Expert Testimony on Pharmacy Dispensing Standards Admitted

The United States Attorney’s Office alleged that Omnicare violated the False Claims Act by failing “to obtain a new prescription” for residents of certain long-term-care facilities “after an old one expired or ran out of refills,” instead continuing to dispense medications through certain computer functionalities.

The Office retained Dr. W. Thomas Smith to review Omnicare’s medication-dispense records from a sample of patients to assess whether Omnicare dispensed non-controlled substances without a valid prescription—as defined by Smith.

Omnicare argued that the testimony from Smith about the requirements of pharmacy law in various states was improper because he testified about matters that are the province of the Court. 

Pharmacy Expert Witness

W. Thomas Smith has served as Dean of Health Sciences and Pharmacy at Manchester University (MU) College of Pharmacy, Natural and Health Sciences since 2017. He is active in several pharmacy professional organizations, including the American Association of Colleges of Pharmacy (AACP) and the American Society for Pharmacy Law (ASPL). He also currently serves as chair-elect of AACP’s Council of Deans and sits on the organization’s Board of Directors.

Want to know more about the challenges W. Thomas Smith has faced? Get the full details with our Challenge Study report.

Discussion by the Court

Smith — a duly qualified expert of pharmacology, who teaches pharmacists about how to comply with the law for a living — testified about whether Omnicare’s dispensing practice was consistent with the core pharmacy requirement in a number of states, whose laws required a valid prescription before dispensing drugs.

In applying state-law requirements to his assessment of Omnicare’s drug authorization records, Smith engaged in the type of pharmacist practice that pharmacists are trained to perform in their day-to-day practice.

Of the dispensings Smith identified as invalid, many were based on the fact that there was no authorization — no prescription whatever — for the drug dispensation. As noted above, the existence of a prescription is a federal requirement, and so required no application of state-specific standards. Moreover, Omnicare had the opportunity both to cross-examine Smith and offer its own competing expert — an option it chose not to exercise.

Held

The Court allowed Dr. W. Thomas Smith to testify as an expert about the pharmacy law requirements in different states.

Key Takeaway:

Experts regularly provide opinions related to legal requirements in regulated industries. Smith’s testimony did not usurp the role of the judge since he made no effort to instruct the jury on FCA law.

Case Details:

Case Caption:	United States Of America Ex Rel. Uri Bassan, Et Al V. Omnicare, Inc.
Docket Number:	1:15cv4179
Court Name:	United States District Court, New York Southern
Order Date:	August 18, 2025