The Los Angeles Times on Monday examined how "high-profile court battles," like those over drugs such as Vioxx and Celebrex, "could soon be a thing of the past" after the U.S. Supreme Court last month ruled that patients injured by most medical devices cannot sue manufacturers. According to the Times, a similar case that will be heard this year could extend the same legal protection to the pharmaceutical industry. In the medical device lawsuit against Medtronic, the Supreme Court ruled that FDA adequately regulates the drug and device industries and that the agency's authority should not be questioned by the courts. In October, the Supreme Court will hear arguments in a lawsuit against Wyeth, "in which it might decide whether FDA approval bars personal-injury lawsuits involving drug companies," the Times reports.

Opponents of the decision in the medical device case "say such an argument would make more practical sense if the FDA were doing a better job," the Times reports. According to the Times, FDA "faces growing challenges and some of its most withering criticism in years, some from within its own walls," as several recent reports have raised serious questions about the agency's performance.

Proponents of the decision "say it is overdue," according to the Times. The drug and medical device industries have "contended for years that the legal environment around their products has grown too restrictive and is stymieing innovation," the Times reports.

However, some legal experts say that without such lawsuits, regulators and the public might never hear of evidence that manufacturers knowingly marketed products they knew were unsafe, according to the Times. David Vladek, a law professor at Georgetown University, asked, "Without the tort system, what reasonable assurance do we have we will learn about the bad actors?" He added, "A lot is lost without these lawsuits" (Costello, Los Angeles Times, 3/3).

Editorials
Two newspapers on Saturday published editorials related to the Medtronic decision. Summaries appear below.Wall Street Journal: The Supreme Court in its ruling "restored a measure of rationality to the way government regulates medicine, while foiling a tort bar plot to rewrite federal statutes via state lawsuits," the Journal writes in an editorial. The editorial concludes, "If FDA regulation fails -- as it often does -- the Supreme Court would be wise to blame the FDA, not the medical industry" (Wall Street Journal, 3/1).

Washington Post: There are "reasons to cheer" the Supreme Court ruling because "[c]onsistent and clear nationwide rules for such companies and products" that "are essential for innovation," the Post writes in an editorial. But there are "reasons to worry" because "[i]f the court continues to find that manufacturers of medical devices should be shielded from lawsuits, victims of defective products or drugs could be left with little or no legal recourse," and it "would also leave the FDA ... as the first and final arbiter of safety." The Post concludes that lawmakers should "consider creating a government-run compensation fund for patients harmed by medical devices, similar to the one established for those harmed by vaccines," and they "should also continue to strengthen the FDA through increased funding and oversight muscle" (Washington Post, 3/1). Reprinted with kind permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation© 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

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