- Should Patients Have The Right To Sue Manufacturers Of Innovative Medical Devices In State Courts Under Consumer Safety 1 (235.22 KiB) Viewed 55 times
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Patients' Right to Sue Manufacturers of Innovative Medical Products Ethics Issue: Should patients have the right to sue manufacturers of innovative medical devices in state courts under consumer safety laws for injuries resulting from use of experimental treatments involving high-risk devices? In Brief: Charles Riegel underwent heart surgery to improve his life-threatening heart condition after his heavily calcified right coronary artery was found to have a 95 percent blockage. Because of the diffuseness of his heart disease and heavy arterial calcification, a rotablator was used to open the artery. Riegel's physician then decided to perform a balloon angioplasty. After several inflations were made without any change in the artery, the artery was stented and several traditional catheters were tried without success. When a new high-risk catheter was stented as a last resort, it also ruptured, and Riegel rapidly deteriorated and sustained serious personal injuries. Riegel and his wife brought suit against Medtronic, the manufacturer of the last catheter that ruptured in Riegel's coronary artery. The experimental catheter was a high-risk medical device that had received fast-track approval from the U.S. Food and Drug Administration (FDA) based on limited but promising clinical data in animal testing. prior to the start of human clinical trials to prove its safety and effectiveness for human use. The Riegels claimed that the device was designed. labeled, and manufactured in a manner that violated New York consumer protection regulations. Medtronic claimed their lawsuit was preempted by federal law. - Riegel v. Meotronic. Inc. 552 U.S. 312 (U.S. Supreme Court 2008). (See Ethical or Unethical Decision at the end of the chapter for discussion of this ethics issue.)