Charlotte Robinson and Bobby Don Bowersock as co-personal representatives of the Estate of Georgia J. Bowersock, deceased, and Mark Bowersock, individually, Plaintiffs-Appellants,
Davol Inc. and C.R. Bard, Inc., Defendants-Appellees.
February 13, 2018
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.
Sykes and Barrett, Circuit Judges, and Griesbach, Chief
District Judge. [*]
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.
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.
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.
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.
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.
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 The novel theory of causation was not peer reviewed,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.
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.
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.
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