Tom Harkin actually said...

If a device manufacturer commits fraud on the FDA, puts a device out there, and injures people--but, they cannot sue and can't get discovery...

So, it doesn't go right back and go through the whole process again.

I was just reminded by my staff that we change drugs all the time for kids--change them all the time--for dosages and recommended treatments...

So, why are medical devices different than drugs?