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    Post: Justice System Shield Medical Device Mnfg'ers

    Posted by Deborah on 2/21/08

    February 21, 2008
    Justices Shield Medical Devices From Lawsuits
    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 agency’s 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 “premarket approval” 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

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