Consumer Law

FDA?s Approval Process For Dangerous Medical Devices Not So ?Rigorous?

By Andy Hoffman

Eureka!  After 30 years of chronic thumb twiddling, the Food and Drug Administration (FDA) is reportedly asking manufacturers of some of the oldest and most dangerous medical devices on the market (like pacemakers) to offer assurances that their products are safe.

According to the Wall Street Journal:

The agency's move represents its first step toward completing its review of devices marketed before 1976, when a law passed giving the FDA authority to review new medical devices. The Government Accountability Office, the nonpartisan government watchdog, in January criticized the agency for taking more than 30 years to complete the review. In the interim, the agency approved more than 200 high-risk medical devices through a process designed for low and moderate-risk devices.

This revelation is particularly disturbing given the U.S. Supreme Court?s much discussed Riegel v. Medtronic decision, which immunized makers of medical devices from lawsuits, so long as the FDA has signed off on them.  Crucial to the high court?s reasoning was the notion that the FDA?s approval process for approving dangerous devices was ?rigorous.? (See Part A of the decision.)  Well, so much for that theory! 

Sadly, as a new study by the Center for Justice & Democracy makes plain, the implications of the Court?s horribly flawed reasoning have been devastating for thousands of people who have been killed or injured by faulty medical devices and have no legal recourse against the companies that made them.

Of course, all of this is to say (yet again!) that Congress must pass the Medical Device Act of 2009 to correct the Supreme Court?s egregious and dangerous error?before even more people get hurt.

Full post as published by ThePopTort on April 09, 2009 (boomark / email).