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The “pre-market approval” of a medical device by the U.S. Food and Drug Administration is a thorough process that imposes specific federal requirements and therefore triggers the pre-emption provisions of the Medical Device Amendments of 1976, a federal judge has ruled. In his 37-page opinion in Davenport v. Medtronic Inc., Senior U.S. District Judge Robert F. Kelly granted summary judgment in favor of Medtronic in a suit brought by a man who claims he suffered serious complication from the Medtronic Activa Tremor Control System, a device implanted in his brain to alleviate the symptoms of Parkinson’s disease. Kelly found that the U.S. Supreme Court’s leading case on MDA pre-emption — the 1996 decision in Medtronic Inc. v. Lohr — left open the question of whether the FDA’s pre-market approval process “imposes specific federal requirements on a medical device to trigger pre-emption pursuant to the MDA.” In Lohr, the justices held that state tort claims were not pre-empted in a case where the FDA had allowed a pacemaker to be marketed because it qualified as “substantially equivalent” to a pre-existing device. The Lohr Court concluded that the plaintiff’s claims were not pre-empted because the “substantially equivalent” review process was not the type of specific federal requirement that triggered pre-emption. But since Lohr, Kelly found, a “vast majority of federal and state courts” have held that the pre-market approval process is specific enough to trigger pre-emption of many state-law claims. And in a pre- Lohr decision, Kelly found, the 3rd U.S. Circuit Court of Appeals had already held in Michael v. Shiley Inc. that pre-market approval triggers MDA pre-emption. Kelly found that Shiley is still good law and that the reasoning of the majority of post- Lohr cases was persuasive. In Horn v. Thermo Cardiosystems Inc., Kelly said, a federal judge in the Middle District of Pennsylvania said that courts have distinguished the pre-market approval process from the “substantially equivalent” process, finding that while the latter focuses only on “equivalence” to an already-existing product, the former “is much more rigorous and focuses on the safety of a new, specific product.” “We agree with this reasoning,” Kelly wrote, “and find that the device-specific and thorough nature of the [pre-market approval] process imposes specific federal requirements that trigger pre-emption.” But despite finding that the MDA’s pre-emption provisions were triggered in Richard Davenport’s case, Kelly found that a majority of Davenport’s claims were not pre-empted “based on the nature of his allegations.” Nonetheless, Kelly went on to find that Medtronic was entitled to summary judgment on all claims because Davenport failed to muster evidence strong enough to counter Medtronic’s defenses. According to court papers, Davenport has suffered from the symptoms of Parkinson’s disease since 1976 when he was 29 years old. In 1998, Davenport heard about the Activa, a device that electronically stimulated targeted tissues in the brain that control movement and muscle function through a process called “deep brain stimulation.” Deep brain stimulation is intended to interrupt the messages to the brain that cause the symptoms of Parkinson’s disease, such as tremors, and suppress the symptoms. As a result, patients are theoretically supposed to achieve greater control over their bodily movements. 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 a device in the chest area, which is programmed using an external console. Davenport’s doctors told him that he needed deep brain stimulation on both sides of his brain, but that the Activa was not yet approved for such a use. At that time, the FDA had approved only “unilateral” use of the Activa, but Davenport’s doctors said he needed a “bilateral” implant of the Activa, which would involve the implantation of two complete systems. Davenport decided to undergo the surgery and at first found that many of the symptoms of his Parkinson’s disease became suppressed. But within a month or two after surgery, Davenport claims, he began to experience problems. The device began to turn off and on for no apparent reason, he claims, and he began feeling fluttering sensations in his chest. Two new devices were implanted in April 1999, but the problems persisted. In October 1999, Davenport was told that he would need a third set of devices installed, but he was unwilling to commit to the surgery. Instead, the Activa systems were turned off and he was discharged from the hospital. In his suit, Davenport brought three claims – negligence; breach of implied and express warranties; and strict products liability. Kelly concluded that two of the three claims survived MDA pre-emption, but none survived summary judgment. The claim for breach of implied warranty is pre-empted by the MDA, Kelly found, because it “meets the second Lohr prong in that it imposes state requirements that relate to the safety and effectiveness of the Activa.” A judgment for breach of implied warranty, Kelly said, “would rest on allegations relating to standards ‘different from or in addition to’ federal requirements set forth in the [pre-market approval process."] As a result, Kelly said, a finding of breach of implied warranty “would necessarily interfere with the [pre-market approval] process and, indeed, supplant it.” But Kelly found that Davenport’s claims of strict products liability and negligent manufacture survived pre-emption because they are “based on the theory that the Activa systems implanted in him did not satisfy … FDA standards.” As a result, Kelly said, the claims “do not impose requirements ‘different from or in addition to’ … FDA requirements.” Kelly also found that the MDA would not pre-empt 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. But Kelly found that Davenport failed to muster the evidence he needed to survive summary judgment on those claims. Kelly found that Medtronic had provided “substantial evidence” that the Activa system complied with the FDA’s pre-market approval process requirements. “Davenport has not provided the court with sufficient evidence to allow a jury to infer that Medtronic did not meet all FDA … standards in relation to his Activa systems,” Kelly wrote. Davenport’s claim of breach of express warranty also failed on summary judgment, Kelly said, because the “undisputed facts” showed that Medtronic had not breached its warranty. Instead, Kelly found 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 [device] replaced.” Davenport was represented by attorney Richard Stanko of Kassab Archibald Jackson O’Brien & List in Media, Pa. Medtronic was represented by attorney John P. Lavelle Jr. of Ballard Spahr Andrews & Ingersoll.

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