Evans v. Rich et al
ORDER GRANTING 9 Defendant Anulex's Motion to Dismiss for Failure to State a Claim; DENYING 15 Plaintiff's Motion to Strike and for Entry of Default ; GRANTING 18 Plaintiff's Motion to Amend Complaint; and DENYING AS MOOT 19 Plaintiff's Motion for Extension of Time to File a Memorandum of Law. Signed by US District Judge Terrence W. Boyle on 6/4/2014. (Fisher, M.)
IN THE UNITED STATES DISTRICT COURT
FOR THE EASTERN DISTRICT OF NORTH CAROLINA
KENNETH RICH, M.D.,
CAPITAL NEUROSURGERY, and
ANULEX TECHNOLOGIES, INC.,
This cause comes before the Court on defendant Anulex's motion to dismiss and
plaintiffs motions to strike and for entry of default, and for leave to file an amended complaint.
For the reasons discussed below, plaintiffs motion for leave to file an amended complaint is
granted, defendant Anulex's motion to dismiss is granted, and plaintiffs motion to strike and for
entry of default is denied.
Plaintiff filed this action in Wilson County Superior Court alleging claims of negligent
misrepresentation, fraud, unfair and deceptive trade practices, and breach of the implied warranty
of merchantability arising out of back surgery performed on plaintiff by defendant Rich.
Plaintiff alleges that Dr. Rich used an "X-Close" suture device, manufactured by Anulex, while
performing a microdiscectomy with annular repair on plaintiff on November 15, 2010. Plaintiff
further alleges that Annulex, which had obtained approval from the FDA for use ofX-close
sutures in soft tissue repair, had not obtained approval from the FDA to use the X-close device in
annular repairs and that Dr. Rich did not obtain permission from plaintiff to participate in the
investigation of the use of the X-close device in his annular repair.
Anulex removed plaintiffs action to this Court on December 20, 2013, pursuant to the
Court's federal questionjurisdiction. 28 U.S.C. §§ 1441; 1331. At the time of Anulex's
removal, service had not been effected on the remaining defendants. 28 U.S.C. § 1446(b)(2).
Anulex then filed the instant motion to dismiss for failure to state a claim upon which relief can
be granted pursuant to Rule 12(b)(6) of the Federal Rules of Civil Procedure. Plaintiff did not
respond to the motion to dismiss. Plaintiff filed a motion to strike Anulex's motion to dismiss
and for entry of default pursuant to Rule 55(a) of the Federal Rules of Civil Procedure against
Anulex. Plaintiff then moved to amend his complaint, filing a proposed amended complaint in
support of his motion almost one month later.
MOTION FOR LEAVE TO FILE AMENDED COMPLAINT
The Court begins its analysis with plaintiffs motion for leave to file an amended
complaint. Rule 15 ofthe Federal Rules of Civil Procedure provides that a party may amend his
pleadings as a matter of right under certain circumstances or with the opposing party's consent or
leave of court. Fed. R. Civ. P. 15(a)(l)-(2). Further, Rule 15 directs that leave to amend should
be freely given whenjustice so requires. Fed. R. Civ. P. 15(a)(2). "This liberal rule gives effect
to the federal policy in favor of resolving cases on their merits instead of disposing of them on
technicalities." Laber v. Harvey, 438 F.3d 404, 426 (4th Cir. 2006). A court should only deny
leave to amend a pleading when the amendment would be prejudicial to the opposing party,
where there has been bad faith on the part of the moving party, or when the amendment would be
futile. Johnson v. Oroweat Foods Co., 785 F.2d 503, 509 (4th Cir. 1986) (citing Foman v.
Davis, 371 U.S. 178, 182 (1962).
The Court finds no prejudice in allowing plaintiff to amend his complaint nor does it find
any bad faith present. Because the Court will consider Anulex's motion to dismiss as addressed
to plaintiffs amended complaint, it declines to consider here whether the proposed amendment is
futile. According, plaintiffs motion for leave to file an amended complaint is GRANTED. The
clerk is DIRECTED to correct the Court's docket to reflect that the amended complaint filed at
docket entry twenty-one is "proposed" and is further directed to file the amended complaint as of
the date of entry of this order.
MOTION TO DISMISS
Although the Court has allowed plaintiff to file an amended complaint, it may consider
Anulex's motion to dismiss as it relates to the remaining count raised against it in plaintiffs
amended complaint. See 6 CHARLES A. WRIGHT, ARTHUR R. MILLER, AND MARY KAY KANE,
FEDERAL PRACTICE AND PROCEDURE§ 1476 (3d ed. 1998) ("defendants should not be required to
file a new motion to dismiss simply because an amended pleading was introduced while their
motion was pending."). Plaintiffs only claim in his amended complaint against Anulex is one
for unfair and deceptive trade practices under N.C. Gen. Stat.§ 75-1.1. As argued in Anulex's
motion to dismiss, however, such claim is impliedly preempted under Buckman Company v.
Plaintiff's Legal Committee, 531 U.S. 341 (2001).
There is no private right of action under the Food, Drug, and Cosmetic Act (FDCA), as
amended by the Medical Device Act (MDA). !d. at 352. Thus, where private litigants are
effectively suing for a violation of the FDCA under the guise of state law, their claims are
impliedly preempted. Loreto v. Proctor & Gamble Co., 515 Fed. App'x 576, 579 (6th Cir. 2013)
(citation omitted). The test for determining whether a state law claim is impliedly preempted is
whether or not the claim would exist in the absence of the FDCA. !d. Though there is a narrow
class of state law claims which may survive Buckman preemption, Riley v. Cordis Corp., 625 F.
Supp. 2d 769, 777 (D. Minn. 2009), Buckman has been applied in particular contexts to
impliedly preempt such state law claims as breach of warranty, negligence per se, design defect,
and failure to warn. In re Medtronic, Inc. Sprint Fide/is Leads Products Liab. Litig., 592 F.
Supp. 2d 1147, 1159-64 (D. Minn. 2009).
In his amended complaint, plaintiff alleges that Anulex conspired with physicians to use
X-close sutures in annular repairs where patients had excellent prognoses for recovery in order to
"stockpile" positive outcome cases so that it might gain FDA approval for use of X-close devices
in annular repairs. At bottom, plaintiff seeks to hold Anulex liable for off-label promotion of its
X-close suture device, but such claim is impliedly preempted as it exists solely by virtue of the
requirements ofthe FDCA. Buckman, 531 U.S. at 353; see also In re Epogen & Aranesp OffLabel Mktg. & Sales Practices Litig., 590 F. Supp.2d 1282, 190-91 (C.D. Cal. 2008) (off-label
promotion violates the FDCA but the FDCA provides for no private right of action; nor can
plaintiffs use "state unfair competition laws as a vehicle to bring a private cause of action that is
based on violations of the FDCA.").
Even if the Court were to assume arguendo that plaintiff's UDTP A claim was not
impliedly preempted by Buckman, plaintiff has failed to state a plausible claim for relief. "To
prevail on a claim of unfair and deceptive trade practices, a plaintiff must show: (1) defendants
committed an unfair or deceptive act or practice; (2) in or affecting commerce; and (3) that
plaintiffwas injured thereby." First Atl. Mgmt. Corp. v. Dunlea Realty Co., 131 N.C. App. 242,
252 (1998). A trade practice is unfair if it is immoral, unethical, oppressive, or substantially
injurious. Id. (citation omitted). Plaintiffhas alleged no facts that would support that any
actions taken by Anulex would rise to the level of an unfair trade practice as that term is defined
by North Carolina law. Thus, plaintiffs sole claim against Anulex must be dismissed.
MOTION TO STRIKE AND FOR ENTRY OF DEFAULT
Plaintiffs motion to strike Anulex's motion to dismiss and for entry of default is denied.
Anulex's motion to dismiss was filed within the time allowed by the clerk's order granting
Anulex's motion to extend time to respond to plaintiffs complaint. Entry of default under Rule
55(a) ofthe Federal Rules of Civil Procedure is therefore inappropriate. Plaintiffs request that
the motion to dismiss be stricken is improper and without merit. The motion is therefore denied.
For the foregoing reasons, plaintiffs motion to amend complaint [DE 18] is GRANTED
and the clerk is DIRECTED to file plaintiffs amended complaint [DE 21] as ofthe date of entry
of this order. The clerk is further DIRECTED to correct docket entry twenty-one to reflect that
the amended complaint filed by plaintiff was "proposed." Plaintiffs motion for extension of
time to file a memorandum of law [DE 19] is DENIED AS MOOT. Defendant Anulex's motion
to dismiss [DE 9] is GRANTED and Anulex is DISMISSED from this action. Plaintiffs motion
to strike and for entry of default [DE 15] is DENIED.
SO ORDERED, this
!f_ day of June, 2014.
T RRENCE W. BOYLE
UNITED STATES DISTRICT JUDGE
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