Medtronic: Implantable defibrillators litigation

Federal District Court Opinions

IN RE MEDTRONIC, INC., (Minn. 11-28-2006) In Re: Medtronic, Inc., Implantable Defibrillators Litigation. 05-MDL-1726 (JMR/AJB). United States District Court, D. Minnesota. November 28, 2006

ORDER

JAMES ROSENBAUM, Chief Judge

The Medtronic, Inc., Implantable Defibrillator Multidistrict Litigation (“MDL”) cases have been transferred to this Court by Order of the Judicial Panel on Multidistrict Litigation. The cases were transferred for consolidated pretrial proceedings pursuant to 28 U.S.C. § 1407. Prior to instituting a full discovery/pretrial schedule, defendant, Medtronic, Inc. (“Medtronic”), has asked the Court to consider its motion for summary judgment based on its claim that federal preemption bars plaintiffs’ claims. The Court has done so. Medtronic’s motion is denied.

I. Background[fn1]

Medtronic manufactures implantable
cardioverter-defibrillators (“ICDs”) and cardiac
resynchronization therapy defibrillators (“CRT-Ds”). Each
device contains a small computer, battery, and capacitor
which stores electrical energy to be used to regulate
cardiac function. These three-ounce devices are surgically
implanted into a subcutaneous pocket. A properly functioning
ICD Page 2 or CRT-D offers potentially lifesaving
treatment for patients susceptible to cardiac arrhythmia.

Medtronic’s defibrillators are Class III medical devices.
These devices are subject to the most intensive review by
the Food and Drug Administration (“FDA”). Under the Medical
Device Amendments (“MDA”) to the Food, Drug, and Cosmetic
Act (“FDCA”), Class III medical devices are used for
“supporting or sustaining human life” or are of
“substantial importance in preventing impairment of human
health.” 21 U.S.C. § 360c(a)(1)(C)(ii)(I) (2002).
Class III devices are subject to a rigorous premarket
approval (“PMA”) process before they may be put on the
market. An applicant for PMA must 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).

Even after approval, medical device manufacturers must
self-report adverse events through the FDA’s medical device
reporting (“MDR”) system. 21 C.F.R. § 803, et. seq.
(2005). These MDR regulations assist the FDA in protecting
“the public health by helping to ensure that devices are .
. . safe and effective for their intended use.” Id. at
§ 803.1(a). The manufacturer must make an FDA report
“no later than 30 calendar days” after it “become[s] aware
of information, from any source, that reasonably suggests
that a device [it] market[s] . . . has malfunctioned and
Page 3 this device or a similar device that [it] market[s]
would be likely to cause or contribute to a death or
serious injury, if the malfunction were to recur.” Id. at
§ 803.50(a).

The FDA first reviewed the devices before the Court when
it considered Medtronic’s Model 7271 defibrillator, which
received its approval on October 9, 1998. Following the
initial approval, Medtronic has systematically modified,
updated, or improved its defibrillators. On these
occasions, Medtronic filed PMA Supplement applications. As
modifications of previously issued PMAs, these later
applications were somewhat less rigorous.

In November, 2000, Medtronic sought FDA approval for its
updated Marquis 7274. A new battery, the Chi 4420L,
constituted a major difference between the proposed Marquis
7274 and its predecessors. Medtronic’s PMA Supplement
application included detailed information and a description
of the new battery. The PMA Supplement application
described modifications of the previous battery design, a
summary of the testing performed on the battery, battery
modeling methodology, and projected the expected life of
the new battery. On March 1, 2000, the Marquis Model 7274
received FDA approval.

Sometime in early 2003, during routine laboratory testing,
Medtronic discovered a defect in the Chi 4420L battery
which caused it to discharge prematurely. Medtronic’s
engineers continued to test the Chi 4420L battery between
February and September of 2003. Page 4 Through these
tests, Medtronic engineers identified and came to
understand the shorting mechanism which led to its observed
battery depletion anomaly. Medtronic did not notify the FDA
or the medical community of this discovery, even though it
had identified, and known for more than six months, a
defect which could cause its defibrillators to lose their
electrical charge in days instead of years.

Medtronic claims it opted against notifying the FDA,
physicians, or patients during this period because it had
not received any field reports of early battery depletion.
Medtronic avers that, absent field reports of failure, it
assumed the potential for depletion was limited to
laboratory conditions. During this six-month period,
Medtronic sold and shipped thousands of Marquis devices
with potentially defective batteries to patients throughout
the country.

Even in the absence of field reports of battery failure or
premature discharge, Medtronic began to redesign its Chi
4420L battery to address the defect in the Spring of 2003.
While this redesign was underway, Medtronic sought and
obtained approval for three additional device models
— the Maximo DR and VR ICDs and Insync II Protect
— each containing the Chi 4420L battery. Each
device’s PMA Supplement application failed to advise the FDA
of the Chi 4420L’s documented shorting problem, or that
this anomaly could lead to premature depletion. Thus, these
new devices received FDA Page 5 approval, and went into
production and distribution with a battery Medtronic knew
could short and discharge prematurely.

On October 6, 2003, Medtronic filed another PMA Supplement
application with the FDA seeking approval to implement
three design changes to the Chi 4420L battery. The
application stated that the prior design had experienced
internal shorts, which it asserted was a “known failure
mode” in the devices. (Ex. O, p. 9.) Medtronic included the
“known failure mode” language in its October, 2003, PMA
Supplement application, despite earlier drafts of the
submissions which described the defect as “a previously
undetected failure mode,” and described and diagramed
details of the known problem. (Ex. F.) Medtronic claims it
deleted references to the “previously undetected failure
mode” from its FDA submissions, because if supplied, the
information might “not [have made] sense to the [FDA]
reviewer.” (Ex. E, Keller Depo. 172:22.)

Based on the information Medtronic supplied, the FDA
approved the new battery’s PMA Supplement application on
October 23, 2003. Even with this new approval in hand,
Medtronic did not notify physicians or patients that its
Marquis devices which contained the Chi 4420L battery posed
a greater risk of battery depletion than its newly-designed
and approved battery. It also continued to ship and sell
ICDs and CRT-Ds containing the Chi 4420L batteries.

Somewhere between February and April, 2004, Medtronic began
to receive field reports of premature battery depletion.
Upon Page 6 receiving this information, Medtronic, for the
first time, reported battery problems through the FDA’s MDR
system.

By December, 2004, more than one year and nine months after
its own discovery of the problem, Medtronic received nine
field returns of devices with premature battery depletion.
Even with this field evidence in hand, it was not until
February, 2005 — two full years after its own
discovery of the battery discharge anomaly — that
Medtronic first warned the public of the defective battery.
At that time, it initiated a voluntary field action, and
sent a “Dear Doctor” letter advising physicians that
certain Marquis devices posed a risk of failure, and
cautioned that “[o]nce a short occurs, [battery] depletion
can take place within a few hours to a few days, after
which there is a complete loss of device function.” (Ex.
H.) On March 16, 2005, the FDA initiated a regulatory
enforcement action against Medtronic, ordering a total
Class II recall of the 87,000 Marquis devices containing
the Chi 4420L battery.

Plaintiffs seek damages for personal injuries resulting
from their receipt of Marquis devices with a defective
battery. Their Master Complaint asserts state law product
liability claims sounding in negligence and strict
liability. Other claims include negligence per se premised
on the FDCA, breaches of express and implied warranties,
misrepresentation by omission, violations of state Consumer
Protection Statutes, and violations of Minnesota Page 7
false advertising and deceptive trade practices statutes.
In addition, plaintiffs seek disgorgement of “unjust
enrichment” related to payment for the devices, and the
spouses of patients seek recovery for derivative loss of
consortium claims.

In support of their opposition to Medtronic’s motion,
plaintiffs have offered the affidavit of Dr. Suzanne
Parisian, a former FDA employee.[fn2] Dr. Parisian avers
that Medtronic failed to inform the FDA of certain
information essential to its continued approval of the Chi
4420L battery. She states that the information Medtronic
supplied was not complete, and failed to advise the FDA of
known defects and failures in its PMA and PMA supplement
applications. In her view, Medtronic failed to take
appropriate action to warn patients and the medical
community about the dangers associated with the devices as
part of the PMA Supplement process. She points to specific
post-marketing requirements, which she claims imposed upon
Medtronic certain obligations which were not fulfilled,
particularly concerning timely performance of
post-marketing studies, timely submission of reports, and
altering devices without prior FDA approval. Assuming these
facts to be Page 8 true, as the Court must at this time,
these allegations have legal consequences.

Medtronic now moves for summary judgment, claiming all of
plaintiffs’ state law claims are preempted by the MDA and
FDA regulations promulgated pursuant to it. Medtronic
argues that plaintiffs’ claims challenge and conflict with
the FDA’s regulatory judgment, as well as the FDA’s
requirements for the devices’ design, labeling, and
manufacturing processes, thus triggering both the doctrines
of express and implied preemption.

II. Analysis

A. Summary Judgment

Summary judgment may only be granted 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). When
material facts or questions of law remain in dispute,
summary judgment must be denied.

B. Preemption

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. IV, cl. 2. In practice, this Page 9 means state laws
conflicting with federal laws or regulations are preempted.
Malone v. White Motor Corp., 435 U.S. 497, 504 (1978).

A court considering a preemption challenge “is not to pass
judgment on the reasonableness of state policy,” but instead
“to decide if a state rule conflicts with or otherwise
`stands as an obstacle to the accomplishment and execution
of the full purposes and objectives’ of the federal law.”
Livadas v. Bradshaw, 512 U.S. 107, 120 (1994) (citation
omitted). Thus, the Court must “ascertain Congress’ intent
in enacting the federal statute at issue.” Metro. Life Ins.
Co. v. Massachusetts, 471 U.S. 724, 738 (1985).

Preemption “is compelled whether Congress’ command is
explicitly stated in the statute’s language or implicitly
contained in its structure and purpose.” Id. at 738
(citations omitted). Express preemption is found when
Congress declares a clear intent to preempt state law.
Hillsborough County v. Automated Med. Labs., Inc., 471 U.S.
707, 712-713 (1985). But state law may be impliedly
preempted, even in the absence of an express Congressional
statement, “when a federal law completely occupies the
field of regulation so that by implication there is no room
for state regulation and the coexistence of federal and
state regulation is not possible.” Missouri Bd. of Exam’rs
for Hearing Instrument Specialists v. Hearing Help Express,
Inc., 447 F.3d 1033, 1035 (8th Page 10 Cir. 2006).
Medtronic asks the Court to find both express and implied
preemption here.

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