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WASHINGTON � A concerted effort by the business community to have federal law preclude, or “pre-empt,” state personal injury laws and other regulations has arrived en masse at the U.S. Supreme Court this term. The justices have agreed to decide five pre-emption cases that involve products liability, transportation of dangerous substances, labor and other areas, and they have asked the U.S. solicitor general for his views on a sixth case seeking review. First out of the argument box will be Riegel v. Medtronic Inc., No. 06-179, on Dec. 3. It asks if a provision in the Medical Device Amendments to the federal Food, Drug, and Cosmetic Act forecloses state-law tort suits claiming injury from the design, manufacture and labeling of a medical device that was granted premarket approval (PMA) by the Food and Drug Administration. While the Riegel case focuses on a specific statutory provision, pre-emption scholar Catherine Sharkey of New York University School of Law said, “More broadly, I actually think the court is poised to begin to fashion a kind of framework for pre-emption jurisprudence. Almost every scholar and litigant calls it a muddle, a mess.” Muddle or mess, the high court’s preemption cases bear “broad consequences for all regulated industries,” which generally prefer uniform, national regulation over varying state regulations, said Mark I. Levy, chairman of the Supreme Court and appellate practice at the Washington office of Atlanta-based Kilpatrick Stockton. Cases such as Riegel, he said, are device-specific, but some raise recurring issues, such as whether there is a presumption against pre-emption and, if so, when it applies and how strong it is, and how much deference courts should give to the federal agency’s position. But they also have broad consequences for consumers and states with strong consumer protection laws, said Arthur Bryant, executive director of Public Justice (formerly Trial Lawyers for Public Justice). “The fact is industry has been pushing to expand federal pre-emption for the past 25 years as a wholesale, get-out-of-jail-free card,” he said. Pre-empted? Charles Riegel, who has since died, sued Medtronic because of serious injuries he suffered when a balloon catheter unexpectedly burst during a 1996 angioplasty. He alleged that the catheter was defectively designed, manufactured and labeled. Medtronic successfully moved for summary judgment, later affirmed by the 2d U.S. Circuit Court of Appeals. Medtronic relied on an express pre-emption provision in the federal Medical Device Amendments � Section 360k(a). The company argued that the FDA’s grant of PMA of the catheter established federal requirements that pre-empt any state requirements different from, or in addition to, the federal requirements. State-law tort liability, it said, would create those types of state requirements and were pre-empted under 360k(a). In the high court, Riegel’s widow, represented by Allison Zieve of Public Citizen Litigation Group, argues that the justices have relied repeatedly on the presumption that a federal statute does not pre-empt the historic police powers of the state absent a finding of Congress’ “clear and manifest intent” to do so. The language of 360k(a), said Zieve, displays no such intent. In an earlier pre-emption decision concerning the Medical Device Amendments ( Medtronic v. Lohr), Zieve also argues that the justices held that, to pre-empt a state-law claim, that claim must correspond to some device-specific federal requirement and the state law must have been developed “with respect to” devices. The PMA process, she argues, does not impose design-specific or labeling requirements, and even if it did, state common law duties correspond � not differ or add � to them. Public Justice’s Bryant, who, along with AARP, a number of state attorneys general and others, supports Zieve, noted that the Medical Device Amendments of 1976 were Congress’ response to the Dalkon Shield products liability fiasco. “Congress concluded consumers needed far more protection from defective and dangerous medical devices,” he recalled. “Industry is arguing here that, because of that, Congress eliminated the rights of medical device victims to hold companies accountable. It would be laughable on its face if you didn’t have so many courts buying into it.” Medtronic, represented by Theodore B. Olson of Los Angeles-based Gibson, Dunn & Crutcher, disagrees with Zieve’s characterization of the PMA process. That process, he contends, is a rigorous one that “culminates in a set of device-specific design, manufacturing and labeling requirements to which the manufacturer must adhere in order to market its device.” Olson argues that a jury verdict for Riegel would have “the same practical effect as a New York regulation requiring Medtronic to design, manufacture and label the Evergreen Balloon Catheter in a manner different than that approved by the FDA.” Those substantive, device-specific requirements � whether imposed by common law or regulation � are pre-empted by Section 360k(a), he tells the court. “If the plaintiffs are right about the PMA process, why would Congress have bothered to put in this elaborate pre-emption scheme?” asked Alan Untereiner, a partner at Washington’s Robbins, Russell, Englert, Orseck, Untereiner & Sauber who represents the Chamber of Commerce as amicus supporting Medtronic. “The FDA issues device-specific regulations for a handful of devices, but the express pre-emption provision is deliberately broad.” An important twist in the case may be the position of the FDA. Until 2004, the agency took the position there was no pre-emption of state-law tort claims, but changed its position that year.

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