Rarely does a medical device case find itself at the Supreme Court of the US. Yesterday, Medtronic insisted that if the FDA approves a device for safety and efficacy, then it should be immune to cases that challenge its design safety.
From the Financial Times:
The case before the court, Riegel v Medtronic , could have big implications for makers of medical devices and possibly other products. The issue before the court was: can patients bring state product liability lawsuits when the federal Food and Drug Administration has authorised a medical device for sale under its most rigorous approval process?
The case is one of several this term in which the justices confront an issue of big importance to the business community: when do federal regulations pre-empt often tougher state personal injury laws?
Read the rest at Financial Times…