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In re Zimmer, NexGen Knee Implant Products Liability Litigation

United States Court of Appeals, Seventh Circuit

March 8, 2018

In re: Zimmer, NexGen Knee Implant Products Liability Litigation Appeal of: Theodore F. Joas and Darlene A. Joas

          Argued May 22, 2017

         Appeal from the United States District Court for the Northern District of Illinois, Eastern Division. No. 13 C 9216 - Rebecca R. Pallmeyer, Judge.

          Before Flaum, Easterbrook, and Sykes, Circuit Judges.


         Theodore Joas underwent a total knee replacement at a Wisconsin hospital and received a Zimmer NexGen Flex knee implant. Within a few years, he began experiencing pain in his new knee. X-rays confirmed that the implant had loosened and required a surgical fix. Joas brought a panoply of claims against Zimmer, Inc., the implant manufacturer. His case was transferred to a multi-district litigation in the Northern District of Illinois, where it was eventually treated as a bellwether case. Applying Wisconsin law, the presiding judge entered summary judgment for Zimmer.

         Joas asks us to reinstate a single claim based on a theory of inadequate warning. His appeal raises some unresolved issues in Wisconsin product-liability law-most notably, the application of the "learned intermediary" doctrine, which the Wisconsin Supreme Court has not yet had an opportunity to address. We predict that the state high court would follow the lead of other states and adopt this doctrine. We affirm the judgment.

         I. Background

         Joas's suit is the second bellwether case in a multidistrict litigation concerning Zimmer NexGen Flex knee implants. Plaintiffs in the litigation allege that they have suffered pain and loss of movement because the NexGen Flex is prone to premature loosening.[1]

         In 2008 Joas had knee-replacement surgery at a hospital in Eau Claire, Wisconsin. His surgeon used a Zimmer NexGen Flex implant. At the time Joas worked for Pepsi Bottling Group, and his job required him to lift and carry heavy loads and to squat repeatedly throughout the day. Soon after the surgery he was able to engage in physical therapy, return to work, and participate in recreational activities like hunting and canoeing. By 2011, however, Joas began to feel pain in his new knee. An x-ray and bone scan revealed aseptic loosening of the tibial component of the implant. Translation: the bond between the implant and the shinbone had weakened. He had revision surgery in October 2012.

         In 2013 Joas sued Zimmer alleging that the NexGen Flex design causes premature loosening for total-knee-replacement patients who engage in activities that require a high degree of knee flexibility. He filed his suit in federal court in New Jersey and raised product-liability claims premised on allegations of defective design, manufacture, and warning.[2] (He also alleged misrepresentation and statutory consumer-protection claims, but he abandoned them at summary judgment.) The New Jersey court transferred the case to a multidistrict proceeding then underway in the Northern District of Illinois addressing lawsuits against Zimmer based on its NexGen Flex implant.

         The judge designated Joas's case as a bellwether and scheduled a trial. In the meantime Zimmer moved for summary judgment on all claims. Among other things, the manufacturer sought to exclude the testimony of Dr. Joseph Fetto, Joas's expert witness. Dr. Fetto's report indicated that his opinion testimony would be based on a differential etiology methodology, which entailed identifying and ruling out potential causes of the tibial loosening to arrive at the likeliest cause of Joas's injury. Applying Rule 702 of the Federal Rules of Civil Procedure and Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993), the judge excluded Dr. Fetto's testimony as unreliable because he did not have any discernible basis for determining which potential causes of the loosening were reasonable and which were not.

         Dr. Fetto was Joas's only expert who would testify that a defect in the knee implant caused his injury. With his expert's testimony excluded, Joas could not prevail on his claims based on defective design or manufacture. The exclusion of Dr. Fetto's testimony also left a causation gap in Joas's claim based on inadequate warning. To the extent that this claim could survive without Dr. Fetto's testimony, the judge rejected it as deficient in other respects and entered summary judgment for Zimmer on all claims.

         II. Discussion

         Joas limits his appeal to his claim based on defective warning. The claim rests on two theories. Joas argues that Zimmer (1) failed to issue proper warnings directly to him as the recipient of the knee replacement; and (2) failed to issue proper warnings to his surgeon, who implanted the device.

         Importantly, Joas does not quarrel with the exclusion of Dr. Fetto's testimony. Rather, he urges us to allow this claim to go forward based on the testimony of Dr. John Dearborn, Zimmer's expert witness. Dr. Dearborn testified in deposition that he would have used two bags of cement to properly bond a knee implant to the patient's shinbone. Joas's surgeon, Dr. Bryan Larson, used only one bag of cement, consistent with his normal practice. Joas maintains that Zimmer had a duty to warn that two bags of cement are needed to achieve a proper bond.

         The judge disallowed the claim for two reasons. First, she applied the learned-intermediary doctrine, which (as relevant here) holds that the manufacturer of a medical device has no duty to warn the patient as long as the manufacturer provides adequate warnings to the physician. Second, the judge held that even if Zimmer had a duty to warn the surgeon, Joas has no evidence of causation because Dr. Larson testified in deposition that he did not read the packaging material Zimmer sent with the NexGen Flex implant. Rather, he testified that he based his surgical technique entirely on his general medical training and his surgical fellowship. So an improved warning, the judge held, would not have made any difference.

         To overcome this factual deficit, Joas asked the judge to recognize and apply a legal presumption that the surgeon would have heeded an improved warning had Zimmer provided one. The judge declined to do so, holding that the proposed "heeding presumption" has no support in Wisconsin law.

         Both aspects of the failure-to-warn claim raise novel questions under Wisconsin law. We turn first to Joas's claim that Zimmer breached a duty to directly warn him. That inquiry requires us to predict whether the Wisconsin Supreme Court would recognize the learned-intermediary doctrine for use in defective-warning cases involving medical devices. We ...

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