mr. mcgarity, a lot of respect for you. you testified before the committee and number of times, you're clearly a very bright guy. as you can see, you and mr. hutt differ quite a bit. i am as concerned about these issues as you are. on the other hand, i am concerned about the best medical devices we can find, i do know there is a balance here that has to occur. i don't think any of us want somebody to be hurt by a medical device and not be compensated if it is truly the fault of the company or anybody else for that matter. it is a tough area, these are tough decisions. my time is up. i was going to ask a question, but that is fine. i just wanted to mention that i respect you. >> thank you. >> i have one other thing i would like to pursue. i am just thinking about this. p.s. the aid does not have subpoena power, does it? >> no. >> the vice manufacturer knows under riegel that they are not subject to court lawsuits. let's say--i was thinking about this, warner/lambert/kent, the fda does not have subpoena power, they approve it,

mr. mcgarity, i want to -- >> a couple points, that might happen but it doesn't. you don't see that many criminal prosecutions hopefully because it doesn't happen that often but the fact of the matter is the underlying fact of the matter is when we get this information about what was going on in the drug company files and device manufacturer files, it is not because fda inspectors got it, it was because the plaintiff sued and we had discovery, we had depositions taken, we had whistle-blowers within the company come forward with that information, but it is not because fda turned it down. >> let me just say this. the fda don't miss much. the constant complaint is they are overregulatory, if anything. i don't know the instance with -- i heard the same points that you made, dr. it:-- dr. maisel, about medtronics. if they wanted those materials they would have gotten them. i don't know the reason behind it. maybe they did in the end. one concern i and others had deals with the mission of the fda with regard to medical devices. the current regulatory system, the device

mr. -- professor mcgarity. pponents claim that this law by reexposing the medical device manufacturers to liability would lead to a loss of innovation in the medical devices market. the kind of innovation mr. roman was talking about. is there any evidence at all to suggest this might be the case? >> i have not seen evidence to that effect at all. i think that a company will be looking forward to the market and lots of decisions -- lots of considerations will affect that determination. but the likelihood that they will be sued if they do a bad job i don't think is one of the major considerations that play out there. and certainly, just looking at the objective evidence of it, i don't see evidence of that, no, sir. >> i want to try to understand something. mr. hutt, maybe i can get somebody else involved in this too. i want to try to understand the difference between drug regulation, fda drug regulation, and medical devices. wyatt versus levine, the court held the pharmaceutical industry doesn't preempt state cour

mr. -- professor mcgarity. opponents claim that this law by reexposing the medical device manufacturers to liability would lead to a loss of innovation in the medical devices market. the kind of innovation mr. roman was talking about. is there any evidence at all to suggest this might be the case? >> i have not seen evidence to that effect at all. i think that a company will be looking forward to the market and lots of decisions -- lots of considerations will affect that determination. but the likelihood that they will be sued if they do a bad job i don't think is one of the major considerations that play out there. and certainly, just looking at the objective evidence of it, i don't see evidence of that, no, sir. >> i want to try to understand something. mr. hutt, maybe i can get somebody else involved in this too. i want to try to understand the difference between drug regulation, fda drug regulation, and medical devices. wyatt versus levine, the court held the pharmaceutical industry doesn't preempt state cou