that he still had extreme pain, he received a prescription from his physician for a medication newly reported to work for pain management. He was on and off the medication for some period of time and was using several other medications concomitantly. The patient experienced severe weakness, lethargy, and nausea, leading to admission to an intensive care unit.
The patient and his wife researched the various medications on the Internet, encountering claims that the manufacturer of the pain medication was promoting the product for off-label use. The lawsuit made 3 arguments: (1) a fraudulent scheme was used to market the product; (2) the product was not safe and effective for treating pain; and (3) the illegal promotional activities caused the plaintiff's illnesses and hospitalization. The patient attempted to apply legal theories related to unfair and deceptive trade practices used in the alleged unlawful promotion of the product, arguing that the drug was the proximate or direct cause of his injuries.
As part of his case, he called a pharmacist to testify as an expert witness. The defendant manufacturer challenged the use of a pharmacist to testify about matters of pharmacology, arguing that his background—BSPharm degree plus a PharmD and recognition as a board-certified pharmacotherapy specialist—did not qualify him in the field of pharmacology. The defendant also challenged the basis on which the expert witness had reached his conclusions related to the case.
The federal court in this southern state looked at the ruling in a prior case from the US Court of Appeals with jurisdiction over that area of the country and ruled that the pharmacist was not so qualified. It also took issue with the basis for the expert witness' opinion. As a result, the court ruled in favor of the defendant manufacturer's motion for a summary judgment, ending the case with a ruling against the plaintiff patient.
An expert witness can play several roles in the course of pursuing a legal claim, not the least of which is translating and explaining to members of the jury technical matters associated with the case. In essence, the specialist needs to be able to teach jury members the relevant science and technology at a level they can understand. Communication skills are key, along with specialized knowledge of the field.
The defendants' challenge of the particular expert witness used by the plaintiff in this case prompted the judge to review the witness' qualifications. The requirement in this state was that the qualifications must be grounded in some specialized skill, knowledge, or experience. Noting that the person being offered as an expert was neither a physician nor holder of a degree in pharmacology, the judge ruled that the pharmacist could not offer a relevant or reliable expert opinion related to pharmacology. The judge looked at the precedent from the Court of Appeals case where a pharmacist with a graduate degree in toxicology was not permitted to testify on an issue of drug interactions without a degree in medicine or pharmacology. He also referred to the decision of a federal trial court in New York, which had accepted this distinction:
"Pharmacology can be described as the study of the effects of drugs on living organisms, while pharmacy, on the other hand, can be described as the profession of reading prescription labels (sic) and dispensing drugs."
The judge here also ruled that even if the credentials of the expert witness were in order, his opinion was unreliable because of the basis used to reach the conclusions. The expert had reviewed the abstracts of 11 case reports, each of which lacked peer review. The expert admitted during his deposition that the case reports were "not scientific proof of causation." Finally, the expert had never attempted to rule out alternative explanations for what had occurred, something that must be done for an expert witness to have credibility and be acceptable. The possibility that some of the other medications being used by the patient had caused the health problems had not been considered.
One study linked multiple pregnancies to an increased risk of developing atrial fibrillation later in life, and another investigated the association between premature delivery and cardiovascular disease.
Clinical features with downloadable PDFs