http://www.nytimes.com/2008/02/21/washington/21device.html February 21, 2008 Justices Shield Medical Devices From Lawsuits By LINDA GREENHOUSE WASHINGTON ‹ Makers of medical devices like implantable defibrillators or breast implants are immune from liability for personal injuries as long as the Food and Drug Administration approved the device before it was marketed and it meets the agency¹s specifications, the Supreme Court ruled on Wednesday. The 8-to-1 decision was a victory for the Bush administration, which for years has sought broad authority to pre-empt tougher state regulation. In 2004, the administration reversed longstanding federal policy and began arguing that ³premarket approval² of a new medical device by the F.D.A. overrides most claims for damages under state law. Because federal law makes no provision for damage suits against device makers, injured patients have turned to state law and have won substantial awards. The Bush administration will continue its push for pre-emption in another F.D.A. case that the court has accepted for its next term, on whether the agency¹s approval of a drug, as opposed to a device, pre-empts personal injury suits. Drugs and medical devices are regulated under separate laws. The case before the court concerned only medical devices that had gone through the premarket approval process specified by the Medical Device Amendments of 1976. Most devices now available reached the market through a different process, under which the F.D.A. found them to be ³substantially equivalent² to those marketed before the 1976 law took effect. The Supreme Court ruled in 1996 that this less rigorous approval process does not pre-empt state damage suits against the manufacturers of ³grandfathered² devices. Devices subject to the premarket approval process, and thus affected by the court¹s opinion, tend to be more technologically advanced, expensive and, in some instances, risky. Examples of devices that have been the subjects of recent lawsuits include an implantable defibrillator, a heart pump, a spinal cord stimulator, a drug-coated stent, an artificial heart valve, and prosthetic hips and knees. It was not immediately clear how many of the thousands of lawsuits against medical device manufacturers would be affected, though some pending cases will almost certainly be nullified. The decision, for example, does not foreclose lawsuits claiming that a device was made improperly, in violation of F.D.A. specifications. Cases may also be brought under state laws that mirror federal rules, as opposed to supplementing them. Next Monday, the court will hear another F.D.A. pre-emption case, on whether a state case can be based on the claim that a drug maker committed fraud by misrepresenting or withholding information from the agency during the approval process. The administration is supporting the manufacturer in that case, Warner-Lambert Co. v. Kent, No. 06-1498, which concerns the diabetes drug Rezulin. Writing for the majority in Wednesday¹s case, Riegel v. Medtronic Inc., No. 06-179, Justice Antonin Scalia said that permitting state juries to impose liability on the maker of an approved device ³disrupts the federal scheme,² under which the F.D.A. has the responsibility for evaluating the risks and benefits of a new device and assuring that it is safe and effective for its intended use. A jury, looking only at the injured plaintiff, will tend to weigh only the dangers of a device and ³is not concerned with its benefits,² Justice Scalia said, adding, ³the patients who reaped those benefits are not represented in court.² The decision affirmed the dismissal of a lawsuit by a patient who was injured during an angioplasty when a balloon catheter burst while being inserted to dilate a coronary artery. The device won F.D.A. premarket approval in 1994, two years before the incident. The patient, Charles R. Riegel, died after the lawsuit was filed, and the case was carried on by his widow, Donna. The medical device statute contains a pre-emption clause that bars states from imposing ³any requirement² related to a medical device that is ³different from, or in addition to² a federal requirement. The question of statutory interpretation at the heart of the case turned on what Congress meant by ³any requirement.² Justice Scalia said that state tort law, by imposing duties of care on product makers, amounted to such an additional requirement. He said the 1976 law ³speaks clearly to the point at issue,² regardless of the federal government¹s previous or current positions. Justice Ruth Bader Ginsburg, the solitary dissenter, said the court had misconstrued Congress¹s intent in adding the pre-emption clause to the 1976 law. The purpose, she said, was to prevent individual states from imposing their own premarket approval process on new medical devices. Devices were not regulated under federal law at the time, and California and other states had stepped in to fill the vacuum by setting up their own regulatory systems. That was all that Congress had in mind, Justice Ginsburg said, not ³a radical curtailment of state common-law suits seeking compensation for injuries caused by defectively designed or labeled medical devices.² She said that Congress had passed the 1976 law ³to protect consumer safety,² not to oust the states from ³a domain historically occupied by state law.² The decision was at odds with the ³central purpose² of the 1976 law, Justice Ginsburg added. Crucial Democratic lawmakers appear to agree with Justice Ginsburg, including Senator Edward M. Kennedy, Democrat of Massachusetts, who heads the Health, Education, Labor and Pensions Committee and was the sole Senate sponsor of the 1976 legislation in question. ³In enacting legislation on medical devices, Congress never intended that F.D.A. approval would give blanket immunity to manufacturers from liability for injuries caused by faulty devices,² Mr. Kennedy said in a statement. He added: ³Congress obviously needs to correct the court¹s decision.² Representative Henry Waxman, the California Democrat who is chairman of the House Committee on Oversight and Government Reform and was on the House panel that approved the 1976 bill, expressed a similar view. ³The Supreme Court¹s decision strips consumers of the rights they¹ve had for decades,² Mr. Waxman said. ³This isn¹t what Congress intended, and we¹ll pass legislation as quickly as possible to fix this nonsensical situation.² The Food, Drug and Cosmetic Act of 1938, under which the F.D.A. regulates pharmaceuticals, does not contain a pre-emption clause. Nonetheless, the administration is arguing in the case the court has accepted for its next term, Wyeth v. Levine, No. 06-1249, that pre-emption is implicit in the structure of the statute. The Supreme Court¹s interest in pre-emption is not limited to the medical arena. In a similar case decided on Wednesday, this one unanimously, the court ruled that the federal law that deregulated the trucking industry in 1980 pre-empted two recent laws adopted by the State of Maine to regulate the shipment of tobacco products into the state. The state laws were intended to prevent children who were not of legal age to buy cigarettes from ordering them over the Internet. The laws placed responsibility on shippers and delivery companies to verify the recipient¹s identity and age. Justice Stephen G. Breyer, writing for the court in this case, Rowe v. New Hampshire Motor Transport Association, No. 06-457, said the state law ³produces the very effect that the federal law sought to avoid, namely, a state¹s direct substitution of its own governmental commands for competitive market forces² in a deregulated environment. Barnaby Feder contributed reporting from New York and Gardiner Harris from Washington. 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