United States District Court, W.D. Louisiana, Lake Charles Division
REPORT AND RECOMMENDATION
KATHLEEN KAY UNITED STATES MAGISTRATE JUDGE
the court is an unopposed Motion to Dismiss [doc. 6] filed
pursuant to Federal Rule of Civil Procedure 12(b)(6) by
defendant Allergan USA, Inc. (“Allergan”). The
matter has been referred to the undersigned for review,
report, and recommendation in accordance with the provisions
of 28 U.S.C. § 636.
motion relates to a suit filed by Stampley under Louisiana
tort law, based on injuries she received from allegedly
defective breast implants. See doc. 1, att. 1, pp.
2-8. Specifically, Stampley alleges that she received a
breast augmentation with NATRELLE saline implants
manufactured by Allergan in 2010. Id. at 2. She
underwent a second operation to replace a defective implant
around September 2014, after noticing a loss in size to her
right breast. Id. at 2- 3. Through this operation
the original implants were replaced with Style 68MP NATRELLE
Saline-Filled Breast Implants, also manufactured by Allergan.
Id. at 3. In January 2017, she began experiencing
chest pain and numbness in her upper extremities.
Id. She underwent medical treatment and testing with
various physicians as her symptoms continued. Id.
Around October 2017, she began to suspect that her implants
might be causing her symptoms. Id. This suspicion
was confirmed on November 14, 2017, when she was diagnosed
with infected breast implants, a defective right breast
implant, and related conditions. Id. The diagnosis
was confirmed after an explant procedure on November 17,
2017, and the implants showed signs of mold and bacterial
growths that had accumulated while they were in the
plaintiff's body. Id. at 3-4. Since that time,
Stampley maintains that she has continuously sought medical
treatment for “residual issues of the defective
implant, including but not limited to autoimmune defect,
leaky gut, and the need for liver detoxification and pain
management.” Id. at 4.
October 24, 2018, Stampley brought suit against Allergan in
the Fourteenth Judicial District Court, Calcasieu Parish,
Louisiana. Id. at 2-8. There she asserted claims for
products liability under the Louisiana Products Liability
Act, Louisiana Revised Statute § 9:2800.51 et
seq., and negligent infliction of emotional distress.
Id. Allergan removed the matter to this court,
alleging diversity jurisdiction under 28 U.S.C. § 1332.
Doc. 1. Allergan now moves to dismiss the complaint,
asserting that the claims are preempted by federal law and
that Stampley also fails to adequately support her claims.
Doc. 6. Stampley does not oppose the motion.
to Dismiss Standards
12(b)(6) of the Federal Rules of Civil Procedure allows for
dismissal of a claim when a plaintiff “fail[s] to state
a claim upon which relief can be granted.” When
reviewing such a motion, the court should focus on the
complaint and its attachments. Wilson v. Birnberg,
667 F.3d 591, 595 (5th Cir. 2012). The court can also
consider matters of which it may take judicial notice,
including matters of public record. Hall v.
Hodgkins, 305 Fed. App'x 224, 227 (5th Cir. 2008)
unpublished) (citing Lovelace v. Software Spectrum
Inc., 78 F.3d 1015, 1017-18 (5th Cir. 1996) and
Norris v. Hearst Trust, 500 F.3d 454, 461 n. 9 (5th
motions are also reviewed with the court “accepting all
well-pleaded facts as true and viewing those facts in the
light most favorable to the plaintiff.” Bustos v.
Martini Club, Inc., 599 F.3d 458, 461 (5th Cir. 2010).
However, “the plaintiff must plead enough facts
‘to state a claim to relief that is plausible on its
face.'” In re Katrina Canal Breaches
Litig., 495 F.3d 191, 205 (5th Cir. 2007) (quoting
Bell Atl. Corp. v. Twombly, 127 S.Ct. 1955, 1974
(2007)). “A pleading that offers labels and conclusions
or a formulaic recitation of the elements of a cause of
action will not do. Nor will a complaint suffice if it tends
naked assertions devoid of further factual
enhancement.” Ashcroft v. Iqbal, 129 S.Ct.
1937, 1949 (2009) (cleaned up). Instead, 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).
Accordingly, the court's task in evaluating a motion to
dismiss under Rule 12(b)(6) is “not to evaluate the
plaintiff's likelihood of success, ” but instead to
determine whether the claim is both legally cognizable and
plausible. Billups v. Credit Bureau of Greater
Shreveport, 2014 WL 4700254, *2 (W.D. La. Sep. 22, 2014)
(quoting Lone Star Fund V (U.S.), L.P. v. Barclays Bank
PLC, 594 F.3d 383, 387 (5th Cir. 2010)).
first argues that Stampley's claims should be dismissed
because they are preempted by federal law. Preemption serves
as a basis for dismissal under Rule 12(b)(6), and the court
may take judicial notice of publicly available government
records to this end. See, e.g., Funk v. Stryker
Corp., 631 F.3d 777, 782-83 (5th Cir. 2011);
Yosowitz v. Covidien LP, 182 F.Supp.3d 683, 687-88
(S.D. Tex. 2016). Accordingly, we first analyze this argument
to determine if the claims should survive and take judicial
notice of the Food and Drug Administration
(“FDA”) records cited by Allergan.
the Medical Devices Amendments (“MDA”) to the
Food, Drugs, and Cosmetics Act (“FDCA”), 21
U.S.C. § 301 et seq., Congress “imposed a
regime of detailed federal oversight” on medical
devices through the FDA. Riegel v. Medtronic, Inc.,
128 S.Ct. 999, 1003-04 (2008). Within this regime devices are
divided into three different classes (Class I, Class II, and
Class III) based on the level of oversight required. Class
III devices require the ...