The opinion of the court was delivered by: ROBERT KELLY, Senior District Judge
Presently pending before this Court is the Motion for Summary Judgment
of Defendant Medtronic, Inc. (Medtronic"). For the following reasons,
Medtronic's Motion will be granted.
Richard Davenport ("Davenport") filed a Complaint against Medtronic on
January 16, 2001. The three-Count Complaint sets forth claims for
negligence*fn1 (Count I), breach of implied and express warranties
(Count II) and strict product liability (Count III) based on Davenport's
experience with the Medtronic Activa Tremor Control System (the
"Activa"). The Activa is a prescription medical device that was
bilaterally implanted in Davenport to help relieve him of symptoms
with Parkinson's disease.*fn2 Davenport alleges that the Activa
systems implanted in him failed to function properly and caused him
substantial damage.*fn3 In the instant Motion, Medtronic claims that all
of Davenport's claims are preempted by federal law and must be dismissed.
Further, Medtronic argues that Davenport's claims fail as a matter of law
pursuant to applicable Pennsylvania law.
Davenport has suffered from the symptoms of Parkinson's disease since
1976 when he was twenty-nine years old. Prior to having the Activa
systems implanted, Davenport used standard
medication treatment and tried other medical procedures in an attempt to
relieve the symptoms of the disease.*fn4 These methods of treatment were
only temporarily successful and caused numerous side effects. Thus, the
failures of these treatment options led Davenport to the surgical implant
of the Activa systems.
The Activa consists of three distinct implanted components: (1) the
implantable pulse generator (the "IPG"), (2) the extension lead (the
"Extension") and (3) the intra-cranial lead (the "Lead"). First, the IPG
is the power source for the Activa and it is inserted in the recipients's
thorax. The IPG is composed of a sealed, oval-shaped, metal container
that houses a special battery and programmable electronics that dictate
the electric charge generated by the battery. Second, the Extension is a
thin insulated wire that contacts the IPG and the Lead. The Extension
transports the electrical pulses from the IPG to the Lead. Finally, the
Lead is a thin insulated wire that enters the brain. The Lead has a
series of tiny electrodes at one end that convey electrical pulses from
the Extension to the tissues in the brain. These pulses are intended to
stimulate portions of the brain to suppress the symptoms of Parkinson's
The Activa operates by electronically stimulating the targeted tissues
in the brain that control movement and muscle function through a process
called Deep Brain Stimulation ("DBS"). The DBS is intended to interrupt
the messages to the brain that cause the symptoms of Parkinson's
disease (i.e. tremors) and suppress these symptoms. As a result of
DBS, patients are theoretically supposed to achieve greater control over
their bodily movements. It should be noted that the surgical implantation
of the Activa is done in two stages. In stage one, a hole is drilled into
the cranium of the patient and the electrodes are introduced into the
brain. The second stage of the procedure calls for the implantation of
the IPG in the chest area. The IPG is then programmed using an external
console and the system is completely activated.
C. The Activa and the Pre-Market Approval Process
A central issue in this case is whether Davenport's state claims are
preempted by the Medical Device Amendments of 1976 to the Federal Food,
Drug, and Cosmetic Act, 21 U.S.C. § 321-394 ("MDA"). Medtronic
contends that Davenport's state claims are preempted because the Activa
went through a pre-market approval ("PMA") process by the Food and Drug
Administration ("FDA"). A brief discussion of the MDA and PMA is
necessary for disposition of the instant Motion.
The MDA establishes a comprehensive regulatory framework for
controlling the safety and effectiveness of medical devices. The MDA
classifies medical devices into three categories (Classes I, II, or III)
based on the risk that the devices pose to the public. Class III devices
are those that "(1) [are] to be used for supporting or sustaining human
life or that [are] of substantial importance in preventing impairment of
public health; or (2) present a potential unreasonable risk of illness
or injury."*fn5 Horn v. Thermo Cardiosystems, Inc., 229 F. Supp.2d 381,
385 (M.D. Pa. 2002)
(citing 21 U.S.C. § 360c(a)(1)(C)(ii)(I-II)). A Class III device is
subject to a strict safety evaluation by the FDA. Significantly,
"[b]efore a Class III device may be introduced to the market, the
manufacturer must provide the [FDA] with a reasonable assurance that the
device is safe and effective under the MDA. To provide that assurance, a
manufacturer must obtain [PMA] from the FDA."*fn6 Mitchell v. Collagen
Corp., 126 F.3d 902, 905 (7th Cir. 1997). The PMA is a rigorous process
in which manufacturers must submit detailed information to have their
If the FDA determines that the manufacturer has established a
"reasonable assurance that the device is safe and effective under the
MDA, the agency then issues an order that allows the manufacturer to
market the device as approved." Steele, 2003 WL 22946150, at *2. "It does
so after a manufacturer demonstrates that the manufacturing and
processing methods and facilities conform to FDA requirements, and that
the proposed labeling of the device is not false or misleading." Id.
(citing 21 U.S.C. § 360e(d)(2)). Subsequently, the manufacturer may
not change the approved labeling, product design or manufacturing process
in any manner that would affect the safety or effectiveness
of the device. Id.
In the instant case, the parties do not dispute that the Activa is a
Class III medical device. Moreover, the parties agree that the Activa
went through the rigorous PMA process and was approved by the FDA before
it was marketed by Medtronic.*fn8 Specifically, on July 31, 1997, "the
FDA approved the PMA application for the [Activa] as indicated for
unilateral thalamic stimulation for suppression of essential and
Parkinsonian tremor." (Def.'s Mem. Supp. Summ. J. at 6). This PMA
indicates that all of the FDA's stringent requirements were satisfied in
relation to the Activa.
D. Davenport's Experience with the Activa
In 1998, Davenport began researching DBS and learned of the Activa
after other methods of treating his Parkinson's disease were
unsuccessful. Initially, Davenport discussed the procedure with one of
his doctors, Dr. Stephen Gollomp ("Dr. Gollomp"), and Dr. Gollomp
recommended that Davenport consider the DBS procedure. However, Dr.
Gollomp explained to Davenport that DBS was not yet approved by the FDA
for the indication that Davenport needed. Specifically, Davenport's
condition necessitated that a bilateral DBS would need to be performed.
Thus, while at that point the FDA had approved only unilateral use of the
Activa, a bilateral implant of the Activa would involve the implantation
of two complete systems (two IPGs, two Extensions and two Leads) to
stimulate both sides of the brain.*fn9 After learning of the FDA's
failure to approve bilateral DBS for patients with Parkinson disease,
Davenport was prompted to write the FDA regarding why bilateral DBS had
not been approved. Davenport received no response from the FDA.
In October of 1998, Davenport met with Dr. Michael Munz ("Dr. Munz") of
Temple University Hospital to discuss bilateral implantation of the
Activa as therapy for his symptoms. Dr. Munz informed Davenport that the
bilateral implantation would be an "off-label use of the [Activa] for his
particular case."*fn10 (Munz Dep. at 88). Dr. Munz told Davenport that
"the FDA ha[d] approved the device that all of the components of the
device were approved, but the FDA . . . was working with Medtronic to
approve it for this particular . . . indication." (Id.).
On November 9, 1998, Dr. Munz performed a surgical bilateral implant of
Activa systems on Davenport. After surgery was completed, the Activa
systems were activated and Davenport found that many of the symptoms of
his Parkinson's disease became suppressed.
Specifically, "he not only had relief from tremors but also obtained
relief from dyskinesia (abnormal moving of extremities in a slow
fashion). . . . He also noted improvement in his stiffness, equilibrium
and balance." (Pl.'s Mem. Opp. Summ J. at 2).
Within a month or two after surgery, Davenport began to experience
problems. For example, the IPGs began to turn off and on for no apparent
reason. Moreover, Davenport began feeling fluttering sensations in his
chest. The problems with the IPGs and the fluttering sensations continued
for months. In fact, the sensations in the chest caused Davenport to
check himself into Chester County Hospital where he was cleared of any
cardiac abnormalities. As a result of these complications, Davenport
visited Dr. Munz in March of 1999 for an evaluation. In conjunction with
this visit, Medtronic representative Denise Kelly ("Kelly") interrogated
Davenport's Activa devices. Kelly was able to identify two possible
explanations for Davenport's complaints: (1) the IPGs had been placed too
close to each other or (2) bodily fluid had leaked into one IPG. (Kelly
Dep. at 37-44).
On April 14, 1999, Dr. Munz removed the IPGs and implanted two new
IPGs, keeping the previously implanted extensions. Dr. Munz attempted to
place the new IPGs farther apart from one another in attempt to prevent
any future complications. In performing the operation, Dr. Munz noticed
that a strand of fatty material had grown in one of the explanted IPG
connectors, the mechanism that attached the IPG to the Extension. At this
time, Dr. Munz hypothesized that the fatty material had created a "fluid
short" that was the cause of Davenport's complications.
On October 5, 1999 (approximately six months after his second surgery),
Davenport had additional problems with the Activa systems. At the
suggestion of Dr. Gollomp, Davenport went to Chester County Hospital.
Again, Kelly interrogated the Activa systems on behalf of Medtronic.
Kelly found that the IPGs were functioning normally, but found that
electricity was not flowing
properly to the contacts in the brain. Subsequently, Davenport was
transferred to Temple University Hospital, where he was put under the
care of Dr. Jack Jallo ("Dr. Jallo"), since Dr. Munz had left the
On October 6, 1999, Dr. Jallo performed another surgery on Davenport to
evaluate the Activa systems. Initially, Dr. Jallo interrogated the IPGs
and found that they were functioning properly. After analysis of the
Extension components of the systems revealed no problems, Dr. Jallo
hypothesized by a process of elimination (since there are only three
separate components to each Activa system) that the Activa systems were
not functioning normally because there were fractures in the Leads that
extended into the brain. Revision and replacement of the Leads was
discussed at the time, but Davenport was unwilling to commit to the
surgery that would be required.*fn11 The Activa systems were turned off
and Davenport was discharged from Temple Hospital on October 9, 1999.
Subsequently, Davenport suffered further medical problems. On October
11, 1999, Davenport was readmitted to Chester County Hospital because he
had sustained a right hemothorax as a result of the October 9, 1999
surgery. Davenport underwent two surgical procedures to correct this
problem. After he was discharged from the hospital on October 23, 1999,
he was readmitted to the same hospital two days later complaining of
"chest pains, shortness of breath and swelling, and was found to have
acute inflammation with hypoalbuminemia and a urinary tract infection."
(Def.'s Mem. Supp. Summ. J. at 15).
E. Procedural History*fn12
Davenport originally filed a Writ of Summons against Medtronic on
November 3, 2000, in the Philadelphia County Court of Common Pleas.
Medtronic removed the case to this Court and Davenport filed his
Complaint on January 16, 2001. The three-Count Complaint set forth claims
for negligence (Count I), breach of implied and express warranties (Count
II) and strict product liability (Count III) based on Davenport's
experience with the Activa systems. Medtronic answered the Complaint on
February 12, 2001.
On January 28, 2003, the Court entered an Order, agreed to by the
parties, regarding testing of the IPGs that were explanted from Davenport
on April 14, 1999. On July 23, 2003, Medtronic completed its testing
pursuant to the aforementioned Order. As stated by Medtronic and conceded
by Davenport, "[b]oth IPGs passed Medtronic's final functional test,
confirming that they satisfied the PMA-approved functional and
performance requirements." (Def.'s Mem. Supp. Summ. J. at 16). Moreover,
as stated by Medtronic and conceded by Davenport, "Medtronic also
performed extensive interaction characterization testing of the two IPGs,
including a series of tests specifically requested by Plaintiff's
expert, and found no interaction between the IPGs that would explain
Plaintiff's complaints of sensations within his chest adjacent to the
IPGs." (Id.) Notably, Davenport has not performed any tests on the IPGs
as he is permitted to pursuant to the January 28, 2003 Order.
Medtronic filed the instant Motion for Summary Judgment on September
22, 2003. Medtronic claims that all of Davenport's claims are preempted
by federal law and must be dismissed. Further, Medtronic argues that
Davenport's claims fail as a matter of law pursuant to applicable
Pennsylvania law. On October 9, 2003, Davenport filed his Response to the
Instant Motion. Additionally, on December 11, 2003, the Court granted
Medtronic's Motion for Leave to File a Reply