Court: United States District Court for the Northern District of Illinois, Eastern DivisionJurisdiction: FederalCase Name: In re Testosterone Replacement Therapy Prods. Liab. Litig. Coordinated Pretrial ProceedingsCitation: 2018 U.S. Dist. LEXIS 143368
Facts
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.
Court Discussion
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.
Held
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.
About the author
Zach Barreto
Zach Barreto is a distinguished professional in the legal industry, currently serving as the Senior Vice President of Research at the Expert Institute. With a deep understanding of a broad range of legal practice areas, Zach's expertise encompasses personal injury, medical malpractice, mass torts, defective products, and many other sectors. His skills are particularly evident in handling complex litigation matters, including high-profile cases like the Opioids litigation, NFL Concussion Litigation, California Wildfires, 3M earplugs, Elmiron, Transvaginal Mesh, NFL Concussion Litigation, Roundup, Camp Lejeune, Hernia Mesh, IVC filters, Paraquat, Paragard, Talcum Powder, Zantac, and many others.
Under his leadership, the Expert Institute’s research team has expanded impressively from a single member to a robust team of 100 professionals over the last decade. This growth reflects his ability to navigate the intricate and demanding landscape of legal research and expert recruitment effectively. Zach has been instrumental in working on nationally significant litigation matters, including cases involving pharmaceuticals, medical devices, toxic chemical exposure, and wrongful death, among others.
At the Expert Institute, Zach is responsible for managing all aspects of the research department and developing strategic institutional relationships. He plays a key role in equipping attorneys for success through expert consulting, case management, strategic research, and expert due diligence provided by the Institute’s cloud-based legal services platform, Expert iQ.
Educationally, Zach holds a Bachelor's degree in Political Science and European History from Vanderbilt University.
