Court: United States District Court for the Eastern District of Pennsylvania
Case Name: Terry v. McNeil-PPC, Inc. (In re Tylenol (Acetaminophen) Mktg., Sales Practices & Prods. Liab. Litig.)
Citation: 2016 U.S. Dist. LEXIS 99176
In this case involving alleged liver damage secondary to painkiller usage, the defendants filed a motion to exclude the testimony of the plaintiff’s pharmacist expert witness. The defendants claimed that the pharmacist expert’s testimony was inadmissible on the basis of Fed. R. Evid. 702 and Daubert.
The Pharmacist Expert Witness
The plaintiff’s expert witness was a clinical pharmacist with a Ph.D. in epidemiology from the University of Minnesota who was hired to opine on causation. He was also accredited as a pharmacovigilance and compliance expert.
After earning his degree in pharmacy, the pharmacist expert completed his residency at a hospital and a clinical pharmacy. The expert pharmacist worked as a medical pharmacy consultant with the Neurology Institute of the National Institute of Health (NIH). He later worked with the Food and Drug Administration (FDA) in the Division of Neuropharmacological Drug Products for 20+ years. At the FDA, the expert held various roles including new drug analysis, epidemiology, and post-marketing monitoring. He was responsible for the instruction of all professional staff, and was required to teach and supervise a variety of pharmacy programs.
The expert wrote or co-authored 50+ articles, abstracts and technical reports. He also worked as an assistant professor of pharmacoepidemiology at the University of Maryland School of Pharmacy Graduate Program for eight years. Prior to this case, the expert had offered expert testimony in 30+ cases.
The court found the pharmacist expert to be sufficiently qualified to offer testimony in this case, noting that the defendant itself had previously hired the expert to consult on specific risks concerning a product. The court also observed that it was not necessary for the expert to be a medical doctor to give his opinions because he was a clinical pharmacist who testified regarding pharmacovigilance.
The court noted that, in order to prepare his opinions, the expert had extensively reviewed of the defendants’ internal company documents, regulatory filings, medical literature, clinical studies and epidemiological studies. He also reviewed the available medical literature on acetaminophen toxicity. The court found his methodology to be sufficiently reliable.
The court believed that the expert’s reliance on his experience and knowledge in analyzing the information available to him was an appropriate methodology for the pharmacovigilance expert and it was not necessary for his testimony to be scientific.
The court was of the opinion that the expert’s testimony regarding the extent of harm caused by acetaminophen toxicity was not inadmissible merely because it involved rough calculations as that affected the weight of the testimony. The court noted that his methodology about legal and regulatory compliance was standard industry procedure, relevant and helpful to the trier of fact, and did not amount to legal opinion.
The defendant’s motion to exclude the testimony of the plaintiff’s pharmacist expert witness was denied.