United States District Court, W.D. North Carolina, Asheville Division
Congburn, Jr. United States District Judge
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).Having considered the Motion and reviewed
the pleadings, the court enters the following Order.
a case regarding the birth control medical device, Essure.
The device was inserted into the plaintiff, and soon
thereafter problems arose, which precipitated this
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”). 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.
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
(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
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).
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.
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.
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.
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
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).
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
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
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, ...