The U.S. Supreme Court delivered an opinion that could frustrate some consumers seeking damages for harm caused by federally approved medical devices.
In an 8-1 decision, the court ruled that a federal law prevents plaintiffs from going after devicemakers with state laws and regulations that go beyond the requirements under federal law.
The case in question involved a Food and Drug Administration-approved Medtronic balloon catheter that burst as plaintiff Charles Riegel underwent angioplasty in 1996, causing Riegel to need emergency bypass surgery.
Riegels lawsuit, filed in U.S. District Court in Albany, N.Y., alleged that the devices design and labeling violated New York state common law. The court dismissed the case, finding that Riegels claim was pre-empted by the federal law called the Medical Device Amendments of 1976. Writing for the majority, Justice Antonin Scalia agrees that making companies liable under state law for FDA-approved devices disrupts the federal scheme no less than state regulatory law to the same effect.
Justice Ruth Bader Ginsburg wrote in a dissenting opinion that it is difficult to believe that Congress would, without comment, remove all means of judicial recourse for large numbers of consumers injured by defective medical devices.
Medtronic issued a news release in which President and Chief Executive Officer Bill Hawkins says the decision "ensures that patients continue to have appropriate access to innovative, life-saving medical devices."
Jon Haber, CEO for the trial lawyers trade group American Association for Justice, said in a written statement that the decision limits the rights of people to receive justice through the legal system when they are injured by the negligence or misconduct of others. -- by Gregg Blesch
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