Donna Riegel filed suit against Medtronic after a Medtronic catheter burst inside the artery of her husband Charles causing him to undergo emergency bypass surgery in 1996. Although Charles Riegel survived the surgery, he passed since, and Donna carried the fight all the way to the Supreme Court.

On Wednesday, February 20, 2008, in an 8-1 decision, the Supreme Court ruled against the estate of Riegel stating that devices subject to PMA are preempted insofar as they are not based on the violation of FDA laws. Federal law requires that a company must submit an application to the U.S. Food and Drug Administration (“FDA”) before a medical device can be sold. Medical devices are classified as Class I, II, or III. Generally speaking, Class III devices pose the most danger to the public. The FDA can approve a Class III medical device when a manufacturer shows that the device is either substantially equivalent to a device already on the market through the 510K process or that the device is safe through the pre-market approval process (PMA).

The catheter that caused Charles Riegel’s injuries was approved by the FDA through pre-market approval (PMA). PMA is the most stringent type of review required by the FDA. The main difference between 510K and PMA is that 510K focuses on substantial equivalency to a product already approved to go to market whereas PMA focuses on the safety of a previously unapproved product.

In simple terms: you can no longer sue a company for putting out a bad medical device if it goes through the PMA process.

What does this mean to you?

The Supreme Court dealt the American public a tremendous blow. No longer are you safe from desperate companies looking for patents to please shareholders. The Court wrongly relies on the supposed “scientific prowess” of an inept and dysfunctional federal Food and Drug Agency.

What can you do?

Only congress can fix this wrong.

WRITE YOUR CONGRESSPERSON [visit Public Citizen at www.citizen.org or People Over Profits at www.peopleoverprofits.org]