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]

Learn More: New York Times

Medtronic first notified physicians in March about the fracture rate at that time and the proper method for implantation. Additional data on adverse events accumulated since then has prompted today’s action.

Implantable cardioverter defibrillators (ICDs) and Cardiac Resynchronization Therapy-Defibrillators (CRT-Ds) are used to treat abnormal heart rhythms that can cause the heart to stop suddenly. ICDs and CRT-Ds shock the heart back into normal rhythm by sending a pulse of energy through an electronic wire or lead that is connected to the heart.

When a defibrillator lead is slightly more prone to fracture, it doesn’t mean that every lead will break. Most leads will function well, as is the case with Sprint Fidelis. In the infrequent circumstance where a lead actually breaks, or “fractures,” the lead may send false signals that cause inappropriate defibrillator shocks, or therapies such as pacing or shocks may not be delivered.

Current adverse event information indicates that fractures have occurred in less than 1 percent of the approximately 268,000 of these leads implanted worldwide. We don’t know if this rate of adverse events will remain constant or increase over the life of these leads.

FDA considers Medtronic’s action to be a product recall, as defined by FDA regulations, and we will soon be issuing a recall classification for this action. We recognize that some patients and health care professionals might inappropriately interpret the word “recall” to mean that the devices must be surgically removed and returned to the manufacturer. Although the leads should no longer be implanted in patients, we do not mean to imply that these leads should be surgically removed.

The leads continue to function properly in the vast proportion of patients. Although there is no test to predict which lead will fracture, FDA agrees with Medtronic’s recommendation that defibrillator settings be adjusted at the patient’s next scheduled follow-up visit with their doctor. Doing so may increase the likelihood that a fracture will be detected before a patient is harmed.

Neither FDA, Medtronic, nor representatives of the Heart Rhythm Society, recommend the routine surgical removal of a fractured lead because removal carries risks. Instead, physicians should weigh the benefits and risks of either continuing to use the lead with careful monitoring or capping the lead so it is no longer useable and implanting a different model.

Read the full statement from the FDA