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Winkler v. Medtronic, Inc.

United States District Court, D. Maryland

November 29, 2018

TINA M. WINKLER, et al., Plaintiffs,
MEDTRONIC, INC., et al., Defendants.


          Paula Xinis United States District Judge

         Pending before the Court in this products liability action is Defendants Medtronic, Inc., and HeartWare, Inc.'s motion to dismiss. ECF No. 30. After a motions hearing, the parties submitted supplemental letter pleadings. ECF Nos. 52, 53. Upon consideration of the parties' arguments, the Court grants in part and denies in part Defendants' motion to dismiss. The Court also will allow Plaintiffs twenty-one days to file a final Amended Complaint to cure the pleading defects as discussed in this opinion, if possible.

         I. Background [1]

         In August of 2014, John C. Winkler (“Winkler”) underwent an operation at Duke University Hospital in North Carolina to have a Left Ventricular Assistive Device (“LVAD”) implanted in his heart. ECF No. 9 ¶ 5. The purpose of the LVAD was to serve as a “bridge” to provide life sustaining left ventricular function while Winkler waited for a heart transplant. Id. On January 4, 2015, the LVAD unexpectedly lost power. Id. The backup systems intended to insure the operation of the LVAD also failed, and Winkler suffered a cardiac arrest and died on January 6, 2015. Id.

         On January 4, 2018, Winkler's children and spouse (“Plaintiffs”) filed suit in the Circuit Court for Montgomery County against HeartWare, Inc. and its parent company Medtronic, Inc. (“Defendants”) as the manufacturers of the LVAD. See ECF No. 2. Plaintiffs assert five claims against both defendants: negligent design (Count I), negligent manufacture (Count II), breach of warranty (Count III), strict liability (Count IV), and wrongful death (Count V). ECF No. 9.

         On March 30, 2018, Defendants removed the action to this Court pursuant to 28 U.S.C. § § 1332, 1441. ECF No. 1. Defendants now move to dismiss Plaintiffs' Amended Complaint, arguing that Medtronic bears no liability because it did not own HeartWare at the time of Winkler's death, and that Plaintiffs' claims are time-barred under the Virginia wrongful death statute. Defendants also assert Plaintiffs' claims are preempted under the Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act. 21 U.S.C. § 360k. Finally, Defendants contend that dismissal is warranted because Plaintiffs have failed to plead facts to support their theory of liability.

         II. Standard of Review

         In ruling on a motion to dismiss, a plaintiff's well-pleaded allegations are accepted as true and the complaint is viewed in the light most favorable to the plaintiff. Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555 (2007). “However, conclusory statements or a ‘formulaic recitation of the elements of a cause of action will not [suffice].'” EEOC v. Performance Food Grp., Inc., 16 F.Supp.3d 584, 588 (D. Md. 2014) (quoting Twombly, 550 U.S. at 555). “Factual allegations must be enough to raise a right to relief above a speculative level.” Twombly, 550 U.S. at 555. “‘[N]aked assertions of wrongdoing' necessitate some ‘factual enhancement' within the complaint to cross ‘the line between possibility and plausibility of entitlement to relief.'” Francis v. Giacomelli, 588 F.3d 186, 193 (4th Cir. 2009) (quoting Twombly, 550 U.S. at 557).

         The purpose of a motion to dismiss under Rule 12(b)(6) “is to test the sufficiency of the complaint.” Presley v. City of Charlottesville, 464 F.3d 480, 483 (4th Cir. 2006) (citation and internal quotation marks omitted). A complaint need only satisfy the standard of Rule 8(a), which requires a “short and plain statement of the claim showing that the pleader is entitled to relief.” Fed.R.Civ.P. 8(a)(2). “Rule 8(a)(2) still requires a ‘showing,' rather than a blanket assertion, of entitlement to relief.” Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555 n.3 (2007). That showing must consist of more than “a formulaic recitation of the elements of a cause of action” or “naked assertion[s] devoid of further factual enhancement.” Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009) (citations omitted).

         III. Analysis

         The Court finds at the outset that Plaintiffs have averred sufficient facts to support personal jurisdiction over Defendants, and on a basic level, to allow the allegations to proceed.[2]However, Plaintiffs' Amended Complaint does not provide sufficient detail for the Court to determine the applicable limitations period to certain claims or whether any of the claims are preempted. The Court addresses each issue in turn.

         A. Applicable Statute of Limitations

         Defendants contend that the Amended Complaint must be dismissed because the Plaintiffs have not filed suit within the two-year limitations period applicable to wrongful death actions under Virginia law. Va. Code Ann. § 8.01-244. Plaintiffs argue that the action is correctly filed under Maryland's wrongful death statute which provides a three-year limitations period for such claims, Md. Code Ann., Cts. & Jud. Proc. § 3-904(g)(1), and that even though Winkler died elsewhere, the Maryland limitations period applies. The Court cannot agree with either party at this juncture.

         Plaintiffs' Amended Complaint avers that the LVAD's design and manufacture defects caused Mr. Winkler's death. In diversity cases, the Court applies the choice of law rules of the state in which it sits. Klaxon Co. v. Stentor Elec. Mfg. Co., 313 U.S. 487, 496-97 (1941). “In a Maryland wrongful death action, based upon a wrongful act occurring outside of Maryland, the Maryland wrongful death statute itself specifies which jurisdiction's law shall govern.” Jones v. Prince George's Cty., 378 Md. 98, 107 (2003). More particularly, when the wrongful act occurs ...

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