Harris Beach attorneys Judi Abbott Curry, Victoria A. Graffeo and Marina Plotkin prevailed on plaintiffs’ appeal to the Second Circuit of product liability failure to warn claims against Pioneer Surgical Technology, Inc. and Zimmer Inc. Tomaselli v. New York & Presbyterian Hosp., No. 17-2059-CV, 2018 WL 1612230 (2d Cir. Apr. 4, 2018). The case arose from in-vivo fracture of a metal cable in a Greater Trochanter Reattachment (“GTR”) device, used to fixate a fractured femur near a hip implant. Plaintiff opted not to have the fractured cable removed. Plaintiff did not submit the opinion of an expert witness but alleged that the GTR device was defective by virtue of fracture of one of the cables annexing the plate to the bone. The District Court dismissed plaintiffs’ array of tort-based and contract-based claims, including negligence, strict products liability for failure to warn, manufacturing defect and design defect, and breach of express and implied warranties. Plaintiffs appealed the dismissal of the failure to warn claims, arguing that the implanting surgeon could not be a learned intermediary under New York law because he acknowledged that he did not read the Instructions for Use prior to plaintiff’s surgery. Nevertheless the implanting surgeon had testified that he had vast experience with these types of devices, was aware of the risk of fracture and thus he did not need to read the accompanying instructions for use inserted into the packaging in accordance with federal law.
The Second Circuit affirmed SDNY’s grant of summary judgement on two independently sufficient grounds. First, the Court reinforced well-established law that competent medical expert testimony is necessary when the issue of causation is beyond the purview of the ordinary person. Absent expert testimony, plaintiff’s own assertion that the fractured cable caused her pain was “uninformed speculation, which, standing alone cannot constitute sufficient evidence … of proximate cause.” Id.
And second, the implanting surgeon qualified as an informed intermediary due to his independent knowledge of the risk of cable fracture. “[W]hile Tomaselli's doctor never saw the specific prepackaged warning indicating that the cables could break, he nevertheless knew that cables in implant devices could break after implantation.” Id.
