Kristiana Burrell v. Bayer Corporation, 918 F.3d 372

Background

Kristiana Burrell received the Essure birth‑control implant; she alleges device failure, a stillbirth, and subsequent hysterectomy caused by Essure.
The Burrells sued Bayer in North Carolina state court asserting negligence, products‑liability, breach of warranties, fraud, and unfair trade practices, and alleged violations of FDA requirements as parallel theories.
Essure is a Class III medical device approved under the FDCA; Congress limited state rules that are "different from, or in addition to" federal requirements (21 U.S.C. § 360k).
Bayer removed to federal court invoking federal‑question jurisdiction under 28 U.S.C. § 1331, arguing the complaints necessarily raise substantial federal questions about compliance with FDA regulation (including reporting duties).
The district court retained jurisdiction under Gunn’s four‑part test and dismissed the case on preemption grounds; the Burrells appealed jurisdiction and the merits.
The Fourth Circuit vacated the federal judgment and remanded to North Carolina state court, holding § 1331 did not authorize removal.

Issues

Issue	Plaintiff's Argument	Defendant's Argument	Held
Whether § 1331 federal‑question jurisdiction exists over state‑law tort/products claims involving an FDA‑regulated device	Burrell: claims are state‑law causes of action; any federal issues are defenses or alternative theories and do not create federal jurisdiction	Bayer: plaintiffs’ complaints necessarily raise federal issues (FDA compliance/preemption), so case "arises under" federal law	No—§ 1331 does not extend to this case; remove improperly denied and case must be remanded
Whether the FDCA/preemption defense makes federal law a "necessarily raised" element of plaintiff’s claims	Burrell: preemption is an affirmative defense; plaintiffs need not plead around it; state‑law elements can be proven without federal law	Bayer: because § 360k preemption is central, plaintiffs must prove deviations from federal standards, making federal law necessary	No—relying on Franchise Tax Bd. and Pinney, anticipated defenses (including preemption) do not satisfy the well‑pleaded complaint rule
Whether plaintiffs’ allegations that rest on federal duties (negligence per se, fraud on FDA, failure to report) convert the claims into federal ones	Burrell: such allegations are alternative theories; at least one supporting state‑law theory exists for each claim that does not require federal law	Bayer: certain pleaded theories expressly depend on federal statutory duties and so necessarily raise federal questions	Even assuming some theories require federal law, jurisdiction still fails because every legal theory supporting each claim need not require federal law; alternatives defeat "necessarily raised" requirement
Whether the federal issues Bayer identifies are "substantial" and consistent with federal‑state balance	Burrell: alleged federal questions are fact‑bound, backward‑looking, party‑specific, and not substantial enough to shift venue to federal courts	Bayer: FDA regulation and need for uniform adjudication of device regulation make the federal questions substantial	No—following Merrell Dow and Grable, the claimed federal issues are factintensive, not of broad federal importance, and allowing removal would upset the congressionally approved division of labor; remand required

Key Cases Cited

Merrell Dow Pharm. Inc. v. Thompson, 478 U.S. 804 (Sup. Ct. 1986) (mere presence of federal issue in state tort claim does not automatically confer § 1331 jurisdiction)
Grable & Sons Metal Prods. v. Darue Eng’g, 545 U.S. 308 (Sup. Ct. 2005) (identifies rare circumstances where a federal issue in a state claim is substantial enough for federal jurisdiction)
Gunn v. Minton, 568 U.S. 251 (Sup. Ct. 2013) (four‑part test for federal‑question jurisdiction where state law supplies cause of action)
Riegel v. Medtronic, Inc., 552 U.S. 312 (Sup. Ct. 2008) (FDCA preemption framework for premarket‑approved medical devices)
Empire HealthChoice Assurance, Inc. v. McVeigh, 547 U.S. 677 (Sup. Ct. 2006) (limitations on § 1331 jurisdiction over state‑law claims implicating federal issues)
Franchise Tax Bd. of Cal. v. Constr. Laborers Vacation Trust, 463 U.S. 1 (Sup. Ct. 1983) (well‑pleaded complaint rule and limits on removal based on defenses)
Pinney v. Nokia, Inc., 402 F.3d 430 (4th Cir. 2005) (preemption defense anticipated in complaint does not create federal jurisdiction)
Mulcahey v. Columbia Organic Chems. Co., 29 F.3d 148 (4th Cir. 1994) (plaintiff may be entitled to recover under alternative state‑law theories; negligence‑per‑se allegation does not necessarily create federal jurisdiction)