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73–753 2011

H.R. 1346, THE MEDICAL DEVICE SAFETY ACT 

OF 2009 

HEARING 

BEFORE THE

SUBCOMMITTEE ON HEALTH 

OF THE

COMMITTEE ON ENERGY AND 

COMMERCE 

HOUSE OF REPRESENTATIVES 

ONE HUNDRED ELEVENTH CONGRESS 

FIRST SESSION 

MAY 12, 2009 

Serial No. 111–39 

( 

Printed for the use of the Committee on Energy and Commerce 

energycommerce.house.gov 


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COMMITTEE ON ENERGY AND COMMERCE 

HENRY A. WAXMAN, California, Chairman 

JOHN D. DINGELL, Michigan 

Chairman Emeritus 

EDWARD J. MARKEY, Massachusetts 

RICK BOUCHER, Virginia 

FRANK PALLONE, JR., New Jersey 

BART GORDON, Tennessee 

BOBBY L. RUSH, Illinois 

ANNA G. ESHOO, California 

BART STUPAK, Michigan 

ELIOT L. ENGEL, New York 

GENE GREEN, Texas 

DIANA DEGETTE, Colorado 

Vice Chairman 

LOIS CAPPS, California 

MICHAEL F. DOYLE, Pennsylvania 

JANE HARMAN, California 

TOM ALLEN, Maine 

JAN SCHAKOWSKY, Illinois 

HILDA L. SOLIS, California 

CHARLES A. GONZALEZ, Texas 

JAY INSLEE, Washington 

TAMMY BALDWIN, Wisconsin 

MIKE ROSS, Arkansas 

ANTHONY D. WEINER, New York 

JIM MATHESON, Utah 

G.K. BUTTERFIELD, North Carolina 

CHARLIE MELANCON, Louisiana 

JOHN BARROW, Georgia 

BARON P. HILL, Indiana 

DORIS O. MATSUI, California 

DONNA M. CHRISTENSEN, Virgin Islands 

KATHY CASTOR, Florida 

JOHN P. SARBANES, Maryland 

CHRISTOPHER MURPHY, Connecticut 

ZACHARY T. SPACE, Ohio 

JERRY MCNERNEY, California 

BETTY SUTTON, Ohio 

BRUCE L. BRALEY, Iowa 

PETER WELCH, Vermont 

JOE BARTON, Texas 

Ranking Member 

RALPH M. HALL, Texas 

FRED UPTON, Michigan 

CLIFF STEARNS, Florida 

NATHAN DEAL, Georgia 

ED WHITFIELD, Kentucky 

JOHN SHIMKUS, Illinois 

JOHN B. SHADEGG, Arizona 

ROY BLUNT, Missouri 

STEVE BUYER, Indiana 

GEORGE RADANOVICH, California 

JOSEPH R. PITTS, Pennsylvania 

MARY BONO MACK, California 

GREG WALDEN, Oregon 

LEE TERRY, Nebraska 

MIKE ROGERS, Michigan 

SUE WILKINS MYRICK, North Carolina 

JOHN SULLIVAN, Oklahoma 

TIM MURPHY, Pennsylvania 

MICHAEL C. BURGESS, Texas 

MARSHA BLACKBURN, Tennessee 

PHIL GINGREY, Georgia 

STEVE SCALISE, Louisiana 

PARKER GRIFFITH, Alabama 

ROBERT E. LATTA, Ohio 

(II) 


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(III) 

SUBCOMMITTEE ON HEALTH

FRANK PALLONE, JR., New Jersey, Chairman 

JOHN D. DINGELL, Michigan 

BART GORDON, Tennessee 

ANNA G. ESHOO, California 

ELIOT L. ENGEL, New York 

GENE GREEN, Texas 

DIANA DEGETTE, Colorado 

LOIS CAPPS, California 

JAN SCHAKOWSKY, Illinois 

TAMMY BALDWIN, Wisconsin 

MIKE ROSS, Arkansas 

ANTHONY D. WEINER, New York 

JIM MATHESON, Utah 

JANE HARMAN, California 

CHARLES A. GONZALEZ, Texas 

JOHN BARROW, Georgia 

DONNA M. CHRISTENSEN, Virgin Islands 

KATHY CASTOR, Florida 

JOHN P. SARBANES, Maryland 

CHRISTOPHER S. MURPHY, Connecticut 

ZACHARY T. SPACE, Ohio 

BETTY SUTTON, Ohio 

BRUCE L. BRALEY, Iowa 

NATHAN DEAL, Georgia, 

Ranking Member 

RALPH M. HALL, Texas 

BARBARA CUBIN, Wyoming 

HEATHER WILSON, New Mexico 

JOHN B. SHADEGG, Arizona 

STEVE BUYER, Indiana 

JOSEPH R. PITTS, Pennsylvania 

MARY BONO MACK, California 

MIKE FERGUSON, New Jersey 

MIKE ROGERS, Michigan 

SUE WILKINS MYRICK, North Carolina 

JOHN SULLIVAN, Oklahoma 

TIM MURPHY, Pennsylvania 

MICHAEL C. BURGESS, Texas 


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C O N T E N T S 

Page 

Hon. Frank Pallone, Jr., a Representative in Congress from the State of 

New Jersey, opening statement .......................................................................... 1 

Hon. Henry A. Waxman, a Representative in Congress from the State of 

California, opening statement ............................................................................. 4 

Prepared statement .......................................................................................... 6 

Hon. John D. Dingell, a Representative in Congress from the State of Michigan, opening statement ....................................................................................... 12 

Hon. Steve Buyer, a Representative in Congress from the State of Indiana, 

opening statement ................................................................................................ 14 

Hon. Bruce L. Braley, a Representative in Congress from the State of Iowa, 

opening statement ................................................................................................ 15 

Hon. Joseph R. Pitts, a Representative in Congress from the Commonwealth 

of Pennsylvania, opening statement ................................................................... 25 

Hon. Michael C. Burgess, a Representative in Congress from the State of 

Texas, opening statement .................................................................................... 26 

Hon. Marsha Blackburn, a Representative in Congress from the State of 

Tennessee, opening statement ............................................................................ 28 

Hon. Anna G. Eshoo, a Representative in Congress from the State of California, prepared statement .................................................................................. 132 

WITNESSES

David Vladeck, J.D., Professor of Law, Georgetown University Law Center ..... 30 

Prepared statement .......................................................................................... 32 

William H. Maisel, M.D., M.P.H., Director, Medical Device Safety Institute, 

Department of Medicine, Beth Israel Deaconess Medical Center, Boston ...... 58 

Prepared statement .......................................................................................... 60 

Gregory Curfman, M.D., Editor, New England Journal of Medicine .................. 66 

Prepared statement .......................................................................................... 68 

Bridget Robb, Gwynedd, Pennsylvania .................................................................. 73 

Prepared statement .......................................................................................... 75 

Richard Cooper, Partner, Williams & Connolly LLP ............................................ 94 

Prepared statement .......................................................................................... 96 

Michael Kinsley, Seattle, Washington ................................................................... 114 

Prepared statement .......................................................................................... 115 

SUBMITTED MATERIAL

Ruling of U.S. District Court of Minnesota, dated May 12, 2009, submitted 

by Mr. Braley ........................................................................................................ 17 

Letter of May 11, 2009, from Albert J. Dahm to Committee, submitted by 

Mr. Shimkus ......................................................................................................... 133 

Letter of May 11, 2009, from Vietnam Veterans of America to Committee, 

submitted by Mr. Shimkus .................................................................................. 135 


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H.R. 1346, THE MEDICAL DEVICE SAFETY ACT 

OF 2009 

TUESDAY, MAY 12, 2009 

HOUSE OF REPRESENTATIVES, SUBCOMMITTEE ON HEALTH, COMMITTEE ON ENERGY AND COMMERCE, Washington, DC. 

The subcommittee met, pursuant to call, at 2:12 p.m., in Room 

2123, Rayburn House Office Building, Hon. Frank Pallone, Jr., 

[chairman of the subcommittee] presiding. 

Present: Representatives Pallone, Dingell, Matheson, 

Christensen, Castor, Sarbanes, Murphy of Connecticut, Braley, 

Waxman (ex officio), Deal, Shimkus, Blunt, Buyer, Pitts, Burgess, 

Blackburn, Gingrey, and Barton (ex officio). 

Staff Present: Rachel Sher, Legislative Counsel; Sarah Despres, 

Legislative Counsel; Eric Flann, FDA Detailee; Alvin Banks, Special Assistant; Lindsay Leshin, Special Assistant; Ryan Long, Minority Chief Health Counsel; Clay Alspach, Minority Counsel; and 

Chad Grant, Minority Legislative Analyst. 

OPENING STATEMENT OF HON. FRANK PALLONE, JR. 

Mr. PALLONE. Good morning. I am so out of it. I have been having too many speeches and too many meetings. I apologize. Good 

afternoon. 

The subcommittee today is a meeting to review H.R. 1346, the 

Medical Device Safety Act of 2009. We have made huge advances 

in medicine over the last few decades. New and emerging technologies hold promises that our great grandparents could never 

have imagined. Many illnesses that were once a death sentence are 

now preventable, curable, or are at least manageable through modern medical treatments. However, though these medical advances 

offer huge benefits, they also present a certain amount of risk. 

For example, there have been recent stories of patients who have 

suffered serious injuries from defective FDA-approved devices like 

implantable cardiac defibrillators and pacemakers. To use an example from my home State of New Jersey, there was a young girl 

who was 14 years old who was one of the victims affected by a 

faulty medical device. Last year, she felt a very strong pain 

through her body that she described as ‘‘a horse trampling me.’’ 

Eventually, she realized that her implantable cardiac defibrillator 

was shocking her, and it continued to do so 18 times. When the 

paramedics arrived at the scene, they found this little girl lying on 

the floor, begging for someone to remove the device from her body. 

She spent the next 4 days at a Children’s Hospital, waiting to have 


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the surgery to remove the device. Though the faulty device is no 

longer inside her body, she still suffers from significant anxiety 

triggered by the slightest heart palpitation or any beeping sound 

she hears. The medical costs this family in New Jersey now bears 

as a result of the surgery and side effects are tremendous. 

Unfortunately, I use that example of the little girl from New Jersey, but the problem is that she and her family have no opportunity for legal recourse, and she is not alone in this problem. 

In February of last year, the U.S. Supreme Court deliberated the 

Riegel v. Medtronic case and made a decision that, in effect, relieved medical device companies from the responsibility of ensuring 

the safety of their products. The Supreme Court ruled that patients 

could not receive compensation for their injuries—medical expenses 

and lost wages—caused by defective premarket approval, PMA devices, or inadequate safety warnings. Now, this decision, in my 

opinion, ignores congressional intent and is contrary to the Medical 

Device Amendments or at least the way they have been interpreted 

since the legislation was passed in 1976. 

For the past 30 years, Federal regulation through the FDA, together with tort liability, played crucial roles in protecting consumers from risky devices. Already, this Supreme Court decision 

has had a devastating impact on patients who have been harmed 

by defective medical devices. For example, a Federal judge in Minnesota threw out more than 1,400 lawsuits filed by patients who 

had defective heart defibrillator wires or leads implanted. Many of 

them died as a result. The judge based his decision on the Riegel 

case and noted that the only way to remedy the situation was for 

Congress to step in. 

It is crucially important that all of the major stakeholders involved in manufacturing medical devices make patient safety their 

main priority. We must be certain that we are taking every step 

necessary to ensure that the technologies designed to save lives are 

not placing people in danger. Much of the data used by the FDA 

in premarket approvals for both drugs and devices is limited in the 

number of individuals who are monitored as well as in the time 

frames that they are collected. These studies are vital in making 

safety and efficacy determinations while, at the same time, getting 

life-saving treatments to patients in a timely fashion. 

However, the Institute of Medicine has recommended that the 

risk and benefits of these treatment options should be monitored 

through the entire life cycle. This means that the manufacturer has 

a responsibility for the safety of their product for as long as it is 

being used by patients, not just during pre-approval trials. 

Until last year, the State court system provided an additional incentive for companies to actually follow this recommendation. Unfortunately, the Riegel v. Medtronic case and its effects have removed that incentive and have provided medical device companies 

with blanket immunity. The court premised its decision on the theory that FDA approval adequately protects patients from unsafe 

medical devices. That theory, in my opinion, has proven false time 

and again. 

So that is why I, along with Mr. Waxman, our full committee 

chairman, introduced the Medical Device Safety Act of 2009, the 

bill we are examining today. This bill protects patients from danVerDate Mar 15 2010 05:42 May 25, 2012 Jkt 073753 PO 00000 Frm 00008 Fmt 6633 Sfmt 6633 E:\HR\OC\A753.XXX A753

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gerous and defective devices by correcting the Court’s flawed interpretation of the Medical Device Amendments of 1976. The bill explicitly clarifies the State product liability lawsuits are preserved 

and puts safety first by eliminating the blanket immunity that 

medical device companies currently enjoy. 

There is precedence for this as the Supreme Court just a few 

months ago ruled in favor of a plaintiff in a case against a drug 

company. In that case, the Court upheld congressional intent and 

placed the responsibility for making the safe products squarely 

within the company’s purview; and it is crucial, in my opinion, that 

we act now to provide patients in need of a medical device with 

that same certainty. 

So I want to thank all of you. I will introduce you after we have 

the opening statements from the rest of the committee. 

I now recognize my colleague from Georgia, Mr. Deal. 

Mr. DEAL. Thank you, Mr. Chairman. Thank you for having this 

hearing today; and thanks to the witnesses who have come to share 

their positions and opinions on this legislation, H.R. 1346. 

Although the legislation is less than one page in length, the legislative impact of the legislation is significant and I think cannot 

be discontinued based on its own brevity. 

The United States is and should remain at the forefront of medical device innovation, a position which I believe would be undermined by this bill. The medical industry in the United States has 

grown as a worldwide leader in innovation and development, providing therapeutic advances for patients and their physicians to 

treat complicated medical conditions as the advance of science and 

medicine in our country continues to grow. This has been shared 

around the world. 

Critical life-saving devices such as neurostimulation devices, cardiac defibrillators, and pacemakers have improved the longevity 

and the quality of life for countless Americans who depend on these 

technologies every day. What must be considered when evaluating 

the merit of legislation to eliminate preemption of State tort claims 

with respect to these critical devices is the resulting impact which 

will occur on the development of new products. 

Eliminating preemption will stifle innovation. In my opinion, it 

will increase the risk among manufacturers who are on the cutting 

edge of medical device development; and it will prove detrimental 

to patients in dire need of innovative solutions to complex, hardto-treat medical conditions. 

In the case that the chairman referred to of Riegel v. Medtronic, 

the United States Supreme Court, as well as six out of seven Federal circuit courts, confirmed the widely held view that the Medical 

Device Amendments Act, MDA, does indeed preempt State common 

law claims with respect to devices approved through the premarket 

approval process, which is the most rigorous approval process for 

medical devices. What seems to have been forgotten is that the 

vast majority of State common law claims involving most medical 

devices are still permitted. 

First, the preemption provision provided under the MDA applies 

to approximately 2 percent of devices approved by the FDA each 

year, those which are approved under the premarket approval 

pathway. The majority of medical devices each year, those which 


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are approved through the 510(k) process, are not preempted under 

current law. 

Second, it is also important to remember that if a device is improperly manufactured or the source company withholds information from the FDA or it misleads the FDA and consumers about the 

safety and effectiveness of the product, the MDA does not preclude 

common law tort liability cases in State court. Patients who incur 

harm are fully capable of pursuing such just recourse for their 

harm. 

I urge the members of this subcommittee to take the same approach which the FDA takes in approving these devices by evaluating the risk versus benefits of this legislation. Given the detrimental impact H.R. 1346 will likely pose on the development and 

innovation of promising new technologies promoted by heightened 

litigious environments surrounding these products, we will be instituting roadblocks contrary to the overall mission of this committee 

and of the Food and Drug Administration, which has the responsibility of improving the health of American patients across the country. 

Thank you, Mr. Chairman. I look forward to the testimony of the 

witnesses, and I yield back. 

Mr. PALLONE. Thank you, Mr. Deal. 

Chairman Waxman. 

OPENING STATEMENT OF HON. HENRY A. WAXMAN 

Mr. WAXMAN. Thank you very much, Mr. Chairman. 

I welcome the witnesses to today’s hearing as well. 

Until February of last year, when Americans were injured by defective medical devices they had a remedy. In most States, they 

were able to sue the manufacturer of that product for damages in 

State court. In fact, the only way patients could obtain compensation was to bring a lawsuit under State law. 

But in February, 2008, the Supreme Court dramatically altered 

this landscape in its Riegel v. Medtronic decision. The court ruled 

that, so long as the FDA has approved a medical device, patients 

injured by that device could no longer seek compensation to help 

them deal with their permanent disabilities, their inability to work, 

and their costly medical procedures. 

Ironically, the decision applies only to the most dangerous and 

most complex devices, the kind of devices that, when they malfunction, often result in death or in severe physical impairment. This 

decision has already had a devastating impact in the over 1,400 

cases brought by injured patients that have been thrown out. We 

learned that another 300 cases were terminated under Riegel and 

that countless other lawsuits will never be brought. 

In the wake of the Court’s decision, it does not matter how badly 

a defective device has harmed a patient. It does not matter how 

egregious the device manufacturer’s conduct was in marketing a 

defective device. Patients have no recourse and no ability to be 

compensated for their injuries. 

The Court’s decision was bad for Americans in another way, too. 

It has destroyed one of the most powerful incentives for safety, the 

possibility of liability. We know that some device companies have 

hidden and have manipulated important safety data. Some have 


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failed to report serious adverse events. Some have failed to disclose 

known defects. Yet, under the Court’s decision, even if a company 

withholds information about potentially fatal defects from physicians, patients, or the FDA, it is still immune from any liability for 

its actions. 

In the absence of liability, all of the financial incentives will 

point medical device companies in the wrong direction. Tragically, 

the end result is that these abusive practices will undoubtedly multiply. 

Now, some would counter the FDA will be there to protect 

against these abuses. The FDA approved these devices, so why 

should we have juries second-guessing the FDA’s expert judgment? 

Well, as a result of chronic underfunding and weak leadership, the 

FDA’s ability to protect the public has plummeted. In fact, the 

FDA’s own science board issued a report saying that the agency is 

so starved of resources that ‘‘American lives are at risk.’’ 

Even if we were to give the FDA every penny it needs, there 

would still be a compelling argument for our system of State liability laws. That is because we operate on a model that relies on the 

industry to innovate, research, develop, and market their products. 

The FDA is not the only one playing this role, so the device companies themselves will always know more about their products than 

will the FDA. 

Here is another problem. The clinical trials upon which the FDA 

relies to approve drugs or devices are often too small to detect less 

frequent risks. Some risks can only be detected when the drug or 

medical device is used in the population at large. 

I was here, as well as Mr. Dingell and very few others on the 

committee, when the medical device law was adopted; and at no 

point in the consideration of that legislation did we expect that the 

preemption language, which was that the FDA has the sole responsibility to approve a product, meant that we were trying to preempt 

the States from the liability laws. Liability laws have always been 

in place to serve a very important role; and I was disappointed to 

see the Supreme Court come up with the decision it did, using that 

language, which of course they did not find in the medical drug section, to preempt the State liability laws. 

I hope that we will overturn the decision of the Supreme Court 

and will allow State laws to continue to play an important role in 

protecting consumers. 

Thank you, Mr. Chairman. 

[The prepared statement of Mr. Waxman follows:] 


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Mr. PALLONE. Thank you, Chairman Waxman. 

The gentleman from Illinois, Mr. Shimkus. 

Mr. SHIMKUS. Thank you, Mr. Chairman. 

We are going to hear many difficult, tough stories today, but I 

know we have Mr. Kinsley here to talk about the other side, and 

I would just plead for people to remember the thousands of people 

who have greatly benefited from—the one aspect I know is the 

cerebellar or the spinal cord stimulators. 

Now, I had a chance to visit with a couple of individuals today— 

Mike Roman from Des Peres, Missouri, and Adam Homhammon, 

who was an Army guy. I had a chance to visit with them, and their 

stories are just as compelling of the serious pain which they were 

under, to a point where they were of no benefit, only to the pharmaceutical companies who had to medicate them severely to ease 

their pain. They were not able to function in today’s society. Because of this technological advance, one walked into my office. The 

other one jumped off the wheelchair and talked to me about how 

his life had been changed for the good. 

Now, the doctors have the Hippocratic oath, which says, ‘‘first do 

no harm.’’ We had better be very, very, very careful that, in trying 

to fix the problems of some, we do not turn over the opportunity 

for this really new, life-giving technology to be available for people 

who desperately need it. 

So, Mr. Chairman, I would preach caution and concern for both 

sides as we move forward; and I yield back the balance of my time. 

Mr. PALLONE. Thank you, Mr. Shimkus. 

Chairman Dingell. 

OPENING STATEMENT OF HON. JOHN D. DINGELL 

Mr. DINGELL. Mr. Chairman, I thank you for holding today’s legislative hearing on H.R. 1346, the Medical Device Safety Act of 

2009. I am an original cosponsor of this legislation, and I strongly 

believe that it is necessary to reinforce congressional intent on a 

very important policy matter. 

I want to thank the witnesses who have joined us today, and I 

look forward very much to hearing their testimony. 

Prior to 1976, in the absence of Federal regulation, States enacted their own laws governing medical devices. So, in an effort to 

streamline medical device safety policy, the Congress acted. In 

1976, we passed the Medical Device Amendments. Our legislative 

intent was to give the FDA the power to regulate the approval of 

medical devices for U.S. consumers. We concluded that it was necessary to include a preemptive clause to make sure that Federal 

regulation, through the FDA, preempted State regulation on medical devices. We included no other preemptions. We did not, I note, 

however, expressly nor implicitly do away with State liability actions. 

Unfortunately, the U.S. Supreme Court in Riegel v. Medtronic, 

Inc. in 2008 decided to create legislative intent where there was 

none and immune medical devices from State product liability law. 

Now, people complain about activist judges. Here is a fine example 

of people who are running out to find congressional intent where 

none existed. 


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I urge my colleagues to remember that there are three coordinate 

and coequal branches of the Federal Government with distinctive 

duties and responsibilities. The appropriate application of Federal 

preemption should be determined by the Congress, not concocted in 

preambles to Federal regulations or decided through case law. 

Though, in 2008, with the Riegel decision, an activist judiciary decided to constrict State authority in the way Congress never intended. Therefore, it is time for the Congress to act properly, to exercise our authority, and to correct this clear judicial overreach. 

In this instance, the use of tort litigation is beneficial, because 

it will protect consumers where Federal regulation fails to anticipate latent danger in medical devices. When the Congress wants 

to preempt, I think it has the great talent in saying so in the legislation. None, I repeat, is here to be found. 

The Food and Drug Administration, I want to note, has been 

starved for resources for a number of years. This has made it almost impossible for them to adequately ensure the safety of the 

products they regulate. All you have to do is look back at the flood 

of unsafe foods, commodities, pharmaceuticals, and of other things 

coming in from China and elsewhere abroad, as well as things that 

are slipping into our American economy because of the total inability of the FDA to properly protect American consumers. 

It is to be noted that the FDA does not have the ability to ensure 

the safety of the products they regulate. The FDA’s IT systems are 

antiquated, its science base has eroded, its laboratories are a joke, 

and it does not have adequate personnel or, quite honestly, adequate authority to deal with its responsibilities. 

I will note, parenthetically, I have a good bill, H.R. 759, that will 

go a long way in addressing this issue, and we can get back to protecting our people in the way we should. Until this can be done, 

we, very frankly, need to see to it that citizens and Attorneys General have the capacity to properly protect American consumers. So, 

until we properly equip the FDA with the resources to do its job, 

consumers should have the ability to seek redress under the law. 

I would note that, as of late, we have seen many instances where 

a lot of do-gooders have run out and have stripped Federal agencies 

of the authority to regulate either legislatively or in courts. We saw 

it in securities, and we saw Enron follow, and a lot of other bad 

things happened. We have seen them do it with regard to banks 

in the repeal of Glass-Steagall, in the deregulation of the securities 

industry, and in the deregulation of banks. Then, all of a sudden, 

we found that we had a magnificent depression on our hands because of the abuses of the banks in their repeating the same things 

that they did in 1920 and in 1929. 

Having said this, there may be a day come when we will no 

longer need State liability to protect consumers from defective medical devices. Unfortunately, that day is not here, and it is not likely 

to come until we have dealt with the weaknesses of the FDA in its 

inadequate budget and in its total inability to properly protect 

American consumers. 

For those who paid attention in 1976, we made our intent clear. 

For those unfortunates needing clarification, we can point to H.R. 

1346. It tells people what we had in mind then and what we have 

in mind now. 


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Thank you, Mr. Chairman, for holding this hearing. I look forward to receiving the testimony of our witnesses. 

Mr. PALLONE. Thank you, Chairman Dingell. 

The gentleman from Missouri, Mr. Blunt. 

Mr. BLUNT. Thank you, Mr. Chairman. Thank you for holding 

this hearing on the Medical Device Safety Act of 2009. 

It is certainly important that we carefully consider the possible 

impacts this legislation could have on patients and on the companies that produce life-saving and life-changing devices for those patients. It is extremely important that any medical device on the 

market undergoes a thorough and appropriate approval process to 

ensure the safety of the patients who need them. 

If a company fails to ensure they are manufacturing the highest 

quality devices and that there are adverse impacts on a patient, 

then they should be held responsible. On the other hand, if the 

manufacturer has done everything in its power to put a device 

through the proper approval processes, to correctly manufacture 

the device and to properly inform its customers, it cannot be held 

responsible for situations beyond its control. 

We need to make sure, as we look at this bill and this subject, 

that companies are not subject to overly burdensome regulations, 

because this would ultimately cause patients to suffer in the form 

of decreased access and decreased innovation of medical devices. 

I look forward to working with you, Mr. Chairman, with Mr. 

Deal, and with the subcommittee as we move forward on this issue. 

I also look forward to the panel today. 

Mr. PALLONE. Thank you, Mr. Blunt. 

Mr. Murphy of Connecticut. 

Mr. MURPHY OF CONNECTICUT. Thank you very much, Mr. Chairman. 

Just very briefly, I would like to thank you for holding this hearing today. I understand that the focus of much of our discussion 

today is going to be the precedence set in Riegel, but, as someone 

new to this debate, I look forward to hearing from the panel about 

their ideas on how to truly make the fundamental reforms to the 

FDA process that Mr. Dingell and many others have referenced. 

I absolutely believe that tort law can be an effective check 

against unsafe products, but I also understand that it can be a 

patchwork check on those products. So I look forward to hearing 

today both about the precedent that has been set and about our opportunity to transform it, but I also look forward to hearing from 

this panel and from those who will come before this committee in 

the future to hear about how we can truly put teeth into the FDA. 

There is no reason to give up on that process; and I stand ready, 

at the very least, to be part of a process by which we can make 

that approval process work once again. 

Thank you, Mr. Chairman. 

Mr. PALLONE. Thank you. 

The gentleman from Indiana, Mr. Buyer. 

OPENING STATEMENT OF HON. STEVE BUYER 

Mr. BUYER. Thank you, Mr. Chairman. 

I want to comment on two points. One came from my dear friend, 

Mr. Waxman. The reason I need to make this point is that he 


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talked about how the FDA, right now being an underfunded agency, is ill-equipped to protect the public because it has been woefully 

underfunded. All right. Let us stop and think about that for a moment: woefully underfunded. 

Mr. Waxman, what did you just do and this committee just do 

with regard to tobacco legislation? You gave it a new mission on 

top of a core mission that is counter to its culture. If, in fact, we 

have an agency that is underfunded, we should be funding the 

agency and should be making sure that it does its job so that the 

best minds in the world can assess these products to make sure 

that we have the gold standard of safety, not to turn it over to juries and to judges and to the cleverness of trial lawyers. That is 

the wrong place. That is the wrong venue. It is the wrong jurisdiction to have the supervision of medical devices. So that is a bizarre 

logic for me. 

The second point is with regard to my other dear friend, Mr. Dingell, who was talking about activist judges. Boy, this is in the 

hands of the beholder when conservative courts are now considered 

to be activist courts because of their interpretation of the law. Now 

whom are they embracing? No, who they are embracing is the circuit, the 11th circuit that is out of step with all other circuits is 

who Mr. Waxman is embracing. 

For the years that I served on the Judiciary Committee, I sought 

to sever the 11th circuit. I would break it into six parts if I could. 

It is the most bizarre circuit with regard to its judgments for the 

country. So for us as a committee to embrace the 11th circuit as 

though that is, in fact, the judgment that should be made for the 

whole of the country, I think it is twisted logic. 

Now, I agree with the judgments of the Supreme Court. I think 

they made the right decision. I think they brought clarity to the 

issue. 

The other point I want to make is that, in the Court’s decision 

in Riegel, it confirmed, yes, that the MDA does preempt State common law with respect to devices approved for the premarket approval process, but it further confirmed that the manufacturer, if 

it engages in wrongful conduct, can be held liable. 

Now, think about if some of us wanted to go to the marketplace 

at risk, pool our capital, and push the bounds of science. We have 

created something. We go through the approval process, and we do 

everything that the FDA says we are supposed to do. Yet what? We 

want to turn that over, even though we have done everything we 

are supposed to do, to all of these State court jurisdictions? 

If I am the manufacturer and I have got a State out there that 

is out of step and bizarre, I will not market that product in that 

State. Then the people who live in that State will suffer. 

Is that the type of equity we bring to America? I do not think 

so. 

I yield back. 

Mr. PALLONE. Mr. Braley of Iowa. 

OPENING STATEMENT OF HON. BRUCE L. BRALEY 

Mr. BRALEY. Thank you, Mr. Chairman, for holding this important hearing. 


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It is a very important distinction to draw that what we are talking about today is a restoration of rights that existed in this country for over 100 years, not the creation of some new cause of action. 

In fact, Justice Ginsburg, in his dissenting opinion, referred to this 

as a radical curtailment of State common law remedy. 

As someone who has not only researched, briefed, and argued 

Federal preemption cases in both State and Federal courts, I can 

tell you from personal experience that the key issue in every Federal preemption case is the original intent of Congress as expressly 

stated and that, in the application of the law to that issue, the 

question is always a presumption against preemption, because it is 

such an extraordinary action to take. 

In fact, the Court, in its opinion, cited the legislative history, 

which is always one of the first things you look at in determining 

congressional intent, and it referred specifically to the Senate sponsor of the bill, Senator Kennedy, who noted at the time the bill was 

introduced that the legislation is written so that the benefit of the 

doubt is always given to the consumer. After all, it is the consumer 

who pays with his health and with his life for medical device malfunctions. 

It also quoted Chairman Waxman, who I am sure would be surprised that he was being cited as one of the contributing members 

whose congressional intent shaped the Court’s eventual outcome. 

One of the things that was also mentioned in the dissenting opinion was the perverse effect of immunity. The Court focused on fact 

that, at the time this Act was brought before Congress in 1976, it 

was at a time when the entire industry, according to the judgment 

of Congress, needed more stringent regulation. If you look at Justice Scalia’s opinion, he notes that, when these devices enter the 

market, they have never been formally reviewed under the MDA 

for safety or efficacy. 

Mr. Chairman, I would like to note, as Chairman Waxman referred to earlier, that just today, in the United States District 

Court for the District of Minnesota, 300 additional people who were 

injured or killed by defective medical devices had their cases 

thrown out because of this decision. 

I would ask unanimous consent for the ruling that was handed 

down today to be included as part of the record. 

Mr. PALLONE. Without objection, so ordered. 

[The information follows:] 


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Mr. BRALEY. Now, one of the things we often hear about are reasons that this bill should not be passed. Let me give you four conservative reasons to support the passage of this bill. 

Number one, it holds corporate wrongdoers accountable when 

they injure or kill people with defective devices. 

Number two, when you provide immunity to medical device manufacturers, you create greater exposure for the physicians who install them and for the hospitals where they are installed. 

Number three, as Dr. Maisel noted last year during our hearing, 

it results in the cost shifting to U.S. taxpayers, who end up paying 

for the care of these patients who have no other remedy. 

Number four, we see a flood of defective medical devices flowing 

in from overseas. 

Those are conservative reasons right there, and that is why we 

need to pass this bill. 

Mr. PALLONE. Thank you. 

The gentleman from Pennsylvania, Mr. Pitts. 

OPENING STATEMENT OF HON. JOSEPH R. PITTS 

Mr. PITTS. Thank you, Mr. Chairman. Thank you for convening 

this hearing. 

The bill we are discussing today, H.R. 1346, would overturn the 

8–1 Supreme Court decision in Riegel v. Medtronic. In this 2008 

decision, the Court held that the preemption clause contained in 

the Medical Device Amendments Act bars common law claims challenging the safety of a medical device granted premarket approval 

by the FDA. This decision is extremely limited in scope. Only those 

devices that receive premarket approval, or PMA—approximately 2 

percent of the new medical devices marketed per year—have express preemption. 

Riegel also makes it clear that preemption does not apply to 

PMA devices if the manufacturer withholds information from the 

FDA, if it misleads the FDA about the safety or effectiveness of its 

product, or if the company manufactures a product improperly. In 

such case, a company can be sued for its wrongful behavior. 

The PMA process is scientifically rigorous. The FDA spends an 

average of 1,200 hours reviewing each application, including a device’s proposed labeling. In granting PMA, the FDA has determined 

that the probable benefit to help from the use of the device outweighs any probable risk of injury or of illness from use. 

Once a device is approved through the PMA process, the manufacturer is subject to reporting requirements, including informing 

the FDA of new clinical or scientific studies regarding a device and 

reporting incidents in which the device failed or contributed to significant injury. 

The FDA can withdraw its approval if a device is found not to 

be safe or effective. The FDA can order a recall if it is determined 

that a reasonable probability exists that a device could cause serious injury or death. 

What would the consequences be if these life-saving, complex devices did not receive express preemption as would be the case if 

H.R. 1346 became law? 

Companies that manufactured and labeled their products according to FDA-approved standards could be sued in State courts and 


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found at fault if a device causes injury or harm. A lay jury would 

be presented with a case in which an individual was harmed by a 

device, and its judgment would be substituted for that of the 

FDA’s. Fifty courts in fifty States could each determine what standard a device should meet. Innovation would be stifled. Venture capital could dry up with the threat of litigation once a product hits 

the market. Manufacturers could pull products from the market or 

could refuse to sell them in certain States as a result of court cases. 

People who desperately need these life-sustaining devices may not 

have access to them. 

No device, no matter what the approval process, will ever be 100 

percent safe and effective, but when the FDA grants premarket approval, it has judged that the benefits of the population at large 

outweigh the risk to the population at large. 

The Riegel case was decided properly, and H.R. 1346 is simply 

bad policy. We all want only those medical devices that are safe 

and effective to be on the market. H.R. 1346 will not help us to 

achieve that. 

I look forward to hearing the witnesses today. 

I yield back. 

Mr. PALLONE. Thank you, Mr. Pitts. 

The gentleman from Texas, Mr. Burgess. 

OPENING STATEMENT OF HON. MICHAEL C. BURGESS 

Mr. BURGESS. I thank the chairman. I thank our witnesses for 

being here with us today and for listening to our opening statements. We will listen to yours in just a moment. 

Certainly, the Food and Drug Administration categorizes devices 

into three categories: Class I devices are subject to minimal requirements. Some easy examples of that would be latex gloves, bedpans, and urinals. Class II devices are subject to more requirements that include such items as hearing aids. 

H.R. 1346 is not aimed at Class I and Class II devices. It is 

aimed at high-risk devices known as Class III. Class III devices are 

considered high risk because they are complex and are used to support or to sustain human life or whose use is of substantial importance in preventing the impairment of human health. They are 

most certainly life-changing devices with no 100 percent guarantee 

of safety or efficacy. With Class III devices, there are calculated 

risks involved. 

Now, when weighing the interests of a manufacturer against the 

life of a human being, there is no question about what side you 

would come down on. You would come down on the side of the 

human being. But preemption does not do that, nor does preemption bar State common tort laws. Preemption is not a get-out-ofjail-free card for bad actors taken to court. If a medical device manufacturer violated the essential premise of producing a safe product, there are still remedies, despite the Supreme Court’s 8–1 ruling in Riegel v. Medtronic. 

What the Supreme Court recognized in Riegel v. Medtronic are 

two things: 

First, the Supreme Court found that premarket approval for devices by the Food and Drug Administration is rigorous, even arduous, with 1,200 hours or more of review for each potential device 


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and with the undergoing of clinical trials, and a company must give 

countless pages of documentation to the scientific experts of the 

Food and Drug Administration. 

A review by the Food and Drug Administration does not end with 

the premarket studies. Postmarket approval is continuous and frequent. If a manufacturer fails to maintain the Food and Drug Administration’s standard of approval by being disingenuous or by the 

failure to be transparent, then approval can be rescinded. 

The strenuous nature of the premarket approval process is evident in the exponential rise in the 510(k) applications where a device is allowed to go to market if there are what are known as 

‘‘substantially equivalent devices.’’ 

Now, Mr. Chairman, I requested a hearing on the 510(k) process 

in March of this year. I am concerned about how devices are being 

approved at the FDA. If the FDA is broken, if the FDA is underresourced, as Chairman Waxman suggested, if the FDA is understaffed and underwater, if the FDA is ill-equipped, inadequate or 

severely underachieving in its Class III medical device process, 

then let us do what is within our power and fix the FDA. 

This subcommittee is not tasked with fixing the legal system. 

H.R. 1346 is tort reform, but it is tort reform at its very worst, utilizing the worst possible mechanism. H.R. 1346 would create a haphazard system, a virtual patchwork of device standards where lay 

jurors are elevated to the same standard of expertise, knowledge, 

and grasp of science as someone on an FDA advisory panel. 

Furthermore, an Attorney General in California or an ambitious 

Attorney General in New York or an even-keeled Attorney General 

in Alabama could each create their own sensational trial with sensational damage figures, regardless of what the Food and Drug Administration does. 

If there ever were congressional intent in the enactment of the 

Medical Device Act of 1976, it would be this: Federal ceilings to 

tort liability, as it relates to medical devices, must exist as a necessity to encourage innovation and healthy progress in medicine. 

Without a ceiling, no doctor will ever use a medical device and risk 

his or her entire professional future to a jury, and no manufacturer 

will ever undertake the risk of producing a single device where a 

single error will result in the destruction of the entire livelihood of 

that company. 

The science of devices should not be in the judicial branch. The 

judicial branch should determine the law, and the law here is written by Congress. So the solution regarding medical devices is to 

give the Food and Drug Administration the resources that they 

need to do the job that they have been tasked to do and not to 

enact H.R. 1346. 

I thank you, and I will yield back the balance of my time. 

Mr. PALLONE. Thank you. 

The ranking member, the gentleman from Texas, Mr. Barton. 

Mr. BARTON. Thank you, Mr. Chairman. 

I am going to submit my full statement for the record, but I do 

want to read one paragraph from the Republican staff committee 

brief for this hearing about H.R. 1346. 


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Before I do that, let me say I do appreciate that we are having 

a legislative hearing. I wish it were on another bill, but at least we 

are having a hearing. 

Let me just put in a nutshell what my position is and what I 

think the positions are of most of the Republicans on this subcommittee. 

Enacting H.R. 1346 will not only overturn the Supreme Court’s 

8–1 decision in Riegel v. Medtronic. It will also severely disrupt the 

innovation in the medical device industry that has existed since the 

enactment of the Medical Device Amendments Act of 1976 and of 

the Federal Food and Drug and Cosmetic Act. 

This disruption will decrease patient access to life-saving medical 

devices, threaten the U.S.’s status as a global leader in medical device innovation, and it will dramatically increase the number of 

lawsuits against device companies. 

So, Mr. Chairman, again, thank you for holding the legislative 

hearing. We will certainly listen to our witnesses, but I would hope 

that you have no intention of moving this bill. There are more important bipartisan issues that we can work on together for the good 

of the country. This is not one of them. 

With that, I yield back. 

Mr. PALLONE. Thank you, Mr. Barton. 

Next is the gentlewoman from Tennessee, Mrs. Blackburn. 

OPENING STATEMENT OF HON. MARSHA BLACKBURN 

Mrs. BLACKBURN. Thank you, Mr. Chairman; and I thank our 

witnesses for their patience today. We have had a lot of conversation so far about the bill that you are going to testify on. I think 

it is important to make just a couple of notes as we move forward 

to your testimony. 

I will submit my full statement, Mr. Chairman. 

As Chairman Dingell said, it was over 30 years that Congress enacted the Medical Device Amendments. They were there to create 

a uniform national process for evaluating the medical devices. They 

have done that. 

Subsequently, the FDA successfully implemented the premarket 

approval process, which gives to the medical technology companies 

specific guidance that they follow to ensure the safety of those devices. They have spent an average of 1,200 hours reviewing every 

single application. That is a lot of time on every one of those applications. 

Now, common sense would dictate that the FDA and the medical 

technology companies are committed to making available the safest 

devices possible to save lives. Anyone who believes that these companies are out to purposefully make poor performing products 

ought to return to Business 101 and realize that companies know 

if you put bad products into the marketplace it will eventually lead 

to a company’s collapse. So, in order to stay competitive, medical 

technology companies like Medtronic, Smith & Nephew, and 

Wright Technologies, which are all in my district, continue to develop and to produce innovative technologies in order to save lives. 

Also, I am troubled that some in Congress would weaken the current device review system in the name of consumer safety. I do 


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think that Act is misnamed. It would be a boon for trial lawyers 

at the expense of public safety. 

I think the other provision we have to look at is that the device 

sector is responsible for almost two million jobs, for thousands of 

jobs in my district alone. I have personally toured many of the facilities and am continually impressed by the innovation, by the research, and by the commitment to saving and to bettering lives 

that I have found at each one of the facilities. 

Thank you, Mr. Chairman. I yield back. 

Mr. PALLONE. Thank you. 

The gentleman from Georgia, Mr. Gingrey. 

Mr. GINGREY. Thank you, Mr. Chairman. 

Today, as a result of advances in medical technology, Americans 

enjoy access to a quality of health care that most nations do not. 

While some countries restrict or ration the types or the amounts 

of drugs and devices that patients can access, American patients 

can receive the latest and the most advanced medical technology, 

such as an artificial hip or the latest cancer medication, that will 

drastically improve and extend their lives. 

Mr. Chairman, ensuring the safety of medical devices is an absolute necessity for our continued access to quality health care. The 

FDA is charged with making certain that all medical devices have 

been thoroughly tested for safety and effectiveness before coming to 

the market. It is one of the FDA’s primary responsibilities, and I 

support increased efforts in this area. 

Unfortunately, modern medical procedures inherently have risks 

associated with them, regardless of advances in technology or of effective oversight. It goes without saying there are very few absolutes in this world. With this thought in mind, I look forward to 

the testimony of our witnesses today. 

I yield back. Hopefully, we will use some of this additional time 

for questions. Thank you, Mr. Chairman. 

Mr. PALLONE. Thank you, Mr. Gingrey. 

That is the end of our opening statements, so we are now going 

to turn to our witnesses. We have just one panel, and I want to 

welcome you all for being here today. Let me introduce each of you, 

from my left to right. 

First is Professor David Vladeck, who is a Professor of Law at 

Georgetown University Law Center here in D.C. 

Next is Dr. William Maisel, who is Director of the Medical Device 

Safety Institute for the Department of Medicine at Beth Israel Deaconess Medical Center in Boston. 

Then we have Dr. Gregory Curfman, who is Editor of the New 

England Journal of Medicine. 

And Bridget Robb, who is—I know that is that Welsh name. I always get it wrong. Gwynedd. 

Ms. ROBB. Gwynedd. 

Mr. PALLONE. Gwynedd, Pennsylvania. 

Then we have Mr. Richard Cooper, who is a partner at Williams 

& Connolly. 

Finally, we have Michael Kinsley from Seattle, Washington. 

Thank you all for being here today. 

Now, the way we work it is we have 5-minute opening statements. They become part of the hearing record. You may, at the 


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discretion of the committee, submit additional statements in writing for inclusion into the record after your testimony. 

STATEMENTS OF DAVID VLADECK, J.D., PROFESSOR OF LAW, 

GEORGETOWN UNIVERSITY LAW CENTER; WILLIAM H. 

MAISEL, M.D., M.P.H., DIRECTOR, MEDICAL DEVICE SAFETY 

INSTITUTE, DEPARTMENT OF MEDICINE, BETH ISRAEL DEACONESS MEDICAL CENTER, BOSTON; GREGORY CURFMAN, 

M.D., EDITOR, NEW ENGLAND JOURNAL OF MEDICINE; 

BRIDGET ROBB, GWYNEDD, PENNSYLVANIA; RICHARD COOPER, PARTNER, WILLIAMS & CONNOLLY LLP, AND MICHAEL 

KINSLEY, SEATTLE, WASHINGTON 

Mr. PALLONE. I am going to start on my left again with Professor 

Vladeck. 

STATEMENT OF DAVID VLADECK, J.D. 

Mr. VLADECK. Mr. Chairman and members of the committee, 

thank you very much for inviting me to be here today. 

The bill, H.R. 1346, proposes to restore consumers injured as a 

result of defects in life-supporting or life-sustaining medical devices 

the right to sue medical device manufacturers. 

My views are these: 

Mr. PALLONE. Professor, just move the mike a little closer; and 

I am going to ask everyone to do the same. It will be easier to hear 

you. 

Mr. VLADECK. I think it is on. 

Mr. PALLONE. It is on, but it is better to speak a little closer to 

it. 

Mr. VLADECK. All right. 

My views are these: 

Riegel v. Medtronic provides very broad immunity from tort liability to manufacturers of medical devices, and the ruling gives 

consumers the worst of both worlds. 

On the one hand, the FDA cannot single-handedly ensure the 

safety of the thousands of medical devices on the market today. Too 

many serious defects have emerged with FDA-approved devices, 

and too many patients have been killed or injured by defective devices to contend otherwise. 

On the other hand, in the aftermath of Riegel, patients injured 

by devices are left with no remedy at all, with no compensation for 

the pain and suffering they endure, with no reimbursements for 

the costs of surgery and of medical care, and with no recompense 

to their loved ones should they die. Making matters worse, manufacturers have little economic incentive to swiftly recall devices or 

to repair defective devices in their market since they are immunized from liability in tort. 

I recognize that Riegel ruled that Congress, in passing the Medical Device Amendments, conferred immunity from tort liability to 

device manufacturers. In my view, Riegel is wrong as a matter of 

history, as a matter of law, and as a matter of policy, and Congress 

ought to swiftly overrule it. 

First, Riegel is wrong as a matter of history. As Chairman Waxman and Mr. Dingell confirmed, the Members of Congress who enacted the Medical Device Amendments know that Congress never 


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intended the Medical Device Amendments’ very narrow preemption 

provision to restrict the rights of injured parties to sue for compensation. Cutting off tort liability was not Congress’ goal in that 

statute. 

Second, it is wrong as a matter of law. The Medical Device 

Amendments were passed to strengthen consumer protection. The 

statute was passed in the wake of the notorious failure of the 

Dalkon Shield, an intrauterine device that harmed and killed many 

women. The legislation was intended to strengthen consumer remedies, and it is odd in the extreme to say that Congress intended 

to insulate manufacturers from the tort liability that was instrumental in bringing justice to people injured by defective medical 

devices. 

The last point and the most important point is that Riegel is 

wrong as a matter of policy. Immunizing device manufacturers— 

and device manufacturers alone in terms of the manufacture of 

medical products—harms the public in several ways: 

First, immunity removes the incentive to manufacturers to fix 

devices quickly and to get defective devices off the market. Time 

and again, we have seen device manufacturers find defects in their 

devices, make important safety improvements, and yet continue to 

sell their older, riskier devices until they sell out their inventory. 

Tort law would constrain that practice. 

Second, immunity weakens the incentives to disclose defects to 

physicians and to patients without delay. Again, time and again, 

we have seen device manufacturers fail to do that. Again, tort liability would constrain that practice. 

Third, immunity eliminates the compensatory justice role served 

by the civil liability system. It shifts all of the costs of injuries and 

deaths from the manufacturers on to consumers, who can ill afford 

it, to insurance companies and, ultimately, to taxpayers. What we 

have done is simply shift the burden of risk off the manufacturer 

onto the shoulders of the taxpayers. 

The arguments that defend Riegel are off target, and history 

proves this point. Life-saving and life-sustaining medical devices 

have been marketed for decades. For all but a very brief period, 

there has been no preemption. Preemption is a fleeting phenomenon. It has not been the norm with respect to medical devices, 

yet for virtually all of the time FDA regulation and State tort litigation have coexisted, each placing an important but complementary discipline on the marketplace without impairing the FDA’s 

function and without any of the harms the defenders of Riegel fear. 

For instance, the United States’ industry for medical devices remains and has always been the most innovative in the world. The 

American manufacturers of medical devices dominate the international market, even though there has long been a backstop of 

tort liability. 

I see my time is up. Let me just make one last point. 

The Supreme Court in Riegel said that preemption was decreed 

by Congress. Congress has the power to fix it. I urge that, without 

delay, Congress restores consumers to the place they were prior to 

Riegel. Thank you very much. 

Mr. PALLONE. Thank you, Professor. 

[The prepared statement of Mr. Vladeck follows:] 


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Mr. PALLONE. Dr. Maisel. 

STATEMENT OF WILLIAM H. MAISEL, M.D., M.P.H. 

Dr. MAISEL. Thank you, Chairman Pallone and distinguished 

members of the committee. Thank you for the opportunity today to 

speak about the importance of the Medical Device Safety Act of 

2009. 

My name is Dr. William Maisel. I am a practicing cardiologist at 

Beth Israel Deaconess Medical Center and am Assistant Professor 

of Medicine at Harvard Medical School in Boston. I am also Director of the Medical Device Safety Institute, an industry independent, 

nonprofit organization dedicated to improving the safety of medical 

devices. I have served as a consultant to the FDA’s Center for Devices and Radiological Health since 2003, and I have previously 

chaired the FDA’s Postmarket and Heart Device Advisory Panels. 

I hope that by the conclusion of my brief remarks today you will 

appreciate that the FDA marketing approval of a medical device 

does not guarantee its safety. In particular, manufacturers’ responsibilities for product safety extend well beyond initial FDA approval, and it is apparent that additional consumer safeguards are 

needed if we are to improve the safety of medical devices for the 

millions of patients who enjoy their benefits. 

We are fortunate to have the preeminent medical regulatory system in the world. The U.S. Food and Drug Administration regulates more than 100,000 different medical devices that are 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. 

Mark Gleeson is a man whose very life depends on one of these 

implantable medical devices—in his case, a pacemaker. Pacemakers are implanted to treat dangerous slow heart rhythms; and, 

in Mr. Gleeson’s case, every single beat of his heart comes from his 

device. The pacemaker itself consists of a battery and of computer 

circuitry and is sealed together in a metal housing. Although pacemaker batteries typically last 5 to 10 years, Mr. Gleeson required 

the surgical replacement of his pacemaker after just 12 months due 

to a short circuit that caused the battery to wear out prematurely. 

St. Jude Medical, the manufacturer of Mr. Gleeson’s pacemaker, 

had become aware of the short-circuit problem 2 years earlier because other faulty devices had been returned to the manufacturer. 

St. Jude asked for and received FDA approval for a modified 

version of the device that corrected the problem, although they continued to distribute already manufactured, potentially faulty pacemakers with the FDA’s knowledge but without public disclosure. 

When Mr. Gleeson needed his faulty pacemaker replaced, he received another potentially faulty device, even though corrected 

pacemakers had been built and were available. Ultimately, St. 

Jude Medical issued a recall of 163,000 pacemakers, including 

Mark Gleeson’s new unit, but not until nearly 2–1/2 years after initially learning of the problem. 

As Mr. Gleeson wrote to me, ‘‘It is unacceptable that St. Jude 

Medical was permitted to continue to sell known defective inventory of a device with impunity.’’ One possible conclusion is that St. 


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Jude Medical weighed the likelihood of death or of serious injury 

against the cost of pulling defective inventory off the market. 

While Mr. Gleeson’s case occurred several years ago, it is not an 

isolated event. Other manufacturers have also knowingly sold potentially defective devices without public disclosure. The FDA annually receives reports of more than 200,000 device-related injuries 

and malfunctions and more than 2,000 device-related deaths, and 

it is challenging for them to identify patterns of malfunction among 

the deluge of adverse event reports. In the majority of cases, the 

FDA relies on industry to identify, to correct, and to report the 

problems, but there is obviously an inherent financial conflict of interest for the manufacturer that is sometimes measured in the billions of dollars. 

The U.S. Supreme Court, with their February, 2008, decision of 

Riegel v. Medtronic, removed an essential consumer safeguard—the 

threat of manufacturer liability. Implanted medical devices have 

enriched and have extended the lives of countless people, but device malfunctions and software glitches have become modern diseases that will continue to occur. The failure of manufacturers to 

provide the public with timely critical information about device performance and malfunctions enables potentially defective devices to 

reach unwary consumers. Patients like Mark Gleeson are sometimes forced to make life-changing decisions with insufficient and 

sometimes inaccurate information. 

We have consumer protections for airline passengers, for cable 

television customers, and for cellular telephone users but surprisingly few for patients who receive life-sustaining medical devices. 

The Medical Device Safety Act of 2009 provides important and necessary consumer safeguards that will minimize adverse health consequences and will improve the safety of medical devices for the 

millions of patients who enjoy their benefits. 

Thank you. 

[The prepared statement of Dr. Maisel follows:] 


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Mr. PALLONE. Thank you. 

Dr. Curfman. 

STATEMENT OF GREGORY CURFMAN, M.D. 

Dr. CURFMAN. I want to thank you for inviting me to participate 

in this important hearing. My name is Gregory Curfman. I am the 

executive editor of the New England Journal of Medicine. I will 

argue that preemption of common law tort actions against medical 

device companies is ill-advised. 

Preemption puts the interest of corporations before the interest 

of patients. It denies patients their rights and will result in less 

safe medical devices for the American people. 

For nearly 200 years, the New England Journal of Medicine has 

been publishing articles on innovative drugs and medical devices. 

We strongly support medical innovation. We are a medical journal. 

But we are a patient-focused medical journal, and we are committed to patient safety. 

Now, Mr. Chairman, innovation and safety are not mutually exclusive. We can and we must have both. Patient safety is a national concern. Major stakeholders throughout our health care system agree that every step must be taken to ensure that medical 

interventions are as safe as possible. 

Unfortunately, one major stakeholder, the medical device industry, has been shielded from the potential consequences of failing to 

adequately disclose risks. This was the result of the U.S. Supreme 

Court decision in Riegel v. Medtronic. Until that ruling, the possibility of litigation for failure to warn or design defect served as a 

strong incentive for device companies to be vigilant about the safety of their products. 

Medical devices are often approved on the basis of only small, 

short-term clinical trials, and a number of devices have been approved through a fast-track process that does not require any clinical testing at all. The approval process leaves patients vulnerable 

to safety problems that have gone unrecognized during the premarketing period only to emerge during the postmarketing period. 

Since the Riegel ruling, as Chairman Waxman has mentioned, 

thousands of lawsuits against medical device manufacturers have 

been tossed out of court by judges following the Supreme Court’s 

lead. 

Now, litigation or the threat of litigation has been effective in removing potentially harmful medical products from the market, and 

there are a number of examples. They include the diet pill, 

dexfenfluramine, or Redux; the COX–2 inhibitor, Rofecoxib or 

Vioxx; and the cholesterol-lowering drug, cerivastatin or Baycol. 

But the examples are not limited to drugs. A number of medical 

devices have been removed from the market after injuries and litigation, among them, the Dalkon Shield that Professor Vladeck 

mentioned, the Bjork-Shiley heart valve and recently the Sprint 

Fidelis cardioverter defibrillator lead that we will hear more about. 

Mr. Chairman, let me be clear, I am not here to promote lawsuits. I am here to promote the interest of patients. I oppose preemption because it removes a legal mechanism by which patients 

who have been harmed can be compensated, and because it will inevitably result in less safe medical devices for the American people. 


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The way to prevent lawsuits is to put safe medical products on the 

market. 

The Supreme Court’s ruling in Riegel was not based on considerations of what is best for the health of the public, but rather on 

a point of statutory law. In marked contrast to Riegel, the Supreme 

Court ruling last March in the drug preemption case, Wyeth v. Levine, dismissed Wyeth’s argument that failure-to-warn suits 

against drug companies are preempted by FDA approval of the 

drug’s label. 

Now, as the law stands, failure-to-warn and design-defect lawsuits are preempted from medical devices, but not from drugs. This 

perplexing state of affairs defies all logic. 

The Medical Device Safety Act of 2009 addresses this legal inconsistency. The bill would nullify the Court’s ruling on Riegel and 

would thereby place medical devices and drugs on a level playing 

field with respect to patients’ rights. I urge you and your colleagues 

in Congress to swiftly pass this legislation. The critical issue of preemption should be decided by officials elected by the people. 

Mr. Chairman, I hope that this testimony is informative and I 

look forward to answering any questions that you may have. 

Mr. PALLONE. Thank you, Doctor. 

[The statement of Dr. Curfman follows:] 


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Mr. PALLONE. Ms. Robb. 

STATEMENT OF BRIDGET ROBB 

Ms. ROBB. Chairman Pallone and members of the Health Subcommittee, thank you for inviting me to speak to you about my personal experiences with the faulty medical device and my reasons 

for supporting the Medical Device Safety Act, H.R. 1346. 

My name is Bridget Robb, and I am a 35-year-old mother and 

resident of Gwynedd, Pennsylvania. On December 31, 2007, I suffered greatly and thought I was going to die because of a defective 

heart device implanted in my body. I am thankful to be here today, 

and I am pleased that Chairman Pallone has reintroduced medical 

safety—the Medical Device Safety Act which would restore the 

right of patients like me to hold manufacturers accountable when 

their products cause injury and sometimes even death. 

Approximately 5 years ago, I was diagnosed with nonischemic 

viral cardiomyopathy and congestive heart failure. In May of 2005, 

to prevent me from dying from a fatal arrhythmia, I had a 

Medtronic cardiac defibrillator implanted in my chest. This heart 

device is a small metal case that contains electronics and a battery. 

Its components work much like a pacemaker, but unlike a pacemaker, an ICD delivers an electrical shock to the heart when the 

heart rate becomes dangerously fast. 

On December 31, 2007, I was awoken from my sleep by a series 

of shocks in my heart which felt as if a cannon was being repeatedly shot at my chest at close range. Along with these recurrent 

shocks was a strong electrical current racing through my body. 

After feeling the first shock, I immediately phoned 911 for help. 

My then 6-year-old daughter, Emma, had snuck into bed with me 

that night and was present during this horrific experience. I remember Emma being scared and confused. She crouched down in 

front of me, hugging her cat and saying, Mommy is dying. She was 

present during the entire 7 minutes I was on the telephone with 

the 911 operator until the EMS arrived. I cannot imagine how terrified she must have been to see her mother in such pain. 

My doctors have told me that I received a total of 31 dangerous 

shocks to my heart in a matter of minutes that morning. Each time 

I was shocked, I saw my life flash before my eyes. It was excruciating pain. At one point I began to pass out and thought that I 

would never see Emma again. 

Every day since then, I have been unable—ever since that day, 

I have been unable to sleep in my own bed due to the trauma that 

I have experienced. I later learned that the agonizing shocks and 

electricity coursing through my body was caused by a defective cardiac lead implanted in my heart, the Sprint Fidelis lead manufactured by Medtronic. A lead is a thin wire that connects the ICD 

to the heart and delivers the actual shock to the heart when is 

beating too fast. Medtronic’s Sprint Fidelis lead was recalled on October 15, 2007, because of its potential to fracture. Despite receiving over 1,000 complaints about the defective lead, it took 

Medtronic 3 years to issue this recall. 

Since this terrifying experience, my health has declined significantly. I visit doctors weekly because of my ongoing health issues 

due to this event. After the inappropriate shocking from my lead, 


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I underwent surgical replacement of my defibrillator and defective 

lead and a second surgery to adjust the new lead. My second surgery resulted in an extended hospital stay where I had to undergo 

a blood transfusion. 

Most recently in September of 2008, my incision ulcerated and 

became extremely painful. I was hospitalized a series of times, once 

for 2 weeks straight, in an effort to cure this problem. To prevent 

an infection to the hardware in my chest, my doctors ultimately decided to remove my defibrillator altogether. Right now, my doctors 

continue to try and stabilize my decreased heart function, and I 

take various medications that carry serious health risks which I 

never took before. 

As you would expect, I risk serious harm each time another procedure is performed. From the time between my diagnosis in 2004 

and the horrifying shocking in December of 2007, I was never hospitalized for my heart failure except to have my defibrillator implanted. My heart function had significantly increased due to my 

medications, and I had a good outlook from my doctors. However, 

since my defective lead misfired, I have been hospitalized at least 

8 times, mostly for 1 to 2 weeks at a time, and my heart function 

is much lower than it used to be. 

I am a single mother, so as you can imagine, this has been trying 

for both my daughter Emma and myself. Each time I am hospitalized, it becomes more difficult on my daughter, since she is afraid 

that one of these times I won’t come home. 

Even though Medtronic’s defective device caused my injury, my 

health insurance plan has been paying for the cost of my medical 

care. It is wrong to shift the cost of medical care from the responsible party to private insurers, patients and, in some cases, to taxpayer-sponsored programs like Medicare and Medicaid. 

I would like to have the opportunity to hold Medtronic accountable for the injuries that I suffered that day and the physical and 

emotional aftereffects that I continue to experience on a daily basis. 

I find it discouraging and demoralizing that I have no recourse for 

my injuries and that a company that manufactured a defective 

product that has harmed me and thousands of other individuals 

has no accountability. 

I encourage Congress to act quickly and pass the Medical Device 

Safety Act. It is extremely important that injured patients have a 

remedy for their injuries and that the cost of their medical expenses and other needs are not borne by Medicare, private insurance, employees and patients themselves. The medical device industry should be accountable for their products just like the drug 

companies or any other industry. 

Thank you for your commitment to this critical issue. I am happy 

to answer any questions that you may have. 

Mr. PALLONE. Thank you, Ms. Robb. Thanks so much for being 

here. 

[The statement of Ms. Robb follows:] 


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Mr. PALLONE. Mr. Cooper. 

STATEMENT OF RICHARD COOPER 

Mr. COOPER. Thank you, Mr. Chairman, members of the subcommittee for inviting me to testify here today. I am here on my 

own, not representing any organization. 

I would like to make three points. The first is, a number of the 

opening statements refer to what the members called defective devices. The fundamental issue here is who ultimately decides whether a device is defective. Is it the physician, the engineers, the material scientists, the chemists, the statisticians and other experts at 

FDA; or is it juries and judges in the 50 States and other jurisdictions that will hear products-liability cases? 

By what process should that decision be made? By people who review enormous volumes of data, who over time, even after approval, receive reports from manufacturers of malfunctions or injuries, who can commission special studies, who can send inspectors 

into manufacturing plants to review all of the manufacturing 

records and interview the employees who design and manufacture 

the products? Or should it be people who listen to a couple of lawyers rant at them and observe witnesses being examined and crossexamined? 

And what perspective should guide that decision-making? The 

perspective of people who look at all those who will use a device, 

those who will benefit from it as well as those who will suffer from 

malfunctions? Or a group that spends day after day in court observing an injured plaintiff? 

I submit to you that the ultimate decision should be made by the 

Food and Drug Administration which, if properly funded and subject to proper oversight, is a national treasure. 

Second, products-liability law is not insurance; it is about fault. 

And a manufacturer that puts on the market a product with a design approved by the Food and Drug Administration with the perspective I have described, by the experts I have described and with 

the procedure I have described is not at fault for marketing a device with that design and, similarly, for other aspects of a device 

that FDA approves. 

Third, the concern about the effect of products-liability litigation 

on incentives for innovation is not mere theory. It is real. 

A number of years ago, I served on a committee of the Institute 

of Medicine that issued a report. The report came out in 1990, 

called Developing New Contraceptives: Obstacles and Opportunities. And one of the principal obstacles to innovation in that medical field that the committee, which included primarily physicians—that the committee identified was products-liability. 

It summarized its conclusion from its analysis as follows; I quote 

from its report: ‘‘Without changes in the products-liability rules and 

procedures, it appears likely that even fewer firms will allocate 

even fewer resources to contraceptive research and development,’’ 

closed quote. That is just one small medical field, and indeed a 

field that probably doesn’t involve devices to which preemption 

under Riegel would apply. 

But the effects of products-liability risks are great. Most medical 

device companies are small. To develop a product in a field that 


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has great risks of litigation is to bet the company on every product, 

and that is imprudent when there are other things that can be 

done. 

Since 1990 and this report was issued, there hasn’t been a lot of 

innovation in contraception. And there are other medical fields 

which are underserved due to liability risks. So that is something 

I would suggest you consider. 

This isn’t corporations versus people. This is how best to serve 

people, how best to serve patients who need medical devices, whose 

lives are supported or sustained by medical devices and whose adverse health conditions can be greatly alleviated by them if companies have the incentive to develop them and they are presented to 

FDA for its review. 

Thank you. 

Mr. PALLONE. Thank you, Mr. Cooper. 

[The statement of Mr. Cooper follows:] 


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Mr. PALLONE. Mr. Kinsley. 

Mr. KINSLEY. Does this work? 

Mr. PALLONE. Good idea to switch seats. 

STATEMENT OF MICHAEL KINSLEY 

Mr. KINSLEY. Thanks for this opportunity to testify, Mr. Chairman. I am here because I was approached last week by Medtronic, 

but I am here representing myself. I am not accepting anything 

from this except for Xeroxing of copies of my testimony. 

I also have—I am not an expert on Federal preemption issues, 

and I don’t even have a view about the question of whether standards should be similar between drugs and devices. I also have no 

view about the goings-on in the 11th Circuit, although it sounds 

pretty exciting. 

I am here for two reasons, first, as a grateful customer of the 

pharmaceutical and medical device industry. I have had Parkinson’s, and I have had it for over 15 years. As I hope you can see 

for yourself, my symptoms are pretty mild. After all that time they 

have not affected my ability to work, to travel or to enjoy life. 

This is true thanks in part to drugs, including many that have 

just come on the market in the years since I was diagnosed. And 

it is true especially because of the surgery I had 3 years ago called 

deep brain stimulation. Now I walk around with wires in my head 

and two pacemaker-type batteries in my chest. But thanks to these 

devices and these pills, I am walking around, which is encouraging 

to me. 

I am also here as a journalist who has written quite a bit about 

the damage done to our economy and to our country by excessive 

litigation in general and product and medical liability lawsuits in 

particular; and with all due respect to Dr. Curfman, if he thinks 

that companies can avoid litigation simply by producing safe products, I think he is naive. We all want the government to protect 

us from dangerous drugs and devices, but we don’t want the government to prevent us from getting helpful or life-saving drugs and 

devices. 

And the central problem is that those are the same devices, the 

ones that threaten us with harm sometimes and the ones that help 

us most of the time. And you do not want a system even if you 

could have it, that only allowed safe devices to be produced because 

that would be too far over on the scale. 

You need to have—in order for maximize the benefit, you have 

to tolerate some risk. And the danger of using litigation to solve 

these problems is that we—it forces us as a society to be overcautious. 

I think I will even stop there. 

Mr. PALLONE. Thank you, Mr. Kinsley. 

[The statement of Mr. Kinsley follows:] 


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Mr. PALLONE. Thank you all. We are going to proceed to questions from the members of the committee now, and I will start with 

my own questions and I guess I will start with Professor Vladeck 

if I may. 

Many people looked at the fact that the Riegel decision was decided with an 8-to-1 vote by the Supreme Court in favor of preemption as evidence that it is clear that all FDA product liability cases 

should be preempted. I wanted to ask you, how could the court be 

wrong about that when it was such an overwhelming margin? 

Can you explain why the Riegel decision was 8-to-1? 

Mr. VLADECK. I can take the Court at its word. What the Court 

said was—and this goes back to an earlier decision by the Court 

in a case involving cigarette labeling alone. 

Many statutes that have preemption provisions use the same 

language, and the language is, requirements are different from or 

in addition to those proscribed by Federal law. And the battleground since 1992, if you can believe it, has been over the word ‘‘requirement.’’ And in Cipollone, where Congress itself wrote the 

warning label, the Court said that it would be odd to hold a tobacco 

company liable for failing to add a warning that Congress itself did 

not write. And so there in Cipollone the Court said the word ‘‘requirement’’ could, in some cases, include common law remedies 

under tort. And since then there has been a series of decisions discussed in both my testimony and Mr. Cooper’s testimony which the 

Court has vacillated on what the word ‘‘requirement’’ meant. 

Finally—and Justice Stevens’ concurrence makes this quite clear. 

Finally, in Riegel, the Court simply gives up the ghost and says, 

going forward, the word ‘‘requirement’’ should be understood to include common law tort remedy. 

Mr. PALLONE. What about—some of my colleagues made statements that they were here at the time, that wasn’t the intent. Was 

that—any of that information, they just ignored it or what? 

Mr. VLADECK. Yes, the Court just ignored it and this is part of 

the Court’s new practice pushed by some of the justices on the 

Court to look simply the attacks to the statute and not to look at 

the statute’s purpose or the underlying legislative history. 

The legislative history of the statute is quite clear. Congress did 

not mean to wipe away tort remedy for people injured by medical 

devices. And there is no argument on that score. 

Mr. PALLONE. I appreciate it. I think it is important. 

Now, the device industry is arguing that a bill overturning the 

Riegel decision like mine would dramatically change the legal and 

financial landscape for device companies. 

But would this bill really change the status quo? My understanding is that the device companies faced State tort suits right 

up until the Riegel decision. So what is your opinion on that? 

Mr. VLADECK. Right. I think that is true with a caveat. 

Prior to Riegel, the courts were divided on whether there was 

preemption of these kinds of cases. The majority of the Federal circuits had ruled that there was preemption, but none of these decisions however, came before the mid-1990s. All of them are postCipollone, post-1992 decisions. None of the device manufacturers 

even argued preemption until post-Cipollone. So it is true that in 

some jurisdictions and in many circuits from maybe the mid-1990s 


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through 2008, there was a preemption defense available to these 

kind of devices. 

But if you look at the history of medical devices in the United 

States, they predate by decades the medical device amendments of 

1976. We have had life-supporting and life-sustaining medical devices on the market for 50 or 60 years, and only in that one brief 

interval, that maybe 10 years post-Cipollone and pre-Riegel was 

their real preemption available. And even then there was no guarantee because device manufacturers could be sued in some jurisdictions, including what some have colorfully referred to as the ‘‘crazy 

11th Circuit.’’ 

Mr. PALLONE. Let me ask you this. You have heard some of my 

colleagues say that the most frequently repeated objection to my 

bill is that it will create 50 State FDAs, and the devices will be regulated differently in different States. And then I think Mr. Cooper 

stated that products-liability cases constitute a kind of regulation 

in disguise. 

What is your opinion about that? 

Mr. VLADECK. I think that is an overstated argument. For every 

other consumer product, except where Congress has expressly preempted State tort law, we see parallel enforcement of State regulation—excuse me—of Federal regulation of products—car, cell 

phone, virtually any other consumer product that complements 

State tort law. They serve distinct functions although they are 

somewhat overlapping. 

I think it is an overstatement to say that a State tort judgment 

is regulation in my meaningful sense. It isn’t. It is not device specific. It doesn’t tell the manufacturer that they must do anything, 

and for that reason, we have seen tort law and Federal regulatory 

law coexist in virtually every sphere of government and private industry that we have in the United States. 

And this complementary role serves an important purpose. One 

is, it compensates people injured through no fault of their own; and 

second, it deters excessive risk-taking. 

We can go up and down the list in terms of massive recalls of 

medical devices; and here, remember, most of these recalls are 

where—Mr. Cooper talked about who makes the decision about defect. In virtually all of these cases, it is the manufacturer and the 

FDA. 

The Sprint Fidelis lead is being recalled because both agreed it 

should be recalled; Bjork-Shiley, the heart valve, 55,000 people; the 

Sulzer heart valve, another 35,000 people; the Medtronic pacemakers. All of these products were recalled after serious defects 

emerged, and both the FDA and all of the experts there and the 

company agreed it was time to get the product off the market. 

That serves—in most of these instances tort law served an incredibly important informational function. That is, we learned 

about the severity and pervasiveness of the defect through tort litigation, not through the imperfect, adverse reporting mechanisms 

that the FDA has. 

Mr. PALLONE. Thank you, Professor. Thank you for your enthusiasm too. 

The gentleman from Illinois, Mr. Shimkus. 


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Mr. SHIMKUS. As much as you don’t want to go to me—no. Thank 

you for the panel and compelling testimony. 

I left—one of the challenges of our jobs as a Member of Congress 

is we hear tough stories all the time, especially in the Health Subcommittee. I left here to go to—it is ALS lobbying day. I had folks 

in my office. So we are—these are things we deal with on a daily 

basis, maybe multiple times. So we appreciate you all being here. 

Ms. Robb, can you give me a time line? You were diagnosed—the 

implantation occurred in 2005? 

Ms. ROBB. I was diagnosed in February of 2004, and the implantation was in May of 2005. 

Mr. SHIMKUS. What would have been your health condition if you 

had not had implantation? 

Ms. ROBB. The device was implanted simply as a safety net; it 

didn’t do anything on a daily basis. I didn’t use the pacemaker portion of it. It just was simply there in case I was to have a fatal 

arrhythmia to, hopefully, shock me out of it and save my life. 

I was on a course of medication that was increasing my heart 

function, and I was doing really well. 

Mr. SHIMKUS. Yes, good. I think that is helpful, and I appreciate 

that. 

Let me turn to Mr. Kinsley from the St. Louis area, a Member 

of Congress from Illinois. Of course, those of us who follow the St. 

Louis Cardinals are huge Jack Buck fans, who suffered from Parkinson’s; and you would not have known that had you not seen him 

and—because his voice was still strong. 

When you moved from your chair from where your seat was to 

Mr. Cooper’s seat, had you not had the implantation, how long 

would that have taken you to do? 

Mr. KINSLEY. Well, it would have taken a few seconds longer 

probably. I mean, I can’t be more specific than that. 

Mr. SHIMKUS. So the implantation for you has been pretty much 

as you stated in your testimony, very helpful in obtaining a livelihood and your standard of living? 

Mr. KINSLEY. Yes. It has been essential, I would say. 

Mr. SHIMKUS. In your testimony, you also talk about the problem 

of having two independent systems, the FDA and tort law, for making the decision on whether a device should be on the market. 

Can you talk about this and explain this analysis of the problem? 

Mr. KINSLEY. Well, you have got the FDA ruling and you have 

got tort law essentially trying to do the exact same thing, which 

is to balance the risks against the benefit. And I was amazed to 

hear that—well, let me start again. 

I think that surely tort law does draw a line under the behavior 

effect—affects the behavior of companies that manufacture devices. 

And any company that loses a case and then—and then continues 

to manufacture the device anyway would lose—would do very badly 

both in the market and before this committee. That would be crazy. 

So I think it is undeniable that these are both systems that affect the decisions of medical device companies; and I think, in effect, the company does whatever, between the two, is the most restrictive. 

Mr. SHIMKUS. Thank you. Let me go to Mr. Cooper real quick. 


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Does a patient have a right to sue the device company if it fails 

to follow FDA requirements in manufacturing the device? 

Mr. COOPER. Yes. The Riegel decision, following the lower decision, made it absolutely clear that States—— 

Mr. SHIMKUS. Let me go to the next one. That is fine. Does a patient have the right to sue if the device labeling is inconsistent 

with FDA requirements? 

Mr. COOPER. Yes. 

Mr. SHIMKUS. Let me go to the next one. Does the patient have 

the right to sue if the company withholds data from the FDA? 

Mr. COOPER. Probably not. 

Mr. SHIMKUS. Does the patient have the right to sue if the company misleads the FDA as to the device’s safety and effectiveness? 

Mr. COOPER. Same answer. But the FDA has tools, including 

criminal prosecution, to deal with that kind of problem. 

Mr. SHIMKUS. And I was going to follow up, Mr. Chairman, with 

a question for Mr. Cooper. 

Can you expound on the small business implications of this legislation? 

Mr. COOPER. Yes. I will give you an example. 

One of the areas that at least some years ago was grossly underserved was medical devices, including breathing instruments and 

the like for prematurely born babies. That is a high litigation risk 

area, a company that develops a product—and there are some products. But a company that develops a product in that area is taking 

an enormous risk of litigation because nothing that humans make 

is perfect, nothing in medicine is perfect. 

I am not a doctor, but that is my understanding. Not medical device, not drugs, not surgical procedure, not laboratory test, nothing 

is perfect. They all fail sometimes. And if you get failures in that 

area, you are going to get litigation, and you are going to get enormous judgments. And small companies, that doesn’t—that is where 

the innovation is, mostly in small companies. 

Mr. SHIMKUS. Thank you. 

Thank you, Mr. Chairman. If I could ask unanimous consent to 

submit two letters one from the Vietnam Veterans of America and 

also from a Mr. Albert Daum, who is in a similar situation of the 

benefits of this type of technology. 

Mr. PALLONE. Without objection, so ordered 

[The information appears at the conclusion of the hearing.] 

Mr. PALLONE. Mr. Braley of Iowa. 

Mr. BRALEY. Thank you, Mr. Chairman. One of the comments 

that was made earlier in the hearing was that preemption is not 

a get-out-of-jail card. 

Professor Vladeck, that is not true, is it? That is exactly what 

preemption is; it is a bar to the courthouse door. In fact, Justice 

Ginsberg mentioned that in the concluding paragraph of her dissent where she writes the Court’s broad reading of section 

360(k)(A) saves the manufacturer from any need to urge these defenses. Instead, regardless of the strength of a plaintiff’s case, suits 

will be barred as an issue; that means before they are even filed. 

Mr. VLADECK. They will be dismissed as soon as they are filed. 


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Mr. BRALEY. Exactly. And if this is a well-known legal doctrine, 

then people aren’t going to take those cases and they are not going 

to file them. 

One of the other comments was, this was going to dramatically 

increase the number of lawsuits against medical device companies, 

but until the Riegel decision clarified this conflict within the circuit, there was nothing that prohibited somebody from pursuing 

this type of relief. 

So the same pace of claims is likely to occur whether or not this 

act is passed? 

Mr. VLADECK. Right, which is why we are seeing so many cases 

dismissed in light of Riegel. 

Mr. BRALEY. Exactly. 

Now, one of the other comments that was made—I think it was 

by Ranking Member Barton, who was quoting from the Republican 

staff committee brief. And he would—he mentioned that this act, 

if passed, would severely disrupt innovation in a medical device industry that has existed since 1976. 

But you pointed out this same dual enforcement mechanism has 

existed literally since the act was passed. So any innovation that 

has been proceeding at pace since 1976, should not in any way be 

affected by this. 

Mr. VLADECK. That is correct. And even well prior to 1976 we 

had medical devices prior to Congress’ passage of the medical device amendment. 

Mr. BRALEY. Thank you. 

Mr. Kinsley, I want to ask you a little bit about what your concerns are, specifically related to the role that tort liability litigation 

plays in medical device and pharmaceutical claims. 

Based upon your background, I assume that you are a firm believer in the Constitution. 

Mr. KINSLEY. Yes. 

Mr. BRALEY. That includes the Bill of Rights which, as we know, 

includes the right to free speech and the right to freedom of the 

press which gives you the ability to do what you do for a living? 

Mr. KINSLEY. Right. 

Mr. BRALEY. Are you supporter of the 7th amendment of the Bill 

of Rights? 

Mr. KINSLEY. Which one is that? 

Mr. BRALEY. It is the one that says, in suits at common law, 

where the value in controversy exceeds $20, the right to trial by 

jury shall be preserved. 

Do you believe in that amendment? 

Mr. KINSLEY. Well, it doesn’t—it is not one that gets my heart 

beating faster. 

Mr. BRALEY. Well, let us talk about that, because you understand 

the historical perspective that led to the passage of the Bill of 

Rights. 

Mr. KINSLEY. Well, let me say something about the Bill of Rights. 

I am the one in the street that is protected from malpractice lawsuits which are called libel suits in the world of the press. And the 

Supreme Court, as I am sure you know, has said that because of 

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mitted malpractice by making a mistake, New York Times v. Sullivan. Every other industry does not have that advantage. 

This is just the opposite of most countries, such as in England 

where journalists live in terror of lawsuits, and everybody else is 

rather calm about it because they somehow or other manage to 

have a system that brings justice in most cases without a lot of the 

absurdities that, in my view, attach to product liability in this 

country. 

Mr. BRALEY. Well, you understand that even journalists are subject to liability under certain circumstances when they engage in 

libel and slander, and there are differing degrees of proof, whether 

you are a public figure or not; and that all factors into determining 

whether there is accountability that, in fact, some journalists have 

been held accountable because they took unreasonable risks in 

what they say about people. 

Mr. KINSLEY. Yes, you have to try really hard to be sued. 

Mr. BRALEY. Let’s talk about that. Because one the things we 

know is, if you are going to sue the manufacturer of a defective 

medical device, not anybody can do that. Did you realize that? 

Mr. KINSLEY. What do you mean? 

Mr. BRALEY. In order to bring that claim, you have to prove the 

manufacturer made a defective device that was unreasonably dangerous, that caused direct harm to someone. And even if you can 

prove that and you are the device manufacturer, you have an absolute defense to those claims if you can prove that the product you 

introduced into the stream of commerce conformed to the state of 

the art at the time that product was manufactured. 

Mr. KINSLEY. As I said in the beginning, I am not an expert in 

this field. But I do think that, as a general rule, our society is overly risk averse; and we pay for that. 

Mr. BRALEY. But in this case, if you are the device manufacturer 

and this state of the art is an affirmative defense that gives you 

complete immunity, you can walk into court and say, Hey, the FDA 

preapproved my product. That was state of the art at the time that 

manufacture—that product was introduced, that is my get-out-ofjail-free card. 

Mr. KINSLEY. Well, that seems like a good get-out-of-jail-free card 

to me. 

Mr. PALLONE. We are a minute over. 

Mr. BRALEY. Thank you, Mr. Chairman. 

Mr. PALLONE. You two were having such a good time here that 

I didn’t really want to stop you. But thank you. 

Mr. Burgess. 

Mr. BURGESS. Thank you, Mr. Chairman. I was enjoying it. It 

took me back 15 years ago when I was a physician in practice and 

every night would tune in Crossfire and watch you and Bob Novak 

go at each other; and I used to enjoy those exchanges as well. What 

concerns me today is, I agree with you more than I recall agreeing 

with you 15 years ago. I must admit I guess things have changed 

in 15 years. 

Let me start with Dr. Curfman. I probably need to ask Dr. 

Maisel the same question, both physicians. 

Can you help us understand the physician’s role in helping to 

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fits associated with any complex medical technology? That role does 

fall to the physician, does it not? 

Dr. MAISEL. It is a common role for physicians to serve as counsel for patients when determining the risks and benefits of any 

therapy, whether it is a medical device, a drug or some procedure. 

I think it is incumbent upon physicians to have accurate and timely information, and one of the things I, as a physician, have struggled with is dealing with medical device malfunctions with incomplete information, inaccurate information or a lack of timely information in handling these cases. 

Mr. BURGESS. And, of course, we all rely upon the Food and Drug 

Administration to help us with those determinations. 

Do you ever find yourself in the course of clinical events reviewing court cases to find out if a device—if you should be counseling 

your patient based upon what has happened in the legal system? 

Dr. MAISEL. I am not sure I am the right person to ask that 

question. I do review the court cases. I find them extremely interesting. I think there is a lot of very interesting information about 

device reliability that is in those court cases. I think a lot has been 

learned from those court cases, and there are things in those court 

cases that are released because of the court cases that otherwise 

wouldn’t be released, including FDA documents. 

Mr. BURGESS. Let me ask Professor Vladeck, in response to a 

question posed by Chairman Pallone about the 8-to-1 decision of 

the Supreme Court, was this consistent with what had been the decisions of lower courts or did they depart from lower court decisions? 

Mr. VLADECK. I think it is fair to say that many lower courts had 

reached the same conclusion that the Supreme Court did. I think 

it is also fair to say that there were many courts, particularly State 

courts that did not. And so you had a deep division within our judicial system about the proper reading of the preemption provision 

of the medical device amendment. 

Mr. BURGESS. But it was not inconsistent with what the lower 

courts had ruled, so in that aspect did not alter the regulatory environment? 

Mr. VLADECK. Remember, no court had ruled that there was preemption under the medical device amendments until the mid1990s. So to the extent there was preemption during this period, 

one is, it was recent; and second, it was incomplete because plaintiffs could engage in forum shopping, and where possible they 

would sue in the jurisdictions that permitted these cases to go forward. 

So it is not as though prior to Riegel any medical device manufacturer had an assurance that a claim would be preempted. 

Mr. BURGESS. Who would engage in the forum shopping? 

Mr. VLADECK. The plaintiffs, yes. 

It is only bad when the other side does it. 

Mr. BURGESS. Mr. Cooper, let me ask you a question if I could. 

There is some suggestion that the effect of the Riegel decision to 

provide broad-based immunity in instances where the medical device failed, a get-out-of-jail-free card, versus a don’t-get-out-of-jailfree. So do you agree with that? Do you think that is true? 


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Mr. COOPER. No, I would not agree with it, Mr. Burgess. The 

Riegel decision applies only to devices that have gone through the 

PMA approval process. That is about 30 products a year, less than 

1 percent of all the devices on the market. 

Mr. BURGESS. Under current law, does the patient have the right 

to sue the manufacturer if the device fails? 

Mr. COOPER. People can always sue. Whether they will win is another matter. And if a manufacturer has—as I discussed earlier in 

answering some question, if a manufacturer fails to comply with 

FDA requirements and the conditions on the PMA approval or the 

manufacturing process, Riegel would not provide any defense. 

The real problem, I think we are grappling with here, is that 

medical devices are going to fail even if they are the best that 

human beings can make; and how do we take care of the people 

in whom they fail or for whom they fail? And that is matter of 

health insurance, disability insurance or life insurance. It is an insurance system. 

And the products-liability system is not intended to be an insurance system. It is based on fault or defect. And if the product isn’t 

defective, if the manufacturer is not at fault, then the plaintiff 

should lose. That is our legal system. 

Mr. BURGESS. And just in the brief time I don’t have left, if, on 

the physician’s part—the physician utilizing the device, if they 

commit an error either in diagnostics or in application of the device, under Riegel, can they be sued? 

Mr. COOPER. Yes. And in Levine, for example, the doctor—the 

clinic, I guess it was—settled. 

And if you look at the facts in the Riegel case, the physician who 

was applying the catheter, the balloon catheter, misapplied it in 

violation of the labeling. Nevertheless, the plaintiff sued the device 

manufacturer. 

Mr. PALLONE. OK. We are going to move on. Thanks. 

The gentlewoman from Florida, Ms. Castor. 

Ms. CASTOR. Thank you, Mr. Chairman. 

Thank you all very much for being here today. Some device companies have argued that the premarket—that the impact of the 

Riegel decision is limited numerically because it only applies to 

PMA devices. Mr. Cooper just made the argument that it only represents 1 percent of all medical devices reviewed by the FDA. 

But is this a fair representation of Riegel and all of the devices? 

Dr. Maisel, does that 1 percent figure accurately represent the actual usage and importance of PMA devices? 

Dr. MAISEL. The best term I can come up with to describe that 

number is ‘‘propaganda.’’ The repeated use of the 1 percent we 

heard or the 2 percent number is fuzzy math. 

The devices that we care about are not tongue depressors and 

bedpans and stethoscopes which are included in the 99 percent. We 

care about the important, life-sustaining devices whose safety patients rely on. 

And those devices—we have also heard a number of approximately 30 new PMA applications a year. The FDA actually sees 

over 1,000 PMA and PMA supplement applications each year, so it 

is much higher than that number. And if you think about the number of patients affected by these devices, it is in the millions. 


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There are more than 10 million Americans living with permanent implanted devices right now, and there are hundreds of thousands if not millions implanted each year. 

Ms. CASTOR. What type of injuries and what type of patients? 

Dr. MAISEL. Well, these devices are—in many cases are life-sustaining devices. We have heard from a patient today here on our 

witness stand that received painful shocks. 

There are devices that can fail to deliver life-sustaining therapy 

when needed. There are pumps that can underdeliver or overdeliver medication. There are stents that can malfunction. Every 

product has the potential to malfunction. 

I would like to clarify. I don’t think a malfunction should equal 

liability for a manufacturer. That is not what we are talking about 

here. We are talking about a manufacturer that fails to meet 

their—the standard of care, that fails to produce a product that is 

as reliable as it should be. 

Ms. CASTOR. And, Professor Vladeck, it is unclear to me, does the 

preemption apply even when the corporation or folks in the company knew or had knowledge that the device was defective even 

after they received the FDA approval? 

Mr. VLADECK. Yes. Even where the companies misleads the FDA, 

it fails to provide information to the FDA. 

There would be preemption not under Riegel, but under 

Buchman v. Plaintiffs. 

Ms. CASTOR. So, Mr. Kinsley, I would ask you about those cases 

when folks in the corporation, or the corporation or personnel knew 

of the danger; does it make sense that consumers are barred from 

seeking compensation from their injuries and lost wages? 

Mr. KINSLEY. When you say ‘‘knew of the danger,’’ if this company has met FDA standards and what they knew was that there 

is something—I mean, either it meets the standards or it doesn’t. 

And if it meets FDA standards, then you shouldn’t have to meet 

a whole other set of standards. 

Ms. CASTOR. Even if they knew that the device was faulty and 

could cause injuries, you are saying if the FDA signed off on 

that—— 

Mr. KINSLEY. Yes. 

Presumably what they knew was—well, if what they knew was 

that the device didn’t meet FDA standards, yes, of course, they 

should be liable. 

Ms. CASTOR. I think the case is that if they receive the premarket approval and approval from the FDA, that it is supposed 

to mean something. But even in the cases they had knowledge that 

the device could cause injury? 

Mr. KINSLEY. Well, I think some things I have heard today and 

things I knew even before suggest, then I think everyone here 

agrees that the FDA could use a little bit of improvement. But—— 

Ms. CASTOR. It would seem to me that the companies in those— 

in that case, have a responsibility to be truthful in the FDA process. 

Mr. KINSLEY. Well, sure. I would say if the company is lying, 

even if it is lying about a product that does meet FDA standards, 

that is not good, and they should maybe lose this immunity they 

get. 


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Ms. CASTOR. Thank you very much. 

Mr. PALLONE. Thank you. 

The gentleman from Indiana, Mr. Buyer. 

Mr. BUYER. Mr. Kinsley, I will be your lifeline. 

Mr. KINSLEY. Thank you. 

Mr. BUYER. I will be your lifeline because I disagree with the 

professor’s testimony. The professor’s testimony said that Federal 

preemption will give protection to a manufacturer if, in fact, they 

voluntarily withhold information, i.e., that is wrongful conduct or 

lying, that is wrongful conduct. 

So if a corporation is involved in wrongful conduct, they are outside of the Federal preemption as according to the Supreme Court 

decision. Is that not correct, Professor? 

Mr. VLADECK. The decision I was referring to—— 

Mr. BUYER. Or is my analysis not yet—is that not correct? 

Mr. PALLONE. Professor, do you have the mic on? 

Mr. VLADECK. I do. It would be correct under the Supreme 

Court’s prior ruling. 

Mr. BUYER. Professor, time out. 

The analysis that I just gave according to Riegel; is that not yet 

correct? 

Mr. VLADECK. Preceding Riegel is Buchman. Every lower court to 

address what I believe is the question you are posing has said that 

that is essentially a fraud on the FDA claim, which is preempted. 

And maybe I am misunderstanding your question. 

Mr. BUYER. It is clear—I believe it is clear after Riegel that if 

a manufacturer of a device, in fact, commits wrongful conduct, it 

can be held liable. That is my lifeline to you, sir, that if somebody 

is lying, they voluntarily withhold that information, you do not get 

the shelter of the law. 

If you participate in wrongful or criminal or conduct that would 

be harmful to our society, you don’t get the shield of the law. That 

is Riegel; is it not? 

Mr. VLADECK. I would hope you are right. Let me just make two 

caveats. With all respect, I think the lower courts have not read 

Riegel to overrule or to in any way affect Buchman. And if you look 

at the cases cited at footnote 25 of my testimony, many of them discuss precisely that issue. 

I would agree with Mr. Cooper that the sanction that would be 

available would be the FDA bringing an enforcement action against 

the company. And the FDA plainly would have the authority to go 

after the company for doing that conduct and could proceed criminally. I am sorry. 

Mr. BUYER. Is your background in tort law? 

Mr. VLADECK. I have done tort law, yes, sir. 

Mr. BUYER. Under products-liability law—now, help me. I am 

just a country lawyer. So under products-liability law, a device 

manufacturer’s liability must be based on some type of fault; is 

that not true? 

Mr. VLADECK. That is correct. 

Mr. BUYER. Some type of fault. So if a manufacturer, though, 

abides by the rules, the regulations, the procedures, the law, where 

are they then at fault? 

Mr. VLADECK. They are not at fault. 


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Mr. BUYER. Right. And that, in fact, is the importance of the preemption, the shield to that manufacturer in the premarket approval process, correct? 

Mr. VLADECK. I think I understand you. Yes. 

Mr. BUYER. Yes. So that is basically—that is why I am say, All 

right, Supreme Court, I understand why you then have made that 

as a ruling, to bring clarity then to all of the other courts and jurisdictions around the country, excepting the hiccup of the 11th Circuit. 

Mr. VLADECK. You are correct that only the 11th Circuit in the 

Federal courts—— 

Mr. BUYER. I am referring to the Federal courts. And you agree 

with that? 

Mr. VLADECK. I am sorry? 

Mr. BUYER. You would agree with what I just said, with regard 

there is one circuit out of balance? 

Mr. VLADECK. That is correct. 

Mr. BUYER. So back to my lifeline to you. 

I just want to be very clear to you here that if, in fact, there is 

a manufacturer, Mr. Kinsley, that in fact has lied, they don’t get 

the protection of the law. And I don’t think any good manufacturer 

out there wants there to be protection against anyone who is not 

playing by the rules. 

If they play outside the foul line, they should feel the full wrath 

of the law. Do you not agree? 

Mr. KINSLEY. Thank you. Thank you for that lifeline. 

Mr. BUYER. I just don’t remember that on Crossfire. I will remember that. 

Here is the other point that I make in my opening. It really does 

concern me because in the year, the 17 years I have been up here, 

I have been a strong advocate of our country being able to attract 

great minds from all over the world to place—come to the marketplace, at risk capital, push the bounds of science for the benefit of 

our society and then under the world. 

If, in fact, we pass a law like this, what are the consequences— 

let me turn to you, Mr. Cooper—what are the consequences going 

to be upon not only innovation, but what—will there be a quilt, 

sort of a patchwork in the marketplace with regard to where manufacturers are going to go to sell their products for fear that one 

State may, in fact, have a different litigious environment? 

Mr. COOPER. There may well be some of that. 

I think the major impact would be lack of development of products where there is great need but also great liability risk. The— 

I think the experience of lawyers who try products-liability cases 

is that juries will do what they need to do to compensate an injured 

plaintiff. Even if the manufacturer had a warning that said, Don’t 

do this, it will kill you, the jury will find that that was inadequate 

because it could have said, It will kill you for sure. 

That is a natural human reaction and it is a problem. And the 

effect of it is on people who need medical devices and they are not 

there. Or they haven’t been improved to the extent that they could 

be if more investment were made, but the manufacturers decided 

to put the investment somewhere else, which presents less liability 

risk. 


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Mr. BUYER. Thank you. Thank you, Professor. 

Mr. PALLONE. Thank you. 

The gentleman from Utah, Mr. Matheson. 

Mr. MATHESON. Thank you, Mr. Chairman. I think this topic is 

certainly an important issue. It represents an intersection of a 

number of key dynamics, including patient safety and health care 

and innovation. And while we all agree that patient safety should 

be a top priority, I think it is also—I think we all probably agree 

that if the device maker has done something wrong, they should be 

held accountable. 

What I am concerned about is that a blanket approach could 

have some far-reaching consequences. If the problem lies elsewhere, say, with the review process at FDA, then this committee 

needs to have a larger conversation beyond this preemption discussion we are having today. I don’t think we should take this issue 

very lightly, and I think we ought to be really careful and not rush 

to legislative action. 

I had a number of questions, all of which have all been covered 

except one, and I will ask real quickly to Mr. Cooper. 

How should we address this issue with the FDA? Do they need 

more power, more authority? Do we need to change the way they 

are structured to protect consumer safety related to medical devices? 

Mr. COOPER. I think they need additional resources. I think, as 

several members have said, the Agency has been underfunded for 

a very long time. The President’s budget makes some headway on 

that with some substantial increase, including for safety-related 

projects. More needs to be done, and there also needs to be good 

oversight. 

My experience at the FDA was that nothing concentrates the 

mind like an upcoming congressional hearing, particularly one by 

the Oversight Subcommittee or by the Health Subcommittee of this 

committee, which has a long and distinguished record of very effective oversight of the agency. I think that is needed as well. 

The FDA has wonderful public servants, dedicated career people, 

who could make a lot more money doing something else but derive 

much value in their lives from serving the public. On the whole, 

I think they do a very good job. It still could be improved, because 

the problems they deal with are immense. 

Mr. MATHESON. Thanks, Mr. Chairman. I yield back. 

Mr. PALLONE. Thank you. 

The gentleman from Georgia, Mr. Gingrey. 

Mr. GINGREY. Mr. Chairman, thank you. 

I want to address my first question to Mr. Cooper. 

The medical devices we are talking about and how they are regulated by the FDA, if you would just walk me through the process 

to approve one of these new devices and would discuss the types 

of postmarket surveillance that is typical of these devices in order 

to identify higher-than-expected complication rates and to notify 

patients and physicians of any failures. 

Mr. COOPER. Well, to try to do it very briefly—— 

Mr. GINGREY. Yes, please. 

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rials, the components of the device, the principle of operation, what 

its intended use or uses are, and what kinds of problems it has to 

deal with. There will be clinical studies, preclinical studies. There 

will be laboratory studies. 

The raw data of all of that and the analyses all go to the FDA. 

The FDA does its own review, its own statistical analyses. It can 

require the companies to do additional studies, to propose labeling 

as submitted. The FDA can ask for samples. So it does a truly comprehensive review of all that is known. 

As has also been pointed out, the studies are limited in terms of 

the number of patients and of the duration of the studies. If you 

waited forever, you would never have any devices approved. So you 

have to cut it off and make a reasonable judgment at some point. 

Then the FDA has to conclude and people have to sign their 

names and be accountable—and they are accountable—for concluding that there is an assurance, a reasonable assurance, that 

the device is effective for its intended use and that it is safe. And 

‘‘safe’’ means not that it is harm-free or risk-free but that the benefits of the product outweigh those risks. 

Then it approves it; and it can approve it with various kinds of 

conditions, including the conditions for further studies as the patient population using the device expands, sometimes exponentially, beyond the limits of the clinical trials, which are the primary 

bases for the approval. 

Manufacturers are required to submit promptly to FDA reports 

of malfunctions or adverse events associated with the use of the device. Device user facilities—hospitals, clinics and the like—are also 

required to report. Physicians, patients and others are encouraged 

to report. Then you can go to the FDA Web site and do that. The 

medical literature is reviewed both by the manufacturer and by the 

FDA; and, in their annual reports, the manufacturers are supposed 

to update the FDA in that area. 

Mr. GINGREY. Mr. Cooper, thank you. I will reclaim my time. 

Thank you for that response. 

Ms. Robb, I wanted to ask you—and thank you so much, of 

course, for being a witness. I am sure it is very difficult for you to 

describe that harrowing experience that you went through several 

years ago, but let me understand: 

As to the defibrillator that was implanted, I am assuming that 

the physician—your cardiologist—decided that you were at great 

risk, because of this cardiomyopathy and, I guess, because of some 

congestive heart failure as well, of going into what we in the medical field call ‘‘ventricular fibrillation,’’ not atrial fibrillation, not 

super-ventricular but ventricular fibrillation, and I am sure you 

were told that this could result in sudden death. So you had this 

surgical procedure. 

You had this defibrillator inserted because if, all of a sudden, you 

went into ventricular fibrillation, without that device to give you 

that shock, which was a pretty good jolt, as you described, when 

it started shocking you, maybe inappropriately—but if it had 

shocked you in the appropriate manner that would have been because, truly, your heart would have gone into ventricular fibrillation. That device would have or it certainly was intended to save 

your life, was it not? 


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Ms. ROBB. It was definitely implanted in me to save my life. I 

had never been shocked before December 31 when it malfunctioned. That was the first time that I had ever been shocked, and 

it was 31 times, but it was put in as a safety net in case I were 

to go into V-tach. 

Mr. GINGREY. Would you agree that you had that put in because 

it was better to have it not needed than to need it and not have 

it? 

Ms. ROBB. Definitely. I would say that, you know, at the time, 

I knew that—they have sort of a cutoff limit with your heart function. When it gets below a certain level, you are at an increased 

risk to go into V-tach, and they recommend to get a defibrillator 

as a life-saving safety net. 

Mr. GINGREY. Well, let me reclaim my time. Thank you for that. 

Mr. Chairman, I just want to say that this is a great hearing, 

and it was an opportunity to hear from some real experts and to 

hear anecdotal testimony from Ms. Robb and, actually, from Mr. 

Kinsley as well. 

It is not easy. This is tough. I am a physician member. Some of 

my colleagues on this panel or on this committee and subcommittee 

are physician members, and we understand that this is a tough 

issue, so I appreciate your being here and for giving testimony and 

for helping us weigh the pros and cons of this legislation. 

With that, Mr. Chairman, I will yield back. 

Mr. PALLONE. Thank you. 

I think we have finished with our questions, but I do want to 

thank all of you for being here today. I agree with what Mr. 

Gingrey just said, that this is, you know, something that we obviously take very seriously, and we have to decide what is the best 

course of action. I think all of you have really helped us in, you 

know, commenting on this legislation as we move forward. So 

thank you all very much. 

What happens procedurally is, if members have questions, they 

can submit them in writing, and you should be notified within the 

next 10 days if there are questions of that nature. Then we would 

ask you to respond in writing. That is the way we proceed. 

Again, thank you so much. 

Without objection, the meeting of the subcommittee is adjourned. 

[Whereupon, at 4:16 p.m., the subcommittee was adjourned.] 

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