Supreme Court Rules on Device Lawsuits
In a decision handed down by the United States Supreme Court last week, patients will be limited to filing state product-liability suits only in the case that device manufacturers violated the regulations of the Food and Drug Administration. The news was posted by Health Imaging.
The national court heard the case after an appeal of the decision from a lower court in the case of Riegel v. Medtronic. That ruling barred a pending lawsuit against Medtronic. The decision will create an environment wherein it becomes more difficult for patients to sue device manufacturers.
The majority opinion ruling, written by Justice Antonin Scalia, indicated that the Medical Device Amendments of 1976 protects medical device manufacturers. That law indicates that federal law overrules state damage claims filed without a simultaneous violation of FDA. It was further noted that lay people who serve on juries do not have the requisite expertise to rule on devices that expert reviewers for the FDA understand.
The one dissenting opinion was filed by Justice Ruth Bader Ginsberg. She argued that the remaining Justices inappropriately restricted the state’s authority.
The full text of the ruling (pdf) is available on the Supreme Court website.
February 28, 2008 Related topics: Legal & legislative