Court: United States District Court for the Northern District of Illinois, Eastern Division
Case Name: In re Testosterone Replacement Therapy Prods. Liab. Litig. Coordinated Pretrial Proceedings
Citation: 2018 U.S. Dist. LEXIS 143368
The plaintiffs filed a multi-district litigation (MDL) against the defendant alleging injuries caused due to taking the defendant’s prescription testosterone replacement therapy (TRT) drugs. It was alleged that these TRT drugs caused the plaintiffs to suffer from arterial cardiovascular injuries or venous thromboembolisms (injuries related to blood clots in the veins).
The defendant filed a motion to exclude the testimony of plaintiffs’ expert witnesses, including the plaintiffs’ pharmacology expert witness.
The Pharmacology Expert
The plaintiffs’ pharmacology expert witness was supremely qualified to opine on the issues at hand. The expert had 40+ years of experience in the research and development of traditional pharmaceutical and biotechnology-derived products, medical devices, and in-vitro diagnostics. Over the course of her career, she founded a full-service clinical contract research organization (CRO) and worked with 50+ companies and on 50+ drugs, biologics, medical devices, and combination products. She held degrees in microbiology and toxicology with pharmacology as a minor. She was also an active industry speaker and educator who served on the advisory boards of multiple organizations.
The pharmacology expert had experience in regulatory affairs, strategic planning, non-clinical testing, and all phases of clinical trials. She successfully lead development programs for a number of novel therapeutics in multiple therapeutic areas, from designing first-in-man studies to directing pivotal licensing studies. Her medical device experience included development of in-vitro diagnostics and encompassed all three classes of medical devices. The pharmacology expert had also prepared numerous regulatory submissions and consulted with the U.S. Food and Drug Administration concerning INDs, NDAs, PLAs/BLAs, 510(k)s, and PMAs.
The defendant argued that the pharmacology expert’s opinion on the underreporting of adverse drug reactions was based on very old studies. The defendant further argued that the underreporting rate was faulty, as the pharmacology expert relied only on 1 of 37 studies in the article on which she based her conclusion. The court noted that these arguments affected only the weight of the expert’s testimony, not its admissibility.
The court also dismissed the defendant’s contention that the expert had mischaracterized testimony by a witness to opine on what the defendant believed to be the rate of underreporting, because the defendant failed to point out any such mischaracterization. Furthermore, the court could find no mischaracterization either. The court noted that the alleged flaws in the expert’s report should be addressed by the defendant during cross-examination.
The court held that the testimony offered by the pharmacology expert witness was reliable, relevant, and assisted the finder of fact. The testimony of the pharmacology expert witness was thus admitted.