Pierre et al v. Medtronic, Inc. et al

Filing 34

ORDER AND REASONS: IT IS ORDERED that the Defendants' 25 motion to dismiss is DENIED with respect to Plaintiffs' construction or composition defect, design defect, and redhibition claims and GRANTED with respect to all other claims, as se t forth in document. Plaintiffs shall have twenty-one (21) days to amend to address the deficiencies identified in this Order and Reasons. If Plaintiffs do not correct those deficiencies within twenty-one (21) days, the deficient claims will be DISMISSED WITH PREJUDICE. Signed by Judge Ivan L.R. Lemelle on 4/23/2018. (jls)

UNITED STATES DISTRICT COURT
EASTERN DISTRICT OF LOUISIANA
DENISE PIERRE, ET AL.

CIVIL ACTION

VERSUS

NO. 17-12196

MEDTRONIC, INC., ET AL.

SECTION "B"(1)
ORDER AND REASONS

Defendants Medtronic Inc. and Covidien LP. filed a Motion to
Dismiss (Rec. Doc. 25) Plaintiffs’ First Amended Complaint (Rec.
Doc. 19). Plaintiffs Denise Pierre and Floyd Baham timely filed an
opposition. Rec. Doc. 27. Defendants then sought, and were granted,
leave to file a reply. Rec. Doc. 33. For the reasons discussed
below,
IT IS ORDERED that the Defendants’ motion to dismiss (Rec.
Doc. 25) is DENIED with respect to Plaintiffs’ construction or
composition defect, design defect, and redhibition claims and
GRANTED with respect to all other claims. Plaintiffs shall have
twenty-one

(21)

days

to

amend

to

address

the

deficiencies

identified in this Order and Reasons. If Plaintiffs do not correct
those deficiencies within twenty-one (21) days, the deficient
claims will be DISMISSED WITH PREJUDICE.
FACTUAL BACKGROUND AND PROCEDURAL HISTORY
On

November

17,

2016,

Plaintiff

Denise

Pierre

underwent

surgery to correct a ventral hernia. See Rec. Doc. 19 ¶ 9. The
surgeons used a piece of Parietex ProGrip Self Fixating Mesh to

1

close the hole in Pierre’s abdominal wall. See id. The piece of
mesh purportedly measured 20 centimeters by 15 centimeters. See
id. Pierre was readmitted to the hospital on December 4, 2016,
because the mesh had allegedly become infected and begun to detach
from Pierre’s abdominal wall. See id. ¶ 10. Pierre alleges that
she received treatment for complications from the mesh in June and
July

of

2017,

complications

and
when

that
the

she
First

continued
Amended

to

suffer

Complaint

from

was

these

filed

in

December 2017. See id. ¶¶ 11-13. Pierre’s father, Floyd Baham, is
also a plaintiff and seeks damages for loss of consortium. See id.
¶ 111.
Plaintiffs lodge various allegations against Defendants about
the safety of the mesh. See Rec. Doc. 19. First, Plaintiffs allege
that the mesh used in Pierre’s surgery was improperly sterilized,
in violation of Defendants’ sterilization procedures, before being
sent to the hospital where Pierre’s surgery took place. See id.
¶¶ 58, 59. Plaintiffs’ complaint states that, because the mesh was
improperly

sterilized,

Pierre

developed

a

severe

infection

following her surgery. See id. ¶¶ 60, 62.
Second,

Plaintiffs

allege

that

Defendants

failed

to

adequately warn about infection and the chance that the mesh would
contract after surgery. See id. ¶¶ 66, 71. Plaintiffs claim that,
if Defendants had adequately warned Pierre’s surgeon, the surgeon
would not have used the mesh. See id. ¶¶ 72, 75.
2

Third, Plaintiffs allege that two design features of the mesh
were unnecessarily dangerous. According to Plaintiffs, the mesh
was made out of polyester and incorporated “thousands of microgrips” to secure the mesh once it was implanted. See id. ¶ 83.
This

design

allegedly

caused

unnecessary

pain

when

the

mesh

contracted after surgery, see id. ¶ 83, and facilitated infection
by lowering the body’s pH around the mesh, see id. ¶ 57. The
complaint

asserts

that

“practical

and

feasible

alternative

designs” were available to Defendants when they manufactured the
mesh that was used in Pierre’s surgery. Id. ¶ 86.
Fourth, Plaintiffs allege that Defendants expressly warranted
that the mesh was “adequately tested,” “safe and fit for its
intended purposes, was of merchantable quality, . . . and did not
produce

dangerous

side

effects

. . . .”

Id.

¶ 91.

Plaintiffs

further allege that the previously-discussed design and production
defects violated these express warranties. See id. ¶¶ 92, 95.
Plaintiffs finally posit that they relied on Defendant’s express
warranties when deciding to use the mesh and would not have done
so otherwise. See id. ¶ 96.
Fifth, Plaintiffs allege that the previously discussed design
and

production

defects

rendered

the

mesh

useless,

such

that

Plaintiffs would not have purchased the mesh if they had known of
the defects. See id. ¶¶ 100-02. Defendants moved to dismiss all
claims for failure to state a claim. See Rec. Doc. 25.
3

LAW AND ANALYSIS
To survive a motion to dismiss under Federal Rule of Civil
Procedure 12(b)(6), a plaintiff’s complaint “must contain ‘enough
facts to state a claim to relief that is plausible on its face.’”
Varela v. Gonzalez, 773 F.3d 704, 707 (5th Cir. 2014) (quoting
Bell Atl. Corp. v. Twombly, 550 U.S. 544, 570 (2007)). When
deciding whether a plaintiff has met his or her burden, a court
“accept[s]

all

well-pleaded

factual

allegations

as

true

and

interpret[s] the complaint in the light most favorable to the
plaintiff, but ‘[t]hreadbare recitals of the elements of a cause
of

action,

establish

supported
facial

by

mere

conclusory

plausibility.”

Snow

statements’

Ingredients,

cannot

Inc.

v.

SnoWizard, Inc., 833 F.3d 512, 520 (5th Cir. 2016) (quoting
Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009)) (some internal
citations and quotation marks omitted).
Plaintiff alleges four claims under the Louisiana Products
Liability Act (LPLA) and one other state law claim. To prevail
under the LPLA, a plaintiff must show that (1) the defendant
manufactured

the

product,

(2)

the

plaintiff’s

damage

was

“proximately caused by a characteristic of the product,” (3) the
characteristic made the product “unreasonably dangerous,” and (4)
the plaintiff’s damage resulted from a reasonably anticipated use
of the product. See La. Rev. Stat. § 9:2800.54(A). A product can

4

be unreasonably dangerous (1) “in construction or composition,”1
(2) “in design,”2 (3) because there is an inadequate warning,3 or
(4) because it failed to “conform to an express warranty.”4 See
id. § 9:2800.54(B). A plaintiff bears the burden of proving all
elements of an LPLA claim. Id. Plaintiff has brought an LPLA claim
under each theory of unreasonable dangerousness.
Plaintiffs

have

adequately

pled

that

Defendants

are

manufacturers under the LPLA. A manufacturer includes an “entity
who

is

in

the

business

of

[producing,

making,

fabricating,

constructing, [or] designing] a product for placement into trade
or commerce.” La. Rev. Stat. § 9:2800.53(1). The definition also
encompasses an “entity who labels a product as his own or who
otherwise holds himself out to be the manufacturer of the product.”
Id.

§ 9:2800.53(1)(a).

manufactured,

supplied,

Plaintiffs
distributed,

allege

that

“Defendants

formulated,

prescribed,

marketed, and sold” the Parietex ProGrip Self Fixating Mesh. See
Rec. Doc. 19 ¶ 5; see also Rec. Doc. 19 ¶¶ 6, 7, 17. Therefore,
Plaintiffs

have

stated

facts

that,

if

true,

establish

that

Defendants are manufacturers under the LPLA.
Plaintiffs have also adequately pled that Pierre was injured
by a reasonably anticipated use of Defendants’ product. Plaintiffs

1
2
3
4

See
See
See
See

La.
La.
La.
La.

Rev.
Rev.
Rev.
Rev.

Stat.
Stat.
Stat.
Stat.

§
§
§
§

9:2800.55.
9:2800.56.
9:2800.57.
9:2800.58.

5

allege that Pierre was injured when Defendants’ mesh was used
during her hernia surgery. See id. ¶¶ 9-13. Plaintiffs also allege
that Defendants intended the mesh to be used in hernia repair
surgery. See id. ¶ 17. Therefore, Plaintiffs have alleged that any
injuries Pierre suffered from the mesh were the result of a
reasonably anticipated use.
Plaintiff’s

first

LPLA

claim

is

for

a

“construction

or

composition” defect. See Rec. Doc. 19 ¶¶ 52-63 (citing La. Rev.
Stat.

§ 9:2800.55).

“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. A
plaintiff “must show not only what a manufacturer's specifications
or performance standards are for a particular product, but how the
product in question materially deviated from those standards so as
to render it unreasonably dangerous.” Lyles v. Medtronic Sofamor
Danek, USA, Inc., 871 F.3d 305, 311 (5th Cir. 2013). A deviation
is material when it “increases the propensity for injury . . . .”
Roman v. W. Mfg., Inc., 691 F.3d 686, 698 (5th Cir. 2012). A
plaintiff must also show how the alleged deviation caused the
plaintiff’s injury. See Rayford v. Karl Storz Endoscopy Am., Inc.,
No. 15-2835, 2016 WL 4398513, at *4-5 (W.D. La. June 22, 2016).
6

Here, Plaintiffs allege that the mesh had a construction or
composition

defect

because

it

deviated

from

Defendants’

specifications when it was improperly sterilized. See Rec. Doc. 19
¶¶ 56-59. Plaintiffs allege that Defendants designed their mesh to
be sterilized with ethylene oxide before the mesh is sent to
hospitals. See id. ¶ 56. Plaintiffs also allege that the failure
to properly sterilize the mesh caused an infection, which is one
of injuries allegedly suffered by Pierre. See id. ¶ 58. Therefore,
Plaintiffs have explained Defendants’ sterilization procedures,
stated a deviation from those procedures, plausibly claimed that
the deviation increased the risk of injury, and alleged that the
deviation in fact caused injury. This is sufficient to state a
claim for a construction or composition defect under the LPLA. See
Lyles, 871 F.3d at 311. But, to be clear, this claim does not
provide

an

sterilization

avenue

for

procedures

Plaintiffs
generally,

to

rather

attack
it

is

Defendants’
only

viable

insofar as Plaintiffs allege that the deviation from Defendants’
sterilization procedures caused injury. See La. Rev. Stat. Ann.
§ 9:2800.55.
Plaintiff’s second LPLA claim is for a “design defect.” See
Rec. Doc. 19 ¶¶ 79-89 (citing La. Rev. Stat. § 9:2800.56). To state
a claim for a design defect, a plaintiff must plead that “there
existed an alternative design for the product that was capable of
preventing the [plaintiff’s] damage” and that the benefits of
7

adopting the alternative design outweighed the costs, both in terms
of any increased burden on the manufacturer and any decreased
utility of the product. See La. Rev. Stat. § 9:2800.56. Plaintiffs
allege that Defendants’ mesh was made out of polyester, which is
allegedly weaker than polypropylene, the material used by other
mesh manufacturers. See Rec. Doc. 19 ¶ 83. Plaintiffs further
allege that, because polyester is weaker than polypropylene, the
standard method for securing surgical mesh is ineffective. See id.
Whereas stronger mesh can be secured with “tacks or sutures[,]”
neither works with Defendants’ mesh because both would tear the
weak polyester mesh. See id. Plaintiffs allege that, to solve this
problem, Defendants’ designed their mesh with “thousands of microgrips” so no sutures or tacks would be needed. Id. Plaintiffs
ultimately allege that Defendants’ mesh caused more pain than mesh
secured

with

tacks

or

sutures

because

Defendants’

mesh

has

“thousands” of points of contact with a patient’s abdominal wall,
each of which is painfully pulled on when the mesh contracts after
surgery. See id.
These allegations state a claim for a design defect under the
LPLA insofar as the defect alleged is Defendants’ combination of
polyester mesh and thousands of micro-grips. See id. Plaintiffs
have stated that this design caused pain, which is one of the
injuries alleged. Moreover, Plaintiffs have stated that other mesh
manufacturers avoid the pain suffered here by using a different
8

mesh material and securing the mesh with tacks or sutures. See id.
These allegations state that there is an alternate design for
Defendants’ product that is both commercially feasible and would
have

prevented

Pierre’s

pain.

Therefore,

Plaintiffs’

Amended

Complaint includes facts sufficient to state a claim for a design
defect under the LPLA. See La. Rev. Stat. § 9:2800.56. However,
Plaintiffs’ design defect claim does not encompass the allegation
that the mesh design caused infection by lowering the pH in
Pierre’s abdomen. See Rec. Doc. 19 ¶ 57. In contrast to the
allegations

about

the

use

of

polyester

and

micro-grips,

the

allegations about lowering a patient’s abdominal pH include no
facts to suggest the existence of a feasible alternative design
that would prevent the alleged injury. See id.
Plaintiffs’ third LPLA claim is for inadequate warning. See
Rec. Doc. 19 ¶¶ 64-78 (citing La. Rev. Stat. § 9:2800.57). “To
recover for a failure to warn . . . , a plaintiff must show: (1)
that the defendant failed to warn the [plaintiff’s] physician of
a risk associated with the use of the product, not otherwise known
to the physician, and (2) that the failure to warn the physician
was both a cause in fact and the proximate cause of the plaintiff's
injury.” Hargrove v. Boston Sci. Corp., No. 13-3539, 2014 WL
4794763, at *11 (E.D. La. Sept. 24, 2014). Here, Plaintiffs allege
that the warning given to Pierre’s physician did not accurately
describe the risk of two complications, that use of the mesh could
9

lead to infection and that the mesh would contract after surgery.
See Rec. Doc. 19 ¶¶ 66, 71. Plaintiffs also allege that Defendants’
failure to warn Pierre and her surgeon caused the surgeon to use
Defendants’ mesh during the surgery. See id. ¶¶ 75, 77.
Plaintiffs’ inadequate warning claim fails because it is
implausible and lacks requisite factual detail. First, Plaintiffs
tether their claim about infection to a marketing document that
they claim lacks adequate warnings about infection. See Rec. Doc.
19 ¶ 66 n.2. But Plaintiffs offer no facts to plausibly suggest
that Pierre’s surgeon relied, or any competent surgeon would rely,
on

this

surgery.

marketing

document

Furthermore,

the

when

deciding

document

whether

itself

to

includes

perform
numerous

references to scientific papers and, importantly, “Instructions
For Use” of Defendants’ mesh. These references indicate that
Defendants did not rely solely, if at all, on the marketing
document to warn users of the risks associated with its products.
Plaintiffs’ total reliance on the marketing document to claim that
Defendants did not warn of a common surgical complication is
implausible, especially given that Plaintiffs would have been
alerted to other more relevant documentation of risks had they
fully examined the marketing document.
Aside from referring to the marketing document, Plaintiffs
provide

no

information

about

what

warning

Pierre’s

surgeon

received and no information about how that warning was deficient.
10

While a “[p]laintiff is not required to detail what an adequate
warning would be and how an adequate warning would have caused
[the] [p]laintiff's treating physician to act differently[,]” a
“[p]laintiff is required to allege that [d]efendants did not
adequately

warn

[p]laintiff’s

treating

physician

of

risks

associated with the product that are not otherwise known to the
patient or physician, and that the inadequate warning constituted
the proximate cause of [p]laintiff’s injuries.” Lewis v. Baxter
Int’l Inc., No. 16-16391, 2017 WL 661324, at *4-5 (E.D. La. Feb.
17, 2017).
While

Plaintiffs

allege

that

Pierre

did

not

know

that

Defendants’ mesh might contract after surgery, Plaintiffs do not
make the same allegation about Pierre’s surgeon. See Rec. Doc. 19
¶ 71. All that Plaintiffs allege is that “[t]he warnings that were
given by Defendants failed to properly warn . . . Petitioner’s
treating/implanting

physicians[]

of

the

increased

risks

of

permanent physical injuries as outlined herein.” Id. Though a
closer call than Plaintiffs’ arguments about the risk of infection,
this allegation is too broad to state a claim because it does not
identify (1) which aspects of the product warranted a warning and
(2) what injuries resulted from the failure to warn. See Lewis,
2017 WL 661324, at *4-5; Doe v. AstraZeneca Pharm., LP, No. 15438, 2015 WL 4661814, at *4 (E.D. La. Aug. 5, 2015) (dismissing

11

failure to warn claim because of “vagueness” about which “specific
adverse effects” warranted a warning).
Plaintiffs’ fourth LPLA claim is for breach of an “express
warranty.”

See

Rec. Doc. 15 ¶¶ 43-49 (citing La. Rev. Stat.

§ 9:2800.58). “A product is unreasonably dangerous when it does
not conform to an express warranty . . . if the express warranty
has induced the [plaintiff] or another person or entity to use the
product

and

because

the

the

[plaintiff]'s

express

warranty

damage
was

was

proximately

untrue.”

La.

Rev.

caused
Stat.

§ 9:2800.58. An express warranty is a “representation, statement
of alleged fact or promise about a product or its nature, material
or workmanship that represents, affirms or promises that the
product or its nature, material or workmanship possesses specified
characteristics or qualities or will meet a specified level of
performance.” La. Rev. Stat. § 9:2800.53(6).
An express warranty is not a “general opinion about or general
praise of a product.” Id. Moreover, representations that a product
is “safe” or “effective and safe for its intended use” do not
create an express warranty because such statements are nothing
beyond a general opinion or praise. See Doe v. AstraZeneca Pharm.
LP, No. 15-438, 2015 WL 4661814, at *4 (E.D. La. Aug. 5, 2015);
Corley v. Stryker Corp., No. 13-2571, 2014 WL 3375596, at *5 (W.D.
La. May 27, 2014). Plaintiffs fail to state a claim for breach of
an express warranty because they only allege that Defendants
12

warranted “that the Product was safe and fit for its intended
purposes, was or merchantable quality, had been adequately tested,
and did not produce dangerous side effects . . . .” Rec. Doc. 19
¶ 91. These are the types of generic expressions of opinion and
praise that fail to state a claim under the LPLA. See La. Rev.
Stat. § 9:2800.53(6) (“general opinion about or general praise of
a product” is not an express warranty); Doe, 2015 WL 4661814, at
*4 (explaining that similar statements did not state a claim under
the LPLA); Corley, 2014 WL 3375596, at *5 (same).
Because Plaintiffs have adequately alleged that Defendants’
product was defective under the LPLA, Plaintiffs’ redhibition
claim may also be viable. Under Louisiana law, a plaintiff has a
cause of action for redhibition when a product has defects that
“render [] the thing useless, or its use so inconvenient that it
must be presumed that a buyer would not have bought the thing had
[s]he known of the defect.” La. Civ. Code art. 2520. Such a defect
gives the buyer “the right to obtain rescission of the sale.” Id.
A

plaintiff

may

make

a

claim

under

the

LPLA

and

in

redhibition; however, redhibition is available only to the extent
the plaintiff seeks to recover the value of the product or other
economic loss. See Pipitone v. Biomatrix, Inc., 288 F.3d 239, 251
(5th Cir. 2002). As discussed above, Plaintiff has adequately
alleged that Defendants’ mesh had some defect that rendered it
useless and that she would not have used Defendants’ mesh had she
13

known of such defect. See Rec. Doc. 19 ¶¶ 100, 102. However,
Plaintiff’s damages as to this claim are limited to the cost of
the product and other economic damages that Plaintiff suffered.
See Guillory v. Pellerin, No. 07-1683, 2009 WL 1010816, at *2 (W.D.
La. Apr. 14, 2009) (citing Aucoin v. S. Quality Homes, LLC, 984
So. 2d 685, 692 (La. 2008)); Barrette v. Dow Agrosciences, LLC,
No. 02-1677, 2002 WL 31365598, at *3-4 (E.D. La. Oct. 18, 2002).
Plaintiff’s

remaining

claims

for

breach

of

warranty

of

fitness for ordinary use, negligence, breach of implied warranty,
negligent misrepresentation, and negligent design are precluded by
the LPLA. The LPLA sets forth the “exclusive theories of liability
for manufacturers for damage caused by their product.” La. Rev.
Stat.

§ 9:2800.52.

“A

[plaintiff]

may

not

recover

from

a

manufacturer for damage caused by a product on the basis of any
theory of liability that is not set forth in th[e] [LPLA].” Id.
Therefore,

Plaintiff’s

remaining

non-LPLA

claims

must

be

dismissed. See Jefferson v. Lead Indus. Ass’n, Inc., 106 F.3d 1245,
1248, 1250-51 (affirming dismissal of claims for “negligence,
fraud by misrepresentation, market share liability, breach of
implied warranty of fitness and civil conspiracy” because of the
LPLA’s exclusivity provision); see also, e.g., Stroderd v. Yamaha
Motor Corp., U.S.A., No. 04-3040, 2005 WL 2037419, at *2-3 (E.D.
La. Aug. 4, 2005) (dismissing a plaintiff’s “negligent repair and

14

breach of contract claims” because of the LPLA’s exclusivity
provision).
Finally, Plaintiffs state in their First Amended Complaint
that they seek, inter alia, attorney’s fees and punitive damages.
Under Louisiana law, punitive damages are permitted only where
expressly authorized by statute. See Int’l Harvester Credit v.
Seale, 518 So.2d 1039, 1041 (La. 1988). Neither the LPLA nor the
Civil Code articles on redhibition allow recovery of punitive
damages. See Bladen v. C.B. Fleet Holding Co., 487 F. Supp. 2d
759, 770-71 (W.D. La. Apr. 25, 2007); Cheeks v. Bayer Corp., No.
Civ. A. 03-132, 2003 WL 1748460, *1-2 (E.D. La. Mar. 28, 2003).
The remedies under the LPLA and redhibition diverge in that
the

LPLA

does

not

allow

recovery

of

attorney’s

fees,

but

redhibition does. See La. Rev. Stat. § 9:2800.53(5) (LPLA); La.
Civ.

Code

art.

2545

(redhibition).

However,

for

a

claim

in

redhibition, attorney’s fees may be awarded only “for the pure
economic loss and not for the damages recovered pursuant to the
LPLA.” See De Atley v. Victoria’s Secret Catalogue, LLC, 20040661, p.4 (La. App. 4 Cir. 5/14/04); 876 So. 2d 112, 115.
New Orleans, Louisiana, this 23rd day of April, 2018.

___________________________________
SENIOR UNITED STATES DISTRICT JUDGE

15