In a recent decision out of the Seventh Circuit, Antrim Pharms. Llc. v. Bio-Pharm, Inc., 2020 U.S. App. LEXIS 4772* (7th Cir. 2020), the court decided a battle of the experts: Bio-Pharm prevailed after Antrim unsuccessfully argued the court should preclude testimony by Bio-Pharm’s expert, HP&M’s own Mark Schwartz, on how the FDA regulates ANDA holders. BioPharm also successfully argued the court should preclude testimony by Antrim’s expert on industry practices and how Bio-Pharm’s alleged breach impaired the value of Antrim’s business.
While we won’t get into the specifics of the case, what is important for our readers’ purposes is that Antrim sought to preclude Bio-Pharm’s expert, Mark Schwartz, because “allowing an FDA officer to testify on a legal issue invades the province of the court.” We all learned in trial practice 101 that experts generally may not testify on pure issues of law, such as the meaning of statutes or regulations – that is the province of the attorneys trying the case, right? But, the decision point out, courts do permit regulatory experts – even those who are lawyers – to testify on complex statutory or regulatory frameworks when it might help the jury understand a complicated framework. Indeed, Fed. R. Evid. 702(a) states “A witness who is qualified as an expert. . . may testify in the form of an opinion or otherwise if: the expert’s . . . specialized knowledge will help the trier of fact to understand the evidence or to determine a fact in issue.” While the court called this issue of preclusion “complicated,” it ultimately denied the motion to preclude the expert and allowed Mark to testify.
The next issue before the Court was whether Antrim’s industry expert with over 20 years of experience in the pharmaceutical industry should have been precluded. This preclusion hinged not on the expert’s qualifications, but his intention to testify about “well-known industry practice and norms” on the issue of the specific ownership interests at issue in the case. The problem was that the expert admitted during deposition that he had no specific knowledge of the ownership interests of either of the parties, even though that was precisely the fact at issue. The court determined that the proffered testimony was not relevant to whether the parties had in fact entered into an agreement to share equity.
In short, this case is a study not only in selecting your experts well, but also ensuring that their testimony is relevant and will help jurors – and the court – better “understand the evidence or determine a fact in issue.” Mark Schwartz – the expert in the case discussed above – has served as an expert witness in other FDA-related litigation, basing that expertise on his 13 years at the FDA in various capacities, including ten years in the Office of Chief Counsel and three years as CBER’s Deputy Director of the Office of Compliance and Biologics Quality.
HP&M is nationally known and ranked for its food, drug and device regulatory knowledge, and HP&M attorneys regularly serve as advocates in disputes, but our readers may not realize the depth of our bench in expert witnesses. That experience ranges from issues such as the FDA regulatory framework, drug and biologic manufacturing, FDA drug and biologic compliance and enforcement (Mark Schwartz) to Hatch-Waxman, drug approval, and biosimilars (Kurt Karst), to the appropriateness of a change to the device without a new 510(k) and device labeling/advertising (Jeff Shapiro) among other topics and experts.