Fitzsimmons v. Biomet Orthopedics et al

Filing 151

ORDER granting in part and denying in part 121 Motion for Summary Judgment. The motion is GRANTED as to (1) the manufacturing defect and failure to warn portions of the strict liability claim in Count One, (2) the breach of implied warranties claim in Count Three, (3) the breach of express warranty claim in Count Four, and (4) the standalone failure to warn claim in Count Five. The motion is otherwise DENIED. See Opinion and Order for details. Signed by Judge John E. Steele on 1/21/2021. (FWH)

Case 2:19-cv-00182-JES-NPM Document 151 Filed 01/21/21 Page 1 of 19 PageID 6916

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

the

defendants’

Dispositive Motion for Summary Judgment and Memorandum of Law (Doc.
#121) filed on October 2, 2020.

Plaintiff filed a Memorandum in

Opposition (Doc. #135) on October 16, 2020, to which defendants’
filed a Reply (Doc. #140) on October 23, 2020.

For the reasons

set forth below, the motion is granted in part and denied in part.
I.
A. Factual Background 1
In December 2008, plaintiff Mark Fitzsimmons underwent a

1

The background facts are either undisputed or read in the
light most favorable to plaintiff as the nonmoving party. However,
these facts, accepted at the summary judgment stage of the
proceedings, may not be the “actual” facts of the case.
See
Priester v. City of Riviera Beach, Fla., 208 F.3d 919, 925 n.3
(11th Cir. 2000).

Case 2:19-cv-00182-JES-NPM Document 151 Filed 01/21/21 Page 2 of 19 PageID 6917

surgical procedure to implant an M2a Magnum hip device.
#121, pp. 2-3; Doc. #135, p. 1.)

(Doc.

The M2a Magnum is a metal-on-

metal articulating device designed, manufactured, and sold by
defendants (collectively “Biomet”).
p. 2; Doc. #135, p. 1.)

(Doc. #1, ¶¶ 3-5; Doc. #121,

The M2a Magnum consists of several

components made of a titanium alloy and a cobalt-chrome-molybdenum
alloy.

(Doc. #121-4, p. 254.)

Prior to the procedure, the

implanting surgeon discussed the risks with plaintiff, but did not
warn about the health effects of metal wear or metallosis.

(Doc.

#121, p. 2; Doc. #121-1, pp. 65-69; Doc. #121-3, p. 203; Doc. #135,
p. 1.)

Following the surgery, plaintiff was essentially pain free

for approximately eight years.

(Doc. #121-1, p. 81.)

In the summer of 2016, plaintiff began hearing a clicking and
squeaking noise from his hip and started experiencing pain.
pp. 83-84.)

A

subsequent

blood

“excessively high” metal ion levels.
68.)

test

revealed

plaintiff

(Id.
had

(Id. p. 88; Doc. #135-6, p.

Specifically, plaintiff’s cobalt serum level was 184.3 and

his chromium serum level was 112.2 micrograms per liter; normal
levels are .1 to .4 and less than 1.4, respectively.
6, p. 69.)

(Doc. #135-

Based on these numbers, revision of the Magnum M2a was

medically necessary and conducted in April 2017.

(Id. pp. 69-71.)

Plaintiff’s postoperative diagnosis included a failed total hip,
excessively

high

cobalt

and

metallosis.

chromium

(Id. pp. 71-72.)

2

levels,

and

significant

Case 2:19-cv-00182-JES-NPM Document 151 Filed 01/21/21 Page 3 of 19 PageID 6918

B. Procedural Background
In May 2017, plaintiff filed a five-count Complaint against
Biomet,

alleging

claims

of

(1)

strict

liability

for

(a)

manufacturing defects, (b) design defects, and (c) inadequate
warnings, (2) negligence, (3) breach of implied warranties, (4)
breach of express warranty, and (5) failure to warn.
pp. 7-14.)

(Doc. #1,

As relief, plaintiff seeks, inter alia, compensatory

and punitive damages.

(Id. p. 14.)

Plaintiff’s case, one of thousands filed against Biomet, 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, the case
was transferred back to this district in February 2019.
#56;

Doc.

#57.)

The

parties

then

engaged

in

(Doc.

case-specific

discovery until September 2020, and the matter is set for trial in
June 2021.

(Doc. #108; Doc. #150.)

On October 2, 2020, Biomet filed the summary judgment motion
currently before the Court.

(Doc. #121.)

For various reasons,

the motion argues Biomet is entitled to summary judgment on all of
plaintiff’s claims, and that the request for punitive damages
should be dismissed. (Id. pp. 1-25.) In his Memorandum, plaintiff
notes that he does not oppose summary judgment on the manufacturing

3

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defect claim, nor the breach of implied and express warranty
claims.

(Doc. #135, p. 1.)

However, plaintiff argues there are

material disputes of fact preventing summary judgment on the design
defect and failure to warn claims, as well as sufficient evidence
to support an award of punitive damages.

(Id. pp. 1-18.)

II.
Summary

judgment

is

appropriate

only

when

the

Court

is

satisfied that “there is no genuine dispute as to any material
fact and the movant is entitled to judgment as a matter of law.”
Fed. R. Civ. P. 56(a).

“An issue of fact is ‘genuine’ if the

record taken as a whole could lead a rational trier of fact to
find for the nonmoving party.”

Hickson Corp. v. N. Crossarm Co.,

Inc., 357 F.3d 1256, 1260 (11th Cir. 2004) (citation omitted).

A

fact is “material” if it may affect the outcome of the suit under
governing law.
248 (1986).

See Anderson v. Liberty Lobby, Inc., 477 U.S. 242,

“A court must decide ‘whether the evidence presents

a sufficient disagreement to require submission to a jury or
whether it is so one-sided that one party must prevail as a matter
of law.’”

Hickson, 357 F.3d at 1260 (quoting Anderson, 477 U.S.

at 251).
In ruling on a motion for summary judgment, the Court views
all evidence and draws all reasonable inferences in favor of the
nonmoving party.
2010).

However,

Tana v. Dantanna’s, 611 F.3d 767, 772 (11th Cir.
“[i]f

reasonable

4

minds

might

differ

on

the

Case 2:19-cv-00182-JES-NPM Document 151 Filed 01/21/21 Page 5 of 19 PageID 6920

inferences arising from undisputed facts, then the court should
deny summary judgment.”

St. Charles Foods, Inc. v. America’s

Favorite Chicken Co., 198 F.3d 815, 819 (11th Cir. 1999) (quoting
Warrior Tombigbee Transp. Co. v. M/V Nan Fung, 695 F.2d 1294, 129697 (11th Cir. 1983)).

“If a reasonable fact finder evaluating the

evidence could draw more than one inference from the facts, and if
that inference introduces a genuine issue of material fact, then
the court should not grant summary judgment.”

Allen v. Bd. of

Pub. Educ. for Bibb Cty., 495 F.3d 1306, 1315 (11th Cir. 2007).
III.
A. Design Defect
The first count of the Complaint alleges strict product
liability, asserting that the M2a Magnum “was in a defective and
unreasonably dangerous condition at the time it was placed in the
stream of commerce.”

(Doc. #1, ¶ 26.)

Specifically, plaintiff

alleges the M2a Magnum
was not reasonably safe for the intended use, subjecting
Plaintiff and others to risks, including the risk that
the acetabular component would not properly grow into
the bone, causing the hip system to prematurely fail and
requiring a complex, risky, and painful surgery to
remove and replace the defective product[.]
(Id.)
A product may be defective by virtue of a design defect, a
manufacturing defect, or an inadequate warning.
Corp., 181 F.3d 1250, 1255 (11th Cir. 1999).

5

Jennings v. BIC

“In order to hold a

Case 2:19-cv-00182-JES-NPM Document 151 Filed 01/21/21 Page 6 of 19 PageID 6921

manufacturer strictly liable for a design defect, the plaintiff
must establish: (1) the manufacturer’s relationship to the product
in question; (2) a defect in the product; and (3) proximate cause
between the defective product and the plaintiff’s injury.” Jozwiak
v. Stryker Corp., 2010 WL 743834, *6 (M.D. Fla. Feb. 26, 2010)
(citing West v. Caterpillar Tractor Co., Inc., 336 So. 2d 80, 87
(Fla. 1976)). 2
Biomet first argues it is entitled to summary judgment on the
design defect claim because of “lack of admissible expert testimony
establishing medical causation.”

(Doc. #121, p. 8); see Payne v.

C.R. Bard, Inc., 2014 WL 1887297, *2 (M.D. Fla. May 12, 2014)
(“Expert testimony is generally necessary to prove that a complex
product like a medical device is defective.”); Savage v. Danek
Med., Inc., 31 F. Supp. 2d 980, 983 (M.D. Fla. 1999) (“A defect
must be proven by expert testimony.”).

Biomet argues that because

the opinions of the two experts plaintiff has retained to opine on

2

A federal court sitting in diversity applies the substantive
law of the state in which it sits.
Ferrero v. Associated
Materials, Inc., 923 F.2d 1441, 1444 (11th Cir. 1991).
In his
Memorandum, plaintiff briefly suggests Missouri law may apply
because plaintiff was first injured when the M2a Magnum was
implanted in Missouri.
(Doc. #135, p. 8 n.3.)
The Court
disagrees. See George v. Wright Med. Tech., Inc., 2020 WL 5880479
(N.D. Feb. 7, 2020) (determining Florida law applied where hip
device was implanted in Illinois but subsequently removed in
Florida); Schenone v. Zimmer Holdings, Inc., 2014 WL 12619899 (M.D.
Fla. Mar. 5, 2014) (determining Florida law applied where medical
device was implanted in New Jersey but subsequently removed in
Florida).

6

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design defect and medical causation are inadmissible, plaintiff
has produced no evidence of causation.

(Doc. #121, pp. 9-10.)

Biomet also argues it is entitled to summary judgment because
plaintiff has failed to disclose any of his treating physicians as
non-retained

experts,

and

because

the

remaining

evidence

establishes that the M2a Magnum did not cause plaintiff’s injuries.
(Id. pp. 10-14.)

The Court disagrees. 3

The two experts at issue were retained by plaintiff to (1)
determine

if

the

M2a

Magnum

implanted

in

plaintiff

was

“unreasonably dangerous and defective in a manner that caused
premature failure” (Doc. #124-1, p. 21), and (2) opine on, inter
alia, injuries that may occur due to metal-on-metal bearing surface
failures (Doc. #125-4, p. 146).
concluded

that

including

the

all
M2a

of

Plaintiff’s engineering expert

Biomet’s

Magnum,

are

metal-on-metal

defective

in

hip

design,

systems,
and

plaintiff’s implant had several specific design defects.
#124-1, pp. 137-44.)

that
(Doc.

Plaintiff’s medical expert opined that

plaintiff “sustained permanent and irreversible damage” to his hip
caused by the M2a Magnum.

(Doc. #125-4, p. 168.)

Such opinions

constitute evidence of both design defect and medical causation,

3

In prior motions, Biomet sought to exclude the testimony
and opinions of the experts at issue.
(Doc. #124; Doc. #125.)
While the Court granted the motions in part, it did not preclude
the witnesses from testifying as to a variety of opinions,
including those relevant now. (Doc. #146.)

7

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and therefore preclude summary judgment.

See Bayes v. Biomet,

Inc., 2020 WL 5095346, *11 (E.D. Mo. Aug. 28, 2020) (“Biomet
contends that Plaintiffs have failed to show that any design defect
in the M2a Magnum caused Mary’s injuries specifically.

Biomet

first argues that Plaintiffs cannot establish specific causation
because [plaintiffs’ medical causation experts’] case-specific
opinions are inadmissible. . . .

Because the Court has denied

Biomet’s motion to exclude the specific causation opinions of [the
medical causation experts], this argument fails.”). 4

Furthermore,

to the extent Biomet argues summary judgment should also be granted
on plaintiff’s standalone negligence claim (Count Two) due to lack
of

admissible

expert

testimony

establishing

medical

causation

(Doc. #121, pp. 1, 8), that argument is similarly rejected.
B. Failure to Warn
Count One of the Complaint alleges a claim of strict liability
based on, inter alia, inadequate warnings.

4

See Jennings, 181 F.3d

Biomet also argues that even if the expert opinions are
admissible, they are still insufficient to create an issue of fact
as to causation. (Doc. #121, p. 14.) Biomet suggests the experts
have contradictory opinions as to malposition and migration of the
implant, and therefore “their testimony taken as a whole fails to
establish either that a defect in the M2a Magnum or Biomet’s
negligence was, more likely than not, a substantial contributing
factor that caused the Plaintiff’s injuries.” (Id. pp. 14-16.)
The Court disagrees. To the extent the expert’s opinions regarding
malposition or migration differ, the opinions regarding design
defect and causation are still admissible and create a disputed
issue of material fact precluding summary judgment.

8

Case 2:19-cv-00182-JES-NPM Document 151 Filed 01/21/21 Page 9 of 19 PageID 6924

at 1255 (noting that a product may be defective by virtue of an
inadequate warning).

Additionally, plaintiff asserts a standalone

failure to warn claim in Count Five, which alleges Biomet had a
duty to warn of the risks associated with the use of the M2a
Magnum,

that

it

failed

to

adequately

warn

plaintiff

and

his

physician of such risks, and that such failure was the direct and
proximate cause of plaintiff’s injuries.

(Doc. #1, ¶¶ 52-58.)

Accordingly, plaintiff’s failure to warn claims are based on both
strict liability (Count One) and negligence (Count Five) theories.
See Am. Coastal Ins. Co. v. Electrolux Home Prods., Inc., 2019 WL
5068577, *3 (M.D. Fla. Oct. 9, 2019) (“Florida tort law includes
both a strict liability and a negligence version of failure to
warn.”); Marzullo v. Crosman Corp., 289 F. Supp. 2d 1337, 1347
(M.D. Fla. 2003) (“The difference between negligent failure to
warn and failure to warn under a strict liability theory is that
a prima facie case of strict liability failure to warn does not
require a showing of negligence.”

(marks omitted)).

“Under Florida Law, a claim for failure to warn, whether in
negligence or strict liability, requires a plaintiff to show ‘(1)
that the product warning was inadequate; (2) that the inadequacy
proximately caused her injury; and (3) that she in fact suffered
an injury from using the product.’”

McCasland v. Pro Guard

Coatings, Inc., 799 Fed. App’x 731, 733 (11th Cir. 2020) (quoting
Eghnayem v. Boston Sci. Corp., 873 F.3d 1304, 1321 (11th Cir.

9

Case 2:19-cv-00182-JES-NPM Document 151 Filed 01/21/21 Page 10 of 19 PageID 6925

2017)).

“While in many instances the adequacy of warnings . . .

is a question of fact,’ the Florida Supreme Court has held that
‘it can become a question of law where the warning is accurate,
clear, and unambiguous.’”

Eghnayem, 873 F.3d at 1321 (quoting

Felix v. Hoffmann-La Roche, Inc., 540 So. 2d 102, 105 (Fla. 1989)).
“To warn adequately, the product label must make apparent the
potential harmful consequences.

The warning must be of such

intensity as to cause a reasonable man to exercise for his own
safety caution commensurate with the potential danger.”
Mr.

Heater,

Inc.,

684

F.3d

1231,

1233

Farias v.

(11th

Cir.

2012) (quoting Scheman-Gonzalez v. Saber Mfg. Co., 816 So. 2d
1133, 1139 (Fla. 4th DCA 2002)).
However, for medical devices such as the M2a Magnum, “the
duty to warn is directed to physicians rather than patients under
the ‘learned intermediary’ doctrine.”

Eghnayem, 873 F.3d at 1321

(quoting Hoffmann-La Roche Inc. v. Mason, 27 So. 3d 75, 77 (Fla.
1st DCA 2009)). 5

“This is so because the prescribing physician

acts as an intermediary between the manufacturer and the consumer,
weighing the potential benefits of a device against the dangers in
deciding whether to recommend it to the meet the patient’s needs.”

5

“Although Florida state case law regarding the learned
intermediary has solely dealt with prescription drugs, we see no
distinction in this instance between drugs, devices, or other
prescription products.” Rounds v. Genzyme Corp., 440 Fed. App’x
753, 755 n.2 (11th Cir. 2011).

10

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Id.

(citing

Felix,

540

So.

2d

at

104).

Accordingly,

“[i]n

determining the adequacy of a warning, the critical inquiry is
whether it was adequate to warn the physician of the possibility
that the [device] may cause the injury alleged by the plaintiff.”
Small v. Amgen, Inc., 134 F. Supp. 3d 1358, 1367 (M.D. Fla. 2015)
(citing Upjohn Co. v. MacMurdo, 565 So. 2d 680, 683 (Fla. 1990)).
In the motion, Biomet argues plaintiff’s failure to warn
claims fail as a matter of law because (1) the M2a Magnum’s
instructions-for-use

are

adequate,

and

(2)

plaintiff

cannot

establish that any alleged failure to warn proximately caused his
injuries.

(Doc. #121, pp. 17-21.)

Because the Court agrees with

the latter argument, it need not address the former.

See Bayes,

2020 WL 5095346, * 14 (“Because the Court grants summary judgment
on this [failure to warn] claim based on Plaintiffs’ failure to
show causation, the Court need not consider Biomet’s alternative
argument that the warning was adequate as a matter of law.”).
“[I]n order to recover for a manufacturer’s failure to warn,
a plaintiff must prove that the manufacturer’s failure to warn the
physician
plaintiff.”

was

the

proximate

cause

of

the

injuries

to

the

Edgar v. Danek Med., Inc., 1999 WL 1054864, *6 (M.D.

Fla. Mar. 31, 1999).

“In other words, the plaintiff must show

that the physician would not have used the device in question if
he or she had been warned by the manufacturer of its risks.”

Id.

However, “[w]here a physician fails to review the warnings issued

11

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by

the

manufacturer,

proximate

cause

cannot

be

established.”

Fields v. Mylan Pharm., Inc., 751 F. Supp. 2d 1260, 1263 (N.D.
Fla. 2009); see also Thom v. Bristol-Myers Squibb Co., 353 F.3d
848, 856 (10th Cir. 2003) (“The majority of courts that have
examined the issue have held that when a physician fails to read
or rely on a drug manufacturer’s warnings, such failure constitutes
the ‘intervening, independent and sole proximate cause’ of the
plaintiff’s injuries, even where the drug manufacturer’s warnings
were inadequate.”); In re Wright Med. Tech. Inc., Conserve Hip
Implant Prods. Liab. Lit., 127 F. Supp. 3d 1306, 1359 (N.D. Ga.
2015) (“[W]here a warning is provided, but a physician does not
read it or rely on it, a person cannot assert a failure to warn
claim, even if the warning is defective.”); Rydzewski v. DePuy
Orthopaedics, Inc., 2012 WL 7997961, *7 (S.D. Fla. Aug. 14, 2012)
(“The Court also points out that Dr. Zahn testified that he did
not read the package insert.

Thus, it is unclear how the inclusion

of additional warnings in that insert would have prevented the
incident.”
Having

(citation omitted)).
reviewed

the

record

evidence,

the

Court

finds

plaintiff has adduced insufficient evidence to create a question
of fact as to causation.

It is undisputed there is no evidence

plaintiff’s implanting surgeon ever read the instructions-for-use
provided by Biomet.
3, pp. 208-09.)

(Doc. #121, p. 20; Doc. #135, p. 2; Doc. #121Furthermore, the surgeon agreed (1) that he

12

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selected the M2a Magnum for plaintiff “based solely on [his]
professional and [his] clinical experience” with the device, (2)
that he did not select the M2a Magnum for plaintiff “based on any
marketing materials” he received from Biomet, and (3) that he did
not select the M2a Magnum “based on anything that [he] heard from
Biomet distributors or sales representatives.” 6
207-08.)

(Doc. #121-3, pp.

The surgeon also testified that while Biomet may have

provided him information about the M2a Magnum, he would have
“independently researched metal-on-metal hip implants” prior to
using them, and that he “would have discussed it with [his]
colleagues, and [they] would kind of decide whether it was worth
doing or not.”

(Doc. #135-1, pp. 37-38.)

Based on this evidence, the Court concludes that even if it
agreed Biomet provided inadequate warnings, plaintiff cannot prove
proximate cause for her failure to warn claims. 7
Biomet,

Inc.,

2020

WL

5849482,

*10

(D.

Md.

See Morris v.

Sept.

30,

2020)

(“Regarding the role that Biomet’s warnings played in his selection
of the Biomet Device, although Dr. Jacobs testified that it is his

6

This testimony effectively undermines plaintiff’s argument
that an issue of causation exists because Biomet provided the
surgeon with marketing materials that allegedly misrepresented the
M2a Magnum’s wear rates. (Doc. #135, pp. 15-16.)
7

The Court’s conclusion also applies to the Complaint’s
standalone negligence claim (Count Two) to the extent it is also
based on a failure to warn. (Doc. #1, ¶¶ 33-39.)

13

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standard practice to familiarize himself with the indications
received from the manufacturer, he did not specifically recall
whether he read the IFU prior to Plaintiff’s surgery.

And perhaps

most notably, Dr. Jacobs testified, ‘I make my own decisions.
research it in peer-reviewed literature.

I

I, by and large, don’t

rely on representatives of companies to give me information,’ ‘I
get

my

information

independently

as

opposed

to

from

manufacturers,’ and ‘I would glean most of my information from the
metal-metal

world

in

general,’ .

.

.

.

Thus,

the

evidence

overwhelmingly shows that Dr. Jacobs placed little weight on
Biomet’s warnings, indicating that different warnings would not
have altered his decision-making.”

(citations omitted)); Bayes,

2020 WL 5095346, *13 (granting summary judgment on failure to warn
claim based on lack of causation where implanting surgeon admitted
to not reading the instructions-for-use and testified that he
relied on professional meetings and medical literature to alert
him of potential risks); Beale v. Biomet, Inc., 492 F. Supp. 2d
1360,

1370-71

(S.D.

Fla.

2007)

(finding

plaintiffs

had

not

presented any evidence to suggest physician “was influenced by
Biomet in any fashion in his decisions to use the device in his
patients” when, inter alia, physician testified (1) “that his
decisions as to patient selection were based upon his years of
experience as a joint-replacement surgeon, and his research into
the various types of replacement joints available on the market,”

14

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and (2) “that none of Biomet’s marketing materials influenced his
decisions in any fashion”).

As plaintiff has failed to present

evidence of causation, a necessary element of the claims, the Court
grants defendant summary judgment on both the strict liability
(Count One) and negligence (Count Five) failure to warn claims. 8
C. Punitive Damages
The Complaint requests, inter alia, an award of punitive
damages from Biomet.

(Doc. #1, p. 14.)

The summary judgment

motion asserts this request should dismissed for a variety of
reasons.

(Doc. #121, pp. 22-25.)

Biomet first suggests that

because “all of Plaintiff’s substantive liability claims fail, his
claim for punitive damages likewise fails as well.”

(Id. p. 22.)

As the Court disagrees that all of the claims in the Complaint are
subject to summary judgment, this argument is rejected.
Next, Biomet argues that even if the Court finds one or more
of

plaintiff’s

claims

survive

summary

judgment,

plaintiff

nonetheless cannot meet the “high standard for an award of punitive

8

There is evidence in the record suggesting that in agreeing
to the M2a Magnum, plaintiff relied upon a marketing brochure
created by Biomet and provided by his surgeon. (Doc. #135-5, pp.
62-65.) To the extent plaintiff relies on such evidence to support
his causation argument, the Court is unconvinced. Under Florida’s
learned intermediary doctrine, “the manufacturer’s duty to warn
runs to the physician, not to the patient.” Beale, 492 F. Supp.
2d at 1368; see also Small v. Amgen, Inc., 134 F. Supp. 3d 1358,
1369 (M.D. Fla. 2015) (“[T]he Court concludes that defendants’
duty to warn of the risks associated with the use of Enbrel ran to
Ms. Small’s physician, not Ms. Small.”).

15

Case 2:19-cv-00182-JES-NPM Document 151 Filed 01/21/21 Page 16 of 19 PageID 6931

damages.”

(Id.)

It also suggests that Indiana law, rather than

Florida, should apply to this issue.

(Id. pp. 23-24); see also

Kirchman v. Novartis Pharm. Corp., 2014 WL 2722483, *3 (M.D. Fla.
June 16, 2014) (“[T]he fact that Florida law governs liability and
compensatory damages in this case does not necessarily mean it
also governs punitive damages.”).

Plaintiff neither disputes nor

concedes which state’s law applies, but nonetheless argues there
is sufficient evidence to submit the issue to a jury.
pp. 17-18.)

(Doc. #135,

The Court agrees with plaintiff.

Under Indiana law, punitive damages may be awarded “only upon
a showing that the defendant acted with ‘malice, fraud, gross
negligence, or oppressiveness which was not the result of a mistake
of fact or law, mere negligence, or other human failing.’”

Bayes

v. Biomet, Inc., 2020 WL 5659653, *1 (E.D. Mo. Sept. 23, 2020)
(quoting Wohlwend v. Edwards, 796 N.E.2d 781, 784 (Ind. Ct. App.
2003)).

In contrast, a defendant may be held liable for punitive

damages under Florida law only if the defendant “was personally
guilty

of

intentional

768.72(2), Fla. Stat.
must

meet

evidence.”

the

misconduct

or

gross

negligence.”

§

Under either state’s law, the plaintiff

requisite

standard

by

“clear

and

convincing

Ind. Code § 34-51-3-2; § 768.72(2), Fla. Stat.

Having

reviewed the evidence submitted by the parties, the Court finds
that a genuine issue of material fact precludes summary judgment
under either standard.

See Nicholson v. Biomet, Inc., 2020 WL

16

Case 2:19-cv-00182-JES-NPM Document 151 Filed 01/21/21 Page 17 of 19 PageID 6932

3399899, *18 (N.D. Iowa Mar. 6, 2020) (“Defendants first argue
that Indiana law, not Iowa law, should govern a punitive damages
award. . . . The Court finds that under either standard, there is
a genuine issue of material fact whether punitive damages are
appropriate on the remaining claims.”).
Plaintiff has produced evidence indicating Biomet was aware
as early as 2006 that metal-on-metal devices produce metal wear
debris, and that such debris may lead to elevated levels of cobalt
and chromium.

(Doc. #135-18.)

The same evidence suggests Biomet

was also aware that such elevated levels could produce various
health hazards, including those eventually suffered by plaintiff.
(Id.)

While Biomet disputes the significance of this evidence

(Doc. #140, p. 5), the Court finds it sufficient to create a
genuine issue of material fact as to whether Biomet was aware of
potential problems with the M2a Magnum and simply ignored them.
See Bayes, 2020 WL 5659653, *2 (“Biomet contends that the method
of FDA approval, the warnings included in the Instructions for
Use, and Biomet’s affirmative steps to make the M2a Magnum safe
preclude a showing of complete indifference or conscious disregard
under Missouri law, or of malice, fraud, gross negligence, or
oppressiveness

under

Indiana

law.

But

Plaintiffs

set

forth

evidence that Biomet was aware of the serious risks of its metalon-metal M2a Magnum implant.

In any event, this Court, though

well aware of the high standard of clear and convincing evidence,

17

Case 2:19-cv-00182-JES-NPM Document 151 Filed 01/21/21 Page 18 of 19 PageID 6933

is not now in a position to determine as a matter of law that
Plaintiffs cannot make a submissible case for punitive damages.”
(citation omitted)); Hardison v. Biomet, Inc., 2020 WL 4334108,
*19 (M.D. Ga. July 27, 2020) (“[T]here is a genuine issue of
material fact that Biomet was aware of and ignored the issues with
the M2a Magnum.

In short, Plaintiff has pointed to evidence that

Biomet knew of issues with the M2a Magnum but decided against
disclosing

that

information.

Accordingly,

the

Court

DENIES

Biomet’s motion for summary judgment as to punitive damages at
this time.”

(citation and emphasis omitted)); Nicholson, 2020 WL

3399899, *19 (determining there was a genuine issue of material
fact that Biomet was aware of issues and ignored them based on,
inter alia, plaintiff’s evidence that Biomet was aware the M2a
Magnum caused elevated levels of metal ions in patients’ bodies);
cf. Morris, 2020 WL 5849482, *13 (granting summary judgment on
punitive damages claim where plaintiff failed to produce evidence
that

Biomet

had

actual

knowledge

of

deliberately disregarded that defect).

a

defect

and

that

it

Although “[d]efeating a

motion for summary judgment on a claim for punitive damages is an
extraordinary high bar,” Nunez v. Coloplast Corp., 461 F. Supp. 3d
1260, 1269 (S.D. Fla. 2020), the Court finds plaintiff has adduced
sufficient evidence to do so.
Accordingly, it is now
ORDERED:

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Case 2:19-cv-00182-JES-NPM Document 151 Filed 01/21/21 Page 19 of 19 PageID 6934

Defendants’

Dispositive

Motion

for

Summary

Judgment

and

Memorandum of Law (Doc. #121) is GRANTED in part and DENIED in
part.

The motion is GRANTED as to (1) the manufacturing defect

and failure to warn portions of the strict liability claim in Count
One, (2) the breach of implied warranties claim in Count Three,
(3) the breach of express warranty claim in Count Four, and (4)
the standalone failure to warn claim in Count Five.

The motion is

otherwise DENIED.
DONE AND ORDERED at Fort Myers, Florida, this
January, 2021.

Copies: Counsel of record

19

21st

day of