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.

Dillion v. Medtronic, Inc.

United States District Court, Sixth Circuit

December 20, 2013

MEDTRONIC, INC., et al., Defendants.


AMUL R. THAPAR, District Judge.

Congress offers two roads into federal court based on federal questions, and the state-court defendants in this case seek to take the one less traveled. Unfortunately that road is closed to them. Although the defendants allege federal law preempts the plaintiffs' claims, preemption is merely a defense, and thus does not count for the purposes of jurisdiction. The Court must therefore remand this case back to state court, since no federal issue appears on the face of the plaintiffs' well-pleaded complaint.


Plaintiffs Winston and Teresa Dillon brought this suit against Medtronic, Inc. and its codefendants (collectively, "Medtronic") in Pike County Circuit Court. See R. 1-1. The Dillons assert various state causes of action including negligence, products liability, and several fraud-related claims. Id. They seek damages for injuries allegedly caused during Mr. Dillon's spine fusion surgery. According to the Dillons, the doctor used Medtronic's Infuse Bone Graft device in a manner that the Food and Drug Administration (FDA) did not approve for inclusion on the device's label. Id. ¶¶ 321-27. And, the Dillons claim Medtronic is responsible for their injuries because it illegally promoted such "off-label" use of Infuse. Id. ¶ 200. Medtronic counters that federal law preempts the Dillons' claims. See R. 14 (motion to dismiss). The defendants accordingly removed the case to this Court, invoking its federal-question jurisdiction to hear cases "arising under" federal law. See R. 1 ¶ 13 (citing 28 U.S.C. § 1331). The plaintiffs moved to remand. See R. 11.

Federal law regulates medical devices pursuant to the Medical Device Amendments (MDA) to the Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. §§ 360c et seq. See Riegel v. Medtronic, Inc., 552 U.S. 312, 316-20 (2008) (describing the rigorous regulatory regime). The MDA provides varying degrees of oversight for medical devices depending on the risks they carry. Id. at 316. Class III devices like Infuse are the most heavily regulated. Id. at 317; R. 1-1 ¶ 136 (discussing Infuse). In line with the comprehensive federal regime, Congress expressly preempted all state requirements-including common law duties, see Riegel, 552 U.S. at 325-relating to medical devices that are "different from, or in addition to, " federal standards. 21 U.S.C. § 360k(a)(1). The MDA preemption clause does not, however, bar so-called "parallel" claims for breaches of common-law duties that also violate federal law. Riegel, 552 U.S. at 330; Medtronic, Inc. v. Lohr, 518 U.S. 470, 495 (1996). Despite occupying much of the medical device field, Congress explicitly chose not to provide a private cause of action to consumers harmed by violations of the FDCA, favoring exclusive government enforcement instead. See Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341, 349 n.4 (2001) (citing 21 U.S.C. § 337(a)). As a result, federal law impliedly preempts state claims based solely on violations of the FDCA. Id. at 352-53; see also Fulgenzi v. PLIVA, Inc., 711 F.3d 578, 586 (6th Cir. 2013) (holding that claims owing their existence to the FDCA regulatory scheme are preempted). Medtronic contends that together, § 360k(a) and § 337(a) preempt the Dillons' state law claims based on off-label promotion, and preemption therefore injects the federal question necessary for this case to fall within the Court's subject matter jurisdiction. See R. 26 at 9-10.


The defendants may remove this case to federal court if the Dillons could have originally brought it here. See 28 U.S.C. § 1441(a). Unlike state trial courts, however, federal district courts do not possess general jurisdiction. As courts of more limited jurisdiction, federal courts instead hold only that power authorized by the Constitution and conferred by statute. See Gunn v. Minton, 133 S.Ct. 1059, 1064 (2013). As the party seeking removal, Medtronic has the burden of demonstrating that the Court has such jurisdiction. Eastman v. Marine Mech. Corp., 438 F.3d 544, 549 (6th Cir. 2006). Kentucky courts are presumptively competent to interpret and faithfully apply federal law. See Mikulski v. Centerior Energy Corp., 501 F.3d 555, 560 (6th Cir. 2007) (en banc).

I. The Law of Federal Question Jurisdiction

The Constitution permits federal courts to hear "Cases... arising under" the Constitution and federal law. U.S. Const. art. III, § 2. Early precedent interpreting Article III suggests this phrase may encompass all cases in which a federal question is anywhere an "ingredient." Osborn v. Bank of the United States, 22 U.S. (9 Wheat.) 738, 823-25 (1824). But see Anthony J. Bellia Jr., Article III and the Cause of Action, 89 Iowa L. Rev. 777, 801-03, 808 (2004) (arguing that this language in Osborn referred to an essential component of the cause of action). Nevertheless, the Constitution describes only cases that Congress may permit federal district courts to hear. District courts have no jurisdiction without congressional authorization since Article III is not self-executing. See Hertz Corp. v. Friend, 559 U.S. 77, 84 (2010). And Congress generally speaking has the discretion to confer only a subset of what jurisdiction the Constitution allows. Id. Largely tracking the language of Article III, Congress has conferred on district courts jurisdiction over "all civil actions arising under the Constitution, laws, or treaties of the United States." 28 U.S.C. § 1331. Despite the similar phrasing to the Constitution, the Supreme Court has concluded § 1331 encompasses fewer cases than constitutionally permitted. See Merrell Dow Pharm. Inc. v. Thompson, 478 U.S. 804, 807-08 (1986).

A. The "Well-Pleaded Complaint" Rule

Most importantly, for statutory purposes a case only "arises under" federal law if a federal issue appears amid the plaintiff's cause of action. See Louisville & Nashville R.R. Co. v. Mottley, 211 U.S. 149, 152 (1908). Commonly known as the "well-pleaded complaint rule, " this venerable principle marks the outermost boundary of federal question jurisdiction under § 1331. See Metro. Life Ins. Co. v. Taylor, 481 U.S. 58, 63 (1987). Applying the wellpleaded complaint rule is thus the first step in assessing jurisdiction. See 13D Charles Alan Wright, et al., Federal Practice and Procedure § 3566 (3d ed.) [hereinafter Wright & Miller] ("Analytically, courts should apply the well-pleaded complaint rule first."). Time and again the Supreme Court has affirmed the rule's primacy, most recently in Vaden v. Discover Bank. 556 U.S. 49, 60-62 (2009).

The well-pleaded complaint rule carries several important implications. First and foremost, a federal issue must be among only those allegations in the complaint necessary for the plaintiff to state a claim. Though a complaint may go far beyond what is needed to plead a cause of action, courts must "look only to the claim itself and ignore any extraneous material." Wright & Miller § 3566. The well-pleaded complaint rule therefore is perhaps more aptly named the "sufficiently pleaded" or "properly pleaded" complaint rule. Problems of terminology aside, the rule's application is clear in most cases. This simplicity makes the well-pleaded complaint rule a "quick rule of thumb" for determining jurisdiction (or at least ruling it out). Franchise Tax Bd. v. Constr. Laborers Vacation Trust, 463 U.S. 1, 11 (1983). Beyond offering predictability, the rule also makes the plaintiff "master of the complaint." Caterpillar Inc. v. Williams, 482 U.S. 386, 398-99 (1987). So, while a plaintiff might have a viable federal claim, he is for the most part free to rely instead on state claims in an effort to keep his case out of federal court. Id. at 399.

Responsive Pleadings: As the well-pleaded complaint rule's name suggests, only the complaint matters. Issues raised in responsive pleadings are irrelevant. Holmes Group, Inc. v. Vornado Air Circulation Sys., Inc., 535 U.S. 826, 832 (2002). As a result, federal questions presented by defenses-or even by the plaintiff's anticipatory rebuttal of an expected defense-cannot support jurisdiction. See Franchise Tax Bd., 463 U.S. at 10. Call it formalistic, but since the goal is simplicity that's sort of the point. Regardless, the no-defense rule serves a functional purpose as well: it prevents a federal district court from unnecessarily asserting jurisdiction based on an issue the defendant might never raise or which the court need not address due to the plaintiff's failure to plead a cognizable claim under state law. See Mich. S. R.R. Co. v. Branch & St. Joseph Counties Rail Users Ass'n, Inc., 287 F.3d 568, 576 (6th Cir. 2002). So, with only ...

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.