Opinion ID: 791494
Heading Depth: 2
Heading Rank: 1

Heading: introduction

Text: 5 Plaintiff-Appellant Michael Sutton brought suit on behalf of a proposed class of persons who underwent cardiac bypass surgery using a medical device called the Symmetry Bypass System Connector (device). Heart surgeons use this device during cardiac bypass surgery to attach saphenous vein grafts to the aortic surface of the heart without sutures. Sutton was implanted with the device during treatment for his heart condition. Defendants-Appellees St. Jude Medical, S.C., Inc., and St. Jude Medical, Inc. (collectively St. Jude) are the designers, manufacturers, and distributors of the device. Sutton alleges that St. Jude failed to use reasonable care and was negligent in designing the device, and further, that the device is defective and unreasonably dangerous, and is sold and marketed without proper warnings. In addition, Sutton specifically alleges the following facts in his complaint: 6 (1) 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, including death (Complaint at 6, ¶ 15; Joint Appendix at 10); 7 (2) St. Jude was informed of adverse consequences associated with the device through incident reports from cardiac surgeons, but despite these warnings, St. Jude continues to market and distribute the aortic connector (Compl. at 6, ¶¶ 16-17; J.A. at 10); 8 (3) as a result of having this allegedly defective and unreasonably dangerous device implanted in him, Plaintiff has 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 its resulting physical injuries (Compl. at 6, ¶ 29; J.A. at 10). 9 Sutton brought a diversity suit on behalf of all persons in whom the device has been implanted. 1 10 Sutton, on behalf of the putative class of persons implanted with the device, seeks the imposition of a medical monitoring fund providing the following: (1) notice to all persons implanted with the device of its potential harm; (2) periodic medical examinations, including necessary studies and tests, to determine the extent of graft compromise and its progression, if any; (3) education for physicians about diagnosing and treating any scarring that may result from using the device; and (4) medical treatment to remove the device from all individuals exhibiting bypass graft compromise as a result of using the device. 11 Pursuant to Rule 12(b) of the Federal Rules of Civil Procedure, St. Jude moved for dismissal of Sutton's complaint. St. Jude asserted Sutton lacks standing to pursue his action, and that he failed to state a claim upon which relief could be granted. Ruling that Sutton did not have standing, the district court dismissed his complaint for lack of subject matter jurisdiction. 2 Sutton timely appealed to this Court.