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Robinson v. Davol Inc.

United States Court of Appeals, Seventh Circuit

January 22, 2019

Charlotte Robinson and Bobby Don Bowersock as co-personal representatives of the Estate of Georgia J. Bowersock, deceased, and Mark Bowersock, individually, Plaintiffs-Appellants,
v.
Davol Inc. and C.R. Bard, Inc., Defendants-Appellees.

          Argued February 13, 2018

          Appeal from the United States District Court for the Southern District of Indiana, Indianapolis Division. No. 1:08-cv-01313-LJM-TAB - Larry J. McKinney, Judge.

          Before Sykes and Barrett, Circuit Judges, and Griesbach, Chief District Judge. [*]

          SYKES, CIRCUIT JUDGE

         C.R. Bard, Inc., manufactures a surgical mesh patch used to repair hernias by implantation. The patch consists of two pieces of mesh that surround a flexible plastic ring. During a hernia repair, the patch is folded to fit through a small incision, then the plastic ring springs back into its original shape and flattens the mesh against the abdominal wall.

         Bard recalled several versions of the patch in late 2005 and early 2006 following reports that the plastic ring was defective. Sometimes the ring broke, exposing a sharp edge that could perforate the patient's intestines. Other times the ring caused the patch to bend and warp, exposing the patch's adhesive to a patient's viscera.

         Prior to the recall, Georgia Bowersock underwent surgery to repair a hernia, and her surgeon implanted a Bard patch. Roughly one year later, on October 31, 2006, she died of complications arising from an abdominal-wall abscess. Her estate and family members sued Bard and Davol Inc., the patent holder for the patch, alleging that a defect in the patch caused her death. To establish medical causation, the plaintiffs retained three experts to opine on the defect and the likely cause of Mrs. Bowersock's death.

         But the experts had trouble establishing causation. Unlike defective patches in other injured patients, Mrs. Bowersock's patch did not adhere to her bowel or perforate her organs with a broken, sharp edge. One expert tried to present a new theory of causation: the patch had "buckled," forming a stiff edge that rubbed against and imperceptibly perforated her internal organs.

         The defendants moved to exclude the expert testimony. The judge granted the motion, finding that the "buckling" theory was not sufficiently reliable. Lacking expert testimony to establish causation, the plaintiffs could not prove their case, and the judge entered summary judgment for Bard and Davol.

         We affirm. The novel theory of causation was not peer reviewed, professionally presented, consistent with Mrs. Bowersock's medical records or autopsy, or substantiated by other cases. The judge therefore did not abuse his discretion in excluding the expert testimony. Summary judgment for the defendants necessarily followed.

         I. Background

         The Composix® Kugel Patch is a prescription medical device designed to repair hernias. Bard manufactures the patch and Davol owns the patent. (We refer to them collectively as "Bard.") The patch consists of two layers of mesh that surround one or two flexible plastic rings called memory rings. The top layer is made of polypropylene; it adheres to the abdominal wall under the hernia and facilitates healing. The bottom layer is made of smooth expanded polytetrafluorethylene; it faces the bowel to prevent the patch from attaching to the viscera. To implant the patch, a physician folds the device and then inserts it into the patient via a small incision. After insertion the memory ring springs back and flattens the patch against the abdominal wall. The patch remains in the body after the hernia heals.

         The patch hit the market in 2001. Users soon began reporting problems with the plastic ring. Sometimes it would altogether fail. Other times the ring would experience "buckling"-that is, the mesh components of the patch would contract, causing the ring to resist and bend, kink, break, or buckle. Although the patch came with instructions for use that contained user warnings, none of the warnings mentioned any of these problems with the plastic ring. On December 22, 2005, Bard recalled all extra-large models. Several months later Bard expanded the recall to include other models.

         On May 25, 2005, Mrs. Bowersock sought medical treatment for an abdominal-wall hernia. On July 22 Dr. Mark O. Lynch performed surgery and implanted a Bard patch, using a model that was included in the second recall. Dr. Lynch testified that he would ...


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