United States District Court, D. Maryland
TINA M. WINKLER, et al., Plaintiffs,
MEDTRONIC, INC., et al., Defendants.
Xinis United States District Judge
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.
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,
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.
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.
Standard of Review
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).
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)
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.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.
Applicable Statute of Limitations
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.
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 ...