A new Supreme Court opinion has come down this week that should make it harder for patients to seek damages for harm caused by FDA-approved medical devices. The ruling held that federal law doesn't allow them to sue device makers using state laws and regs that go above and beyond federal requirements. The suit arose from a case filed by Charles Riegel, who sued when an FDA-approved Medtronic balloon catheter burst as he underwent an angioplasty in 1996. Riegel based his suit on the contention that the device's design and labeling violated New York law. But the high court dismissed the case, holding that Riegel's state claim was pre-empted by the federal Medical Device Amendments of 1976.
To learn more about the case:
- read this Modern Healthcare item
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