KRISTIANA TWEED BURRELL, individually and as Administratrix of the Estate of Ariel Grace Burrell; TRAVIS BURRELL, Plaintiffs - Appellants,
BAYER CORPORATION, an Indiana corporation; BAYER HEALTHCARE LLC, a Delaware corporation; CHRISTOPHER FORD WILLIAMS; STACY D. TRAVIS, Dr.; BILTMORE OB-GYN, P.A.; BAYER ESSURE INC., f/k/a Conceptus, Inc., a Delaware corporation; BAYER HEALTHCARE PHARMACEUTICALS, INC., a Delaware corporation, Defendants - Appellees.
Argued: October 30, 2018
from the United States District Court for the Western
District of North Carolina, at Asheville. Max O. Cogburn,
Jr., District Judge. (1:17-cv-00031-MOC-DCK)
Tejinder Singh, GOLDSTEIN & RUSSELL, P.C., Washington,
D.C., for Appellants.
L. Maley, SIDLEY AUSTIN LLP, Washington, D.C., for Appellees.
Fleming, Rand P. Nolen, Jessica Kasischke, Sylvia Davidow,
FLEMING, NOLEN & JEZ, L.L.P., Houston, Texas; Thomas C.
Goldstein, GOLDSTEIN & RUSSELL, P.C., Bethesda, Maryland,
Jonathan F. Cohn, Virginia A. Seitz, Christopher A. Eiswerth,
Morgan Branch, SIDLEY AUSTIN LLP, Washington, D.C., for
FLOYD and HARRIS, Circuit Judges, and Donald C. COGGINS, Jr.,
United States District Judge for the District of South
Carolina, sitting by designation.
HARRIS, Circuit Judge:
Tweed Burrell and her husband filed suit against Bayer in
connection with a female sterilization device known as
Essure, alleging that Burrell suffered a stillbirth and then
underwent a hysterectomy due to complications from the
device. The Burrells commenced this action in North Carolina
state court, seeking damages for violations of North Carolina
tort and products liability law.
issue we confront in this appeal is not the merits of the
Burrells' claims, but whether those claims should be
heard in state or federal court. According to Bayer, this is
a federal case: Although the Burrells seek relief under state
law, their claims necessarily implicate significant questions
regarding Bayer's compliance with federal regulations and
thus give rise to federal question jurisdiction under 28
U.S.C. § 1331. We disagree. As the Supreme Court has
emphasized, § 1331 confers federal jurisdiction over
state-law causes of action only in a "special and
small" class of cases. Empire HealthChoice
Assurance, Inc. v. McVeigh, 547 U.S. 677, 699 (2006).
Because the Burrells' state-law action against Bayer does
not fall within that special class, it should be decided by
North Carolina's courts. We therefore vacate the district
court's contrary judgment and direct that the case be
remanded to state court.
crux of Bayer's argument for federal question
jurisdiction is that because Essure is regulated by the
federal government, the Burrells' suit regarding Essure
will require the resolution of important federal-law
questions. We begin by briefly describing the federal laws
and regulations that govern Essure, to provide necessary
context for Bayer's position and the proceedings in this
is a permanent female contraceptive consisting of metal
coils, known as "micro-inserts," inserted into a
woman's fallopian tubes. Once released through a
disposable delivery system, the micro-inserts expand and
anchor in the fallopian tubes, causing fibrous tissue growth
that blocks the tubes and prevents pregnancy.
is regulated by the Food and Drug Administration
("FDA") as a Class III medical device, under the
1976 Medical Device Amendments to the Federal Food, Drug, and
Cosmetic Act ("FDCA" or "Act"). Class III
devices are subject to the most stringent oversight under the
Act, see 21 U.S.C. § 360c(a)(1)(C), and a novel
Class III device like Essure cannot be distributed until it
receives premarket approval from the FDA, id. §
360e. Following premarket approval, a manufacturer cannot
amend the device design without FDA sign-off, can make only
limited changes to the device's labeling, and must submit
to the FDA information regarding adverse events related to
the device,  among other requirements. See id.
§§ 360e(d)(5)(A)(i), 360i(a); 21 C.F.R. §
does not establish a private right of action to enforce these
requirements under federal law. With respect to state-law
remedies, the Act includes an express preemption provision,
prohibiting states from imposing requirements on
premarket-approved Class III medical devices - like Essure -
that are "different from, or in addition to"
federal requirements. 21 U.S.C. § 360k(a). That leaves
room, as the Supreme Court has explained, for state-law
remedies for violations of common-law duties that
"parallel" federal regulatory requirements.
Medtronic, Inc. v. Lohr, 518 U.S. 470, 495 (1996);
see also Riegel v. Medtronic, Inc., 552 U.S. 312,
330 (2008). A claim that a Class III device "violated
state tort law notwithstanding compliance with the
relevant federal requirements" would be preempted under
§ 360k(a), because it seeks to impose
"addition[al]" state-law requirements on the
federally-approved device. Riegel, 552 U.S. at 330
(emphasis added). But a claim "premised on a
violation of FDA regulations" is not preempted,
because "the state duties in such a case
'parallel,' rather than add to, federal
requirements." Id. (emphasis added).
received premarket approval from the FDA in 2002.
Accordingly, the Burrells may proceed against Bayer under
North Carolina law consistent with § 360k(a) to the
extent (and only to the extent) that the state-law duties on
which they rely "parallel" the federal requirements
that apply to Essure. What relief is available under North
Carolina law is of course a question of state and not federal
Tweed Burrell received an Essure implantation in December
2013. According to Burrell, tests performed in the ensuing
months found that the device was causing only a partial
blockage of her left fallopian tube, and thus failing to
provide contraceptive protection.
5, 2015, Burrell discovered that she was pregnant when she
felt fetal movement. Two days later, she experienced
abdominal pain and vaginal bleeding, and went into premature
labor at home. Burrell was admitted to the hospital, where
her baby was delivered stillborn at an estimated 24 to 27
weeks. Burrell was diagnosed with placental abruption, a
serious pregnancy complication in which the placenta
prematurely separates from the uterus. Subsequent doctor
visits confirmed that Burrell's Essure implant had failed
and was eroding through the left fallopian tube. To remove
the device, Burrell then was required to undergo a total
hysterectomy - that is, a surgical procedure to remove her
December 2016, Burrell and her husband filed separate
lawsuits in North Carolina state court against the Bayer
Corporation and related defendants (collectively,
"Bayer"). The lawsuits, later consolidated, seek
damages for personal injuries, emotional distress, and
wrongful death under various state-law causes of action,
relying primarily on four core allegations. First and most
prominently, the Burrells allege that Bayer failed to
disclose to the medical community or the FDA numerous adverse
events similar to those they experienced, depriving them of
proper warning about Essure's risks. Second, they assert
that Bayer failed to update its labeling and marketing
materials to reflect these risks, further depriving them of
adequate warning. Third, they claim that Bayer sold Essure
implants with manufacturing defects, suggesting that one of
these defects may have been present in ...