drug. you can change a device. >> why can't you change a @@@ device technology is very well recognized. an iterative process. we had a vivid description of how it develops over time. you can't change a drug overtime. it is what it is. >> professor at the 11. >> there are differencees between drugs and devices but the difference had to do with the warning, the warning is much more like a device in the sense that the due process that you

can change the warning, if the warning is in working or something else has come up that needs to be changed, it is the same iterative process. i suggest the difference is not that great at all. >> >> reporter: drugs all the time for dosages and recommended treatment for drugs. >> that is changing the labeling. it is not changing the molecular entity, which is the drug. you can change the device by adding something to it, by putting bells and whistles on it. you can do that once you have a molecular entity. >> seems to me they're changing drug that all times. i haveat all times.

i have to think about that. >> dirksen senate office building what people who are injured to be fairly compensated when injuries are the results of another person's negligence. i don't think any of us want to prevent people from receiving fair compensation. you have expressed yourself that way as well. it seems to me the nba has verified by the wrinkled decision, provides device manufacturers, some level of protection from litigation, many avenues remain open. >> that is correct. >> under current law patient can sue a manufacturer if the device fails. >> it is a very complex issue as to exactly where product liability would be cut off and would not. if the manufacturer follow the requirements of fda laid down in

the p.m. a approval, which is very specific, they said exactly how the device will be made and how it will be labeled. if those are followed, there could be no liability. if they fail to follow them, you are correct, there could be. >> if there is a manufacturing defect, what about that? >> that would mean, if you are saying there is failure to follow the fda requirement, that kind of the fact, yes. but there is one thing we have to understand, drugs have problems, they don't act perfectly, and as a result a drug or device that might save my life could hurt someone else even though it is a perfectly good device or drug.

the fact that it hurts someone does not mean there is a defect. it may be working the best it can, and it may save 999 lives and fail to save the one thousand life. that doesn't mean it is defective. >> if it is labeled in a matter that is inconsistent with the fda requirements, the you consider that? >> yes. >> device manufacturer may be liable if they mislead the fda during the pre-market approval process. >> not only would they be liable, they would be criminally liable. it is a criminal violation of the act in any way to withhold information from fda or submit false information. >> a patient could also -- associated with an fda approval. >> yes. >> it seems to me device manufacturer can be proved negligent or otherwise, follow

the statutory pre-emption, has little or no affect. america leads the world in the development of life sustaining medical devices. the entrepreneurial environment, which is very unique to this industry, is the backbone of what sets medical innovation apart from other countries throughout the world war around the world. the medical technology industry is one of the few that is continuing to create economic opportunities for thousands of american families despite the challenging economic environment. the decision to develop a medical device is highly risk dependent. for many, it begins with an entrepreneur or startup company competing to attract venture capital and other investments to bring their products to the next stage. venture capitalists are risk

focused. when deciding to invest in a promising medical technology, venture-capital lists take many matters into consideration such as patient benefit, intellectual property, protection and risk of liability and any uncertainty in any of those elements could be a significant deterrent to investing in any kind of promising technology. i am very concerned that without the preemption and the uncertainty of the risk of liability, medical device development and innovation could be stifled, you indicated you feel that way as well. >> i have personal experience with that. i sit on the board of directors, ten small biotechnology companies, some of which are engaged in the development of medical devices. and the decisions made by venture capitalists based upon such issues as potential

liability, directly affect every one of those companies. >> i would like to get the answers. >> okay. time is up. >> thank you, mr. chairman. i will be brief. i may not take five minutes because i'm not going to ask a question. i want to thank all of our witnesses, we assembled quite and expertise of experience and knowledge and personal stories. several months ago, we were in this room, i have deep respect for senator harkin. the date and tobacco, the fda was the only agency in the world that could regulate tobacco, the only ones who had the expertise. the cdc wasn't good enough, there was no other agency. the fda was the only gold

standard, they had the only braintrust that could run through a complicated process, and a month ago, debating health care reform. in that health care reform debate, we talked about. we needed better outcomes. more outcomes of the american people. now we are here because of the results of an 8-1 supreme court nomination. thirty-three years later, this is the single most important thing we have on our plate.

twice as long as i have -- let me read from your testimony. judges and juries throughout the country, inconsistent with the terminations. the result would be revelatory chaos. regulatory chaos, you have no investment. no venture-capital at the table to drive the next device, you therefore have no innovation.

you decrease the outcome. the new england journal of medicine stated that $0.54 of every dollar paid is devoted to administrative costs. it is becoming clear, the supreme court has signed where you can go to court, and more pocketbooks. i want to make sure anyone who is injured in this country is taking care of and i don't question your injuries one bit if there was a defect.

i think mr. hutt covered that when a manufacturer is negligent on something, if a manufacturer does not follow that prescribed by the fda, if a manufacturer, fda requirements are fairly clear, they are black and white, there is no gray area, i have found. whether it is drugs, devices or biologics, it is specific on marketing and everything. the country goes outside of that, they are basically open game. i am going to conclude, 40 seconds left. i want to ask unanimous consent entered into the record, from the blind veterans association. we therefore strongly urge you to impose the medical device safety act of 2009 and the american military society deciding which new medical

devices are safe enough to be sold in this country as a job for doctors and scientists, the u.s. veterans hostas committee, opposition to this legislation is given by a belief in the need for greater access to hospice care. a number of companies, the american health care association, american insurance association, business roundtable, national association of manufacturers, u.s. chamber of commerce, their last line, for these reasons and others that detailed in the attached letter, we urge you to impose this legislation. i would ask unanimous consent. prius thank our witnesses for

being here. >> i want to thank all the witnesses for being here today especially the two men, the patients, thank you for your testimony. i have one question, wanting to ask, not sure who this is addressed to. for individuals who have a defective device and you have to go back in the hospital and have a device removed, and other payments whether the actual surgery, hospital, physician, who pays for that? >> an excellent question, very important question, an area of health reform. the answer is patients pay for that, taxpayers pay for that because insurers get billed, the number one payer, i suspect, of medical device defect is the federal government, medicare, some may argue that we have two cash for clunkers programs and this is one of them were the

government is paying for defective medical devices. >> i think we are all concerned about cost and cost containment and that is a very big issue. yes, mr. hutt? >> there is a provision in the medical device amendment of 1976 that authorizes fda to order the company to pay for a defective device and the requirement of explaining. >> does the patient individually have to petition -- how does that process work? >> the fda can, on its own initiative, order that, any patient could ask for it. >> on a recall basis? >> on a petition basis. >> that is all, mr. chairman. >> i will start to -- you can

start me again on that five minutes. i must say for the record that before rego was decided, the device manufacturers were subject to laws, it wasn't until the real decision that the door shut. am i correct in that? >> no, sir. there were a number of court decisions before riegel -- before riegel the device manufacturer did not know if they going to win or lose. let me just say for the record that the last year before the riegel decision, the last year before the top 25 medical device

companies had a net profit of $173 billion net profit, they were doing quite well. they were coming up with new devices all the time even though they didn't know if they would be subject to a tort claim or not. it doesn't seem innovation was stifled. i must also say, regardless of the difference between drugs and devices, new drugs on the market all the time, they are not preempted from tort claims. mr. maisel, is it not true that after medtronic started receiving reports, you state it was within months of initial market release, they did not recall until three years later, fda inspection report cited them

for objectionable conditions, failing to implement appropriate directed and preventive action procedures related to the company's investigation of the product anomaly. dr. maisel, do you believe the fda approval process is so good that manufacturers of these devicess should receive immunity when they are faulty or cause injuries? you have been there. tell us about it. >> the fda does an exceptional job of evaluating medical devices and they are extremely thorough. the biggest issue i have is this concept and manufacturer liability stops device approval. i tried to outline in my testimony all the responsibilities of a manufacturer after the fda approves their device, there is now manufacturing the product, they have to ensure stability. there are many compliance guidelines they need to follow for manufacturing. it is simply impossible for the

fda to monitor individual companies when there are 15,000 manufacturers, and 100,000 devices being produced. the idea that only those companies that get caught by the fda are the ones that are going to be held liable, i think, is bad policy, it is also interesting to note that a u.s. house committee report in june 2006 noted the decline in enforcement reports and enforcement activity of the fda, the number of warning letters issued by the fda declined 50% between 2000, and 2005. every single office at the fda had a decline, with the device center having the largest decline in the number of enforcement letters issued. the concept that we are going to rely on the fda catching manufacturers doing something wrong in order to support consumer liability is a bad policy. >> but mr. hutt says once you

make a device -- suggested does -- you can change the device, you can change them. if they make a change on a device, does it have to go all the way back to the beginning and go through premarket approval? >> manufacturers can make modifications to their device and they need to let the fda know about that and submit supplements to their p.m. a application. >> it doesn't go through the whole process again. >> that is an excellent point because the medtronic differ later we are talking about was a supplement application, it was not an original p.m. a. >> i did not know that. >> the supplement application had no clinical data. they made a modification to their lead, it was never implanted in a human before it was approved by the fda, no human data was submitted to the fda to support its approval. the device is approved on the basis of bench testing and animal data and it goes close to 300,000 patients. the question isn't why are we

here? is it is -- it is obvious why we're here. was inevitable something like this would happen. >> you told me something i did not know. you said device manufacturer like this medtronic they fibril later, when it went through the free market approval and everything, it was approved, later on, they made it change to it but it didn't have to go back and be approved and they did note human trials. >> it did need to be approved. the original p.m. a was submitted in 1992, the supplement that approved the lead in question was approximately supplement 25 or 30, somewhere in that range and each of those supplements goes back to the fda for consideration and supplements often do not require human clinical testing, you're looking at a lead, 15 years removed from the original p.m. and there is not a lot of clinical data submitted to support its approval. the idea that that lead will function perfectly well and the manufacturer will never be

liable for it seems an interesting policy. >> i am a minute over. >> thank you, mr. chairman. they have any comment about anything that has been said so far? >> supplemental p.m. a which is required for any change of any kind, is required to be approved by fda using the same standards of safety and effectiveness as the original p.m. a, senator harkin. i don't want there to be any conclusion -- confusion about that. the fda looks at the entire p.m. a when the supplement is submitted. and either approves the device as change, as safe and effective, or not. so there is no distinction between the original and the supplemental p.m. a. the fda in this instance,

perhaps incorrectly, i do not know the facts, what they did was they looked at all the data on safety and effectiveness in humans, they concluded that the new lead did not require additional human data. i am not a scientist and i cannot say they were right or they were wrong. dr. maisel is more qualified than i to make that judgment. but i don't want there to be any confusion about what the process was. >> mr. mulvihill, did you sue because of the difficulty went through? did you intend to sue? >> when this first happened did not intend to sue. i like my doctors in davenport, iowa. i didn't know there had been a problem. i wasn't told that. in october of the year that i had my problem, months, months

later, a friend called me and said the you see the paper about medtronics? i got thinking about it, looked at it, my wife and i discussed it. i didn't do anything for longtime, it was the end of january, first part of february before i contacted the firm and they agreed to take a lawsuit. >> mr. roman, you will be going from this hearing to my home state of utah, to the bottom of the speedway to set your fifth land speed record. >> yes, sir. >> i don't want to call you nuts but we are very proud of that. >> the thing we are most proud of is the second opportunity the family has been given. one of the things we try to do is in corporate wounded warrior project, the military show they

come out with us and the service logo goes down, the marines are first, i get a lot of grief for this the my rule is first in, first to win. we take a u.s. military with us. >> i wish you the best of luck in your endeavor. you stated in your testimony that the first simulator did not work for you and the technology from the second stimulator pushed the envelope and was risky. considering those factors can you explain what made you decide to get the second device and have you had any regrets since you got the second device? >> plain and simple, family. i wanted my family back. i wanted a chance at a normal life. the original trial didn't go well. it was like being electrocuted. from my rectum to the top of my head, it felt pounding and for me it didn't work.

go out five years later, the morphine levels are 300 levels of morphine in day, i am hallucinating, suicidal thoughts are pretty constant. for me it was desperation. >> better quality of life. >> didn't know where else to turn. during that time, it was remarkable how this technology had change. it was like night and day, it was based on the implant technology, it was very smooth, i could steer it and control it a lot more than the pounding. >> i am glad you did what you did. 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, it goes on the market. there's a recall but because they cannot sue, they cannot get discovery to find out if they ever committed fraud on the fda.

i hope i have made myself clear. the device manufacturer commits fraud on the fda, puts the device out and injures people but they cannot sue and they cannot get discovery to get at these documents, you will never know whether or not they committed fraud on the fda or not. what is wrong with that line of reasoning? >> can you ask me a specific question? fda does not have subpoena power, but any fda inspector has the authority to obtain records inspection by visiting the company, and they can demand any form of record relating to information on safety and effectiveness in the files of the company. they have 100% of 42 obtain them.

this is extremely important, it is a violation regarded by the fda as the most serious violation if a company that fails to submit all of the relevant safety and effectiveness information as part of their p.m. a, when i was chief counsel, i can assure you the one area i always considered criminal sanctions was the failure of our company to report things they were required to report, either with the original application for after a drug or device was marketed, when there are also reporting requirements. the fda's criminal authorities is the strongest criminal authority under any federal statutes. it does not require knowledge or intent by the company or the individual. it is what we call strict