Lussan v. Merck Sharp & Dohme Corp et al
ORDER granting 7 Motion to Dismiss. For the foregoing reasons, Plaintiff's complaint is DISMISSED WITH PREJUDICE. Signed by Judge Sarah S. Vance on 6/1/2017. (cg)
UNITED STATES DISTRICT COURT
EASTERN DISTRICT OF LOUISIANA
MERCK SHARP & DOHME CORP.,
SECTION “R” (4)
ORDER AND REASONS
Defendants Organon USA, Inc., Merck Sharp & Dohme Corp., and
Merck & Co., Inc., (collectively “Merck”) move the Court to dismiss Meryl
Lussan’s complaint pursuant to Federal Rule of Civil Procedure 12(b)(6). 1
Lussan does not oppose the motion. Because Lussan fails to plead a plausible
claim under the Louisiana Products Liability Act, the Court dismisses her
This is a Louisiana law products liability case. According to plaintiff’s
complaint, defendants design, manufacture, market, and sell Implanon and
Nexplanon, both of which are birth control implants designed to prevent
R. Doc. 7.
pregnancy.2 Plaintiff alleges that in approximately March of 2011, she had
an Implanon implant inserted.3 Between June and August of 2011, plaintiff
allegedly suffered urinary tract infections, lower right abdominal pain,
burning, and painful bowel movements.4 In March of 2012, plaintiff had her
Implanon implant replaced with a Nexplanon implant. 5 Plaintiff alleges that
over the next two years, she experienced multiple urinary tract infections,
bowel issues, lower back pain, significant weight loss, nausea, vomiting,
headaches, and other symptoms. 6 Despite these issues, when her implant
expired in January, 2015, plaintiff had it replaced with a new Nexplanon
On January 4, 2017, plaintiff sued Merck in state court, 8 alleging that
Implanon and Nexplanon were defective and unreasonably dangerous, and
that plaintiff’s use of Implanon and Nexplanon caused her injuries. 9 Plaintiff
also alleged that defendants made false, misleading, and inaccurate
representations, that the implants were “inherently dangerous in a manner
R. Doc. 1-2 at 3-4 ¶¶ 2, 3, 7.
Id. at 3 ¶ 2.
Id. ¶¶ 2, 3.
Id. ¶ 3.
Id. ¶ 4.
Id. at 2.
Id. at 3 ¶ 6.
that exceeded any purported, inaccurate and/or insufficient warnings,” and
that the implants were unreasonably dangerous in their construction and/or
On April 10, 2017, Merck removed the case to this Court on the basis
of diversity jurisdiction. 11 Defendants now move to dismiss, arguing that
plaintiff fails to state a claim for which relief can be granted. Plaintiff has not
responded to defendants’ motion.
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 Atlantic 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. A court must accept all well-pleaded facts as true, viewing them in the
light most favorable to the plaintiff. Gines v. D.R. Horton, Inc., 699 F.3d
812, 816 (5th Cir. 2012) (quoting In re Katrina Canal Breaches Litig., 495
Id. at 4 ¶¶ 8, 9.
R. Doc. 1.
F.3d 191, 205 (5th Cir. 2007)). But a court is not bound to accept as true legal
conclusions couched as factual allegations. Iqbal, 556 U.S. at 678.
A legally sufficient complaint must establish more than a “sheer
possibility” that the plaintiff’s claim is true. Id. 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. (citing
Twombly, 550 U.S. at 555). In other words, the face of the complaint must
contain enough factual matter to raise a reasonable expectation that
discovery will reveal evidence of each element of the plaintiff’s claim.
Lormand v. U.S. Unwired, Inc., 565 F.3d 228, 257 (5th Cir. 2009). 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, see Jones v. Bock,
549 U.S. 199, 215 (2007); Carbe v. Lappin, 492 F.3d 325, 328 n.9 (5th Cir.
2007), the claim must be dismissed.
In Louisiana, the Louisiana Products Liability Act provides the
exclusive theories of liability of a manufacturer for damages caused by its
product. La. Stat. Ann. § 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.; 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 unreasonably dangerous when such damage arose from
a reasonably anticipated use of the product by the claimant or another person
or entity.” La. Stat. Ann. § 9:2800.54(A).
A product is unreasonably dangerous for the purposes of the statute “if
and only if” it is unreasonably dangerous: (1) in construction or composition,
(2) in design, (3) because of inadequate warning, or (4) because of
nonconformity to an express warranty. Id. at § 9:2800.54(B)(1–4). Thus,
construction/composition defect, design defect, inadequate warning, and
breach of express warranty.
“While the statutory ways of establishing that a product is
unreasonably dangerous are predicated on principles of strict liability,
negligence, or warranty, respectively, neither negligence, strict liability, nor
breach of express warranty is any longer viable as an independent theory of
recovery against a manufacturer.” Jefferson v. Lead Indus. Ass’n, Inc., 930
F. Supp. 241, 245 (E.D. La. 1996) aff’d, 106 F.3d 1245 (5th Cir. 1997) (citing
Automatique New Orleans, Inc. v. U-Select-It, Inc., 1995 WL 491151 at *3
n.2 (E.D. La. Aug. 15, 1995) (no independent negligence claim); J. Kennedy,
A Primer on the Louisiana Products Liability Act, 49 La. L. Rev. 565, 589-90
Plaintiff’s complaint is heavy on legal conclusions but light on factual
The complaint generally alleges that the implants were
unreasonably dangerous in their construction and/or composition, and
plaintiff alleges false representations and “insufficient warnings.”12 Viewing
plaintiff’s allegations in the light most favorable to plaintiff, the Court
interprets her complaint as attempting to assert that the implants were
unreasonably dangerous because of their construction/composition, because
of inadequate warnings, and because of nonconformity with an express
warranty, all theories of liability under the LPLA. The Court next considers
whether plaintiff’s allegations satisfy the LPLA.
Construction or Composition
To establish a claim for defective construction or composition under
the LPLA, 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
R. Doc. 1-2 at 4 ¶¶ 8, 9.
from otherwise identical products manufactured by the same manufacturer.”
La. Stat. Ann. § 9:2800.55. Here, plaintiff alleges that Merck’s products are
“unreasonably dangerous in their construction and/or composition,” but her
complaint is devoid of any factual allegations as to how the products are
defectively constructed or composed. She makes no allegations regarding
any possible deviations from Merck’s specifications or performance
standards, nor does plaintiff allege any deviations from identical products
manufactured by Merck. She also does not allege specifically how the
unidentified defect caused plaintiff’s injuries. 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 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.
Accordingly, her defective construction or composition claim must be
For inadequate warning claims regarding pharmaceutical products,
Louisiana applies the “learned intermediary doctrine.” Stahl, 283 F.3d at
265. Under this doctrine, a drug manufacturer “discharges its duty to
consumers by reasonably informing prescribing physicians of the dangers of
harm from a drug.” Id. (citing Anderson v. McNeilab, Inc., 831 F.2d 92, 93
(5th Cir. 1987)). Accordingly, drug manufacturers have “no duty to warn the
patient, but need only warn the patient’s physician.” Willett v. Baxter
Intern., Inc., 929 F.2d 1094, 1098 (5th Cir. 1991).
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. 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.
Plaintiff fails to allege facts giving rise to an inadequate warning claim
under the LPLA. She merely asserts that any warnings were “insufficient.”
She makes no mention of any specific risks that were not disclosed to her
doctor, and she does not allege that a specific failure to warn caused her
injuries. Nor does she allege that but for this insufficient warning, her doctor
would not have used or prescribed the product. These deficiencies are fatal
to plaintiff’s inadequate warning claim, and the claim must be dismissed. See
Huffman v. Squibb, No. 16-3714, 2016 WL 6024532, at *2 (E.D. La. Oct. 14,
2016) (dismissing inadequate warning claim under LPLA because plaintiff
did not allege that adequate warning would have changed the decision of
treating physician); Hargrove v. Boston Sci. Corp., No. 13-3539, 2014 WL
4794763, at *11 (E.D. La. Sept. 24, 2014) (same); Watson, 2013 WL 1558328,
at *5 (dismissing inadequate warning claim under LPLA because plaintiff did
not allege “facts suggesting how allegedly inadequate warning caused her
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. Stat. Ann.
§ 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. Stat. Ann. § 9:2800.53(6).
The statute adds that “general opinion[s]” or “general praise” of a product do
not qualify as express warranties. Id.
Here, plaintiff’s allegations are plainly insufficient to state a breach of
express warranty claim.
Plaintiff alleges that defendants made
representations that were false, misleading, and inaccurate when they
represented that their implants were safe and effective, and that the implants
were reversible, in that they could be removed whenever the patient
desired.13 Plaintiff fails to offer any specifics as to Merck’s representations
that could amount to a warranty. Nor does she allege that any express
representation induced her to use Implanon or Nexplanon or that any such
representation induced her doctor to prescribe either of them. Nor does she
allege how the asserted representations were untrue.
contradicts her allegation that the representation that the implants were
replaceable was false in other parts of her complaint. 14 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 was untrue. 15 See
Robertson v. AstraZeneca Pharm., LP, No. 15-438, 2015 WL 5823326, at *5
(E.D. La. Oct. 6, 2015) (citations omitted). Plaintiff’s failure to do so, along
with her failure to allege that the warranty induced the use of the implants
renders her breach of warranty claim insufficient under Twombly and Iqbal.
See Henderson v. Dasa, No. 13-08, 2014 WL 1365968, at *3 (E.D. La. Apr. 7,
R. Doc. 1-2 at 4 ¶ 9.
See id. at 3 ¶ 3 (“Plaintiff . . . removed the Implanon implant and
inserted Nexplanon as a replacement.”); id. ¶ 4 (“Plaintiff had the Nexplanon
removed as it expired and had Nexplanon reinserted.”).
To the extent that plaintiff relies on statements made in
advertisements or in marketing materials, these statements generally “are
not warranties because they are ‘puffery,’ ‘general praise,’ or ‘general
opinion.’” Robertson, 2015 WL 5823326, at *5 (quoting Becnel, 2014 WL
4450431, at *5; La. Stat. Ann. § 9:2800.53(6)).
2014) (dismissing plaintiff’s express warranty claim because plaintiff’s
complaint “is devoid of any allegations regarding the content of the alleged
warranty, much less an explanation of how that warranty was untrue”);
Robertson, 2015 WL 5823326, at *5 (dismissing breach of express warranty
claim under LPLA because plaintiff failed to “make more than a general
reference to [an express warranty]”); Flournoy v. Johnson & Johnson, No.
15-5000, 2016 WL 6474142, at *3-4 (E.D. La. Nov. 2, 2016) (stating that
plaintiffs’ LPLA breach of express warranty claim fails to meet the requisite
pleading standard because “it does not identify the contents of any warranty
or how that warranty induced the Plaintiff to use the product”); see also Doe
v. AstraZeneca Pharmaceuticals, LP, No. 15-438, 2015 WL 4661814, at *4
(E.D. La. Aug. 5, 2015) (rejecting breach of express warranty claim despite
plaintiff’s allegation that product was represented as safe and effective).
Dismissal With Prejudice
In sum, even when construed in the light most favorable to plaintiff,
plaintiff’s allegations are insufficient to raise a right to relief above the
speculative level.16 Twombly, 550 U.S. at 555. Rule 8 of the Federal Rules
Plaintiff’s complaint does not allege anything related to the
design of Implanon and Nexplanon. Even if plaintiff’s barebones complaint
could be read to assert a design defect claim under the LPLA, the claim would
fail because she fails to allege that safer alternative designs of the implants
exist and she fails to allege that these unidentified alternative designs would
of Civil Procedure “demands more than an unadorned, the-defendantunlawfully-harmed-me accusation.” Gulf Coast Hotel-Motel Ass’n v. Miss.
Gulf Coast Golf Course Ass’n, 658 F.3d 500, 504 (5th Cir. 2011) (citing Iqbal,
556 U.S. at 678). Therefore, these claims are dismissed.
Merck’s motion to dismiss asks the Court to dismiss plaintiff’s
complaint with prejudice. Plaintiff did not respond to Merck’s motion, and
therefore presents no argument against a dismissal with prejudice. Nor does
plaintiff request leave to amend her complaint. See Fed. R. Civ. P. 15(a)(2).
As such, the Court has no basis to determine how plaintiff would overcome
the deficiencies in her complaint.
Accordingly, plaintiff’s complaint is
dismissed with prejudice. See Cinel v. Connick, 15 F.3d 1338, 1346 (5th Cir.
1994) (affirming dismissal with prejudice when plaintiff did not ask for leave
to amend and therefore failed to specify how he would amend complaint to
overcome previous 12(b)(6) dismissal); Alsenz v. Aurora Bank, FSB, 641 F.
App’x 359, 363 (5th Cir. 2016) (same).
have prevented her injuries. See, e.g., Kennedy, 2014 WL 4093065, at *4
(“The failure to plead that an alternative design was available for the product
is enough to doom the [claim], as the existence of an alternative design is a
necessary element to a design defect claim under . . . the LPLA.”) (citation
omitted); see also Aucoin, 2012 WL 2990697, at *10.
For the foregoing reasons, Merck’s motion is GRANTED. Plaintiff’s
complaint is DISMISSED WITH PREJUDICE.
New Orleans, Louisiana, this _____ day of June, 2017.
SARAH S. VANCE
UNITED STATES DISTRICT JUDGE
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