Category — Medical Device

Jan. 26, 2012 – On Wednesday, January 25, the Fourth Circuit affirmed a West Virginia federal court’s decision dismissing a claim involving a Class III, FDA-approved Medtronic SynchroMed pump on grounds it was preempted by the express preemption provision of the 1976 Medical Device Amendments (“MDA”) to the Food, Drug, and Cosmetics Act.  The case is  Walker v. Medtronic, Inc., No. 10-2219 (4th Cir. Jan. 25, 2012). [Read more →]

[This post comes to us from Diane Romza-Kutz , Robert E. Browne, Jr., John F. Costello, Jr. and Matthew M. Morrissey of Troutman Sanders' Life Sciences Practice Team.  We thought it might be of interest to our readers.]

Sept. 12, 2011 -  The recent furor in the medical device industry over a new recommendation that the U.S. Food & Drug administration abandon its approval process for medical devices has prompted a new round of public meetings and comment. This provides a critical opportunity for the medical device industry to comment on these potential new hurdles to market entry. [Read more →]

July 20, 2011 -   The plaintiffs’ bar is always looking for new ways to pick the pockets of manufacturers, particularly in prescription drug and medical device cases where medical malpractice caps limit a plaintiff’s ability to recover against physicians.  Since the U.S. Supreme Court’s 2008 decision in Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), however, this task has become more difficult in cases involving FDA-approved Class III medical devices. [Read more →]