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Plaintiff Has Standing in Defective Device Lawsuit
A patient implanted with a medical device is vulnerable to injury if that device is defective, even long after the operation and recovery phases have passed. Some courts have recognized a right to certain types of recovery when there is a prospect of future injury, but others have not. In the recent case of Sutton v. St. Jude Medical S.C. Inc., 2005 U.S. App. LEXIS 18013 (6th Cir. 9/23/05), the U.S. Court of Appeals for the Sixth Circuit was asked to answer a related threshold question of first impression in a medical monitoring case: Does an increased risk of harm requiring current medical monitoring serve as a sufficient injury in fact to confer standing to sue?
Fear Caused By Defective Heart Device
In Sutton, plaintiff Michael Sutton, who had a heart condition, brought suit on behalf of a proposed class of persons who underwent cardiac bypass surgery that employed a medical device called the Symmetry Bypass System Connector (the device), manufactured, designed and distributed by St. Jude Medical, S.C. Inc., and St. Jude Medical Inc. (collectively St. Jude). Heart surgeons use this device during cardiac bypass surgery to attach saphenous vein grafts to the aortic surface of the heart without sutures. Sutton claimed that the device had “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, including death. He alleged that St. Jude failed to use reasonable care and was negligent in designing the device, and further, that the device was defective, unreasonably dangerous and sold and marketed without proper warnings. Sutton complained that St. Jude had been made aware of the device's problem through incident reports, but continued to market it despite this knowledge. Sutton himself has as yet suffered no injury.
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