Increased Risk of Harm Sufficient Basis for Standing in Class Action
In Sutton v. St. Jude Medical S.C., Inc. et. al., (opinion issued 8/23/05) the United States Court of Appeals for the Sixth Circuit considered the question of whether an increased risk of harm requiring current medical monitoring is sufficient injury to confer standing to bring a class action. This issue was one of first impression in this Circuit. Michael Sutton sued St. Jude on behalf of a proposed class of persons who underwent cardiac bypass surgery using a medical device called the Symmetry Bypass System Connector. The device is used by heart surgeons during cardiac bypass surgery to attach saphenous vein grafts to the aortic surface of the heat without sutures. St. Jude Medical, S.C., Inc. and St. Jude Medical, Inc. are the designers, manufacturers, and distributors of the device.
Sutton was implanted with the device during treatment for his heart condition. Sutton alleged in his complaint that St. Jude failed to use reasonable care and was negligent in designing the device. He also alleged the device is defective and unreasonably dangerous and is sold and marketed without proper warnings. Sutton pled that the device has led to severe and disabling medical conditions resulting from collapse and scarring of the graft in numerous patients necessitating removal of the device and/or monitoring for further harm. Sutton alleged that St. Jude was informed of the adverse consequences of the device but continues to market and distribute the device. Sutton pled that, as a result of having the device implanted in him, he had suffered economic losses and large medical expenses and has a device in his body which increases his risk for aortic bypass stenosis or occlusion and resulting injuries.
Sutton sought through his complaint imposition of a medical monitoring fund providing: (1) notice to all persons implanted with the device of its potential harm; (2) periodic medical examinations; (3)education for physicians about diagnosing and treating any scarring that may result from the device; and (4) medical treatment to remove the device from all individuals exhibiting bypass graft compromise as a result of using the device.
St. Jude filed a motion to dismiss the complaint pursuant to Rule 12(b) of the Federal Rules of Civil Procedure asserting that Sutton lacked standing and that he failed to state a claim upon which relief could be granted. The District Court ruled that Sutton lacked standing and dismissed the complaint for lack of subject matter jurisdiction.
The United States Court of Appeals for the Sixth Circuit reversed. The Sixth Circuit explained that the District Court found Sutton’s alleged injury purely hypothetical because he did not provide the Court with information from which the Court could assess his alleged increased risk of harm from implantation of the device. The Sixth Circuit disagreed, finding that the District Court incorrectly attempted to evaluate the merits of Sutton’s contention that he is entitled to medical monitoring costs. The Sixth Circuit cautioned that during the threshold standing inquiry which was required at this stage of the litigation, the District Court should have accepted Sutton’s allegations as true and construed the complaint in Sutton’s favor. The Sixth Circuit noted that, in recent years, plaintiffs have regularly been awarded medical monitoring costs in both toxic tort and product liability cases.
The Court further found that it was not necessary that Sutton demonstrate a vast increase in the risk of injury at this phase of the litigation in order to show standing. The Sixth Circuit explained that Sutton’s allegations of increased risk of harm when comparing those individuals implanted with the device to those undergoing traditional surgery, accepted as true at this stage, were sufficient. The Court noted that waiting for a plaintiff to suffer physical injury before allowing any redress whatsoever is both overly harsh and economically inefficient.