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Burrell v. Bayer Corporation Bayer Healthcare LLC

United States District Court, W.D. North Carolina, Asheville Division

May 10, 2017



          Mox O. Congburn, Jr. United States District Judge

         THIS MATTER is before the court on the pending Motion to Dismiss (#11) in this matter as well as the plaintiff's Motion to Reconsider or Alternatively Certify for Appeal (#33).[1]Having considered the Motion and reviewed the pleadings, the court enters the following Order.


          I. Background

         This is a case regarding the birth control medical device, Essure. The device was inserted into the plaintiff, and soon thereafter problems arose, which precipitated this suit.[2]

         Essure is a Class III medical device regulated by the Food and Drug Administration (FDA), and it is manufactured and marketed collectively by the Bayer defendants (“Bayer” or “Bayer defendants”).[3] The FDA's authority over such medical devices derives from the Federal Food, Drug, and Cosmetic Act (FDCA) as amended by the Medical Device Amendments (MDA) of 1976, et seq. The MDA included a statutory framework highly relevant to the instant case.

         Under the MDA, Class III medical devices are subject to FDA pre-market approval as to the “reasonable assurance” of their safety and effectiveness. See 21 U.S.C.A. § 360c(a)(1)(C). Pursuant to the MDA, Essure was granted pre-market approval by the FDA in 2002. The MDA also includes an express preemption clause, 21 U.S.C. § 360k, which contains the following general rule:

(a) General rule. Except as provided in subsection (b), 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. § 306k(a).[4]

         Following the problems encountered by the plaintiff, suit was filed in North Carolina state court in December 2016. Inter alia, the plaintiff's Complaint (#1-1, #1-2) asserts the following causes of action: (1) negligence, (2) products liability, (3) breach of express warranty, (4) breach of implied warranty, (5) fraud, (6) unfair or deceptive trade practices, and (7) medical malpractice against defendant Travis and Biltmore OB-GYN. Complaint (#1-2). The case was removed by defendants in January 2017.

         Subsequent to removal, the Burrell family (then in two separate cases) filed a Motion to Remand (#16). The cases were consolidated for pre-trial matters, see Order (#36), and the Motion to Remand was denied. (#31). The plaintiff now asks the court to reconsider its prior Order regarding remand under Rule 59.

         Defendants have filed Motions to Dismiss. The Motion to Dismiss (#11) filed by the Bayer defendants is ripe for review and fully briefed. After reviewing the applicable standards under Rules 12(b)(6) and 59, the court will examine the arguments regarding the pending Motion.

         II. 12(b)(6) Standard

         In determining whether a claim can survive a motion under Rule 12(b)(6), the Supreme Court held in Bell Atlantic Corp. v. Twombly, 550 U.S. 544 (2007) that the “no set of facts” standard only describes the “breadth of opportunity to prove what an adequate complaint claims, not the minimum adequate pleading to govern a complaint's survival.” Id. at 563. The Court specifically rejected use of the “no set of facts” standard because such standard would improperly allow a “wholly conclusory statement of claim” to “survive a motion to dismiss whenever the pleadings left open the possibility that a plaintiff might later establish some ‘set of [undisclosed] facts' to support recovery.” Id. at 561 (alteration in original).

         Post Twombly, to survive a Rule 12(b)(6) motion to dismiss, a claimant must allege facts in his complaint that “raise a right to relief above the speculative level.” Id., at 555.

[A] plaintiff's obligation to provide the “grounds” of his “entitle[ment] to relief” requires more than labels and conclusions, and a formulaic recitation of the elements of a cause of action will not do ....

Id. (second alteration in original; citation omitted). Further, a complaint will not survive Rule 12(b)(6) review where it contains “naked assertion[s] devoid of further factual enhancement.” Id., at 557. Instead, a claimant must plead sufficient facts to state a claim for relief that is “plausible on its face.” Id. at 570 (emphasis added).

         Subsequent to Twombly, the Court revisited the Rule 12(b)(6) pleading standard in Ashcroft v. Iqbal, 556 U.S. 662 (2009). In Iqbal, the Court determined that Rule 8 “demands more than an unadorned, the defendant-unlawfully-harmed-me accusation.” Id. at 678. The Court explained that, “to survive 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.'” Id. (citing Twombly, supra) (emphasis added). What is plausible is defined by the Court:

[a] claim has facial plausibility when the plaintiff pleads sufficient factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged.

Id. This “plausibility standard” requires “more than a sheer possibility that a defendant has acted unlawfully.” Id. Thus, a complaint falls short of the plausibility standard where a plaintiff pleads “facts that are ‘merely consistent with' a defendant's liability....” Id. While the court accepts plausible factual allegations made in a claim as true and considers those facts in the light most favorable to plaintiff in ruling on a motion to dismiss, a court “need not accept as true unwarranted inferences, ...

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