Burrell v. Bayer Corporation, et al
Filing
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ORDER denying 16 Motion to Remand to State Court. Signed by District Judge Max O. Cogburn, Jr on 03/17/17. (emw)
UNITED STATES DISTRICT COURT
WESTERN DISTRICT OF NORTH CAROLINA
ASHEVILLE DIVISION
DOCKET NO. 1:17-cv-00031-MOC-DCK
KRISTIANA TWEED BURRELL,
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Plaintiff,
v.
BAYER CORPORATION
BAYER HEALTHCARE LLC
BILTMORE OB-GYN, P.A.
BAYER HEALTHCARE
PHARMACEUTICALS, INC.
BAYER ESSURE, INC.
CHRISTOPHER FORD WILLIAMS
STACY D TRAVIS,
ORDER
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Defendants.
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THIS MATTER is before the court on the plaintiff’s Motion to Remand (#16). A
parallel Order will be entered in the related case of Burrell v. Bayer et al., Case No. 1:17cv-32. Having considered the Motion and reviewed the pleadings, the court enters the
following Order.
FINDINGS AND CONCLUSIONS
I.
Background
The instant case, and its analogous related case (No. 1:17-cv-32) were filed in
December 2016 in North Carolina state court. Each of these cases relate to Ms. Kristiana
Tweed Burrell’s use of Essure, a FDA-approved Class III medical device, which was
marketed collectively by the Bayer defendants (“Bayer” or “Bayer defendants”). Essure
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is a form of permanent birth control. Plaintiff’s allegations, inter alia, accuse the Bayer
defendants of violations of both federal law and state laws in the manufacturing,
marketing, sale, and distribution of the Essure birth control device. (#16) at 3.
The Bayer defendants, with the consent of the other defendants in this case, filed a
Notice of Removal (#1) on January 26, 2017. On February 10, 2017, plaintiff Kristiana
Burrell filed a Motion to Remand to State Court (#16) and accompanying Memorandum
of Law (#17). The matter has been fully briefed, and is ripe for review.1
II.
Legal Standard
Subject matter jurisdiction is a threshold issue for justiciability in federal court.
Absent a proper basis for subject matter jurisdiction, a removed case must be remanded
to state court. Steel Co. v. Citizens for a Better Env't, 523 U.S. 83, 96 (1998). The party
asserting federal jurisdiction has the burden of proving that subject matter jurisdiction
exists. Richmond, Fredericksburg & Potomac R. Co. v. United States, 945 F.2d 765, 768
(4th Cir.1991).
Federal courts are courts of limited jurisdiction, and removal of cases is generally
proper only when it may have otherwise been brought in federal court originally.
Darcangelo v. Verizon Communications, Inc., 292 F.3d 181, 186 (4th Cir. 2002). Here,
there is not diversity of citizenship among the parties.2 Accordingly, subject matter
1
The court notes that a number of Motions are pending in this matter and its related case, including the Motion to
Consolidate (#28) and Motion to Dismiss (#11). As the court would lack jurisdiction to rule on such matters if the
case were to be remanded, it will analyze the Motion to Remand (#16) first.
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As removal here is not related to diversity of citizenship, the court acknowledges the plaintiff’s objection to
removal based on the Forum Defendant Rule, 28 U.S.C. § 1441(b)(2) but need not address it as it is inapplicable to
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jurisdiction must relate to federal question jurisdiction. See 28 U.S.C. § 1331 (“The
district courts shall have original jurisdiction of all civil actions arising under the
Constitution, laws, or treaties of the United States.”).
In interpreting the court’s statutory authority under federal question jurisdiction,
the Supreme Court has distinguished between cases where federal law creates the cause
of action asserted, such as 42 U.S.C. § 1983, and where a claim “necessarily raise[s] a
stated federal issue, actually disputed and substantial, which a federal forum may
entertain without disturbing any congressionally approved balance of federal and state
power.” Merrill Lynch, Pierce, Fenner & Smith Inc. v. Manning, 136 S. Ct. 1562, 1570,
194 L. Ed. 2d 671 (2016) (quoting Grable & Sons Metal Products, Inc. v. Darue
Engineering & Mfg., 545 U.S. 308, 314 (2005)). In doing so, the Court, in a unanimous
decision, articulated a four-part test, writing:
That is, federal jurisdiction over a state law claim will lie if a federal issue is:
(1) necessarily raised, (2) actually disputed, (3) substantial, and (4) capable
of resolution in federal court without disrupting the federal-state balance
approved by Congress. Where all four of these requirements are met, we
held, jurisdiction is proper because there is a “serious federal interest in
claiming the advantages thought to be inherent in a federal forum,” which
can be vindicated without disrupting Congress's intended division of labor
between state and federal courts.
Gunn v. Minton, 133 S. Ct. 1059, 1065 (2013) (citations omitted).
Within this Circuit, the appellate court has noted that federal law can either create
the cause of action or federal jurisdiction may rest on plaintiff’s right to relief depending
the instant case. As plaintiff noted, removal was not based on diversity jurisdiction. Pl. Memorandum (#17) at 8.
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on resolution of a substantial question of federal law. See Battle v. Seibels Bruce Ins. Co.,
288 F.3d 596, 606–07 (4th Cir. 2002). Removal from state court is available if the face of
the complaint raises a federal question that could have been the basis for an original
action in district court. Lontz v. Tharp, 413 F.3d 435, 439–40 (4th Cir. 2005); see also
Moehring v. Mortg. Elec. Registration Sys., Inc., No. 3:13-CV-00567-MOC, 2014 WL
1091071, at *8 (W.D.N.C. Mar. 17, 2014).
III.
Discussion
The court will examine the claims made by plaintiff under the Supreme Court’s
four-part test as to examine whether the face of the complaint raises a federal question
that would be the basis for original action in federal court.
A. Necessarily Raised and Actually Disputed
The plaintiff’s Complaint (#1-1, #1-2) necessarily raises federal law. The plaintiff
concedes that he has alleged that the defendants violated the federal requirements of the
Federal Food, Drug and Cosmetic Act (FDCA). (#17) at 3. It is undisputed that Essure
was a Class III medical device. Such devices are subject to pre-market approval by the
FDA. As such, they are subject to the Medical Device Amendments of 1976 (“MDA”) to
the FDCA. See 21 U.S.C. § 360k(a).
The Complaint is replete with references to the FDA. Federal oversight of the
Bayer defendants is a necessary part of this case, and plaintiff raises the question of the
Bayer defendants’ duties under the FDCA, as amended by the MDA, and whether they
complied with such responsibilities. Accordingly, the plaintiff’s Complaint necessarily
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raises federal issues, particularly agency action and the MDA, and the actions of the
Bayer defendants and health providers under such federal oversight are the subject of this
and the related suit.
In objecting to the application of federal jurisdiction, the plaintiff relies, in large
part, upon cases that do not bind this court. See Johnson v. Bayer Corp., No. 4:16-CV729 (CEJ), 2016 WL 3015187, at *1 (E.D. Mo. May 26, 2016), appeal dismissed (Aug.
29, 2016); Rios v. Bayer Corp., No. 16-CV-1010-SMY-RJD, 2016 WL 5929246, at *2
(S.D. Ill. Oct. 12, 2016).
In one case, currently on appeal to the Seventh Circuit, a court applied that
Circuit’s federal question jurisdictional test to find that the allegation that defendants’
conduct “violates the FDCA and consideration of federal regulations may indeed be
involved in the disposition of this action, those facts alone are insufficient to create
federal question jurisdiction.” Rios, 2016 WL 5929246, at *2. The court respectfully
disagrees. The Rios court focused on the fact that the FDCA did not create a cause of
action. Id. Subsequent to the Supreme Court ruling cited in Rios, and as explained above,
there are two pathways that cases can be brought under federal question jurisdiction. In
Rios, like here, there is no cause of action under the FDCA. However, there is a second
way, the plaintiff’s right to relief could necessarily arise out of federal law. See Merrill
Lynch, supra. Accordingly, the analysis should not begin and end with the question of
whether the federal law creates a cause of action; instead, under the Supreme Court’s
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more recent guidance, courts must look to whether federal law is necessarily implicated.
The answer here is yes.
The MDA, as noted in 21 U.S.C. § 360k, provides the federal government with
exclusive authority over the safety and effectiveness of medical devices, subject to the
exemptions noted in that law. The federal law reads:
(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. § 360(k)(a).3 The law is implicated here clearly. In order to succeed, the
plaintiff must demonstrate that the device or defendants’ conduct deviated from
prevailing law. In the case of the device’s marketing and manufacture, those relevant
laws are federal in nature. Accordingly, they are implicated here and in dispute.
B. Substantial and Able to be Decided Without Disrupting the Federal-State
Balance
The court notes plaintiff’s contention that Johnson covers the “exact same arguments” and “same exact theories” as
in this case. (#17) at 4. The Johnson court found that the plaintiffs’ claim in that case “must be for conduct that
violates the FDCA” and that the “federal issues in the complaint were necessarily raised and are actually disputed.”
Johnson, 2016 WL 3015187, at *3.
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Plaintiff cites to a case from the Eastern District of Missouri for the proposition
that the issues in this case are not “substantial” and would upset the federal-state balance.
In that case, Johnson v. Bayer Corp., the court’s colleague elsewhere on the federal bench
noted that the issues involved with that suit related to Essure were related to the MDA
and FDCA and actually in dispute. 2016 WL 3015187, at *3. The court reasoned that it was
not “substantial” as “Congress specifically declined to create a federal private cause of
action under the FDCA.” Johnson, 2016 WL 3015187, at *3. Moreover, the Johnson
court reasoned that Congress “declined to preempt all state remedies or divest state courts
of jurisdiction in the FDCA” and as such the adjudication of state law claims would
“disrupt the federal-state balance approved by Congress.” Id.
The court is guided by later Supreme Court precedent, which explicitly rejected
the dispositive reading of earlier case law. See Grable at 318 (“Accordingly, Merrell Dow
should be read in its entirety as treating the absence of a federal private right of action as
evidence relevant to, but not dispositive of, the “sensitive judgments about congressional
intent” that § 1331 requires.”). If the Supreme Court actually intended there to be two
pathways to federal question jurisdiction (federally-created or “arising from” federal
law), it simply cannot be that the lack of a federal cause of action would foreclose the
second pathway. The lack of a private, federally-created cause of action may be a “clue”
to Congressional intent behind § 1331, but it is far from dispositive if the second pathway
(“arising from” federal law) is to be of any real-world application. See Grable at 318.
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With regard to the federal-state balance, Congress in this case passed the MDA,
explicitly pre-empting state law as a general rule. It would be farcical to override that
explicit Congressional act with the implicit notion that § 1331 was written with FDAapproved medical devices like Essure in mind. In setting up the MDA, Congress acted
with the intent that medical devices would be regulated exclusively by the FDA and state
law would be generally preempted. See 21 U.S.C. § 360k. Accordingly, it would not
upset the federal-state balance to have such claims be brought in federal court, as FDAapproved Class III devices require pre-market approval under the MDA as to their safety
and effectiveness.
The crux of the plaintiff’s Complaint here, as it is in her husband’s related case,
was that the medical device was not safe, they were not warned of the attendant risks, it
was manufactured inappropriately, and it was marketed using unfair trade practices. As
one of many examples from the Complaint, it is argued that “[u]nder federal law and
regulations, the Bayer defendants were under a continuing duty to comply with the
requirements listed…and with the FDCA in the manufacture, development, promotion,
marketing, labeling, and sale of Essure.” Complaint (#1-2) at ¶ 197. Federal law governs
those duties, under the MDA, and the FDA has authority to regulate products like Essure,
as it did when it inspected the Bayer’s manufacturing facilities and issued a Black Box
Warning. See Complaint (#1-1) at ¶ ¶89-105, 132. Indeed, plaintiff’s Complaint (#1-1)
itself notes that the “FDCA requires medical device manufacturers like the Bayer
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defendants to maintain and submit information as required by FDA regulation…including
submitting Adverse Reaction Reports…and establishing internal procedures for
reviewing complaints and event reports, 21 C.F.R. § 820.198(a).” Id. at ¶ 55. Moreover,
the plaintiff’s Complaint (#1-1) alleges that the Bayer defendants had a duty to
reasonably warn the users of the product about the risks involved and that the failure to
meet relevant federal obligations violated state law. Id. at ¶ 57.
The labeling of FDA-approved medical devices is governed by the FDA under the
MDA, and state law is generally pre-empted under 21 U.S.C. § 360k. It does not upset
the federal-state balance to allow federally-approved medical devices to be sued for
alleged safety risks and labeling defects in federal court. Further, the dispute is indeed
substantial as it challenges the federal oversight of Class III medical device products and
the fact that there is no private right of action under the FDCA is not dispositive.
IV.
Conclusion
Upon review of the Supreme Court’s four-part test, as articulated in Gunn, the case
presently before the court meets the standard to be adjudicated in federal court under
federal question jurisdiction. It is properly a case that “arises from” federal law, as the
MDA was passed by Congress to govern the safety and effectiveness of Class III medical
devices, like Essure. See 21 U.S.C. § 360k. Accordingly, remand would be inappropriate.
Both this and the coordinate case, 1:17-cv-32, could be properly brought in federal court
as the face of the complaint “arises from” federal law—the FDCA as amended by the
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MDA—and raises a substantial federal question under § 1331. See Battle 288 F.3d at
606-07.
ORDER
IT IS, THEREFORE, ORDERED that plaintiff’s Motion to Remand (#16) is
DENIED.
Signed: March 17, 2017
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