Just about a year ago, we posted about an interesting device case in which the U.S. District Court for the Central District of Illinois, in an opinion by Chief Judge Michael P. McCuskey, found inadmissible plaintiff’s expert witness testimony that his knee implant failed due to alleged oxidation caused by the method Zimmer used to sterilize the product. Fuesting v. Zimmer Inc., 2009 WL 174163 (C.D. Ill., 1/26/09).
Last week the federal appeals court affirmed the judgment for the knee implant maker. Fuesting v. Zimmer Inc., 2010 WL 271728 (7th Cir. 1/25/10). Fuesting had alleged he received the Zimmer-made implant in 1994. In 2001, he began experiencing pain in the knee, and his doctor removed the prosthesis in November of that year. Fuesting sued, alleging that Zimmer’s sterilization of the prosthesis by gamma irradiation in air (GIA) rendered it defective. At trial, his expert witness, Dr. Pugh, testified that GIA caused the prosthesis to oxidize and delaminate, resulting in premature failure. A jury returned a verdict for plaintiff, but the Seventh Circuit vacated the judgment after finding that Pugh’s testimony did not meet the requirements for admissibility of expert testimony under Fed. R. Evid. 702 and the standards set forth in Daubert.
On remand, Fuesting proffered the testimony of a second expert witness, Dr. Rose. But the trial court found that Dr. Rose had not bridged the analytical gap between accepted principles and his complex conclusions. He had not, and could not, show that the prosthesis failed because of the sterilization method used. The expert testimony as to defect also failed.
On appeal, the Seventh Circuit stated that Dr. Rose’s testimony did not show that his theory that these knee implants oxidize “in vivo” had sufficient acceptance in the scientific community. He failed to point to any peer reviewed studies that discuss the oxidation rates of this type of implant in vivo. Dr. Rose failed to cite any articles or studies that he or any one else conducted regarding how one can discern whether the alleged oxidation occurred before or after implantation. Dr. Rose also did not rule out possible alternative methods of causation. Nor did he explain how the device’s oxidation caused the device to fail, as the mere presence of oxidation does not prove that the oxidation caused the device to malfunction.
Dr. Rose also failed to “bridge the analytical gap” between the accepted fact that GIA sterilization causes at least some amount of oxidation and his ultimate conclusion that Fuesting’s knee implant in particular failed because GIA, rather than another sterilization method, was used. Last, Dr. Rose failed to show that better sterilization alternatives existed in 1991. He concluded, in one sentence of his report, and without any support, that the industry standard was to sterilize implants in an inert gas instead of air. In fact, no manufacturer at that time employed any of the proffered methods, and Dr. Rose cited no contemporary articles counseling the use of such methods. For all these reasons, the district court did not abuse its discretion in excluding Dr. Rose’s testimony.