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February 3, 2004.

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.


  A. Introduction

  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 associated Page 2 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 Page 3 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 disease.

  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 Page 4 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) Page 5 (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 devices approved.*fn7

  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 Page 6 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 Page 7

  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. Page 8 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 Page 9 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 Hospital.

  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 Page 10

  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 Page ...

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