United States District Court, E.D. Kentucky, Southern Division
OPINION & ORDER
K. CALDWELL, CHIEF JUDGE
matter is before the Court on a Motion to Remand to Perry
County Circuit Court filed by plaintiffs (DE 6). The
plaintiffs have also requested a hearing with this Court in
connection with their Motion to Remand (DE 11). For the
following reasons, plaintiffs' motion to remand (DE 6) is
GRANTED and plaintiffs' motion for
hearing (DE 11) is DENIED.
plaintiffs originally filed this civil suit in Perry Circuit
Court on January 31, 2017 (DE 1-1, Complaint). In their
Complaint, Plaintiffs named five defendants: Bayer
Corporation, Bayer Healthcare LLC, Bayer Essure, Inc., (f/k/a
Conceptus, Inc.), and Bayer Healthcare Pharmaceuticals, Inc.
(collectively herein called the “Bayer
defendants”), Appalachian Regional Healthcare, Inc.
(d/b/a Hazard ARH Regional Medical Center)
(“ARH”), and James Delmar Dawson Jr., M.D.
Defendants timely removed the action to this Court on grounds
of both federal question and diversity jurisdiction. (DE 1,
at 2-3). Plaintiffs claim this Court has no jurisdiction and
have asked that the matter be remanded back to state court.
(DE 6). The issues have been sufficiently briefed by both
parties and a hearing is not necessary.
case involves the plaintiffs' use of a permanent birth
control device called “Essure.” Plaintiffs
Patterson and Record both underwent surgery at ARH to have
the Essure device implanted, Patterson in 2016 and Record in
2013. Defendant Dawson performed the implant procedure on
plaintiff Patterson, and a non-party, Misty Thompson,
performed the implant procedure on plaintiff Record. Both
plaintiffs allege that they suffered injuries because ARH
failed to properly inform them of the risks associated with
the device, and failed to use reasonable care in implanting
the device (DE 1-1).
plaintiffs contend that the device was originally created by
Conceptus, Inc., a company bought by Bayer in 2013 (DE 1-1,
at 18-20). In 2002, Essure was granted pre-market approval as
a Class III medical device by the Food and Drug
Administration, pursuant to the Medical Device Amendments to
the Federal Food, Drug, and Cosmetic Act See (DE 1-1
at 35). The plaintiffs do not attack the pre-market approval
process. Instead, the plaintiffs' complaint alleges the
Bayer defendants failed to conform to FDA requirements
regarding post-market monitoring of the device. As a specific
example of this conduct, plaintiffs allege that Conceptus
failed to report to the FDA adverse effects that were
discovered once Essure became widely used in the market,
despite having an affirmative duty to do so (DE 1-1, at 2,
75). Plaintiffs allege that these actions constitute a
violation of various state tort laws and that, but for the
violations, the plaintiffs would never have used the device
several motions are pending in this matter, the Court must
first determine whether removal from Perry County Circuit
Court was proper. On a motion to remand, the burden rests
with the defendant to prove that this Court has original
jurisdiction. Eastman v. Marine Mech. Corp., 438
F.3d 544, 549 (6th Cir. 2006).
jurisdiction exists through either diversity of citizenship,
see 28 U.S.C. §§ 1332(a) and 1441(b), or
federal question jurisdiction, see 28 U.S.C.
§§ 1331 and 1441(a). When doubts as to the
propriety of removal exist, “the removal statute should
be strictly construed and all doubts resolved in favor of
remand.” Eastman, 438 F.3d at 550. The Court
considers the parties' arguments on jurisdiction below.
Federal Question Jurisdiction
have consistently applied the “well-pleaded
complaint” rule when reviewing federal question
jurisdiction on a motion to remand. “To determine
whether the claim arises under federal law, we examine the
‘well pleaded' allegations of the complaint and
ignore potential defenses….” Mikulski v.
Centerior Energy Corp., 501 F.3d 555, 560 (2007)
(quoting Beneficial Nat'l Bank v. Anderson, 539
U.S. 1, 6 (2003)). As a result of the rule, “federal
questions presented by defenses-or even by the
plaintiff's anticipatory rebuttal of an expected
defense-cannot support jurisdiction.” Dillon v.
Medtronic, Inc., 992 F.Supp.2d 751, 755 (2014) (citing
Franchise Tax Bd. v. Constr. Laborers Vacation
Trust, 463 U.S. 1, 10 (1983)). “So, with only rare
exception, a dispute over whether federal law trumps the
plaintiff's state cause of action does not satisfy §
1331, since preemption is usually raised as a defense.”
Id. (citing Caterpillar Inc. v. Williams,
482 U.S. 386, 393 (1987). “'[R]emoval and
preemption are two distinct concepts, ' and the fact that
plaintiffs' claim might ultimately prove to be preempted
does not establish that it is removable to federal
court.” Strong v. Telectronics Pacing Systems,
Inc., 78 F.3d 256, 261 (6th Cir. 1996) (quoting
Warner v. Ford Motor Co., 46 F.3d 531 (6th Cir.
their Complaint, Plaintiffs assert various state-law tort
claims against the defendants. See (DE 1-1, Pl.
Complaint); see also (DE 6-2, Pl. Mem. in Support of
Mtn. to Remand, at 3). As such, the claims within the
well-pleaded complaint do not directly arise under federal
law or jurisdiction. However, the United States Court of
Appeals for the Sixth Circuit recognizes three exceptions to
the well-pleaded complaint rule, by which defendants can
still show that federal jurisdiction is proper. See
Mikulski, 501 F.3d at 560. The first two exceptions,
artful-pleading and complete preemption, are inapplicable in
this case. The artful pleading doctrine requires there first
to be a federal cause of action that the plaintiff is trying
to artfully plead around, which Congress has not provided
under the FDCA. See Mikulski, 501 F.3d at 560; 21
U.S.C. § 337(a). Further, the Sixth Circuit has
specifically declined to extend the doctrine of complete
preemption to the Medical Device Amendments of the FDCA.
See Strong, 78 F.3d at 259. Thus, only the third
exception, the substantial federal question doctrine, is at
The substantial federal question doctrine
Complaint does not directly raise a federal question. The
United States Supreme Court has held, however, that federal
courts have federal question jurisdiction over state law
claims that raise a substantial federal issue, but only when
the exercise of such jurisdiction will not upset the balance
of state and federal judicial responsibilities. See
Grable & Sons Metal Products, Inc., v. Darue Engineering
& Manufacturing, 545 U.S. 308, 125 S.Ct. 2363
Sixth Circuit, relying on Grable, has developed a
three-part test to determine whether state law claims
implicate federal question jurisdiction:
(1) The state-law claim must necessarily raise a disputed
federal issue; (2) the federal interest in the issue must be
substantial; and (3) the exercise of jurisdiction must not
disturb any congressionally approved ...