[House Hearing, 111 Congress]
[From the U.S. Government Publishing Office]


 
            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            JOE BARTON, Texas
  Chairman Emeritus                    Ranking Member
EDWARD J. MARKEY, Massachusetts      RALPH M. HALL, Texas
RICK BOUCHER, Virginia               FRED UPTON, Michigan
FRANK PALLONE, Jr., New Jersey       CLIFF STEARNS, Florida
BART GORDON, Tennessee               NATHAN DEAL, Georgia
BOBBY L. RUSH, Illinois              ED WHITFIELD, Kentucky
ANNA G. ESHOO, California            JOHN SHIMKUS, Illinois
BART STUPAK, Michigan                JOHN B. SHADEGG, Arizona
ELIOT L. ENGEL, New York             ROY BLUNT, Missouri
GENE GREEN, Texas                    STEVE BUYER, Indiana
DIANA DeGETTE, Colorado              GEORGE RADANOVICH, California
  Vice Chairman                      JOSEPH R. PITTS, Pennsylvania
LOIS CAPPS, California               MARY BONO MACK, California
MICHAEL F. DOYLE, Pennsylvania       GREG WALDEN, Oregon
JANE HARMAN, California              LEE TERRY, Nebraska
TOM ALLEN, Maine                     MIKE ROGERS, Michigan
JAN SCHAKOWSKY, Illinois             SUE WILKINS MYRICK, North Carolina
HILDA L. SOLIS, California           JOHN SULLIVAN, Oklahoma
CHARLES A. GONZALEZ, Texas           TIM MURPHY, Pennsylvania
JAY INSLEE, Washington               MICHAEL C. BURGESS, Texas
TAMMY BALDWIN, Wisconsin             MARSHA BLACKBURN, Tennessee
MIKE ROSS, Arkansas                  PHIL GINGREY, Georgia
ANTHONY D. WEINER, New York          STEVE SCALISE, Louisiana
JIM MATHESON, Utah                   PARKER GRIFFITH, Alabama
G.K. BUTTERFIELD, North Carolina     ROBERT E. LATTA, Ohio
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

                                  (ii)
                         Subcommittee on Health

                FRANK PALLONE, Jr., New Jersey, Chairman
JOHN D. DINGELL, Michigan            NATHAN DEAL, Georgia,
BART GORDON, Tennessee                   Ranking Member
ANNA G. ESHOO, California            RALPH M. HALL, Texas
ELIOT L. ENGEL, New York             BARBARA CUBIN, Wyoming
GENE GREEN, Texas                    HEATHER WILSON, New Mexico
DIANA DeGETTE, Colorado              JOHN B. SHADEGG, Arizona
LOIS CAPPS, California               STEVE BUYER, Indiana
JAN SCHAKOWSKY, Illinois             JOSEPH R. PITTS, Pennsylvania
TAMMY BALDWIN, Wisconsin             MARY BONO MACK, California
MIKE ROSS, Arkansas                  MIKE FERGUSON, New Jersey
ANTHONY D. WEINER, New York          MIKE ROGERS, Michigan
JIM MATHESON, Utah                   SUE WILKINS MYRICK, North Carolina
JANE HARMAN, California              JOHN SULLIVAN, Oklahoma
CHARLES A. GONZALEZ, Texas           TIM MURPHY, Pennsylvania
JOHN BARROW, Georgia                 MICHAEL C. BURGESS, Texas
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
  
                             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


            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 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 
dangerous 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, hard-to-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 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 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.
    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.
    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 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.
    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 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-of-jail-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 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 under-resourced, 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.
    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 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 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 
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. 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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    RPTS KESTERSONDCMN MAYER[3:10 p.m.]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. 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, 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 cross-examined?
    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 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 post-Cipollone, 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 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.
    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.
    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.
    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 the First Amendment, we are protected even 
when we have committed 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-of-jail-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 evaluate and helping an appellant understand the risks and 
benefits 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 mid-
1990s. 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-jail-free. So do you agree with that? Do you 
think that is true?
    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.
    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.
    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.
    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.
    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.
    Mr. Cooper.--as has been stated, the applications tend to 
be voluminous. The FDA needs to understand the ingredients or 
materials, 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?
    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.]
    [Material submitted for inclusion in the record follows:] 

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