Fitzsimmons v. Biomet Orthopedics

UNITED STATES DISTRICT COURT

MIDDLE DISTRICT OF FLORIDA

FORT MYERS DIVISION

MARK FITZSIMMONS,

Plaintiff,

v. Case No: 2:19-cv-182-FtM-29NPM

BIOMET ORTHOPEDICS, INC.,

BIOMET, INC., and BIOMET

MANUFACTURING CORP.,

Defendants.

OPINION AND ORDER

This matter comes before the Court on defendants’ Motions to

Exclude expert testimony (Doc. #124; Doc. #125), filed on October

2, 2020. 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.

I.

In December 2008, plaintiff Mark Fitzsimmons underwent a

surgical procedure to implant a M2a Magnum Hip System in his left

hip. (Doc. #1, ¶ 20.) The M2a Magnum implant was designed,

manufactured, marketed, promoted, and sold by defendants

(collectively “Biomet”). (Id. ¶¶ 3-5.) Plaintiff’s implant

subsequently failed, causing significant metallosis and requiring

a revision surgery in April 2017. (Id. ¶ 21.) Plaintiff filed

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-

14.)

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).

After considerable pretrial proceedings in the MDL court,

including rulings on motions to exclude common-issue expert

opinions, this case was transferred back to this district in

February 2019. (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. (Doc. #108.) 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).

II.

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:

(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 methods; and

(d) the expert has reliably applied the

principles and methods to the facts of the

case.

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

and reliable. 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

traditional and appropriate means of attacking shaky but

admissible evidence.” 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

banc). Expert testimony is admissible if (1) the expert is

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)). The

admission of expert testimony is a matter within the discretion of

the district court, which is accorded considerable leeway in making

its determination. Frazier, 387 F.3d at 1258.

III.

A. Mari Truman

Mari Truman is a biomedical engineer with a B.S.E. in

biomedical engineering and a master’s degree in mechanical

engineering. In re Biomet M2a Magnum Hip Implant Prods. Liab.

Litig., 2017 WL 10845178, *10 (N.D. Ind. Dec. 21, 2017). The MDL

court previously denied defendants’ motion to exclude Truman from

offering the following general opinions: (1) all metal-on-metal

devices are defectively designed; (2) metal-on-polyethylene

devices are a reasonably safe alternative to metal-on-metal

devices; (3) defendants should have conducted additional testing

of its metal-on-metal devices; (4) defendants should have provided

additional and more aggressive warnings to surgeons about the risks

associated with its metal-on-metal devices; (5) defendants

downplayed the risks of its metal-on-metal devices; and (6)

excessive metal ions cause certain clinical effects in patients

with metal-on-metal devices. Id. at *11-15.

In a case-specific report, Truman now offers additional

opinions regarding plaintiff’s particular implant. (Doc. #124-1,

pp. 19-226.) In its motion, defendants seek to preclude Truman

from offering several of these opinions, including (1) four

biomechanical opinions, (2) five new common-issue opinions, and

(3) any medical-causation opinions. (Doc. #124, pp. 7-17.) The

Court will address each of these in turn.

(1) Biomechanical Opinions

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. (Doc.

#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

implanted. (Id.) 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.” (Id.) At her deposition, Truman

testified that in physically examining plaintiff’s device, “it was

pretty obvious in looking at the cup that there was uneven wear on

that cup.” (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.) Instead, Truman

“estimate[d] a ballpark quantity based on some rough dimensions,”

as described in her report. (Id. pp. 274-75.) Defendants seek

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”). The

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

wear rate. (Doc. #132-2, p. 47) (calculating a loss rate of 88.5

mm3 per year). Accordingly, defendants’ request to exclude

Truman’s opinion as to the amount and rate of wear is denied.

b. Separation, Migration, and Third-Body Wear

In her report, Truman offered various opinions on the

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 (Id.) The

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. (Id.) The Court disagrees. Truman’s

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.) At her

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

1 “‘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.

2 “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.

stated that the lack of a “head stripe wear pattern” was consistent

with “very small head separation.” (Doc. #124-1, p. 60.) The

Court finds this sufficient to support the admission of the

testimony. 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.

9-10.) 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.) When

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.”

3 Defendants also argue Truman should not be permitted to

opine that head separation caused edge loading. (Doc. #124, p.

10.) 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

loading. (Id.) As the Court has determined Truman’s opinion

regarding head separation is not speculative, defendants’ argument

regarding edge loading is also rejected.

(Doc. #124-2, p. 282.) Based on x-rays, Truman estimated the

migration occurred within the first two to three weeks after the

surgery. (Id. pp. 282-83.) Nonetheless, Truman testified that

she would “defer to the orthopedic people to have opinions on the

x-rays.” (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.

Finally, defendants seek to exclude Truman’s opinion

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.) To

the extent defendants suggest the opinion is speculative or

irrelevant, the Court disagrees. Truman’s report cited the

presence of third-body wear on the device’s bearings (Doc. #124-

1, 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’

request.

4 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

same).

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.) The

“prescribed allowance for deviation from perfect shape that’s

provided on the print” is called the “tolerance band.” (Id. pp.

301-02.) 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

range. (Id. p. 303.) Accordingly, Truman agreed that “we don’t

know what the actual taper mismatch would have been for

[plaintiff’s] devices in their manufactured condition.” (Id. pp.

303-04.)

Defendants argue Truman’s opinion should be excluded as

“entirely speculative” because “she performed no measurements on

[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

measurements of plaintiff’s device, Truman’s opinion that

plaintiff’s device contained a taper mismatch outside of the

acceptable range is speculative. See Hardison, 2020 WL 4334108,

*13 (excluding Truman’s taper mismatch opinion as “overly

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.

d. Corrosion

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

(Doc. #124-1, p. 68.) She also cited scientific literature

discussing corrosion and its effects. (Id. pp. 68-69.) At her

deposition, Truman reiterated that there was corrosion, but

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

5 “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

5594059, *4.

rather “simply bases her statements on her visual inspection of

the device and a review of photographs.” (Doc. #124, p. 12.) The

Court disagrees. 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

opinion. 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.”).

(2) Common-Issue Opinions

Next, defendants seek to prevent Truman from offering various

opinions on the grounds that they are common-issue opinions not

previously disclosed. (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 case-

specific) 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” common-

issue opinions, but rather case-specific opinions that apply

directly to plaintiff. (Doc. #132, pp. 9-11.) Accordingly, the

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. In re

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

plaintiff received. (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

it now. (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

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. Conversely,

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.” (Doc. #124-1,

p. 142.) The Court agrees with defendants that this is a common-

issue opinion that should have been provided in Truman’s MDL

report. (Doc. #124, p. 14.) At her deposition, Truman

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

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

instructions or specialized tools, and that this constituted

system design and warning defects in the Magnum system. (Doc.

#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

In her case-specific report, Truman opined that

“[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

“should have told surgeons about the risk of edge loading,

6 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.

excessive wear and excessive metal ions when the M2a Magnum cup is

inserted at inclination angles ˃ 45˚ (50˚ max with measurement

error).” (Id. p. 144.) Defendants suggest this is a new common-

issue opinion, and therefore should be excluded. (Doc. #124, p.

14.) The Court agrees in part.

Truman’s opinion on this issue is actually two separate

opinions. 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. Plaintiff argues

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 (Doc. #132, p.

10.) The Court disagrees. Truman’s opinion is not specific to

the surgeon who implanted the device in plaintiff, but rather

applies to all surgeons conducting hip implants. Accordingly, the

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

7 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.)

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.

8 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

into commerce.

. . .

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.)

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.) At her

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.” (Doc.

#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.

11.) To the extent Truman offered this opinion in her MDL report9,

the Court will decline defendants’ request to exclude it as a new

common-issue opinion.

(3) Medical-Causation Opinions

Finally, defendants seek to preclude Truman from offering

medical-causation opinions due to her lack of appropriate

qualifications. (Doc. #124, pp. 15-17.) Because plaintiff

9 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.) Truman

concluded the “data show that there is no beneficial effect in

reducing dislocations in head sizes above 36 mm.” Id. p. 131.

concedes Truman “will not issue medical causation opinions in this

case” (Doc. #132, p. 11), this issue has been rendered moot.

B. George Kantor

George Kantor is a board-certified orthopedic surgeon,

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. The

MDL court previously denied defendants’ motion to exclude Kantor

from offering the following general opinions: (1) metal-on-metal

devices generally are defectively designed and their risks

outweigh their benefits; (2) defendants’ instructions for use were

inadequate; and (3) elevated metal ions might cause cancer. Id.

at *15-18.

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. (Doc.

#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)

plaintiff experienced cobalt and chromium toxicity; and (5)

plaintiff will need future medical treatments and surgeries.

(Doc. #125, pp. 6-23.) The Court will address each of these in

turn.

(1) Specific Causation

As noted, Kantor opines that plaintiff has sustained

permanent damage caused by defendants’ implant. (Doc. #125-2, p.

168.) Defendants seek to exclude this opinion on the grounds that

it is “derived from an unreliable methodology.” (Doc. #125, p.

6.) 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

the parties, as well as Kantor’s case-specific report and

deposition testimony, the Court disagrees.

The issue essentially boils down to whether Kantor conducted

a sufficient differential diagnosis in determining the cause of

plaintiff’s injuries. (Id. p. 7.) A “[d]ifferential diagnosis

is accomplished by determining the possible causes for the

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.” Guinn

v. AstraZeneca Pharm. LP, 602 F.3d 1245, 1253 (11th Cir. 2010)

(marks and citation omitted)). “When properly conducted, a

differential diagnosis can be a reliable methodology under

Daubert.” Id. However, “an expert does not establish the

reliability of his techniques or the validity of his conclusions

simply by claiming that he performed a differential diagnosis on

a patient.” Id. (citation omitted). Furthermore, while “a

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.” Id.;

see also Redd v. DePuy Orthopaedics, Inc., 700 Fed. App’x 551, 554

(8th Cir. 2017) (“Although . . . an expert need not rule out all

possible causes of an injury, an expert nonetheless should

‘adequately account[] for obvious alternative explanations.’”

(quoting Fed. R. Evid. 702 advisory committee notes to 2000

amendment)).

Defendants argue that Kantor’s differential diagnosis is

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

alternative explanations.” Redd, 700 Fed. App’x at 554.

Accordingly, if the improper positioning of the device does not

10 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.

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

adequately accounted for alternative opinions despite not

considering defendant’s alternative suggestion that metallosis was

caused by unrelated spinal surgery where defendant offered no

evidence attributing metallosis to the spinal surgery, and

therefore such an alternative explanation was not an “obvious”

one).

In support of its argument that Kantor failed to consider an

obvious alternative cause, defendants offer the testimony of the

orthopedic surgeon who performed the revision surgery on

plaintiff. (Doc. #125, pp. 3, 9-11.) In a deposition, the

surgeon testified that during the surgery, he found that the angle

of the acetabular cup component of plaintiff’s implant was

unacceptable.11 (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

11 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. (Doc.

#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

moot.

levels were caused by the malposition of the implant. (Id. p.

86.) 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

surfaces. (Doc. #125-5, pp. 362, 367-68.) The Court finds this

evidence sufficient to demonstrate the improper positioning of the

implant could be a possible cause of plaintiff’s injuries.

Having reviewed Kantor’s report and deposition, the Court is

satisfied that Kantor gave appropriate consideration to whether

plaintiff’s implant was positioned improperly. Kantor’s report

noted that the THA surgery occurred in December 2008, and there

were no complications with either the surgery or in the immediate

post-operative course. (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

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.) Kantor

testified that his opinion was also informed by his experience

“looking at thousands and thousands and thousands of hips.” (Id.

p. 339.)

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

opinion fails. 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

came to that conclusion “go to the weight, rather than the

admissibility, of Kantor’s causation opinion”).12

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”).

(2) Edge Loading and Impingement

At his deposition, Kantor testified that he did not see any

evidence of edge loading in plaintiff’s case. (Doc. #125-5, pp.

378-79, 417, 419.) He also testified that plaintiff’s metal ion

levels would not be consistent with either edge loading or

impingement of the device. (Id. pp. 416, 419.) Defendants seek

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.) The Court

disagrees.

Defendants’ argument is premised on its assertion that

“Kantor concedes that an analysis of [plaintiff’s] device is

necessary to determine whether impingement or edge loading

contributed to [plaintiff’s] cobalt-chromium levels.” (Id.)

However, the evidence does not support this assertion. During his

deposition, Kantor conceded that he had not examined plaintiff’s

device or spoke with Truman about her opinions. (Doc. #125-5, p.

316.) 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. (Id. pp.

319-20.) 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.” (Id. pp.

321, 322.) Nonetheless, he specifically testified that his case-

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

inspection. (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]

report.” (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. The

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

her opinions”).

(3) Cause of Elevated Cobalt-Chromium Levels

During his deposition, Kantor testified plaintiff’s metal-

ion 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-

18.) Defendants seek to exclude this opinion as “entirely

unsupported by scientific or factual evidence.” (Doc. #125, p.

16.) 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. (Id.

pp. 16-17.)

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

opinion”).13

13 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.

(4) 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.” (Doc. #125-4,

p. 163.) 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.

21.)

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. (Id.

pp. 19-20; Doc. #145, p. 5.) At his deposition, Kantor was asked

what threshold he used for cobalt and chromium to identify

plaintiff’s levels as dangerously high, and he responded as

follows:

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

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 metal-

on-polyethylene device,” and “it certainly does not establish a

baseline for abnormal levels of cobalt-chromium.” (Doc. #125, p.

20.)

In the article, which defendants attached as an exhibit to

their motion, the authors reviewed twenty-seven patients who

underwent revision for an adverse local tissue reaction secondary

to corrosion of a metal-on-polyethylene device. (Doc. #125-9, p.

783.) 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

corrosion diagnosis. (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.” (Id.

p. 786.) 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. (Doc. #125,

pp. 18-19.) During his deposition, Kantor testified that

plaintiff’s cobalt and chromium levels were “catastrophically” and

“frighteningly high.” (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

these, Kantor should be precluded from testifying about the

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

cold welding). The Court disagrees.

In addition to the above, Kantor also identified “excessive

fatigue” and musculoskeletal problems as symptoms of cobalt

toxicity, both of which plaintiff has experienced. (Doc. #125-5,

pp. 391-93.) 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.” (Id. pp.

391, 392.) Because Kantor has linked plaintiff’s symptoms with

the systemic effects of ion toxicity, the Court will deny

defendants’ request to exclude the opinion at issue. Defendants

may use plaintiff’s limited symptoms to challenge the opinion that

plaintiff is suffering from the systemic effects of cobalt or

chromium toxicity.

(5) Future Medical Care

Finally, defendants seek to preclude Kantor from opining on

plaintiff’s future medical care. (Doc. #125, pp. 21-23.) The

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

damages are established with reasonable certainty.’” (quoting

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.” Montesinos, 43

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

following:

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

irreversible.

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-

polyethylene] alternatives, there is a significantly

increased risk of dislocations, infections, and peri-

prosthetic 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

complications. Future revision and reconstructive

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.)

Defendants argue that Kantor should be prevented from

offering any opinions on plaintiff’s future medical care because

such opinions are speculative. (Doc. #125, pp. 21-23.) This

argument is based on defendants’ assertion that Kantor’s

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.) The Court

finds defendants have misinterpreted the testimony.

At the deposition, Kantor testified that if the estimates of

plaintiff’s life expectancy based on actuarial charts were

accurate, “there is no question that he will have additional

surgery.” (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

infection. (Id. pp. 478-79.)

The Court agrees with plaintiff that taken together, Kantor’s

testimony establishes that plaintiff will require a future

revision surgery, the cause of which currently cannot be stated

with certainty. (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

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.’”). Based

on Kantor’s report describing the likely complications metal-on-

metal hip implant patients experience and the likelihood plaintiff

will require a future revision surgery, as well as Kantor’s

testimony that “there is no question” such a surgery will be

required, the Court finds Kantor’s opinions are reasonably

certain. Accordingly, the Court denies defendants request to

exclude Kantor’s future medical care opinions.14

Accordingly, it is hereby

ORDERED:

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.

14 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

planning” expert. (Doc. #125-11, pp. 792-811.) As defendants

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.

DONE and ORDERED at Fort Myers, Florida, this 18th day

of November, 2020.

Z tkteol

JQH E. STEELE

5 IOR UNITED STATES DISTRICT JUDGE

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