An interesting issue recently arose (but was not resolved) in In re: Proton-Pump Inhibitor Products Liability Litigation, 2022 WL 2188038 (D.N.J. June 17, 2022) (“PPI”).  The ability of an FDA expert witness to testify was challenged under 18 U.S.C. §207, a federal conflict of interest statute.  We have never seen that statute invoked in connection with an ex-FDA witness before, and apparently neither has anyone else, since the opinion observes that “the fact pattern presented here is something of an unprecedented issue.”  Id. at *4 (citation and quotation marks omitted).  So we thought we’d alert our readers.

Continue Reading Regulatory Witnesses – Something Else To Watch

We are patrolling the advance sheets for Rule 702 decisions as part of our preparation for an upcoming DRI panel.  Not all of the cases are brand-spanking new and not all are wonderful.  Consider Wood v. American Medical Systems Inc., 2021 WL 1178547 (D. Col. March 26, 2021), for example.   It is a vaginal mesh case

We are on a DRI panel this September in Nashville discussing challenges to expert testimony, so we are especially vigilant when it comes to new cases on this subject. The rulings on expert admissibility in United States v. Biogen Idec., Inc., 2022 U.S. Dist. LEXIS 120549 (D. Mass. July 8, 2022), are not especially

Not too long ago we researched precedent that forbade persons claiming to be “FDA experts” from opining that products are “adulterated” or “misbranded.”  In that post, we mentioned that this research is a subset of a “general” precedent “precluding expert opinions on questions of law,” which we didn’t get into because Bexis’ book addressed it.