H.R. v. Medtronic, Inc.

Decision Date13 February 2014
Docket NumberCase No. 1:13–cv–859.
Citation996 F.Supp.2d 671
PartiesH.R., a minor, by and through her Parents and Natural Guardians, Steve and Tricia REUTER, Plaintiffs, v. MEDTRONIC, INC., et al., Defendants.
CourtU.S. District Court — Southern District of Ohio


Anne M. Valentine, Leeseberg & Valentine, Columbus, OH, Curtis Brooks Cutter, Kershaw, Cutter & Ratinoff, LLP, Sacramento, CA, for Plaintiffs.

Bethany Palmer Recht, Brandi M. Stewart, James Eugene Burke, Keating, Muething & Klekamp, Cincinnati, OH, for Defendants.


TIMOTHY S. BLACK, District Judge.

This civil action is before the Court on Plaintiffs' motion to remand (Doc. 20) and the parties' responsive memoranda (Docs. 24, 28 1).2


Plaintiffs allege state law causes of action for: (1) negligence; (2) informed consent; (3) battery; (4) fraudulent concealment and inducement; (5) intentional infliction of emotional distress; (6) loss of consortium; (7) strict product liability; (8) strict liability (inadequate warning or instruction); (9) defective design, formulation and/or manufacture or construction; (10) breach of express and implied warranties; and (11) fraud. (Doc. 7). These causes of action are based upon Plaintiffs' allegations that the Medtronic Defendants improperly and illegally promoted and sold a bone graft device, the Infuse® Bone Grate, for unapproved and unreasonably dangerous surgical applications. ( Id.) Plaintiffs contend that because the Infuse® was used in a manner inconsistent with the Food and Drug Administration (“FDA”) approval, Defendants should be found liable for negligent use and promotion of the Infuse® through an off-label manner. ( Id. at ¶ 24). Additionally, Plaintiffs allege that as a result of an unapproved surgery performed by the Medical Defendants with the Infuse®, Plaintiff, an infant child, suffered severe and permanent injuries, including seizures, intracranial pressure, and neurological damage. ( Id. at ¶ 91).

Defendants removed the case from Hamilton County Court of Common Pleas to the Southern District of Ohio. (Doc. 1). Subsequently, Plaintiffs filed the motion to remand, arguing that this case was improperly removed from state court because no federal cause of action exists. (Doc. 20). Conversely, Defendants assert that because the Infuse® is classified as a Class III, FDA premarket approved device under the Medical Device Amendments of 1976 (“MDA”) to the Federal Food, Drug, and Cosmetic Act of 1938 (“FDCA”), 21 U.S.C. § 360k(a), the case properly belongs under federal jurisdiction.


On a motion for remand, the question is whether the district court lacks subject matter jurisdiction. 28 U.S.C. § 1447(c). Defendant bears the burden of establishing that removal was proper. Long v. Bando Mfg. of Am., Inc., 201 F.3d 754, 757 (6th Cir.2000). Removal raises significant federalism concerns and, for this reason, federal courts must strictly construe such jurisdiction. Merrell Dow Pharm. Inc. v. Thompson, 478 U.S. 804, 808, 106 S.Ct. 3229, 92 L.Ed.2d 650 (1986).3 Accordingly, a federal court must resolve any doubt of its removal jurisdiction in favor of state court jurisdiction. Shamrock Oil & Gas Corp. v. Sheets, 313 U.S. 100, 108–09, 61 S.Ct. 868, 85 L.Ed. 1214 (1941). In other words, the issue is whether the case was properly removed in the first instance. Provident Bank v. Beck, 952 F.Supp. 539, 540 (S.D.Ohio 1996). Specifically, whether the plaintiff's well-pleaded complaint asserts a cause of action created by federal law or depends on the resolution of a substantial question of federal law. Jordan v. Humana Military Healthcare Serv., Inc., No. C–3–06–51, 2006 WL 1207914, at *1, 2006 U.S. Dist. LEXIS 25845, at *1 (S.D.Ohio May 2, 2006).

Removal of an action to federal court based on original jurisdiction is provided for in 28 U.S.C. §§ 1441(a), 1331 as to: “all civil actions arising under the Constitution, laws, or treaties of the United States.” Defendants maintain that Plaintiffs' complaint contains a claim “arising under” federal law. “The ‘arising under’ gateway into federal court has two distinct portals.” Eastman v. Marine Mech. Corp., 438 F.3d 544, 550 (6th Cir.2006). This Court has original jurisdiction if Plaintiff's well-pleaded complaint establishes that either federal law creates the cause of action, or that Plaintiff's right to relief involves the resolution or interpretation of a substantial question of federal law. Id.

The well-pleaded complaint rule provides that “federal jurisdiction exists only when a federal question is presented on the face of the plaintiff's properly pleaded complaint.” Loftis v. United Parcel Serv., Inc., 342 F.3d 509, 514 (6th Cir.2003) (quoting Caterpillar Inc. v. Williams, 482 U.S. 386, 107 S.Ct. 2425, 96 L.Ed.2d 318 (1987)). Because the plaintiff is the master of his complaint, the fact that a claim could be stated under federal law does not prevent a plaintiff from only stating it under state law. Eastman, 438 F.3d at 550.

Although the majority of cases removed to federal court set forth causes of action that plainly raise federal issues, there are three exceptions to the “well-pleaded complaint” that confer federal question jurisdiction when a federal cause of action is not evidenced on the face of the complaint: (1) the artful-pleading doctrine; (2) the complete preemption doctrine; and (3) the substantial-federal-question doctrine.Mikulski v. Centerior Energy Corp., 501 F.3d 555, 560 (6th Cir.2007).

Under the artful pleading doctrine, federal question jurisdiction exists when a plaintiff shrouds its complaint with state law claims in order to avoid federal jurisdiction when its claims are truly federal causes of action. See Her Majesty the Queen in Right of the Province of Ontario v. City of Detroit, 874 F.2d 332, 339 (6th Cir.1989). However, rarely will the federal court “seek to determine whether the real nature of the claims is federal, regardless of plaintiff's characterization, [instead] most [removal courts] correctly confine this practice to areas of the law pre-empted by federal substantive law.' ” Mikulski, 501 F.3d at 561.

Under the complete-preemption doctrine, federal question jurisdiction exists when Congress has “intend[ed] the preemptive force of a federal statute to be so extraordinary that ‘any claim purportedly based on that pre-empted state law is considered, from its inception, a federal claim, and therefore arises under federal law.’ Mikulski, 501 F.3d at 563. The Supreme Court has only applied the complete-preemption doctrine in three areas: (1) Section 301 of the Labor Management Relations Act of 1947, 29 U.S.C. § 185; (2) the Employee Retirement Income Security Act of 1975, 29 U.S.C. §§ 1001–1461; and (3) the National Bank Act, 12 U.S.C. § 39.

Finally, under the substantial-federal-question doctrine, federal question jurisdiction exists when the state-law claim necessarily state[s] a federal issue, actually disputed and substantial, which a federal forum may entertain without disturbing a congressionally approved balance of federal and state judicial responsibilities.” Grable & Sons Metal Products, Inc. v. Darue Eng'g & Mfg., 545 U.S. 308, 314, 125 S.Ct. 2363, 162 L.Ed.2d 257 (2005). More plainly stated, a state law cause of action may arise under federal law where “the vindication of a right under state law depends on the validity, construction, or effect of federal law.” Mikulski, 501 F.3d at 565.


This Court finds that the substantial federal question doctrine applies to the instant case.

“Where a well-pleaded complaint does not seek relief under federal law, a court may find removal proper if the plaintiff's complaint raises a ‘substantial’ federal question.” Landers v. Morgan Asset Mgmt, Inc., No. 08–2260, 2009 WL 962689, at *5, 2009 U.S. Dist. LEXIS 30891, at *17 (W.D.Tenn. Mar. 31, 2009). Under Sixth Circuit and Supreme Court precedent, “the substantial-federal-question doctrine [has] three parts: (1) the state-law claim must necessarily raise a disputed federal issue; (2) the federal interest in the issue must be substantial; and (3) the exercise of jurisdiction must not disturb any congressionally approved balance of federal and state judicial responsibilities.” Nayyar v. Mt. Carmel Health Sys., No. 2:12cv189, 2012 WL 3929830, at *2, 2012 U.S. Dist. LEXIS 128050, at *5 (S.D.Ohio Sept. 10, 2012) (citing Mikulski v. Centerior Energy Corp., 501 F.3d 555, 568 (6th Cir.2007) ( en banc ), in turn citing Grable, 545 U.S. at 313–14, 125 S.Ct. 2363).

Notably, a district court in Tennessee recently denied remand in a materially similar case also arising from the alleged off-label promotion of the Infuse® device, holding that it “ha[d] jurisdiction” over claims such as those asserted here “under the substantial-federal-question doctrine.” Jenkins v. Medtronic, Inc., No. 2:13cv2004, 984 F.Supp.2d 873, 875–76, 876–78, 2013 WL 6172234, at *1, 2–3, 2013 U.S. Dist. LEXIS 165787, at *3, *8 (W.D.Tenn. Nov. 21, 2013).4 The Court finds Jenkins to be directly on point and persuasive.5

A. Disputed Federal Issue

The first step in the Grable analysis is to determine whether Plaintiffs' claims “necessarily raise a disputed federal issue.” Mikulski, 501 F.3d at 568. Since the Infuse® is a Class III, premarket approved device under the Medical Device Amendments (“MDA”) to the Food, Drug, and Cosmetic Act (“FDCA”), 21 U.S.C. Sections 360(c)et seq., the Court looks to the MDA to examine this first element.

The MDA expressly preempts any state requirement on devices intended for human issue that is “different from, or in addition to, any requirement applicable under [the MDA] or that “relates to the safety or effectiveness of the devise.” 21 U.S.C. § 360k(a). The only way a state requirement can be exempted from this express preemption is if “the [state] requirement is more stringent than a...

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