Brocato v. DePuy Orthopaedics, Inc. et al

Filing 22

ORDER AND REASONS granting in part and denying in part 8 Motion to Dismiss for Failure to State a Claim. Signed by Judge Ivan L.R. Lemelle. (ijg)

UNITED STATES DISTRICT COURT
EASTERN DISTRICT OF LOUISIANA
LAURIE BROCATO

CIVIL ACTION

VERSUS

NO. 14-2607

DEPUY ORTHOPAEDICS, INC., ET AL.

SECTION “B”(1)

ORDER AND REASONS
I.

NATURE OF MOTION AND RELIEF SOUGHT
Before the Court is Defendants’, DePuy Orthopaedics, Inc.

and

Johnson

failure

to

&

Johnson,

state

a

(“Defendants”)

claim

upon

which

Motion

to

relief

can

Dismiss
be

for

granted

pursuant to Fed. R. Civ. P. 12(b)(6) (Rec. Doc. 8). Plaintiff
opposes the instant motion. (Rec. Doc. 18).
II. FACTS AND PROCEDURAL HISTORY
Plaintiff, Laurie Brocato, is a citizen of the State of
Louisiana. (Rec. Doc. 1 at 2). Defendant DePuy Orthopaedics,
Inc. is a corporation organized under the laws of the State of
Indiana,

with

its

principal

place

of

business

in

Warsaw,

Indiana. (Rec. Doc. 1 at 2). Defendant Johnson & Johnson is a
corporation organized under the laws of the State of New Jersey,
with

its

principal

place

of

business

in

New

Brunswick,

New

Jersey. (Rec. Doc. 1 at 2).
Plaintiff

filed

the

instant

suit

alleging

products

liability claims under the Louisiana Products Liability Act, La.
Rev. Stat. ann. § 9:2800.51, et seq., (the “LPLA”) in the Civil
District Court for the Parish of Orleans on July 24, 2014. (Rec.
Doc. 1). Defendants filed a notice of removal on November 14,
1

2014,

invoking

this

Court’s

federal

diversity

subject

matter

jurisdiction pursuant to 28 U.S.C. § 1332. (Rec. Doc. 1).
Plaintiff’s petition alleges that on March 20, 2014, she
underwent knee replacement surgery in both her left and right
knees.

(Rec.

Doc.

8

at

2).

She

further

alleges

that

DePuy

Smartset GHV Bone Cement, manufactured by Defendants, was used
in both operations. (Rec. Doc. 8 at 2). Plaintiff claims that
following her surgeries, she experienced pain in both knees,
which required her to undergo a total revision surgery in her
left

knee

on

November

11,

2014,

and

that

she

presently

contemplates a similar revision in the right knee. (Rec. Doc. 8
at 2). According to Plaintiff, her complications were caused by
defects in Defendants’ bone cement which caused loosening of her
tibial implant from its cement mantle. (Rec. Doc. 1-1 at 3).
Thus,

Plaintiff

seeks

to

recover

damages

for

the

revision

surgeries, as well as for: (1) significant harm, conscious pain
and

suffering,

significant

physical

mental

injury

anguish,

and

bodily

emotional

impairment;

distress

and

loss

(2)
of

quality of life, continued physical limitations, pain, injury,
damages, harm, and future mental and emotional distress; and (2)
medical

expenses

and

other

economic

harm,

including

loss

of

income. (Rec. Doc. 1 at 4).1

1

Louisiana law prohibits a plaintiff from specifying a numerical dollar
amount in the complaint; however, Defendants have satisfied their burden in
the context of the instant notice of removal of proving by a preponderance of
the evidence that the amount-in-controversy exceeds $75,000 for purposes of
diversity jurisdiction. See La. Code Civ. Proc. Art. 893(A)(1); Earl v.
Myers, 2010 WL 4875656, at *2 (E.D. La. Nov. 23, 2010)(dollar amount);
2

Defendants move to dismiss Plaintiff’s claims under Fed. R.
Civ. P. 12(b)(6) for failure to state a claim upon which relief
can be granted. For the reasons that follow, IT IS ORDERED that
Defendants’ Motion GRANTED IN PART, AND DENIED IN PART.
III. CONTENTIONS OF MOVANT
Defendants argue Plaintiff has failed, in the context of
the

instant

Motion

to

Dismiss,

to

allege

sufficient

factual

content to bring her allegations beyond the realm of the merely
conclusory. Thus, Defendants argue, Plaintiff’s Complaint fails
to satisfy the requirements of federal pleading standards as
prescribed in Bell Atl. Corp. v. Twombly, 550 U.S. 544 (2007)
and Ashcroft v. Iqbal, 556 U.S. 662 (2009).
IV. CONTENTIONS OF OPPONENTS
In
granted

opposition
leave

to

to
file

dismissal,

Plaintiff

sought

an

Complaint

(Rec.

Amended

and
Doc.

was
21),

which, Plaintiff argues, succeeds in allowing her LPLA claims to
hurdle the standards of Rule 12(b)(6).
V. MOTION TO DISMISS STANDARD
Rule

12(b)(6)

of

the

Federal

Rules

of

Civil

Procedure

allows a party to move for dismissal of a complaint for failure
to state a claim upon which relief can be granted. Such a motion
is rarely granted because it is viewed with disfavor. See Lowrey
v. Tex. A & M Univ. Sys., 117 F.3d 242, 247 (5th Cir.1997)

DeAguillar v. Boeing, 11 F. 3d 55, 58 (5th Cir. 1993)(the defendant’s burden
for removal purposes).
3

(quoting

Kaiser

Aluminum

&

Chem.

Sales,

Inc.

v.

Avondale

Shipyards, Inc., 677 F.2d 1045, 1050 (5th Cir. 1982)).
When reviewing a motion to dismiss, courts must accept all
well-pleaded

facts

as

true

and

view

them

in

the

light

most

favorable to the non-moving party. Baker v. Putnal, 75 F.3d 190,
196 (5th Cir. 1996). However, “[f]actual allegations must be
enough to raise a right to relief above the speculative level.”
Bell

Atl.

Corp.

v.

Twombly,

550

U.S.

544,

555

(2007).

“To

survive a motion to dismiss, a complaint must contain sufficient
factual matter, accepted as true, to state a claim to relief
that is plausible on its face.” Gonzales v. Kay, 577 F.3d 600,
603 (5th Cir. 2009)(quoting Ashcroft v. Iqbal, 129 S.Ct. 1937,
1949

(2009))(internal

quotation

marks

omitted).

The

Supreme

Court in Iqbal explained that Twombly promulgated a “two-pronged
approach” to determine whether a complaint states a plausible
claim for relief. Iqbal, 129 S.Ct. at 1950. First, courts must
identify those pleadings that, “because they are no more than
conclusions, are not entitled to the assumption of truth.” Id.
Legal conclusions “must be supported by factual allegations.”
Id. “Threadbare recitals of the elements of a cause of action,
supported by mere conclusory statements, do not suffice.” Id. at
1949.
Upon

identifying

the

well-pleaded

factual

allegations,

courts “assume their veracity and then determine whether they
plausibly give rise to an entitlement of relief.” Id. at 1950. A
claim has facial plausibility when the plaintiff pleads factual
4

content that allows the court to draw the reasonable inference
that the defendant is liable for the misconduct alleged.” Id. at
1949.

This

is

a

“context-specific

task

that

requires

the

reviewing court to draw on its judicial experience and common
sense.” Id. The plaintiffs must “nudge[] their claims across the
line from conceivable to plausible.” Twombly, 550 U.S. at 570.
VI. DISCUSSION
Under

Louisiana

law,

the

LPLA

establishes

the

exclusive

theories of liability for manufacturers for damage caused by
their products. La. Rev. Stat. ann. § 9:2800.52; Jefferson v.
Lead Indus. Ass’n Inc., 106 F.3d 1245, 1248 (5th Cir. 1997).2 The
act

allows

a

plaintiff

to

recover

for

damage

caused

by

a

product, only if it is shown that the product was “unreasonably
dangerous”

in

one

of

four

ways:

(A)

in

construction

or

composition, (B) in design, (C) through inadequate warning, or
(D) via nonconformity with an express warranty. La. Rev. Stat.
ann. §§ 9:2800.54(1)-(4). Thus, a prima facie case under the
LPLA requires the plaintiff to establish four general elements:
(1) that the defendant is a manufacturer of the product within
the

meaning

of

the

act,

(2)

that

the

claimant’s

damage

was

proximately caused by a characteristic of the product, (3) that
said

characteristic

rendered

the

product

“unreasonably

dangerous” in one of the four foregoing manners, and (4) the
claimant’s damage arose from a reasonably anticipated use of the

2

No party disputes Defendants’ status as “manufacturers” for purposes of the
LPLA, nor applicability of that legislation in the instant matter.
5

product

by

the

claimant

or

someone

else.

Stahl

v.

Novartis

Pharm. Corp., 283 F.3d 254, 21 (5th Cir. 2002). In the instant
case, Plaintiff asserts claims under all four of the statutorily
recognized theories of liability; each is addressed in turn.
A. Construction or Composition
A

product

is

unreasonably

dangerous

in

construction

or

composition if, at the time the product left its manufacturer’s
control,

the

product

deviated

in

a

material

way

from

the

manufacturer’s specifications or performance standards for the
product or from otherwise identical products manufactured by the
same manufacturer. La. Rev. Stat. ann. § 9:2800.55. Thus, the
pertinent provision of the LPLA provides a remedy for damages
caused by a product that is defective due to a mistake in the
manufacturing process. Stahl, supra, 283 F.3d at 263. This must
be kept distinct from a product whose defect inheres in its
design (e.g., where all units of the same product model suffer
from the same inherent flaw).
In her amended complaint/opposition, Plaintiff sets forth
an explanation of the process by which bone cements, generally,
operate. (See Rec. Doc. 18 at 3). According to Plaintiff, bone
cements consist of two components: a liquid monomer and a solid
powder. (Rec. Doc. 18 at 3). When the two components mix, they
begin to dissolve, resulting in a viscous mix of dissolved small
particles

(from

the

powder)

and

partially

dissolved

large

polymer particles. Id. Importantly, if the smaller particles are
coated with another substance or consist of a mix of polymer and
6

another material, the dissolution process is impeded, resulting
in

unpredictable

viscosity

behavior,

which

Plaintiff

alleges

results in a lack of fixation of implants. Id.
In

the

instant

case,

Plaintiff

alleges

that

Defendants’

product is defective because gentamicin sulfate, a compound used
in the bone cement, preferentially locates on or in the small
particles. (Rec. Doc. 18 at 3). This, Plaintiff argues, makes
the resulting viscosity unpredictable and greatly affects the
handling and efficacy of the cement. (Rec. Doc. 18 at 3).
The particularities of the process by which bone cements
operate as a general product category are not germane to the
instant

cause

of

action,

in

which

context

Plaintiff

must

establish that the particular bone cement used in Plaintiff’s
surgeries

either

deviated

from

Defendants’

own

performance

standards or specifications, or identical products manufactured
by

Defendants.

In

support

construction

or

“performance

standards”

promulgated

by

composition,

of

Plaintiff

contained

Defendants

her

as

in

well

claims
points
an
as

of

two

alleged

Instruction

Leaflet

a

to

defective

510(k)

premarket

notification submitted by Defendants. (See Rec. Doc. 18 at 6).
The cited provisions state:
Smartset® GHV Gentamicin, SmartSet® GMV
Endurance
Gentamicin
DePuy®
CMW
1
Gentamicin, DePuy® CMW 2 Gentamicin and
DePuy® CMW3 Gentamicin bone cements are
self-curing,
radiopaque,
polymethyl
methacrylate based cements, which contain 1
gram of (active) gentamicin in 40 grams of
bone cement powder and which are used for
7

securing a metal or polymeric prosthesis to
living bone in arthroplasty procedures.
. . .
Smartset GHV Bone Cement is a self curing
cement, to which one gram of (active)
Gentamicin is included in 40 grams of bone
cement powder and 0.5 grams of (active)
gentamicin is included in 20 grams of bone
cement powder, for allowing the seating and
securing of a metal or plastic prosthesis to
living bone.
(Rec. Doc. 18 at 6). Assuming, arguendo, that the foregoing may
properly

be

characterized

as

design

specifications

and/or

performance standards, Plaintiff makes absolutely no allegations
as to how Defendants’ product deviated therefrom in a material
way. Plaintiff asserts that “the design specifications by which
the

seating

and

securing

of

metal

or

plastic

prosthesis

to

living bone, including the design specifications employed by the
Defendants,

are

described

in

Paragraphs

12A

and

12B”

(the

substance of which the Court has paraphrased, supra). (Rec. Doc.
18 at 6). Further, she argues:
The descriptions of the defect contained in
Defendants’
bone
cement
set
out
in
Paragraphs 12A through 12F also describe how
Defendants’
bone
cement
deviated
in
a
material way from their specifications and
performance standards at the time the bone
cement left the Defendants’ control.
Id. This statement apparently relates to the description of how
gentamicin sulfate contributes to unpredictable curing behavior.
Plaintiff’s arguments, however, contain no allegation that the
bone cement used in Plaintiff’s operation did not, for example,
include

the

specified

proportions
8

of

bone

cement

powder

to

gentamicin sulfate, nor even that the subject bone cement is not
used

for

“allowing

the

seating

and

securing

of

a

metal

or

plastic prosthesis to living bone,” as described in the Leaflet,
supra. Nor do the “performance standards” contain any statements
relating

to

predictability

Plaintiff
composition

of

seems

to

of

curing

behavior

believe

her

bone

cement

Defendants’

or

viscosity.

contention
causes

that

the

unpredictable

viscosity levels (which her arguments necessarily suggest is a
condition affecting all units of the particular DePuy Smartset
GHV bone cement presently at issue) satisfies her burden under
the

construction/composition

provision

of

the

LPLA.

This

reflects a misapprehension of the distinction between claims of
defective

construction

or

composition

and

claims

of

design

defects. Because Plaintiff has failed to articulate in any way
that the particular bone cement used in her procedures either
did not meet the cited performance standards or specifications,
or that it deviated from the construction or composition of
identical bone cements manufactured by Defendants (i.e., that
some manufacturing defect resulted in anomalous composition of
the particular bone cement used when compared with other units
of DePuy Smartset GHV), she has failed to state a cause of
action for defective construction or composition under the LPLA
and

applicable

federal

pleading

standards.

See

Welch

v.

Technotrim, Inc., 34-355 (La. App. 2 Cir. 1/24/01), 778 So. 2d
728,

733

(“claimant

must

demonstrate

not

only

what

a

manufacturer’s specifications or performance standards are for a
9

particular product, but how the product in question materially
deviated from those standards”)(emphasis added). IT IS ORDERED
therefore that Defendants’ motion to dismiss Plaintiff’s claims
of

defective

construction

or

composition

under

the

LPLA

is

GRANTED.
B. Defective Design
A product is unreasonably dangerous in design if, at the
time

the

product

left

its

manufacturer’s

control:

(1)

There

existed an alternative design for the product that was capable
of preventing the claimant’s damage; and (2) the likelihood that
the product’s design would cause the claimant’s damage and the
gravity of that damage outweighed the burden on the manufacturer
of adopting such alternative design and the adverse effect, if
any, of such alternative design on the utility of the product.
La. Rev. Stat. ann. § 9:2800.56.
As

noted

above,

Plaintiff’s

principal

allegation

of

a

defect in Defendants’ bone cement is that the use of gentamicin
sulfate

and

the

composition

of

the

cement

contribute

to

unpredictable viscosity and curing behavior which hinders its
effective operation in procedures such as those undergone by
Plaintiff.3 In support of this conclusion, Plaintiff cites data
from
3

the

Manufacturer

and

User

Facility

Device

Experience

The Court notes that here the focus is on the intended composition of
Defendants’ product generally, which condition may, under the right
circumstances, support a design defect claim under the LPLA. This is in
contrast with a defective construction or composition claim which requires
the particular product to deviate in construction or composition from
identical products manufactured by the defendant. This distinction forms the
basis of Plaintiff’s failure to adequately state a claim under the
construction/composition theory of the LPLA, discussed supra.
10

(“MAUDE”)

database

Administration

maintained

(“FDA”).

(Rec.

by

the

Doc.

18

federal
at

Food

5).

and

Drug

According

to

Plaintiff, the MAUDE data indicate that:
[S]ince
its
introduction,
the
reported
yearly rate of loosening of implants due to
failure of DePuy Smartset GHV has increased
from zero per year in 2005, to approximately
25 per year in 2014. In that nine year span,
approximately 123 instances of loosening of
implants due to DePuy Smartset GHV cement
failure have been reported.
(Rec. Doc. 18 at 4). By comparison, Plaintiff argues that bone
cements

produced

by

competitors

using

different

compositions

resulted in much lower recorded failure rates. Plaintiff states:
In contrast to DePuy Smartset GHV, the MAUDE
database shows that similar cements had much
lower loosening rates in the same time
period; E.G., Simplex P with tobramycin had
only one reported loosening during the same
nine years, and Palacos R + G, with
gentamicin,
had
only
three
reported
loosenings in the same nine years.
(Rec. Doc. 18 at 4). Accordingly, Plaintiff argues the higher
rates of loosening seen in Defendants’ products as opposed to
those

of

competitors

establishes

that

an

alternative

design

capable of preventing Plaintiff’s damage existed at the time
Defendants’ product left their control. She further argues that
the presence on the market of similar bone cements with more
favorable

performance-results

establishes

that

Plaintiff’s

damage and the gravity of that damage outweighed the burden on
the

manufacturer

adverse

effect,

of
if

adopting
any,

of

the
such

alternative
alternative

design
design

utility of the product. La. Rev. Stat. ann. § 9:2800.56.
11

and

the

on

the

While

Plaintiff’s

allegations

relating

to

the

issues

created by the composition of Defendants’ bone cement and the
existence

of

alternative

products

on

the

market

would

not

support her burden of proof at trial or in the context of a
motion

for

summary

judgment,

she

has

asserted

factual

allegations which, accepted as true, assert plausible claims for
relief sufficient to survive dismissal. In the instant matter,
Plaintiff

alleges

that

the

composition

of

Defendants’

bone

cement, particularly through use of gentamicin sulfate, causes
DePuy

Smartset

GHV

to

exhibit

unstable

curing

and

fixing

behavior, which resulted in loosening of her tibial implant. She
has

demonstrated

that

similar

products

with

different

compositions exist on the market and has produced preliminary
data that such products demonstrate fewer instances of loosening
than Defendants’ product. Thus, she has stated a cause of action
under the LPLA for defective design. Compare, Watson v. Bayer
Healthcare Pharmaceuticals, Inc., No. 13-212, 2013 WL 1558328
(E.D.La. Apr. 11, 2013)(granting dismissal of defective design
claims where the plaintiff “failed to allege how [the product’s]
design is defective, what aspect of [its] design caused her
injuries, or how the defective design relates to her injuries.”)
Accordingly,

IT

IS

ORDERED

that

Defendants’

motion

to

dismiss Plaintiff’s design defect claim is DENIED.
C. Inadequate Warning
A

product

is

unreasonably

dangerous

because

an

adequate

warning about the product has not been provided if, at the time
12

the

product

possessed

a

manufacturer

left

its

manufacturer’s

characteristic
failed

to

use

that

control,

may

cause

reasonable

the

product

damage

care

to

and

provide

the
an

adequate warning of such characteristic and its danger to users
and handlers of the product. La. Rev. Stat. ann. § 9:2800.57.
Importantly, such a claim requires the plaintiff to show both:
(1) the inadequacy of the warning provided and (2) that the
inadequate warning was the cause of his injuries. Broussard v.
Procter & Gambel Co., 463 F. Supp. 2d 596, 609-10 (W.D. La.
2006)(citing

La.

Rev.

Stat.

ann.

§§

9:2800.54(A),

9:2800.57A(A)).
Defendants

argue

that

Louisiana

applies

the

“learned

intermediary doctrine” to LPLA claims involving medical devices,
such that the manufacturer’s duty to warn extends only to the
claimant’s

physician.

(Rec.

Doc.

8-1

at

9)(citing

Stahl

v.

Novartis Pharmaceuticals Corp., 283 F.3d 254, 265-66, 268 (5th
Cir. 2002)). Thus, according to Defendants, Plaintiff’s failure
to allege that a proper warning would have changed the decision
of the treating physician, fails to state a claim to relief
under

the

LPLA

for

inadequate

warning.

The

cited

authority,

however, reveals that Defendants misconstrue how the doctrine
applies in practice.
In
Louisiana

Stahl,

supra,

decisions

to

the

Fifth

conclude

Circuit
that

a

considered
“line

of

various

Louisiana

authority suggests that a warning regarding a particular adverse
drug reaction is adequate as a matter of law if the package
13

insert clearly and unambiguously mentions the specific ailment
suffered

by

the

plaintiff

AND

the

plaintiff’s

prescribing

physician unequivocally testifies that the information provided
in the warning was adequate to provide that physician with a
reasonable understanding of the risks involved.” 283 F.3d at 267
(citing White v. Slidell Mem’l Hsop. & Med. Ctr., No. 89-2691,
1990 WL 111447 (E.D. La. July 26, 1990); Cobb v. Syntex Labs,
Inc., 444 So.2d 203, 205-06 (La. App. 1983); Timm v. Upjohn Co.,
624 F.3d 536, 539 (5th Cir. 1980)). The Court then concluded:
“For summary adjudication of an inadequate warning claim to be
appropriate,

the

plaintiff’s

prescribing

physician

must

also

unequivocally testify that the warning was inadequate to inform
him or her of the risks involved in prescribing the drug.” Id.
at 267.
The

“learned

intermediary

doctrine”

is

an

affirmative

defense under which Defendants bear the burden of establishing
that they adequately informed the intermediate physician of the
risks associated with use of their product. See, e.g., Ebel v.
Eli Lilly and Co., 536 F. Supp. 2d 767, 772 (S.D. Tex. Jan. 29,
2008)(citing Reyes v. Wyeth Laboratories, 498 F.2d 1264, 1276
(5th Cir. 1974)(“Defendant has the initial burden of proving
that decedent received the medication through a physician with
whom the decedent had a physician-patient relationship and that
the warning Defendant provided to the prescribing physician was
adequate.”). As noted above, the Fifth Circuit has interpreted
Louisiana

jurisprudence

in

this
14

area

to

condone

summary

adjudication

only

where

the

defendant

points

both

to

an

unambiguous mention of the subject risk and testimony of the
treating physician establishing his understanding of such risk
based

on

the

warning.

Plaintiff’s

opposition

cites

to

an

“Instruction Leaflet for the Personal Attention of the Surgeon”
allegedly posted on the internet by Defendants, which includes
what Plaintiff characterizes to be a “generic” warning that:
“The most frequent adverse reactions reported with acrylic bone
cements are: . . . Pain and/or loss of function. . . . Loosening
or

displacement

of

the

prosthesis.”

(Rec.

Doc.

18-1

at

8).

Assuming without resolving that this amounts to an unambiguous
mention

of

the

specific

ailment

suffered

by

Plaintiff,

Defendants have not come forward with unequivocal testimony of
Plaintiff’s

treating

physician

as

to

the

adequacy

of

this

warning. They have further failed to make any claim or showing
as to the adequacy of this warning in pleadings. Plaintiff has,
however,

amended

her

complaint

to

allege

that

her

treating

physician would not have used Defendants’ bone cement had he
been aware of the risks associated therewith. (See Rec. Doc. 181

at

8).

Particularly

in

light

of

the

MAUDE

data

cited

by

Plaintiff, which appears to show a higher incidence of loosening
associated

with

Defendants’

product

than

its

competitors’,

Plaintiff has carried her burden of making a plausible showing
of entitlement to relief on her inadequate warning claim under
the LPLA.4 Defendants have failed to make out their affirmative
4

Under

the

LPLA,

a

manufacturer

who
15

acquires

post

hoc

knowledge

of

a

“learned

intermediary”

defense

under

relevant

jurisprudence.

Whether Plaintiff will succeed beyond the summary judgment phase
or at trial on this issue is for another day. Accordingly, IT IS
ORDERED that

Defendants’

motion

to

dismiss

Plaintiff’s

inadequate warning claims under the LPLA is DENIED.
D. Breach of Express Warranty
A
conform

product
to

manufacturer

an

is

unreasonably

express

about

the

dangerous

warranty
product

made
if

the

when

at

it

any

does

not

by

the

warranty

has

time

express

induced the claimant or another person or entity to use the
product and the claimant’s damage was proximately caused because
the express warranty was untrue. La. Rev. Stat. ann. § 9:2800.
58. Thus, under this provision, Plaintiff bears the burden of
establishing:

(1)

that

an

express

warranty

relating

to

the

product existed, (2) that such warranty induced Plaintiff’s or
another person’s use of the product, and (3) that her damage was
caused because the express warranty was untrue (i.e., that the
product

failed

to

conform

to

the

warranty).

See

Caboni

v.

General Motors Corp., 278 F.3d 448, 452 (5th Cir. 2002).
“Express warranty” is defined under the LPLA as:
[A] representation, statement of alleged
fact or promise about a product or its
nature,
material
or
workmanship
that
represents, affirms or promises that the
characteristic of the product that may cause damage and the danger of such
characteristic is “liable for damage caused by his subsequent failure to use
reasonable care to provide an adequate warning of such characteristic and its
danger to users and handlers of the product.” La. Rev. Stat. ann. §
9:2800.57. Thus, if Defendants learned after introduction of their product
into the market of the failures reported in the MAUDE database, they may have
come under a duty to supplement their warnings, instructions, etc.
16

product
or
its
nature,
material
or
workmanship
possesses
specified
characteristics or qualities or will meet a
specified level of performance. [It] does
not mean a general opinion about or general
praise of a product.
La. Rev. Stat. ann. § 9:2800.54(6)(emphasis added).
In

the

instant

case,

Plaintiff

alleges:

“Defendants

represented to the medical community that its [sic] bone cement
was

safe

and

fit

for

its

intended

purpose,

that

it

was

of

merchantable quality, that it did not produce any unwarned-of
dangerous
(Rec.

side

Doc.

effects,

18-1

at

and
10).

that

it

was

According

adequately

to

tested.”

Plaintiff,

these

representations were made via, inter alia, Defendants’ labeling,
advertising,

marketing

representations,

materials,

publications,

detail

notice

persons,

letters,

and

seminar

regulatory

submissions. (Rec. Doc. 18-1 at 11). Plaintiff points to no
specific
which

characteristic,

Defendants

are

quality,
alleged

or

to

level
have

of

made

performance

of

statements

or

representations concerning their bone cement. It is axiomatic
that

an

“express

warranty”

must

be

expressed.

Plaintiff’s

statements that “Defendants concealed in these representations
their knowledge of the defect,” as well as their statements
above, reveal -- at most -- mere implied warranties or the basis
for an inadequate warning claim.
Even if the Court were to construe Plaintiff’s claims, set
forth,

supra,

in

the

discussion

relating

to

defective

composition or construction, to represent specified “performance
17

standards,”

as

noted

in

that

section,

Plaintiff

makes

no

allegation as to how Defendants’ bone cement failed to adhere to
those

standards

(e.g.,

by

manifesting

a

composition

with

different proportions of ingredients than those represented). In
any event, Plaintiff has made absolutely no showing as to the
existence

of

an

express

warranty,

and

IT

IS

ORDERED

that

Defendants’ motion to dismiss Plaintiff’s claims under the LPLA
for breach of express warranty is GRANTED.
VII. CONCLUSION
In
Motion

light
to

of

Dismiss

the
is

above,

IT

GRANTED

IS
as

ORDERED
to

that

Plaintiffs’

Defendants’
defective

construction/composition and breach of express warranty claims,
but

DENIED

as

to

Plaintiffs’

inadequate

warning

and

design

defect claims under the LPLA.
New Orleans, Louisiana, this 25th day of February, 2015.

____________________________
UNITED STATES DISTRICT JUDGE

18