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Hart v. Medtronic, Inc

United States District Court, D. New Jersey

November 30, 2017

KEVIN HART, Plaintiff,

          Joseph D. Cronin, Esq. CRONIN LAW FIRM LLC Attorney for Plaintiff.

          Aaron Van Nostrand, Esq. GREENBERG TRAURIG LLP Attorney for Defendants.




         Plaintiff Kevin Hart (hereinafter, “Plaintiff”) brought this suit against Defendants Medtronic, Inc., Medtronic International[1], and Medtronic Minimed, Inc.[2], alleging that an insulin pump, designed, manufactured and sold by Defendants, caused serious injuries to Plaintiff. This matter comes before the Court upon the Defendant's motion to dismiss Plaintiff's Amended Complaint under Rule 12(b)(6), Fed. R. Civ. P.. [Docket Item 12.] The primary issue is whether Plaintiff's common law tort claims arising from use of a medical device that obtained premarket approval from the U.S. Food and Drug Administration (“FDA”) are preempted by federal law, namely, 21 U.S.C. § 360k(a). For the following reasons, the motion to dismiss will be granted without prejudice to allow Plaintiff one final opportunity to propose a Second Amended Complaint setting forth a non-preempted claim, consistent with this Opinion.

         II. BACKGROUND[3]

         A. Factual Background

         Kevin Hart, is an adult male residing in New Jersey. (Am. Comp. ¶ 1.) Plaintiff suffers from Type I diabetes. (Id. at ¶ 17.) To help control his diabetes, Plaintiff used the MiniMed 530G insulin pump (the “Pump”) designed, sold, and manufactured by Medtronic, Inc. and Medtronic MiniMed, Inc. (“Defendants”). (Id. at ¶ 17.) On April 24, 2014, while Plaintiff was asleep, his Pump administered a potentially lethal dose of insulin. (Id. at ¶ 18.) When Plaintiff woke up and realized that he had been administered too much insulin, he went to the bathroom to attempt to remedy the situation. (Id. at ¶ 19.) Plaintiff ultimately lost consciousness, fell to the floor, and entered into a prolonged seizure. (Id. at ¶ 20.) As a result, Plaintiff sustained a series of injuries including head lacerations, severe bruising, severe muscle aches, hearing loss, tinnitus, chronic headaches, neck pain, nerve pain in the right arm, cracked teeth, diminished mental acuity and depression, as well as resulting “extreme economic hardship.” (Id. at ¶¶ 21-22.) To treat the physical and mental injuries, Plaintiff alleges he sought the treatment of various specialists, underwent various diagnostic testing and physical therapy and received a root canal. (Id. at ¶ 22.)

         B. FDA Premarket Approval Process

         The medical device at issue is a Class III product that has gone through the rigorous “Premarket Approval Process” (“PMA)” before obtaining the FDA's approval for use, as now described. The FDA regulates medical devices pursuant to the Medical Device Amendments (“MDA”) of 1976 to the Food, Drug and Cosmetic Act (“FDCA”). There are three classes of medical devices intended for human use -- Class I, Class II and Class III. 21 U.S.C. § 360c. The separate classes represent the different levels of oversight required by the FDA “depending on the risk [the device] presents.” Riegel v. Medtronic, Inc., 552 U.S. 312, 316 (2008). Class I devices -- elasticbandages, examination gloves, etc. -- are subject to the lowest level of oversight, for example, “labeling requirements.” Id.; see also 360c(a)(1)(A). Class II devices -- powered wheelchairs, surgical drapes, etc. -- are subject to more rigorous oversight, such as “performance standards and post market surveillance measures.” Riegel, 552 U.S. at 316; see also 360c(a)(1)(B). Class III devices --replacement heart valves, pacemakers, etc.-receive the most arduous oversight.

         Class III devices need to go through a Premarket Approval process that includes manufacturers submitting, among other things, “full reports of all studies and investigations of the device's safety and effectiveness that have been published or should reasonably be known to the applicant; a full statement of the device's ‘components, ingredients, and properties and of the principle or principles of operation'; ‘a full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and, when relevant, packing and installation of, such device'; samples or device components required by the FDA; and a specimen of the proposed labeling.” Riegel, 552 at 318 (citing § 360e(c)(1)).

         PMA does not end the oversight process for Class III devices. If the manufacturer wants to make any changes to the product it must apply for additional approval from the FDA, which is evaluated under similar criteria to the premarket approval. Id. at 319 (citing § 360e(d)(6)). Even if the manufacturer decides not to make any changes, it is still subject to reporting requirements such as needing to inform the FDA of any new clinical investigations concerning the device, or reporting incidents where the device may have caused death or serious injury or malfunctioned in a way that would likely contribute to death or serious injury if the malfunction occurred again. Id. (citing 21 C.F.R. §§ 814.84(b)(2); 803.50(a)).

         C. MiniMed 530G Insulin Pump

         The Pump is classified as a Class III product that has gone through the PMA approval process, and was approved on September 26, 2014. (Def. Br. at 5.) Since receiving the preapproval, Defendants have submitted and received approval for multiple changes to the original device. (Id.)

         D. Procedural History

         Plaintiff initially filed a Complaint before the Superior Court of New Jersey, Camden County, on April 18, 2016. (Docket Item 1 ¶ 1.) On September 6, 2016, Defendant timely removed the case to federal court alleging diversity jurisdiction pursuant to 28 U.S.C. § 1332. (Id. at ΒΆ 6). On November 10, 2016, Plaintiff filed an Amended Complaint, alleging six causes of action: (1) Strict Product Liability; (2) Negligent Design and Manufacture; (3) Post-Sale Negligence; (4) Failure to Test/Warn; (5) Breach of Warranty; and (6) Punitive Damages. [Docket Item 12.] Defendants filed a Motion to Dismiss, Plaintiff ...

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