JARRETT v. WRIGHT MEDICAL TECHNOLOGY, INC. et al
Filing
107
ORDER - This cause is before the Court on the Motion for Summary Judgment [Dkt. 84] filed by Defendant Wright Medical Technology, Inc. ("Wright Medical"). Plaintiffs Coleman and Paula Jarrett commenced this action in 2012 and it was tran sferred to the United States District Court for the Northern District of Georgia as part of a multi-district litigation styled "CONSERVE Hip Implant Product Liability Litigation, MDL 2329" ("the MDL"). This case was remanded and transferred to our court to proceed individually on July 6, 2018. Defendants' Motion for Summary Judgment Dkt. 84 is GRANTED as to Plaintiffs' manufacturing defect, failure-to-warn, and fraud theories under the IPLA as well as Plaint iffs' punitive damages request and DENIED as to Plaintiffs' IPLA claim based on a design defect theory and the loss of consortium claim. The case will proceed accordingly. Signed by Judge Sarah Evans Barker on 9/22/2021. *** SEE ORDER *** (CKM)
UNITED STATES DISTRICT COURT
SOUTHERN DISTRICT OF INDIANA
INDIANAPOLIS DIVISION
COLEMAN JARRETT, et al.
)
)
Plaintiffs,
)
)
v.
)
)
WRIGHT MEDICAL TECHNOLOGY, INC., )
)
Defendant.
)
No. 1:12-cv-00064-SEB-DML
ORDER
This cause is before the Court on the Motion for Summary Judgment [Dkt. 84]
filed by Defendant Wright Medical Technology, Inc. ("Wright Medical"). Plaintiffs
Coleman and Paula Jarrett commenced this action in 2012 and it was transferred to the
United States District Court for the Northern District of Georgia as part of a multidistrict
litigation styled "CONSERVE® Hip Implant Product Liability Litigation, MDL 2329"
("the MDL"). This case was remanded and transferred to our court to proceed
individually on July 6, 2018.
On October 1, 2018, Plaintiffs filed their Second Amended Complaint in this
individual action, setting forth claims against Wright Medical under the Indiana Products
Liability Act, IND. CODE § 34-20-1-1, et seq. ("the IPLA") relating to Mr. Jarrett's receipt
of hip implant components from Wright Medical's CONSERVE® product line during a
July 17, 2006 left total hip arthroplasty. Plaintiffs allege that, based on purported defects
in the CONSERVE® devices, generally relating to alleged design defects that allegedly
caused excessive metal ion release and loosening of the CONSERVE® Cup device, Mr.
1
Jarrett was forced to undergo a second "revision" surgery on July 12, 2010 to remove the
CONSERVE® devices. In addition to the IPLA claim, Plaintiffs also allege a loss
consortium claim as well as a request for punitive damages. Wright Medical has moved
for summary judgment on each of Plaintiffs' claims.
For the reasons detailed below, we GRANT Defendant's Motion for Summary
Judgment as to Plaintiffs' manufacturing defect, failure-to-warn, and fraud theories under
the IPLA as well as Plaintiffs' punitive damages request and DENY the motion as to
Plaintiffs' IPLA claim based on a design defect theory and the loss of consortium claim.
Factual Background
I.
Wright Medical's CONSERVE® Devices
Hip arthroplasty is a surgical procedure that involves replacing the failed natural
hip joint with a fabricated replacement, which is intended to improve mobility and relieve
pain associated with degenerative hip disease and other bone quality conditions. Exh. A.
at 5; Exh. D at 1–3; Exh. E at 1. Wright Medical's CONSERVE® line of products, which
belong to a category of hip prostheses referred to as metal-on-metal ("MoM"), is one type
of fabricated replacement used in such procedures. The components of a MoM
prostheses include a linerless, high carbon, cobalt-chrome cup, and a large diameter high
carbon, cobalt-chrome femoral head. See FDA Publication, Effectiveness of Metal-onMetal Hip Implants, available at https://www.fda.gov/medical-devices/metal-metal-hipimplants/effectiveness-metal-metal-hip-implants (last updated March 15, 2019); see also
Exh. F. Wright Medical began moving into the MoM hip prosthesis market in the early
2
1990s and strove to be the first company to market such products in the United States.
Exh. 1 at WMTMDL0068460.
II.
Wright Medical's Knowledge of Risks Related to CONSERVE® Devices
In November 1995, two Wright Medical employees, including the Vice President
of Development & Technology, attended a four-day conference on MoM technology at
which questions were raised regarding whether MoM devices were a good alternative to
poly devices and attendees were informed that more needed to be learned and studied
regarding the risks associated with metal-metal bearing surfaces. Exh. 2. That same
year, Wright Medical was notified by several surgeons and medical product designers of
several significant risks regarding MoM devices that required further testing, including
concerns regarding metal toxicity, inflammation, bone loss, allergic reaction, local tumor
formation, systemic effects, soft tissue necrosis, osteolysis, and blood-born metal ions.
Carroll Dep. at 106–111, 134–35. Wright Medical was also aware at that time that the
McKee-Farrar device, a MoM design first used in 1960, was removed from the market in
the 1970s because of problems with osteolysis, inflammation, cystic responses, cytoxic
metal ions, and tissue reactions in implant patients, which conditions necessitated
revisions in 50% of the implants. Id. at 113–14.
Wright Medical knew, both when it designed its CONSERVE® devices and
throughout the time it was developing, manufacturing, marketing, and selling those
devices, of the principles and concerns associated with MoM devices generating wear
debris and releasing toxic cobalt and chromium heavy metal ions. Id. at 106–110, 114–
16, 164–66; Fisher Dep. at 170–71, 173–74, 176, 326–27; Batts Dep. at 101–105;
3
Timmerman Dep. at 76, 85. Wright Medical was also aware prior to Mr. Jarrett's hip
replacement surgery that cobalt and chromium ions can cause metallosis, necrosis,
inflammation, bone loss, cup loosening, ALVAL, and pseudotumors, and that such ions
can have toxic effects, cytotoxicity, indirect sensitization, and carcinogenicity, but was
unaware of the long-term consequences to patients of exposure to such ions. Carroll Dep.
at 97–99, 113–15, 134–35, 169–70, 238; Exh. 5 and Exh. 9 to Mosely Dep.; Timmerman
Dep. at 85. Wright Medical's biggest concern in selling its CONSERVE® devices was
the issue of metal ion release; the "number one concern" of surgeons "was the metal
ions." Fisher Dep. at 173; Jerome Dep. at 95. At least as early as 2003, Wright Medical
understood that, because "metallic particulate debris is approximately an order of
magnitude smaller than PE debris, … even low rates of volumetric wear can lead to a
large number of particles." Exh. 8.
Prior to marketing and selling the CONSERVE® devices, including the device
implanted in Mr. Jarrett in 2006, Wright Medical did not conduct any studies to
investigate the risks associated with metal ion release or other "hot-button" issues that led
surgeons to reject MoM implants in the 1970s. Moseley Dep. at 80; Exh. 11 at 20–26.
Nor did Wright Medical perform any biocompatibility or other testing to determine
whether metal-ion release from the CONSERVE® devices was safe. Fisher Dep. at 190–
93; Svarczkopf Dep. at 157–63; Moseley Dep. at 80.
4
III.
Wright Medical's Marketing of the CONSERVE® Devices
Wright Medical marketed its CONSERVE® devices and components under the
tagline: "Tested, Trusted." Exh. 13. The company's marketing materials included the
following testimonials from patients and surgeons:
• "Before the surgery, I couldn't run. I couldn't play soccer. Now, there's no pain in
the joint at all. Hip replacement gave me my life back." Exh. 15.
• "Because the procedure allows him to be as aggressive as we wanted to be, there –
there was no reason for me to tell him to hold back." Exh. 16.
• "Some patients have been able to pursue more vigorous activities, including
martial arts, hockey, running marathons, even climbing Mount Kilimanjaro." Exh.
17.
• "Wright Medical, which makes the Conserve Total hip said hip replacement lasts
25 to 30 years." Exh. 18.
In marketing its CONSERVE® devices, Wright Medical determined in 2004 that
it needed to "address the metal ion issue in order to convince surgeons … that metal ions
are not an issue with [its] system." Exh. 40 to Timmerman Dep.; accord Batts Dep. at
114. In line with this strategy, at a 2002 meeting, Wright Medical instructed its sales
representatives, who acted as the company's direct contact with surgeons, that "[t]he
effects of metal ion release are known and have been demonstrated to be safe" and that
"[t]he effects of polyethylene debris are known, and have been demonstrated to lead to
revision surgery." Exh. 29 to Watson Dep.
Wright Medical represented in its marketing materials that MoM hips had a long
clinical use but did not provide information regarding the failure rates of either MoM or
poly devices. Smith Dep. at 51. Wright Medical's marketing materials also stated that it
5
was widely believed that less than one percent of patients have MoM hypersensitivity
reactions and that, in a clinical trial with 1800 patients, none suffered a pseudotumor
following surgery, but did not provide information regarding whether that study applied
to total hip replacements. Id. at 52–53.
IV.
Mr. Jarrett's Original Hip Surgery
In 2006, Mr. Jarrett experienced increasing hip pain exacerbated by a fall and
ultimately underwent a left total hip replacement performed by Andrew Parr, M.D. on
July 17, 2006 for bone-on-bone degenerative joint disease. Parr Dep. at 7; 47; C. Jarrett
Dep. at 65–66. At the time of the surgery, Mr. Jarrett was 47 years of age and had a
medical history that included other concurrent conditions including obesity, degenerative
lumbar disease and radiating pain, enlarged prostate, and diabetes, among others,
although he reported that, before his fall, he was still able to remain relatively active.
Parr Dep. at 42, 45–46; C. Jarrett Dep. at 42, 50, 52, 72. Based on Mr. Jarrett's condition,
Dr. Parr chose to implant CONSERVE® MoM devices. Parr Dep. at 22, 28.
Prior to the surgery, Mr. Jarrett did not have any specific discussions with Dr. Parr
regarding the devices that would be used, beyond a general conversation in which Dr.
Parr explained that, based on Mr. Jarrett's relatively young age and activity level, the
implanted devices would be MoM. Jarrett Dep. at 79–80. Mr. Jarrett did not conduct any
research regarding Wright Medical or the CONSERVE® devices or speak with anyone
from Wright Medical prior to his hip replacement surgery and does not recall receiving
any brochures or materials from Wright Medical. Id. at 11–12, 92. According to Mr.
Jarrett, he did not know that he was being implanted with Wright Medical products at the
6
time of his surgery and only learned that fact after initially incorrectly filing a lawsuit
against a different device manufacturer, Zimmer. Id. at 90, 92.
V.
Dr. Parr's Decision to Use a CONSERVE® Implant
Mr. Jarrett's physician, Dr. Parr, testified that orthopedic doctors like himself "deal
with the state of the art as it exists at the time," meaning that they select "the best
treatment to [their] knowledge at that time." Parr Dep. at 20. Dr. Parr selected the
CONSERVE® MoM devices for Mr. Jarrett in 2006 based on certain benefits of those
devices as compared to other alternatives, including metal-on-plastic and ceramic-onceramic devices, available at that time. Id. at 24–29. Dr. Parr testified that metal-onplastic devices had traditionally been used for hip replacements but that "plastic []
traditionally wor[e] out relatively quickly" and MoM bearings had emerged as an
alternative to potentially "improve the wear characteristics over metal on plastic" devices.
Id. at 27. MoM devices also "had less propensity for squeaking" as compared to the
ceramic-on-ceramic devices, which devices Dr. Parr testified were known to potentially
"fracture and break into pieces." Id. at 26–27.
With regard to the CONSERVE® MoM devices in particular, Dr. Parr testified
that one significant risk of hip replacement surgery is the risk of dislocation, and the
CONSERVE® device had a larger head that resulted in a reduced risk of dislocation. Id.
at 23–25. The CONSERVE® devices were also "modular," meaning that the device
could more easily be positioned to resemble the patient's natural anatomy, improving
stability. Id. According to Dr. Parr, because of these characteristics, patients like Mr.
Jarrett, who wanted "the potential benefit of decreasing the wear rate" from plastic
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devices, and who were "younger, [and] more active" and wanted to "improve on
dislocation rates," were "candidates" for MoM hip replacement. Id. at 27, 29, 41–42, 45–
46.
Dr. Parr testified that, prior to Mr. Jarrett's surgery, the CONSERVE® total hip
system had been utilized for only a short period of time and Dr. Parr knew that there was
a possibility of "wear to the bearing surfaces" and that "patients who were implanted with
metal-on-metal total hips would be expected to show … some metal ions both around the
hip and measurable in laboratory studies." Id. at 25, 28. However, at the time of Mr.
Jarrett's surgery, Dr. Parr was unaware of the extent of metallosis that could occur with
MoM devices and he had not been informed of issues related to pseudotumors or that
physicians using MoM devices were experiencing higher revision rates in their patient
populations. Id. at 104–105. Dr. Parr testified that, in fact, "nobody was aware of" the
prevalence of issues related to metal ions "early on," in 2006. Id. at 98. Mr. Jarrett's
orthopedic surgeon expert, John Waldrop, M.D., likewise testified that the extent of
issues related to MoM devices was not known in the orthopedic community until years
after Mr. Jarrett's first surgery. Waldrop Dep. at 50.
Dr. Parr testified that he had "a general knowledge of" Wright Medical's
instructions for use, but he could not say for sure whether he saw any Wright Medical
product brochures. Parr Dep. at 95, 104. Rather, he based his decision to use the
CONSERVE® devices "more off of just the actual research data and those things more so
than the marketing." Id. at 95. According to Dr. Parr, if he had been aware of the
problems associated with MoM devices at the time of Mr. Jarrett's surgery, he would not
8
have used the CONSERVE® device, but that "nobody was aware of those issues early on
[]." Id. at 98, 99. Dr. Parr discontinued using large diameter MoM hips in 2010 or 2011
based on "published issues with metallosis and early failure with large-diameter metalon-metal hips …." Id. at 98.
VI.
Product Warnings and Dr. Parr's Independent Knowledge of Risks
The CONSERVE® devices were accompanied by Wright Medical's product
inserts, commonly known as instructions for use ("IFU"). Exh. J. The IFUs were
available to Dr. Parr prior to Mr. Jarrett's surgery and outlined certain risks,
contraindications, and other instructions for the prescription and implantation of the
components. Id.; Parr Dep. at 32. As relevant here, the IFU for the CONSERVE®
products contains the following warnings:
Metal Components. Some of the alloys used to produce orthopedic
prostheses may contain some elements that may be carcinogenic in tissue
cultures or intact organisms. Questions have been raised in scientific
literature as to whether or not these alloys may be carcinogenic to actual
prosthetic recipients. Studies conducted to evaluate these questions have not
produced convincing evidence of such phenomenon.
Exh. J at WMTMDL0006703.
The IFU contains additional warnings concerning various "Adverse Effects,"
including the following:
2.
With all joint replacements, asymptomatic localized, progressive
bone resorption (osteolysis) may occur around the prosthetic components as
a consequence of foreign body reaction to particulate matter. Particulate is
generated by interaction between components, as well as between the
components and bone, primarily through wear mechanisms of adhesion,
abrasion, and fatigue. Secondarily, particles can also be generated by thirdbody wear. Osteolysis can lead to future complications necessitating
9
removal and replacement of prosthetic components. See Important Physician
Information section for more information.
3.
Although rare, metal sensitivity reactions in patients following joint
replacement have been reported. Implantation of foreign material in tissue
can result in histological reactions involving macrophages and fibroblasts.
…
10.
Allergic reactions to the prosthetic component materials can occur.
Id. at WMTMDL0006708-09.
With regard to patient selection, the IFU provides in relevant part as follows:
2.
Patient's weight. An overweight or obese patient can produce high
loads on the prothesis, which can lead to failure of the prothesis.
Id. at WTMDL0006700.
Apart from the IFU, Dr. Parr testified that he was independently aware of potential
risks of metal wear from the bearing surface and potential release of metal ions in MoM
implants, including the CONSERVE® devices at issue here. Parr Dep. at 24, 25, 98. Dr.
Parr's knowledge was in part based on his participation in an investigational study using
Wright Medical hip systems, including the CONSERVE® Cup, that was conducted from
2004 to 2006, in order to "evaluat[e] a strategy to decrease … metal ion" wear particles
from the MoM bearing surfaces. Id. at 14–16, 21–22; Exh. 3 to Parr Dep. According to
Dr. Parr, at the time of Mr. Jarrett's surgery in July 2006, he would have told patients, and
did inform Mr. Jarrett, of these specific risks of metal wear, metal ions, and the potential
for loosening prior to performing the hip replacement. Parr Dep. at 35, 37, 47–48.
However, at the time of Mr. Jarrett's surgery, Dr. Parr did not know that metal levels
10
could continue to increase throughout the duration of an implant and thus was not aware
of the extent of metallosis that could occur. Id. at 104, 121.
Dr. Parr discussed the risk-benefit information of which he was aware with Mr.
Jarrett in recommending a MoM articulation. Id. at 29–30; Jarrett Dep. at 84–85. Mr.
Jarrett acknowledges that he understood at the time of his surgery that any surface,
whether metal, ceramic, or plastic, will eventually wear. C. Jarrett Dep. at 85.
VII.
Mr. Jarrett's Recovery from Left Hip Replacement and Revision Surgery
Following his July 2006 left hip replacement, Mr. Jarrett recovered well. Id. at 93.
Mr. Jarrett's medical records indicate that he did not consult his orthopedic surgeon, Dr.
Parr, until May 2009, approximately three years after his initial surgery, when he reported
experiencing pain and hearing clicking and other noises coming from his left hip. Parr
Dep. at 64, 65. At that time, Mr. Jarrett also reported having fallen on a few occasions in
the prior year. Id. at 66–67. Mr. Jarrett underwent x-rays which showed a slight area of
lucency around the components as well as basic lab testing to rule out infection, but he
received no other treatment. Id. at 67–70.
Mr. Jarrett's symptoms continued and approximately one year later, in June 2010,
he fell while stepping down off a curb. Jarrett Dep. at 101–102. He felt a sharp pain
when he fell and went to the emergency room where he was diagnosed with a fracture of
the acetabulum, the socket of his natural hip joint. Id. at 102; Parr Dep. at 71–72. The xray indicated that the metal acetabular shell component of the CONVERSE® implant had
completely loosened and rotated vertically within the acetabulum. Parr Dep. at 75, 78.
On July 12, 2010, Mr. Jarrett underwent revision surgery on his left hip performed by Dr.
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Parr. Id. at 70. The CONSERVE® devices were not retained and there are no metal ion
tests to confirm the presence of metal ions in serum. Exh. A at vii, No. 3; Waldrop Dep.
at 64; Jarrett Dep. at 109. The only available physical evidence from the revision surgery
are pathology tissue samples which did not show the presence of metallic particles. Exh.
D at 4.
In Dr. Parr's revision operative report, he noted that Mr. Jarrett had suffered a
"[f]ailed [loose] left acetabular component" with "left hip pseudotumor related to metal
on metal articulation with paraprosthetic osteolysis and major osseous defect." Dkt. 9328; Parr Dep. at 78. Dr. Parr described encountering during the surgery a build-up of a
yellow-brown fluid as well as a large amount of brown and grayish tissue surrounding the
acetabular component of Mr. Jarrett's hip, which Dr. Parr believed to be a pseudotumor.
Dkt. 93-28; Parr Dep. at 88. Following the revision surgery, Dr. Parr sent some of that
tissue to pathology, where it was determined to be a hematoma, not a pseudotumor. Parr
Dep. at 88–89.
Mr. Jarrett recovered well from the left hip revision surgery and his last
appointment with Dr. Parr was in January 2011. Parr Dep. at 81. Mr. Jarrett is not
currently seeing an orthopedic doctor for his left hip. Jarrett Dep. at 57.
VIII. Expert Testimony of John I. Waldrop, M.D.
John I. Waldrop, M.D., is an orthopedic surgeon whom Plaintiffs have identified
as an expert to offer opinions concerning "the implantation and failure of the Wright
Medical CONSERVE® Total Hip Implant Device associated with" Mr. Jarrett. Dkt. 87-1
at 1. Dr. Dr. Waldrop has been practicing medicine for 40 years, maintaining an active
12
practice performing hip and knee arthroplasties. He estimates that he has performed
more than 5,000 to 6,000 total hip procedures and, since 2010, has revised 64 hips, many
of which were metal-on-metal implants, including five to ten CONSERVE® devices. Id.
In his practice, Dr. Waldrop has observed five general "characteristics" of metallosis 1
caused by MoM hip implants: (1) discolored fluid in the joint; (2) "death or necrosis of
local tissue in the hip area"; (3) "cystic responses" or pseudotumors; (4) other tissue
reactions including inflammation, discoloration, and staining; and (5) elevated cobalt and
chromium levels. Dkt. 87-2.
With regard to Mr. Jarrett's case specifically, Dr. Waldrop testified that he
"examined the medical records of Coleman Jarrett including digital x-rays of his
prothesis," and based on his review of these materials and his education, training, and
experience, he has formed the opinion that the failure of Mr. Jarrett's CONSERVE® total
hip implant "was due to the pain associated with metallosis, corrosion, and component
loosening associated with metal-on-metal hip failures," that the findings during Mr.
Jarrett's revision surgery "including the noted pseudotumor, corrosion, and other
indicative findings of a metallosis reaction are consistent with [his] own clinical findings
on revision of metal-on-metal prosthesis," and that Mr. Jarrett's "pain prior to the
revision, necessity of the revision, and injuries after the revision are the result of the
defective metal-on-metal prosthesis." Dkt. 87-1 at 2.
1
Metallosis is a blood poisoning condition that develops as a result of having high levels of toxic
metals in the blood.
13
IX.
Expert Testimony of John D. Jarrell, Ph.D, PE
Plaintiffs have also identified as an expert John D. Jarrell, Ph.D., PE, a licensed
Professional Mechanical Engineer since 1996 who is actively involved in engineering
analysis, design, product development, and research. He graduated from Brown
University with a B.S. and M.S. in Materials Science and Engineering and a Ph.D. in
Biology, Medical Science and Engineering and has received medical training in
histology, physiology, microbiology, and pathology. Dkt. 88-1.
In his report, based on his experience, training, education, review of Wright
Medical Technology documents, FDA documents, published scientific literature and
inspection and testing of over 100 Wright Medical hip implant components, Dr. Jarrell
opines that Wright Medical's CONSERVE® hip system design is defective. Dr. Jarrell
identifies Wright Medical's use of a large metal cup against a large metal ball for the
articulating bearing surfaces as the major defect in the CONSERVE® hip system, which
in his opinion results in metal wear and the release of metal ions into surrounding tissues
that can cause injury, or metallosis, as well as eventual cup loosening and device failure.
Dr. Jarrell also opines that Wright Medical's wear testing was inadequate in that it
was performed "under ideal circumstances, which does not replicate patient use and
clinical results" and failed to "identify the risks associated with exposure to cobalt and
chromium metal wear debris, metal ions and corrosive products of [the] Conserve®
product line in comparison to the traditional small metal head on poly design." Id. at 5.
To support these conclusions, Dr. Jarrell's report sets forth results from wear testing he
14
performed on CONSERVE® devices, from which he determined that 25% of the thirtythree (33) CONSERVE® hips he tested exhibited more wear than advertised, specifically
14 times more wear than anticipated. Id. at 21.
X.
The Instant Litigation
On January 17, 2012, Mr. Jarrett filed his complaint in this action. The case was
transferred to the Northern District of Georgia on February 27, 2012 as part of MultiDistrict Litigation ("MDL") No. 2329, In re: Wright Medical Technology, Inc., Conserve
Hip Implant Products Liability Litigation and remanded from the MDL to our court on
July 6, 2018. Mr. Jarrett amended his complaint a few months later, on October 1, 2018.
Now before the Court is the motion for summary judgment filed by Wright Medical. The
motion has been fully briefed and is ripe for ruling.
Legal Analysis
I.
Summary Judgment Standard
Summary judgment is appropriate where there are no genuine disputes of material
fact and the movant is entitled to judgment as a matter of law. Fed. R. Civ. P. 56(a);
Celotex Corp. v. Catrett, 477 U.S. 317, 322–23 (1986). A court must grant a motion for
summary judgment if it appears that no reasonable trier of fact could find in favor of the
nonmovant on the basis of the designated admissible evidence. Anderson v. Liberty
Lobby, Inc., 477 U.S. 242, 247–48 (1986). We neither weigh the evidence nor evaluate
the credibility of witnesses, id. at 255, but view the facts and the reasonable inferences
15
flowing from them in the light most favorable to the nonmovant. McConnell v. McKillip,
573 F. Supp. 2d 1090, 1097 (S.D. Ind. 2008).
II.
Discussion
Plaintiffs have alleged in this litigation a cause of action under the IPLA, asserting
design defect, failure to warn, and fraud theories, as well as claims for loss of consortium
and punitive damages. 2 Wright Medical has moved for summary judgment on each of
these claims, which we address in turn below.
A. IPLA Claim
Under Indiana law, the IPLA "governs all actions that are (1) brought by a user or
consumer; (2) against a manufacturer or seller; and (3) for physical harm caused by the
product," regardless of the legal theory upon which the action is brought. IND. CODE
§ 34-20-1-1. "Under the Act, a manufacturer who places 'into the stream of commerce
any product in a defective condition unreasonably dangerous to any user or consumer …
is subject to liability for physical harm caused by that product.'" Kaiser v. Johnson &
Johnson, 947 F.3d 996, 1007 (7th Cir. 2020) (quoting IND. CODE § 34-20-2-1). To
succeed on a claim under the IPLA, the plaintiff must establish that "(1) he or she was
harmed by the product; (2) the product was sold 'in a defective condition unreasonably
dangerous to any user or consumer'; (3) the plaintiff was a foreseeable user or consumer;
(4) the defendant was in the business of selling the product; and (5) the product reached
2
Plaintiffs originally also asserted a manufacturing defect theory under the IPLA but abandoned
that claim in their response in opposition to Defendant's motion for summary judgment.
Accordingly, Defendant is entitled to summary judgment as to that theory of defect under the
IPLA.
16
the consumer or user in the condition it was sold." Bourne v. Marty Gilman, Inc., 452
F.3d 632, 635 (7th Cir. 2006).
A medical device falls within the IPLA definition of a product. See IND. CODE
§ 34-6-2-114 (defining "product" as "any item or good that is personalty at the time it is
conveyed by the seller to another party" in a transaction not "wholly or predominantly the
sale of a service rather than a product"). A plaintiff can establish that a product, such as
the CONSERVE® device, was defective "by showing one of the following: a design
defect, a manufacturing defect, or a failure to warn." Ritchie v. Glidden Co., 242 F.3d
713, 720 (7th Cir. 2001); see also Brewer v. PACCAR, Inc., 124 N.E.3d 616, 621 (Ind.
2019) ("A product may be defective under the IPLA if it is defectively designed, if it has
a manufacturing flaw, or if it lacks adequate warnings about dangers associated with its
use.").
In this case, Plaintiffs allege that the Wright Medical CONSERVE® device that
was implanted in Mr. Jarrett was defective under the first and third of these theories, to
wit, design defect and failure to warn. The IPLA "grounds design-defect and failure-towarn liability in negligence: a plaintiff must 'establish that the manufacturer or seller
failed to exercise reasonable care under the circumstances in designing the product or in
providing the warnings or instructions.'" Kaiser, 947 F.3d at 1008 (quoting IND. CODE
§ 34-20-2-2). "Under either theory, a plaintiff must prove that the defendant breached the
duty of reasonable care owed to him—whether in the product's design or in its
warnings—and the breach proximately caused his injury." Id.
17
There is a rebuttable presumption under the IPLA that the product that caused a
plaintiff's physical harm was not defective, and the manufacturer or seller was not
negligent, if, before the sale by the manufacturer, the product "was in conformity with the
generally recognized state of the art applicable to the safety of the product at the time the
product was designed, manufactured, packaged, and labeled" or "complied with
applicable codes, standards, regulations, or specifications established, adopted,
promulgated, or approved by the United States or by Indiana, or by an agency of the
United States or Indiana." IND. CODE § 34-20-5-1; see also Kaiser, 947 F.3d at 1017.
This presumption applies to all product liability claims, regardless of theory. See
Indianapolis Athletic Club, Inc. v. Alco Standard Corp., 709 N.E.2d 1070, 1075 (Ind. Ct.
App. 1999). Once established, the opposing party has a burden of producing evidence to
overcome the presumption and avoid dismissal. See Cansler v. Mills, 765 N.E.2d 698,
705 (Ind. Ct. App. 2002), overruled on other grounds by Schultz v. Ford Motor Co., 857
N.E.2d 977 (Ind. 2006)).
1. Design Defect
We turn first to address Plaintiffs' design defect claim under the IPLA. As
discussed above, to succeed on such a claim, a plaintiff "must establish that the
manufacturer or seller failed to exercise reasonable care under the circumstances in
designing the product…." IND. CODE § 34-20-2-2. Thus, a plaintiff must prove that "(1)
the defendant owed a duty to the plaintiff; (2) the defendant breached that duty; and (3)
the breach proximately caused an injury to the plaintiff." Simpson v. Gen. Dynamics
18
Ordnance and Tactical Systems-Simunition Operations, Inc., 429 F. Supp. 3d 566, 577
(N.D. Ind. 2019) (citation omitted). Additionally, "[e]xpert testimony is needed under
Indiana law to establish both defect and causation when 'the issue is not within the
understanding of a lay person.'" Lyons v. Leatt Corp., No. 4:15-CV-17-PRC, 2017 WL
4117775, at *8 (N.D. Ind. Sept. 14, 2017); accord Owens v. Ford Motor Co., 297 F.
Supp. 2d 1099, 1103–04 (S.D. Ind. 2003) (requiring expert testimony where the existence
of a defect depends on matters beyond the understanding of a lay person). We find in this
complex products liability scenario that the nature of the alleged design defects and the
cause of Mr. Jarrett's injuries are both matters that exceed the understanding of a lay
person; thus, expert testimony is required to establish both that the CONSERVE® device
implanted in Mr. Jarrett was defectively designed and causation.
We turn first to address whether Plaintiffs have adduced sufficient evidence to
raise a genuine issue of material fact regarding whether the CONSERVE® device was
defectively designed. Upon a careful review of the record, we find that they have.
Plaintiffs' expert, Dr. Jarrell, opines in his report that the cobalt chromium components
used in the CONSERVE® device generate excessive toxic wear, that the design of the
CONSERVE® device, namely, its use of a large metal ball and cup component, results in
inadequate lubrication between the metal components of the device, further exacerbating
the wear issues, and finally, that Wright Medical's in vitro testing of the wear rate of the
CONSERVE® device's metal components was inadequate because it did not accurately
replicate the conditions encountered when the hip is implanted in a live patient, resulting
19
in data that significantly underestimated the actual wear levels associated with the device.
This testimony, if believed by the jury, would be sufficient to support a finding that the
design of the CONSERVE® device was defective, rendering the device unreasonably
dangerous.
Wright Medical, of course, has its own experts who disagree with Dr. Jarrell's
conclusions and are expected to testify to the contrary. However, it is well-established
that "[t]he question of whether the expert is credible or whether his [] theories are correct
given the circumstances of a particular case is a factual one that is left for the jury to
determine after opposing counsel has been provided the opportunity to cross-examine the
expert regarding his conclusions and the facts on which they are based. … It is not the
trial court's role to decide whether an expert's opinion is correct." Smith v. Ford Motor
Co., 215 F.3d 713, 719 (7th Cir. 2000) (internal citation omitted). Accordingly, the
question of whether the CONSERVE® device was defectively designed must go to the
jury.
We turn next to address whether Plaintiff has adduced sufficient evidence to raise
a genuine issue of material fact regarding causation, which is a closer question. Because
the CONSERVE® device implanted in Mr. Jarrett was not retained after his revision
surgery, no tests were performed on the device itself to measure its wear levels. There
are also no metal ion laboratory values available indicating the presence of metal ions in
Mr. Jarrett's blood; rather, we understand the uncontested testimony of Wright Medical's
expert, Edward DiCarlo, M.D., to be that "[p]articles of metallic debris [were] not
20
present" in Mr. Jarrett's tissue following the revision surgery. DiCarlo Rep. at 4
(emphasis added).
In the absence of laboratory evidence showing the presence of metal ions in Mr.
Jarrett's blood, Plaintiffs rely solely on what they characterize as Mr. Jarrett's "clearly
observable and distinctive injuries from metallosis" as proof of causation. 3 Pls.' Resp. at
13. In support of this claim, Plaintiffs point to Dr. Parr's revision operative report which
notes as a post-operative diagnosis "pseudotumor related to metal-on-metal articulation."
Exh. 28. In that report, Dr. Parr also described that the "posterior wall and superior part
of the acetabulum eroded away by pseudotumor or loose component" and observed a
"yellowish-brown fluid" in the joint. Id. Dr. Parr testified that these findings are
indicative of metal-on-metal failures, which "present a very distinctive appearance." Parr
Dep. at 116. Likewise, Plaintiffs' expert, Dr. Waldrop, opined that the failure of Mr.
Jarrett's CONSERVE® total hip implant "was due to the pain associated with metallosis,
corrosion, and component loosening associated with metal-on-metal hip failures,"
observing that the findings during Mr. Jarrett's revision surgery "including the noted
pseudotumor, corrosion, and other indicative findings of metallosis reaction are
consistent with [his] own clinical findings on revision of metal-on-metal prosthesis."
Waldrop Rep. at 2.
3
We previously granted Wright Medical's motion to exclude Dr. Jarrell's specific causation
testimony in this case. Accordingly, Plaintiffs' arguments in opposition to Wright Medical's
motion for summary judgment that rely on that excluded testimony are not addressed here.
21
Wright Medical rejoins that Plaintiffs' evidence is insufficient to raise a genuine
issue of material fact regarding causation because the primary indicator of metallosis in
Mr. Jarrett's case that was cited by both Dr. Parr and Dr. Waldrop is the existence of a
pseudotumor, yet when that mass was sent for microscopic examination, it was
determined to be a hematoma, not a pseudotumor. Parr Dep. at 88–89. Wright Medical
argues that, because hematomas, unlike pseudotumors, are indicative of traumatic
injuries, such as a fall, as opposed to injuries from metal wear, (DiCarlo Rep. at 4),
Plaintiffs' design defect claim fails for lack of evidence of causation. While the
significance of this distinction is certainly an issue that Wright Medical can pursue with
Plaintiffs' witnesses on cross-examination, it is not a sufficient basis on which to grant
summary judgment in Wright Medical's favor on Plaintiffs' design defect claim. In
addition to the pseudotumor, Dr. Parr and Dr. Waldrop both testified regarding other
hallmark signs of metallosis that Mr. Jarrett exhibited, which in their view establish that
metal wear was the cause of Mr. Jarrett's injuries. Wright Medical's experts not
surprisingly opine otherwise, but as discussed above it is not within our purview to
determine which of the parties' experts espouse the factually correct view; that is the
jury's province. See Smith, 215 F.3d at 719 ("It is not the trial court's role to decide
whether an expert's opinion is correct."). Accordingly, Wright Medical is not entitled to
summary judgment on Plaintiffs' design defect claim.
22
2. Failure to Warn
A failure to warn claim under Indiana law requires proof "that the manufacturer or
seller failed to exercise reasonable care under the circumstances … in providing warnings
or instructions." IND. CODE § 34-20-2-2. A product is defective for failure to warn "if
the seller fails to: (1) properly package or label the product to give reasonable warnings
of danger about the product; or (2) give reasonably complete instructions on proper use of
the product." IND. CODE § 34-20-4-2. When assessing the adequacy of a warning in the
context of a medical device, Indiana law applies the "learned-intermediary doctrine,"
meaning that "a medical-device manufacturer can discharge [its] duty by providing
adequate warnings to physicians." Kaiser, 947 F.3d at 1015, regardless of whether such
warnings reach the patient. Under this doctrine, the plaintiff "must not only show that a
manufacturer's warning was inadequate, but that such inadequacy affected the prescribing
physician's use of the product and thereby injured the plaintiff." Minisan v. Danek Med.
Inc., 79 F. Supp. 2d 970, 978–79 (N.D. Ind. 1999). In other words, the relevant inquiry is
whether the plaintiff can show that supplemental warnings would have caused his
physician to take a different course of action. Kaiser, 947 F.3d at 1016.
Here, Plaintiffs allege that Mr. Jarrett was forced to undergo a revision surgery
because of alleged defects in the CONSERVE® components, namely, the generation of
wear between the metal components of the devices resulting in metallosis and acetabular
loosening. The IFU that accompanied the CONSERVE® devices at issue included
specific warnings about these potential risks, including the wear of metal components, the
23
potential of a reaction to wear particle release, and the loosening of prosthetic
components. Specifically, the IFU provides that "[s]ome of the alloys used to produce
orthopedic prostheses may contain some elements that may be carcinogenic in tissue
cultures or intact organisms," and that, while studies had not provided any convincing
evidence of such, "[q]uestions have been raised in the scientific literature as to whether or
not these alloys may be carcinogenic to actual prosthetic recipients." Exh. J at
WMTMDL0006703. The IFU further warns that "[p]articulate is generated by
interaction between components, as well as between the components and bone, primarily
through wear mechanisms of adhesion, abrasion, and fatigue." Id. at WMTMDL0006708.
Warnings that rare "metal sensitivity reactions in patients following joint replacement
have been reported," including "histological reactions involving macrophages and
fibroblasts," were also included in the applicable IFU. Id. Finally, regarding acetabular
loosening, the IFU warns generally that "[p]rosthetic components can loosen or migrate
due to trauma or loss of fixation." Id. The law is well-established that "[w]here the
manufacturer warns of the precise adverse effect of which the plaintiff complains, the
warning may be deemed adequate as a matter of law." Tucker v. SmithKline Beecham
Corp., 701 F. Supp. 2d 1040, 1066 (S.D. Ind. 2010) (citing Ziliak v. AstraZeneca LP, 324
F.3d 518, 521 (7th Cir. 2003); Crisostomo v. Stanley, 857 F.2d 1146, 1153 (7th Cir.
1988)).
Even assuming that Wright Medical's warnings regarding the CONSERVE®
devices at issue were inadequate in some way, Defendant is entitled to summary
24
judgment on Plaintiffs' failure to warn claim because the evidence establishes both that
Dr. Parr was independently aware of the risks of which Plaintiffs complain and that
stronger warnings would not have caused him to take a different course of action with
regard to Mr. Jarrett's care because the extent of the risks associated with MoM devices
were not known at the time of Mr. Jarrett's surgery and Dr. Parr did not rely on Wright
Medical's marketing materials in deciding to implant the CONSERVE® devices in Mr.
Jarrett.
Dr. Parr's deposition testimony demonstrates that he was aware in 2006 of various
potential risks associated with MoM implants, including those alleged in this litigation to
have caused Mr. Jarrett's injuries. Specifically, Dr. Parr testified that he was aware, prior
to Mr. Jarrett's initial surgery, of the possibility of wear to the metal bearing surfaces and
that patients implanted with MoM devices would likely have a measurable amount of
metal ions around the hip. He also knew that the CONSERVE® devices had only
recently come on the market at the time of Mr. Jarrett's surgery and understood that the
full scope of potential issues related to the release of metal ions was at that time
unknown. Prior to Mr. Jarrett's surgery, Dr. Parr had been involved in an investigational
study of Wright Medical's CONSERVE® devices to "evaluate serum ion concentrations
in patients" with "metal-on-metal bearings," in part in response to "concerns" from "some
clinicians … over elevated metal ion exposure." Exh. K at 2–3; Parr Dep. at 15–17.
Given Dr. Parr's intimate knowledge of the then-known potential risks associated with
MoM devices at the time he recommended the CONSERVE® devices to Mr. Jarrett by
25
virtue of his involvement with Wright Medical to research those risks, Wright Medical
cannot be held liable for failing to inform or actively misleading Dr. Parr under a failure
to warn theory.
Plaintiffs rejoin that Dr. Parr was not made aware of the extent of the dangers
associated with the CONSERVE® devices, including the risk of pseudotumors,
metallosis, and metal sensitivity, as well as other information including high failure rates
reported by other physicians and poor registry performance of the devices, and that Dr.
Parr testified that, had he known such information in 2006, he may not have
recommended the CONSERVE® devices to Mr. Jarrett. However, it is axiomatic that
manufacturers do not have a duty to warn of risks not yet known. See Meharg v. I-Flow
Corp., No. 1:08-cv-184-WTL-TAB, 2010 WL 711317, at *3 (S.D. Ind. Mar. 1, 2010)
(granting summary judgment on failure to warn claim in favor of the defendant on
grounds that such a claim is premised on risks that were known or should have been
known at the time of the plaintiff's surgery, not on risks only discovered later). Here, Dr.
Parr testified that "nobody was aware of" the full scope of risks associated with metal
ions and metallosis "early on" in 2006, a fact confirmed by Plaintiffs' own expert, Dr.
Waldrop, who testified that he and other orthopedic surgeons were the ones who were
discovering the issues with MoM devices that led to metallosis as they performed
surgeries using those devices, but that he had not become aware of the extent of the
issues until 2008 or 2009. Parr Dep. at 98 (emphasis added); Waldrop Dep. at 50.
Likewise, the data cited by Plaintiffs in support of their failure to warn claim showing
26
poor registry performance of the CONSERVE® devices is dated 2011, five years after
Mr. Jarrett's surgery. Accordingly, the fact that Wright Medical's warnings may not have
contained this information does not alter our conclusion that Plaintiffs' failure to warn
claim cannot survive summary judgment. Likewise, Dr. Parr's decision in 2010 or
2011—at least four years after Mr. Jarrett's surgery—to discontinue using MoM devices
once the full extent of the issues related to such devices was known is irrelevant to our
analysis.
Finally, although Dr. Parr testified that he had a general understanding of the
warnings contained in the IFU applicable to the CONSERVE® devices and agreed that it
was important to be able to rely on the accuracy and completeness of the warnings
contained therein, he stated that he did not utilize Wright Medical's marketing materials
in deciding which devices to implant and instead relied on his own orthopedic experience
and the "actual research data." Parr Dep. at 94–95. Thus, Plaintiffs' claim that Wright
Medical sales representatives were actively misleading physicians regarding the safety of
the CONSERVE® devices is irrelevant to our analysis because no evidence has been
adduced to establish that Dr. Parr relied on any statements by Wright Medical's sales
representatives or other marketing materials in making treatment decisions for Mr. Jarrett
such that stronger warnings from those sources would have altered Dr. Parr's decision to
use the CONSERVE® devices. For these reasons, Wright Medical is entitled to
summary judgment in its favor on Plaintiffs' failure to warn claim.
27
3. Fraud
The elements of common-law fraud in Indiana are: "(1) a material
misrepresentation of past or existing fact which (2) was untrue, (3) was made with
knowledge of or in reckless ignorance of its falsity, (4) was made with the intent to
deceive, (5) was rightfully relied upon by the complaining party, and (6) which
proximately caused the injury or damage complained of." Kesling v. Hubler Nissan, Inc.,
997 N.E.2d 327, 335 (Ind. 2013) (quotation marks and citation omitted). Fraud is not
limited only to affirmative representations; rather, "[t]he failure to disclose all material
facts by one on whom the law imposes a duty to disclose constitutes actionable fraud."
First Bank of Whiting v. Schuyler, 692 N.E.2d 1370, 1372 (Ind. Ct. App. 1998).
Here, the primary basis of Plaintiffs' fraud claim mirrors their failure-to-warn
claim. Plaintiff has presented no evidence identifying any particular fraudulent
statements upon which Mr. Jarrett himself relied, which "indicates that the gravamen" of
the fraud claim is Wright Medical's failure to warn about particular risks or dangers
associated with the CONSERVE® devices. See Huskey v. Ethicon, Inc., 29 F. Supp. 3d
736, 744 (S.D.W.V. 2014) (observing that the plaintiffs' "'fraud-based claims' … are
simply repackaged failure-to-warn claims."). To the extent that Plaintiffs' fraud claim is
premised on the same allegations as their failure-to-warn claim, it fails for the same
reasons. Accordingly, Plaintiffs' claim for fraud insofar as it is based on Wright
Medical's alleged failure to disclose known risks and its active misrepresentation and
concealment of such risks cannot survive summary judgment.
28
The only other basis for Plaintiffs' fraud claim is their allegation that Wright
Medical promoted, marketed, and sold the Thin Shell, a component used in the
CONSERVE® devices, with no regulatory clearance of that component for use in any
device. Plaintiffs claim that Wright Medical's active promotion of this component
constituted a fraud against Mr. Jarrett and the entire medical community that is a distinct
injury from any failure to warn. It is not entirely clear from the briefing the exact basis
for this theory of fraud. To the extent that this claim is based on alleged
misrepresentations to the FDA during the regulatory process, it is well established that "it
is the Federal Government rather than private litigants who are authorized to file suit for
noncompliance with the medical device provisions…." Buckman Co. v. Plaintiffs' Legal
Committee, 531 U.S. 341, 349 n.4 (2001); see also Lautzenhiser v. Coloplast A/S, No.
4:11-cv-86-RLY-WGH, 2012 WL 4530804, at *7 (S.D. Ind. Sept. 29, 2012) (recognizing
that the Supreme Court held in Buckman that "'fraud on the FDA' claims could not be the
subject of federal litigation").
If, however, Plaintiffs are claiming that, in marketing and promoting the Thin
Shell, Wright Medical made false and misleading statements regarding the regulatory
process or its outcome to the medical community and the public, any such fraud claim
still fails because Plaintiffs have adduced no evidence to establish that either Mr. Jarrett
or Dr. Parr reviewed or were even aware of any such undefined statements or information
pertaining to regulatory clearance, much less that either relied upon those statements in
making treatment decisions. As discussed above, Dr. Parr testified that he did not review
29
or rely on marketing materials in deciding to implant the CONSERVE® device and Mr.
Jarrett stated that he did not conduct any independent research or review any brochures,
documents, or statements from Wright Medical prior to his surgery. In fact, Mr. Jarrett
was not even aware at the time of his surgery that the device that would be implanted was
Wright Medical's. Accordingly, because the undisputed evidence establishes that neither
Mr. Jarrett nor Dr. Parr relied on any allegedly false or misleading statements related to
the regulatory clearance issues, Wright Medical is entitled to summary judgment on
Plaintiffs' fraud claim based on this theory.
B. Loss of Consortium
Plaintiff Paula Jarrett has alleged a claim for loss of consortium based on injuries
she allegedly suffered in relation to her husband's underlying product defect claims. In
Indiana, a loss of consortium claim is derivative of the injured spouse's personal injury
claim. Price v. Kuchaes, 950 N.E.2d 1218, 1231 (Ind. Ct. App. 2011). Here, beyond
arguing that, if the Plaintiffs' IPLA claim is dismissed in its entirety, the loss of
consortium claim must also be dismissed, Wright Medical has presented no independent
argument in support of dismissal of Mrs. Jarrett's claim. Because we have found, for the
reasons detailed above, that Plaintiffs' IPLA claim based on a design defect theory
survives summary judgment, we hold that Mrs. Jarrett is likewise entitled to proceed on
her loss of consortium claim.
30
C. Punitive Damages
To recover punitive damages under Tennessee law, 4 a plaintiff must prove that the
defendant acted "maliciously, intentionally, fraudulently, or recklessly." TENN. CODE
ANN. § 29-39-104(a)(1). Tennessee law provides that punitive damages may "be
awarded only in the most egregious of cases" and must be proved by "clear and
convincing evidence" so as to restrict punitive damages to only those cases of "truly
reprehensible" conduct." Hodges v. S.C. Toof & Co., 833 S.W.2d 896, 901 (Tenn. 1992).
Here, Plaintiffs claim that they are entitled to punitive damages on grounds that
Wright Medical not only failed to provide sufficient warnings of the risks of the
CONSERVE® devices to surgeons such as Dr. Parr, but also actively misled physicians
regarding known risks associated with the devices. However, we have granted summary
judgment in Wright Medical's favor on Plaintiffs' failure-to-warn and fraud claims. For
those same reasons, Wright Medical is entitled to summary judgment on Plaintiffs'
punitive damages request.
III.
Conclusion
For the reasons detailed above, Defendants' Motion for Summary Judgment [Dkt.
84] is GRANTED as to Plaintiffs' manufacturing defect, failure-to-warn, and fraud
theories under the IPLA as well as Plaintiffs' punitive damages request and DENIED as
4
Both parties agree that, because Plaintiffs' claim that they are entitled to punitive damages is
based on allegations that Wright Medical downplayed or disregarded risks associated with the
CONSERVE® devices and failed to provide adequate warnings to dissuade surgeons from using
the devices, and Wright Medical's determination of relevant warnings and creation of its IFUs
and other marketing materials occurred in Tennessee, Tennessee law governs punitive damages
in this case.
31
to Plaintiffs' IPLA claim based on a design defect theory and the loss of consortium
claim. The case will proceed accordingly.
IT IS SO ORDERED.
9/22/2021
Date: _________________________
_______________________________
SARAH EVANS BARKER, JUDGE
United States District Court
Southern District of Indiana
32
Distribution:
Brian K. Brake
THE MILLER FIRM LLC
bbrake@millerfirmllc.com
Anne A. Gruner
DUANE MORRIS LLP
AAGruner@duanemorris.com
Shayne Hodge
THE MILLER LAW FIRM, LLC
shodge@millerfirmllc.com
J. Scott Kramer
DUANE MORRIS LLP
jskramer@duanemorris.com
Eric Charles Lewis
LEWIS LEGAL SERVICES, P.C.
cmecf.lewislegal@live.com
Tayjes Shah
THE MILLER FIRM, LLC
tshah@millerfirmllc.com
Blake N. Shelby
FROST BROWN TODD LLC (Indianapolis)
bshelby@fbtlaw.com
Robert B. Thornburg
FROST BROWN TODD LLC
rthornburg@fbtlaw.com
33
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