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Clark v. Medtronic, Inc.: US District Court : CIVIL PROCEDURE | MEDICAL - MDA preemption of claims regarding defibrillator; no res ipsa loquitur

1When considering a motion for summary judgment, the court views the
facts most favorably to the plaintiff, the nonmoving party. See
Ludwig v. Anderson, 54 F.3d 465, 470 (8th Cir. 1995). The facts
set forth in this opinion are based on the parties pleadings, and
are not binding determinations.
Demetrus Claude Clark )
v. ) ORDER
Medtronic, Inc. )
Plaintiff, Demetrus Claude Clark, claims defendant, Medtronic,
Inc. (Medtronic), was negligent in manufacturing and marketing
its Model 7278 Maximo implantable cardioverter-defibrillator
(ICD). Medtronic moves for summary judgment based on federal
preemption. Defendants motion is granted.
I. Background1
A. Federal Premarket Approval Process
ICDs are implantable, silver-dollar size, highly-technical
electronic devices designed to detect, and almost-instantaneously
treat, ventricular tachycardia, or fibrillation, a life-threatening
condition. A properly functioning ICD administers an electrical
pulse which reestablishes a regular heartbeat. The United States
Food and Drug Administration (FDA) classifies ICDs as Class III
medical devices.
Class III devices are used in extraordinarily dangerous
situations. They frequently represent the cutting edge of
medicine. The devices are used only when the patient is in such
danger that, although the devices themselves may subject the
patient to risks, those risks are less than those faced if the
device is not used. See 21 U.S.C. 360c(2)(C) ([T]he safety and
effectiveness of a device are to be determined . . . weighing any
probable benefit to health from the use of the device against any
probable risk of injury or illness from such use.).
Class III medical devices are regulated under the Medical
Device Amendments (MDA) to the Food, Drug, and Cosmetic Act. 21
U.S.C. 360e; Riegel v. Medtronic, Inc., 128 S.Ct. 999, 1003-04
(2008). A manufacturer which markets a Class III device must meet
the FDAs rigorous premarket approval standards. It must also
demonstrate a reasonable assurance that the device is both safe
. . . [and] effective under the conditions of the use prescribed,
recommended, or suggested in the proposed labeling thereof. 21
U.S.C. 360e(d)(2)(A)(B)(2004).
On September 8, 2003, as part of Medtronics application for
ICD Model 7278 premarket approval, defendant submitted (i) a
multivolume application for the device, including full reports of
all information published . . . or which should reasonably be
known to the applicant concerning investigations which have been
made to show whether or not such device is safe and effective;
(ii) a full statement of the devices components, ingredients,
and properties and of the principle or principles of operation;
(iii) a full description of the methods . . . facilities and
controls used for, the manufacture of the device; (iv) samples of
the device; and (v) a sample of the proposed label. 21 U.S.C.
360e(c)(1). Model 7278's application was submitted as a supplement
to a prior premarket approval granted for its predecessor, Model
7271. The FDA granted premarket approval for Model 7278 in
October, 2003.
Once FDA Class III approval is granted, a manufacturer is
restricted in the devices design specifications, manufacturing
processes, and labeling. Any proposed change is allowed only after
submission and approval of a supplemental application, which must
provide a detailed description of the change, data in support
thereof, and a statement that the change complies with all
requirements of the Food, Drug, and Cosmetic Act. 21 U.S.C.
360e(d)(6)(A)(i). The manufacturer must also report the results of
new scientific studies or investigations related to the safety or
effectiveness of the device on an ongoing basis, 21 C.F.R.
814.84(b)(2), along with any incidents where the device caused
death or serious injury, or where it malfunctioned in a way that
could lead to death or serious injury if the malfunction recurred.
21 C.F.R. 803.50(a).
The Commissioner of the FDA is authorized to withdraw approval
upon a finding of new information indicating the device is either
ineffective or unsafe. 21 U.S.C. 360e(e)(1). Here, no
supplement was filed, meaning the FDAs initial Model 7278 approval
remained in effect at all times relevant to this case.
B. Plaintiffs Device
Plaintiff received a Medtronic Model 7278 Maximo ICD on
September 8, 2004. The device was implanted after plaintiff was
diagnosed with non-ischemic cardiomyopathy, a disease of the heart
muscle which is not caused by coronary artery disease. Nonischemic
cardiomyopathy leads to arrhythmia, and, in some cases,
causes heart failure.
After the implantation, plaintiff returned to the hospital six
times complaining that the ICD was delivering inappropriate
shocks. Eventually, hospital staff determined the inappropriate
shocks were caused by T-wave oversensing. T-wave refers to that
portion of an electrocardiogram representing the repolarization, or
recovery, of the ventricles in the heart. This is one of the
elements measured to detect arrhythmia. On September 28, 2006,
plaintiffs Model 7278 was replaced with a different ICD
manufactured by St. Jude Medical, Inc. Plaintiff has not reported
any misfirings since.
Plaintiff, a citizen of Mississippi, filed his complaint in
the United States District Court for the District of Minnesota.
Defendant is headquartered in Minnesota, and concedes personal
jurisdiction and venue. Plaintiff alleges multiple state tort
claims including strict liability, breach of warranty, negligence,
misrepresentation, and violation of Minnesotas consumer protection
laws. Plaintiff claims defendant (1) was negligent in the design
and manufacture of ICD Model 7278; or (2) failed to warn him, his
doctor, or the FDA of unreasonable risks in its manufacture or
reliability. Defendant moves for summary judgment, invoking
federal preemption, and argues plaintiffs claims challenge and
conflict with the FDAs regulatory judgment and its ICD labeling
and manufacturing process requirements.
II. Legal Standard
Summary judgment may be granted only when there are no
material facts in dispute and the moving party is entitled to
judgment as a matter of law. Fed. R. Civ. P. 56; Celotex Corp. v.
Catrett, 477 U.S. 317, 322-23 (1986); Anderson v. Liberty Lobby,
Inc., 477 U.S. 242, 247-48 (1986). The question of federal
preemption under the MDA is reserved to the Court and is properly
resolved on summary judgment. See Riegel v. Medtronic, Inc., 451
F.3d 104, 105 (2nd Cir. 2006), affd, 128 S.Ct. 999 (2008).
Federal preemption derives from the Supremacy Clause of the
United States Constitution. The Constitution establishes the laws
of the United States as the supreme Law of the Land . . . any
Thing in the Constitution or Laws of any State to the Contrary
notwithstanding. U.S. Const. art. VI, cl. 2. State laws which
conflict with federal laws or regulations are preempted. Malone v.
White Motor Corp., 435 U.S. 497, 504 (1978).
The United States Supreme Court extensively examined federal
preemption in the context of medical devices in Riegel v.
Medtronic, Inc., 128 S.Ct. 999 (2008). Riegel considered an
inflatable catheter which ruptured in a patients artery. The
catheter was a Class III medical device which had received FDA
premarket approval. The Supreme Court affirmed the district
courts decision that the MDA pre-empted Riegels claims of strict
liability; breach of implied warranty; and negligence in the
design, testing, inspection, distribution, labeling, marketing, and
sale of the catheter. The Court also pre-empted a negligent
manufacturing claim insofar as it was not premised on the theory
that Medtronic violated federal law. Riegel, 128 S.Ct. at
In Riegel, the Supreme Court established a two-part test to
decide whether the MDA preempts a state claim. A court must first
determine whether the Federal Government has established
requirements applicable to the particular medical device. Id. at
1006. Second, a court must determine whether the state law claims
are based on requirements different from, or in addition to the
federal requirements, relating to safety and effectiveness or any
requirement under the MDA. Id. (quoting 21 U.S.C. 360k(a)). In
applying the two-part test, the Court distinguished premarket
approval from substantial equivalence review. Substantial
equivalence review under 510(k) of the MDA is essentially an
2There is absolutely no suggestion that Medtronics Model 7278
Maximo ICD at issue before this Court is grandfathered in any
exemption from federal safety review focused merely on whether a
device is substantially equivalent to a device that has been
grandfathered, by being marketed prior to the MDAs effective
date.2 Id. at 1007. Unless a device is grandfathered, premarket
approval is the mechanism by which the federal government reviews
the safety of, and approves specific requirements for, individual
devices having no MDA exemption. Id. Therefore, the Court noted,
[p]remarket approval . . . imposes [federal] requirements under
the MDA preemption clause. Id. at 1007.
The second part of the Riegel test asks whether state tort
laws are different from, or in addition to federal requirements.
21 U.S.C. 360k(a)(1). Preemption applies to both state statutory
and common law. Riegel, 128 S.Ct. at 1008. However, state laws
which parallel federal laws are not preempted, so long as they
neither add to nor vary from federal requirements. Id. at 1011.
While the Supreme Court conceded the possibility of a private
action for violation of FDA regulations, it held Riegels plaintiff
alleged the device violated state tort law notwithstanding
compliance with the relevant federal requirements. Id.
Consequently, the Court found federal preemption.
III. Analysis
The ruling in Riegel is directly on point. Here, plaintiffs
claims parallel those in Riegel. And, perforce, the MDA preempts
them. As in Riegel, plaintiff alleges his device did not perform
as expected; he particularly claims his ICD fired inappropriately
instead of maintaining and regulating his hearts rhythm. The
Court assumes this to be true, but the assumption does not save his
claim. In Riegel, the balloon catheter exploded instead of
expanding the plaintiffs arterial lumen.
In fine, plaintiff claims Medtronic violated the premarket
approval requirements when it manufactured a defective ICD, or,
alternatively, that premarket approval was fraudulently obtained
by Medtronics having concealed known defects in its ICDs design
or manufacture. The gravamen of plaintiffs argument is that he
would not have endured inappropriate shocks if Medtronics Model
7278 had been manufactured in compliance with a properly obtained
premarket approval, or that premarket approval would not have been
granted had defendant told the FDA of the risks of T-wave
Plaintiffs claims fail because, faced with Medtronics motion
for summary judgment, he offers no evidence to support his
assertions. He relies, instead, on the doctrine of res ipsa
loquitur for the proposition that full compliance would have
resulted in a problem-free device. Res ipsa loquitur does not
suffice. Res ipsa loquitur permits an inference of negligence when
there can be no other explanation. But this is not a barrel
falling from a second-story warehouse door. See Byrne v. Boadle,
159 Eng. Rep. 299 (1863).
A Medtronic ICD is a complex device which can fail for a
variety of reasons, including medical complications, body rejection
phenomena, allergic reaction, and surgical techniques, all of which
occur without someone acting in a negligent manner. Mozes v.
Medtronic, Inc., 14 F. Supp. 2d 1124, 1129 (D. Minn. 1998). If
negligence were the only cause of a Class III devices failure,
there would be no need for the MDAs ongoing reporting
requirements. See 21 C.F.R. 814.84(b)(2). Plaintiff is
ultimately wrong when he assumes that premarket approval guarantees
the device is completely safe. As the Supreme Court aptly
recognized, the premarket approval process is ultimately a costbenefit
analysis in which the potential health benefits are weighed
against the potential risks. Riegel, 128 S.Ct. at 1008.
Plaintiffs res ipsa loquitur argument is undermined when he
asserts that the most likely cause of the inappropriate shocks was
T-wave oversensing, and Medtronics representative was negligent in
recommending this model to treat his condition. In making this
allegation, plaintiff essentially concedes Model 7278s
susceptibility to T-wave oversensing was possibly caused by
plaintiffs unique physiology, rather than any general defect.
Because defendants negligence is not the only possible explanation
for this devices failure, plaintiffs reliance on res ipsa
loquitur cannot be sustained.
His case also fails because T-wave oversensing is a recognized
risk in this product. Plaintiff is plain wrong when he claims
Medtronic violated its premarket approval authority knowing of the
risk of T-wave oversensing without informing the FDA. The record
shows the FDA was fully informed of this risk. The devices
FDA-approved manual includes warnings about T-wave oversensing;
therefore, it is simply not true defendant concealed this risk.
More importantly, Congress has granted the FDA exclusive power to
enforce MDA premarket approvals. Buckman Co. v. Plaintiffs Legal
Comm., 531 U.S. 341, 352 (2001). In fact, private actions to
enforce the MDA are expressly prohibited under 21 U.S.C. 337(a).
Consequently, plaintiff would not be able to raise this claim even
if it were supported by the facts.
Plaintiff tries to save his claims from preemption by
resorting to the Supreme Courts allowance of state claims narrower
than federal claims, and its concession that a narrower
requirement might be different from the federal rules in a
literal sense. Medtronic, Inc. v. Lohr, 518 U.S. 470, 495
(1996). This argument is unavailing.
Plaintiff fails to show which of his state claims are, in any
fashion, narrower than those which are MDA/Riegel preempted. Nor
has he shown how any of his claims might be narrower. It is
difficult to imagine precisely which narrower state claims still
exist after Riegel, but, in any case, plaintiff has failed to show
how his claims are among them. Because plaintiffs claims are not
based on a breach of the MDA as enforced by the FDA, the claims are
not grounded in state laws that parallel federal requirements.
Thus, plaintiffs claims are preempted.
III. Conclusion
For the foregoing reasons, the Court finds plaintiffs claims
are preempted by federal law, and therefore fail as a matter of
Accordingly, IT IS ORDERED that defendants motion for summary
judgment [Docket No. 23] is granted. Plaintiffs claims are
dismissed with prejudice.
Dated: August 18, 2008
United States District Judge


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