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 renewed
motion to dismiss the Second Amended Complaint. ECF No. 67.
The Court had previously permitted Plaintiffs to amend the
Complaint one final time to cure their pleading defects.
Having reviewed the pleadings and the Second Amended
Complaint, the Court deems a hearing unnecessary.
See Loc. R. 105.6. For the following reasons, the
Second Amended Complaint is still insufficient to overcome
preemption under the Medical Devices Act and is, therefore,
dismissed with prejudice.
August of 2014, John C. Winkler (“Winkler”)
underwent an operation at Duke University Hospital in North
Carolina to implant a HeartWare Ventricular Assistive System
(“HVA”) in his heart. ECF No. 9 ¶ 5. The
purpose of the HVA was to serve as a “bridge” to
provide life sustaining left ventricular function while
Winkler waited for a heart transplant. Id. Two years
prior, Medtronic's predecessor company, HeartWare, Inc.,
sought and obtained from the United States Food and Drug
Administration (“FDA”) premarket approval for the
HVA. ECF No. 63 ¶ 5. The HVA is classified by the FDA as
a Class III device subject to the agency's most intensive
review and approval process. Id.; Williams v.
Smith & Nephew, Inc., 123 F.Supp.3d 733, 736 (D. Md.
the HVA's component parts is the battery power supply.
ECF No. 63 ¶ 4. The HVA includes two batteries connected
to the device's controller. Id. One battery
provides the power to the device while the other serves as a
backup. Id. When the main battery source is depleted
to less than 25% power, the HVA controller is designed to
switch automatically to the backup battery supply.
January 4, 2015, the HVA device in Winkler experienced a
tragic power failure. When the primary battery pack power
fell below 25%, the HVA controller switched to the backup
battery. Id. However, the backup battery had been
fully depleted due to faulty power cells. Id. The
HVA pump, therefore, stopped working and Winkler suffered
cardiac arrest. Id. Winkler died on January 6, 2015.
Plaintiffs filed this action on January 4, 2018, in the
Circuit Court for Montgomery County, Maryland. ECF No. 2 at
1. Defendants removed the matter to this Court and moved to
dismiss the claims on preemption and limitations grounds. ECF
Nos. 1, 30. This Court in its previous written opinion noted
that the claims as pleaded were subject to dismissal on
preemption grounds. ECF No. 54 at 8-9. However, the Court
permitted Plaintiff a final opportunity to amend the
Complaint to cure the pleading defects, if possible.
Id. at 9. Winkler has now amended the claims and
Medtronic renews it motion to dismiss. ECF Nos. 63, 67.
Because Winkler failed to aver any facts demonstrating that
the claims arose from Defendants' violations of any FDA
regulation, giving rise to a permissibly parallel claim, the
Court grants Medtronic's motion to dismiss with
Standard of Review
ruling on a motion to dismiss, a plaintiff's well-pleaded
allegations are accepted as true and viewed in the light most
favorable to the plaintiff. Mylan Labs., Inc v.
Matkari, 7 F.3d 1130, 1134 (4th Cir. 1993).
“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
Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555
(2007)). “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.
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)
contend that Winkler has failed to cure the deficiencies in
the Second Amended Complaint to avoid preemption under the
Medical Device Amendments (“MDA”) to the Federal
Food, Drug, and Cosmetic Act. 21 U.S.C. § 360k. As
previously discussed, the MDA imposes a “regime of
detailed federal oversight” on medical devices.
Riegel v. Medtronic, Inc., 552 U.S. 312, 316 (2008).
The MDA provides for various tiers of scrutiny depending on a
medical device's safety risks, with the most stringent
oversight afforded to Class III devices. Id. at
316-17. Premarket approval by the FDA for Class III devices
involves a “rigorous” process of FDA scrutiny and
review. Williams, 123 F.Supp.3d at 736. The FDA
crafts each premarket approval process specifically for the
individual medical device and conditions the sale and use of
the device on the manufacturer's compliance with
enumerated safety requirements. Riegel, 552 U.S. at
322-23. Where, as here, the FDA has issued premarket approval
to a Class III device, that approval requires the device to
be manufactured “with almost no deviations from the
specifications in its approval application . . . [to]
provide a reasonable assurance of safety and
effectiveness.” Id. at 323. As part of
premarket approval, the FDA imposes oversight and monitoring
requirements to ensure continued safe use of the device.
Walker v. Medtronic, Inc., 670 F.3d 569, 574 (4th
the FDA had imposed a comprehensive regulatory scheme aimed
at ensuring the safety of Class III devices, the MDA
expressly preempts lawsuits based on “state
requirements” that are “‘different from, or
in addition to, any requirement applicable . . . to the
device' under federal law.'” Riegel,
552 U.S. at 321-22 (quoting 21 U.S.C. § 360k(a)(1)).
Accordingly, common law tort claims based on a violation of
FDA regulations may go forward if the claims are based on,
essentially, failures to comply with the FDA regulations
applicable to the Class III premarket approval directives for
the particular device. Id. at 330 (citing
Medtronic, Inc. v. Lohr, 518 U.S. 470, 495 (1996)
(“[T]he state duties in such a case
‘parallel,' rather than add to, federal
requirements.”)). Claims that are “different
from, or in addition to” the federal requirements are
preempted by federal law. Id.
Second Amended Complaint includes five causes of action:
negligent manufacture, failure to warn, breach of warranty,
strict liability, and wrongful death. ECF No. 63 ¶¶
7-23. None of the claims, however, may proceed because the
Plaintiffs have averred no facts by which this Court could
plausibly infer any violations of the FDA requirements. The
Second Amended Complaint adds no detail pertinent to this