Medtronic Statement Regarding U.S. Supreme Court’s Granting of Certiorari in Riegel Case

The United States Supreme Court today granted review in Riegel v. Medtronic (NYSE:MDT), a case in which a U.S. Food and Drug Administration- (FDA) approved balloon catheter was used contrary to labeling instructions by the patient's physician. The decision to take up the case means that for the first time, the Supreme Court will decide whether a patient is precluded from seeking state court remedies against the manufacturer of a device approved by the FDA through its rigorous Pre-Market Approval (PMA) process.

In the Riegel case, an Evergreen balloon catheter – no longer manufactured by Medtronic – was inflated by the patient's physician beyond the labeling restrictions and used in a patient for whom it was contraindicated. The trial court in Albany, N.Y., dismissed the suit, finding that the patient was not entitled to state law remedies in light of the prior FDA approval of the device. The Second Circuit Court of Appeals upheld that decision.

All but one of the seven federal circuit courts that have addressed the question of medical device preemption of PMA devices has upheld the doctrine.

In briefing to the Supreme Court on the Riegel case, the FDA and the Solicitor General of the United States argued that the Second Circuit decision in Riegel was correct, the same position argued by Medtronic.

The Supreme Court will hear the case in the term beginning October 2007.

About Medtronic
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology – alleviating pain, restoring health and extending life for millions of people around the world.