Kubicki ex rel. Kubicki v. Medtronic

• Decision Date: 21 March 2013
• Docket Number: Civil Action No. 12-00734 (CKK)
• Court: U.S. District Court — District of Columbia
• Parties: JOHN KUBICKI & KAREN KUBICKI ON BEHALF OF CAROLINE KUBICKI, Plaintiffs, v. MEDTRONIC, ET AL., Defendants.

JOHN KUBICKI & KAREN KUBICKI ON BEHALF OF CAROLINE KUBICKI, Plaintiffs,

v.MEDTRONIC, ET AL., Defendants.

Civil Action No. 12-00734 (CKK)

UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA

Date: March 21, 2013

MEMORANDUM OPINION

Plaintiffs John Kubicki and Karen Kubicki ("Plaintiffs") bring this products liability action on behalf of Caroline Kubicki, as her parents and legal guardians, against Defendants Medtronic, Inc., Medtronic Diabetes, and Medtronic Minimed, Inc. (collectively "Defendants"). Presently before the Court is Defendants' [4] Motion to Dismiss. Upon careful consideration of the parties' submissions, the applicable authorities, and the record as a whole,¹ the Court shall GRANT-IN-PART and DENY-IN-PART Defendants' motion. Specifically, the Court shall dismiss, without prejudice, Plaintiffs' misrepresentation, fraud, and unlawful trade practices claims due to Plaintiffs' failure to plead these claims with sufficient particularity as required by Federal Rule of Civil Procedure 9(b). The Court shall also dismiss Plaintiffs' implied warranty claims as duplicative of their strict products liability claims. However, the Court shall denyDefendants' motion insofar as it argues that all of Plaintiffs' claims are expressly and impliedly preempted by federal law. Accordingly, Plaintiffs' remaining claims - specifically, negligence, strict liability, express warranties, and failure to warn - survive dismissal.

I. BACKGROUND

The following facts from Plaintiffs' Complaint are accepted as true for purposes of the Court's resolution of Defendants' motion to dismiss. This case arises out of Caroline Kubicki's use of the Medtronic MiniMed Paradigm REAL-Time Insulin Infusion Pump Model MMT-522 (the "522 Pump"), a prescription medical device indicated for management of diabetes that is manufactured and sold by Defendants. When functioning properly, the 522 Pump administers insulin to the user on a continuous or intermittent basis as needed by the user. Compl. ¶ 12. This process is accomplished through a small syringe in the pump which is connected to the user by way of a small cannula and a serious of electronics and complex algorithms which calculate the insulin dosage necessary for the user throughout the day and night. Id. Plaintiffs allege that on September 9, 2007, Ms. Kubicki's 522 Pump malfunctioned, causing her to suffer a hypoglycemic episode - i.e., critically low blood glucose levels - which rendered her unresponsive and unarousable and resulted in a temporary coma and severe and permanent brain injury. Id. ¶¶ 16-19. Ms. Kubicki currently resides in a group home due to the constant care that she requires for her activities of daily living. Id. ¶ 19.

On March 29, 2012, Plaintiffs, acting on behalf of Ms. Kubicki in their capacity as her parents and legal guardians, filed the instant Complaint in District of Columbia Superior Court, which Defendants subsequently removed to this Court, see Notice of Removal, ECF No. [1]. Plaintiffs' Complaint alleges that Defendant Medtronic, Inc., Defendant Medtronic Diabetes (a division of Medtronic, Inc.), and Defendant Medtronic MiniMed, Inc. (a subsidiary ofMedtronic, Inc.) are each engaged in the business of designing, licensing, manufacturing, distributing, selling, marketing, and/or introducing into interstate commerce the 522 Pump, Compl. ¶¶ 3-8. Plaintiffs' Complaint asserts the following counts against all Defendants: negligence,² strict liability,³ misrepresentation by seller,⁴ fraud,⁵ express warranties,⁶ implied warranties,⁷ violation of the District of Columbia Unlawful Trade Practices Act, D.C. Code § 28-3904,⁸ and failure to warn.⁹ Plaintiffs assert entitlement to compensatory and punitive damages, see Compl., Counts XXV-XXVIII, and pray for judgment against Defendants, individually and collectively, in the amount of fifty million dollars, and for additional aggravating circumstances damages, costs, and fees. Compl. at 44.

II. LEGAL STANDARD

Federal Rule of Civil Procedure 12(b)(6) provides that a party may move to dismiss on the grounds that the complaint "fail[s] to state a claim upon which relief can be granted." A complaint must contain "a short and plain statement of the claim showing that the pleader is entitled to relief," FED .R. CIV. P. (8)(a), "in order to give the defendant fair notice of what the ... claim is and the grounds upon which it rests." Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555,127 S. Ct. 1955, 167 L. Ed. 2d 929 (2007) (citation omitted). Although "detailed factual allegations" are not necessary to withstand a Rule 12(b)(6) motion to dismiss for failure to state a claim, a plaintiff must furnish "more than labels and conclusions" or "a formulaic recitation of the elements of a cause of action." Id. "Threadbare recitals of the elements of a cause of action, supported by mere conclusory statements, do not suffice." Ashcroft v. Iqbal, 556 U.S. 662, 678, 129 S. Ct. 1937, 173 L. Ed. 2d 868 (2009). "Nor does a complaint suffice if it tenders naked assertion[s] devoid of further factual enhancement." Id. (citation omitted). Rather, a complaint must contain sufficient factual allegations that, if accepted as true, "state a claim to relief that is plausible on its face." Twombly, 550 U.S. at 570. "A claim has facial plausibility when the plaintiff pleads factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged." Iqbal, 556 U.S. at 663.

In evaluating a Rule 12(b)(6) motion to dismiss, a court may consider "the facts alleged in the complaint, documents attached as exhibits or incorporated by reference in the complaint," or "documents upon which the plaintiff's complaint necessarily relies even if the document is produced not by [the parties]." Ward v. D.C. Dep't of Youth Rehab. Servs., 768 F. Supp. 2d 117, 119 (D.D.C. 2011) (citations omitted). The court must construe the complaint in a light most favorable to the plaintiff and must accept as true all reasonable factual inferences drawn from well-pleaded factual allegations. In re United Mine Workers of Am. Employee Benefit Plans Litig., 854 F. Supp. 914, 915 (D.D.C. 1994); see also Schuler v. United States, 617 F.2d 605, 608 (D.C. Cir. 1979) ("The complaint must be 'liberally construed in favor of the plaintiff,' who must be granted the benefit of all inferences that can be derived from the facts alleged."). While the court must construe the complaint in the plaintiff's favor, it "need not accept inferences drawn by the plaintiff if such inferences are unsupported by the facts set out in the complaint."Kowal v. MCI Comm'ns Corp., 16 F.3d 1271, 1276 (D.C. Cir. 1994). Moreover, the court is "not bound to accept as true a legal conclusion couched as a factual allegation." Twombly, 550 U.S. at 555 (citation omitted); accord Taylor v. FDIC, 132 F.3d 753, 762 (D.C. Cir. 1997).

III. DISCUSSION

Defendants assert several arguments as to why Plaintiffs' Complaint should be dismissed. First, Defendants argue that the Complaint must be dismissed in its entirety because Plaintiffs' claims are expressly preempted by the Medical Device Amendment ("MDA"), 21 U.S.C. § 360k, to the Federal Food, Drug and Cosmetics Act ("FDCA"), 21 U.S.C. § 301 et seq. Second, Defendants argue that, to the extent Plaintiffs' claims seek to enforce the provisions of the FDCA and the implementing regulations of the Food and Drug Administration ("FDA"), they are impliedly preempted as explained by the Supreme Court in Buckman Company v. Plaintiffs' Legal Committee, 531 U.S. 341 (2001), and precluded by the "no private right of action" provision of the FDCA, 21 U.S.C. § 337(a), which prohibits private plaintiffs from directly enforcing federal law. Third, Defendants argue that, in addition to being preempted, Plaintiffs' claims for misrepresentation, fraud, and violation of the District of Columbia Unlawful Trade Practices Act are barred for the separate and independent reason that Plaintiffs have not sufficiently pled these claims because they fail to articulate any misrepresentations made to them by Defendants. Fourth, Defendants argue that Plaintiffs' breach of implied warranty claims must be dismissed because they are pled in conjunction with strict products liability claims, but Plaintiffs fail to allege any contractual privity with Defendants. Finally, Defendants argue that because no amendment would cure the foregoing defects in Plaintiffs' complaint, the Court should dismiss Plaintiffs' case in its entirety, without leave to amend.

The Court shall address each of Defendants' arguments in turn.

A. Express Preemption

Congress enacted the MDA to extend the coverage of the FDCA to medical devices. See Medtronic, Inc. v. Lohr, 518 U.S. 470, 474, 116 S. Ct. 2240, 135 L. Ed. 2d 700 (1996). The MDA divides medical devices into three categories, based upon the risks that the devices pose to the public. Id. at 477. Class III devices are subject to the greatest level of oversight because they "present[ ] a potential unreasonable risk of illness or injury" or are "purported or represented to be for a use in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health." Id. at 478 (citing § 360c(a)(1)(C)). Before a manufacturer may introduce a new Class III device to the market, the manufacturer must provide the FDA with a "reasonable assurance" that the device is safe and effective through a "rigorous" process known as "premarket approval" - widely referred to as "PMA." Id. at 478 (citing 21 U.S.C. § 360e(d)(2)). After the FDA grants premarket approval to a device, its regulatory efforts do not end, as the manufacturer continues to have various reporting and other post-approval obligations to the agency. Most notably for this case, once the FDA approves a device, the manufacturer is required to report to the FDA any information that reasonably suggests that the device (1) "[m]ay have...