BOWERSOCK et al v. DAVOL, INC. et al

Filing 74

ORDER ON DEFENDANTS' MOTION FOR SUMMARY JUDGMENT - Defendants', Davl, Inc. and C.R. Bard, Inc., Motion for Summary Judgment (Dkt. 30), is GRANTED. Defendants', Davol, Inc. and C.R. Bard, Inc., Motions in Limine to exclude the testi mony of Dr. Stephen Ferzoco (Dkt. 33) and Dr. William A. Hyman (Dkt. 39), as well as the Motion in Limine to limit the testimony of Dr. Roland Kohr (Dkt. 37), are GRANTED. The Court will enter judgment accordingly. (See Order.) Signed by Judge Larry J. McKinney on 2/23/2017. (LDH)

UNITED STATES DISTRICT COURT
SOUTHERN DISTRICT OF INDIANA
INDIANAPOLIS DIVISION

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

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No. 1:08-cv-01313-LJM-TAB

ORDER ON DEFENDANTS’ MOTION FOR SUMMARY JUDGMENT
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 § 34-231-1.
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.
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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

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The Court has attempted to set out the facts that are either undisputed or, if disputed,
in the light most favorable to the Plaintiffs as the non-moving parties. In order to
streamline this Order, unless otherwise noted the Court will cite to the ECF page number
or numbers where the relevant facts are set forth in a party’s brief and such citation should
be presumed to include the exhibits cited therein. It should also be presumed that when
using the Plaintiffs’ Statement of Disputed Facts (Dkt. 43), the Court incorporates the
citations utilized by Bard in its Statement of Undisputed Facts as well (Dkt. 32).
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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; 91:1692:7. 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

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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.

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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

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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 mesh is buckled. On further examination, I do not identify any ring
break.
Id. at 4.
Dr. Ferzoco then speaks in general with respect to the cause of defects in the CK
Patch indicating that the fixed ring allows the material to buck and warp into dangerous
conditions. Id. He further states, “It is my opinion that forces acting on the ring caused
the mesh to buckle and fold in an abnormal configuration. These forces include required
forces [sic] used to implant the device, body forces and contracture forces.” Id. Dr.
Ferzoco also mentions that Bard’s own medical literature review on contracture forces
identifies dozens of articles that pre-date the commercialization of the CK Patch implanted
in Georgia. Id. He states that the buckling that results from these forces “can cause a
multitude of injuries including, but not limited to perforation and fistula as a result of ring
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break or puncture caused by a sharp, buckled patch edge.” Id. Dr. Ferzoco concludes,
to a reasonable degree of medical certainty, “that Ms. Bowersock’s defective Composix
Kugel Mesh patch placed in 2005 buckled, causing adhesions leading to an abcess
formation and sepsis ultimately leading to her death.” Id. at 5.
At his deposition, Dr. Ferzoco opined that the ring buckled, creating a sharp edge,
which could breach the bowel. Ferzoco Dep. 22:18-23:4. He reviewed the CK Patch and
stated that it was “contorted, buckled, [and] certainly could have led to exposure of the
underlying bowel, a nidus for possible adhesions, erosions, and infection.” Id. at 25:2026:3. He admitted that he did not see any direct evidence of eroded bowel. Id. at 26:46. Nonetheless, Dr. Ferzoco believed that there was communication between the bowel
and the wound based on the presence of fecal bacteria, which was found during the
second culture on the microbiology report. Id. at 27:20-28:10. He believed that the
communication occurred “with the mesh rubbing up against the bowel causing a fistula or
break and then sealing up prior to explanation or discovery of the mesh in the bowel.” Id.
at 109:6-15.

Dr. Ferzoco admitted that, other than the second culture, he saw no

evidence of bowel involvement. Id. at 28:22-3; 46:3-9; 72:12-24. He stated, however,
that he believed that enterococcus (fecal) bacteria was present on the first culture from
October 4, 2006, but that it was not properly cultured. Id. at 100:12-20. Dr. Ferzoco
based this latter opinion on his education, training, and experience with similar patients.
Id. at 100:21-24.
Dr. Ferzoco conceded that the autopsy did not demonstrate any visual perforations
of the bowel. Id. at 46:10-47:6. When questioned further about the lack of perforations
found during the autopsy, Dr. Ferzoco stated, “Well, there had to be some perforation for

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her to get her bacteria. Again, my opinion is there had to be some perforation, whether
or not it had sealed at the time by the autopsy … [and] [t]hat they were unable to visualize
a perforation.” Id. at 58:17-4. He also stated that it could have been a “microperforation
that was unable to be well-visualized at the time of the autopsy.” Id. at 58:4-6. Dr.
Ferzoco believed that the bacteria from the bowel would travel through the edge of the
CK Patch’s material “because of the buckling, [forming] a channel that allows it to egress
through the midline of the wound.” Id. at 68:18-69:6. He believed that the physicians
who treated her, as well as Dr. Kohr, simply missed the bowel perforation. Id. at 179:711.
Dr. Ferzoco ruled out cross-contamination due to the location of the wound. Id. at
88:24-89:16. He found that it was “highly unlikely” that the enterococcus came in through
the skin. Id. at 112:20-22. He stated that his review of the medical literature, the records
in Georgia’s case and the patch itself “demonstrates to me that it is a very strong
possibility, more likely than not, that she had a violation of her GI tract that caused the
development of an abscess, which subsequently grew out a bowel species of bacteria
that led to her death.” Id. at 112:23-113:10.
Dr. Ferzoco admitted that he had not seen any published medical literature that
describes a theory such as the one he was offering, i.e. where there was not a ring break
or mesh erosion, but where “the ring rubbed against the bowel and the bowel opened up,
allowed infection to develop, and then closed before anybody could discover the source
of the infection.” Id. at 108:10-23. He stated, however, “Based on my education, training,
and experience my discussions with other surgeons, it is not a unique possibility.” Id. at
108:24-109:5. Dr. Ferzoco indicated that there was medical literature that discussed

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microperforations in patients that suffered from diverticulitis. Id. at 174:14-175:13. He
admitted, that his “nidus” theory was not described in the medical literature, but stated
that he had seen it occur in other patients. Id. at 124:2-125:1; 1515:14-18. Dr. Ferzoco
could not identify in which patients he had seen the nidus effect take place, nor could he
produce those records to defense counsel. Id. at 149:13-150:1. See also id. at 193:1-9
(“Q: Are you relying on your specific patient experience of these nidus and infection cases
with ringed products for your opinions about Ms. Bowersock having, in your mind, a nidus
causing an infection in ring product? A: Yes. Q: Are you going to produce those records?
A: I don’t know if I will be able to have access to those records.”). Dr. Ferzoco also stated
that he had never presented his nidus theory in a formal or professional setting. Id. at
153:4-10.
H. DR. ROLAND KOHR
As previously stated, Dr. Kohr performed an autopsy on Georgia in October 2006
at the request of her family. Kohr Dep. at 5:13-15; 13:2-11. He listed pneumonia and
diffuse alveolar damage as the cause of death following the autopsy, both of which are
issues with the lungs. Id. at 17:12-17. Dr. Kohr stated that he did not find that any internal
organs were breached, but stated that “there could have been superficial breaches
scarred over with additional inflammation and as much inflammation as scarring without
adhesions, what could have happened earlier is not necessarily going to show up at this
time.” Id. at 44:3-14. He admitted that he could not see any breach of Georgia’s
intestines, colon, bowel or any other internal organs “with the naked eye.” Id. at 44:1521. Dr. Kohr was aware of the CK Patch implant, but did not smell or see any pus or
abnormalities where it was placed. Id. at 48:8-51:5. Nonetheless, he indicated that the

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“presence of the extensive adhesions in the suprapubic area, lower abdomen, suggest
that there is a possibility that there had been a breach.” Id. at 59:17-19. When questioned
about this latter statement, Dr. Kohr stated, “I’m very suspicious that some of that did
happen, yes.” Id. at 60:9-13. Dr. Kohr acknowledged that enterococcus faecalis, the
bacteria found in Georgia’s second culture, could enter through an open wound or incision
and that he has seen this occur in other patients. Id. at 101:10-103:16. He also indicated
that the course of her cultures does not necessarily indicate that there was a breach of
Georgia’s bowel. Id. at 104:18-105:8. In fact, Dr. Kohr looked for communication from
the bowels to the abdominal wall during Georgia’s autopsy but did not see any. Id. at
108:17-109:14. He stated that he did not notice any bowel adhered to the CK Patch when
he performed the autopsy and that it would be obvious if that had been the case. Id. at
119:11-21.

Nonetheless, Dr. Kohr concluded that the breach of the bowel, in the

“absence of having documented any major problems at the time of surgery a year earlier,
it’s got to be related at some point to inflammation.” Id. at 138:21-139:9.
Dr. Kohr stated that he considered himself a retained expert of the Plaintiffs when
he drafted an affidavit at their request. Id. at 69:13-70:8; 73:22-74:8. In preparation of
his affidavit, Dr. Kohr reviewed medical literature, as well as information relating to the
CK Patch sent to him by Plaintiffs’ counsel. Id. at 70:9-18; 78:12-79:8; Kohr Aff., ¶¶ 5, 6.
He stated in his affidavit, “[I]t is my opinion based on reasonable medical probability that
complications with the Kugel mesh caused the abscess and infection in the anterior
abdominal wall leading to Ms. Bowersock’s severe sepsis, multi-organ failure, pneumonia
and diffuse alveolar damage, and was therefore the proximate cause of her death.” Kohr
Aff., ¶ 7.

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I. DR. WILLIAM HYMAN
Dr. William Hyman, an expert retained by the Plaintiffs, has been a professor of
biomedical engineering at Texas A&M University since 1972 and has previously served
as chair of the biomedical engineering program. Dr. Hyman Curriculum Vitae at 1. Dr.
Hyman has written extensively on medical device safety and taught classes on that
subject as well as medical device design, implant materials, and FDA regulations. Id. at
2-16.
Dr. Hyman stated in his expert report, “[i]n summary, my opinion is that the design
of the Composix Kugel Hernia Patch is defective, and that its defects were a direct cause
of Ms. Bowersock’s injuries and death.” Hyman Report at 3. He further noted that
“alternative economically feasible and fundamentally safer designs were available and, in
fact, known to and considered by Davol/Bard, who nonetheless chose to pursue and
maintain the patch’s defective design.” Id.
Dr. Hyman testified that he had never examined Georgia’s exhumed CK Patch nor
viewed any pictures of it, but that he had seen the patch in Dr. Ferzoco’s video. Hyman
Dep. 34:25-35:16. Dr. Hyman stated that based on the inference of a bowel injury, the
CK Patch more likely than not curved towards the bowel. Id. at 46:4-19. He concluded
that a bowel injury occurred in Georgia on the basis of the second bacterial culture as
well as the medical testimony of Dr. Ferzoco, whose deposition he read prior to his own
deposition. Id. at 46:20-47:3. Dr. Hyman conceded, however, that he was not an expert
on bacteria extracted from cultures and that he only has “some knowledge about it.” Id.
at 47:4-11. He also admitted, “I’m not a microbiologist and I’m not offering an independent
opinion on the microbiology of her infection.” Id. at 59:5-20.

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Dr. Hyman stated that he was not aware of any medical literature that describes
an intact ring CK Patch issue where the patch rubs against the bowel causing damage,
but stated that the case reports he has worked on are consistent with that damage
mechanism. Id. at 60:18-61:17. When questioned further, Dr. Hyman conceded that he
could not remember any case similar to the injury he believes Georgia suffered. Id. at
63:18-64:18; see also id. at 66:3-11 (“Q: … is there some other case that you can point
to of another patient from any source, published, unpublished, just that you saw in
litigation, whatever, that describes the same mechanism of injury to what you’re talking
about here? [Objection]. A: Not that I recall at this time.”).
Dr. Hyman admitted that he did not know the source of Georgia’s bacteria when
she first presented in October 2006. Id. at 49:4-8.
II.

PROCEDURAL HISTORY

Plaintiffs filed suit in this Court on September 20, 2008.

Dkt. 1.

It was

subsequently transferred to the United States District Court for the District of Rhode Island
by the Judicial Panel on Multidistrict Litigation to the In Re: Kugel Mesh Hernia Patch
Products Liability Litigation, 1:07-md-01842-ML-LDA (D.R.I.) (“MDL”). The case was
remanded back to this Court on November 29, 2016. All pretrial filings have been
completed, including this motion for summary judgment filed by Bard.

Bard has

contemporaneously filed motions to exclude or limit Plaintiffs’ experts in support of its
motion for summary judgment.
III.

SUMMARY JUDGMENT STANDARD

As stated by the Supreme Court, summary judgment is not a disfavored procedural
shortcut, but rather is an integral part of the federal rules as a whole, which are designed

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to secure the just, speedy, and inexpensive determination of every action. See Celotex
Corp. v. Catrett, 477 U.S. 317, 327 (1986); see also United Ass’n of Black Landscapers
v. City of Milwaukee, 916 F.2d 1261, 1267-68 (7th Cir. 1990). Motions for summary
judgment are governed by Federal Rule of Civil Procedure 56, which provides in relevant
part: “The Court shall grant summary judgment if the movant shows that there is no
genuine dispute as to any material fact and the movant is entitled to judgment as a matter
of law.” Fed. R. Civ. P. 56(a).
Once a party has made a properly-supported motion for summary judgment, the
opposing party may not simply rest upon the pleadings but must instead submit
evidentiary materials showing that a fact either is or cannot be genuinely disputed. Fed.
R. Civ. P. 56(c)(1). A genuine issue of material fact exists whenever “there is sufficient
evidence favoring the nonmoving party for a jury to return a verdict for that
party.” Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 249, (1986). The nonmoving party
bears the burden of demonstrating that such a genuine issue of material fact
exists. See Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 586–87
(1986); Oliver v. Oshkosh Truck Corp., 96 F.3d 992, 997 (7th Cir. 1996). It is not the duty
of the Court to scour the record in search of evidence to defeat a motion for summary
judgment; rather, the nonmoving party bears the responsibility of identifying applicable
evidence. See Bombard v. Ft. Wayne Newspapers, Inc., 92 F.3d 560, 562 (7th Cir.
1996).
In evaluating a motion for summary judgment, the Court should draw all
reasonable inferences from undisputed facts in favor of the nonmoving party and should
view the disputed evidence in the light most favorable to the nonmoving party. See Estate

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of Cole v. Fromm, 94 F.3d 254, 257 (7th Cir. 1996). The mere existence of a factual
dispute, by itself, is not sufficient to bar summary judgment. Only factual disputes that
might affect the outcome of the suit in light of the substantive law will preclude summary
judgment. See Anderson, 477 U.S. at 248; JPM Inc. v. John Deere Indus. Equip. Co., 94
F.3d 270, 273 (7th Cir. 1996). Irrelevant or unnecessary facts do not deter summary
judgment, even when in dispute. See Clifton v. Schafer, 969 F.2d 278, 281 (7th Cir.
1992). If the moving party does not have the ultimate burden of proof on a claim, it is
sufficient for the moving party to direct the Court to the lack of evidence as to an element
of that claim. See Green v. Whiteco Indus., Inc., 17 F.3d 199, 201 & n. 3 (7th Cir. 1994).
“If the nonmoving party fails to establish the existence of an element essential to his case,
one on which he would bear the burden of proof at trial, summary judgment must be
granted to the moving party.” Ortiz v. John O. Butler Co., 94 F.3d 1121, 1124 (7th Cir.
1996).
IV.

ANALYSIS

A. APPLICABLE INDIANA LAW
Plaintiffs allege claims for negligence, violation of the “Indiana Deceptive Trade
Practices Act,” 2 strict product liability, intentional infliction of emotional distress, failure to
warn, breach of implied warranty, and fraud. 3 Dkt. 1. The parties agree that Plaintiffs’
claims should be consolidated under the Indiana Products Liability Act (“IPLA”), which the

2

There is no such claim in Indiana, but Plaintiffs cite to the Indiana Deceptive Consumer
Sales Act (“IDCSA”), Ind. Code § 24-5-.5. et seq. Accordingly, the Court construes this
count as a claim under the IDCSA.
3 Plaintiffs concede that they are not pursuing claims for a manufacturing defect, implied
warranty of merchantability, or negligent infliction of emotional distress. Dkt. 41, pp. 2728.
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Indiana legislature intended “to govern all product liability actions, whether the theory of
liability is negligence or strict liability in tort.” Dague v. Piper Aircraft Corp., 418 N.E.2d
207, 212 (Ind. 1981). See also, dkt. 41, p. 27. Indeed, the IPLA governs all actions “(1)
brought by a user or consumer; (2) against a manufacturer or seller; [] (3) for physical
harm caused by a product; regardless of the substantive legal theory or theories upon
which the action is brought.” Ind. Code § 34-20-1-1. Importantly, both negligence and
strict products liability claims under the IPLA require Plaintiffs to demonstrate that the
alleged defect in the CK Patch was a proximate cause of Georgia’s injury. See Ford
Motor Co. v. Rushford, 868 N.E.2d 806, 810 (Ind. 2007); see also Kovach v. Caligor
Midwest, 913 N.E.2d 193, 197 (Ind. 2009).
Plaintiff Mark Bowersock has also brought a claim under the Indiana Wrongful
Death Act (“IWDA”). The elements for a claim under IWDA are “a duty owed by the
defendant to the decedent, breach of that duty, and an injury proximately caused by the
breach.” Tom v. Voida, 654 N.E.2d 776, 787 (Ind. Ct. App. 1995).
Bard alleges that the Plaintiffs’ experts are not qualified to testify under Federal
Rule of Evidence 702 (“Rule 702”) and Daubert. Thus, Bard argues that Plaintiffs are
unable to establish causation and therefore their claims must fail. 4 For the following
reasons, the Court agrees.

4

Bard does not seek summary judgment for lack of causation on Mark Bowersock’s IWDA
claim, but rather argues that Mark Bowersock cannot bring this claim as an incapacitated
adult, which is a prerequisite to bringing a claim. As the element of causation is not met,
the IWDA claim must fail. Accordingly, the Court need not address any alleged defects
of the Complaint.
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B. EXPERT TESTIMONY ON CAUSATION
1. Dr. Ferzoco Testimony
Bard asserts that Dr. Ferzoco’s opinions are not based on any scientific support
and must be excluded under Rule 702. Bard also seeks exclusion of Dr. Ferzoco’s theory
because it is based solely on his own patient experience, but he has failed to produce
any patient records, rendering such an opinion unreliable and therefore inadmissible.
Under Rule 702 and Daubert, the Court follows a two-prong framework: the Court
must determine whether A(1) the proposed witness would testify to valid scientific,
technical, or other specialized knowledge[,] and (2) [the Court must determine whether]
his testimony will assist the trier of fact.@ Ammons v. Aramark Unif. Servs., Inc., 368 F.3d
809, 816 (7th Cir. 2004) (quotations and citations omitted). The first prong Aof this
framework evaluates the reliability of the testimony.@ Id. To determine whether an
expert=s opinions are reliable, the Court A>must determine whether the expert is qualified
in the relevant field and whether the methodology underlying the expert=s conclusions is
reliable.=@ Id. (quoting Zelinski v. Columbia 300, Inc., 335 F.3d 633, 640 (7th Cir. 2003)).
This requires the Court to consider whether the testimony has been subjected to the
scientific method, ruling out any subjective belief or unsupported speculation. See Porter
v. Whitehall Labs. Inc., 9 F.3d 607, 614 (7th Cir.1993).
Under the second prong, the Court Aevaluates the testimony=s relevance.@ Id. The
opinion may assist the trier of fact with any issue involved in the case; the expert need
not opine about the ultimate issue. See Smith v. Ford Motor Co., 215 F.3d 713, 718 (7th
Cir. 2000). An expert may opine as to the hypothetical or probable causes of an event if
such testimony would aid the jury. Id. at 718-19. However, the hypothetical alternative
must itself have an analytically sound basis such that it is more than mere speculation.
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Id. at 719 (citing DePaepe v. Gen. Motors Corp., 141 F.3d 715, 720 (7th Cir. 1998)). The
Court may not decide if the expert=s opinion is correct; rather, it must only determine
whether the expert=s testimony is pertinent to an issue in the case. Id.
Dr. Ferzoco essentially puts forth two interrelated opinions: (1) the presence of
fecal bacteria in Georgia’s second of three cultures indicates bowel involvement; and (2)
the CK Patch, whose ring did not break, buckled and rubbed against Georgia’s colon
causing bowel contents to be released through an opening that either closed back up
prior to being discovered or was not visible, either of which led to the infection (the nidus
theory). Ferzoco Dep. 28:22-3; 46:3-9; 72:12-24; 108:10-23. While it might be said that
Dr. Ferzoco utilized the scientific method in determining bowel involvement based on this
second culture, Dr. Ferzoco is unable to set forth a reliable, scientific opinion as to how
the CK Patch’s alleged buckling caused Georgia’s injury. Dr. Ferzoco admits that the
type of “buckling” he describes in Georgia’s case is markedly different than that found in
other cases in the MDL of which this case was a part, which involve the polypropylene
side of the patch being exposed to the bowel. Id. at 24:16-19; 29:15-20; 63:3-22; 64:1565:5; see also, Ferzoco Report at 4 (“The buckling and warping allows the polypropylene
side of the mesh to come into contact with bowel and intra-abdominal organs, leading to
a wide range of complications including adhesions, fistula formation and abscess
formation.”). Consequently, Dr. Ferzoco proposes his new opinion, the nidus theory,
which he asserts is the result of the CK Patch rubbing against the bowel to create a
perforation that allows bowel contents to spill over. 5 The rubbing against the colon

5

Plaintiffs argue that the “nidus” theory is simply Dr. Ferzoco’s word to describe the point
of infection. Dkt. 45 at 8. In other words, the nidus is the location that the CK Patch
rubbed against the bowel creating an opening that allowed for bowel contents to spill over.
17

creates either microperforations too small to be seen with the naked eye or perforations
that closed up prior to performance of the autopsy, but Dr. Ferzoco could not say
definitively which occurred in the instant case. Id. at 58:17-59:11.
Dr. Ferzoco readily admits that his nidus theory has not been described in the
medical literature or peer review.

Id. at 108:10-23; 124:2-12; 126:9-13; 152:8-18.

Moreover, none of the symptoms he describes are found in Georgia’s medical records or
the autopsy report.

Id. at 28:22-29:3; 31:6-11; 46:3-9; 47:13-48:14; 59:22-60:10.

Furthermore, his theory is not based on any of the materials provided in connection with
other CK Patch cases. Id. at 183:22-184:6. Finally, Dr. Ferzoco admits that his nidus
theory has never been presented in a formal or professional setting. Id. at 153:4-10.
Dr. Ferzoco’s sole support for his nidus theory is his previous patient experience.
Id. at 124:2-125:1; 193:1-6. However, Dr. Ferzoco stated that he could not identify any
patients by name or produce medical records to substantiate his theory. Id. at 149:13150:1; 193:1-9. Moreover, his expert report is devoid of any information relating to the
treatment of patients that received a similar diagnosis to Georgia Bowersock.

See

Ferzoco Report. Accordingly, his testimony does not withstand the reliability strictures
set forth in Daubert and Rule 702.
It is the Court’s duty to ensure that “any and all scientific testimony or evidence
admitted is not only relevant, but reliable.” Daubert, 509 U.S. at 589. In doing so, the
Court must “determine whether the evidence is genuinely scientific, as distinct from being
unscientific speculation offered by a genuine scientist.” Rosen v. Ciba-Geigy Corp., 78

For purposes of clarity, however, the Court will refer to this type of alleged bucking as the
nidus theory.
18

F.3d 316, 318 (7th Cir. 1996). “Either ‘hands-on testing’ or ‘review of experimental
statistical, or other scientific data generated by others in the field’ may suffice as a
reasonable methodology upon which to base an opinion.” Clark v. Takata Corp., 192
F.3d 750, 759 (7th Cir. 1999) (citing Cummins v. Lyle Indus., 93 F.3d 362. 369 (7th Cir.
1996)).
While it appears from his curriculum vitae that Dr. Ferzoco certainly has the
requisite knowledge, skill, experience, education, and training to provide an expert
opinion in this matter, the underlying reasoning for his conclusions is insufficient to deem
his testimony reliable. Plaintiffs claim that his opinions and knowledge of the human body,
his experience in hernia repair surgery, his training and experience in implanting hernia
mesh prosthetics, and the well-documented problems found with the CK Patch should be
sufficient to qualify Dr. Ferzoco to testify as an expert on causation in this case. But
Plaintiffs fail to connect any of these qualifications with Dr. Ferzoco’s specific opinion
here. In fact, Dr. Ferzoco is only able to base his nidus causation theory, which has not
been tested or subjected to peer review, on his prior experience with other patients.
Setting aside the fact that Dr. Ferzoco is unable to produce any documentation or
recollection relating to his previous patients exhibiting the nidus theory, it is clear that his
methodology cannot be based on any of the factors set forth in Daubert.

See Takata

Corp., 192 F.3d at 758 (“In determining whether an expert’s testimony is reliable, the
Daubert factors are applicable in cases where an expert eschews reliance on any rigorous
methodology and instead purports to base his opinion merely on ‘experience’ or
‘training.’”).

19

As has been stated more fully above, Dr. Ferzoco’s theory has not been “(1) tested,
(2) subjected to peer review and publication, (3) analyzed for known or potential error
rate, and/or is (4) generally accepted within the specific scientific field.” Lapsley v. Xtek,
Inc., 689 F.3d 802, 810 (7th Cir. 2012). Plaintiffs provide no other medical doctor or
literature that has reviewed, tested, or described similar diagnoses to that advocated by
Dr. Ferzoco. The fact that Dr. Ferzoco has allegedly seen his nidus theory occur in
unnamed patients is simply not enough; for while experts “commonly extrapolate from
existing data[,] … nothing in either Daubert or the Federal Rules of Evidence requires a
district court to admit opinion evidence which is connected to existing data only by the
ipse dixit of the expert.” Gen. Elec. Co. v. Joiner, 522 U.S. 136, 146 (1997). See also,
Zenith Elec. Corp. v. WH-TV Broad. Corp., 395 F.3d 416, 419 (7th Cir. 2005) (“A witness
who invokes ‘my expertise’ rather than analytic strategies widely used by specialists is
not an expert as Rule 702 defines that term.”).
Plaintiffs respond that an expert’s experience alone may provide sufficient
foundation for expert testimony. They cite to Dr. Ferzoco’s extensive experience with
hernia repair and his post-recall CK Patch monitoring program to establish his credentials
as an expert in this field. Although it is true that experience alone may provide a sufficient
foundation for expert testimony, Dr. Ferzoco is unable to point to any specific experience
that would provide that necessary foundation.

By simply alluding to prior patient

experience to support his causation theory without providing any explicit details that could
be explored by Bard’s counsel, Dr. Ferzoco’s opinions cannot be deemed sufficiently
reliable under Rule 702. See Olinger v. U.S. Golf Ass’n, 52 F. Supp. 2d 947, 950 (N.D.
Ind. 1999) (“This record discloses a well-credentialed expert who employs an undisclosed

20

methodology to arrive at disclosed opinions. The court cannot evaluate the reliability of
the undisclosed methodology or [] the principles that support the methodology.”).
Accordingly, the Court finds that Dr. Ferzoco’s testimony as to the causation of
Georgia’s injuries must be excluded and Bard’s Motion in Limine must be GRANTED.
2. Dr. Hyman Testimony
Bard also seeks the exclusion of Dr. Hyman’s testimony on the basis of reliability.
Bard points to the fact that Dr. Hyman never performed any testing on his causation
theory, nor could he estimate or quantify the amount of deformation required to cause an
injury to occur. Hyman Dep. 76:4-23; 78:23-79:5. Moreover, Dr. Hyman never performed
any testing on a CK Patch or any other hernia mesh products with a composite ring. Id.
at 92:19-93:24. Furthermore, Dr. Hyman was unaware of any test or study demonstrating
his proposed failure mechanism or any test that resulted in a bowel injury due to the
deformation of the CK Patch as he described it. Id. at 113:9-114:20; 119:3-121:17; 122:5125:6. Dr. Hyman never examined Georgia’s CK Patch nor viewed images of the CK
Patch after removal of the tissue. Id. at 34:25-35:6; 36:7-37:5. He could not state where
Georgia’s CK Patch ring distorted. Id. at 46:3-11. Dr. Hyman was only able to cite to a
bowel injury on the basis of the medical culture and the opinion of Dr. Ferzoco, despite
admitting that he is not an expert on cultures and only had “some knowledge about
[them].” Id. at 46:16-47:11.
Plaintiffs do little to establish the reliability of Dr. Hyman’s causation opinion.
Plaintiffs concede that Dr. Hyman is not a medical doctor and cannot offer medical
opinions, but believe that he should be able to testify as to: “1) why the patch buckled,
and 2) why the well-known phenomenon could cause the injuries suffered by Ms.
Bowersock and opined to by Dr. Ferzoco.” Dkt. 48 at 24.
21

With respect to the instant motions, the latter opinion is of most concern. Plaintiffs
do not cite to any of the Daubert factors or any specific qualifications or expertise that
would allow Dr. Hyman to testify as to how the CK Patch buckled and caused Georgia’s
injury. Plaintiffs focus on Dr. Hyman’s ability to talk about buckling and contracture forces,
but fail to set forth any evidence to establish the reliability of his opinion as to medical
causation. “The proponent of the expert bears the burden of demonstrating that the
expert’s testimony would satisfy the Daubert standard.” Lewis v. CITGO Petroleum Corp.,
561 F.3d 698, 704 (7th Cir. 2009) Accordingly, Plaintiffs have failed to meet their burden
to establish that Dr. Hyman is qualified to testify as to the cause of Georgia’s death and
any such evidence to be proffered by Dr. Hyman is hereby excluded; Bard’s Motion in
Limine is GRANTED.
3. Dr. Kohr Testimony
Bard also seeks to exclude Dr. Kohr as an expert in this case. Bard argues that
Plaintiffs’ failure to disclose Dr. Kohr as an expert under Rule 26 of the Federal Rules of
Civil Procedure (“Rule 26) requires exclusion of any expert testimony that he may offer.
Bard also contends that Dr. Kohr did not submit an expert report and therefore cannot
offer expert testimony
Rule 26 requires plaintiffs to disclose any person that it intends to use as an expert.
Rule 26(a)(2)(A). Such witnesses must provide a written report that sets forth the facts
and bases for their opinions. Rule 26(a)(2)(B). “The sanction for failure to comply with
this rule is the ‘automatic and mandatory’ exclusion of the omitted evidence, ‘unless nondisclosure was justified or harmless.’” Happel v. Walmart Stores, Inc., 602 F.3d 820, 824
(7th Cir. 2010) (citing Hammel v. Eau Galle Cheese Factory, 407 F.3d 852, 869 (7th Cir.
2005)).
22

Plaintiffs concede that Dr. Kohr is not an expert in this case, and argue that he is
only testifying as a fact witness with respect to his treatment of Georgia, i.e. the autopsy
and exhumation of her body. Plaintiffs do not even attempt to argue that the nondisclosure was justified or harmless. Plaintiffs state that Dr. Kohr will 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. But this fact alone – that Dr. Kohr will testify as to facts outside his
treatment of Georgia – renders his testimony expert in nature. Plaintiffs’ counsel paid Dr.
Kohr a $4,000.00 retainer and provided him with records to review prior to his deposition
testimony. Kohr Dep. at 73:22-79:8. Moreover, Plaintiffs’ counsel sent Dr. Kohr medical
records and literature about the CK Patch, met with him, and paid him to draft an affidavit
approximately seven years after the initial autopsy. Id. at 67:13-69:1. Thus, it is clear
that Plaintiffs seek to have Dr. Kohr testify outside of his actual treatment of Georgia;
therefore, it would be deemed expert testimony and subject to the disclosure
requirements of Rule 26. See Meyers v. Nat’l R.R. Passenger Corp. (Amtrak), 619 F.3d
729, 734-35 (7th Cir. 2010) (“a treating physician who is offered to provide expert
testimony as to the cause of the plaintiff’s injury, but who did not make that determination
in the course of providing treatment, should be deemed to be one ‘retained or specially
employed to provide expert testimony in the case,’ and thus required to submit an expert
report in accordance with Rule 26(a)(2)” (citing Rule 26(a)(2)(B)). Although Dr. Kohr may
present treatment evidence concerning the autopsy and exhumation of Georgia’s body,
he may not testify as to any newly formed opinions that exceed that role, which includes
evidence of causation not included in his Autopsy Report.

23

C. CAUSATION
Both the IPLA and IWDA require that a plaintiff prove causation to establish a
claim. 6 See infra, pt. IV, A. In support of their claims, Plaintiffs have proffered the
testimony of Drs. Ferzoco and Hyman, but, as stated more fully above, these experts do
not withstand the standards set forth in Daubert and Rule 702.

7

Further, Dr. Kohr’s

proffered opinions on causation failed to satisfy the disclosure requirements of Rule 26.
Because Plaintiff is unable to submit any admissible evidence with respect to causation,
Bard’s Motion for Summary Judgment is hereby GRANTED.
V.

CONCLUSION

For the reasons stated herein, the Defendants’, Davol, Inc. and C.R. Bard, Inc.,
Motions in Limine to exclude the testimony of Dr. Stephen Ferzoco (Dkt. 33) and Dr.
William A. Hyman (Dkt. 39), as well as the Motion in Limine to limit the testimony of Dr.
Roland Kohr (Dkt. 37), are GRANTED; in addition, Defendants’, Davl, Inc. and C.R. Bard,
Inc., Motion for Summary Judgment (Dkt. 30), is GRANTED.

The Court will enter

judgment accordingly.
IT IS SO ORDERED this 23d day of February, 2017.

________________________________
LARRY J. McKINNEY, JUDGE
United States District Court
Southern District of Indiana

Distribution attached.

Bard also seeks summary judgment on various other grounds, but, because the
causation analysis is dispositive as to all claims, the Court declines to address the
remaining arguments.
7 Plaintiffs have also proffered the expert testimony of Suzanne Parisian, M.D., but admit
that she offers no case-specific testimony with respect to Georgia’s cause of death. See
Dkt. 46 at 5.
6

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Distribution:
Christopher S. Stake
DELANEY & DELANEY LLC
[e-mail]
Kathleen Ann DeLaney
DELANEY & DELANEY LLC
[e-mail]
Robert Thomas Dassow
HOVDE DASSOW & DEETS LLC
[e-mail]
William Frederick Eckhart
HOVDE DASSOW & DEETS LLC
[e-mail]
Eric L. Alexander
REED SMITH LLP
[e-mail]
Jesse Ash
REED SMITH LLP
[e-mail]
Matthew D. Jacobson
REED SMITH LLP
[e-mail]
Michael K. Brown
REED SMITH LLP
[e-mail]
Susanne N. Scovern
SCOVERN LAW
[e-mail]

25