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Bowersock v. Davol, Inc.

United States District Court, S.D. Indiana, Indianapolis Division

February 23, 2017

BOBBY DON BOWERSOCK, and CHARLOTTE ROBINSON as Co-Personal Representatives of the Estate of Georgia J. Bowersock, deceased, and MARK BOWERSOCK Individually, Plaintiffs,
v.
DAVOL, INC., C.R. BARD, INC., Defendants.

          ORDER ON DEFENDANTS' MOTION FOR SUMMARY JUDGMENT

          LARRY J. McKINNEY, JUDGE

         This case is before the Court on Defendants', Davol, Inc. and C.R. Bard, Inc. (collectively, “Bard”), Motion for Summary Judgment (Dkt.30) on Plaintiffs', Bobby Don Bowersock, Charlotte Robinson, and Mark Bowersock (collectively “Plaintiffs'”), Complaint. Dkt. 1. Plaintiffs allege that a hernia patch manufactured by Bard and implanted in Georgia Bowersock was defective and ultimately led to her death, in violation of the Indiana Products Liability Act. Ind. Code § 20-1-1. Mark Bowersock has also asserted an individual claim under the Indiana Wrongful Death Act. Ind. Code § 34-23-1-1.

         In addition to its Motion for Summary Judgment, Bard has filed motions to exclude the testimony of Plaintiffs' experts Dr. Stephen Ferzoco (Dkt. 33) and Dr. William A. Hyman (Dkt. 39), as well as a motion to limit the testimony of Dr. Roland Kohr (Dkt. 37).

         For the reasons set forth below, the Court GRANTS Bard's motions.

         I. BACKGROUND

         A. COMPOSIX KUGEL PATCH AND INSTRUCTIONS FOR USE

         The Composix Kugle Patch (“CK Patch”) is a prescription medical device created by Bard for use in hernia repair. Dkt. 43 at 2.[1] The CK Patch was declared by the Food and Drug Administration (“FDA”) to be “substantially equivalent” to a device that had already been declared by the FDA to be safe and effective. Id. at 3. The CK Patch consists of a dual layer of polypropylene mesh on one side, and an expanded polytetrafluoroethylene layer (“ePTFE”) on the other side. Hyman Report at 2. The ePTFE is intended to prevent damage to internal organs. Id. The CK Patch design also contains a polyethylene terephthalate (“PET”) overlap-welded “memory ring.” Id. The purpose of the ring 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. at 5. The ring, however, remains implanted for the life of the patient along with the mesh components following insertion of the patch. Id. at 2, 9.

         The CK Patch came with Instructions for Use (“IFU”), which detailed indications, contraindications, warnings, and precautions associated with the patch. Dkt. 43 at 5. The IFU did not, however, warn against potential dangers associated with the ring. Id.; Lynch Dep. 148:7-149:6. The IFU states that “there is a possibility for adhesion formation when the polypropylene is placed in contact with the bowel or viscera.” Dkt. 43 at 6. The Warnings section of the IFU provides that “[i]f an infection develops, treat the infection aggressively. The prosthesis may not have to be removed. An unresolved infection, however, may require removal of the prosthesis.” Id. The IFU also warns against “plac[ing] the mesh surface against the bowel” because “[t]here may be a possibility for adhesion formation.” Id. at 7.

         B. CK PATCH RECALL

         In December 2005, Bard initiated a recall of extra-large models of the CK Patch following reports that memory recoil rings were breaking. Dkt. 31, Ex. 7. In March 2006, Bard expanded the recall to other models, specifically the 202 and 204 CK Patches manufactured before January 2004, as well as model 209 CK Patches manufactured before March 2006. Id., Ex. 8.

         C. IMPLANTATION OF CK PATCH INTO GEORGIA BOWERSOCK

         Georgia Bowersock presented to Dr. Mark Lynch in May 2005 with an abdominal wall hernia. Lynch Dep. 86:9-19. Dr. Lynch indicated that Georgia was at a high risk of infection and recurrence, and that she exhibited severe chronic obstructive pulmonary disease (“COPD”), cardiac issues, obstructive sleep apnea, morbid obesity, and was a long-term smoker. Id. at 79:12-22; 80:14-82:5. Dr. Lynch went over the risks and benefits of hernia repair surgery with Georgia, to which she consented. Id. at 86:1-87:2; 91:16-92:7. Dr. Lynch implanted the CK Patch into Georgia in July 2005. Id. at 89:21-90:8.

         Following the implantation of the CK Patch and several follow up appointments for discharge and wound healing issues, on September 19, 2005, Dr. Lynch instructed Georgia to return if she had any problems with her incision, signs of infection, or any issues in her abdominal area. Id. at 111:8-113:18; 115:7-16. Georgia did not call Dr. Lynch's office or return for treatment. Id. at 115:15-116:4.

         D. GEORGIA BOWERSOCK'S OCTOBER 2006 HOSPITAL VISITS

         Over a year later, on October 4, 2006, Georgia presented to the emergency room at Terre Haute Regional Hospital, with an abdominal wall abscess that was draining pus and blood. Dkt. 31, Ex. 13 at 7. A culture of the abscess revealed the presence of staphylococcus aureus, a common skin bacteria. Kumar Dep. 47:9-48:3. Georgia was prescribed antibiotics and sent home. Id. at 48:4-10. She returned to the hospital on October 13, 2006. Dkt. 31, Ex. 13 at 10. By October 17, 2006, she was on a ventilator and immobile; Georgia had an abscess in the anterior abdominal wall, which her primary care physician and attending physician at the hospital, Dr. Pardeep Kumar, believed to be the source of the infection. Kumar Dep. 14:4-12; 41:17-21. On October 17, 2006, a second culture of the abdominal wall abscess revealed the presence of enterococcus faecalis - a bacteria that often inhabits the gastrointestinal tract - as well as staphylococcus epidermidis, a skin bacteria. Id. 48:21-49:5. See also, Dkt. 31, Ex. 13 at 8.

         Georgia passed away on October 31, 2006. Dkt. 31, Ex. 14. Dr. Kumar signed her death certificate, listing the cause of death as pneumonia and renal failure. Id.

         E. GEORGIA BOWERSOCK'S AUTOPSY

         Dr. Roland Kohr performed an autopsy on Georgia on October 31, 2006. See Dkt. 31, Ex. 15. Dr. Kohr listed the cause of death as “[p]neumonia and diffuse alveolar damage.” Id. at 2. The Autopsy Report further indicated that the “small bowel and colon are intact without perforation, diverticula or palpable tumors.” Id. at 5. The Autopsy Report also mentioned anatomic findings of dense abdominal adhesions and abdominal wall fistula. Id. at 2.

         In his summary, Dr. Kohr stated, “Georgia Bowersock was a 59 year old white female who presented to Regional Hospital on October 13 complaining of an abdominal wall draining wound. She had undergone a herniorrhaphy many months earlier, and had developed questionable complications.” Id. at 3. It further stated that “[d]uring her admission she developed sepsis, and then progressed eventually to respiratory failure.” Id.

         F. EXHUMATION OF GEORGIA BOWERSOCK

         On September 19, 2013, Dr. Kohr exhumed Georgia's body at Plaintiffs' request. See Dkt. 38, Ex. 6. The exhumation was conducted to retrieve the CK Patch for further study. Id. at 3.

         G. DR. STEPHEN FERZOCO

         Dr. Stephen Ferzoco is the former director of Brigham and Women's Hernia Center at Faulkner Hospital. Dkt. 31, Ex. 27 at 2. He is a board certified general surgeon that specializes in gastrointestinal and general surgery with a particular interest in complex abdominal hernias and he has used the CK Patch in his practice. Id. Following the CK Patch recall, Dr. Ferzoco developed and ran a medical monitoring program to follow and evaluate patients that had received CK Patch implants. Id.

         Dr. Ferzoco was hired as the Plaintiffs' expert to opine about Georgia's case. Id.

         Dr. Ferzoco reviewed the explanted mesh taken from Georgia post-exhumation, as well as her medical records and autopsy reports. Id. at 3. In his expert report, Dr. Ferzoco states that his “opinions are based on my review of the above referenced materials, my education, my medical training, and my practice as a general surgeon with a specialty in gastrointestinal surgery, including surgeries involving the Composix Kugel Mesh patches.” Id. In his report, Dr. Ferzoco opined that Georgia's death was a result of sepsis caused by a defective CK Patch. He states:

It is my opinion that the abscess and sepsis were caused by a defective mesh product leading to warping of the mesh and dense adhesions to the intestines. This insult of the warped or buckled patch led to the infection and need for hospitalization. Upon my inspection of the mesh, it is apparent that the ...

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