Case Notes

Where a plaintiff establishes facts, if accepted as true, to suggest an increased risk of future harm after being implanted with a defective medical device, the plaintiff may have standing to bring his claim. Sutton v. St. Jude Medical S.C., Inc., No. 04-5211, U.S. Sixth Circuit Court of Appeals, Aug. 23, 2005.

Sutton commenced a lawsuit on his own behalf and that of a class of persons who underwent cardiac bypass surgery using a medical device to attach vein grafts to the heart without sutures. Sutton claimed that this device was defective and unreasonably dangerous and led, among other things, to severe disabling conditions resulting in the collapse of the graft and necessitated increased medical monitoring. Because Sutton commenced this action representing a class of individuals who had not yet been injured, he was required to establish standing. The court held that Sutton could not establish standing because Sutton could not clearly establish his injury. The appellate court disagreed. It held that the facts as set forth by Sutton, if accepted as true, were sufficient to suggest an increased risk of future harm as a result of being implanted with the medical device. It further held that Sutton was not required, for the purpose of standing, to clearly demonstrate his injury.