Searching over 5,500,000 cases.

Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.

Burrell v. Bayer Corp.

United States Court of Appeals, Fourth Circuit

March 14, 2019

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

          Appeal 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.

          Erika L. Maley, SIDLEY AUSTIN LLP, Washington, D.C., for Appellees.

         ON BRIEF:

          George 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, for Appellants.

          Jonathan F. Cohn, Virginia A. Seitz, Christopher A. Eiswerth, Morgan Branch, SIDLEY AUSTIN LLP, Washington, D.C., for Appellees.

          Before FLOYD and HARRIS, Circuit Judges, and Donald C. COGGINS, Jr., United States District Judge for the District of South Carolina, sitting by designation.

          PAMELA HARRIS, Circuit Judge:

         Kristiana 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.

         The 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.



         The 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 case.

         Essure 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.

         Essure 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, [1] among other requirements. See id. §§ 360e(d)(5)(A)(i), 360i(a); 21 C.F.R. § 814.39(a), (d).

         The Act 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).

         Essure 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 law.


         Kristiana 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.

         On June 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 uterus.

         In December 2016, Burrell and her husband filed separate lawsuits in North Carolina state court against the Bayer Corporation and related defendants (collectively, "Bayer").[2] 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 ...

Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.