FDA May Raise Standards For Testing Data

It’s welcome news to read that “[t]he Food and Drug Administration is developing guidelines that will set tougher scientific standards for data from tests on humans that makers of medical devices submit when seeking approval of their products, a top agency official said.” [The text of the full NY Times article is here.]

Considering all the problems with everything from defibrillators to stents and the fact that medical device manufacturers whose products go through the pre-market approval process enjoy almost total immunity for injuries to consumers, it’s about time the FDA gets tougher on manufacturers.

I’ve been involved in many medical device cases. Every case has made it clear that the FDA is not set up to insure our safety. Our civil justice system has to be equipped to hold manufacturers liable when their products injure people. Hopefully, we’ll soon see passage of a medical device amendment that will allow injured consumers their day in court.