gave the food and drug administration long overdue authority to regulate medical devices. in support of that bill, senator kennedy said at the time i quote, today, the medical device industry plays a prominent role at the very heart of american medicine. many devices today are actually used to sustain life. we will grow more and more dependent upon medical devices in the future. we stand to benefit a great deal from them but we must be sure that they are safe and effective in order to avoid needless injury and death. end quote. today, this committee will hear testimony on precisely the issue that senator kennedy sought to address, the need to ensure that the medical devices that patients rely on to stay healthy and in many cases, alive, are safe and effective. we are here because last year in a supreme court case regal versus medtronic, inc. the court held the medical device, whose

express purpose was to provide for the safety and effectiveness of medical devices, end quote, the court said that this law preempts state tort claims when a medical device causes harm. this means complete immunity from lawsuits for corporations that endanger consumers with unsafe devices. the upshot is that a negligent corporation cannot be held accountable and victims could not receive fair compensation and thus, consumers are at risk. unfortunately, this had catastrophic consequences for ordinary americans. take the example of avery de growe of mchenry, illinois. she was born with a hereditary heart defect that put her at risk. when she was only 2 years old, her doctor recommended she have a defibrillator implanted in her chest. at age 3, she was playing in her basement when the defibrillator shocked her nine times. when her mother picked her up she felt electric shocks through her daughter's body. avery's parents had the faulty

defibrillator replaced but medtronic told them the company would not cover the cost. avery's parents are still struggling to pay off the medical bills. i am told avery is here in the audience today. is avery here today? hi, avery. good to see you. i like the daisy you have in your hair, by the way. consider judd orcott of oregon, during his national guard service, he was -- sustained a spinal cord injury. in an effort to reduce pain, he had his herniated disc replaced with an artificial disc manufactured by dupuis spine. instead of experiencing relief from the artificial disc, judd experienced extreme pain and bouts of paralysis. however, because of the court's ruling in regal, judd has no recourse to seek remedies for his injuries. today, we'll hear from an iowan

who received 22 electric shocks within a span of 53 minutes from a faulty medtronic defibrillator. because of the faulty device, he suffered enormous pain, was forced into early retirement and is unable to perform basic functions such as even driving on the interstate. we'll be hearing him testify here today. as a senior member of this committee i have worked hard along with others here, senator hatch and others, to ensure that the fda performs its job well. while the fda approval of medical devices is important, it cannot be the sole protection for consumers. i say that because fda approval is simply inadequate to replace the long-standing safety incentives and consumer protections provided by long-standing state tort law. no matter how diligently and effectively the fda does its job, it simply cannot guarantee that no defective, dangerous and deadly medical device will reach consumers. as the former director of the fda center for devices and radiological health frankly acknowledged, he said quote, the

fda's system of approval devices isn't perfect and unexpected problems do arise. last year, 15 devices were recalled due to defects. in 2009, there have already been ten. the fact is the fda conducts the approval process with minimal resources, and simply does not have adequate funds to generally assure that devices are safe or to properly and effectively re-evaluate approvals as new information becomes available. moreover, the fda relies on manufacturers to provide information about their products. once on the market, the fda relies on manufacturers to track devices and monitor for problems. however, without the threat of any liability, there is little incentive for manufacturers to report problems to the fda or to the public. this puts thousands of consumers at risk of harm. indeed, thousands have already been harmed in instances where manufacturers knew of problems with the device, but withheld that information from the

patients. in our system of justice, access to the court system is critical to exposing dangers and bringing about remedies. through discovery, litigation can help uncover previously unavailable information on adverse effects of products that might not have been caught during the regulatory process. litigants can demand documents and information on product risks that might not have been shared with the fda. in this way, the public as a whole is alerted to dangers in these medical products. finally, preserving people's ability to sue when injured provides a very powerful incentive to manufacturers to use the utmost care. in short, the threat of liability is the safety net that helps repair problems when the fda or manufacturers fail to warn consumers properly. as the supreme court noted in another case concerning drug companies, the wyeth versus

levine case, state tort suits uncover unknown drug hazards and provide incentives for drug manufacturers to disclose safety risks promptly. i ask, why would we not hold device manufacturers to that same standard as we hold drug companies? i think sadly, the supreme court fundamentally misread congress' intent in passing the medical device amendments in 1976. the court's ruling however is not the final say on this matter and to quote chief justice roberts, in every area involving an interpretation of a statute, the final say is not with the supreme court. the final say is with congress. and if they don't like the supreme court's interpretation of it, they can change it. end quote. i might just at parenthetically aaside, we found that with the americans with disabilities act. when the supreme court in three cases narrowed the scope of the americans with disabilities act.

in clear contradiction of what we put in our report language. when we pass a bill, we don't put in every little single thing. we add report language to try to give guidance as to what congress' intent is. well, the supreme court just threw that overboard. they didn't pay attention to it and so we had to offer the americans with disabilities act amendments two years ago, it took us about a year to get them through and the order got through last year and president bush signed them into law. which we then overturned the supreme court's decisions to fully enlighten them as to what congress really wanted to do. so this is something that is not unheard of. senator kennedy as he did 30 years ago, is fighting to ensure that consumers are safe. he has introduced a medical device safety act, s.r. 512, which would reverse the regal decision. this bill is really about real people who have been led -- let down sometimes catastrophically.

they have no way to hold those who harm them accountable. i would yield to our ranking member, senator hatch. >> thank you, senator harkin. we appreciate the leadership you provide and miss our friend, senator kennedy. we welcome all of you witnesses here today. this is a very important hearing and this is a very important subject or should i say, set of subjects. mr. chairman, i want to start off by discussing the context in which we are holding today's hearing. as everyone in this room knows, congress is in the middle of debating and drafting legislation aimed at overhauling our nation's health care delivery system. obviously, we are somewhat divided over what is the best approach in this effort but i think we all want to see something done to reduce the health care costs in this country. as we all know, the medical device amendments of 1976, the mda we call it, established rigorous system of federal oversight of medical devices. under this system, devices carrying the greatest health risks are subject to premarket

approval by the fda. during this process, fda officials spend a tremendous amount of labor intensive time and hours reviewing a single device, consulting outside experts and analyzing the safety and effectiveness profile associated with the use of the device. i'm sure our panel will discuss this process in more detail so i'll just say that the fda's premarket approval process for medical devices is extremely rigorous and very costly to the manufacturers, and really, to those who hope for the benefits that can come from these medical devices, and as history has shown, the fda is exceptionally efficient. in addition to requiring premarket approval, the mda also requires those who manufacture and market the applicable devices to report to the fda on the implementation and use of all approved devices. these reports include any new and relevant clinical investigations and scientific studies of which the

manufacturer knows or reasonably should know. device manufacturers must also report to the fda any incidents, malfunctions or adverse events that may have contributed to a serious injury. the fda has the authority to revoke its approval and/or order a recall if it determines the device is unsafe under the conditions of its approval and labeling. in addition to these rigorous approval and oversight requirements, the mda included an explicit preemption provision prohibiting states from establishing or continuing quote, any requirement, unquote, which quote, is different from or in addition to, unquote, any federal requirement applicable to the device or which quote, relates to the safety or effectiveness of the device, unquote. this provision was common sense, given the rigorous and costly nature of the fda approval process, it was in the best interests of all shareholders, excuse me, stake holders,

including patients and consumers, that the states be prevented from supplanting this system with their own regimes. as we're all aware in last year's regal versus medtronic decision that my distinguished friend has mentioned, the supreme court held that this explicit preemption provision also applied to tort claims filed pursuant to state common law. this is not a surprise move by the court. it was an 8-1 decision that affirmed the position taken by the overwhelming majority of the circuit courts. yet i have to say the personal injury lawyers and their allies in congress have painted this decision as an unexpected change in the law in order to advance their pre-existing agenda to weaken federal preemption. the result of this effort is the medical device safety act. the legislation we're discussing today would alter the mda's preemption provision to state that it does not apply to actions for liability under state law. now, my opposition to this approach stems from many

factors. first, i do not believe that randomly selected jurors have the necessary@@@@#7rr$"rr part because they know that the financial risks of litigation are greatly reduced once the process is completed. however, if this legislation is enacted and manufacturers are required to ensure that they have approval of the fda as well as that of any 12 random people

in any one of the states, the risks of marketing a device will greatly increase, and the cost of these devices will go even higher. as a result, innovation will be stifled and fewer and fewer devices will be brought to the marketplace. additionally, we will inevitably see a rise in the overall cost for devices as a means to offset the cost to more frivolous lawsuits. as someone who tried these suits in the past, in my early legal career, or service, i have to say a high percentage of the lawsuits were brought to get defense costs. they were frivolous suits. they have been running up the cost of health care in our society beyond belief, and frankly, when there are legitimate lawsuits, there ought to be ways of being able to arrive at just compensation for those who have been injured. but most often or not, and since the costs of defense, i

generally think of them as between $50,000 and $200,000, you know, it's many times in the interest of the people to just pay the cost of defense rather than to defend the cases and take a chance with a runaway jury. now, this is not only a detriment to health care reform but not only will this adversely affect an industry that employs millions of people during a time of economic crisis, it would also harm patients as they will not benefit from the ingenuity and continuing advancement in technology we currently are benefiting from, the vast majority. that in my opinion will be the most devastating effect of this legislation. indeed, we have one of the most if not the most innovative and vibrant medical device industries in the world that provides life-saving solutions to millions of americans ask people all around the world every year. at a time when our unemployment

is rapidly headed towards double digits, it would be a mistake for us to take some of the steps that are currently being discussed which include, on top of this legislation, taking billions out of the productive sector that employs thousands of americans to produce life-saving treatments to pay for an ill-advised massive government expansion and control of our health care system. making this proposition even worse is the fact that it's unnecessary. we all want to ensure that those who have been truly victimized by the negligence of another party are able to receive adequate compensation for their injuries. however, the current system, including the statutory preemption, does not prevent plaintiffs who have legitimate claims from being compensated. under the mda device manufacturers can only benefit from the protections of preemption if they followed the system to the letter. if they withhold or falsify information in their disclosures to the fda they will be charged

with defrauding the federal government. similarly if a single device is not built exactly to approved specifications or doesn't include fda-approved labels the manufacturer will be liable for damages. in addition, if a device is improperly planted or used the mda will not protect a doctor from being sued for malpractice. when a manufacturer is legitimately at fault, they will be liable under current law. when they are not at fault the mda provides a narrowly crafted safe haven from costly litigation. as stated this exceptionally narrow exemption has great benefits. the mda has allowed unparalleled advancement in medical device technology. due in no small part to the fact that the rules for safety and liability can't be rewritten in 50 different separate jurisdictions. if an acted the legislation we're discussing today would remove this protection and as a result, i believe it is the patients who are going to suffer. i look forward to hearing the

testimony from our panel today and i hope that during this discussion, we can get to the bottom of some of these issues. in particular, i'd like to hear some explanation as to why we should empower laymen on state juries to overrule the studies, analysis, and findings of our fda experts. in addition, i hope we can debate these issues looking toward the future and the effects this legislation will have on the advancement of medical technology. the increased costs to our already out of control health care spending and the lives of those who were benefit from such technology. let me just say that we're happy to have all of you here today. each of you has important testimony to give to us. we're grateful you take time to be here. i particularly want to mention mr. hunt, who is in my opinion the dean of all fda lawyers, who really understands this business as well if not better than anybody in america today. peter, we're very happy to have you here and we appreciate you taking time for what we know is a busy schedule to come and help

us work through there and understand this better. but i've known you for all of my 33 years in the united states senate. you're totally honest, a decent man. you also have written textbooks and have been literally the dean for all of us in trying to understand all the intricacies of the fda. particularly appreciate my friend up here, senator harkin. he and i have worked very closely together, not only on medical devices, i've worked very closely with the chairman, senator kennedy. we worked on all kinds of other things, including the americans with disabilities act. we managed that bill on the floor, the two of us, and i remember when we walked out and saw all those folks who were just praying that we'd get that bill through, we both broke down in tears as did all of them. so i want to thank senator harkin for chairing this hearing in the absence of our esteemed chairman of the committee. i again want to thank all of our witnesses for appearing and being with us today.

thanks, mr. chairman. >> thank you very much, senator hatch. and we'll now go to -- i'm told we've got a couple of votes coming up here very soon. what we'll try to do is go down the panel, and if you'd just take maybe five minutes to summarize, then when we break to go vote, we'll come back for questions and finishing up the panel. i just don't know exactly how soon those votes are going to be called -- maybe right now. i want to note for the record we have a new member of our committee with us today. their the first hearing of our distinguished senator from the state of minnesota. we welcome you to the committee. >> thank you. >> i want to say i started and that seat right down there, i remember back in the last century. >> the way he used to beat me up on television, i'm happy to see him way over there. >> it's great to serve with both of you. we welcome you, mr. change. you too, mr. first, start from my left, go to

the right, over this way. first we'll start with dr. myzell, founder and director of the medical device safety institute at beth israel deaconist medical center. assistant professor of medicine at harvard medical center. he has an active cardiology practice and directs the pacemaker and defibrillator service at beth israel deaconist medical center. received his md from cornell university, his mph from harvard school of public health, completed internal medicine in cardiovascular training at brigham hospital. and is the former chairman of the fda's circulatory system medical device advisory panel. dr. myzell, welcome. as for you and all witnesses your statements will be made part of the record in their entirety. if you could sum it up in five to seven minutes, i'd be most appreciative. >> thank you, mr. chairman,

committee members. good afternoon. thank you very much for the opportunity today to speak about the importance of the medical device safety act of 2009. i am a practicing cardiologist at beth israel deaconess medical center. i direct the medical device safety institute, an independent industry independent ant, nonprofit organization dedicated to improving the safety of medical devices. i served as consultant to fda center for devices in radiologic health since 2003 and previously chaired the fda's poe-market and heart device advisory panels. i hope that you will appreciate that fda marketing clearance or approval of a medical device does not guarantee its safety. in particular, manufacturers' responsibilities for product safety extend well beyond initial fda approval. the u.s. supreme court's regal decision eliminates an important consumer safeguard, the threat of manufacturer liability, and

will lead to less safe medical devices and an increased number of patient injuries. we are very fortunate to have the preeminent regulatory system in the world. the u.s. food and drug administration regulates more than 100,000 different medical devices manufactured by more than 15,000 companies. they receive several thousand new and supplemental device applications annually, and they are mandated by congress to complete their premarket evaluations in a timely fashion. thankfully, there are many superb fda engineers, physicians, scientists and public servants who work tirelessly to try to ensure that only safe and effective medical devices reach the american public. unfortunately, it is not uncommon for unanswered questions regarding device safety and effectiveness to remain at the time of fda approval. this creates the potential for a large number of patients to be rapidly exposed to a newly approved product in the absence of long-term follow-up data. for example, close to 268,000

patients had been immigranted with the medtronics defibrillator before it was recalled in october 2007. we'll hear more on that later. it was then determine the wire was prone to fracture and a fracture of the lead which connects the implantable defibrillator to the heart may result in serious health consequences, including painful electric shocks or death. the medtronic lead was approved on the basis of no human clinical data. although medtronic began receiving reports within months of release, they did not recall the lead until more than three years later. an fda inspection report issued after the recall cited medtronic for "objectionable conditions" noticing they failed to implement appropriate corrective and preventive action procedures related to the company's investigation of the product anomalies. in addition, when the fda inspection team requested certain documents according to the fda inspection report, medtronic would not let the fda

team view them. the delay in issuing a product recall, the fda citation, and failure to provide fda with requested documents did nothing to eliminate medtronic's protection under the preemption doctrine. medtronic claimed immunity citing the supreme court regal decision and the u.s. district court agreed. the fda annually receives reports of more than 200,000 device-related injuries and malfunctions and more than 2,000 device-relate the deaths. it's challenging for the agency to identify patterns of device malfunction among the deluge of reports. the vast majority of recalls are initiated by the manufacturer but manufacturers have an inherent financial conflict of interest often measured in billions of dollars. in numerous cases manufacturers have knowingly sold potentially defective devices without public disclosure. during fiscal year 2006 alone, 651 recall actions were initiated involving 1,550

products reminding us fda product approval does not ensure device reliability or performance. it is clear that medical device manufacturers have responsibilities that extend far beyond fda approval and that comes have failed to meet their obligations. yet the u.s. supreme court ruled in their regal decision that manufacturers could not be sued under state law by patients harmed by product defects from fda-approved medical devices. as a result, consumers are unable to seek compensation from manufacturers for their injuries, lost wages or health expenses. more importantly, a vital consumer safeguard, the threat of manufacturer liability, has been eliminated. implanted medical devices have enriched and extended the lives of countless people but device malfunctions have become modern diseases that will continue to occur. manufacturers have important responsibilities for product safety that extend well beyond fda approval. the idea that manufacture liability for a medical device should end at fda approval is a

dangerous policy. additional consumer protections is offered by the medical guys safety act of 2009 are essential to minimize adverse health consequences and to improve the safety of medical devices for the millions of patients who enjoy their benefits. thank you. >> thank you very much, dr. maisel. now we'll turn to professor thomas mcgarity who holds the long-endowed chair in administrative law at university of texas school of law. he has taught administrative law, environmental law and torts at texas law school since 1980. professor mcgarity received his ba in 1971 from rice university, his jd in 1974 from university of texas. after a clerkship with the honorable william e doyle of the tenth circuit court of appeals, he served as attorney vizner the office of general counsel of the epa. professor mcgarity has written extensively about administrative law and published "the preemption war: when federal

bureaucracies trump local juries." professor mcgarity, @@@@@'6#+g"r in areas that are subject to traditional state regulation. and this reflects our federalist system where we have a federal government but we also have 50 state governments. medical devices were not regulated at the federal level at all until 1976, when the shield tragedy motivated congress to enact the mda of

'76. the purpose of the statute was to protect the users of devices to ensure they did not enter the market in the first place. the medical device amendments did have and do have a preemption clause in them. it does use the magic word "requirement" as the supreme court held in the regal opinion. that was no doubt added to the statute because several states were enacting their own regulatory regimes in the absence of a federal regime to fill the void. it is -- the statute lacked a savings clause for common law claims, no doubt because in 1976, it never occurred to anyone that the word "requirement" would include state common law, but supreme court in 1992 held that it did

for purposes of that statute. and we've seen in the regal case that it now has interpreted the preemption clause in the mda to mean the same thing. now, while the courts' reasoning is open to criticism, the point that you made earlier is that congress is in the position to fix this. congress is in the position -- is the ultimate decisionmaker when it comes to preemption. and i think, therefore, that taking up s-540 is a good idea for the reason that it preserves corrective justice for those who have been wronged. corrective justice is a bedrock principle of civil society that goes back at least as far as aristotle. the compensation of the common law provides corrective justice by requiring manufacturers of definitely designed or manufactured products to compensate innocent victims. now, tort law also provides an

important back stop to the regulatory system by sending a message to potential defendants to collect the data necessary to evaluate their products and to take action to prevent future harm. device manufacturers that conduct the clinical trials that are continually receiving the reports and to collect data from all sources are in a much better position than the doctors out in the field, than the patients certainly, or even the fda, to evaluate the safety of their devices. they're also in a far better position to do something about it once problems do arise. the manufacturers' incentive to comply with the common law duty reinforces, therefore, the protective function of the medical device amendments. now, what are the consequences of preemption? well, on very rare occasions congress has, in fact, explicitly preempted common law

claims. every time it's done that that i'm aware of, it has provided either a federal cause of action or some compensation regime to provide that important compensation function. when a court interprets the word "requirement" to preempt state common law claims, there's a void left. there is no corrective justice. it also robs the common law of its back stop role to back up the federal system, the regulatory system. now, there are other policy considerations as well. institutional confidence. yes, fda has expertise but it is also subject to capture. and fda approval is still relevant and often determinative. i would say most often determinative in common law litigation. fda has traditionally lacked resources. it can be manipulated by companies who defraud the

agency. it is not the case that a party who has alleged that he's been damaged because a company's defrauded the agency is entitled to compensation for that. indeed, the supreme court in the buckman case held that that claim is preempted. by federal law. so whereas the federal government may pursue the frauds, or fraudulent practices, it is not something that a defendant -- a plaintiff who has been harmed can seek compensation for. we have other functions. federalism, as already mentioned, an important consideration in our government. and the argument that somehow allowing compensation will overdeter companies just isn't supported by hard, empirical data. i looked in -- i can't find good, strong studies saying that, well, yes, we have fewer

devices out there, fewer drugs for that matter, because people are able to claim compensation when they are damaged. the decision to preempt common law is uniquely within the power of congress. i commend the committee for taking up that question. thank you. >> thank you, professor mcgarity. now we'll turn to michael m the lahill, graduate of iowa state university, the foremost university in the entire universe. after graduation worked as a golf course superintendent for 13 years. for the next 28 years worked for a turf equipment distributor designing and selling golf course irrigation systems. mr. mulvehill is the victim of a faulty medical device and will speak to that experience. thank you for being here.

>> i had a medtronics fib regulator implanted in march 2006. arrythmia was my problem. june 30th, 2007, i had a very painful, life-changing episode. my wife and i were driving to see our son, daughter-in-law and grandchildren in haddenfield, new jersey. on that saturday morning i was driving east of springfield, ohio, on i-70, in a construction zone, when the device went off. first thought we hit road debris but could not understand what the blue flash was that i'd seen. i tried to navigate the car toward the shoulder of the road. the device shocked me again and again. mary, my wife, was calling 911. i don't remember how many times that device went off. all i recall is the excruciating

pain and the fear i was feeling. responders showed up and took me to a small hospital in london, ohio. they rolled me in on a gurney. the device went off again. i'd moved my head. it lifted me up off that gurney and dropped me right back down on it. i remember looking at what i was assuming a very experienced nurse. her eyes were really, really wide open with concern. and my wife, because i was screaming so bad, she had to go outside, she told me later. i talked to ross hart institute at ohio state, put a big magnet on me, transported me into columbus to that hospital. checked in at the ross heart institute. i was exhausted. very scared. and i hurt. medtronics rep came into the room and read the device. told us it shocked me 22 times in 53 minutes. he added that it was an

electrical problem, electrical wire lead problem. not the device. # we had several doctors come in later that day and came into the room. one of them told my wife and i how lucky we were that i had not wrecked the car, because i had been driving. the lead replacement surgery for scheduled for monday, july 2nd, early afternoon. i was admitted for three days from saturday to tuesday, and i was discharged around noon on july the 3rd. mary drove us on to our son's house and the entire way back to our house in bettendorf. after this episode i found driving on freeways, highways, interstates, made me very anxious, made me very tense and fearful of the device going off. i was afraid i might wreck some other car, hit somebody, kill myself, et cetera. this anxiety had a huge impact

on me and my job. i'd been a golf irrigation specialist for the distributor that covered 77 counties in iowa, 17 in illinois, three in wisconsin. that's a lot of driving. i was no longer able to properly do my job due to anxiety, fear that i suffered any time i drove any distances on highways. it also affected my personal life, this inability to drive. i had annual fishing trips planned for the fall of 2007. they were both impacted. the first trip was to deer river, minnesota. one of my fishing buddies drove the whole way up there and back, about 1,200 miles round trip. while in deer river, i experienced some chest pains, i thought. i went to an emergency room. the doctor concluded i was likely suffering from ulcers. on returning home, my doctor located the ulcers and placed me

on antacid medication, et cetera. about a month after that, october '07, was the next fishing trip. again, one of the fellows on the trip was kind enough to do all the driving. i was able to stay up there a day and a half out of the nine-day trip. the anxiety, nerves, whatever you want to call it, fear got to me. the same fellow drove me home 380 miles from here. then went back up to finish his vacation. it's affected our personal life too. mary and i can't take those trips to see the family and friends. it limited mary's travels. since i worry her more, she's not there to calm me down. after all this worry, deposition, anxiety i was feeling i decided i needed professional help and i began seeing a psychologist who taught me relaxation techniques. they seemed to help calm me down. i also at that time decided the travels and pressures of my sales job were too much to

handle so i moved my retirement up to january 3rd of 2008. about a year and a half sooner than i'd planned. i had several device checks in '08, three trips to the e.r. within six months of the lead replacement. majority of these visits were from me feeling that something was not right. one of my biggest questions at this time is, what effect the numerous shocks from the medtronic device had had on my heart. any unexpected twinge or unusual feeling in the chest area makes me tense, and i begin to wonder if the device is working properly or whether i need to go to the hospital. it's not a fun way to live. my hope is that no one else ever has to go through the pain and agony that i experienced with the fractured lead and that medtronic is held responsible for the injuries it has caused other patients like me. thank you. >> thank you very much for a very profound statement, mr. mulvihill.

now we turn to peter barton hutt, senior counsel in the law firm of covington and burming, specializing in food and drug law. he began his practice in 1960 and has been with the firm ever since. he's a lecturer at harvard law school where he has taught the last 16 years. from 1971 to '75, he was the chief counsel for the fda. mr. hutt is a graduate of yale university and harvard law school with a master of law degree in food and drug law from nyu school of law. mr. hutt, welcome to the committee. please proceed. >> thank you, mr. chairman. i appear before you today at the invitation of the committee to present my own personal views on section 521 of the federal food, drug and cosmetic act which provides for national uniformity in the regulation of medical devices. section 521 was enacted, of course, as part of the medical

device amendment of 1976. as i relayed in think prepared statement, the medical device amendments of 1976 and specifically section 721 were enacted or developed during my tenure as chief counsel for fda, and i was deeply involved in their development. the medical device bills that were forwarded to congress by president nixon in 1971 and 1973 contained no provision that related to the effect of the law or proposed law on state law. in august 1973, however, representative paul g. rogers, democratic member of congress from florida, who was chair of the house subcommittee on public health and environment, introduced medical device legislation that for the first

time included a national uniformity provision. on behalf of fda i strongly supported national uniformity in the@@@@@ um@ @ h$b" considering today that would permit product liability decisions by judges and juries that are inconsistent with fda decisions. mr. chairman, because of the time constraint, i will summarize my testimony with

seven brief points. first, s-540 applies only to devices that are determined by fda to be safe and effective under the rigorous premarket approval system. we call these premarket approval or pma devices. s-540 does not apply to devices that go through the simplified section 510-k procedures. second, pma devices are the life-saving and life-sustaining devices that represent the cutting edge of modern science. they are, for example, stents to keep arteries open. they are artificial hearts to keep people alive while they can get a real heart. they are the innovative new technology that should be encouraged, not hindered or discouraged. third, these pma devices

represent only a small fraction of all medical devices. since 1976, only about .05% of all medical devices have gone through the rigorous pma devices. the supreme court determined that the other 99.5% that go through the simplified 510-k process are not entitled to national uniformity. and thus, this legislation does not affect those. fourth, the pma devices uniquely require highly sophisticated judgment on safety and effectiveness, as senator hatch has pointed out. the mds and ph.d.s that fda spend more than 1,000 hours, over more than a year, to review each one of these devices. no one can possibly argue that

lay judges and juries can do a better job. fifth, allowing judges and juries to second-guess fda divisions on pma devices strikes at the very heart of the pma system. if judges and juries can ignore fda, why can't doctors, hospitals, and patients? and even companies ignore fda? s-540 fosters distrust and disrespect for fda decisions and undermines the public health protection that the pma system is intended to provide. sixth, product liability awards punish companies. there's no question about that. but they do not in any way contribute to safer or more effective pma devices. it is the inevitable adverse events that we know will always occur with a device that lead

fda and companies to correct deficiencies and improve the device. but by the time a lawsuit is brought and completed, the problem has been corrected and the safety issue has been resolved to the extent that it can be. if it's not inherent in the device. finally, i fully support compensation of people injured by pma devices. there's no question about that. but the solution is not to farm out fda decisions to juries throughout the country. the answer is not to replace national uniformity with national inconsistency and regulatory chaos. the jury system is nothing short of a lottery. some plaintiffs win big, others come away with nothing. it is an inherently unfair

system. the goal of providing compensation can most fairly and comprehensively be addressed by a statutory procedure like the national childhood vaccine injury act of 1986. under that system, unlike the product liability system, all patients injured by a pma device would be fairly compensated. and not just those who are fortunate to find a persuasive trial attorney and a sympathetic judge and jury. thank you, sir. >> thank you very much, mr. hutt. and now we go to michael roman. michael roman is from kirkwood, missouri. that's not too far from iowa. >> no, sir. >> he's a formula one racer. he's here to discuss his

experience with a medical device that's enabled him to continue racing. welcome. >> thank you, mr. chairman. as well as members of the committee. my wife susie and i come here today with a simple story to share with the committee. a story of help, hope and heroes. in 1994 while working in a hospital in st. louis, missouri, i had a knee arthro copy done to repair a torn meniscus and developed a staph infection. my nightmare began that day as well as any family's. i've endured 28 weeks of iv antibiotics are 33 surgeries, three progressive amputations to try to save the leg, and the leg is now gone completely at the hip. i immediately began to experience phantom limb pain. they were so severe i could only make it through the day with really increasingly large doses of medications. medications like vicadin, oxycontin, morphine. medicines that left me with only a hazy recollection of the last

decade of my life. it was during that time that i sought out any and all treatment options to control my pain. these included a radiation, injections, implantable drug pumps. in 2000 we even tried a spinal cord stimulater. it's a device that electrically stimulates the spinal cord to disrupt those pain signals as they travel to the brain. the spinal cord stimulater we tried was based off of old pacemaker technology. and honestly, it was worse than the problem it was designed to treat. it replaced one type of pain with a new one that was far worse for me and my family. so back on the meds we went. finally, in 2005, i tried a new type of spinal cord stimulater. this one did manage to provide me with some relief. and hope for recovery. the precision plus spinal cord stimulater. this is designed off of technology that is from the cochlear implant, designed to

help people hear again. this system allows me to manage my pain no matter what my activity level is. if i'm watching tv or relaxing, or on the salt flats in beautiful utah trying to set a new record. once i got the device, the first thing we as a family did was, i need to get off the pain medicines. that's what we slowly started to do. i slowly started to get my life back. because i got it back, my wife susie is with me today. you know, in addition to our racing we travel all over the country and speak to pain patients and doctors about the treatment options that are out there. and it was as a result of these experiences is what allowed us to accept your invitation to be here today to talk about this. i think it's a very important issue. and during these, we've talked to many of our veterans coming back from conflicts in iraq and afghanistan. i do know how hard it is to seek out treatments and how scary it can be.

and the technology i had implanted in 2005 was absolutely cutting-edge technology. was it risky? it was. did i understand that the technology may not work? i absolutely did. did my doctor sit down and express to me not only all the risks of a normal operation but the risk of this product? we positively did. you know, part of our call to action was, what if congress had enacted this medical device safety act back in 2000? for me and my family, it would have been game over. it really does scare us to think where we would be as a family today if some researcher in 2002 decided the status quo was good enough. that the $60 million in investment made in developing, testing, and marketing the device and putting the cutting-edge fda product on the market, only to have that product's value systematically

reduced by lawsuits, just weren't worth it. you see, there's millions of people out there. some of them of your family members who one day might benefit from breakthroughs in therapy still in development. we need to think about these people and these families. parents, husbands, brothers. when we think about the consequences of this bill. do i want safe products? absolutely. for me, the question is a very simple one, senator. who decides? is it the fda experts or juries made up of people just like me, no particular expertise. and i think the hardest part is that juries see only that injured person. they don't see the thousands and thousands of patients that have been benefited from a technology. to me, the choice is clear. we need safe products. we need innovation. and i think the best way to do that is not through litigation, but through a well-funded, strong fda. thank you. >> thank you very much, for a

very profound statement and about your experiences. now, i don't know when we're going to start votes. but we'll start a round of just five-minute questions so we can try to get everybody in. whoever's running the clock, start me at five. there you go, thank you. thank you all very much for being here today. this is obviously a grave and extremely important issue and one that we are going to address hopefully soon. i wanted to start with 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 court liability. the court held the fda has long maintained state law offers an additional and important layer of consumer protection that complements fda regulation.

so, why are medical devices different than drugs? >> well, let me try to explain that in several different layers. first of all, we're talking here about a statutory scheme that could be applied but hasn't been applied to drugs. so, on a pure legislative basis, they've been handled differently by congress at different times. that's just setting on the statutory basis. with regard to the difference between them, there's a huge difference between medical devices and drugs. for example, the standards for safety and effectiveness for medical devices are significantly different under the federal food, drug and cosmetic act. that was done purposefully by the people who drafted the legislation, and i was one of those who did draft the medical it was because medical devices

are contractions, and drugs are fixed molecule's. you can change medical devices, you can't change a molecular entity that is called a drug. for a wide variety of public policy reasons, congress has seen fit to do things differently from these two types of very different products. >> so congress made the decision. >> yes. >> so obviously we can make a difference. >> no question, i don't disagree, this is not a constitutional issue, this is a statutory issue. >> okay. the different the tween drugs and devicess is a difference that we have stated legislatively. >> there is an inherent difference in them also. you can't change a drug, you can change the device. >> as i id