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Stampley v. Allergan USA Inc.

United States District Court, W.D. Louisiana, Lake Charles Division

March 15, 2019




         Before 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.



         This 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.

         On 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.[1]


         Motion to Dismiss Standards

         Rule 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 Cir. 2007)).

         Such 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)).

         III. Application

         Allergan 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.

         A. Legal standards

         Under 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 ...

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