Thursday, February 21, 2008

SCOTUS Riegel Opinion: Preemption as to Medical Devices

The U.S. Supreme Court issued its opinion in Reigel. You may find it here.

The ruling will affect the medical devices most frequently targeted in lawsuits, cutting-edge products such as bone screws and defibrillator wires that undergo the FDA'S pre-market approval process. Because that process typically takes almost a year, companies use it relatively sparingly, filing only 43 new applications with the FDA in 2005.

From one blog:

"The medical device industry, or at least the most innovative part of it, received major relief from product liability litigation yesterday in Riegel v. Medtronic (now online at 2008 WL 440744)." As the blogger posted: "As long as [device makers] with PMA-approved devices comply with federal law, [device makers are] not going to be subject to much in the way of product liability." Source here.

For more news, go here.