Wilhite v. Medtronic Inc

CourtDistrict Court, N.D. Alabama
DecidedMarch 6, 2024
Docket2:23-cv-00423
StatusUnknown

This text of Wilhite v. Medtronic Inc (Wilhite v. Medtronic Inc) is published on Counsel Stack Legal Research, covering District Court, N.D. Alabama primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Wilhite v. Medtronic Inc, (N.D. Ala. 2024).

Opinion

UNITED STATES DISTRICT COURT FOR THE NORTHERN DISTRICT OF ALABAMA SOUTHERN DIVISION

STEPHANIE WILHITE, o/b/o The ) Estate of Linda Wilder, ) ) Plaintiff, ) ) Case No. 2:23-cv-00423-SGC v. ) ) MEDTRONIC, INC., ) ) Defendant. )

MEMORANDUM OPINION1

This is a products liability action brought against Medtronic, Inc., by Stephanie Wilhite, proceeding on behalf of the Estate of Linda Wilder. The matter is before the court on Medtronic’s motion to dismiss the amended complaint. (Doc. 11).2 For the reasons stated below, the motion is due to be granted, and this action is due to be dismissed with prejudice. I. Procedural History Wilhite commenced this action in the Circuit Court of Jefferson County, Alabama. (Doc. 1-1). Medtronic removed the action to this district court on the basis of diversity jurisdiction and then filed a motion to dismiss Wilhite’s claims as

1 The parties have consented to the exercise of dispositive jurisdiction by a magistrate judge pursuant to 28 U.S.C. § 636(c). (Doc. 13).

2 Citations to the record refer to the document and page numbers assigned by the court’s CM/ECF electronic document system and appear in the following format: (Doc. __ at __). insufficiently pleaded and, alternatively, preempted by federal law. (Docs. 1, 3). Wilhite responded by filing an amended complaint, effectively mooting Medtronic’s

motion to dismiss because that motion addressed what was no longer the operative pleading. (Docs. 8, 10). Medtronic then filed a motion to dismiss the claims asserted in the amended complaint as preempted by federal law and, alternatively,

insufficiently pleaded. (Doc. 11). The motion has been fully briefed. (Docs. 15, 16). II. Allegations of Amended Complaint

Medtronic designed, manufactures, and sells the Evera XT DR Defibrillator (an “Evera” or the “Evera”). (Doc. 8 at ¶ 18). The Evera is a Class III medical device regulated by the U.S. Food and Drug Administration (the “FDA”). (Doc. 8 at ¶ 9).

Wilhite alleges the design and manufacturing of the Evera was defective and the testing of the device before placing it on the market was inadequate, insofar as the defibrillator was susceptible to a rapid and unexpected decrease in battery life that could result in full battery depletion within as little as one day. (Doc. 8 at ¶ 76).

She alleges Medtronic knew or should have known of the defect before placing the Evera on the market, failed to provide adequate warnings regarding the issue to the FDA or the public, and instead disseminated false and misleading information

regarding the reliability and longevity of the Evera and minimized the risks associated with the defibrillator. (Doc. 8 at ¶¶ 6, 11, 29-31, 35, 42-46, 50, 52-53, 76, 81). Wilhite asserts Medtronic had “a continuing duty to comply with the

requirements listed in [its] PMA and with the FDCA in the manufacture, development, promotion, marketing, labeling, distribution, testing, and sale of [the Evera]” and cites 24 sections from the Code of Federal Regulations, “[v]iolations

[of which] also constitute violations of [Medtronic’s] parallel state duties.” (Doc. 8 at ¶¶ 62, 63).3 Medtronic recalled the Evera on February 3, 2021, due to the battery issue described above. (Doc. 8 at ¶ 7). Wilhite alleges the recall should have come sooner.

(Doc. 8 at ¶ 76(d)). Wilder, who had an Evera implanted on an unspecified date prior to the recall, died on April 5, 2021. (Doc. 8 at ¶¶ 6, 8). Her physician determined her death was caused by the failure of her Evera – more specifically, that

there was an issue with the Evera’s generator or that the Evera “went through its full prescription and stopped shocking.” (Doc. 8 at ¶ 8).4 Based on these allegations, Wilhite asserts a claim against Medtronic under the Alabama Extended Manufacturer’s Liability Doctrine (the “AEMLD”) and

claims for negligence, negligence per se, wantonness, and breach of implied

3 As discussed below, “PMA” is shorthand for “premarket approval,” a process of review that a medical device for human use must pass before being placed on the market. “FDCA” refers to the 1938 Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq.

4 As of March 22, 2021, Wilder’s defibrillator indicated it had 2.2 years of remaining battery life. (Doc. 8 at ¶ 8). warranty under Alabama law. Wilhite does not assert a standalone fraud claim. However, as stated, she alleges Medtronic made false representations regarding the

reliability and longevity of the Evera and concealed information about the risk of rapid and unexpected battery depletion. In the interest of thoroughness, the court will construe the amended complaint as asserting claims for false representation and

fraudulent suppression, as well. III. Standard of Review

Rule 12(b)(6) must be considered against the backdrop of Rule 8(a)(2) of the Federal Rules of Civil Procedure. Rule 8(a)(2) “requires only ‘a short and plain statement of the claim showing that the pleader is entitled to relief,’ in order to ‘give the defendant fair notice of what the … claim is and the grounds upon which it rests.’” Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 555 (2007) (quoting Conley

v. Gibson, 355 U.S. 41, 47 (1957)). Rule 8 “does not require ‘detailed factual allegations,’ but it demands more than an unadorned, the defendant-unlawfully- harmed me accusation.” Ashcroft v. Iqbal, 556 U.S. 662, 677 (2009) (quoting Twombly, 550 U.S. at 555). “[L]abels and conclusions,” “a formulaic recitation of

the elements of a cause of action,” and “naked assertion[s] devoid of further factual enhancement” are insufficient. Id. at 678 (quoting Twombly, 550 U.S. at 555, 557) (internal quotation marks omitted). To survive a motion to dismiss for failure to state a claim on which relief may be granted brought pursuant to Rule 12(b)(6), “a complaint must contain sufficient

factual matter, accepted as true, to ‘state a claim to relief that is plausible on its face.’” Id. (quoting 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.” Id. (citing Twombly, 550 U.S. at 556). “The plausibility standard is not akin to a ‘probability requirement,’ but it asks for more than a sheer possibility that a defendant has acted unlawfully.” Id. (citing Twombly, 550 U.S. at 556).

IV. Discussion

The Medical Device Amendments of 1976 (the “MDA”), 21 U.S.C. § 360c et seq., gives the FDA regulatory authority over medical devices for human use. Riegel v. Medtronic, Inc., 552 U.S. 312, 316 (2008).5 The FDA classifies medical devices into three categories based on the level of risk presented. Id. at 316-17 (citing § 360c(a)(1)). Class III is the highest risk category. Id. at 317 (citing § 360c(a)(1)(C)).

Before a company may sell a Class III medical device, it must obtain premarket approval (“PMA”) from the FDA. Id. (citing § 360c(a)(1)(C)). PMA “is a ‘rigorous’

5 The MDA amended the 1938 Federal Food, Drug, and Cosmetic Act (the “FDCA”), 21 U.S.C.

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