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Calloway v. Coloplast Corp.

United States District Court, W.D. Louisiana, Monroe Division

February 5, 2019





         Before 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.


         On July 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, [1] 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. Id.[2]

         On 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.

         On 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. # 19].

         On 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”)

         The 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 motion.[3]

         Standard of Review

         The 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. 9(b).

         To 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).

         Assessing 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. 1827 (1989).

         When 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 record).

         Analysis I.


         In 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 omitted).

         The MDA 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 devices.” Id.[4]

         “The 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).

         In 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 requirement-

(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.

         As a result,

[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 ...

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