    [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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