United States District Court, W.D. Louisiana, Monroe Division
A. DOUGHTY MAG. JUDGE
REPORT AND RECOMMENDATION
L. HAYES UNITED STATES MAGISTRATE JUDGE.
the undersigned Magistrate Judge, on reference from the
District Court, is defendant Coloplast Corp.'s motion to
dismiss plaintiffs' complaint for failure to state a
claim upon which relief can be granted [doc. # 8]. The motion
is opposed. For reasons set forth below, it is recommended
that the motion be granted.
31, 2018, Manuel Calloway (“Calloway”) and Drew
Siller Calloway filed the instant suit for damages against
Coloplast Corp. (“Coloplast”) and ABC Insurance
Co. pursuant to the Louisiana Products Liability Act, La.
R.S. 9:2800.51, et seq. (“LPLA”), as a
result of a purportedly defective “penile inflatable
implant, ” a/k/a the Titan Prosthesis,  which was
manufactured by Coloplast and surgically implanted into
Calloway on December 13, 2016. See Compl. Following
the surgery, Calloway suffered cellulitis, infection of the
prosthesis, and incontinence, that required another
hospitalization from December 31, 2016, through January 4,
2017, to treat these issues. Id. After recovery,
Calloway was unable to inflate the prosthesis on several
occasions, and when he did so, the pain was unbearable.
Id. Calloway also asserted that the Titan Prosthesis
caused him to suffer permanent urethra damage, which will
necessitate future surgeries. Id. Calloway seeks
damages for extreme pain and suffering and emotional
distress. Id. In addition, Drew Siller Calloway
asserted claims for loss of consortium and support.
August 31, 2018, Coloplast filed the instant motion to
dismiss for failure to state a claim upon which relief can be
granted on the twin grounds that: 1) plaintiffs' state
law claims under the LPLA are preempted by the express
preemption provision of the Medical Device Amendments
(“MDA”), 21 U.S.C. § 360k, to the Federal
Food, Drug & Cosmetic Act (“FDCA”), 21 U.S.C.
§ 301, et seq.; and 2) plaintiffs' state
law claims fail to allege sufficient facts to support a
plausible claim for relief.
October 8, 2018, plaintiffs filed their response in
opposition to defendant's motion to dismiss. [doc. # 18].
On October 15, 2018, Coloplast filed its reply brief. [doc. #
December 26, 2018, however, the court reviewed the complaint
and discerned that it did not set forth a basis for the
court's exercise of subject matter jurisdiction. (Dec.
26, 2018, Order [doc. # 20]). This discovery prompted a
series of court initiated amendments, which ultimately
culminated with a third amended complaint filed on January
23, 2019, that finally succeeded in alleging and establishing
diversity jurisdiction, 28 U.S.C. § 1332. See
Third Amend. Compl. (“TAC”)
court notes that an “amended complaint supersedes the
original complaint and renders it of no legal effect, unless
the amended complaint specifically refers to and adopts or
incorporates by reference the earlier pleading.”
King v. Dogan, 31 F.3d 344, 346 (5th Cir.
1994) (citing Boelens v. Redman Homes, Inc., 759
F.2d 504, 508 (5th Cir.1985)). Here, the TAC merely inserts
the previously missing jurisdictional allegations, and then
re-asserts all of the substantive allegations from the
original complaint. See the TAC. Therefore, the sole
complaint before the court is the TAC, to which the court
will apply the arguments raised by defendant's
Federal Rules of Civil Procedure sanction dismissal where the
plaintiff fails “to state a claim upon which relief can
be granted.” Fed.R.Civ.P. 12(b)(6). A pleading states a
claim for relief, inter alia, when it contains a
“short and plain statement . . . showing that the
pleader is entitled to relief . . .” Fed.R.Civ.P.
8(a)(2). Circumstances constituting fraud or mistake,
however, must be alleged with particularity. Fed.R.Civ.P.
withstand 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.” Ashcroft v. Iqbal, 556 U.S. 662, 129
S.Ct. 1937, 1949 (2009) (citing Bell Atl. Corp. v.
Twombly, 550 U.S. 544, 127 S.Ct. 1955 (2007)). A claim
is facially plausible when it contains sufficient factual
content for the court “to draw the reasonable inference
that the defendant is liable for the misconduct
alleged.” Id. Plausibility does not
equate to possibility or probability; it
lies somewhere in between. See Iqbal, supra.
Plausibility simply calls for enough factual allegations to
raise a reasonable expectation that discovery will reveal
evidence to support the elements of the claim. See
Twombly, 550 U.S. at 556, 127 S.Ct. at 1965.
Although the court must accept as true all factual
allegations set forth in the complaint, the same presumption
does not extend to legal conclusions. Iqbal, supra.
A pleading comprised of “labels and conclusions”
or “a formulaic recitation of the elements of a cause
of action” does not satisfy Rule 8. Id.
“[P]laintiffs must allege facts that support the
elements of the cause of action in order to make out a valid
claim.” City of Clinton, Ark. v. Pilgrim's
Pride Corp., 632 F.3d 148 (5th Cir. 2010).
whether a complaint states a plausible claim for relief is a
“context-specific task that requires the reviewing
court to draw on its judicial experience and common
sense.” Iqbal, supra. (citation omitted). A
well-pleaded complaint may proceed even if it strikes the
court that actual proof of the asserted facts is improbable,
and that recovery is unlikely. Twombly, supra.
Nevertheless, a court is compelled to dismiss an otherwise
well-pleaded claim if it is premised upon an invalid legal
theory. Neitzke v. Williams, 490 U.S. 319, 109 S.Ct.
considering a motion to dismiss, courts generally are limited
to the complaint and its proper attachments. Dorsey v.
Portfolio Equities, Inc., 540 F.3d 333, 338
(5th Cir. 2008) (citation omitted). However,
courts may rely upon “documents incorporated into the
complaint by reference, and matters of which a court may take
judicial notice” - including public records.
Dorsey, supra; Norris v. Hearst Trust, 500
F.3d 454, 461 n9 (5th Cir. 2007) (citation
omitted) (proper to take judicial notice of matters of public
response to concerns that state-law governance of medical
devices was inadequate, Congress passed the MDA, which gave
the Food and Drug Administration (the “FDA”)
authority to regulate medical devices and expressly preempted
certain state regulations.” Bass v. Stryker
Corp., 669 F.3d 501, 506 (5th Cir.2012) (citations
established three levels of oversight for medical devices
(Class I, Class II, and Class III) depending on the risks
presented by each. Riegel v. Medtronic, Inc., 552
U.S. 312, 316, 128 S.Ct. 999, 1003 (2008); see also
21 U.S.C. § 360c(a). The devices receiving the most
federal scrutiny are those in Class III. Riegel,
supra. Indeed, the MDA established a “rigorous
regime of premarket approval for new Class III
FDA spends an average of 1, 200 hours reviewing each
application, and grants premarket approval only if it finds
there is a ‘reasonable assurance' of the
device's ‘safety and effectiveness' . .
.” Riegel, 552 U.S. at 318, 128 S.Ct. at 1004
(internal citations omitted). The premarket approval process
also includes review of the device's proposed labeling.
Id. Further, “[o]nce a device has received
premarket approval, the MDA forbids the manufacturer to make,
without FDA permission, changes in design specifications,
manufacturing processes, labeling, or any other attribute,
that would affect safety or effectiveness.”
Id. (citation omitted).
light of this comprehensive premarket approval process, the
MDA includes an express preemption provision, which, subject
to an exception not applicable here, states that, no State or
political subdivision of a State may establish or continue in
effect with respect to a device intended for human use any
(1) which is different from, or in addition to, any
requirement applicable under this chapter to the device, and
(2) which relates to the safety or effectiveness of the
device or to any other matter included in a requirement
applicable to the device under this chapter.
21 U.S.C. § 360k.
[a] state-law tort claim to recover for injuries allegedly
caused by a medical device is preempted if: (1) “the
Federal Government has established requirements applicable to
[the device]”; and (2) the claims are based on
state-law requirements that are “‘different from,
or in addition ...