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Newsome v. Bayer Corp.

United States District Court, E.D. Kentucky, Southern Division

April 23, 2018

BAYER CORPORATION, et al., Defendants.

          OPINION & ORDER


         This matter is before the Court on a Motion to Remand to Pike County Circuit Court filed by plaintiffs (DE 10). For the following reasons, plaintiffs' motion to remand (DE 10) is GRANTED.

         I. BACKGROUND

         The plaintiffs originally filed this civil suit in Pike Circuit Court on February 24, 2017 (DE 1-1, Complaint). In their Complaint, Plaintiffs named five defendants: Bayer Corporation, Bayer Healthcare LLC, Bayer Essure, Inc., (f/k/a Conceptus, Inc.), and Bayer Healthcare Pharmaceuticals, Inc. (collectively herein called the “Bayer defendants”), and Pikeville Medical Center, Inc. (“PMC”). Defendants timely removed the action to this Court on grounds of both federal question and diversity jurisdiction. (DE 1, at 2-3). Plaintiffs claim this Court has no jurisdiction and have asked that the matter be remanded back to state court. (DE 10).

         This case involves the plaintiffs' use of a permanent birth control device called “Essure.” Plaintiffs each underwent surgery at PMC to have the Essure device implanted, Newsome and Varney in 2012, and Howell in 2013. All plaintiffs allege that they suffered damages because PMC failed to properly inform them of the risks associated with the device, and failed to use reasonable care in implanting the device. (DE 1-1). In November of 2013, plaintiff Howell learned that she was pregnant and vaginally delivered her son on June 30, 2014. (DE 1-1, at 73-74).

         The plaintiffs contend that the device was originally created by Conceptus, Inc., a company purchased by Bayer in 2013. (DE 1-1, at 9-12). In 2002, Essure was granted pre-market approval as a Class III medical device by the Food and Drug Administration, pursuant to the Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act. See (DE 1-1 at 19-20). The plaintiffs do not attack the pre-market approval process. Instead, the plaintiffs' complaint alleges the Bayer defendants failed to conform to FDA requirements regarding post-market monitoring of the device. As a specific example of this conduct, plaintiffs allege that Conceptus failed to report to the FDA adverse effects that were discovered once Essure became widely used in the market, despite having an affirmative duty to do so (DE 1-1, at 40-52). Plaintiffs allege that these actions constitute a violation of various state tort laws and that, but for the violations, the plaintiffs would never have used the device (DE 1-1).

         II. ANALYSIS

         Although several motions are pending in this matter, the Court must first determine whether removal from Pike County Circuit Court was proper. On a motion to remand, the burden rests with the defendant to prove that this Court has original jurisdiction. Eastman v. Marine Mech. Corp., 438 F.3d 544, 549 (6th Cir. 2006). Original jurisdiction exists through either diversity of citizenship, see 28 U.S.C. §§ 1332(a) and 1441(b), or federal question jurisdiction, see 28 U.S.C. §§ 1331 and 1441(a). When doubts as to the propriety of removal exist, “the removal statute should be strictly construed and all doubts resolved in favor of remand.” Eastman, 438 F.3d at 550. The Court considers the parties' arguments on jurisdiction below.

         A. Federal Question Jurisdiction

         Courts have consistently applied the “well-pleaded complaint” rule when reviewing federal question jurisdiction on a motion to remand. “To determine whether the claim arises under federal law, we examine the ‘well pleaded' allegations of the complaint and ignore potential defenses….” Mikulski v. Centerior Energy Corp., 501 F.3d 555, 560 (2007) (quoting Beneficial Nat'l Bank v. Anderson, 539 U.S. 1, 6 (2003)). As a result of the rule, “federal questions presented by defenses-or even by the plaintiff's anticipatory rebuttal of an expected defense-cannot support jurisdiction.” Dillon v. Medtronic, Inc., 992 F.Supp.2d 751, 755 (2014) (citing Franchise Tax Bd. v. Constr. Laborers Vacation Trust, 463 U.S. 1, 10 (1983)). “So, with only rare exception, a dispute over whether federal law trumps the plaintiff's state cause of action does not satisfy § 1331, since preemption is usually raised as a defense.” Id. (citing Caterpillar Inc. v. Williams, 482 U.S. 386, 393 (1987). “'[R]emoval and preemption are two distinct concepts, ' and the fact that plaintiffs' claim might ultimately prove to be preempted does not establish that it is removable to federal court.” Strong v. Telectronics Pacing Systems, Inc., 78 F.3d 256, 261 (6th Cir. 1996) (quoting Warner v. Ford Motor Co., 46 F.3d 531 (6th Cir. 1995).

         In their Complaint, Plaintiffs assert various state-law tort claims against the defendants. See (DE 1-1, Pl. Complaint); see also (DE 10-3, Pl. Mem. in Support of Mtn. to Remand, at 1). As such, the claims within the well-pleaded complaint do not directly arise under federal law or jurisdiction. However, the United States Court of Appeals for the Sixth Circuit recognizes three exceptions to the well-pleaded complaint rule, by which defendants can still show that federal jurisdiction is proper. See Mikulski, 501 F.3d at 560. The first two exceptions, artful-pleading and complete preemption, are inapplicable in this case. The artful pleading doctrine requires there first to be a federal cause of action that the plaintiff is trying to artfully plead around, which Congress has not provided under the FDCA. See Mikulski, 501 F.3d at 560; 21 U.S.C. § 337(a). Further, the Sixth Circuit has specifically declined to extend the doctrine of complete preemption to the Medical Device Amendments of the FDCA. See Strong, 78 F.3d at 259. Thus, only the third exception, the substantial federal question doctrine, is at issue.

         1) The substantial federal question doctrine

         Plaintiffs' Complaint does not directly raise a federal question. The United States Supreme Court has held, however, that federal courts have federal question jurisdiction over state law claims that raise a substantial federal issue, but only when the exercise of such jurisdiction will not upset the balance of state and federal judicial responsibilities. See Grable & Sons Metal Products, Inc., v. Darue Engineering & Manufacturing, 545 U.S. 308, 125 S.Ct. 2363 (2005).

         The Sixth Circuit, relying on Grable, has developed a three-part test to determine whether state law claims implicate federal question jurisdiction:

(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.
Mikulski, 501 F.3d at 568.

         a. Whether the state law claim raises a disputed federal issue

         In Plaintiffs' Complaint, the claims for relief arise exclusively under state law. The Supreme Court has specifically stated that the MDA only preempts state requirements that are “different from, or in addition to” requirements imposed by federal law, leaving room for independent state causes of action. Riegel v. Medtronic, Inc.,552 U.S. 312, 330 (2008). “Thus, § 360k does not prevent a State from providing a damages remedy for claims premised on a violation of FDA regulations; the state duties in such a case ‘parallel, ' rather than add to, federal requirements.” Id. In this case, it is unclear that litigation regarding the defendants' state duties-duties that merely parallel ...

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