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.WL a9 Litzgation Update a WASHINGTON LEGAL FOUNDATION& 2009 Massachusetts Avenue, N.W. Washington, D.C. 20036 October 13,1994 S WLF WINS SUIT AGAINST FDA TO STOP OVERREGULATION OF HEART VALVES (Washington Legal Foundation v. Shalala) The Washington Legal Foundation (WLF)'s two-and-one-half year effort to end the Food and Drug Administration's (FDA) counterproductive regulation of human-tissue heart valves came to a successful conclusion this week. Facing almost certain defeat in litigation brought by RTLF, FDA agreed to withdraw its controversial regulations. WLF has long contended that FDA's regulations have placed significant roadblocks in the paths of heart patients who seek human-tissue heart valve transplant surgery -- despite strong clinical evidence that such surgery is both safe and effective and is far superior to alternative treatments. FDA's capitulation means that human-tissue heart valves (also known as allograft valves) will no longer be classified as Class III medical devices - the classification that leads to the most stringent level of government regulation. While FDA will continue to monitor the work of the nonprofit tissue banks that supply allograft valves to ensure that they comply with FDA's "good manufacturing practices" requirements, the rescission of the Class III classification will result in the lifting of virtually all other FDA regulation. WLF filed its lawsuit, Washington Legal Foundauion v. Shalala, in March 1993 on behalf of two women in need of heart valve surgery and one of the nation's top cardiac surgeons: Dr. Robert B. Karp, Chief of Cardiac Surgery Section at the University of Chicago Medical Center. Under federal law, WLF is entitled to collect from the federal government the substantial attorney fees (in excess of $75,000) it incurred in pursuing the lawsuit to its successful conclusion. However, pursuant to its longstanding policy of not seeking taxpayer-funded fee awards, WLF will not seek to collect any fees in this case. FDA conceded defeat in the case just as the case was headed for final resolution in the courts. FDA's final court papers were due to be filed this month, and the case had been scheduled for oral argument on November 16, 1994 before a three-judge panel of the United States Court of Appeals for the District of Columbia Circuit. Although allograft valves have been widely used in heart surgery for more than three decades, FDA only began asserting regulatory authority in this area three years

~ ago. In June 1991, FDA ruled for the first time (and with virtually no advance warning) that allograft valves were Class III medical devices and thus should be subject to FDA's stringent premarket approval (PMA) requirements. Obtaining a PMA for allograft valves could have taken as long as five years. From the time of FDA's imposition of the Class III classification until this week's withdrawal of the classification, use of allograft valves in valve-replacement surgery has been so heavily restricted as to make them unavailable to many heart patients. WLF's argued in its lawsuit that FDA's action not only violated the law but also made no medical sense in light of the universal acceptance of allograft valve transplants within the medical community as safe and effective. Allograft valves are viewed as essential for the survival of many infants born with heart defects. Dr. Richard A. Hopkins, Director of Pediatric Cardiac Surgery at Georgetown University Medical Center and a supporter of WLF's on-going efforts to reform FDA policy, has been blunt in his assessment of FDA's policy: he said in support of a WLF petition to FDA that FDA's "bureaucratic regulatory posturing" could cause "the needless death of children." Hopkins added: "[T]his adversarial posture by the FDA is counterproductive to the patient's benefit, totally unnecessary, and an unprovoked antagonistic approach, which will result in children's death, higher costs of medical care, and enormously increased bureaucratic administrative requirements for the delivery of optimal health care." FDA has agreed to publish in the Federal Register within the next week a notice ~ rescinding its 1991 decree that had imposed strict regulations on allograft valves. Hence- forth, FDA regulation will be limited to ensuring that suppliers of allograft valves comply with "good manufacturing practices" - such as screening the health of human- tissue heart valve donors. FDA also acknowledged that existing laws covering regulation of "medical devices" may be too cumbersome to apply to human-tissue transplants, and that new, more streamlined legislation addressing such transplants may be warranted. WLF is a public interest law and policy center with more than 100,000 members and supporters nationwide. It devotes a substantial portion of its resources to defending the rights of individuals and businesses to go about their affairs without undue interference from government regulators. For further information, contact WLF Chief Counsel Richard Samp, (202) 588-0302. 0 ~ ~- co cx~ ~ ~-+.