by
Colby Coates, Editor in Chief | February 28, 2008
In a case with enormous consequences to medical devices and equipment, the Supreme Court, by an 8 to 1 vote, has ruled that Medtronic cannot be sued under state law as a manufacturer of a federally approved medical device.
The Court affirmed that Medtronic and other manufacturers are protected under the Medical Device Amendments of 1976, which, among other things, bars states from imposing on medical devices any requirement which is different from what's already won FDA approval.
Medtronic lawyer and former U.S. Solicitor General Theodore Olson successfully argued that the FDA and not the courts was the right forum for imposing requirements on cutting-edge medical devices.
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