United States District Court, S.D. Indiana, Indianapolis Division
BOBBY DON BOWERSOCK, and CHARLOTTE ROBINSON as Co-Personal Representatives of the Estate of Georgia J. Bowersock, deceased, and MARK BOWERSOCK Individually, Plaintiffs,
DAVOL, INC., C.R. BARD, INC., Defendants.
ORDER ON DEFENDANTS' MOTION FOR SUMMARY
J. McKINNEY, JUDGE
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.
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).
reasons set forth below, the Court GRANTS Bard's motions.
COMPOSIX KUGEL PATCH AND INSTRUCTIONS FOR USE
Composix Kugle Patch (“CK Patch”) is a
prescription medical device created by Bard for use in hernia
repair. Dkt. 43 at 2. 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.
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.
CK PATCH RECALL
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.,
IMPLANTATION OF CK PATCH INTO GEORGIA BOWERSOCK
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.
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.
GEORGIA BOWERSOCK'S OCTOBER 2006 HOSPITAL VISITS
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.
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.
GEORGIA BOWERSOCK'S AUTOPSY
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.
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.
EXHUMATION OF GEORGIA BOWERSOCK
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.
DR. STEPHEN FERZOCO
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.
Ferzoco was hired as the Plaintiffs' expert to opine
about Georgia's case. Id.
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 ...