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A woman who claims a defective heart pump caused her husband’s death has lost her bid to revive a products liability suit against the pump’s manufacturer now that a divided panel of the 3rd U.S. Circuit Court of Appeals has ruled that all of her state law claims are expressly pre-empted by the federal Medical Device Amendments. In Horn v. Thoratec Corp., the two-judge majority concluded that since the HeartMate heart pump was subjected to “extensive” scrutiny by the U.S. Food & Drug Administration in a “pre-market approval” process, or PMA, any lawsuit over the pump’s design or labeling could result in a judgment that conflicts with those federal requirements. “Any finding in Horn’s favor based on her general claims of negligence or defective design and manufacture — be it by a jury or a court — would necessarily amount to a state substantive requirement ‘different from, or in addition to’ the federal requirements imposed by the FDA,” Senior U.S. Circuit Judge Leonard I. Garth wrote. Garth, who was joined by U.S. Circuit Judge Thomas L. Ambro, concluded that the lower court had correctly dismissed the suit because any judgment in Horn’s favor would “stand as an obstacle to … and would conflict with the federal requirements imposed by the PMA.” But a dissenting judge said he would have revived the suit because Horn’s common-law claims of design defect and negligence would not create any “specific requirements” under state law that would trigger pre-emption under the MDA. “In my view, because Horn’s suit is not seeking to impose any specific requirement on the HeartMate, it is not pre-empted,” U.S. Circuit Judge Julio M. Fuentes wrote. Allowing a common-law liability claim, Fuentes said, “would simply have the effect of encouraging [Thoratec] and other device manufacturers to go above and beyond FDA standards, and this effect would clearly not contradict the MDA’s purpose of enhancing medical device safety.” Fuentes said he believed that U.S. District Judge James F. McClure Jr. of the Middle District of Pennsylvania erred by looking only at whether the federal regulation — the PMA — was specific to a particular device and “not examining whether the state law under which Horn sued was device-specific.” Horn’s lawyers, Allison M. Zieve and Brian Wolfman of Public Citizen Litigation Group in Washington, D.C., argued that a state common-law claim is pre-empted only if the state claim is device-specific and the purportedly pre-empting federal regulation is device-specific. But Thoratec’s lawyer, Alan E. Untereiner of Robbins Russell Englert Orseck & Untereiner, also in Washington, argued that McClure was correct in analyzing only the federal side of the equation because the U.S. Supreme Court’s 1996 decision in Medtronic Inc. v. Lohr made that the only relevant inquiry. Since Lohr, the federal circuits have split on when and how to apply federal pre-emption in the context of a PMA. The 7th and 9th circuits have held that pre-emption requires only a device-specific federal regulation, but the 10th Circuit has held that pre-emption also requires a device-specific state law. Fuentes complained that the 3rd Circuit majority had erred by following the 7th and 9th circuits’ lead. “Although my colleagues acknowledge some kind of state-law specificity requirement, they effectively agree with the 7th and 9th circuits in holding that even the most generalized tort claims, such as those in the case before us, are pre-empted,” Fuentes wrote. But Garth found that Horn’s lawyers placed too much reliance on Lohr, a case in which the justices, by a 5-4 vote, revived a plaintiff’s products liability claims over a pacemaker. Garth found that the FDA approval process at issue in Lohr was “not the same detailed approval process that was employed by the FDA to approve the HeartMate.” Instead, Garth noted, the pacemaker at issue in Lohr was marketed after the FDA determined that it was “substantially equivalent” to an existing FDA-approved device. As a result, Garth said, the Medtronic pacemaker “did not undergo the far more thorough and rigorous PMA approval process” that the HeartMate received. Although the justices allowed the plaintiff in Lohr to pursue her claim that the pacemaker had a defective lead, Garth found that the “key” to the high court’s holding was its conclusion that the FDA’s process for approving “substantially equivalent” medical devices had not imposed any federal “requirement” to the device, but instead was a “generic federal standard.” Garth found that the Lohr court “did not consider whether the more rigorous PMA process … constitutes ‘a specific federal regulation’ … which, in turn, imposes strict FDA requirements upon the manufacturer.” Although the Lohr decision never addressed the PMA process, Garth found that the decision nonetheless “suggested … that the analysis would have been significantly different if the device at issue in Lohr had weathered a more exacting federal investigation, such as the PMA process.” According to the suit, Horn’s husband, Daniel Horn, suffered a heart attack in January 1998, and doctors concluded that he was in need of a heart transplant. But before a suitable donor could be found, Horn’s condition deteriorated and a HeartMate was implanted. The HeartMate is a pump that assists the blood flow between the heart’s ventricle and the aorta. The device employs a tube that is surgically attached to the heart through the ventricle, and carries blood from the heart into the pump. Another tube brings blood from the pump to the aorta, where it is dispersed to the body. Horn’s lawsuit alleged that the design of the second tube was flawed because it requires doctors to apply a suture to a screw ring to ensure that it does not rotate. The suit said doctors had discovered that the suture on Horn’s HeartMate had worn off and the screw ring linking the pump to the second tube had disconnected. The disconnection allowed an air bubble to travel to Horn’s brain. Although doctors reconnected the screw ring and linked it back to the pump, it was too late. Horn suffered a brain hemorrhage and was rendered brain dead. In May 1998, his organs were donated for transplant, and he was pronounced dead.

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