American Clinical Laboratory Ass’n v. FDA November 04, 2024 The 1976 Medical Device Amendments to the Food, Drug, and Cosmetic Act (FDCA) authorize the Food and Drug Administration (FDA)…
Public Citizen v. Food and Drug Administration (Seprafilm) February 01, 2021 Public Citizen sued the Food and Drug Administration (FDA) over its failure to respond to a Public Citizen citizen petition,…
Jones v. Medtronic, Inc. December 18, 2017 In Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), the Supreme Court held that the express preemption provision of the…
Caplinger v. Medtronic, Inc. January 11, 2016 In this products liability action, a woman sued a medical device manufacturer that promoted its product for an unapproved use…
Medtronic, Inc. v. Stengel June 23, 2014 This case arose from Medtronic’s failure to inform physicians and patients about a known risk of a medical device, which…
Lamere v. St. Jude Medical February 19, 2013 This case arose in 2007, when Thomas Lamere, who had been implanted 19 years earlier with a heart valve manufactured…
Degelmann v. Advanced Medical Optics October 30, 2012 In this case, a panel of the Ninth Circuit held that a “guidance document” issued by the Food and Drug…
Hughes v. Boston Scientific Corp. January 21, 2011 In this products liability action, a Mississippi woman is sued a medical device manufacturer whose product malfunctioned in the course…
Riegel v. Medtronic, Inc. February 20, 2008 After suffering serious injury when a balloon catheter burst while he was undergoing an angioplasty procedure, Charles Riegel and his…
