We should give them the resources. We've asked them to do a myriad of things, and yet we don't give them the resources to carry it out.

Before Riegel was decided, the device manufacturers were subject to tort laws.

Manufacturers who commit fraud on the FDA are not immune from lawsuits.

I think sometimes they do good things, other times they don't do what they should be doing.

Well, the ultimate goal is to get the very best devices we can to really help people like Mr. Mulvihill, like Mr. Roman, in ways that they've got to be helped.

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 to get at these documents, then you will never know whether or not they committed fraud on the FDA…

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 and things, for drugs.

I don't know where they'd get the money to hire these high-price lawyers from these big law firms.

FDA needs adequate appropriations.

So, the way I see it--before Riegel, the device manufacturers didn't know if they'd win or lose in a tort claim, right?

To me, that choice is clear. We need safe products and we need innovation, and the best way to achieve both goals is not through litigation created by this bill, but through a strong, well-funded FDA.

The FDA does not have subpoena power, does it?

You're saying that a device manufacturer, like this Medtronic defibrillator, when it went through the whole premarket approval and everything, and it was approved, later on they made a change to it, but it didn't have to go back and be…

So, why are medical devices different than drugs?

They could penalize the company. They could seize the offending illegal products.

I don't care how small they are, they'd better meet the most stringent standards of safety and efficacy.

But, under Riegel, if there is--if they can say, 'My gosh, we'll never have to give those documents up.'