Fitzsimmons v. Biomet Orthopedics et al
ORDER granting in part and denying in part 124 Motion to Exclude the Opinions and Testimony of Mari Truman and Memorandum in Support and 125 Motion to Exclude the Opinions and Testimony of George S. Kantor, M.D. and Memorandum in Support. See Order for details. Signed by Judge John E. Steele on 11/18/2020. (FWH)
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UNITED STATES DISTRICT COURT
MIDDLE DISTRICT OF FLORIDA
FORT MYERS DIVISION
BIOMET ORTHOPEDICS, INC.,
BIOMET, INC., and BIOMET
OPINION AND ORDER
This matter comes before the Court on defendants’ Motions to
Exclude expert testimony (Doc. #124; Doc. #125), filed on October
Plaintiff filed Memorandums in Opposition (Doc. #132;
Doc. #134) on October 16, 2020, to which defendants filed Replies
(Doc. #144; Doc. #145) on November 10, 2020.
For the reasons set
forth below, the motions are granted in part and denied in part.
In December 2008, plaintiff Mark Fitzsimmons underwent a
surgical procedure to implant a M2a Magnum Hip System in his left
(Doc. #1, ¶ 20.)
The M2a Magnum implant was designed,
(Id. ¶¶ 3-5.)
subsequently failed, causing significant metallosis and requiring
a revision surgery in April 2017.
(Id. ¶ 21.)
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suit against defendants in May 2017, alleging (1) strict products
liability, (2) negligence, (3) breach of implied warranties, (4)
breach of express warranty, and (5) failure to warn.
(Id. pp. 7-
Plaintiff’s case, one of thousands filed against defendants,
was consolidated for pretrial proceedings into a Multi-District
Litigation (MDL) action in the United States District Court for
the Northern District of Indiana.
In re: Biomet M2A Magnum Hip
Implants Prods. Liab. Litig., 896 F. Supp. 2d 1339 (J.P.M.L. 2012).
opinions, this case was transferred back to this district in
(Doc. #56; Doc. #57.)
The parties then engaged
in case-specific discovery until September 2020, and the matter is
set for trial for March 2021.
Now at the summary
judgment stage, the parties have filed various motions to exclude
case-specific expert opinions, including defendants’ two motions
currently before the Court seeking to preclude opinions from Mari
Truman (Doc. #124) and George Kantor (Doc. #125).
The admission of expert testimony is governed by Rule 702 of
the Federal Rules of Evidence, which provides that:
A 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:
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(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
facts or data;
(c) the testimony is the product of reliable
principles and methods; and
(d) the expert has reliably applied the
principles and methods to the facts of the
Fed. R. Evid. 702.
Rule 702 contemplates that the district court
serve as gatekeeper for the admission of scientific testimony in
order to ensure that any and all expert testimony is both relevant
Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579,
589 (1993); Tampa Bay Water v. HDR Eng’g, Inc., 731 F.3d 1171,
1183 (11th Cir. 2013).
“The Supreme Court did not intend, however,
that the gatekeeper role supplant the adversary system or the role
of the jury: vigorous cross-examination, presentation of contrary
evidence, and careful instruction on the burden of proof are the
McDowell v. Brown, 392 F.3d 1283, 1299
(11th Cir. 2004) (marks and citations omitted).
In determining the admissibility of expert testimony under
Rule 702, the Court applies a “rigorous” three-part inquiry.
United States v. Frazier, 387 F.3d 1244, 1260 (11th Cir. 2004) (en
Expert testimony is admissible if (1) the expert is
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qualified to testify on the topic at issue, (2) the methodology
used by the expert is sufficiently reliable, and (3) the testimony
will assist the trier of fact.
Arthrex, Inc., v. Parcus Med.,
LLC, 2014 WL 3747598, *1 (M.D. Fla. July 29, 2014) (citing Tampa
Bay Water, 731 F.3d at 1183).
The burden of laying the proper
foundation for the admission of expert testimony “is on the party
offering the expert, and the admissibility must be shown by a
preponderance of the evidence.”
Kilpatrick v. Breg, Inc., 613
F.3d 1329, 1335 (11th Cir. 2010) (quoting McCorvey v. Baxter
Healthcare Corp., 298 F.3d 1253, 1256 (11th Cir. 2002)).
admission of expert testimony is a matter within the discretion of
the district court, which is accorded considerable leeway in making
Frazier, 387 F.3d at 1258.
A. Mari Truman
In re Biomet M2a Magnum Hip Implant Prods. Liab.
Litig., 2017 WL 10845178, *10 (N.D. Ind. Dec. 21, 2017).
court previously denied defendants’ motion to exclude Truman from
offering the following general opinions: (1) all metal-on-metal
devices; (3) defendants should have conducted additional testing
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of its metal-on-metal devices; (4) defendants should have provided
additional and more aggressive warnings to surgeons about the risks
excessive metal ions cause certain clinical effects in patients
with metal-on-metal devices.
Id. at *11-15.
opinions regarding plaintiff’s particular implant.
In its motion, defendants seek to preclude Truman
biomechanical opinions, (2) five new common-issue opinions, and
(3) any medical-causation opinions.
(Doc. #124, pp. 7-17.)
Court will address each of these in turn.
a. Amount and Rate of Wear
In her report, Truman examined the rate of wear in plaintiff’s
implant by creating a 3D model of the device’s head and cup.
#124-1, p. 64.)
Truman estimated the implant had a total wear
volume of 719 mm3, or approximately 89.9 mm3 per year it was
Using wear volume measurements provided by
defendants, Truman determined plaintiff’s “M2a Magnum bearings
surface experienced greater than advertised wear and therefore
greater than expected wear.”
At her deposition, Truman
testified that in physically examining plaintiff’s device, “it was
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pretty obvious in looking at the cup that there was uneven wear on
(Doc. #124-2, p. 309.)
Because the wear was “so
obvious” and “excessive,” Truman did not feel it was necessary to
have physical measurements.
(Id. pp. 274, 309.)
“estimate[d] a ballpark quantity based on some rough dimensions,”
as described in her report.
(Id. pp. 274-75.)
to exclude Truman’s opinion because she “performed no physical
measurements,” and her opinion “is based largely on a speculative
‘visual’ assessment of the device at issue.”
(Doc. #124, p. 7.)
The Court disagrees that Truman’s assessment is speculative,
since it is based on physical examination of plaintiff’s device.
See Hardison v. Biomet, Inc., 2020 WL 4334108, *12 (M.D. Ga. July
27, 2020) (noting that Truman’s opinion was “based on more than
mere speculation after visually inspecting the device”).
Court finds defendants’ argument goes to the weight of Truman’s
opinion, and not its admissibility.
See Bayes v. Biomet, Inc.,
2020 WL 5594059, *5 (E.D. Mo. Sept. 18, 2020) (“That Truman did
not . . . confirm these opinions with testing of the implant goes
to the weight, rather than the admissibility, of her opinions.”)
The Court’s conclusion is bolstered by the evidence presented by
defendants’ own expert, who calculated a substantially similar
(Doc. #132-2, p. 47) (calculating a loss rate of 88.5
Truman’s opinion as to the amount and rate of wear is denied.
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b. Separation, Migration, and Third-Body Wear
condition of plaintiff’s implant, noting “evidence of cup damage
and third body wear of the bearings.” 1
(Doc. #124-1, p. 49 n.6.)
Truman also opined that due to the cup’s position, there was “edge
loading” in plaintiff, and likely “head separation.” 2
report also cited evidence from one of plaintiff’s doctors that
the device had migrated after it was implanted.
(Id. p. 47.)
Defendants seek to exclude Truman’s opinions on head separation,
migration, and third-body wear.
(Doc. #124, pp. 8-10.)
Defendants argue that Truman’s opinion that head separation
occurred is speculative.
The Court disagrees.
report indicated the device likely had head separation due to
plaintiff’s reported hearing of a clicking noise after the implant
was in place for eight years.
(Doc. #124-1, p. 49 n.6.)
deposition, Truman conceded she “didn’t see significant evidence”
of head separation, but testified that the clicking noise was
consistent with it.
(Doc. #124-2, p. 322-23.)
Her report also
“‘Third-body wear’ occurs when foreign particles are
deposited on the articulating (moving) surfaces of the hip implant.
These particles can cause scratching and increased friction
between the articulating surfaces.” Bayes, 2020 WL 5594059, *5.
“Head separation occurs when the femoral head component of
a hip implant is not properly seated in the cup. This can result
in increased friction and wear at the rim of the acetabular cup,
known as ‘edge-loading.’” Bayes, 2020 WL 5594059, *5.
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stated that the lack of a “head stripe wear pattern” was consistent
with “very small head separation.”
(Doc. #124-1, p. 60.)
See Bayes, 2020 WL 5594059, *5 (permitting Truman to
testify regarding the presence of head separation because the
opinion was based on, inter alia, the observed clicking noise).
That Truman did not rule out other potential causes of the clicking
sound, or was not able to say the head separation was “a clinically
significant event” (Doc. #124-2, p. 344), are matters which go to
the weight of the testimony, not its admissibility. 3
Defendants next seek to prevent Truman from offering any
opinions on whether and when migration occurred.
(Doc. #124, pp.
Defendants argue such an opinion would be “undoubtedly
unreliable and misleading” because Truman did not perform any
formal or scientific measurements, and because it contradicts the
opinion of plaintiff’s own orthopedic expert.
(Id. p. 10.)
asked at deposition if there was evidence of migration, Truman
testified, “It did appear to me that the cup had changed angle
from the time it was implanted to the time it was retrieved, yes.”
Defendants also argue Truman should not be permitted to
opine that head separation caused edge loading. (Doc. #124, p.
While conceding edge loading did occur, defendants argue
that Truman speculates that head separation occurred, and
therefore she cannot testify that head separation caused edge
As the Court has determined Truman’s opinion
regarding head separation is not speculative, defendants’ argument
regarding edge loading is also rejected.
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(Doc. #124-2, p. 282.)
Based on x-rays, Truman estimated the
migration occurred within the first two to three weeks after the
(Id. pp. 282-83.)
Nonetheless, Truman testified that
she would “defer to the orthopedic people to have opinions on the
(Id. p. 433.)
Because Truman has stated she will defer
to the medical experts on migration, defendants’ request to exclude
Truman’s opinion as to when migration occurred is rendered moot. 4
The motion is otherwise denied as to the existence of migration.
regarding third-body wear.
Defendants generally state that all
of Truman’s opinions on the above issue are speculative, and state
all the opinions should be excluded. (Doc. #124, pp. 8-10.)
presence of third-body wear on the device’s bearings (Doc. #1241, p. 49 n.6), and Truman testified that “a lot” of the damage to
the device was “due to third body wear” (Doc. #124-2, pp. 324-25).
The Court finds this evidence admissible and will deny defendants’
The Court agrees with plaintiff (Doc. #132, p. 6) that
Truman is allowed to rely on the opinions of the medical experts
on this issue. See In re Biomet, 2017 WL 10845178, *15 (noting
that while Truman cannot testify as an expert on a medical issue,
she can permissibly rely on other experts’ opinions regarding the
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c. Taper Mismatch
In her report, Truman determined that both modular taper
interfaces in the M2a Magnum femoral head of plaintiff’s implant
were “defective because the production prints allowed a taper fit
mismatch > 4’30”.”
(Doc. #124-1, pp. 141-42.)
At her deposition,
Truman acknowledged that because it is impossible to manufacture
devices perfectly every time, there is an allowance for how much
a device “can deviate from perfect.”
(Doc. #124-2, p. 301.)
“prescribed allowance for deviation from perfect shape that’s
provided on the print” is called the “tolerance band.”
In determining the taper interfaces of plaintiff’s
implant were outside the tolerance range and therefore defective,
Truman acknowledged that she did not have the prints for the
devices that were used in plaintiff’s implant, and was not able to
determine the actual dimensions of the tapers used.
(Id. p. 300.)
Without the actual print or manufacturing records for plaintiff’s
implant, or the ability to examine the devices’ tapers, Truman was
not able to tell where those devices fell within the tolerance
(Id. p. 303.)
Accordingly, Truman agreed that “we don’t
[plaintiff’s] devices in their manufactured condition.”
“entirely speculative” because “she performed no measurements on
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[plaintiff’s] device to determine if a mismatch even existed here.”
(Doc. #124, pp. 11-12.)
The Court agrees.
Because Truman used
the production prints for the implant rather than the actual
plaintiff’s device contained a taper mismatch outside of the
acceptable range is speculative.
See Hardison, 2020 WL 4334108,
speculative” because it related to the device generally and not
the plaintiff’s specific device).
Accordingly, the Court will
grant defendants’ request to exclude this testimony.
In her report, Truman stated that plaintiff’s “Magnum head
could not be removed due to CCW [clinical cold welding] and
corrosion product is visually evident at the base of the tapers.” 5
discussing corrosion and its effects.
(Id. pp. 68-69.)
admitted she could not say how much there was or whether “it was
severe or just a little bit.”
(Doc. #124-2, p. 327.)
Defendants argue Truman’s opinion regarding corrosion should
be inadmissible “because she did not perform any testing,” but
“The term ‘clinical cold welding’ describes taper corrosion
so severe that the taper insert and femoral head components of a
hip implant become permanently fused together.” Bayes, 2020 WL
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rather “simply bases her statements on her visual inspection of
the device and a review of photographs.”
(Doc. #124, p. 12.)
See Hardison, 2020 WL 4334108, *12-13 (“As to
the corrosion in the device, Biomet argues that Ms. Truman’s
failure to test—when Ms. Truman had the opportunity to do so—Mr.
Hardison’s device for corrosion renders her corrosion opinions
inadmissible speculation. . . . Here, Ms. Truman’s opinion is based
on more than mere speculation after visually inspecting the device,
and she cites to scientific literature to support her conclusion.
. . . Thus, the Court will not exclude Ms. Truman’s corrosion
The Court remains confident that a thorough and sifting
cross examination will sufficiently allow Biomet to point out any
criticism it may have regarding her lack of testing.”).
Next, defendants seek to prevent Truman from offering various
opinions on the grounds that they are common-issue opinions not
(Doc. #124, p. 13.)
In transferring this
case, the MDL court noted that “[t]he admissibility under Rule 702
of opinions and testimony for all generic (meaning not casespecific) experts to be used at trial have been heard and ruled
upon in the MDL.”
(Doc. #40, p. 9.)
Accordingly, any opinions
Truman now seeks to offer on common issues would be precluded.
Plaintiff responds that Truman’s opinions are not “new” commonissue
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directly to plaintiff.
(Doc. #132, pp. 9-11.)
Court will examine each opinion at issue.
a. Appropriate Installation Position
The MDL court previously determined Truman was qualified to
offer opinions on the adequacy of defendants’ warnings.
Biomet, 2017 WL 10845178, *13.
In an MDL common-issue report,
Truman offered opinions applicable to the family of devices known
as M2a devices, as well as the specific M2a Magnum device which
(Doc. #124-2, p. 248.)
In her case-specific
report, Truman opined that defendants “did not have sufficient
warnings to alert surgeons concerning the appropriate installation
position” of the M2a Magnum device to minimize various risks.
(Doc. #124-1, p. 138.)
Defendants argue that because Truman did
not offer this opinion in her common-issue report, she cannot offer
(Doc. #124, pp. 13-14.)
The Court agrees.
In her common-issue report, Truman’s opinion regarding the
appropriate installation position and defendants’ failure to warn
was specific to the M2a-38 device, not the M2a Magnum device.
(Doc. #124-2, pp. 372-74.)
Truman acknowledged as much at her
deposition, agreeing that her case-specific opinion was “slightly
different” than her MDL opinion, as she had “been working on some
other M2a-38 reports and . . . had specifically used that one.”
(Id. p. 374.)
Plaintiff argues that because Truman’s MDL opinions
related to the family of M2a devices, her more specific opinion
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regarding the M2a Magnum falls within the MDL general opinions.
(Doc. #132, pp. 9-10.)
The Court disagrees.
Truman’s MDL opinion
was specific to a device within the M2a family, and that device
was not the M2a Magnum.
Accordingly, to the extent Truman now
applies that opinion to the M2a Magnum, it is a new common-issue
opinion and inadmissible.
See Bayes, 2020 WL 5594059, *4 (“[To]
the extent Biomet seeks to exclude common-issue opinions included
in Truman’s MDL report, the Court denies the motion.
to the extent Truman’s rebuttal report includes new or different
common-issue opinions not included in her MDL report, the Court
grants Biomet’s motion to exclude those opinions.”).
b. Cold Welding
In her case-specific report, Truman opined that the M2a Magnum
had “several warning defects,” and specifically that defendants
“did not warn of cold welding in the M2a Magnum.”
The Court agrees with defendants that this is a common-
issue opinion that should have been provided in Truman’s MDL
acknowledged that while her MDL report discussed warnings “at some
length,” “[t]he cold welding issue wasn’t brought up in the MDL.”
(Doc. #124-2, p. 392.)
While Truman testified that the opinion
was specific to plaintiff “because he had clinical cold welding in
his devices,” she agreed that “[t]his is a general opinion that
relates to what [she] see[s] as warning failures, not only warning
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failures that only occurred in [plaintiff’s] case.”
(Id. p. 393.)
Because Truman’s opinion is a novel common-issue opinion, the Court
will exclude it. 6
c. Assembly Instructions and Tools
Truman opined that defendants failed to provide assembly
system design and warning defects in the Magnum system.
#124-1, p. 142.)
Because plaintiff concedes this opinion is not
relevant to this case (Doc. #132, p. 10), the Court will grant
defendants’ request to exclude it (Doc. #124, p. 14).
d. Positional Tradeoffs
“[p]ositioning of total hip bearings involves tradeoffs,” and that
surgeons are justified in attempting to restore the
normal biomechanics of the patient’s hip joint using
standard techniques unless they are clearly informed in
advance of surgery by a THA [total hip arthroplasty]
prothesis manufacturer that use of a specific implant
design may fail and cause patient harm when used outside
a specific and more restricted envelope.
(Doc. #124-1, pp. 143-44.)
Truman further opined that defendants
To the extent plaintiff argues Truman’s opinion is case
specific because she examined plaintiff’s explanted device and it
displayed cold welding (Doc. #132, p. 10), the Court disagrees.
The opinion at issue is not that plaintiff’s device displayed cold
welding, which would be a case-specific opinion, but rather that
defendants failed to warn of cold welding in the M2a Magnum, which
is a common-issue opinion.
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excessive wear and excessive metal ions when the M2a Magnum cup is
inserted at inclination angles ˃ 45˚ (50˚ max with measurement
(Id. p. 144.)
Defendants suggest this is a new common-
issue opinion, and therefore should be excluded.
(Doc. #124, p.
The Court agrees in part.
Truman’s opinion on this issue is actually two separate
First, Truman opines that a surgeon is justified in
attempting to restore normal biomechanics of a hip joint unless
warned otherwise by a prothesis manufacturer.
this is a case-specific opinion because defendants “contend that
the excessive wear of metal ions in Plaintiff was caused by
malpositioning of the Magnum device at implant.” 7
The Court disagrees.
(Doc. #132, p.
Truman’s opinion is not specific to
the surgeon who implanted the device in plaintiff, but rather
applies to all surgeons conducting hip implants.
opinion is a common-issue opinion.
Furthermore, because it seems
undisputed that Truman did not offer this opinion in her prior MDL
report, the Court will grant defendants’ request to exclude it.
Truman has also opined that defendants should have warned
surgeons regarding potential dangers if the implant was inserted
Defendants have offered evidence that the cause of
plaintiff’s elevated ion levels was the improper or malpositioned
angle of the implant. (Doc. #124-6, p. 573.)
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at certain angles.
Truman testified at her deposition that she
“offer[ed] opinions about angles” in her MDL report (Doc. #124-2,
p. 440), and a review of the MDL report confirms this assertion. 8
The Court finds these opinions substantially the same as the
opinion offered in Truman’s case-specific report, and therefore
the latter cannot be considered “new.”
Accordingly, the Court
declines to exclude this portion of the opinion.
In her MDL report, Truman offered the following opinions:
Since Biomet chose to sell the M2a products and they
chose not to test the performance at high inclination
angles or under head micro separation conditions which
were known to cause excessive wear in all THA devices,
they should have communicated this to the surgeons, and
they should have included AGRESSIVE WARNINGS concerning
the high risk of excessive metal wear debris, and
excessive high Co and Cr ions, and they should have
pointed out the potential harms associated with
excessive wear and elevated metal ions. These warnings
should have been present when the device was introduced
. . .
Biomet also should have had the knowledge concerning
appropriate inclination and anteversion angles for MoM
[metal-on-metal] articulations and should have shared
information concerning the risks and should have taught
against, warned about or contraindicated installation in
angles > ~ 50˚ and combined anteversion > 25˚ but did
not do so. These instructions should have been in their
surgical techniques and other training materials.
In re Biomet M2a Magnum Hip Implant Prods. Liab. Litig., MDL-2391
(Doc. #3387-2, pp. 126, 139.)
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e. Cup Orientation and Stability
In her case-specific report, Truman opined that “[w]hen the
cup is oriented to improve not only stability, but also wear . .
., there was little or no added stability achieved by the use of
femoral heads larger than 36mm.”
(Doc. #124-1, p. 144.)
deposition, Truman agreed this was “a general statement, a common
opinion” that did not specifically apply to plaintiff, but also
noted she “did discuss this in [her] MDL [report] also.”
#124-2, pp. 439-40.)
Plaintiff concedes that Truman’s opinion is
not relevant to her specific findings in this case, but nonetheless
argues it “is allowable as a general opinion because the MDL Judge
struck none of Ms. Truman’s general opinions.”
(Doc. #132, p.
To the extent Truman offered this opinion in her MDL report9,
the Court will decline defendants’ request to exclude it as a new
Finally, defendants seek to preclude Truman from offering
Truman’s MDL report discussed dislocations and range of motion,
as well as whether “the risk of dislocation would reduce as the
head diameter increases.”
In re Biomet M2a Magnum Hip Implant
Prods. Liab. Litig., MDL-2391 (Doc. #3387-2, pp. 130.)
concluded the “data show that there is no beneficial effect in
reducing dislocations in head sizes above 36 mm.” Id. p. 131.
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concedes Truman “will not issue medical causation opinions in this
case” (Doc. #132, p. 11), this issue has been rendered moot.
B. George Kantor
specializing in hip, knee, and shoulder replacement, and has
performed roughly 5,000 total hip arthroplasty procedures over the
course of his career.
In re Biomet, 2017 WL 10845178, *15.
MDL court previously denied defendants’ motion to exclude Kantor
from offering the following general opinions: (1) metal-on-metal
outweigh their benefits; (2) defendants’ instructions for use were
inadequate; and (3) elevated metal ions might cause cancer.
Kantor has now prepared a case-specific report which offers
a variety of opinions and concludes that plaintiff “has sustained
permanent and irreversible damage” because of the implant.
#125-4, p. 168.)
Defendants seek to exclude several of Kantor’s
opinions, including the following: (1) plaintiff’s implant caused
plaintiff’s injuries; (2) edge loading or impingement did not cause
plaintiff’s elevated cobalt-chromium levels; (3) a component of
plaintiff’s device caused his elevated cobalt-chromium levels; (4)
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(Doc. #125, pp. 6-23.)
The Court will address each of these in
permanent damage caused by defendants’ implant.
(Doc. #125-2, p.
Defendants seek to exclude this opinion on the grounds that
it is “derived from an unreliable methodology.”
(Doc. #125, p.
Specifically, defendants argue Kantor “failed to give due
consideration to obvious alternative causes,” such as malposition
of the device.
(Id. pp. 7-14.)
Having reviewed the arguments of
deposition testimony, the Court disagrees.
The issue essentially boils down to whether Kantor conducted
a sufficient differential diagnosis in determining the cause of
(Id. p. 7.)
A “[d]ifferential diagnosis
patient’s symptoms and then eliminating each of these potential
causes until reaching one that cannot be ruled out or determining
which of those that cannot be excluded is the most likely.”
v. AstraZeneca Pharm. LP, 602 F.3d 1245, 1253 (11th Cir. 2010)
reliability of his techniques or the validity of his conclusions
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simply by claiming that he performed a differential diagnosis on
reliable differential diagnosis need not rule out all possible
alternative causes, it must at least consider other factors that
could have been the sole cause of the plaintiff’s injury.”
see also Redd v. DePuy Orthopaedics, Inc., 700 Fed. App’x 551, 554
(8th Cir. 2017) (“Although . . . an expert need not rule out all
unreliable because he “improperly rules out malposition as an
alternative cause” of plaintiff’s injuries. 10
(Doc. #125, p. 9.)
The Court must first determine whether Kantor was required to
consider malposition at all prior to determining whether Kantor
erred in ruling out malposition as an alternative cause.
As noted, a causation expert need only account for “obvious
Accordingly, if the improper positioning of the device does not
Defendants also suggest Kantor failed to eliminate edge
loading or impingement as possible causes of plaintiff’s injuries
because Kantor failed to physically examine the implant. (Doc.
#125, pp. 12-13.) This argument will be addressed later in the
Opinion and Order.
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constitute an obvious alternative explanation, Kantor could not
have erred by failing to consider it.
See Bayes v. Biomet, Inc.,
2020 WL 5095346, *9 (E.D. Mo. Aug. 28, 2020) (finding Kantor
considering defendant’s alternative suggestion that metallosis was
caused by unrelated spinal surgery where defendant offered no
therefore such an alternative explanation was not an “obvious”
In support of its argument that Kantor failed to consider an
obvious alternative cause, defendants offer the testimony of the
(Doc. #125, pp. 3, 9-11.)
In a deposition, the
surgeon testified that during the surgery, he found that the angle
(Doc. #125-3, pp. 85-86.)
The surgeon testified
that because he has never seen elevated cobalt and chromium ion
levels like plaintiff experienced unless the device was in a
malposition, it was his opinion that plaintiff’s elevated ion
Plaintiff disputes this, as the surgeon later testified,
after reviewing plaintiff’s radiographic findings, that it did not
appear the device was in a malposition when implanted.
#134, pp. 9-10; Doc. #125-3, pp. 106-07).
Because the Court
ultimately finds Kantor adequately considered the positioning of
the device as a cause of plaintiff’s injuries, this dispute is
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levels were caused by the malposition of the implant.
Kantor himself testified that malposition of the implant’s
components would cause significant damage to the prothesis, and
could cause edge loading and increased wear of the articulating
(Doc. #125-5, pp. 362, 367-68.)
The Court finds this
evidence sufficient to demonstrate the improper positioning of the
Having reviewed Kantor’s report and deposition, the Court is
satisfied that Kantor gave appropriate consideration to whether
plaintiff’s implant was positioned improperly.
noted that the THA surgery occurred in December 2008, and there
were no complications with either the surgery or in the immediate
(Doc. #125-4, p. 161.)
Kantor then made
the following observations:
Intra operative x-rays confirmed appropriate component
positioning and excellent placement of both femoral and
acetabular components. There is no evidence of component
malposition and intra operative trial x-rays and
multiple post operative follow up interval x-rays
confirm well seated well positioned components that are
stable and go onto complete osteointegration by May and
June of 2009. The acetabular abduction (acetabular
component) angle measures consistently at 46 degrees
with proper version and the femoral component exhibits
excellent canal fill and placement. At 6-month post
index THA implantation there is no evidence of
radiolucencies, osteolysis or bone destruction from
toxic metal ion wear debris.
(Id. pp. 161-62.)
At his deposition, Kantor testified that his
opinion that there was no evidence of malposition was based on his
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measurements and his review of x-rays taken during the surgery, as
well as x-rays taken one week, two weeks, six months, and eighteen
months after the surgery.
(Doc. #125-5, pp. 329-30.)
testified that his opinion was also informed by his experience
“looking at thousands and thousands and thousands of hips.”
Based on this evidence, the Court finds Kantor adequately
considered whether plaintiff’s implant was in a malposition, and
therefore defendants’ argument to exclude his specific causation
See Bayes, 2020 WL 5095346, *8 (rejecting argument
that Kantor did not “adequately account for the position of the
left acetabular cup” because Kantor “denies that the left cup was
out of position at all,” and defendant’s criticisms in how Kantor
admissibility, of Kantor’s causation opinion”). 12
Defendants also argue that Kantor erred by ignoring the
evidence of the revision surgeon. (Doc. #125, pp. 9-11.) During
his deposition, Kantor was asked if he would defer to the surgeon
as to the position of the component at the time of revision, and
Kantor replied that he “absolutely would not.” (Doc. #125-5, p.
351.) Kantor explained why he would not defer to the surgeon’s
opinion (id. pp. 351-53), and the Court does not find this to be
improper. See Bayes, 2020 WL 5095346, *8-9 (rejecting argument
that Kantor’s opinion was inadmissible for failing to account for
contradictory evidence and noting defendant would have the
opportunity to cross-examine Kantor regarding such evidence); see
also Synergetics, Inc. v. Hurst, 477 F.3d 949, 956 (8th Cir. 2007)
(noting “mere disagreement with the assumptions and methodology
used does not warrant exclusion of expert testimony”).
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Edge Loading and Impingement
At his deposition, Kantor testified that he did not see any
evidence of edge loading in plaintiff’s case.
378-79, 417, 419.)
(Doc. #125-5, pp.
He also testified that plaintiff’s metal ion
impingement of the device.
(Id. pp. 416, 419.)
to exclude these opinions on the grounds that Kantor never analyzed
plaintiff’s device, and therefore the opinions “are based on
nothing more than assumptions.”
(Doc. #125, p. 15.)
“Kantor concedes that an analysis of [plaintiff’s] device is
However, the evidence does not support this assertion.
deposition, Kantor conceded that he had not examined plaintiff’s
device or spoke with Truman about her opinions.
(Doc. #125-5, p.
He also noted that he would like to examine the device in
the future, which may provide additional information regarding the
generation of metal ions and the device’s wear patterns.
He stated he “would be curious to see if there is
equatorial edge loading” due to the design of the implant, and
that an analysis of the device “has some relevance.”
Nonetheless, he specifically testified that his case-
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specific opinions did not require visual inspection of plaintiff’s
implant, and that he was able to stand by those opinions with a
reasonable degree of medical certainty without performing a visual
(Id. p. 486.)
Kantor clarified that his desire to
examine the device was “more for intellectual curiosity as opposed
to anything substantive or anything that [he] would change in [his]
(Id. pp. 486-87.)
Thus, Kantor did not testify that a physical examination of
the device was necessary to determine whether edge loading or
impingement caused plaintiff’s metal-ion levels, and he stated
such an examination was unnecessary for any of his opinions.
Court therefore denies defendants’ motion to exclude on this issue.
To the extent it is relevant, defendants may raise Kantor’s failure
to examine the device on cross-examination.
See Bayes, 2020 WL
5594059, *5 (expert’s inability to examine device to confirm her
opinions “goes to the weight, rather than the admissibility, of
Cause of Elevated Cobalt-Chromium Levels
During his deposition, Kantor testified plaintiff’s metalion levels were “frighteningly high,” and offered four potential
sources of the ions.
(Doc. #125-5, p. 417.)
One such source was
corrosion of the device’s “mixed-metal coupling.”
(Id. pp. 417-
unsupported by scientific or factual evidence.”
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(Doc. #125, p.
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Specifically, defendants argue that the components of the
coupling at issue cannot be the source of cobalt-chromium ions
because they are made of a titanium alloy, not mixed metals.
The Court agrees.
The Court will exclude Kantor’s opinion
that the titanium alloy components of the device caused plaintiff’s
elevated cobalt-chromium levels.
See Gen. Elec. Co. v. Joiner,
522 U.S. 136, 146 (1997) (“[N]othing in either Daubert or the
Federal Rules of Evidence requires a district court to admit
opinion evidence that is connected to existing data only by the
ipse dixit of the expert.
A court may conclude that there is
simply too great an analytical gap between the data and the opinion
proffered.”); McDowell v. Brown, 392 F.3d 1283, 1299 (11th Cir.
2004) (noting there must be a “fit” with respect to the offered
opinion and the facts of the case, and “there is no fit where a
large analytical leap must be made between the facts and the
In his response, plaintiff does not challenge defendants’
assertion that the components at issue are made of a titanium
alloy. Rather, plaintiff argues there is sufficient evidence to
support the opinion that plaintiff’s injuries were caused by
elevated cobalt-chromium levels, and that such levels were caused
by the device.
(Doc. #134, pp. 13-14.)
However, whether the
device caused plaintiff’s elevated cobalt-chromium levels is
separate from whether Kantor can opine that the levels were caused
by the specific components at issue.
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Cobalt and Chromium Toxicity
In his report, Kantor noted that plaintiff’s “preoperative
cobalt and chromium levels were 184 and 112 respectively,” and
that “[i]t is now a well documented and established fact that blood
or serum metal ion levels above 1 are abnormal.”
At his deposition, Kantor testified that “any level
above 1, of either cobalt or chromium, but especially cobalt, will
result in tissue damage,” and that “1 is the upper limits of
normal[,] above which there is damage.”
(Doc. #125-5, p. 388.)
Defendants seek to preclude Kantor from opining that a cobalt or
chromium level above one is “abnormal,” asserting that such an
opinion “is completely without scientific basis.”
(Doc. #125, p.
Defendants’ argument is based on its claim that the scientific
literature Kantor relied upon to opine that metal ion levels above
one are abnormal does not actually support that assertion.
pp. 19-20; Doc. #145, p. 5.)
At his deposition, Kantor was asked
Well, I use the – it’s not what I use. It’s what we use.
We have now established what the appropriate chromium
levels are. And I would refer you to Plummer and Jacobs,
JBJS, 1964, and every subsequent neurology evaluation
since then. There’s probably 100, but that’s the
sentinel definitive -- the definitive study -- that
anything above 1 is abnormal. Anything above 1 can cause
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ARMD, adverse reaction to metal debris. So anything
above 1 is abnormal.
(Doc. #125-5, p. 387.)
Defendants argue Kantor misrelies on the
Plummer and Jacobs article because it “merely provides a guideline
cobalt level to assist in the diagnosis of corrosion in a metalon-polyethylene device,” and “it certainly does not establish a
baseline for abnormal levels of cobalt-chromium.”
(Doc. #125, p.
In the article, which defendants attached as an exhibit to
underwent revision for an adverse local tissue reaction secondary
to corrosion of a metal-on-polyethylene device.
(Doc. #125-9, p.
The authors examined the patients’ preoperative cobalt and
chromium levels, which were elevated in each patient, and concluded
that “serum metal levels are a good initial screening test” for a
(Id. pp. 785, 786.)
In doing so, the
authors stated that in evaluating serum metal levels, “anything
greater than 1 [part per billion] is considered abnormal.”
The Court finds this sufficient support for Kantor’s
opinion that “serum metal ion levels above 1 are abnormal,” and
therefore denies defendants’ request to exclude the testimony.
Defendants also seek to preclude Kantor from testifying about
the systemic effects of cobalt and chromium toxicity.
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plaintiff’s cobalt and chromium levels were “catastrophically” and
(Doc. #125-5, p. 387.)
When asked what
systemic effects occur as a result of cobalt toxicity, Kantor
identified cardiovascular issues, central nervous system effects,
and thyroid problems.
(Id. pp. 390-91.)
Defendants argue that
because it is undisputed plaintiff has not suffered from any of
systemic effects of cobalt and chromium toxicity.
(Doc. #125, pp.
18-19); see also Bayes, 2020 WL 5594059, *4 (finding expert’s
opinion regarding clinical cold welding was irrelevant and would
not assist the jury if the patient did not experience clinical
The Court disagrees.
In addition to the above, Kantor also identified “excessive
toxicity, both of which plaintiff has experienced.
Kantor also testified that while plaintiff has “been
very fortunate” in the symptoms he’s experienced, “the jury is not
out in terms of the development of systemic effects.”
Because Kantor has linked plaintiff’s symptoms with
defendants’ request to exclude the opinion at issue.
may use plaintiff’s limited symptoms to challenge the opinion that
plaintiff is suffering from the systemic effects of cobalt or
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Future Medical Care
Finally, defendants seek to preclude Kantor from opining on
plaintiff’s future medical care.
(Doc. #125, pp. 21-23.)
parties agree that an award for future medical damages requires
such damages be reasonably certain.
(Id.; Doc. #134, p. 18); see
also Montesinos v. Zapata, 43 So. 3d 97, 99 (Fla. 3d DCA 2010)
(“[A]n award of future economic damages is appropriate ‘when such
Auto-Owners Ins. Co. v. Tompkins, 651 So.2d 89, 91 (Fla. 1995)).
It is plaintiff’s burden to establish that future medical expenses
“will more probably than not be incurred,” and that burden “will
only be met with competent substantial evidence.”
So. 3d at 99 (citations omitted).
In his report, Kantor discussed the potential problems that
may arise due to a failed metal-on-metal implant, noting the
When MoM implant failure occurs in this manner,
necrosis of the bone, tendons and tissue can be a direct
result of the premature failure of the device. This
outcome can result in permanent damage to the bone and
soft tissues adjacent to the patient’s implant, which is
Complications resulting from the premature failure
of the MoM implants, such as the Biomet MoM hip implants,
include the likelihood of a patient needing multiple
future revision surgeries with increasing complexities
of those revision procedures to be expected, especially
in light of the bone and tissue damage that often
accompany the failure of a MoM hip implant. In comparison
to MoP [metal-on-polyethylene] or CoP [ceramic-on-
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polyethylene] alternatives, there is a significantly
increased risk of dislocations, infections, and periprosthetic pathologic fractures published in multiple
joint registries in countries following the sub set of
MoM prosthetic implant systems.
(Doc. #125-4, p. 159.)
With regards to plaintiff specifically,
Kantor made the following conclusion:
Because of the extensive bone necrosis/destruction
[plaintiff] is at risk for periprosthetic fracture to
both the pelvic and femoral bones that serve as the
foundation for his THA. These complications are well
documented in the literature and are common in my
practice and all hip surgeons undertaking complex
removal and revision of MoM THA systems. Due to his
relatively young age at index surgery (55 years) he will
unfortunately have to deal with these issues in the
future. He will in all likelihood require even more
difficult reconstructive revision procedures that are
associated with increased risk and well documented
procedures to his right hip will require addressing the
ongoing osteolysis (bone loss) that is progressive and
compromising the acetabular and femoral bone foundation
of his total hip arthroplasty construct. The osteolysis
and bone destruction that the patient has and is
currently experiencing must be evaluated on a regular
basis even if his symptoms are currently minimal. The
risk of peri-prosthetic fracture in these cases is well
documented and unfortunately difficult technically for
the revision surgeon to correct. Radiographic studies
including plain films, CAT Scans and special MRIs are of
paramount importance for assessment of progressive metal
ion disease and its future destruction to the bone and
soft tissues of the right THA of [plaintiff].
(Id. pp. 168-69.)
offering any opinions on plaintiff’s future medical care because
such opinions are speculative.
(Doc. #125, pp. 21-23.)
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deposition testimony demonstrates he was either unable to offer an
estimate on the possibility of future revision surgeries, or
offered an estimate below fifty percent.
(Id. p. 22.)
finds defendants have misinterpreted the testimony.
At the deposition, Kantor testified that if the estimates of
accurate, “there is no question that he will have additional
(Doc. #125-5, p. 474.)
Kantor further explained that
he believed “the primary problem” was going to be a periprosthetic
fracture, and estimated there was a twenty to forty percent chance
of a revision surgery due to such a fracture.
(Id. pp. 474-76.)
He also stated he was unable to answer whether revision surgery
would be needed due to a dislocation, and that there was a ten to
twenty percent chance plaintiff would need the surgery due to an
(Id. pp. 478-79.)
The Court agrees with plaintiff that taken together, Kantor’s
revision surgery, the cause of which currently cannot be stated
(Doc. #134, p. 18.)
To the extent Kantor
qualified his opinion about the need for a future surgery, such a
qualification goes to the opinion’s weight and not admissibility.
See White v. Westlund, 624 So. 2d 1148, 1151 (Fla. 4th DCA 1993)
(“[W]hatever qualification is placed on the opinion by the expert
(i.e., surgery is possible or likely) goes to the weight of the
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opinion, and not its admissibility.
Therefore, we agree that a
medical expert may testify that future medical procedures are
‘possible’ or ‘likely,’ and need not phrase an opinion in terms of
such surgery or treatment being ‘reasonably necessary.’”).
on Kantor’s report describing the likely complications metal-onmetal hip implant patients experience and the likelihood plaintiff
testimony that “there is no question” such a surgery will be
Accordingly, the Court denies defendants request to
exclude Kantor’s future medical care opinions. 14
Accordingly, it is hereby
Defendants’ Motion to Exclude the Opinions and Testimony of
Mari Truman and Memorandum in Support (Doc. #124) and Motion to
Exclude the Opinions and Testimony of George S. Kantor, M.D. and
Memorandum in Support (Doc. #125) are GRANTED in part and DENIED
in part as set forth above.
Defendants also seek to exclude evidence of any medical
treatments required by a future revision surgery, such as physical
therapy, x-rays, ultrasounds, and rehabilitation. (Doc. #125, pp.
22-23.) Plaintiff has offered evidence of such treatments via a
medical care projection created by plaintiff’s “life care
(Doc. #125-11, pp. 792-811.)
have filed a separate motion to exclude this expert’s opinions and
testimony (Doc. #122), the Court finds it unnecessary to address
this issue at this time.
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DONE and ORDERED at Fort Myers, Florida, this
of November, 2020.
Counsel of Record
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