United States District Court, D. New Jersey
D. Cronin, Esq. CRONIN LAW FIRM LLC Attorney for Plaintiff.
Van Nostrand, Esq. GREENBERG TRAURIG LLP Attorney for
B. SIMANDLE U.S. DISTRICT JUDGE.
Kevin Hart (hereinafter, “Plaintiff”) brought
this suit against Defendants Medtronic, Inc., Medtronic
International, and Medtronic Minimed, Inc., 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.
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.)
Premarket Approval Process
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.
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
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)).
MiniMed 530G Insulin Pump
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.)
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 ¶
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 ...