Ennis & Ennis, P.A. is a national law firm that specializes in mass torts, defective medical devices and product liablity cases. If you have been injured you need to know your legal rights. Contact the lawyers of Ennis & Ennis today for a free case evaluation.

Supreme Court Hears Arguments in Device Preemption Case

-FDA News

12/11/2007 - The Supreme Court heard oral arguments in Riegel v. Medtronic last week and will rule on whether the express preemption provision of the Federal Food, Drug and Cosmetic Act (FDCA) preempts state-law claims seeking damages for injuries caused by medical devices with FDA premarket approval (PMA).

Charles Riegel and his wife sued Medtronic after he was injured when a Medtronic balloon catheter burst during an angioplasty procedure. The Riegels alleged state-law claims for negligent design, testing, inspection, manufacture, distribution, labeling, marketing and sale of the device, as well as strict liability and breach of express and implied warranty.

Medtronic sought summary judgment on grounds of express preemption under the Medical Device Amendments to the FDCA. The district court granted Medtronic’s motion and the U.S. Court of Appeals for the Second Circuit affirmed the ruling.

The outcome of this case is significant for the most technologically sophisticated companies that must use PMA applications for approval rather than 510(k) notifications, James Beck, counsel with law firm Dechert’s product liability group, said.

If you or a loved one have had the device replaced or plan to have it replaced you may be entitled to compensation regardless if you suffered as a result of complications from surgery or the device itself. Contact the Medtronic attorneys of Ennis & Ennis today for a free confidential case evaluation. Our on staff nurse and lawyers are standing by to answer any questions you may have regarding the Medtronic pacemaker defects, a possible Medtronic class action lawsuit, or any other type of Medtronic Pacemaker litigation.