United States District Court, E.D. Pennsylvania
February 3, 2004.
RICHARD DAVENPORT, Plaintiff,
MEDTRONIC, INC., Defendant
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.
B. The Activa
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
Brief and Medtronic's Reply Brief was deemed filed. The Court held
a Hearing regarding the instant Motion on December 19, 2003.
II. SUMMARY JUDGMENT STANDARD OF REVIEW
Pursuant to Rule 56(c) of the Federal Rules of Civil Procedure, summary
judgment is proper "if there is no genuine issue as to any material fact
and the moving party is entitled to judgment as a matter of law." FED.
R. CIV. P. 56(c). Essentially, the inquiry is "whether the evidence
presents a sufficient disagreement to require submission to the jury or
whether it is so one-sided that one party must prevail as a matter of
law." Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 251-252 (1986). The
moving party has the initial burden of informing the court of the basis
for the motion and identifying those portions of the record that
demonstrate the absence of a genuine issue of material fact. Celotex
Corp. v. Catrett, 477 U.S. 317, 323 (1986). An issue is genuine only if
there is a sufficient evidentiary basis on which a reasonable jury could
find for the non-moving party. Anderson, 477 U.S. at 249. A factual
dispute is material only if it might affect the outcome of the suit under
governing law. Id. at 248.
To defeat summary judgment, the non-moving party cannot rest on the
pleadings, but rather that party must go beyond the pleadings and present
"specific facts showing that there is a genuine issue for trial." FED.
R. CIV. P. 56(e). Similarly, the non-moving party cannot rely on
unsupported assertions, conclusory allegations or mere suspicions in
attempting to survive a summary judgment motion. Williams v. Borough of
W. Chester, 891 F.2d 458, 460 (3d Cir. 1989)(citing Celotex, 477 U.S. at
325 (1986)). Further, the non-moving party has the burden of producing
evidence to establish prima facie each element of its claim. Celotex, 477
U.S. at 322-23. If the court, in viewing all reasonable inferences in
favor of the non-moving party, determines that there is no genuine issue
of material fact, then summary judgment is proper. Id. at 322; Wisniewski
Johns-Manville Corp., 812 F.2d 81, 83 (3d Cir. 1987).
As previously noted, Davenport's three-Count Complaint sets forth
claims for negligence (Count I), breach of implied and express warranties
(Count II) and strict product liability (Count III) based on his
experience with the Activa. In the instant Motion, Medtronic claims that
all of Davenport's claims are expressly 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. The Court will now
address each of these arguments in light of the applicable summary
A. Preemption Generally
Article VI of the United States Constitution provides that the laws of
the United States "shall be 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. Thus, "any state law that
conflicts with federal law is `without effect.'" Cipollone v. Ligget
Group, Inc., 505 U.S. 504, 516 (1992) (citation omitted). Express
preemption, where there is a explicit federal statutory command that state
law be displaced, is one manner by which federal law may preempt state
law.*fn13 St. Thomas-St. John Hotel & Tourism Ass'n, Inc.
v. Gov't of the U.S. Virgin Is., 218 F.3d 232, 238 (3d Cir. 2000).
"Whether federal law preempts a state law establishing a cause of action
is a question of congressional intent." Hawaiian Airlines, Inc. v.
Norris, 512 U.S. 246, 252 (1994). Further, "[i]f the statute contains an
express preemption clause, the task of statutory construction must in the
first instance focus on the plain wording of the clause, which
necessarily contains the best evidence of Congress' preemptive intent."
CSX Transp., Inc. v. Easterwood, 507 U.S. 658, 664 (1993). In the instant
case, Medtronic moves for summary judgment claiming that all of
Davenport's state-law claims are expressly preempted by a provision of
B. The MDA's Preemption Clause
Section 360k of the MDA expressly preempts specific state-law
requirements regarding medical devices. The preemption provision states
[N]o state or political subdivision of a State may
establish or continue in effect with respect to a
device intended for human use any requirement
(1) which is different from, or in addition to,
any requirement applicable under this chapter to
the device, and
(2) which relates to the safety and effectiveness
of the device or to any other matter included in a
requirement applicable to the device under this
21 U.S.C. § 360k(a). As one court in the Third Circuit recently
emphasized, "although at first glance the language of Section 360k(a)
might seem fairly straightforward, that section has spawned a legion of
cases attempting to determine its preemptive scope." Steele, 2003 WL
22946150, at *7.
In Medtronic, Inc. v. Lohr, the Supreme Court, in a plurality opinion,
discussed the preemptive scope of Section 360k. 518 U.S. 470 (1996). The
issue in Lohr was whether state tort claims were preempted because the
FDA allowed a Class III pacemaker device to be marketed because it
qualified as "substantially equivalent" to a pre-existing device.*fn14
Id. at 484. In Lohr, the
plaintiff received a pacemaker (a Class III medical device) from a
manufacturer. Id. at 481. The FDA allowed the pacemaker to be marketed
because it was "substantially equivalent" to a preexisting medical device
and was therefore exempted from the PMA process. Id. at 492. The
plaintiff who received the device developed a serious heart condition that
required surgery after the pacemaker malfunctioned. Id. at 481. Plaintiff
filed suit against the manufacturer alleging both negligence and strict
liability claims for defective design, failure to warn and negligent
The Court concluded that the plaintiff's claims were not preempted
based on the fact that the "substantially equivalent" review process was
not the type of specific federal requirement that triggered preemption.
Id. at 501 (stating that the "substantially equivalent" approval process
"reflects important but entirely generic concerns about device regulation
generally, not the sort of concerns regarding a specific device or field
of device regulation which the statute or regulations were designed to
protect from potentially contradictory state requirements"). In deciding
the case, the Lohr Court offered guidance concerning when the MDA
mandates that state-law claims are preempted. First, there must be a
federal requirement that is specific to the particular device. Id. at
500. Second, there must be a state-law requirement that relates "to the
safety and effectiveness of the device or to any other matter included in
a requirement applicable to the device." Id. Finally, the state
requirement must be "different from or in addition to" federal
The majority of the Justices in Lohr also clarified that state
common-law claims could be preempted pursuant to the MDA preemption
provision if the aforementioned elements were met. Horn, 229 F. Supp.2d at
389 (M.D. Pa. 2002)(citations omitted). Specifically, in his
concurrence, Justice Breyer stated that "the MDA preempts a state
requirement embodied in a state statute, rule, regulation, or other
administrative action, [as it would] pre-empt a similar requirement that
takes the form of a standard of care or behavior imposed by a state-law
tort action." Lohr, 518 U.S. at 504 (Breyer, J., concurring in part and
concurring in the judgment). Significantly, for purposes of the instant
case, the Court also emphasized that "nothing in § 360k denies [a
state] the right to provide a traditional damages remedy for violations
of common-law duties when those duties parallel federal requirements."
Id. at 495. As stated by Horn, this statement clarifies that "so long as
the [plaintiff's] claims [seek] to enforce only the specific regulations
that the FDA imposed upon the [medical device], those claims [do] not
constitute different or additional requirements and [are] not preempted."
Horn, 229 F. Supp.2d at 389.
The Lohr Court left open the question of whether the PMA process itself
imposes specific federal requirements on a medical device to trigger
preemption pursuant to the MDA. Nevertheless, post-Lohr, a vast majority
of federal and state courts have held that the PMA approval process sets
specific federal requirements on a medical device that provoke preemption
of state-law claims. See, e.g., Brooks v. Howmedica, Inc., 273 F.3d 785,
795-96 (8th Cir. 2001), cert. denied, 535 U.S. 1056 (2002); Martin v.
Medtronic, Inc., 254 F.3d 573, 584 (5th Cir. 2001), cert. denied,
534 U.S. 1078 (2002); Kemp v. Medtronic, Inc., 231 F.3d 216, 226-27 (6th
Cir. 2000), cert. denied, 534 U.S. 818 (2001); Mitchell, 126 F.3d at 911
(7th Cir. 1997); Enlow v. St. Jude Med., Inc., 210 F. Supp.2d 853, 858-62
(W.D. Ky. 2001); Easterling v. Cardiac Pacemakers, Inc., 986 F. Supp. 366,
373-75 (E.D. La. 1997); Richman v. W.L. Gore & Assocs.
988 F. Supp. 753, 758 (S.D.N.Y. 1997);
Fry v. Allergan Med. Optics, 695 A.2d 511, 516 (R.I. 1997); Green v.
Dolsky, 685 A.2d 110, 117-18 (Pa. 1996). Further, prior to Lohr, the
Court of Appeals for the Third Circuit ("Third Circuit') held that the
PMA imposes federal requirements that trigger preemption pursuant to the
MDA.*fn15 Michael v. Shiley, Inc., 46 F.3d 1316, 1324 (3d Cir. 1995).
Courts within this Circuit have recently agreed with the position of this
strong majority concerning the preemptive impact of the PMA and have
found that this position is consistent with Shiley. Steele, 2003 WL
22946150, at *11, Horn, 229 F. Supp.2d at 390.
This Court follows the position of Shiley and the strong majority and
finds that the Activa's PMA process imposes specific federal requirements
that trigger preemption pursuant to the MDA's preemption clause and the
first prong of the Lohr Court's guidance. This Court agrees that the "PMA
of a product's design, testing, intended use, manufacturing methods,
performance standards and labeling, is `specific to the product,' and
therefore preempts state-law claims that would impose requirements
`different from, or in addition to' the agency's determination on those
matters." Steele, 2003 WL 22946150, at *11 (citing Mitchell, 126 F.3d at
913). As Horn emphasized,
many courts have distinguished the PMA process from
the [`substantially equivalent'] process, holding PMA
to be a specific requirement, even after Lohr's
holding that [the `substantially equivalent' process]
does not trigger preemption. They point to the fact
that while the [`substantially equivalent' review]
focuses only on `equivalence' to an already-existing
product, the PMA process is much more rigorous and
focuses on the safety of a new, specific product.
229 F. Supp.2d at 390. We agree with this reasoning and find that
the device-specific and thorough nature of the PMA process imposes
specific federal requirements that trigger preemption.
C. Preemption of Davenport's Claims
The fact that this Court follows the majority view and Shiley, and
finds that PMA of the Activa triggers preemption because it qualifies as
a specific federal requirement, does not end the inquiry. We must still
determine whether the specific claims set forth by Davenport are
preempted based on the other Lohr preemption factors and Section 360k of
the MDA. In this case, this Court finds that a majority of Davenport's
claims are not preempted based on the nature of his allegations.
1. Strict Product Liability and Negligence Claims
Davenport's strict product liability claim is premised on the theory
that the Activa systems had manufacturing defects when they left the
control of Medtronic. (Comp. ¶ 34). In terms of the negligence
claim, Davenport's allegations are two-pronged. Davenport alleges that
the Activa systems implanted in him were negligently manufactured. (Id.
¶¶ 24-25). Moreover, Davenport alleges that Medtronic was negligent in
allowing bilateral implantation of the Activa when it knew that the FDA
had only approved the device for unilateral implantation at the time of
his initial surgery. (Id. ¶ 26). Based on the nature of these strict
product liability and negligence claims, it is clear from Lohr and
subsequent case-law that these claims are not preempted pursuant to the
As previously noted, the Lohr Court emphasized that "nothing in §
360k denies [a state] the right to provide a traditional damages remedy
for violations of common-law duties when those duties parallel federal
requirements." Lohr, 518 U.S. at 495. As the Court of Appeals for the
Fifth Circuit ("Fifth Circuit") recognized, "[t]his language tells us
that tort suits based on a manufacturer's failure to follow the FDA's
regulations and procedures are not preempted. . . . In the context of the
PMA process,. . . state tort suits that allege, as the basis of their
claim, that the approved FDA requirements have not been met are not
preempted." Martin, 254 F.3d at 583; see also Mitchell, 126 F.3d at 913
n.6 ("To the extent that the [Plaintiff's] complaint may be read as
alleging that [the
manufacturer] was negligent in adherence to standards of the FDA in the
PMA, the negligence claim would not be preempted."); Horn, 229 F. Supp.2d
at 389 (emphasizing that the Lohr Court "stated that as long as the
plaintiffs' claims sought to enforce only the specific regulations that
the FDA imposed upon the pacemaker, those claims did not constitute
different or additional requirements and were not preempted").
In the present case, Davenport's strict product liability and negligent
manufacturing claims are based on the theory that the Activa systems
implanted in him did not satisfy PMA/FDA standards. These claims do not
impose requirements "different from or in addition to" PMA/FDA
requirements, which is a requirement for preemption under Lohr and
Section 360k of the MDA. As such, the strict product liability and
negligent manufacture claims are not preempted pursuant to the MDA.
Further, Davenport's claim that Medtronic was negligent in allowing a
bilateral implantation of the Activa, when the FDA had only approved the
device for unilateral implantation, is also not preempted as this claim
concerning Medtronic's conduct does not fall within the realm of the
MDA's preemption clause.
2. Express Warranty Claim
The foundation for Davenport's express warranty claim is not clear from
the face of the Complaint or his Response to this Motion.*fn16 However,
at the Hearing on the instant Motion,
Davenport clarified that the express warranty he bases his claim
upon is an express Limited Warranty that applied to the Leads in the
Activa systems (the "Limited Warranty").*fn17 In terms of preemption, in
light of caselaw within and outside the Third Circuit, it is clear that
the MDA does not preempt express warranty claims.
As Steele recognized, "because express warranties `arise from
representations of the parties,' and therefore `do not result from the
independent operation of state law,' the MDA does not preempt state law
claims of breach of express warranty." 2003 WL 22946150, at *14 (quoting
Shiley, 46 F.3d at 1325); see also Mitchell, 126 F.3d at 915 ("[Express]
warranties arise from the representations of the parties and are made as
the basis of the bargain between them. A state judgment based on the
breach of an express representation by one of the parties does not
necessarily interfere with the operation of the PMA, and therefore we
cannot say that such a cause of action is preempted."). The MDA
preemption clause does not preempt an express warranty claim based on a
warranty that is a product of the parties' bargain because any
"requirements" imposed by the warranty are created by the warrantor and
not imposed by state law as required for MDA preemption. Steele, 2003 WL
22946150, at *14 (citing Cippollone, 505 U.S. at 526). In the instant
case, based on the aforementioned authority, it is clear that Davenport's
express warranty claim is not preempted pursuant to the MDA, as the
Limited Warranty arose from representations of Medtronic and not from the
independent operation of state law.
3. Implied Warranty Claim
The basis for Davenport's implied warranty claim is not clear from the
face of Davenport's Complaint.*fn18 In fact, Davenport's only stated
basis for his implied warranty claim is the same as for his express
warranty claim.*fn19 Nevertheless, at the Hearing on the instant Motion,
Davenport clarified that his claim was based on the implied warranty of
merchantability. (Summ. J. Hr'g Tr. at 25). In relation to preemption, in
light of case-law within and outside this Circuit, it is clear that the
MDA does preempt Davenport's implied warranty claim.
The implied warranty of merchantability, as described in the Uniform
Commercial Code ("U.C.C.") and adopted by Pennsylvania, is "a warranty
that the goods will pass without objection in the trade and are fit for
the ordinary purposes for which such goods are used." Borden, Inc. v.
Advent Ink Co., 701 A.2d 255, 258 (Pa. Super. 1997)(quoting Moscatiello
v. Pittsburgh Contractors Equip. Co., 595 A.2d 1190, 1193 (Pa. Super.
1992)). The warranty "serves to protect buyers from loss where the goods
purchased are below commercial standards." Hornberger v. Gen. Motors
Corp., 929 F. Supp. 884, 888 (E.D. Pa. 1996). An implied warranty claim
is centered around the accepted standards of design and manufacture of
products in the state of Pennsylvania. Shiley, 46 F.3d at 1324-25.
In light of the factors described in Lohr, this implied warranty claim
is preempted by Section 360k of the MDA. First, as previously established
in Section III. B. of this Memorandum, the PMA imposed specific federal
requirements relating to the Activa. Second, this U.C.C. cause of action
meets the second Lohr prong in that it imposes state requirements that
relate to the safety and effectiveness of the Activa. Finally, a judgment
for breach of implied warranty would rest on allegations relating to
standards "different from or in addition to" federal requirements set
forth in the PMA. Specifically, the accepted standards of design and
manufacture for products in the state of Pennsylvania would be "different
from or in addition to" the requirements set through the PMA process.
Thus, "a state judgment for breach of implied warranty that rested on
allegations about standards other than those permitted by the FDA would
necessarily interfere with the PMA process and, indeed, supplant it."
Mitchell, 126 F.3d at 915. This determination is in accord with cases
within and outside this Circuit that have found that implied warranty of
merchantability claims are preempted by the MDA's preemption clause.
Id.; Shiley, 46 F.3d at 1325; Enlow, 210 F. Supp.2d at 862; In re
Orthopedic Bone Screw Prods. Liab. Litig., No. MDL 1014, 1996 WL 221784,
at *8 (E.D. Pa. Apr. 8, 1996).
In summary, Davenport's strict product liability, negligence and breach
of express warranty claims survive federal preemption pursuant to the
MDA. However, Davenport's implied warranty of merchantability claim is
preempted in light of Lohr and other relevant case-law. We must now
examine whether Davenport's non-preempted claims should reach the trial
stage in light of the summary judgment standard and Medtronic's state-law
D. Failure to Meet Summary Judgment Standard
The fact that the majority of Davenport's claims survive preemption
does not automatically protect his claims from summary judgment. This
Court must decide whether Davenport has met his burden as the non-moving
party at the summary judgment stage. In this case, we find that Davenport
has failed to meet his burden on the remaining claims. Thus, we find that
Davenport's strict product liability, negligence and breach of express
warranty claims are not entitled to go to a
1. Brief Summary of Burdens at Summary Judgment Stage*fn20
As previously noted, pursuant to Rule 56(c), summary judgment is proper
"if there is no genuine issue as to any material fact and the moving
party is entitled to judgment as a matter of law." FED. R. CIV. P. 56(c).
The court must determine whether there is a genuine issue of triable
fact. Anderson, 477 U.S. at 249. It is clear that "when the non-moving
party bears the burden at trial and the movant meets its burden of
directing the court to items demonstrating the absence of a genuine issue
of material fact, the non-moving party must produce evidence sufficient
to create a genuine issue." Kozma v. Medtronic, Inc., 925 F. Supp. 602,
609 (N.D. Ind. 1996)(citing Celotex Corp., 477 U.S. at 324).
Significantly, the non-moving party cannot sustain this burden through
unsupported assertions, conclusory allegations or mere suspicions in
attempting to survive a summary judgment motion. Williams, 891 F.2d 458,
460 (3d Cir. 1989)(citing Celotex Corp., 477 U.S. at 325 (1986)). "If the
non-moving party fails to meet this evidentiary burden, the court
should, in most circumstances, grant summary judgment in favor of the
movant." Kozma, 925 F. Supp. at 609 (citing Celotex Corp., 477 U.S. at
322). In the instant case, Davenport has failed to meet his evidentiary
burden for all of his non-preempted claims.
2. Strict Liability and Negligence Claims
As previously established, Davenport's strict product liability and
negligent manufacture claims are not preempted because they are based on
Medtronic's purported non-compliance with FDA/PMA standards.
Nevertheless, Medtronic challenges these allegations by
presenting evidence that Davenport's Activa systems were in fact FDA/PMA
compliant. Medtronic has provided the Court with substantial evidence
through traceability records and testing that indicate that Davenport's
Activa systems met all FDA/PMA requirements. We find that Medtronic has
proven that there is no genuine issue of material fact concerning this
compliance issue. Davenport has not provided the Court with sufficient
evidence to allow a jury to infer that Medtronic did not meet all FDA/PMA
standards in relation to his Activa systems.
Davenport claims that two significant problems with his Activa systems
demonstrate that the devices did not satisfy all FDA/PMA requirements.
First, Davenport asserts that the fact that fatty material was found in
one of the IPG connector mechanisms explanted from his body indicates
that the Activa systems were not FDA/PMA compliant. (Pl.'s Mem. Opp.
Summ. J. at 12). Specifically, Davenport claims that the entire IPG
component (including the IPG connector) should be water-tight pursuant to
FDA/PMA standards.*fn21 (Id.). Second, Davenport contends that the fact
that the Leads malfunctioned (and possibly fractured) after his second
surgery indicates that certain FDA/PMA requirements were not met. (Id.).
Davenport has presented the Court with two expert reports from Mr. Ted
Milo ("Milo"), his electrical engineer, in support of these allegations
relating to the Activa systems variance from FDA/PMA requirements. (Pl.'s
App., Ex. A; Pl.'s Suppl. App., Ex. B).
In fulfilling its burden at this summary judgment stage, Medtronic has
directed the Court to concrete and substantial evidence that Davenport's
Activa systems met all FDA/PMA standards. For example, Medtronic
submitted to the Court traceability records that indicate that all
components of the specific Activa systems at issue were manufactured and
tested in accordance with FDA/PMA requirements. (Def.'s App., Tab 27).
Further, in accordance with this Court's January 28, 2003 Order,
Medtronic tested the IPGs that were explanted from Davenport on April
14, 1999. As stated by Medtronic and specifically conceded by Davenport
in his Response to the instant Motion, "[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
[Davenport'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.) Significantly, Davenport has not performed
any tests on the IPGs as he is permitted to pursuant to the January 28,
2003 Order that would refute these findings.
In similar cases, courts have examined the parties' burdens at this
summary judgment stage. For example, in Kozma, the court had to consider
whether plaintiffs' claim for adulteration/negligent manufacturing of a
pacemaker could withstand the defendant manufacturer's summary judgment
motion. 925 F. Supp at 603 (N.D. Ind. 1996). As an initial matter, the
court found that the adulteration/negligent manufacturing claim was not
preempted because the plaintiffs' claim was based on the premise that the
manufacturer failed to comply with FDA regulations with respect to the
specific pacemaker at issue. Id. at 609. In terms of the parties' burdens
at the summary judgment stage, the court stated the following:
Here, the Defendant has offered considerable proof
that it complied with FDA regulations in every aspect
of the design, manufacture and labeling of its pulse
generator and leads. This evidence is sufficient to
shift the burden to the Plaintiffs to produce evidence
that the Defendant had not complied with FDA
regulations in manufacturing the specific
pacemaker involved in this case. The Plaintiffs have
not done so.
Id. (emphasis added). In Kozma, despite the plaintiff's's failure to meet
their burden, the court denied the defendant's motion for summary
judgment on the adulteration/negligent manufacturing claim because "the
Plaintiff had not had the opportunity to inspect the allegedly defective
pacemaker." Id. at 610. The court found that summary judgment would be
"premature" because the manufacturer had always had control of the
pacemaker and that discovery was needed concerning the device. Id.
In addition, in Brooks v. Howmedica, Inc., the Court of Appeals for the
Eighth Circuit ("Eighth Circuit") considered whether the district court
properly dismissed the plaintiff's claim that the defendant manufacturer
failed to comply with FDA regulations regarding product instructions. 273
F.3d at 798. Initially, the Eighth Circuit agreed with the lower court's
conclusion that the failure to comply claim was not preempted by the
MDA. Id. at 799. The Eighth Circuit then went on to affirm the lower
court's decision that the claim should be dismissed at summary judgment
because the plaintiff had not presented sufficient evidence of the
manufacturer's failure to comply with federal law. Id. Specifically, the
Court stated that "[plaintiff] has presented no evidence that [the
manufacturer] violated federal regulations or refused to add warnings
drafted by the FDA, changed FDA-approved labels, failed to meet regular
reporting requirements, failed to report a known hazard to the FDA, or
failed to comply with federal law in any other respect." Id.
In the instant case, Davenport has pointed to the fact that tissue was
found in the IPG connector in an attempt to show the IPGs were not
manufactured in accordance with FDA/PMA requirements. Davenport states
that "the presence of fatty material where the FDA requirement mandates
that there be no such material constitutes failure of this product to
meet FDA standards. . . ." (Pl.'s Mem. Opp. Summ J. at 12). Davenport's
assertion is based on his claim that Milo stated in his expert reports
that these devices should be sealed and water-tight pursuant to the FDA.
However, after a thorough examination of Milo's expert reports, we find
no reference in the reports to any FDA/PMA requirements that were
allegedly breached if the IPG connector was not completely
water-tight.*fn22 While Milo's report mentions the impact of
"failed insulation" within his reports, he does not point to any FDA/PMA
requirements in relation to the sealed nature of the IPGs. Instead, Milo's
report makes broad conclusory statements such as the "IPGs implanted in
November of 1998 should not malfunction as it did in Mr. Davenport unless
these devices were defective." (Pl.'s Supp. App., Ex. B., at 26). Moreover,
Davenport himself does not point to any specific FDA/PMA requirement in
terms of the sealed nature of the IPG. Further, this case is unlike
Kozma in that Davenport and his expert had the opportunity to test the
explanted IPG to refute Medtronic's evidence of FDA/PMA compliance. Even
accepting every inference for Davenport at this stage in the litigation
(i.e. that a "fluid short" in the IPG caused Davenport's complications),
Davenport and his expert have simply not produced sufficient evidence to
support the claim that Medtronic failed to comply with FDA/PMA
requirements in the manufacturing of the IPGs at issue.
Davenport also directs the Court to the fact that the Leads
malfunctioned after Davenport's second surgery in an attempt to show that
the Leads did not meet FDA/PMA standards. In his Response to the instant
Motion, Davenport alleges that "Milo has stated his opinion that the
leads should not have malfunctioned as they did, if these leads had been
in compliance with FDA standards." (Pl.'s Mem. Opp. Summ. J. at 13).
Again, after a thorough examination of Milo's expert reports, the Court
finds no reference in the reports to any FDA/PMA requirement that was not
met even if these leads became fractured or frayed while in Davenport's
body. Even at this stage, Davenport and his expert cannot simply point to
the malfunction itself to prove that the Leads were not
manufactured in accordance with FDA/PMA specifications. Accepting
every inference for Davenport at this stage in the litigation (i.e. that
frayed or fractured Leads caused Davenport's complications), Davenport
and his expert have not produced sufficient evidence to support the claim
that Medtronic failed to comply with FDA/PMA requirements in the
manufacturing of the Leads.
We find that Davenport has failed to show that there is a triable issue
of fact concerning whether the Activa systems met FDA/PMA standards.
Notably, at the Hearing on the instant Motion, the Court gave Davenport
an additional opportunity to direct the Court to evidence that FDA/PMA
standards were not met. In fact, a week prior to the Hearing, the Court
provided both parties with detailed questions that the Court directed the
parties to address.*fn23 In this document, the
Court specifically asked the following: (1) "what FDA/PMA requirement
mandates that the IPGs must be water tight?" and (2) "what FDA/PMA
requirement was violated when the leads allegedly malfunctioned?" See
supra note 20.
At the Hearing, after a lengthy dialogue between the Court and
Davenport's counsel, the Court was never directed to any specific FDA/PMA
requirements that were not met in relation to the IPGs or the Leads.
(Hr'g Tr. at 13-22). Instead, Davenport's counsel could only make the
conclusory assertion that some FDA/PMA requirement must not have been met
since tissue was found in the IPGs, the Leads malfunctioned and Davenport
experienced problems. (Id.). This argument ignores the fact that there
may have been other causes for Davenport's issues with the Activa
systems, notwithstanding that the devices were manufactured within
FDA/PMA standards.*fn24 At the Hearing,
just as in the Response to the instant Motion, Davenport has failed
to direct the Court to any FDA/PMA requirement Medtronic did not meet.
For example, Davenport has not pointed to any manufacturing process,
component requirement, or testing standard that Medtronic did not satisfy
in relation to the Activa systems at issue. Davenport has failed to
support his argument that his Activa systems were not manufactured in
accordance with FDA/PMA standards.
Davenport's strict product liability and negligent manufacturing claims
only survive preemption because they are based on the premise that the
Activa systems at issue were not in compliance with FDA/PMA standards.
Medtronic has presented substantial evidence that Davenport's Activa
devices were manufactured within FDA/PMA standards. In response,
Davenport has made only conclusory allegations and has not presented this
Court with sufficient evidence to create a triable issue of fact on this
issue. Therefore, summary judgment in Medtronic's favor is appropriate
for the strict product liability and negligence manufacture claims.
Finally, the Court finds no basis for Davenport's secondary negligence
claim that Medtronic was negligent in "allowing bilateral implantation of
[the Activa systems] when [it] knew that the FDA had allowed only
unilateral implantation of the device." (Comp. ¶ 26). In
Pennsylvania, the elements of a negligence claim are: (1) a duty or
obligation recognized by the law, requiring the actor to conform to a
certain standard of conduct; (2) a failure to conform to that standard;
(3) a casual connection between the conduct and the resulting injury; and
(4) actual loss or damage resulting to the interests of another. Morena
v. S. Hills Health Sys. Co., 462 A.2d 680, 684 n.5 ( Pa. 1983). This
aspect of the negligence claim also fails because Davenport has failed to
produce any evidence or authority that shows that Medtronic was prima
facie negligent in allowing Dr. Munz to perform a bilateral implant of
Neither party disputes that the bilateral implant of the Activa
qualified as an "off-label"
usage (i.e. use of a device for a purpose that has not been approved by
the FDA) of the Activa systems. As Medtronic notes, it is well
established that the FDA does not prohibit "off-label" use of medical
devices. Southard v. Temple Univ. Hosp., 781 A.2d 101, 104 (Pa. 2001).
While the FDA controls the marketing and labeling of medical devices, it
does not attempt to interfere with the practice of medicine. Id.;
21 U.S.C. § 396 ("Nothing in this chapter shall be construed to limit
or interfere with the authority of a health care practitioner to
prescribe or administer any legally marketed device to a patient for any
condition or disease within a legitimate health care practitioner-patient
relationship."). The Supreme Court has emphasized that off-label use "is
an accepted and necessary corollary of the FDA's mission to regulate in
this area without directly interfering with the practice of medicine."
Buckman Co. v. Plaintiff's Legal Comm., 531 U.S. 341, 350 (2001).
Courts have dismissed similar claims at summary judgment that were
based on a manufacturer allowing a physician to use a medical device in
an "off-label" manner. Little v. Depuy Motech, Inc., No. 96-0393, 2000 WL
1519962, at *9 (S.D. Cal. June 13, 2000)("Dr. McKinley's decision to use
[the manufacturer's] device in an `off-label' manner does not subject the
manufacturer to liability, even if it knows of the off-label use.
Accordingly, [the manufacturer] cannot be held liable for Dr. McKinley's
decision to implant the [manufacturer's] device in an off-label
manner."); Cox v. Depuy Motech, Inc., No. 95-3848, 2000 WL 1160486, at
*8-9 (S.D. Cal. Mar. 29, 2000)("A physician may use any device legally on
the market in any way the physician deems appropriate which may be
consistent with the seller's labeling or `off-label,' as in this case. A
seller is not liable even if it knows of the off-label use."). Based on
the foregoing authority, and the fact that Davenport has presented no
evidence to support this aspect of the negligence claim, the Court finds
that summary judgment in Medtronic's favor is appropriate on this aspect
of the negligence claim.
3. Express Warranty Claim
As previously established, Davenport's express warranty claim is not
preempted because any express warranty would have arose from the
representations of the parties and not from the independent operation of
state law. Nevertheless, Medtronic has presented evidence that
Davenport's express warranty is baseless and should therefore be
dismissed at the summary judgment stage, notwithstanding that the claim
survives preemption. Davenport has failed to produce any evidence
supporting this claim to create a triable issue of fact. Thus, the court
agrees with Medtronic that summary judgment in favor of Medtronic is
appropriate regarding the express warranty claim.
Pennsylvania law specifically defines how express warranties are
formed. As set forth by the U.C.C. and Pennsylvania statute, an express
warranty can be formed in the following ways:
1) Any affirmation of fact or promise made by the
seller to the buyer which relates to the goods and
becomes part of the basis of the bargain creates
an express warranty that the goods shall conform
to the affirmation or promise;
2) Any description of the good which is made part of
the basis of the bargain creates an express warranty
that the goods shall conform to the description; and
3) Any sample or model which is part of the basis
of the bargain creates an express warranty that
the whole of the goods shall conform to the sample
13 Pa.C.S. § 2313. "Express warranties arise from the representations
of the parties which are made the basis of the bargain." Shiley, 46 F.3d
In the present case, in his Complaint and Response to the instant
Motion, Davenport does not clarify the language of the express warranty
upon which he bases his claim. However, at the Hearing, Davenport
clarified that he was moving pursuant to language in the Limited Warranty
relating to the Leads. The Limited Warranty states:
Should the Lead fail to function within normal
tolerances due to a defect in materials or workmanship
within a period of one (1) year,
commencing with the date of implantation of the Lead,
Medtronic will, at its option: (a) issue a credit to
the purchaser of the replacement Lead equal to the
Purchase Price . . . against the purchase of any
Medtronic Lead required as its replacement, or (b)
provide a functionally comparable Lead at no charge.
(Def.'s App., Ex. H). The undisputed facts of this case show that
Medtronic has not breached this warranty. Conversely, the facts display
that Davenport himself has decided not to avail himself of the express
warranty because he refuses to have the surgical procedure necessary to
have the Leads replaced. We find that this express warranty claim should
be dismissed at summary judgment because Davenport has presented no
evidence that Medtronic has breached any express warranty.*fn25
In summary, the Court finds that Davenport's strict product liability,
negligence and express warranty claims should be dismissed at the summary
judgment stage even though the claims survive preemption pursuant to the
MDA. Davenport has failed to produce sufficient evidence on these claims
to proceed to a jury. The Court finds there are no triable issues of fact
surrounding these remaining claims and that Medtronic is entitled to
judgment as a matter of law.
E. Failure of Claims Pursuant to Pennsylvania Law
A portion of Davenport's claims also fail under Pennsylvania law.
Comment k of Section 402A precludes the application of a strict product
liability theory in this case. Further, the caselaw is clear that
Davenport's implied warranty claim fails as well because of the nature of
prescription medical devices. Thus, the Court finds that Medtronic is
entitled to summary judgment on Davenport's claims for these alternative
1. Strict Product Liability Claim
Pennsylvania has adopted Section 402A of the Restatement (Second) of
Torts, which places liability on manufacturers of products sold "in a
defective condition unreasonably dangerous to the user or consumer."
Mazur v. Merck & Co., 964 F.2d 1348, 1353 (3d Cir. 1992). Comment k
of Section 402A, however, entitled "Unavoidably Unsafe Products," alters
the strict liability rule on certain products. Comment k "denies
application of strict liability to products such as prescription drugs,
which, although dangerous in that they are not without medical risks, are
not deemed defective and unreasonably dangerous when marketed with proper
warnings." Hahn v. Richter, 673 A.2d 888, 889-90 (Pa. 1996). In Hahn, the
Supreme Court of Pennsylvania made clear that 402A is inapplicable to
prescription drugs. Id. at 891. "The Supreme Court of Pennsylvania
recognizes that prescription drugs present a unique set of risks and
benefits in that what may be harmful to one patient may be beneficial to
another." Taylor v. Danek Medical, Inc., No. 95-7232, 1998 WL 962062, at
*7 (E.D. Pa. Dec.29, 1998).
Subsequent to Hahn, the Supreme Court of Pennsylvania has never
addressed whether prescription medical devices, as opposed to just
prescription drugs, should fall within the realm of Comment k and qualify
as "unavoidably unsafe products." Nevertheless, numerous courts in the
Eastern District of Pennsylvania have predicted that the Pennsylvania
Supreme Court will follow its reasoning in Hahn and hold that
prescription medical devices are not covered by Section 402A. Murray v.
Synthes (U.S.A.) Inc., No. 95-7796, 1999 WL 672937, at *7 (E.D. Pa. Aug.
23, 1999); Burton v. Danek Med., Inc., No. 95-5565, 1999 WL 118020, at *7
(E.D. Pa. Mar. 1, 1999); Taylor, 1998 WL 962062, at *7. This Court agrees
with the reasoning in these cases and finds that Comment k precludes
application of Section 402A to prescription medical devices. Thus,
Davenport's strict product liability claim relating to the Activa
prescription medical device must fail since it is not covered by Section
2. Implied Warranty of Merchantability Claim
Similar to the reasoning in Hahn relating to application of Section
402A, "Pennsylvania courts have held that the nature of prescription
drugs also precludes claims for breach of the implied warranty of
merchantability." Burton, 1999 WL 118020, at *7 (citing Makripodis v.
Merrell-Dow Pharms., Inc., 523 A.2d 374, 376-77 (Pa. Super. 1987)); see
also Murray, 1999 WL 672937, at *7. As noted by other courts, "this
reasoning would also preclude implied warranty claims for prescription
medical devices." Murray, 1999 WL 672937, at *7. Thus, Davenport is
unable to maintain his claim for breach of the implied warranty of
merchantability since it relates to a prescription medical device.
In summary, only Davenport's implied warranty of merchantability claim
is preempted pursuant to the MDA. Nevertheless, Davenport's remaining
claims (strict product liability, negligence and express warranty claims)
are not entitled to reach a jury because Davenport has failed
to meet his summary judgment burden regarding these claims. Finally,
Davenport's strict product liability and implied warranty of
merchantability claims simply fail as a matter of Pennsylvania law.
For the reasons that are set forth above, the Court finds summary
judgment in Medtronic's favor is appropriate in this matter. There are no
genuine issues of fact surrounding any of Davenport's claims and
Medtronic is entitled to judgment as a matter of law. Accordingly,
Medtronic's Motion for Summary Judgment will be granted.
An appropriate Order follows.
AND NOW, this 3rd day of February, 2004, upon consideration of
Defendant's Motion for Summary Judgment (Doc. No. 27), and the Response
and Reply thereto, it is hereby ORDERED that Defendant's Motion is