Parra et al v. Coloplast Corp.
ORDER granting 9 Motion to Dismiss for Failure to State a Claim. Party Coloplast Corporation dismissed. Signed by Judge Sarah S. Vance on 1/3/2017. (mmm)
UNITED STATES DISTRICT COURT
EASTERN DISTRICT OF LOUISIANA
STEPHEN G. PARRA
SECTION “R” (2)
ORDER AND REASONS
Before the Court is defendant Coloplast Corp.’s motion to dismiss
plaintiffs Stephen G. Parra and Elaine Parra’s lawsuit. 1 For the following
reasons, the Court GRANTS defendant’s motion.
This is a Louisiana law products liability case. According to plaintiffs’
petition, defendant Coloplast manufactures and distributes the Coloplast
Titan, an inflatable penile prosthesis.2 The Titan is a self-contained, fluidfilled system designed to allow those suffering from erectile dysfunction to
achieve an erection. 3 Plaintiff Stephen Parra suffered from organic erectile
dysfunction as a result of the prostate cancer treatment he received, and
R. Doc. 9.
R. Doc. 1-1 at 1 ¶ 5.
Id. at 1-2 at ¶¶ 5-8.
sought a penile implant. 4
Plaintiff had surgery to implant the Titan
prosthesis on or about April 28, 2015. 5
According to Parra, his initial recovery was unremarkable, but he soon
began to experience multiple, painful problems with the prosthesis,
including repeated spontaneous inflations, without release. 6 The prosthesis
eventually stopped working entirely, and plaintiff alleges that he will need to
have surgery to either repair or replace the prosthesis. 7 Plaintiff also alleges
that the Titan’s malfunction has caused permanent nerve damage and other
damages which will require additional future surgeries. 8
On April 27, 2016, plaintiff and his wife Elaine Parra filed a petition in
the Civil District Court for the Parish of Orleans against Coloplast. 9 On
August 15, 2016, plaintiffs filed a supplemental and amending petition. 10 The
petition alleges that Coloplast was negligent and that the Titan implant was
defective and unreasonably dangerous under the Louisiana Products
Liability Act (LPLA), due to defective design and/or construction,
Id. at 2 ¶ 8.
Id. ¶ 9.
Id. ¶ 10.
Id. ¶ 11.
Id. at 1.
Id. at 5.
inadequate warnings, and for failure to comply with an express warranty. 11
Stephen Parra seeks damages including, but not limited to, past, present and
future pain and suffering; past, present and future mental suffering; past,
present and future loss of wages and/or loss of earning capacity; past,
present and future medical expenses; permanent disability; loss of
enjoyment of life; and permanent disfigurement and scarring.12 Plaintiff
Elaine Parra also seeks damages for loss of consortium, service, and society
as a result of the physical and emotional injuries, damages, and mental and
physical trauma sustained by her husband Stephen. 13
On September 14, 2016, defendant removed the case to this Court on
the basis of diversity jurisdiction. 14 On October 12, 2016, defendant filed this
motion to dismiss, arguing that plaintiffs’ state law claims are preempted
pursuant to the Medical Device Amendments (MDA), 21 U.S.C. § 360k, to
the Federal Food, Drug & Cosmetic Act (FFDCA), 21 U.S.C. § 301, et seq.15
Defendant additionally argues that plaintiffs’ amended petition fails to state
a claim to relief that is plausible on its face. Plaintiffs have not filed a
response and do not oppose defendant’s motion.
Id. at 2-3 ¶ 12.
Id. at 3 ¶ 13.
Id. ¶ 14.
R. Doc. 1.
R. Doc. 9.
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
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.
Plaintiffs bring their claims pursuant to the LPLA. The LPLA provides
the exclusive remedy against a manufacturer for damages caused by its
product. La. Stat. Ann. § 9:2800.52. A plaintiff may not recover 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 § 2800.54(B)(1–4). Thus, the
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
(1989)). Similarly, breach of implied warranty is unavailable as a theory of
recovery for personal injury. Id.
Defendant first argues that plaintiffs’ LPLA claims are preempted by
the Medical Device Amendments, 21 U.S.C. § 360k, to the Federal Food,
Drug & Cosmetic Act, 21 U.S.C. § 301, et seq. Defendant concedes that it
owns and manufactures the Titan. 16 The Titan is a Class III device under the
FFDCA and is subject to the FDA’s pre-market approval process. The Court
has taken judicial notice of the FDA’s website, which indicates that the Titan
underwent the FDA’s pre-market approval process under the FFDCA.17 See
Scianneaux v. St. Jude Medical S.C., Inc., 961 F. Supp. 2d 808, 812 (E.D. La.
2013) (taking judicial notice of the FDA’s website). The website further
indicates that the FDA has approved several modifications to the design,
manufacturing process, and labeling of the Titan. 18 See Spier v. Coloplast
Corp., 121 F. Supp. 3d 809, 815 (E.D. Tenn. 2015) (“It is clear that the Titan
Prosthesis received and has since maintained PMA status.”).
The MDA expressly preempts state law claims against manufacturers
when the effect is to establish “safety or effectiveness” standards that are
“different from, or in addition to” the requirements for pre-market approved
products under the FFDCA. 21 U.S.C. § 360k. Therefore, to the extent that
state law claims impose duties on Class III PMA devices that are different or
in addition to the requirements set forth by the FDA, they are necessarily
R. Doc. 9-1 at 7.
FDA database of premarket approvals, accessible at
preempted. See Riegel v. Medtronic, Inc., 552 U.S. 312, 329-30 (2008).
However, “parallel” state actions—state law claims that are premised on
violations of FDA regulations—are permitted. Id. at 330; see also Medtronic,
Inc. v. Lohr, 518 U.S. 470, 495 (1996).
Plaintiffs, therefore, may bring suit under the LPLA only if they can
show that it was a violation of FDA regulations that rendered the Titan
“unreasonably dangerous.” Scianneaux, 961 F. Supp. 2d at 812 (quoting
Riegel, 552 U.S. at 330). Moreover, the allegations that Coloplast violated
FDA regulations must satisfy the pleading requirements of Twombly. See
Bass v. Stryker Corp., 669 F.3d 501, 509-10 (5th Cir. 2012) (affirming the
conclusion that “to plead a parallel claim successfully, a plaintiff’s allegations
that the manufacturer violated FDA regulations must meet the Twombly
plausibility standard,” and applying that standard to plaintiff’s claim).
Although a formal finding of a violation by the FDA is not required, id. at 509
(citing Hughes v. Boston Scientific Corp., 631 F.3d 762, 772 (5th Cir. 2011)),
the plaintiff must at least “specif[y] with particularity what went wrong in
the manufacturing process and cite the relevant FDA manufacturing
standards [the defendant] allegedly violated.” Id. at 510 (quoting Funk v.
Stryker Corp., 631 F.3d 777, 782 (5th Cir. 2011)).
The Court addresses plaintiffs’ manufacturing and design defect claims
first. Here, plaintiffs’ petition makes no mention of anything that went
wrong in the manufacturing process and similarly mentions no violation of
any federal design or manufacturing requirements. 19 Therefore, plaintiffs
make no argument explaining how the design, manufacture, or sale of the
Titan deviated from FDA requirements. The Fifth Circuit explained in
Rodriguez v. American Medical Systems, Inc. that failure to connect an
alleged violation of federal design or manufacturing requirements to a state
law design or manufacturing defect is fatal to those claims. 597 F. App’x 226,
230 (5th Cir. 2014) (finding plaintiff’s state law claims regarding Class III
device not parallel and therefore preempted because plaintiff failed to allege
a “violation of any federal requirement relating to design or manufacturing
of the implant,” and failed to “allege a specific defect in the manufacturing
process or design, any deviation from the FDA-approved design or
manufacturing processes, or any causal connection between a violation of
federal requirements and [plaintiff’s] injuries.”); Spier, 121 F. Supp. 3d at 816
(holding that “[p]laintiff’s complaint does not suggest defendant has failed
to conform to the FDA requirements prescribed by its premarket approval or
In fact, neither plaintiffs’ original petition nor their supplemental
petition makes any mention of the FDA at all.
has deviated from or violated any federal statute or regulation . . . . Therefore,
the Court finds the exception for parallel claims does not apply, . . . and the
claim is preempted by the MDA.”). The fatal flaw identified by Rodriguez
applies here as well. Thus, plaintiffs’ petition does not plead a parallel
manufacturing or design defect action and these claims are preempted by the
Plaintiffs’ failure to warn claim is similarly preempted. As above, the
Court takes judicial notice that the FDA has approved the labeling and
specific warning instructions for the Titan. See also Spier, 121 F. Supp. 3d at
817 (“[T]he FDA has already approved specific warnings and instructions for
the Titan Prosthesis.”).
Plaintiffs’ petition makes no mention of the
approved FDA warnings and contains no allegations that defendant has
deviated from these accepted warnings and instructions in any manner. As
such, plaintiffs’ failure to warn claim seeks to impose liability for defendant’s
failure to include warnings or instructions that are not required by federal
law. Therefore, the claim is not parallel to FDA requirements but is in
addition to them, and is preempted.20 See Riegel, 552 U.S. at 329-30; Gomez
v. St. Jude Med. Daig Div. Inc., 442 F.3d 919, 931 (5th Cir. 2006) (affirming
Even if plaintiffs’ claims were not preempted, it would not
survive a motion to dismiss because plaintiffs’ claims fail to satisfy the
plausibility requirement of Twombly. See Bass, 669 F.3d at 509-10.
district court’s ruling that plaintiff’s LPLA failure to warn claim was
preempted because FDA had approved warnings and instructions); Spier,
121 F. Supp. 3d at 817.
Breach of Warranty LPLA Claim
Plaintiffs’ petition also asserts a breach of express warranty claim
under the LPLA. As the Fifth Circuit has noted, breach of express warranty
claims can survive MDA preemption if the warranty arises “‘from the
representations of the parties and are made as the basis of the bargain
between them’ and may ‘not necessarily interfere with the operation of the
PMA.’” Gomez, 442 F.3d at 932 (quoting Mitchell v. Collagen Corp., 126
F.3d 902, 915 (7th Cir. 1997). But if the warranty at issue contradicts the
FDA’s requirements, Spier, 121 F. Supp. 3d at 818, or the warranty is
intertwined with the FDA’s standards, the claim will be preempted. Gomez,
442 F.3d at 932.
Here, plaintiffs have failed to plead their express warranty claim with
enough particularity to allow the Court to determine if the claim is
preempted. See Spier, 121 F. Supp. 3d at 818-19. This failure does not affect
the outcome, however, because even if this claim is not preempted, it fails to
establish a plausible breach of express warranty claim under Twombly. As
discussed above, in addition to pleading a violation of FDA regulations, a
plaintiff must plead facts in support of each element of a claim under the
LPLA, including “(1) that the defendant is a manufacturer of the product; (2)
that the claimant’s damage was proximately caused by a characteristic of the
product; (3) that the characteristic made the product unreasonably
dangerous in one of the four ways provided in the statute; and (4) that the
claimant’s damage arose from a reasonably anticipated use of the product by
the claimant or someone else.” Jefferson, 930 F. Supp. at 245 (citing La. Stat.
Ann. § 9:2800.54).
Plaintiffs’ petition does no more than recite the bare elements of an
LPLA claim. See Iqbal, 556 U.S. at 678. Further, plaintiffs’ petition does not
set forth the necessary factual allegations to plead a sufficient breach of
express warranty claim under the LPLA.
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. La. Stat. Ann. § 9:2800.58; see also Caboni v. Gen.
Motors Corp., 278 F.3d 448, 452 (5th Cir. 2002). Here, plaintiffs’ petition
makes no such allegations. The petition does not allege that the supposed
express warranty induced plaintiff to use the Titan, and beyond the legal
conclusion that an express warranty existed, the petition does not allege with
specificity anything about the express warranty, including when it was made
and who made it. See Robertson v. AstraZeneca Pharmaceuticals, LP, No.
15-438, 2015 WL 5823326, at *5 (E.D. La. Oct. 6, 2015) (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 identify how that warranty induced the Plaintiff to use
In conclusion, plaintiffs’ breach of express warranty claim contains
insufficient factual allegations to raise a right to relief above the speculative
level. Twombly, 550 U.S. at 555. Rule 8 of the Federal Rules of Civil
Procedure “demands more than an unadorned, the-defendant-unlawfullyharmed-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, to the extent that plaintiffs’ breach of express warranty
claim is not preempted by the MDA, it must be dismissed for failure to state
Defendant’s motion to dismiss asks the Court to dismiss plaintiffs’
petition with prejudice.21 Plaintiffs did not respond to defendant’s motion,
and therefore present no argument against a dismissal with prejudice.
Because plaintiffs have already had one opportunity to amend their petition
and continue to provide nothing more than conclusory allegations, the
petition will be dismissed with prejudice. See Scianneaux, 961 F. Supp. 2d
For the foregoing reasons, defendant’s motion to dismiss is
GRANTED, and plaintiffs’ petition is DISMISSED WITH PREJUDICE.
New Orleans, Louisiana, this _____ day of January, 2017.
SARAH S. VANCE
UNITED STATES DISTRICT JUDGE
R. Doc. 9-1 at 1.
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