Dillon v. Medtronic, Inc.
2014 WL 37759, 2014 U.S. Dist. LEXIS 747, 992 F.Supp.2d 751 (2014)
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Rule of Law:
A defendant's assertion of a federal preemption defense, or a plaintiff's state-law claims that merely align with federal law to avoid preemption, do not establish federal question jurisdiction under 28 U.S.C. § 1331 unless a federal issue is a necessary element of the plaintiff's well-pleaded complaint, or federal law provides an exclusive cause of action under the complete preemption doctrine.
Facts:
- Winston and Teresa Dillon brought a lawsuit against Medtronic, Inc. and its codefendants in Pike County Circuit Court.
- The Dillons asserted various state causes of action, including negligence, products liability, and fraud-related claims.
- The Dillons sought damages for injuries they allegedly sustained during Mr. Dillon’s spine fusion surgery.
- The Dillons claimed that the doctor used Medtronic’s Infuse Bone Graft device in a manner that the Food and Drug Administration (FDA) did not approve for its label (an “off-label” use).
- The Dillons further claimed Medtronic was responsible for their injuries because it illegally promoted such “off-label” use of the Infuse device.
- Medtronic contended that federal law, specifically the Medical Device Amendments (MDA) to the Food, Drug, and Cosmetic Act (FDCA), preempted the Dillons’ state law claims.
Procedural Posture:
- Winston and Teresa Dillon (plaintiffs) brought suit against Medtronic, Inc. (defendants) in Pike County Circuit Court.
- Medtronic (defendants) removed the case to the U.S. District Court for the Eastern District of Kentucky, invoking federal-question jurisdiction.
- The Dillons (plaintiffs) moved the District Court to remand the case back to state court.
- The District Court initially granted the motion to remand, sending the case back to Pike County Circuit Court for lack of subject-matter jurisdiction.
- Medtronic (defendants) moved the District Court to reconsider its ruling on account of clear legal error.
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Issue:
Does a defendant's assertion of a federal preemption defense, or a plaintiff's state-law claim that must comply with federal law to avoid preemption, establish federal question jurisdiction under 28 U.S.C. § 1331 when no federal cause of action exists?
Opinions:
Majority - Amul R. Thapar
No, a defendant's assertion of federal preemption as a defense, or state-law claims that align with federal law to avoid preemption, do not establish federal question jurisdiction under 28 U.S.C. § 1331 unless Congress has provided an exclusive federal cause of action that completely preempts state law or the state claims are artfully pled to disguise a federal claim. The court reasoned that federal courts are courts of limited jurisdiction and only possess power authorized by the Constitution and conferred by statute, such as 28 U.S.C. § 1331. Under the venerable “well-pleaded complaint rule,” a case only “arises under” federal law for statutory purposes if a federal issue appears as a necessary element of the plaintiff’s cause of action, meaning issues raised in responsive pleadings, like defenses (including preemption), are irrelevant. The court identified two main roads to federal court for federal questions: when federal law creates the cause of action (the Holmes test) or when state claims raise significant federal issues (the Grable/Gunn test). However, even for the latter, the federal issue must still appear on the face of the plaintiff's well-pleaded complaint. Exceptions to the well-pleaded complaint rule—complete preemption and artful pleading—only apply where federal law has so completely occupied a field that any state claim is inherently federal, and crucially, where there exists an alternative federal cause of action that the plaintiff could have invoked. In this case, the Dillons’ complaint explicitly disclaimed reliance on any federal remedy and asserted only state law claims. The Medical Device Amendments (MDA) to the FDCA, which Medtronic cited, explicitly do not provide a private cause of action (21 U.S.C. § 337(a)), thereby precluding both complete preemption and artful pleading doctrines as bases for jurisdiction. The court also found that the Dillons’ claims, while needing to avoid preemption by aligning with federal law, were not “premised on violation of federal law” such that a federal issue was a necessary element of their state causes of action. Even a single claim of negligence 'per se' based on federal law was insufficient because the broader negligence claim was supported by alternative nonfederal theories.
Analysis:
This case significantly reinforces the strict application of the well-pleaded complaint rule, affirming that federal preemption, when raised merely as a defense, does not create federal question jurisdiction. It clarifies the narrow scope of the 'complete preemption' doctrine, emphasizing the critical requirement that Congress must have created an exclusive federal cause of action. By stressing that even the 'significant federal issue' test from Grable demands the federal issue be a necessary element of the plaintiff's own claim, not merely a factor for avoiding a defense or an alternative theory, the court limits avenues for removal based on embedded federal questions. This decision underscores the plaintiff's power as 'master of the complaint' in choosing a state forum, unless a federal cause of action is inescapably implicated.
