Hernia Patch Case Tossed Out Along with Expert Causation Opinions

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A District Court in Indiana recently awarded summary judgment to a medical device manufacturer upon finding the plaintiffs were unable to proffer any expert causation evidence that satisfied the requirements of Federal Rule of Evidence 702 and Dabuert. See Bowersock v. Davol, Inc., No. 108CV01313LJMTAB, 2017 WL 711849, at *1 (S.D. Ind. Feb. 23, 2017).  Plaintiffs, representatives of the Estate of Georgia Bowersock, alleged that a hernia patch manufactured by C.R. Bard, Inc. (“Bard”) and implanted in Bowersock was defective and ultimately led to her death.  Bard moved for summary judgment and to exclude the testimony of Plaintiffs’ experts Dr. Stephen Ferzoco and Dr. William Hyman, as well as to limit the testimony of Dr. Roland Kohr.  The court agreed that these experts lacked qualifications or failed to put forth reliable testimony on medical causation, and thus, Plaintiffs could not establish a violation of the Indiana Products Liability Act.

Bard manufactures the Composix Kugle Patch (“CK Patch”), a prescription medical device for use in hernia repair.  The CK patch consists of a dual layer of polypropylene mesh on one side, and an expanded polytetrafluoroethylene layer on the other side, which is designed to prevent damage to internal organs.  The patch also contains a “memory ring,” the purpose of which is to facilitate initial placement of the mesh by the surgeon as a result of the ring’s tendency to cause the mesh to lay flat. Id.  The ring, along with the rest of the device, remains implanted for life following insertion of the patch.  The Instructions for Use (“IFU”) accompanying the patch did not warn against potential dangers associated with the ring.  The IFU did note the “possibility for adhesion formation when the polypropylene is placed in contact with the bowel or viscera.” Id.  The IFU also provided that if an infection develops, to treat it aggressively and that an unresolved infection “may require removal of the prosthesis.” Id.  Finally, the IFU warned against placing the mesh surface against the bowel because of the possibility for adhesion formation. Id. By March 2006, Bard had recalled several models of the CK Patch following reports that memory recoil rings were breaking. Id. at *2.

In July 2005, Dr. Mark Lynch implanted the CK Patch into Bowersock for an abdominal wall hernia. Id.  Over a year after the implantation, on October 4, 2006, Bowersock presented to the emergency room with an abdominal wall abscess, which revealed the presence of staphylococcus aureus, and was prescribed antibiotics and sent home.  She returned to the hospital on October 13, and was on a ventilator and immobile within four days.  She had an abscess in the anterior abdominal wall, which her primary care physician and attending physician at the hospital believed to be the source of the infection.  Id.  A second culture of the abscess revealed the presence of enterococcus faecalis, a bacteria that often inhabits the gastrointestinal tract, and staphylococcus epidermidis, a skin bacteria.  Ms. Bowersock passed away on October 31, 2006. Id.

Dr. Stephen Ferzoco is a board certified general surgeon who specializes in gastrointestinal surgery with a particular interest in complex abdominal hernias and who has used the CK Patch in his practice.  Following the recall, Dr. Ferzoco developed and ran a medical monitoring program to follow and evaluate patients that had received CK Patch implants.  Dr. Ferzoco reviewed the explanted mesh taken from the deceased, as well as her medical records and autopsy reports.  He opined that Bowersock’s death was a result of sepsis caused by a defective CK Patch.  Specifically, the defective mesh product led to warping of the mesh and dense adhesions to the intestines that led to the infection.  Dr. Ferzoco concluded from his inspection that the mesh was buckled but did not identify any ring break. Id. at *3.  He also opined generally regarding the cause of defects in the CK Patch and that the fixed ring allows the material to buck and warp, which can cause a multitude of injuries, including perforation and fistula. Id.  However, Dr. Ferzoco admitted that he had not seen any published medical literature that describes the theory he was offering in Ms. Bowersock’s case. Id. at *4.

The court found that Dr. Ferzoco was unable to set forth a reliable, scientific opinion as to how the CK Patch’s alleged buckling caused Bowersock’s injury.  Whereas other CK Patch cases involved the polypropoylene side of the mesh coming into contact with bowel and intra-abdominal organs, under Dr. Ferzoco’s “nidus theory,” the CK Patch rubbed against Bowersock’s bowel to create a “microperforations” too small to be seen with the naked eye that allowed bowel contents to spill over, or perforations that closed up prior to performance of the autopsy. Id. at *7.  Dr. Ferzoco admitted that his nidus theory had neither been described in the medical literature nor peer reviewed.  None of the symptoms he described were found in Bowersock’s medical records or autopsy report, and the theory was not based on any of the materials provided in connection with other CK Patch cases.  Instead, Dr. Ferzoco’s purported support for this theory was his prior experience with other patients.  However, Dr. Ferzoco could not identify any patients by name or produce medical records to substantiate his theory.  The court found that “[t]he fact that Dr. Ferzoco has allegedly seen his nidus theory occur in unnamed patients [was] simply not enough.” Id. at *8.  While the court agreed with Plaintiffs that Dr. Ferzoco’s extensive experience with hernia repair and his post-recall CK patch monitoring program established that he had the requisite credentials and knowledge to qualify as an expert, he was unable to point to any specific experience to connect his qualifications with his opinions in this case. Id.

Plaintiffs’ second causation expert was Dr. William Hyman, a professor of biomedical engineering who has written extensively and taught classes on medical device safety, design, implant materials and FDA regulations.  Dr. Hyman opined that the design of the CK Patch is defective and that its defects were a direct cause of Ms. Bowersock’s injuries and death.  Dr. Hyman never examined Ms. Bowersock’s patch nor viewed any pictures of it, but he saw the patch in Dr. Ferzoco’s video.  The court excluded Dr. Hyman’s testimony with relative ease.  Dr. Hyman is not a medical doctor or an expert on cultures, but purportedly based his causation opinion on the second medical culture showing the presence of fecal bacteria and the opinion of Dr. Ferzoco. Id. at *9.  The court noted that Dr. Hyman did not perform any testing on a CK Patch or any other hernia mesh products with a composite ring, was unaware of any test or study demonstrating his proposed failure mechanism, and did not examine Bowersock’s CK Patch or view images of it after removal of the tissue.  He could not state where the ring distorted, nor could he estimate the amount of deformation required to cause an injury.  For these reasons, the court found Dr. Hyman was not qualified to testify as to why the “well-known phenomenon” of patch buckling could cause the injuries suffered by Ms. Bowersock. Id.

Finally, the court limited the testimony of Dr. Ronald Kohr, who performed an autopsy of Bowersock on October 31, 2006 and reported her cause of death to be pneumonia and diffuse alveolar damage, to treatment evidence concerning the autopsy and exhumation of Bowersock’s body.  Although Plaintiffs did not disclose Dr. Kohr as an expert, they sought to have him testify that he possessed a lack of information relating to safety issues in the CK Patch and that, had he been provided such information prior to the autopsy, he would have rendered a different cause of death.  The court excluded this causation testimony for failure to satisfy the disclosure requirements of Rule 26. Id. at *10.

Because Plaintiffs were unable to submit any admissible evidence with respect to causation, the court granted Bard’s motion for summary judgment.

Bowersock’s lawsuit, which was remanded to Indiana federal court from the Rhode Island multidistrict litigation in December, involved an atypical factual scenario among the hernia patch cases.  Plaintiffs relied on expert opinions that adopted familiar defect arguments and seemingly attempted to stretch them to conform to the facts at hand.  Yet, Bard argued, and the court agreed, that these essentially novel causation theories did not hold up under Dabuert scrutiny.  Although Dr. Ferzoco had extensive experience with patients who received CK Patch implants, his causation opinion was excluded because it was based on a theory that had not been tested, subjected to peer review and publication, analyzed for error rate, or generally accepted within the scientific field.  Therefore, in granting Bard’s motion, the court rejected the premise that an expert’s experience alone will always provide sufficient foundation for expert testimony.