United States District Court, N.D. Illinois, Eastern Division
MEMORANDUM OPINION AND ORDER
REBECCA R. PALLMEYER United States District Judge.
Zimmer Inc. manufactures knee implants, among other medical
devices. Plaintiffs in this multidistrict litigation
proceeding (MDL) are individuals whose native knees were
replaced by Zimmer NexGen Flex knee implants during total
knee replacement (TKR) surgery. They allege that they have
suffered pain and loss of movement, and in some cases, have
had to undergo revision surgeries, because the NexGen Flex
device is prone to premature loosening.
second case to be scheduled for a bellwether trial in this
MDL was brought by Plaintiff Theodore Joas and his wife,
Darlene Joas. Mr. Joas underwent revision surgery in 2014
because of loosening in the tibial component of his NexGen
Flex implant, loosening that he alleges resulted from a
defect in the implant's design. The first bellwether
case-brought by Plaintiff Kathy Batty and her husband, Thomas
Batty-went to trial roughly one year ago and resulted in a
jury verdict for Zimmer. See Batty v. Zimmer, Inc.,
No. 12 C 6279 . In advance of the Batty trial,
this court issued a number of rulings on evidentiary matters
and on Zimmer's motion for summary judgment. See,
e.g., In re Zimmer Nexgen Knee Implant Prod. Liab.
Litig., No. 11 C 5468, 2015 WL 3669933, at *1 (N.D. Ill.
June 12, 2015) [hereinafter "Batty
Opinion"] (ruling on motions to exclude testimony of two
of plaintiff's experts, Dr. Thomas Brown and Dr. Joseph
Fetto, and granting motion for summary judgment in part and
denying it in part). In Joas's case, the parties have
again filed a number of motions in limine, including
requests from both sides to exclude testimony from certain of
the other's expert witnesses, and Zimmer has again moved
for summary judgment on all counts.
opinion, the court addresses Zimmer's motion to exclude
the testimony of Dr. Joseph Fetto  under Federal Rule of
Evidence 702 and Daubert v. Merrell Dow Pharm.,
Inc., 509 U.S. 579 (1993), as well as Zimmer's
motion for summary judgment . Zimmer argues that Dr.
Fetto's testimony should be excluded because his opinion
regarding the cause of the loosening in Joas's tibial
component is based on an unreliable methodology. Dr. Fetto
employed a differential diagnosis, or "differential
etiology, " an accepted and well-established method for
determining causation, but Zimmer argues that Dr. Fetto
failed to apply the method correctly. In addition to its
criticism of Dr. Fetto's testimony, Zimmer contends that
Plaintiffs lack reliable expert testimony to establish that
the design of the NexGen Flex knee was defective or that any
alleged defect caused Joas's injury. Zimmer also argues
that there was nothing inadequate about the warning contained
in the device's package insert and that Plaintiffs have
not shown that any change in Zimmer's warning would have
prevented Joas's injury.
respond that the biomechanical engineering testimony of Dr.
Thomas Brown and the statistical analysis offered by Dr.
David Madigan will provide a sufficient basis for the jury to
conclude that the NexGen Flex contains a design defect.
Further, they assert that Dr. Fetto's testimony, which is
based on his examination of Joas and a review of his medical
records, will establish that the implant's defective
design was the cause of Joas's injury. In support of
their failure-to-warn claims, Plaintiffs contend that Zimmer
failed to warn about the risks of engaging in high-flexion
(that is, bending the knee beyond 120 degrees) activities
with the NexGen Flex knee and failed to provide adequate
instructions to surgeons about the amount of cement required
to affix the implant to the patient's bone. That
Zimmer's warnings were inadequate and that improved
warnings would have avoided Joas's injury are points so
obvious, they insist, that no expert testimony is necessary
to establish them.
reasons discussed below, the court concludes that, because
Dr. Fetto failed to apply his stated methodology in a
reliable manner, his testimony must be excluded. The court
also concludes that Plaintiffs have failed to present
sufficient evidence to allow a jury to find for them on any
of their claims. The court therefore grants Zimmer's
motion for summary judgment on all counts.
February 2008, at the relatively young age of 54, Joas
underwent total knee replacement surgery because rheumatoid
arthritis was causing persistent pain in his left knee.
(Report of Dr. Joseph Fetto, re: Theodore Joas (July 22,
2016), Ex. B to Zimmer's Mem. in Supp. of Mot. to Exclude
Test. of Dr. Joseph Fetto (hereinafter "Def.'s Fetto
Mem.") [32-2], (hereinafter "Fetto Rep."), at
2.) Dr. Bryan Larson performed the surgery at Sacred Heart
Hospital in Eau Claire, Wisconsin, and selected the Zimmer
NexGen Flex knee implant that would replace Joas's native
knee. (Id.) As the court has discussed previously,
the NexGen Flex implant was designed to allow patients to
achieve higher flexion than they could when using the
"Standard" version of Zimmer's NexGen implant.
See Batty Opinion, 2015 WL 3669933, at
*2-*3. At the time of his surgery, Joas weighed
202 pounds and stood five feet, seven inches tall, giving him
a body mass index (BMI) of 31. (Dep. of Dr. Joseph Fetto, Ex.
C to Def.'s Mem. in Supp. of Mot. to Excl. Testimony of
Dr. Joseph Fetto [32-3] (hereinafter "Fetto Dep.), at
recovery from surgery went well, and he was eventually able
to return to work for Pepsi Bottling Group, where his job
required him to lift and carry heavy loads and to squat
repetitively during the course of a day. (Id.) After
returning to work, Joas continued to engage in physical
therapy at home and also participated in other physical
activities, including exercising on a stationary bicycle and
recreational hunting, canoeing, and fishing. (Id.)
At some point in 2011 or 2012, however, Joas again began to
experience pain in his left knee. (See Dep. of
Theodore Joas, Ex. L to Def.'s Mem. in Supp. of Mot. to
Excl. Testimony of Dr. Joseph Fetto [32-12] (hereinafter
"Joas Dep.), at 200:1-11.) In August 2012, Dr. William
Decesare ordered an x-ray and bone scan of Joas's knee,
the results of which were consistent with aseptic loosening
of the tibial component of Joas's implant. (Fetto Rep. at
2.) Joas then saw an orthopedic surgeon, Dr. Scott Cameron,
who concurred with the diagnosis of aseptic loosening of the
tibial component and performed a revision of that component
in October 2014, again at Sacred Heart Hospital in Eau
contend that Joas's tibial component loosened because the
design of the NexGen Flex causes premature loosening in TKR
patients who engage in high-flexion activities following
their surgeries, a risk about which Zimmer allegedly failed
to warn. Plaintiffs' complaint alleged a host of claims:
strict liability design defect, strict liability failure to
warn, strict liability manufacturing defect, negligence,
negligent misrepresentation, breach of express warranty,
breach of implied warranty, violation of Wisconsin consumer
protection law, unjust enrichment, and fraudulent
concealment. (See Pls.' Approved Short Form
Compl.  at 5-8.) Plaintiffs also alleged that Zimmer's
wrongdoing supports an award of punitive damages.
(Id. at 8.) Zimmer has moved for, and advanced
arguments in support of, summary judgment on all counts, but
Plaintiffs responded only to the arguments regarding design
defect, failure to warn, negligence, and punitive damages. In
support of their design defect and negligence claims,
Plaintiffs offer the expert testimony of Dr. Brown, Dr.
Madigan, and Dr. Fetto. In particular, Plaintiffs rely on the
testimony of Dr. Brown and Dr. Madigan to support the
contention that the NexGen Flex design predisposes the
implant to tibial loosening, while Dr. Fetto's testimony
is offered to establish that it was a defect in the NexGen
Flex that caused Joas's loosening. Plaintiffs offer no
expert testimony in support of their failure-to-warn claims.
The court discusses the proposed testimony of Plaintiffs'
experts below, before discussing the facts underlying
Plaintiffs' failure-to-warn claims.
Dr. Brown's Proposed Expert Testimony
court discussed Dr. Brown's biomechanical engineering
opinions extensively in its ruling on Zimmer's
Daubert motion to exclude his testimony in
Batty. See Batty Opinion, 2015 WL 3669933,
at *7-*18. Over Zimmer's objections, the court permitted
Dr. Brown to testify that the design of NexGen Flex
predisposes the implant to femoral and tibial loosening.
Id. Unlike in Batty, there is no evidence
in this case that the femoral component of Joas's implant
loosened, so the court will confine its discussion to Dr.
Brown's theory of tibial loosening. Essentially, the
theory of tibial loosening Dr. Brown presented in
Batty is as follows: When individuals engage in
high-flexion, weight-bearing activities (deep squatting, for
example), there is the potential for significantly elevated
loading to concentrate on the posterior (that is, the rear)
surface of the tibial component. This high concentration of
loading can then cause the tibial component to
"rock" or "toggle, " which could lead to
loosening of the component, or "fixation interface
failure, " over time. See Id. at *16; (Supp.
Expert Report of Thomas Brown, Ex. A to Def.'s Mot. for
Summ. J. [34-1] (hereinafter "Brown Supp. Rep."),
at 1.) Patients who receive the NexGen Standard implant are
unlikely to flex their knees to an angle greater than 130
degrees, Dr. Brown explains, because at that angle of
flexion, the femoral bone would impinge on, or collide with,
the tibial component. (See Expert Report of Thomas
Brown, Ex. 3 to Pls.' Resp. to Zimmer's Second
Daubert Mot. [121-1] (hereinafter "Brown
Rep."), at 48.) The NexGen Flex, however, has a
posteriorly extended femoral component, which allows patients
who receive the implant to achieve an additional 25 degrees
of flexion before "impingement" would occur.
(Id. at 49.) Dr. Brown's initial expert report,
prepared in advance of the Batty trial, criticized
Zimmer for failing to conduct testing to compare the
propensity for micro-motion under "worst-case
scenarios" for the respective Standard and Flex designs;
that is, Zimmer did not compare the micro-motion of the
Standard knee's tibial component at its maximum flexion
angle of 130 degrees with that of the Flex knee's tibial
component at its maximum flexion angle of 155 degrees.
(Id.) According to Dr. Brown's theory, the
increased flexion in patients with Flex implants would cause
increased loading forces on the posterior surface of the
tibial component as well as additional shifting of the force
toward the component's posterior edge. (See
Brown Supp. Rep. at 1.)
Batty, the court declined to exclude Dr. Brown's
opinion regarding tibial loosening because Dr. Brown had
reliably explained why the Flex design would be more prone to
tibial loosening than would the Standard design under high
flexion. Batty Opinion, 2015 WL 3669933, at *16.
Although Dr. Brown did not conduct any tests to show that the
Flex knee actually would be subject to increased
micro-motion (and thus loosening) at high-flexion angles, the
court noted that testing of an opinion is not a prerequisite
for its admissibility. The court concluded that Dr. Brown was
free to criticize Zimmer's internal testing and to infer
what an alternative testing protocol would have revealed.
Id. at *17. In the supplemental report that Dr.
Brown recently submitted, he attempts to quantify the moment
(that is, the product of the contact force and the distance
of the femoral component's posterior translation, or
shift) that would tend to cause toggling or micro-motion at
various flexion angles. (See Brown Supp. Rep. at 6.)
But in this supplemental report, and during his most recent
deposition, Dr. Brown's clarification of his opinions
casts doubt upon the court's previous conclusion that Dr.
Brown could reliably infer that patients implanted with a
Flex device, as opposed to a Standard device, actually would
experience increased toggling and micro-motion of their
tibial components. Though Dr. Brown's modeling did find
toggle moment increases in the range of 30% to 60%-80% at
various high-flexion angles, he conceded that without
reliable interfacial stress data for the tibial components of
Flex devices, "there is no way to formally quantify
whether or not these levels of additional toggle moment
demand would represent an unacceptable risk for fixation
interface failure." (Id. at 7.) He opines that
the increased toggle moments warrant serious concern and
should have prompted Zimmer to investigate whether the toggle
moment levels he has quantified would cause interface
failure, but he admits that he has "no way of
knowing" what the results would have been, had Zimmer
conducted the appropriate testing. (Dep. of Thomas Brown, Ex.
B to Def.'s Mem. in Supp. of Second Daubert Mot.
[34-2] (hereinafter "Brown Dep."), at 97:15-98:15.)
his initial expert report and his supplemental report, Dr.
Brown discusses alternative implant designs. As mentioned
above, Dr. Brown compared the NexGen Flex with the NexGen
Standard and concluded that a patient's ability to
achieve high flexion with the NexGen Flex knee could increase
the risk of toggling, and thus loosening, of the
implant's tibial component. But Dr. Brown concedes that
"there seems little if any reason for concern about
NexGen-Flex performance below the [range of 120 to 130
degrees]." (Brown Supp. Rep. at 6- 7.) And if a patient
were to engage in flexion above the range of 130 degrees, Dr.
Brown admitted it would be safer for him or her to do so with
a Flex implant than with a Standard implant. See
Batty Opinion, 2015 WL 33669933, at *17 (citing
Brown's deposition testimony from Batty). In his
initial report, Dr. Brown also mentions that some of
Zimmer's academic collaborators, including Dr. Peter
Walker and Drs. Guoan Li and Harry Rubash, were concerned
about the possibility of excessive posterior edge loading of
the polyethylene insert but that Zimmer "opted not to
implement specific design suggestions by Walker and Li and
Rubash" in the NexGen Flex. (Brown Rep. at 31.)
According to Brown, Zimmer eventually did implement
"several of these changes, " but in a different
product. (Id.) The one design feature of that
subsequent product that Dr. Brown mentions is the elimination
of a required two-millimeter bone cut prior to implantation
of the device (a design change that has no relevance to
tibial loosening, according to Dr. Brown). (Id. at
38.) In his supplemental report, Dr. Brown also alludes to a
specific design alternative conceived by Drs. Li and Rubash.
The one paragraph in his report devoted to that design reads
As early as 2001 or 2002, Drs. Li and Rubash had conceived an
alternative to some of the key features of the then-existing
form of the Zimmer Nexgen Flex device. In my opinion their
design modification was biomechanically reasonable. They
wrote to Zimmer suggesting that Zimmer implement that design
modification. However, Zimmer did not do so. Incorporation of
this proposed design change would have constituted an
alternative to the then-existing NexGen Flex design.
(Brown Supp. Rep. at 7.)
Dr. Madigan's Proposed Expert Testimony
purposes of this particular ruling, the court need not
discuss Dr. Madigan's proffered opinions in great detail.
Dr. Madigan is a statistician who conducted a meta-analysis
of clinical trial studies involving patients with knee
implants. (See generally Report of David Madigan,
Ex. A to Def.'s Mem. in Supp. of Mot. to Excl. Testimony
of Dr. David Madigan [36-1].) Based on his analysis, Dr.
Madigan concluded that Zimmer's Flex implants likely
cause a higher risk of revision than standard devices.
(Id. at 12.) In particular, by focusing on 10-year
studies, he concluded that the probability that Flex implants
cause a higher risk of revision than standard devices
approaches 100%, and that the probability that Flex implants
cause a higher risk of aseptic loosening than standard
devices is 96.8%. Zimmer charges that Dr. Madigan's
conclusions are based on an unreliable methodology, but for
purposes of this opinion, the court assumes that his
testimony would be admissible. The court does note, however,
that although Dr. Madigan offers an opinion that Flex
implants have a higher risk of revision and of aseptic
loosening than standard devices, he does not offer any
opinion about (1) the absolute rate at which Flex devices are
likely to loosen or to be revised over a particular time
period or (2) any aspect of the Flex design that might cause
the alleged higher risk of revision relative to the standard
Dr. Fetto's Proposed Expert Testimony
Batty trial, Dr. Fetto submitted a general report
detailing his opinions on the Zimmer Flex knee, as well as a
report specific to Ms. Batty's knee replacement. In this
case, Dr. Fetto has submitted a report on Joas's knee
replacement. Dr. Fetto's case-specific Joas
report incorporates the general report he prepared for the
MDL as a whole.
The Court's Ruling on Dr. Fetto's Opinions in
Batty, the court allowed Dr. Fetto to testify to
opinions on biomechanics, but excluded opinions regarding (1)
risks of component loosening, (2) the adequacy of
Zimmer's warnings, and (3) the adequacy of Zimmer's
pre-market testing. Batty Opinion, 2015 WL 3669933,
at *1. Some of Dr. Fetto's opinions that were excluded in
Batty, regarding Zimmer's warnings and
pre-market testing, are not applicable in this case, but his
opinions on component loosening are relevant. In
Batty, the court "[could not] discern any
reliable methodology supporting Dr. Fetto's opinions
regarding the design defect, [or] the risk of aseptic
loosening . . . and conclude[d] that those opinions must be
excluded." Id. at *19.
the court declined to admit Dr. Fetto's opinion that the
design of the Zimmer knee replacement "forces loading
onto the posterior margin of the tibial component and reduces
overall contact area between the femoral and tibial
components." Id. at *21 (internal citations
omitted). Dr. Fetto asserted that this posterior loading
"produces a lift-off stress on the front of the tibial
component, " which "strains the bond between the
tibial component and the tibial bone." Id.
(internal citations omitted). The court acknowledged that Dr.
Fetto cited evidence showing a higher revision rate for
Zimmer high flex knees, but concluded that Dr. Fetto did not
"sufficiently explain why he sees a link between the
higher revision rates and the evidence of posterior
loading." Id. at *22. The report he offered in
Batty offered several explanations why eccentric
loading causes high-flex components to loosen. At least two
of these opinions are resurrected in Dr. Fetto's report
on Joas. First, he again opines that high flexion causes
greater forces pulling the bone and component apart:
"bonds between the component and bones . . . are
susceptible to 'tensile loading, ' that is, forces
that pull the bone and component apart from one
another." Id. at *23. Additionally, he asserts
"that if testing shows lift-off of the polyethylene tray
from the tibial baseplate, that lift-off implies that the
forces are sufficient to lift the tibial baseplate from the
bone[.]" Id. Both of these opinions were
excluded because Dr. Fetto did not explain how the studies he
cited supported this conclusion. Id. at *23-27.
the court in Batty pointed out that Dr. Fetto did
not describe "why the Zimmer high-flex design,
as opposed to high flexion generally, creates an increased
risk of posterior edge loading." Id. at *22
(emphasis in original). The court concluded: "In sum,
Dr. Fetto has not sufficiently explained how he reached the
conclusion that Zimmer's designs cause aseptic loosening
of the tibial component[, ]" because "he has failed
to connect the dots in a way that enables the court to
adequately examine the bases for his conclusions and conduct
a reliability analysis." Id. at *32.
Consequently, Dr. Fetto's opinions that Zimmer's
high-flex design increased the risk of component loosening
were excluded. Id. at *32.
Dr. Fetto's Report on Joas
parties agree that the court's rulings regarding the
admissibility of Dr. Fetto's opinions in Batty
also apply in this case. (Tr. of Aug. 26, 2016 Hr'g, Ex.
E to Def.'s Fetto Mem. [32-5], at 15:13-22.) Dr. Fetto
has submitted a new report specific to Joas's tibial
component loosening. In this new report, Dr. Fetto conducts a
differential etiology, which purports to consider all
reasonable potential causes of an ailment and systematically
rule out causes one by one. (Fetto Rep. at 3.) "[I]n a
differential etiology, the doctor rules in all the potential
causes of a patient's ailment and then by systematically
ruling out causes that would not apply to the patient, the
physician arrives at what is the likely cause of the
ailment." Myers v. Illinois Cent. R.R. Co.,
629 F.3d 639, 644 (7th Cir. 2010). To support his etiology,
Dr. Fetto reviewed Joas's medical records, radiologic
images, depositions of Joas and his treating doctors, and
Joas's explanted device. (Fetto Rep. at 1, 7-8.) Dr.
Fetto also interviewed Joas twice and conducted a physical
exam and medical history. (Id. at 1.)
Fetto begins by determining which causes to rule in.
Dr. Fetto's list of potential causes included:
"trauma, medical comorbidities,  infection, particulate
debris, surgical error, problems with the cement, and
mechanical causes." (Id. at 3.) Dr. Fetto also
rules in "patient factors" such as excessive
weight, poor quality bone, or excessive activities.
(Id.) Although he notes that
"polyethylene wear that in turn causes microscopic
particulate debris which causes an immunologic reaction in
the bone, " is a potential cause of loosening, he
apparently does not rule that in because "Dr. Cameron[,
who performed Joas's revision surgery, ] testified that
there was not a dramatic amount of wear debris."
(Id. at 2.)
Dr. Fetto rules out causes that he opines were not
the cause of Joas's component loosening. He reviewed
"the records provided and the depositions provided"
and found no evidence of comorbidities, infection, or poor or
improper surgical technique. (Id. at 3- 4.) He also
finds no "evidence of improper rehabilitation or level
of activity following his surgical procedures[.]"
(Id. at 4.) Second, he opines that Joas engaged in
high-flexion activities, but that they were not
"abusive." (Id. at 5.) Third, Dr. Fetto
states that he found no evidence of bone problems, metabolic
disorders, or other medical conditions. (Id. at 6.)
Finally, he states that he "considered [Joas's]
medication history, including his rheumatoid arthritis
medications, and did not see anything in the medical records,
surgical reports or diagnostic imaging, that would suggest
they contributed to the aseptic loosing." (Id.
at 6.) As a result, Dr. Fetto concludes "[t]his leaves
only mechanical sources of failure related to the specific
design of the implant Joas received to be considered."
(Id. at 4.)
concluded that this final cause could not be ruled out, Dr.
Fetto devotes the remainder of the report to explaining why
the design defect caused Joas's knee replacement failure.
(Id. at 4-6.) Dr. Fetto opines that Joas's knee
implant failed for the same reasons stated in his general
report. According to Dr. Fetto, as a replaced knee bends and
achieves greater degrees of flexion, the following occurs:
First, external rotation of the femur causes posterior
translation (that is, shifting back) of the lateral femoral
condyle. (Id. at 4.) Second, posterior
migration of the femoral component causes asymmetric loading
of the tibial plateau and the femoral component.
(Id.at 4.) Third, asymmetric contact of the femoral
condyles, or liftoff, causes excessive and asymmetric
loading. (Id.) Dr. Fetto concludes that this
asymmetric loading places undue stress on the tibia, which he
opines is what happened to Joas. (Id.) He concludes
that the asymmetric loading "is evident in Joas's
case, which demonstrated aseptic loosening beneath the tibial
component." (Id.) Dr. Fetto notes that
"[t]hese findings are consistent with the eccentric
loading described . . . in my general report associated with
Zimmer High Flex implants." (Id.)
Fetto opines that higher flexion "puts excessive stress
on the component-cement interface and can lead to early
failure." (Id. at 5.) Dr. Fetto concludes that
the design of the implant, combined with high-flexion
activities, caused the device to become "debonded from
the cement" used in the interface. (Id.) Dr.
Fetto does not refer to any literature or give any
explanation for why the implant design, and asymmetric
loading generally, causes debonding, and in turn, loosening.
He does assert that aseptic failure of the tibial component
is recognized in the medical literature-the court presumes
that he is referring to literature recognizing aseptic
failure of the NexGen Flex's tibial component-but he does
not cite to specific studies. (Id.) In sum, Dr.
Fetto attributes Joas's component loosening to asymmetric
loading: "Joas'[s] tibial implant loosened because
of the asymmetric loading related to its design."
with each NexGen Flex device, Zimmer includes a "package
insert" containing instructions about implanting the
device and warnings about the product's risks, including
the risk of component loosening. Plaintiffs insist that
Zimmer's warnings are inadequate. At his deposition, Joas
testified that he remembered reading written materials that
were "probably from Zimmer, " assuring him he
"would get back to [his] active style, that [the
implant] is a good knee." (Joas Dep. 168:15-169:8.)
Plaintiffs note that Zimmer's marketing materials did not
mention that high-flexion activities may cause early failure
of the NexGen Flex device. But as Zimmer points out, Dr.
Larson, Joas's implanting surgeon, testified at his
deposition that he, himself, never reviewed the relevant the
package inserts prior to performing Joas's TKR surgery.
(Dep. of Bryan Larson, Ex. D to Def.'s Reply in Supp. of
Mot. for Summ. J. [129-5] (hereinafter "Larson
Dep."), at 83:24-84:24.)
also assert that Zimmer's surgical technique instructions
were deficient. In particular, they rely on the testimony of
one of Zimmer's experts, Dr. John Dearborn, who believes
that the one bag of cement that Dr. Larson used to affix
Joas's implant to his bones was inadequate. (Dep. of John
Dearborn, Ex. 6 to Pls.' Mem. in Opp'n. to Def.'s
Mot. for Summ. J. [114-6] (hereinafter "Dearborn
Dep."), at 50:1-5.) According to Dr. Dearborn, cement
should be applied across the entire tibial plateau at a
consistent and continuous level of thickness. (Id.
at 106:25-107:6.) Had Dr. Larson properly cemented Joas's
device, using at least two bags of cement, Dr. Dearborn
believes that Joas's knee implant would not have failed
as early as it did. (Id. at 82:24-83:2.)
Zimmer's Surgical Technique Guide for the NexGen Flex
device does address cementing; it directs that "[i]f
bone cement is being used, [surgeons should] apply cement to
the underside of the tibial plate, around the keel, on the
resected tibial surface, and in the tibial IM canal."
(Zimmer Surgical Technique Guide, Ex. 17 to Pls.' Resp.
to Zimmer's Stmt. of Undisputed Material Facts [115-17],
at 11.) Plaintiffs point out that the guide does not specify
the number of cement bags that a surgeon should use. Dr.
Dearborn's expert report, however, states expressly that
"[t]he basic surgical technique for implanting the
[NexGen Flex] is well-documented in Zimmer's Surgical
Technique Guide, but surgeons are primarily guided in their
technique by the basic medical training they received during
residency and/or fellowship training." (Report of Dr.
John Dearborn, Ex. C to Def.'s Reply Mem. in Supp. of
Mot. for Summ. J. [129-3] (hereinafter "Dearborn
Rep."), 18.) Dr. Larson testified that he reviewed
"parts of" the surgical technique guide back in the
early 2000s, but confirmed that he learned his surgical
technique-including the technique for cementing the
components-"from [his] residency and [his] fellowship
training." (Larson Dep. 85:13-86:6.)
Zimmer's Motion to Exclude Dr. Fetto's
702 of the Federal Rules of Evidence, which governs the
admissibility of expert testimony, states:
witness who is qualified as an expert by knowledge, skill,
experience, training, or education may testify in the form of
an opinion or otherwise if:
(a) the expert's scientific, technical, or other
specialized knowledge will help the trier of fact to
understand the evidence or to determine a fact in issue;
(b) the testimony is based on sufficient facts or data;
(c) the testimony is the product of reliable principles and