Supremes bolster preemption defense

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In a major test of the preemption principle, the US Supreme Court ruled 8-1 that patients can't file common-law claims challenging the safety and effectiveness of an FDA-approved medical device.

The case, Riegel v. Medtronic, involved a suit by the family of a man injured when a balloon catheter made by Medtronic burst while he was undergoing angioplasty after suffering a heart attack.

Writing for the majority, Justice Antonin Scalia said “Premarket approval is a ‘rigorous' process” that should preempt state laws.

The lone dissenter was Justice Ruth Bader Ginsburg.

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