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Washington, D.C. --- U.S. Rep. Frank Pallone, Jr. (D-NJ), Chairman of the House Energy and Commerce Subcommittee on Health, issued the following statement in response to a U.S. Supreme Court decision yesterday seriously curtailing patients' rights. The Court ruled 8 to 1 that medical device manufacturers are immune from liability if the U.S. Food and Drug Administration (FDA) approved the device before it was marketed.
"The Supreme Court ignored the clear intent of Congress yesterday when it ruled that medical device manufacturers are immune from liability if the FDA gave the product its seal of approval before the product was marketed. This disturbing decision denies patients any legal recourse if they are a victim of a faulty medical device, and gives the device makers immunity for the life of a product regardless of any defects or problems that arise after that initial approval.
"The Supreme Court's decision shows why it is more necessary than ever for Congress to step in and restore the protections that patients are entitled to if they are the victim of a life-altering accident caused by a medical device."
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