I’d be interested in seeing responses about this decision by the Supreme Court. It seems the Supreme Court has ruled that no one can fault the safety of medical equipment in a lawsuit if that equipment has been approved by Federal regulators.

Under federal law, a company must substantiate the safety and effectiveness of a medical device before the U.S. Food and Drug Administration will approve it for the marketplace.

State lawsuits are barred to the extent they would impose requirements that are different from federal requirements, said the ruling by Justice Antonin Scalia.

In dissent, Justice Ruth Bader Ginsburg said that Congress never intended “a radical curtailment of state common-law lawsuits seeking compensation for injuries caused by defectively designed or labeled medical devices.”

But Scalia, in response, said, “It is not our job to speculate upon congressional motives.”

Seven federal appeals courts including the one in Riegel’s case have interpreted federal law on medical devices as prohibiting state lawsuits. The 11th U.S. Circuit Court of Appeals in Atlanta and the Illinois Supreme Court have ruled otherwise.

Charles Riegel’s family alleged that the catheter produced by Medtronic Inc. of Fridley, Minn., outside Minneapolis had a design defect and an inadequate warning label.

On the one hand, it makes a lot of sense to me that, if a company has gained Federal approval, this could be seen as “due diligence.” Otherwise, no company could ever know if they had done enough. On the other hand, I could imagine an argument that court precedents have a role in determining what should count as due diligence. (Though I don’t see how jury awards could really do that; you would need judges writing decisions for that to work.)

If anyone has an opinion, feel free to comment.