Pellegrin v. C.R. Bard, Inc. et al

Filing 27

ORDER AND REASONS granting 5 Motion to Dismiss for Failure to State a Claim. Plaintiff's claims are DISMISSED WITHOUT PREJUDICE. Plaintiff has 21 days to amend her complaint. Failure to timely amend will result in dismissal of the complaint with prejudice. Signed by Judge Sarah S. Vance on 6/20/2018. (cg)

UNITED STATES DISTRICT COURT
EASTERN DISTRICT OF LOUISIANA
KIMBERLY PELLEGRIN
VERSUS

CIVIL ACTION
NO. 17-12473

C.R. BARD, ET AL.

SECTION “R” (4)

ORDER AND REASONS
Defendants Medtronic, Inc. and Covidien, LP move to dismiss
plaintiff’s complaint. 1

For the following reasons, the Court grants the

motion.
I.

BACKGROUND
This case arises out of an allegedly defective product manufactured by

defendants.2 Plaintiff Kimberly Pellegrin alleges she was diagnosed on
October 23, 2014 with gastritis, gastroparesis, and diabetes. 3

Plaintiff

asserts that on October 25, 2014, she was rushed to the hospital and further
diagnosed with a “perforated duodenal ulcer.” 4 She alleges she was also
suffering from tachycardia, hypotension, sepsis, acute kidney injury,

1
2
3
4

R. Doc. 5.
R. Doc. 1 at 3 ¶ 11.
Id. at 3 ¶ 13.
Id. at 3 ¶ 14.

abnormal coagulation profile, and gastrointestinal bleeding. 5 That same day,
plaintiff underwent surgery to repair the perforated ulcer and was implanted
with defendants’ allegedly defective product, Parietex Composite Mesh.6 She
does not allege the purpose for which the product was implanted.
Confusingly, plaintiff’s opposition to defendants’ motion provides a
different medical diagnosis and different dates for plaintiff’s surgery. The
Court notes that the complaint appears to be a near-verbatim copy of two
other complaints recently filed against defendants. See No. 17-6075 (E.D.
La. June 23, 2017); No. 17-11836 (E.D. La. Nov. 6, 2017). Plaintiff now states
in her opposition that she underwent “hernia repair surgery” in March 2014
and again in July 2015, and that during both surgeries she was “repaired”
with defendants’ product. 7 The Court relies only on the factual information
provided in the complaint. See Goodwin v. Hous. Auth. of New Orleans, No.
11-1397, 2013 WL 3874907, at *9 n. 37 (E.D. La. July 25, 2013) (noting that
it is “inappropriate to raise new facts and assert new claims in an opposition
to a motion to dismiss”). In any event, the alternative information provided
by plaintiff in her opposition would not alter the Court’s analysis or
conclusions. It does, however, undermine the credibility of her counsel, who

5
6
7

Id.
Id.
See R. Doc. 19 at 2.
2

is obligated under Rule 11 not to file a pleading containing factual assertions
that do not have evidentiary support or will not have such support after
discovery. See Fed. R. Civ. P. 11(b)(3).
Plaintiff alleges that defendants’ product caused her to experience
“severe and permanent bodily injuries,” including “excruciating abdominal
pain and swelling, difficulty walking, and physical pain.”8 She alleges that at
some point she underwent subsequent surgery “to remove and/or repair the
damage” cause by defendants’ product. 9 Plaintiff alleges that defendants’
product contains “numerous defects,” and specifically states that the product
“abrades tissues” and does not perform its intended purpose.10 Plaintiff does
not allege that she experienced tissue abrasion.
On November 14, 2017, plaintiff sued Medtronic, Covidien, C.R. Bard,
Inc., and Davol, Inc. for damages. The complaint brings claims under
various provisions of the Louisiana Products Liability Act (LPLA), La R. S. §§
9:2800.51, et seq., and for redhibition, La. Civ. Code arts. 2520, et seq. On
March 6, 2018, plaintiff voluntarily dismissed all claims against C.R. Bard

8
9
10

R. Doc. 1 at 3 ¶ 15.
Id. at 3 ¶ 16.
Id. at 4 ¶ 17.
3

and Davol.11 The remaining defendants now move to dismiss plaintiff’s
complaint. 12

II.

LEGAL STANDARD
To survive a Rule 12(b)(6) motion to dismiss, the plaintiff must plead

“sufficient factual matter, accepted as true, to ‘state a claim to relief that is
plausible on its face.’” Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009) (quoting
Bell Atl. Corp. v. Twombly, 550 U.S. 544, 570 (2007)). A claim is facially
plausible when the plaintiff pleads facts that allow the court to “draw the
reasonable inference that the defendant is liable for the misconduct alleged.”
Id. at 678. A court must accept all well-pleaded facts as true and must draw
all reasonable inferences in favor of the plaintiff. See Lormand v. U.S.
Unwired, Inc., 565 F.3d 228, 232 (5th Cir. 2009).
A legally sufficient complaint must establish more than a “sheer
possibility” that the plaintiff’s claim is true. Iqbal, 556 U.S. at 678. It need
not contain detailed factual allegations, but it must go beyond labels, legal
conclusions, or formulaic recitations of the elements of a cause of action. Id.
In other words, the face of the complaint must contain enough factual matter

11
12

R. Doc. 15.
R. Doc. 5.
4

to raise a reasonable expectation that discovery will reveal relevant evidence
of each element of the plaintiff’s claim. Lormand, 565 F.3d at 257. The claim
must be dismissed if there are insufficient factual allegations to raise a right
to relief above the speculative level, Twombly, 550 U.S. at 555, or if it is
apparent from the face of the complaint that there is an insuperable bar to
relief, Jones v. Bock, 549 U.S. 199, 215 (2007).

III. DISCUSSION
Defendants move to dismiss the complaint for two reasons. First,
defendants argue plaintiff’s claims are prescribed under the applicable
statute of limitations. Second, defendants argue that plaintiff has failed to
plead sufficient factual support to satisfy the pleading standard required by
Iqbal and Twombly.
A.

Prescription

Plaintiff’s products liability claims are subject to the general one-year
prescriptive period applicable to delictual actions under Louisiana law. La.
Civ. Code art. 3492. The prescriptive period “commences to run from the
day injury or damage is sustained.” Id. Under Louisiana law, “damages are
said to be sustained ‘when the damage has manifested itself with sufficient
certainty to support accrual of a cause of action.’” Jenkins v. Bristol-Myers
5

Squibb Co., 689 F. App’x 793, 795 (5th Cir. 2017) (quoting Cole v. Celotex
Corp., 620 So. 2d 1154, 1156 (La. 1993)); see also Grenier v. Med. Eng’g
Corp., 243 F.3d 200, 203-04 (ruling that the plaintiff’s cause of action under
the LPLA accrued once she had “suffered some physical injury” because of
the defendant’s allegedly defective product). “Prescription is an affirmative
defense, and defendants bears the burden of its proof at trial.” Ducre v. Mine
Safety Appliances, Inc., 963 F.2d 757, 760 (5th Cir. 1992). If a complaint
reveals on its face that the prescriptive period has run, “the burden shifts to
the plaintiff to prove a suspension or interruption of the prescriptive period.”
Younger v. Marshall Indus., Inc., 618 So. 2d 866, 869 (La. 1993); see also
Eastin v. Entergy Corp., 865 So. 2d 49, 54 (La. 2004).
The complaint alleges that plaintiff was implanted with defendants’
product over three and a half years ago during surgery on October 25, 2014, 13
and that she experienced “severe and permanent bodily injuries” because of
the implant.14

Plaintiff also asserts she has undergone “subsequent

surgeries” to repair the damage defendants’ product has caused.15
Importantly, the complaint does not provide any indication of when plaintiff
first experienced her alleged injuries, or when plaintiff’s “subsequent

13
14
15

R. Doc. 1 at 3 ¶ 14.
Id. at 3 ¶ 15.
Id. at 3 ¶ 16.
6

surgeries” were performed. Accordingly, the Court cannot determine from
the face of the complaint when plaintiff’s injuries manifested and her cause
of action accrued. See Jenkins, 689 F. App’x at 795. Because the prescriptive
period commences on the day the cause of action accrues, the Court cannot
find plaintiff’s claims facially prescribed.
Defendant argues that plaintiff’s claim is facially prescribed because
the prescriptive period started on the date of plaintiff’s surgery over three
and a half years ago. 16 But that is not correct. Plaintiff’s cause of action
accrued, and thus the prescriptive period commenced, when plaintiff “first
suffered some physical injury.” Grenier, 243 F.3d 200, 203-04. Plaintiff
does not provide a date on which she first experienced her alleged injuries.
The Court cannot infer from other information provided in the complaint
whether the onset of plaintiff’s injuries was immediate upon the
implantation of the product or developed later. Nor can the Court determine
when she had revision surgery.
Plaintiff’s redhibition claim is subject to a one-year prescriptive period
beginning from the date the buyer discovers the alleged defect. La. Civ. Code
art. 2534(A)(1), (B).

16

As with plaintiff’s claims under the LPLA, the

See R. Doc. 5-1 at 13.
7

redhibition claim is not facially prescribed because the complaint does not
allege when plaintiff first experienced her injuries.
Plaintiff should note, however, that it is only the vagueness of her
complaint that prevents the Court from finding her claims facially
prescribed. Plaintiff alleges she underwent surgery more than three years
before filing this complaint, during which she was implanted with
defendants’ allegedly defective product. Because plaintiff does not allege
when and how her injuries manifested themselves, her date of injury cannot
be ascertained.

In any amended complaint, the Court directs plaintiff to

include specific allegations explaining what injuries she suffered and when
she first experienced those injuries.
B.

Sufficiency of the Pleading
1. The Louisiana Products Liability Act

In Louisiana, the LPLA provides the exclusive theories of liability of a
manufacturer for damages caused by its product. La. R. S. § 9:2800.52. A
plaintiff may not recover from a manufacturer in tort under any theory of
liability that is not set forth in the LPLA. Id.; see also Stahl v. Novartis
Pharm. Corp., 283 F.3d 254, 261-62 (5th Cir. 2002). The statute provides
that a manufacturer “shall be liable to a claimant for damage proximately
caused by a characteristic of the product that renders the product
8

unreasonably dangerous when such damage arose from a reasonably
anticipated use of the product by the claimant or another person or entity.”
La. R. S. § 9:2800.54(A).
A product is unreasonably dangerous for the purposes of the statute
“if and only if” it is unreasonably dangerous either (1) in construction or
composition, (2) in design, (3) because of inadequate warning, or (4) because
of nonconformity to an express warranty. Id. § 9:2800.54(B)(1-4). Thus, the
LPLA

limits

the

plaintiff

to

four

theories

of

recovery:

construction/composition defect, design defect, inadequate warning, and
breach of express warranty. The complaint includes causes of action for each
of these theories of recovery. The Court next considers whether plaintiff’s
allegations satisfy the LPLA.
a. Construction or composition
To establish a claim for defective construction or composition, plaintiff
must establish that, “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. R. S. §
9:2800.55. Plaintiff alleges that defendants’ product “was sold in a defective

9

condition” 17 which created “a high risk of unreasonable and dangerous
injuries . . . including that the material in the product abrades tissues.”18 But
her complaint lacks any factual allegations as to how the particular product
with which she was implanted deviated from defendants’ specifications,
performance standards, or identical products manufactured by defendants.
Nor does plaintiff allege how any such defect would cause the product to
abrade tissues or that her tissues were in fact abraded, causing her injuries.
Rather, the complaint merely includes a conclusory allegation that the
product “deviated in a material way from defendants’ manufacturing
performance standards and/or it differed from otherwise identical products
manufactured to the same design formula.” 19
Federal courts applying the LPLA have made clear that defective
construction or composition claims require more than conclusory
allegations, and will not survive motions to dismiss without allegations of
how the product is defective and how this defect caused the plaintiff’s
injuries. See, e.g., Aucoin v. Amneal Pharm., LLC, No. 11-1275, 2012 WL
2990697, at *10 (E.D. La. July 20, 2012) (granting motion to dismiss
plaintiff’s defective construction or composition claim because plaintiff did

17
18
19

R. Doc. 1 at 11 ¶ 51.
Id. at 4 ¶ 17.
Id. at 12 ¶ 52.
10

not allege that product deviated from production standards or identical
products); Watson v. Bayer Healthcare Pharm., Inc., No. 13-212, 2013 WL
1558328, at *4 (E.D. La. Apr. 11, 2013) (granting motion to dismiss plaintiff’s
defective construction or composition claim because plaintiff did not allege
how product deviated from production standards or how the unknown defect
caused her alleged injuries); Kennedy v. Pfizer, Inc., No. 13-3132, 2014 WL
4093065, at *3 (W.D. La. Aug. 15, 2014) (same); Becnel v. Mercedes-Benz
USA, LLC, No. 14-0003, 2014 WL 4450431, at *4 (E.D. La. Sept. 10, 2014)
(same). Plaintiff’s conclusory allegations therefore do not rise to the level of
plausibility required by Twombly and Iqbal. Thus, plaintiff’s defective
construction or composition claim must be dismissed.
b. Inadequate warning
For inadequate warning claims, Louisiana applies the “learned
intermediary doctrine.” Stahl, 283 F.3d at 265; see also Willett v. Baxtern
Int’l Inc., 929 F.2d 1094, 1098 (5th Cir. 1991) (applying the “learned
intermediary doctrine” in an LPLA action against a medical device
manufacturer). Under this doctrine, a manufacturer “discharges its duty to
consumers by reasonably informing prescribing physicians of the dangers of
harm” from the device. Stahl, 283 F.3d at 265 (citing Anderson v. McNeilab,
Inc., 831 F.2d 92, 93 (5th Cir. 1987)). Accordingly, “the manufacturer has no
11

duty to warn the patient, but need only warn the patient’s physician.” Willet,
929 F.2d at 1098.
To prevail on an inadequate warning claim, plaintiff must demonstrate
“(1) that the defendant failed to warn the 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 plaintiff’s injury.” Id. at 1098-99. This causation requirement means that
the plaintiff must show that “a proper warning would have changed the
decision of the treating physician, i.e., that but for the inadequate warning,
the treating physician would not have used or prescribed the product.” Id.
at 1099.
Plaintiff alleges that defendants’ product contained insufficient
warning of the “high risk” of “dangerous injuries” it could cause, in particular
that the product “abrades tissues.”20

Plaintiff further alleges that had

“defendants adequately warned the plaintiff’s healthcare providers of the
risks associated with the product, the healthcare providers, acting as
reasonably prudent healthcare providers, would have elected not to use the
product.”21

20
21

These conclusory allegations amount to “naked assertions

R. Doc. 1 at 14 ¶ 66.
Id. at 15 ¶ 68.
12

devoid” of the “factual enhancement” necessary to survive a motion to
dismiss. Iqbal, 556 U.S. at 678 (quoting Twombly, 550 U.S. at 557). In
particular, the plaintiff fails to assert that the product’s characteristic that
may cause damage (its supposed high risk of abrading tissues22) actually
caused her injuries. There is no indication in the complaint that plaintiff’s
tissues were abraded at any point since her surgery, let alone as a result of
defendants’ product, or that an abrasion was the cause of her injury. Thus,
plaintiff fails to assert that the alleged inadequate warning is causally
connected to her injuries, which renders her inadequate warning claim
implausible. See Iqbal, 556 U.S. at 678; see also Watson, 2013 WL 1558328,
at *5 (dismissing plaintiff’s inadequate warning claim because the complaint
failed to “allege facts suggesting how [defendant’s] allegedly inadequate
warning caused [plaintiff’s] specific injury”). These deficiencies require the
Court to dismiss plaintiff’s inadequate warning claim.
c. Defective design
Next, plaintiff alleges that defendants’ product was unreasonably
dangerous in its design. To establish the elements for this claim, the plaintiff
must allege that:

22

Id. at 14 ¶ 66.
13

(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. R. S. § 9:2800.56.
Plaintiff alleges the product was “defective in its design”23 particularly
because it “abrades tissues,”24 and that there existed “practical and feasible
alternative designs that would have prevented”25 plaintiff’s injuries. These
conclusory statements also fail to satisfy the pleading standard required by
Iqbal and Twombly. Plaintiff fails to sufficiently allege what aspect of
defendants’ product design caused it to abrade tissues, how the alleged defect
contributed to her specific injuries, or what other alternative designs existed
at the time of her surgery. See Flournoy v. Johnson & Johnson, No. 15-5000,
2016 WL 6474142, at *3 (E.D. La. Nov. 2, 2016) (plaintiff’s conclusory
allegation that “there existed an alternate design for the product that was
capable of preventing” plaintiff’s injuries was insufficient to sustain a
defective design claim); Watson, 2013 WL 1558328, at *4-5 (dismissing
complaint that failed to allege how defendant’s design was defective and
23
24
25

R. Doc. 1 at 15-16 ¶ 73.
Id. at 16 ¶ 76.
Id. at 17 ¶ 79.
14

what aspect of the defective design caused plaintiff’s injuries). Accordingly,
plaintiff’s defective design claim contains an insufficient allegation that an
alternative design existed, and the claim must be dismissed.
d. Breach of express warranty
Under the LPLA, a manufacturer of a product that is unreasonably
dangerous because it does not conform to an express warranty about the
product is liable for damages caused by that non-conformity. La. R. S. §
9:2800.58. To establish a breach of express warranty claim, a plaintiff must
show that (1) there was an express warranty made by the manufacturer about
the product; (2) the express warranty induced the plaintiff to use the
product; and (3) the plaintiff’s damage was proximately caused because the
express warranty was untrue. Id.; see also Caboni v. Gen. Motors Corp., 278
F.3d 448, 452 (5th Cir. 2002).
The LPLA defines “express warranty” as “a representation, statement
of alleged fact or promise about a product . . . that represents, affirms or
promises that the product . . . possesses specified characteristics or qualities
or will meet a specified level of performance.” La. R. S. § 9:2800.53(6). The
statute adds that “general opinion[s]” or “general praise” of a product do not
qualify as express warranties. Id.

15

Plaintiff’s allegations are plainly insufficient to state a breach of
express warranty claim. Plaintiff alleges that defendants made express
representations to plaintiff, plaintiff’s physicians, “other consumers,” and
the “medical community” that defendants’ product is safe to use and does
not “produce dangerous side effects.” 26 Plaintiff further alleges that she
allowed defendants’ product to be implanted into her “as a result” of these
representations,27 and that her injuries were a “direct and proximate
result” 28 of the alleged breach of warranty.
Plaintiff’s claim for breach of warranty is nothing more than a
“threadbare recital[] of the elements of [the] cause of action, supported by
mere conclusory statements.” Iqbal, 556 U.S. at 678. In particular, plaintiff’s
vague and conclusory allegations fail to specify the contents of defendants’
representations or how they were factually untrue or inadequate. While
plaintiff is not required to identify the exact language used in the warranty,
she must specify the warranty in question and explain why the warranty is
untrue. See Flournoy, 2016 WL 6474142, at *3 (plaintiff’s breach of warranty
claim dismissed for failing to sufficiently “identify the contents of any
warranty”); see also Robertson v. AstraZeneca Pharm., LP, No. 15-438, 2015

26
27
28

R. Doc. 1 at 18 ¶ 84.
Id. at 19 ¶ 89.
Id. at 20 ¶ 90.
16

WL 5823326, at *5 (E.D. La. Oct. 6, 2015) (plaintiff’s allegation that
defendant made representations in “materials presented to the FDA” was not
specific enough to state a claim for breach of warranty); Doe v. AstraZeneca
Pharm., LP, No. 15-438, 2015 WL 4661814, at *4 (E.D. La. Aug. 5, 2015)
(plaintiff’s allegation that defendant represented to the market that
defendant’s product was “safe” and “effective” did not satisfy pleading
standard). Because plaintiff has failed to satisfy the pleading standard for
her breach of express warranty claim, that claim must also be dismissed.
2. Redhibition
The LPLA “establishes the exclusive theories of liability for
manufacturers for damage caused by their products,” La. R. S. § 9:2800.52,
and damages for personal injury from defective products cannot be
recovered from manufacturers in redhibition. But redhibition remains
available against a manufacturer to recover economic loss. See Pipitone v.
Biomatrix, Inc., 288 F.3d 239, 251 (5th Cir. 2012) (“Courts have interpreted
the LPLA as preserving redhibition as a cause of action only to the extent the
claimant seeks to recover the value of the product or other economic loss.”).
A plaintiff suing in redhibition must prove that “(1) the thing sold is
absolutely useless for its intended purposes[,] or that its use is so
inconvenient that it must be supposed that he would not have bought it had
17

he known of the defect; [and] (2) that the defect existed at the time he
purchased the thing, but was neither known [n]or apparent to him . . . . ”
Alston v. Fleetwood Motor Homes of Ind., 480 F.3d 695, 699 (5th Cir. 2007)
(citing Dalme v. Blockers Mfd. Homes, Inc., 779 So.2d 1014, 1028 (La. App.
2001).
As with plaintiff’s claims under the LPLA, plaintiff’s redhibition claim
must be dismissed because the complaint fails to sufficiently allege how
defendants’ product was defective. See Guidry v. Janssen Pharm., Inc., No.
15-4591, 2016 WL 633673, at *5 (E.D. La. Feb. 17, 2016) (dismissing
redhibition claim for plaintiff’s failure to allege facts that would allow the
Court to “plausibly recognize any particular defect” in defendant’s product).
C.

Leave to Amend

Lastly, plaintiff requests leave to amend her complaint in the event the
Court finds her claims prescribed or insufficiently pleaded. 29 The Court will
“freely give leave [to amend] when justice so requires.” Fed. R. Civ. P. 15(a).
The Supreme Court has held that “[i]f the underlying facts or circumstances
relied upon by a plaintiff may be a proper subject of relief, he ought to be
afforded an opportunity to test his claim on the merits.” Foman v. Davis,
371 U.S. 178, 182 (1962).

29

Leave to amend, however, “is by no means

R. Doc. 19 at 11-12.
18

automatic.” Halbert v. City of Sherman, 33 F.3d 526, 529 (5th Cir. 1994).
The Court considers multiple factors, including “undue delay, bad faith or
dilatory motive on the part of the movant, repeated failure to cure
deficiencies by amendments previously allowed, undue prejudice to the
opposing party by virtue of allowance of the amendment, [and] futility of
amendment.” Foman, 371 U.S. at 182.
The Court finds that none of these factors militate against granting
leave to amend. The Court grants plaintiff leave to amend her complaint
within twenty-one (21) days of the entry of this order.

IV.

CONCLUSION
For the foregoing reasons, the Court GRANTS defendants’ motion to

dismiss.

Plaintiff’s claims are DISMISSED WITHOUT PREJUDICE.

Plaintiff has 21 days to amend her complaint. Failure to timely amend will
result in dismissal of the complaint with prejudice.

20th
New Orleans, Louisiana, this _____ day of June, 2018.

_____________________
SARAH S. VANCE
UNITED STATES DISTRICT JUDGE

19