Court: United States District Court for the Southern District of West Virginia, Charleston Division
Case Name: In re C. R. Bard, Inc.
Citation: 2018 U.S. Dist. LEXIS 151673
This case was a part of one of the seven MDLs concerning the use of transvaginal surgical mesh to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI). In the seven MDLs, there were more than 16,000 cases pending, approximately 1,500 of which were in the Bard MDL, 2187 MDL.
In this case, the court was set to resolve pretrial issues in a timely and expeditious manner and resolve the disputes related to important evidence. The court had decided to conduct pretrial discovery and motions practice on the individualized basis.
Through referencing other cases, the court determined that the process of providing clinical consultations to physicians, which requires pathologists to examine clinical information through specimens, reports, or physician’s findings and reach a pathologic diagnosis, qualifies them to render an opinion on human clinical response to polypropylene mesh.
The Defense Calls a Pathology Expert
Bard offered a board-certified pathologist and the Chair of Pathology and Laboratory Medical Director of Stamford Hospital Health System in Stamford, Connecticut, as an expert witness on general pathology issues related to Bard’s Avaulta and Align products for POP and SUI repair. The expert had more than 25 years of experience evaluating human tissue response to neoplastic conditions. He had subspeciality in gynecologic pathology and had also taught pathology to medical students and residents. On a daily basis, the expert provided diagnostic microscopic evaluations to the consulting physician patients.
The plaintiffs moved to preclude the expert from offering opinions on the following matters:
1) The Design and Physical Properties of Pelvic Mesh Products
The plaintiffs argued that the expert was not qualified under Federal Rule of Evidence 702 to render an opinion on the design of the mesh products in question, specifically with respect to the biocompatibility of polypropylene. He was not a biomaterials expert and had never performed mechanical or chemical testing on polypropylene mesh.
2) The Adequacy of Instructions for Use
The plaintiffs also argued that as a pathologist, the expert was not qualified to render an opinion on the adequacy of the instructions for use.
In Tyree v. Boston Scientific Corp. and Sanchez v. Boston Scientific Corp., where the parties had demanded the exclusion of an expert pathologist who testified on the general pathology of vaginal mesh implantation, the court held that the expert’s extensive experience in pathology qualified him to submit opinions regarding the human clinical response to polypropylene mesh. The expert frequently engaged in the process of reaching a diagnosis through clinical and pathologic correlation, which required him to examine clinical information through specimens, reports, or physician’s findings.
The court found that the qualifications of the two experts were not materially different. Hence, the pathology expert was qualified to offer expert testimony on the biocompatibility of polypropylene and opine on the relationship between design characteristics and the physiological response in patients.
Regarding the expert’s qualifications to opine on the adequacy of IFU, the court held that without additional expertise in the specific area of product warnings, a doctor, such as a pathologist, was not qualified to opine on the adequacy of a product warning IFU merely because of his experience in reviewing product inserts or reviewing the actions of gynecologists.
The plaintiffs’ motion was denied in part and granted in part.