[House Hearing, 110 Congress]
[From the U.S. Government Publishing Office]



 
   SHOULD FDA DRUG AND MEDICAL DEVICE REGULATION BAR STATE LIABILITY 
                                CLAIMS?

=======================================================================

                                HEARING

                               before the

                         COMMITTEE ON OVERSIGHT
                         AND GOVERNMENT REFORM

                        HOUSE OF REPRESENTATIVES

                       ONE HUNDRED TENTH CONGRESS

                             SECOND SESSION

                               __________

                              MAY 14, 2008

                               __________

                           Serial No. 110-212

                               __________

Printed for the use of the Committee on Oversight and Government Reform


  Available via the World Wide Web: http://www.gpoaccess.gov/congress/
                               index.html
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              COMMITTEE ON OVERSIGHT AND GOVERNMENT REFORM

                 HENRY A. WAXMAN, California, Chairman
EDOLPHUS TOWNS, New York             TOM DAVIS, Virginia
PAUL E. KANJORSKI, Pennsylvania      DAN BURTON, Indiana
CAROLYN B. MALONEY, New York         CHRISTOPHER SHAYS, Connecticut
ELIJAH E. CUMMINGS, Maryland         JOHN M. McHUGH, New York
DENNIS J. KUCINICH, Ohio             JOHN L. MICA, Florida
DANNY K. DAVIS, Illinois             MARK E. SOUDER, Indiana
JOHN F. TIERNEY, Massachusetts       TODD RUSSELL PLATTS, Pennsylvania
WM. LACY CLAY, Missouri              CHRIS CANNON, Utah
DIANE E. WATSON, California          JOHN J. DUNCAN, Jr., Tennessee
STEPHEN F. LYNCH, Massachusetts      MICHAEL R. TURNER, Ohio
BRIAN HIGGINS, New York              DARRELL E. ISSA, California
JOHN A. YARMUTH, Kentucky            KENNY MARCHANT, Texas
BRUCE L. BRALEY, Iowa                LYNN A. WESTMORELAND, Georgia
ELEANOR HOLMES NORTON, District of   PATRICK T. McHENRY, North Carolina
    Columbia                         VIRGINIA FOXX, North Carolina
BETTY McCOLLUM, Minnesota            BRIAN P. BILBRAY, California
JIM COOPER, Tennessee                BILL SALI, Idaho
CHRIS VAN HOLLEN, Maryland           JIM JORDAN, Ohio
PAUL W. HODES, New Hampshire
CHRISTOPHER S. MURPHY, Connecticut
JOHN P. SARBANES, Maryland
PETER WELCH, Vermont
------ ------

                      Phil Barnett, Staff Director
                       Earley Green, Chief Clerk
               Lawrence Halloran, Minority Staff Director


                            C O N T E N T S

                              ----------                              
                                                                   Page
Hearing held on May 14, 2008.....................................     1
Statement of:
    Lutter, Randall, Ph.D., Deputy Commissioner for Policy, Food 
      and Drug Administration....................................   186
    Quaid, Dennis and Kimberly, parents of newborn twins, Thomas 
      Boone Quaid and Zoe Grace Quaid, who were victims of a 
      heparin overdose due to inadequate safety warnings by the 
      manufacturer; William H. Maisel, M.C., M.P.H., director, 
      Medical Device Safety Institute, Department of Medicine, 
      Beth Israel Deaconess Medical Center, Boston; Aaron S. 
      Kesselheim, M.D., J.D., Harvard Medical School, Division of 
      Pharmacoepidemiology; and David A. Kessler, M.D., J.D., 
      professor of pediatrics and epidemiology and biostatistics, 
      School of Medicine, University of California, San 
      Francisco, former Food and Drug Administration Commissioner    10
        Kesselheim, Aaron S......................................    27
        Kessler, David A.........................................    33
        Maisel, William H........................................    20
        Quaid, Dennis............................................    10
    Vladeck, David, J.D., professor of law, Georgetown University 
      Law Center; Gregory Curfman, M.D., editor, New England 
      Journal of Medicine, accompanied by Stephen Morrissey, 
      M.D., managing editor, New England Journal of Medicine; 
      Christine Ruther, president and chief engineer, C&R 
      Engineering, Inc.; State Representative David Clark, 
      National Conference of State Legislatures; and John E. 
      Calfee, Ph.D., American Enterprise Institute...............   111
        Calfee, John E...........................................   164
        Clark, David.............................................   152
        Curfman, Gregory.........................................   140
        Ruther, Christine........................................   147
        Vladeck, David...........................................   111
Letters, statements, etc., submitted for the record by:
    Calfee, John E., Ph.D., American Enterprise Institute, 
      prepared statement of......................................   166
    Clark, David, State Representative, National Conference of 
      State Legislatures, prepared statement of..................   154
    Curfman, Gregory, M.D., editor, New England Journal of 
      Medicine, prepared statement of............................   142
    Issa, Hon. Darrell E., a Representative in Congress from the 
      State of California, various articles......................    59
    Kesselheim, Aaron S., M.D., J.D., Harvard Medical School, 
      Division of Pharmacoepidemiology, prepared statement of....    29
    Kessler, David A., M.D., J.D., professor of pediatrics and 
      epidemiology and biostatistics, School of Medicine, 
      University of California, San Francisco, former Food and 
      Drug Administration Commissioner, prepared statement of....    35
    Lutter, Randall, Ph.D., Deputy Commissioner for Policy, Food 
      and Drug Administration, prepared statement of.............   190
    Maisel, William H., M.C., M.P.H., director, Medical Device 
      Safety Institute, Department of Medicine, Beth Israel 
      Deaconess Medical Center, Boston, prepared statement of....    22
    Quaid, Dennis, parent of newborn twins, Thomas Boone Quaid 
      and Zoe Grace Quaid, who were victims of a heparin overdose 
      due to inadequate safety warnings by the manufacturer, 
      prepared statement of......................................    13
    Ruther, Christine, president and chief engineer, C&R 
      Engineering, Inc., prepared statement of...................   149
    Vladeck, David, J.D., professor of law, Georgetown University 
      Law Center, prepared statement of..........................   114
    Waxman, Chairman Henry A., a Representative in Congress from 
      the State of California:
        Prepared statement of....................................     4
        Prepared statement of Ms. Levine.........................   219


   SHOULD FDA DRUG AND MEDICAL DEVICE REGULATION BAR STATE LIABILITY 
                                CLAIMS?

                              ----------                              


                        WEDNESDAY, MAY 14, 2008

                          House of Representatives,
              Committee on Oversight and Government Reform,
                                                    Washington, DC.
    The subcommittee met, pursuant to notice, at 10:10 a.m. in 
room 2154, Rayburn House Office Building, Hon. Henry A. Waxman 
(chairman of the committee) presiding.
    Present: Representatives Waxman, Cummings, Kucinich, 
Tierney, Watson, Lynch, Higgins, Yarmuth, Braley, Norton, 
McCollum, Sarbanes, Welch, Davis of Virginia, Burton, Shays, 
Souder, Platts, Issa, McHenry, and Bilbray.
    Staff present: Kristin Amerling, general counsel; Karen 
Nelson, health policy director; Karen Lightfoot, communications 
director and senior policy advisor; Andy Schneider, chief 
health counsel; Sarah Despres, senior health counsel; Ann Witt, 
health counsel; Steve Cha, professional staff member; Earley 
Green, chief clerk; Caren Auchman and Ella Hoffman, press 
assistants; Zhongrui ``JR'' Deng, chief information officer; 
Leneal Scott, information systems manager; William Ragland, 
Miriam Edelman, Bret Schorthorst, Jen Berenholz, and Lauren 
Belive, staff assistants; Larry Halloran, minority staff 
director; Jennifer Safavian, minority chief counsel for 
oversight and investigations; Keith Ausbrook, minority general 
counsel; Jill Schmaltz and Benjamin Chance, minority 
professional staff members; Kristina Husar, minority counsel; 
Patrick Lyden, minority parliamentarian and Member services 
coordinator; Brian McNicoll, minority communications director; 
John Ohly, minority staff assistant; and Meredith Liberty, 
minority staff assistant and correspondence coordinator.
    Chairman Waxman. The meeting of the committee will please 
come to order.
    This morning the committee will hear testimony on an issue 
that affects all of us: the legal liability of manufacturers 
that produce dangerous drugs and medical devices.
    Currently, when Americans are injured by any sort of 
defective product they have a remedy. In most States, they can 
sue the manufacturer of a product in a State court. Under a 
radical legal doctrine being advocated by the pharmaceutical 
and device industries and the Food and Drug Administration 
under the Bush administration, this will change. Patients hurt 
by defective drugs and medical devices would no longer have the 
ability to seek compensation for their injuries. This doctrine 
is known as preemption. The result is that one of the most 
powerful incentives for safety, the threat of liability, would 
vanish.
    One of our witnesses today will describe the case of Joshua 
Oukrop, a 21 year old student who died in 2005 when his cardiac 
defibrillator malfunctioned. Joshua's device failed because of 
a design flaw. The manufacturer knew about this flaw at the 
time of Joshua's death, but neither Joshua, his physician, nor 
his parents did.
    Three years elapsed between the time the manufacturer first 
learned of the defect and the time the manufacturer withdrew 
the defibrillator from the market. All the while, doctors, who 
didn't have any other information, continued to implant this 
device known to the company to be defective. Ultimately the 
defect was linked to seven deaths.
    In the lawsuits that followed, the manufacturer argued that 
it should be immune from liability because FDA approved the 
defibrillator. This type of argument received a significant 
boose when the Supreme Court ruled earlier this year that FDA 
approval of a complicated medical device preempts most 
liability claims.
    Think of the message that the manufacturer is trying to 
send. Even if a company withholds information about potentially 
fatal defects from physicians, patients, and the FDA, it is 
still going to be immune from liability for its actions.
    This morning we will have two expert panels to help us 
understand the implications of this legal doctrine of 
preemption. We will also have the chance to question FDA about 
why it is now taking the side of the manufacturers on this 
crucial public safety issue.
    For decades the Food and Drug Administration believed that 
State liability cases actually helped the agency regulate drugs 
and medical devices, but under the Bush administration FDA has 
reversed course. Now FDA advocates that once a product receives 
FDA approval, the manufacturer should be absolved of the 
responsibility for injuries caused by their products. This is 
exactly the wrong time for FDA to be saying, Trust us.
    As a result of chronic under-funding and weak leadership, 
FDA's ability to protect the public is plummeting. FDA's own 
Science Board just issued a report that said the agency is so 
starved of resources that American lives are at risk. But even 
with an FDA with more funding and better leadership, there 
would still be a compelling need for our system of State 
liability laws.
    Some drug and device companies have hidden and manipulated 
important safety data. Some have failed to report serious 
adverse events, and some have failed to disclose even known 
defects. If manufacturers face no liability, all the financial 
incentives will point them in the wrong direction, and these 
abusive practices will multiply.
    And there is another problem. The clinical trials upon 
which FDA relies to approve drugs or devices are often too 
small to detect the risks. Some risks can only be detected when 
the drug or medical device is used in the population at large. 
Without the risk of liability, companies would have little 
incentive to give FDA timely reports about these dangers. All 
the resources in the world will not fix these inherent 
problems.
    Patients who are injured by approved drugs and devices 
deserve compensation to help them deal with their permanent 
disabilities, their inability to work, and their costly medical 
procedures, but the only way patients can obtain compensation 
is to bring a lawsuit under State laws.
    Today we will be considering a fundamental question with 
high stakes for everyone in America who depends on drugs and 
medical devices: should the companies that produce these 
products be absolved of their legal obligation to ensure the 
safety of their products?
    [The prepared statement of Chairman Henry A. Waxman 
follows:]

[GRAPHIC] [TIFF OMITTED] T6191.099

[GRAPHIC] [TIFF OMITTED] T6191.100

    Chairman Waxman. I am grateful to our witnesses for being 
with us today to discuss this issue, and I look forward to 
their testimony, but before we call upon them I want to 
recognize my colleagues for opening statements.
    Mr. Davis.
    Mr. Davis of Virginia. Thank you, Mr. Chairman.
    The title of today's hearing asks a controversial question: 
should FDA drug and medical device regulation bar State 
liability claims? But framing the issue as an either/or 
proposition offers an illusory choice between non-existent 
absolutes, between total Federal preemption and unrestrained 
litigation of medical claims in 50 State court systems. The 
real, harder question is: when in the interest of public health 
must FDA regulations preempt liability claims under State law.
    Finding that answer means threading a course around the 
horror stories of both sides of the debate and finding the 
right balance between Federal regulatory reinforcement of 
interstate standards and plaintiff's recourse to separate State 
tort systems to pursue claims against drug and device makers.
    At stake in striking that balance: the health of patients 
and the protection of consumers too often caught in the cross-
fire between predatory trial lawyers and FDA regulated 
companies trying to shield themselves from post-approval 
claims.
    If either side wins, we all lose. Total preemption means 
dangerous and defective products could hide behind narrowly 
based FDA findings of safety and effectiveness. Total 
litigation would raise medical costs, stifle drug and device 
development, and subject both companies and patients to an 
endless labyrinth of conflicting standards.
    Already dense product labeling would become a State-by-
State legal litany for lawyers rather than a clinical guide for 
doctors and patients.
    In a letter to Congress five former FDA general counsels 
who served in Republican and Democratic administrations dating 
back to 1972 put it this way: ``If every State, judge, and jury 
could fashion their own labeling requirements for drugs and 
medical devices, it would be regulatory chaos for these two 
industries that are so vital to the public health and FDA's 
ability to advance the public health by allocating scarce space 
in product labeling to the most important information would be 
seriously eroded.''
    That by consensus among FDA lawyers also effectively rebuts 
those who claim the current administration has somehow skewed 
longstanding FDA policy toward preemption. FDA took affirmative 
steps to preempt State interference in drug and device warnings 
under Presidents, and FDA will have to do so under future 
administrations.
    Current preemption policy is nothing novel or radical, but 
a dynamic response to an increasingly litigious environment 
that undermines the effectiveness of the long-established FDA 
regulatory system.
    Those same FDA legal experts concluded: ``There is a 
greater need for FDA intervention today because plaintiffs and 
courts are intruding more heavily on FDA's primary jurisdiction 
than ever before.''
    Some might argue State court awards provide a layer of 
consumer protection FDA regulation alone does not offer. That 
is true when the manufacturer hides relevant data from the FDA 
or otherwise violates Federal regulations on drug abuse review. 
But when the regulated company is in compliance with all key 
Federal requirements, allowing State judges and juries to 
second-guess FDA experts and scientific advisory panels adds 
instability, not protection, to a system the Nation relies upon 
for vital medical advances.
    Criticism of the FDA process as under-funded, understaffed, 
or too limited in scope argue for changes at the Federal level, 
not for replacing one consistent regulatory standard with 50 
fragmented approaches.
    The hard truth is drug and devices will always pose some 
level of risk, but that cold fact will never comfort those that 
are harmed. The suffering caused by inadequate safety warnings 
on drug and devices or by practitioners' negligence in misusing 
those products can be heart-wrenching. We will hear such an 
account from Mr. and Mrs. Quaid this morning. But even the most 
compelling individual stories can't overthrow the collective 
judgment that the national weighing of benefits and risks best 
serves the public health.
    Striking a pose on one side of an emotional debate is easy, 
but maintaining the appropriate balance between public health 
and private relief is more difficult.
    We appreciate that Chairman Waxman has agreed with our 
request to bring some balance to today's witness panels by 
inviting testimony from the Food and Drug Administration and 
the American Enterprise Institute.
    The reach of expressed and implied Federal preemption of 
drug and device regulation is an important evolving issue, and 
we very much appreciate the chairman's continued focus on this, 
as well as other public health matters.
    Thank you.
    Chairman Waxman. Thank you very much, Mr. Davis.
    While it is usually the practice for just the chairman and 
the ranking member to give opening statements, I do want to 
recognize other Members who may wish to make a brief opening 
statement.
    Mr. Braley.
    Mr. Braley. Thank you, Mr. Chairman, and thank you for 
holding this important hearing.
    This doctrine of Federal preemption has been around a long 
time, and it historically evolved to be used in very limited 
circumstances where Congress clearly expressed an intent to 
preempt a field of law that the States historically have had 
the ability to enforce in their own jurisdictions, but in the 
past 7 years under the Bush administration we have seen a 
radicalization of the use of Federal preemption, not just in 
the courts but in Federal agencies who have taken it upon 
themselves to include in preambles language that effectively 
preempts the role of Congress under the Constitution to decide 
when and where to preempt State law.
    This is the real radical threat that is endangering the 
lives of consumers all over this country, and it is time this 
Congress started to wake up and focus on this problem. Our role 
in the Constitutional framework is being usurped by 
administrative appointees, many of whom come out of academic 
and research backgrounds that have been long advocating a 
doctrine called tort reform. All you have to do is look at 
where they come from and the advocacy of those interest groups 
to find out what their true motivation is. It is no accident 
that the President has mentioned tort reform in every single 
State of the Union Address he has given, including the State of 
the Union this year.
    It is time for us to talk about what is going on here. My 
friend talked about the increasingly litigious environment, but 
that is completely contrary to documented evidence which shows 
that in State courts across this country the number of products 
liability claims is declining every year, and there is a 
doctrine already in place in those State court claims called 
the state-of-the-art defense, which is a total defense to 
product liability cases, and in order to prove that defense you 
simply have to show that the product and the language used to 
describe it conform to the state-of-the-art at the time it was 
manufactured and distributed.
    When the FDA has an extensive approval process like the one 
we are talking about here today, that is a fundamental 
component of a state-of-the-art defense, so there is already 
substantial opportunity in State court proceedings to assert 
the very defense that we are here to talk about today.
    I look forward to the testimony of our witnesses and the 
opportunity to explore this in greater detail.
    Thank you.
    Chairman Waxman. Thank you, Mr. Braley.
    Mr. Souder.
    Mr. Souder. Thank you, Mr. Chairman.
    I want to associate myself with Mr. Davis' comments. I 
believe that, as you look at the industry, not only do you have 
a proliferation of variations of State laws, as we all know, 
most things don't go to trial. You negotiate and settle out of 
court. The variations, the potential will sit on innovation.
    In the hip, knee, and joint replacement I have three of the 
four largest manufacturers in the world in my congressional 
district. They have bought the biggest manufacturers in Germany 
and Switzerland. We have soldiers killed in Iraq or people who 
would have been killed but now come back with shoulder and hip, 
knees. They are not 80 years old, they are 18 to 22 years old. 
We are trying to figure out how to do skin grafting. We are 
into types of things that we know little about how this is 
going to project. You try to do as much science as you can.
    You cannot deal in technical innovation with variations of 
politicized State regulations. You have to have increasingly in 
this world some kind of standard or, quite frankly, they won't 
pursue new innovations. We ran into this with the orphan drug 
laws that innovations in flu prevention, innovations in AIDS, 
that unless you have some kind of ability to estimate your cost 
in areas where you don't know what return you are going to 
have, you have to have some sort of logical method to keep the 
lawsuits down.
    At the same time, there have to be protections that, when 
companies conceal, abuse, that there is clear warning, because 
it is unbelievably tragic when it happens to you that there is 
a byproduct, something that costs a life, that costs damage out 
of something because of a product that was supposed to help. 
That is terribly tragic, but when we look at this balance--I 
want to read Justice Breyer's as it came to print. She said, 
``You came up and began and said this drug has side effects 
that hurt people, and that is a risk when you have a drug and 
it is a terrible thing if the drug hurts people.''
    There is a risk on the other side. There are people who are 
dying or seriously sick, and if you don't get the drug to them, 
they die. So there is a problem: you have to get drugs to 
people, and at the same time the drug can't hurt them.
    Now, would you rather have to make that decision as to 
whether a drug is on the balance going to save people or in the 
balance going to hurt people, an expert agency on the one hand 
or 12 people pulled randomly for a jury from a jury roll who 
see before them only the people the drug hurt and don't see 
those people who need the drugs to cure them? That is one of 
our dilemmas when we go into a court situation as opposed to a 
research area or, quite frankly, why you have people at the FDA 
trying to balance this.
    Yes, there needs to be a legal appeal. The question is: 
where should the legal appeal be, how organized should it be? 
And one of the challenges is, if you are trying to deal with 50 
courts, in addition to the international, what you will do is 
stop the innovation. What we have is a balance.
    I have been critical of FDA on the other side of being too 
cautious at times, but here I believe there has to be some 
weighing of this balance which will get lost if it is just 
going to be decided in 50 States by basically jury trial.
    I yield back.
    Chairman Waxman. Thank you, Mr. Souder.
    Any other Members with to make opening statements? Mr. 
Tierney. Ms. Watson. Mr. McHenry.
    [No audible response.]
    Chairman Waxman. If not, we will proceed to recognize our 
first panel of witnesses.
    Dennis Quaid is the parent of newborn twins, Thomas Boone 
Quaid and Zoe Grace Quaid, who were victims of a heparin 
overdose due to inadequate safety warnings by the manufacturer. 
Today Mr. Quad will explain the impact that this event had on 
his family and share his views on the need for patient access 
to the State court system.
    Dr. William H. Maisel is a cardiologist and the director of 
the Medical Device Safety Institute within the Department of 
Medicine at Beth Israel Deaconess Medical Center in Boston, MA. 
Dr. Maisel previously chaired two FDA advisory panels and has 
been a consultant to FDA since 2003. He will be providing 
testimony regarding the FDA's approval process for medical 
devices, as well as medical-device-related safety issues he has 
encountered as a physician.
    Dr. Aaron S. Kesselheim is both a lawyer and an internal 
medicine physician. Dr. Kesselheim is a clinical fellow in the 
Department of Medicine in Harvard School of Public Health and 
an associate physician in the Division of Pharmacoepidemiology 
at Brigham and Women's Hospital. Dr. Kesselheim will be 
testifying about the role of litigation in defining drug risks.
    Dr. David Kessler served as FDA Commissioner from 1990 
until 1997. He is currently a professor of pediatrics and 
epidemiology and biostatistics in the School of Medicine at 
University of California, San Francisco. As a former FDA 
Commissioner, Dr. Kessler will be providing testimony regarding 
FDA's historical stance on the issue of preemption.
    We are delighted to have all of you here today to present 
your testimony and your views to us.
    It is the policy of this committee that all witnesses that 
testify do so under oath, so if you would please stand and 
raise your right hands I would like to administer the oath.
    [Witnesses sworn.]
    Chairman Waxman. The record will show that each of the 
witnesses answered in the affirmative.
    You have presented to us prepared statements, and those 
prepared statements will be part of the record in full. We 
would like to ask if you would to try to limit the oral 
presentation to 5 minutes. We have a timer where the red light 
showing right now, which would indicate that the time has 
expired. It will be green, and the last minute it will turn 
yellow, and then eventually turn red after 5 minutes.
    Mr. Quaid, we are delighted to have with us. You are one of 
my constituents, and so I especially want to welcome you today.

  STATEMENTS OF DENNIS AND KIMBERLY QUAID, PARENTS OF NEWBORN 
TWINS, THOMAS BOONE QUAID AND ZOE GRACE QUAID, WHO WERE VICTIMS 
OF A HEPARIN OVERDOSE DUE TO INADEQUATE SAFETY WARNINGS BY THE 
   MANUFACTURER; WILLIAM H. MAISEL, M.C., M.P.H., DIRECTOR, 
 MEDICAL DEVICE SAFETY INSTITUTE, DEPARTMENT OF MEDICINE, BETH 
 ISRAEL DEACONESS MEDICAL CENTER, BOSTON; AARON S. KESSELHEIM, 
        M.D., J.D., HARVARD MEDICAL SCHOOL, DIVISION OF 
    PHARMACOEPIDEMIOLOGY; AND DAVID A. KESSLER, M.D., J.D., 
  PROFESSOR OF PEDIATRICS AND EPIDEMIOLOGY AND BIOSTATISTICS, 
 SCHOOL OF MEDICINE, UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, 
        FORMER FOOD AND DRUG ADMINISTRATION COMMISSIONER

                   STATEMENT OF DENNIS QUAID

    Mr. Quaid. Thank you, Mr. Chairman, and thank you for 
inviting me here today to share my family's story. My wife 
couldn't be here. She is at home taking care of our twins. But 
it is our hope that these proceedings may raise public 
awareness about the issue that is here before us, and that is 
preemption of suits concerning injuries or death caused by FDA-
approved drugs.
    This is an issue I am sure most Americans are not aware of, 
but it is one that could adversely affect all Americans, my 
family included.
    I am sure that many of you already know that our newborn 
twins recently received a near-fatal overdose of blood-thinning 
medication, heparin, at Cedars-Sinai Medical Center in Los 
Angeles. Our twelve-day-old infants were mistakenly injected 
not once but twice over an 8-hour period with a massive 
overdose of 10,000 units of the anti-coagulant drug heparin, 
which is 1,000 times the normal does of 10 units of Hep-Lock 
that our twins should have received. Both products are 
manufactured by Baxter Health Care Corp.
    How could this have happened? Well, the answer became very 
clear to us after talking with the doctors and nurses and doing 
a little bit of research on our own. The 10 units of Hep-Lock 
and Baxter's 10,000 unit of Heparin are deadly similar in their 
labeling and size. The 10,000-unit label, which I believe you 
have there, Mr. Chairman, is dark blue, and the 10-unit bottle 
is light blue. If the bottles are slightly rotated, which they 
often are when they are stored, they are virtually 
indistinguishable. The similar labeling is what led to the 
tragic deaths of three infants and severe injuries to three 
others in Indianapolis the year before, and it was also the 
major factor in the overdosing of our twins.
    After the Indianapolis incident, Baxter sent out a warning 
to hospitals, and afterward, 7 months later, even changed the 
label of their Heparin to distinguish it from Hep-Lock. But 
Baxter failed to recall the deadly misleading bottles that were 
still on the market and stocked in hospitals, including Cedars-
Sinai.
    We consider this to be a dangerous decision by Baxter made 
for financial reasons, and our feelings are they recall 
automobiles, they recall toasters, they even recall dog food, 
but Baxter failed to recall a medication that, due to its 
labeling, had already killed three infants and severely injured 
three others just a year earlier, and then a year after the 
Indianapolis incident, the very same incident happened to our 
12-day-old infants.
    However mistakes did occur at Cedars, the overdosing of our 
twins was a chain of events of human error, and the first link 
in that chain was Baxter. Baxter's negligence, the cause of 
that, was an accident waiting to happen.
    Now, since this brush with tragedy my wife and I have found 
out that such errors are, unfortunately, all too common. Up to 
100,000 patients in the United States, alone, die in hospitals 
every year because of medical errors.
    We have also learned a lot about the legal system in a very 
short time, and it was very surprising, I must tell you. Like 
many Americans, I have always believed that a big problem in 
this country has been frivolous lawsuits. But now I know that 
the courts are often the only path that families have that are 
harmed by a drug company's negligence.
    Now we face something that could cause grave harm to all 
Americans. The Supreme Court is about to decide whether the law 
preempts most lawsuits concerning injuries from drugs and their 
labeling simply because the drug was approved by the Federal 
Food and Drug Administration.
    In our case against Baxter, the company is relying on this 
very same argument before the Supreme Court, that when the FDA 
allowed Baxter's Heparin onto the market, the FDA also 
immunized Baxter from any liability. So says Baxter. Our case 
may not even be heard before a judge or a jury, no matter how 
negligent it was in designing its labels or in failing to take 
the Heparin with the old label off the shelves after it knew 
about the tragedy in Indianapolis.
    Now, it is hard for me, Mr. Chairman, to imagine that this 
is what Congress intended when it passed the Food, Drug, and 
Cosmetic Act in 1938. Did Congress intend to give appointed 
bureaucrats in the FDA the right to protect a drug company from 
liability, even when that company cuts corners and jeopardizes 
public safety?
    Federal ban on lawsuits against drug companies would not 
just deny victims compensation for the harm that has been done 
to them; it would also relieve drug companies of the 
responsibility to make drugs as safe as they can be, and, 
moreover, to correct problems after that drug has been on the 
market.
    Now, let's hope that the Supreme Court will not put 
barriers in front of patients who are harmed by drug companies, 
but if the court does decide for the drug companies, in favor 
of them, I respectfully ask this Congress to pass corrective 
legislation on an emergency basis.
    I thank you for your time.
    [The prepared statement of Mr. Quaid follows:]

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    Chairman Waxman. Thank you very much, Mr. Quaid.
    Dr. Maisel.

                 STATEMENT OF WILLIAM H. MAISEL

    Dr. Maisel. Thank you, Chairman Waxman. Good morning. 
Ranking Member Davis, distinguished committee members. My name 
is Dr. William Maisel.
    I am a practicing cardiologist at Beth Israel Deaconess 
Medical Center and assistant professor of Medicine at Harvard 
Medical School in Boston. I also direct the Medical Device 
Safety Institute, an industry independent organization 
dedicated to improve the safety of medical devices. I have 
served as a consultant to the FDA Center for Devices and 
Radiologic Health since 2003, and have previously chaired the 
FDA's Post-Market and Heart Device Advisory Panels.
    I hope that by the conclusion of my brief comments today 
you will appreciate that FDA marketing clearance or approval of 
a medical product does not guarantee its safety. For this 
reason, it is critical that patients receive accurate, timely, 
easily understood information to assist them in making informed 
decisions. 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 very 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 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 pre-market evaluations in a timely fashion.
    Mark Gleeson is a man whose very life depends on one of 
these implanted 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 computer 
circuitry sealed together in a metal housing. Pacemaker 
batteries typically last five to 10 years, so you can imagine 
how Mr. Gleeson must have felt when he required surgery to 
replace his defective pacemaker after just 12 months due to a 
short circuit that caused his battery to wear out prematurely. 
Fortunately, Mr. Gleeson was able to safely have his new 
pacemaker fitted.
    St. Jude Medical, the manufacturer of Mr. Gleeson's 
pacemaker, had become aware of the short circuit problem 2 
years prior to Mark Gleeson's pacemaker failure, because other 
faulty pacemakers had been returned to the manufacturer. After 
studying the problem for over a year and validating the fix, 
St. Jude asked for and received FDA approval for a modified 
version of the device that corrected the problem. Although the 
approval came several months prior to Mr. Gleeson's device 
failure, St. Jude Medical continued to distribute the already 
manufactured potentially faulty pacemakers.
    Mark Gleeson was unlucky enough not just to receive the 
faulty pacemaker, but also to receive a potentially faulty 
device when his first faulty pacemaker was replaced, even 
though corrected pacemakers had been built and were marketed 
and were available.
    Ultimately, St. Jude Medical issued the recall of 163,000 
pacemakers, including Mark Gleeson's new unit, but not until 8 
months after receiving FDA approval for the corrected device 
and nearly 2\1/2\ years after initially learning of the 
problem.
    Mr. Gleeson wrote a letter to me, and he said, ``I have 
been on a journey through the Food and Drug Administration 
trying to determine why an incident dealing with a medical 
device was allowed to happen to me.'' He adds, ``Although my 
present pacemaker is working fine, every day I expect something 
to fail.''
    While Mark Gleeson's case occurred several years ago, it is 
not an isolated event. Other manufacturers have knowingly sold 
potentially defective devices without public disclosure. We 
heard earlier from Chairman Waxman about Guidant Corp. who 
identified and corrected a design flaw that could result in the 
short-circuit of an implantable defibrillator, a device that 
treats both dangerous slow and dangerous fast heart rhythms. 
Although the company reported the malfunctions to the FDA and 
received approval for the device modification, it continued to 
sell its inventory of 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, FDA relies upon 
industry to identify, correct, and report the problems, but 
there is obviously an inherent financial conflict of interest 
for the manufacturers, sometimes measured in billions of 
dollars.
    Implanted medical devices have enriched and 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 and the FDA to provide the 
public with timely critical information about device 
performance, malfunctions, and fixes 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 few for patients who receive life-sustaining medical 
devices. Additional consumer safeguards are needed if we are to 
minimize adverse health consequences and improve the safety of 
medical devices for the millions of patients who are fortunate 
enough to enjoy their benefits.
    Thank you.
    [The prepared statement of Dr. Maisel follows:]

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    Chairman Waxman. Thank you very much, Dr. Maisel.
    Dr. Kesselheim.

                STATEMENT OF AARON S. KESSELHEIM

    Dr. Kesselheim. Thank you. Chairman Waxman, Ranking Member 
Davis, and members of the committee, my name is Aaron 
Kesselheim. I am an internal medicine physician in the Division 
of Pharmacoepidemiology at Brigham Women's Hospital and an 
instructor of medicine at Harvard Medical School in Boston, and 
I conduct research on the ways that legal and regulatory issues 
affect medical practice, in particular related to the uses of 
prescription drugs.
    It is an honor to have the opportunity today to talk to you 
about the important role litigation plays in the drug safety 
system. Lawsuits against pharmaceutical manufacturers usually 
involve charges that the manufacturer failed to exercise proper 
care in warning about the risks of their drug products. 
Preempting or blocking such lawsuits, in my view, would to 
great harm to the public health. The reason is that a drug's 
manufacturer plays the central role in the development and 
dissemination of knowledge about its product.
    After FDA approval of a drug, important new data about 
adverse events often arise, but the FDA does not have the 
resources to fully monitor the uses and outcomes of all 
approved drugs. As a result, the FDA cannot certify a drug's 
ongoing safety. The drug's manufacturer is often in a position 
to identify emerging safety problems with its own product, but 
it has an inherent conflict of interest in that role. 
Manufacturers have a strong financial incentive to promote 
their drugs' effectiveness and increase sales of their 
products. Manufacturers may also sometimes be faced with data 
that suggests limiting the use of their product or withdrawing 
it from the market altogether.
    Manufacturers faced with this conflict of interest can make 
poor decisions that adversely affect the public health.
    First, manufacturers have misrepresented findings in 
medical publications. For example, in the case of the anti-
inflammatory Vioxx, a manufacturer-organized study was 
criticized because the authors did not accurately represent all 
the safety data they had regarding serious cardiovascular side 
effects. The exclusion of that data minimized the appearance of 
cardiovascular risks to physicians reading the study and using 
it as a basis for prescribing decisions.
    Second, manufacturers have minimized safety signals in 
their reports to the FDA. When Vioxx was associated with an 
increased risk of mortality in two manufacturers' studies, the 
manufacturer delayed communication of certain findings to the 
FDA and ultimately reported it in a way that clouded the 
appearance of risk.
    In the case of a cholesterol-lowering medicine, Baycol, the 
manufacturer received early reports suggesting an increased 
risk of a rare form of muscle breakdown and kidney failure, but 
the company did not conduct timely followup analyses or pass 
along internal analyses of drug safety signals to the FDA. A 
company memorandum reportedly stated, ``If the FDA asks for bad 
news, we have to give; but if we don't have it, we can't give 
it to them.''
    At the same time, when manufacturers promote a drug to 
physicians and patients, they tend to inflate its benefits and 
downplay its risks. Vioxx's manufacturer continued actively 
promoting its wide use, even after it reportedly knew about the 
drug's association with cardiovascular adverse events.
    The Vioxx and Baycol cases are just two recent examples 
illustrating how a manufacturers' dual role as the promoter of 
drug sales and the collector of safety information led to 
decisions detrimental to the public health. In this context, 
our research shows that litigation plays an important oversight 
role aside from helping people injured by dangerous products 
obtain financial recoveries.
    First, lawsuits can help bring important data to light so 
that physicians can make better prescribing decisions. Second, 
lawsuits help reveal improper business tactics, punish such 
actions, and hopefully prevent such similar behavior from 
occurring on other occasions in the future. Third, lawsuits can 
help reveal gaps in FDA policies and procedures in the 
oversight of drug safety.
    In sum, FDA approval does not end the process of 
information development about drug risks and benefits that 
define the safety of a drug and how a drug should properly be 
used. Without the possibility of litigation against 
manufacturers and their executives, we are likely to see 
greater misrepresentation of safety-related data and more 
potentially inappropriate use of harmful medications.
    Manufacturers continue to have a key role in the 
development and organization of safety and efficacy data about 
their products, but they also have an inherent conflict of 
interest when evaluating their own products.
    In my view, it is therefore important to continue to 
encourage manufacturers to act responsibly by subjecting their 
decisionmaking to judicial review.
    Thank you, and I welcome your questions.
    [The prepared statement of Dr. Kesselheim follows:]

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    Chairman Waxman. Thank you very much, Dr. Kesselheim.
    Dr. Kessler.

                 STATEMENT OF DAVID A. KESSLER

    Dr. Kessler. Mr. Chairman, I would like to discuss why the 
FDA system of drug and medical device regulation is not 
entirely adequate for assuring the protection of the public 
health.
    There are two very different aspects to drug review, and it 
is important to understand each in the debate on preemption. 
First is the period leading through approval. Manufacturers are 
supposed to submit all pre-clinical and clinical data. FDA has 
to review that data. FDA makes an affirmative decision that the 
drug can go on the market if the drug meets the statutory 
standards for safety and efficacy.
    Let me move on to the second phase of a drug's life. The 
drug is on the market. If a drug is studied in a few thousand 
patients and a serious and life-threatening drug reaction 
occurs in an incidence of 1 in 10,000, it is likely that 
serious and life-threatening risk will not have been seen in 
the clinical trials and will only emerge after the drug is on 
the market.
    Companies have to file adverse reaction reports. Thousands 
of adverse reaction, drug and device adverse reaction reports, 
come into the agency each year.
    Those who favor preemption focus on the first part of a 
drug's life, the approval process. They suggest that the FDA's 
approval of a drug's labeling reflects the agency's definitive 
judgment, but I believe it is wrong to focus on the moment of 
approval as the determination of the preemption question. The 
relevant timeframe is post-approval as much as it is pre-
approval, and the question is: what did the FDA and the drug 
company know about a drug's risk at the time the patient 
sustained the injury?
    As I just discussed, the FDA's knowledge base of the risks 
posed by a new drug is far from static. At the time of 
approval, the FDA's knowledge base may be close to perfect for 
that moment in time, but it is also highly limited, because at 
that point the drug has been tested on a relatively few small 
population of patients. The fact is that companies will always 
have better and more timely information about their products 
than FDA will ever have at its disposal.
    Moreover, there are real limits on FDA. There are limits on 
FDA authority that prevent it from acting quickly in some 
settings, and, most importantly, there are real limits imposed 
by the limited resources the agency has available. Even if 
FDA's funding were doubled or tripled, its resources and 
ability to detect emerging risks on the thousands of marketed 
drugs and devices would still be dwarfed by those of the drug 
and device companies who manufacture those products.
    For that reason, the tort system has historically provided 
a critical incentive to drug and device companies to disclose 
important information to physicians, patients, and the FDA 
about newly emerging risks. My greatest concern with preemption 
is that it would, I believe, dramatically reduce the incentives 
for manufacturers to act quickly and responsibly to detect, 
analyze, investigate, and take action on potentially serious 
and life-threatening adverse reactions once a drug is on the 
market.
    Mr. Chairman, I need to stress that it is the 
manufacturers, not the agency, that are in a far better 
position to know when a new risk emerges from a drug or device, 
and it is the manufacturer that has the ability to make swift 
changes to a drug or device's warning or product features.
    Thank you, Mr. Chairman.
    [The prepared statement of Dr. Kessler follows:]

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    Chairman Waxman. Thank you very much, Dr. Kessler.
    I am now going to recognize members of the committee to ask 
questions for 5 minutes, and I will start with myself.
    Mr. Quaid, to understand what happened to your twins, you 
had on the screen earlier--and I hope they will put it back 
up--a picture of the two vials. I do have them right here. They 
look very, very much alike, but one is 10,000 times the potency 
of the other.
    Mr. Quaid. Sorry to correct you, but it is 1,000 times the 
potency.
    Chairman Waxman. But the one that was 1,000 times more was 
the one that was administered to your children, is that right?
    Mr. Quaid. Yes, sir. Not once but twice over an 8-hour 
period.
    Chairman Waxman. Not once, but twice?
    Mr. Quaid. Yes.
    Chairman Waxman. And I imagine what happened is, if you 
look at the two bottles they look so closely alike that busy 
nurses and doctors and others in the hospital made the mistake 
of confusing one for the other.
    This wasn't the first time this mistake was made, because 
in September 2006 there was a tragic situation in Indianapolis 
when two Heparin vials were confused for each other and six 
babies were injured and three babies died. So you would think 
if something like this already happened there would have been 
action spurred all around the country to inform people about 
it.
    The time line suggests that action took a very long time. 
It took 5 months just to get a letter out to warn health care 
professionals, 13 months to issue a new label. What do you 
think of that length of time to get some action by the 
manufacturer?
    Mr. Quaid. Well, I think there is too much time, sir. The 
incident in Indianapolis, when that occurred, although I can't 
speak with the full knowledge of that case, but I think that 
may have been at the point of what was referred to earlier as 
the state-of-the-art. No one was aware at that time that it was 
really a problem. This was a case that got reported and 
received attention because of the deaths of the incidents.
    At that time I do believe that it would have been prudent 
for Baxter to recall all the Heparin that they had out there in 
the 10,000-unit bottles or/and the Hep-Lock to differentiate 
them for use. This was not done.
    As you said, it took 4 or 5 months to get a warning out to 
hospitals, and I think it was 11 to 13 months before they 
actually changed the bottle of the Heparin to differentiate it 
from the Hep-Lock.
    Chairman Waxman. The label was supposed to have been 
changed. Baxter didn't recall the product. They kept the vials 
with the old labels on the shelf, even though they were going 
to change the labels, but they didn't recall those that were 
already out.
    You brought a case against Baxter in the State court, and 
then Baxter filed a motion to dismiss your case because on the 
facts the drug had been approved originally by the FDA. So what 
Baxter is arguing is that your case should be dismissed because 
FDA preempted the whole area of regulation of Heparin and it 
seems that what they are doing now in this decision is to try 
to say you can't even go to the State court to seek redress of 
your grievances. Your children were overdosed, and you want to 
get action against the manufacturer that had some 
responsibility.
    If we go along with this preemption theory, it seems to me 
we are giving a company a free pass when they know there is a 
problem with one of its products, when it drags its feet in 
letting the consumers know about the problem and fixing it, and 
when someone gets hurt by the product during that time just 
because the product had originally been approved by FDA.
    I want to ask Dr. Kessler, you are a former FDA 
Commissioner. You may not know the details of this case, but 
according to the time line Baxter changed its Heparin label in 
October 2007, but it wasn't until December of that year that 
FDA approved the label change.
    What significance is there? How is this possible? How could 
Baxter change the label and then later get approval for the 
change by the FDA?
    Dr. Kessler. Mr. Chairman, both drug and device law allow 
manufacturers to make safety changes on their label, and those 
changes should not be delayed.
    Chairman Waxman. So the company can make the change on its 
own? They don't need FDA approval?
    Dr. Kessler. They need to submit at the time they make the 
change, they need to tell the agency, and then the agency can 
review it subsequently. But this is about safety, Mr. Chairman.
    Chairman Waxman. Why wouldn't FDA have recalled the product 
or told Baxter to recall the product that had the old labels on 
them?
    Dr. Kessler. Well, the agency can act subsequently, but 
there is an interim period of time where the company can take 
action, deal with the safety. FDA can learn about it, but there 
is that period of time that it takes the agency to review. It 
is about information, Mr. Chairman, and when does the agency 
get that information. Here the company has that information. It 
can act. It submits it to the agency. But then the question is 
what that period of time is.
    Chairman Waxman. Thank you very much.
    Mr. Davis.
    Mr. Davis of Virginia. Thank you very much.
    Thank you very much, Mr. Quaid. Thank you. You put a face 
to the problem, which is helpful to us in terms as we try to 
understand. I think if this had been my kids, I would be suing 
everybody in sight. This kind of thing should not happen. But I 
am curious to understand why you are just suing Heparin. Why 
not the hospital and the nurses, as well, who took the wrong 
vials off? I think this is after the hospital had gotten a 
letter. I mean, wouldn't you get everybody? There is 
culpability to go around here.
    Mr. Quaid. Yes, sir. Those letters that were sent out, 
warnings, they are sent out to hospitals. There are so many 
warnings that are sent out that stack up on desks, and not 
everyone is aware of them completely.
    To address your question about pursuing the hospital, we 
have 8 years to sue the hospital. Our twins survived, and 
apparently with no damage to them, although we really don't 
know what the long-term effects may be.
    I am hesitant to sue people. As I say, I did not believe in 
frivolous lawsuits and I certainly don't consider this to be 
one, but we don't want to bring down our medical institutions. 
We really need them. What we are seeking at the present time is 
to get Cedars to work with us to help solve this problem and 
improve patient safety.
    Mr. Davis of Virginia. OK. Thank you very much.
    Dr. Kessler, fellow Lord Jeff, you support preemption when 
there is a direct conflict between State and regulatory action. 
In the case of Wyeth v. Levin, phenergan, an injectable anti-
nausea medication included in its label warnings included the 
mode of administration. The label stated that intramuscular 
injection was preferred, and intra-arterial injection can cause 
gangrene and extreme care should be exercised.
    Now, the manufacturer requested changes to its label to 
prohibit this mode of injection, but FDA rejected those changes 
because in some specific instances intra-arterial injection may 
be appropriate.
    Now, my question is this: do you think the Vermont Supreme 
Court requiring a labeling change that was rejected by the FDA 
is an example where preemption should be allowed because of the 
direct conflict?
    Dr. Kessler. I think, Congressman Davis, I think you summed 
it up well in your opening statement. I don't want to get into 
the very specific facts of a particular case, but I do believe 
there are times and there are criteria when there is a case for 
preemption, and I have supported in several instances case of 
preemption. I think when an agency takes substantive and 
definitive action, I think when there is a direct conflict 
between the State action and the agency action that would 
thwart the ability of the agency to achieve its statutory 
goals, and I think when there is a public health reason to 
favor preemption, I think there are criteria.
    Mr. Davis, the Congress supported, for example, take the 
nutrition facts panel that is on all packaged foods. It 
wouldn't makes sense for States to be enacting a separate 
nutrition facts panel. So there are times when the agency acts.
    The important thing to understand is that at the moment the 
agency has the NDA, assuming the company has told them 
everything. The agency is in a good position to know 
everything. But that is not the kind of cases we are talking 
about.
    Much of this happens as you see people learn information 
after the drug is on the market.
    Mr. Davis of Virginia. That is right.
    Dr. Kessler. And who is in the position to act and what are 
the appropriate incentives? I am concerned that if you have 
preemption, if you have blanket preemption, preemption across 
the board, then you are going to take away incentives for the 
companies to act quickly.
    Mr. Davis of Virginia. I agree. I would note that the only 
regulatory action--regulatory action, I am not talking about 
their legal preference--by the current administration is a 
proposed rule relating to the circumstances under which 
manufacturers can make a label change without prior FDA 
approval, so when they find a problem they can fix it without 
FDA approval. I think that is moving in the right direction.
    Dr. Kessler. But I would urge that when we are talking 
about safety--and that is what we are talking about--and a 
company has information, FDA is going to want that company to 
act quickly and expeditiously.
    Mr. Davis of Virginia. I would hope so.
    Dr. Kessler. I have never yet been in a position where a 
company says, we want to put something on that label because we 
are concerned about safety, and the FDA says, No, hold it. We 
are not concerned as you are about safety.
    So we want to create the incentive for companies to act 
expeditiously and responsibly.
    Mr. Davis of Virginia. Can I just make one comment? I 
remember, though, with antidepressants, when they all of the 
sudden put the labels on, for a while there was a hiatus. 
People quit taking antidepressants. Teen suicides went up. It 
is a balance where you want FDA involved, as well.
    Dr. Kessler. You are exactly right. They are complex 
questions, and no one is saying that if the agency has 
considered the matter and has looked at the evidence and said 
the evidence doesn't support that association with that risk, 
of course that should be evidence.
    Juries and judges, those cases, if the agency has acted 
definitively, that is important evidence that should give the 
manufacturers comfort.
    Mr. Davis of Virginia. Thank you all. I appreciate the 
testimony. It is helpful. Thank you.
    Chairman Waxman. Thank you, Mr. Davis.
    Mr. Braley.
    Mr. Braley. Mr. Quaid, I want to applaud you and your wife 
for your efforts to improve patient safety. This is an issue 
that has been known to the Federal Government for a number of 
years. In 2000 the Institutes of Medicine came out with a 
seminal comprehensive study called To Err is Human, which 
concluded that every year 44,000 to 98,000 people die in 
hospitals due to preventable medical errors. That is just the 
deaths, not the injuries like your children. And then 3 years 
later they came out with a comprehensive study on patient 
safety and things the Federal Government should be doing to 
improve patient safety. So thank you for using your tragedy to 
put a human face on this issue.
    My question for the physicians on the panel, and in order 
to give us a better understanding of exactly what happened, is 
we are talking here about a mix-up with a drug called Heparin. 
Are you three familiar with complications known as Heparin-
induced thrombocytopenia or white clot syndrome?
    Dr. Kesselheim. Yes.
    Mr. Braley. And can you describe for us what the 
devastating consequences of those complications are for a 
patient who has been administered Heparin therapy?
    Dr. Kesselheim. They can clot in all different veins and 
arteries and receive end organ damage to their kidneys and 
brain and heart, and it can ultimately be fatal.
    Mr. Braley. And also can lead to severe limb amputation, 
correct?
    Dr. Kesselheim. Yes.
    Mr. Braley. Dr. Maisel, I want to talk to you about the St. 
Jude's pacemaker that you discussed briefly in your opening 
statement. Do you remember that?
    Dr. Maisel. Of course.
    Mr. Braley. One of the patients you discussed was a Mr. 
Gleeson whose pacemaker failed due to some device that was 
prone to short circuiting?
    Dr. Maisel. Yes.
    Mr. Braley. Do you remember that? One of the things that we 
all know is that occasionally there are medical devices that 
just don't work. That doesn't necessarily mean they are 
defective, does it?
    Dr. Maisel. I think it does mean that they are defective, 
but it doesn't mean that the manufacturer is at fault.
    Mr. Braley. That is exactly right.
    Dr. Maisel. So we should make a distinction between 
malfunctions that are inevitable for complex devices that a 
manufacturer may have done due diligence and done their best to 
try to get those devices to market and have them safe. The 
distinction here is that the manufacturer was aware of a 
problem. It was a problem that they fixed and they failed both 
to notify the public about that fix and they also failed to 
retrieve from inventory the devices that they knew were prone 
to malfunction, and there were a number of devices that were 
implanted into patients. Those implants could have been 
prevented. So a number of patients were unnecessarily exposed 
to a defective, potentially defective, device.
    Mr. Braley. And one of the things that we hear a lot about 
and we have heard here today at this hearing is predatory trial 
lawyers and frivolous lawsuits, but in this case Mr. Gleeson 
never even filed a suit, did he?
    Dr. Maisel. In his letter to me he said that no law firm 
would take his case, and he actually said, ``I should have died 
to have had a better case.'' He was somewhat frustrated. 
Obviously he had received a defective device and then had been 
re-implanted with a potentially defective device, but he did 
not seek legal redress.
    Mr. Braley. Let's talk about that. Let's talk about who 
bears the ultimate burden of taking care of patients who are 
injured or killed. Well, if they are killed obviously they are 
no longer with us, but if they are severely injured due to a 
defective medical device and there is no source of recovery 
under State law because of Federal preemption, and that family 
does not have the means to provide for the medical care that is 
necessary, who ultimately pays the price for that defective 
product?
    Dr. Maisel. I think you and I pay that price, the taxpayers 
pay that price. Many of the medical expenses are paid by 
Medicare or other insurers. In Mr. Gleeson's case he received a 
letter that said that his maximum benefit from St. Jude, the 
maker of his device, would be $600, plus he would get a 
``free'' pacemaker. The expenses associated with a surgical 
procedure to replace a pacemaker are typically over $10,000, so 
we all pay for that.
    Mr. Braley. And going up every year, correct?
    Dr. Maisel. Yes.
    Mr. Braley. So one of the things that we know is when we 
have a radical shift in a Federal application of a policy like 
preemption is that there is a cost shifting that goes along 
with that.
    Dr. Maisel. I think that is right. I think it is not like 
these things are not paid for.
    Mr. Braley. And the cost shifting winds up in the laps of 
the taxpayers of this country?
    Dr. Maisel. I think that is right.
    Mr. Braley. Now, one of the other issues you talked about 
was the Guidant defibrillator. Do you remember that?
    Dr. Maisel. Yes.
    Mr. Braley. And you testified about the problems with that 
device, and according to your testimony the company had known 
about those problems years before it came to public light. Did 
it ever tell the FDA about the problems that it discovered?
    Dr. Maisel. Guidant first modified their device in April 
2002 after they were aware of two or three malfunctions of the 
device. Guidant did submit adverse event reports through the 
medical device reporting system that the FDA has, but that is a 
needle in a haystack. There are over 200,000 adverse event 
reports that the FDA receives annually. For pacemakers and 
defibrillators, alone, there are tens of thousands of 
malfunctions over the last 15 or 16 years, so it is very 
difficult for the FDA, even if they receive an individual case 
report, to connect the dots. That responsibility falls on the 
manufacturer.
    Ultimately, Guidant mitigated their device, meaning that 
they fixed it, they put a new device out onto the market, and 
it wasn't until a New York Times story was pending because the 
parents and physicians of Jeffrey Oukrop, who was harmed by the 
device, went to the New York Times, did the story actually 
become public.
    It is interesting. Guidant had an independent panel that 
they put together to review the whole process related to this 
device, and it is a 133-page report that is very comprehensive, 
and I found this one sentence very sobering. They say in this 
case the criteria would not have triggered an FDA recall if not 
for the New York Times article. If those parents and those 
physicians had not gone to the New York Times, it is quite 
likely we wouldn't be here talking about this today.
    Mr. Braley. Thank you.
    Chairman Waxman. Thank you, Mr. Braley.
    Mr. Souder.
    Mr. Souder. Thank you, Mr. Chairman.
    I want to start with a simple point here, and that is that 
once again we are faced with a hearing that presumes to talk 
about an issue that has eight Democrat-selected witnesses and 
two Republican. We appreciate the two Republican, but that is 
not a balanced hearing.
    The first panel that gets the most attention at every 
hearing has no balance. How can I ask questions and hear 
debate? I have no one on the one side. Everybody is advocating 
the legislative position that the chairman supports. We can't 
have a debate.
    I want to raise some questions, because apparently nobody 
is going to raise the other side in this first panel unless I 
do it.
    Chairman Waxman. Will the gentleman yield to me?
    Mr. Souder. Yes.
    Chairman Waxman. I do want to indicate that we have taken 
all the recommendations of the Republican side of the aisle for 
witnesses. There are witnesses on subsequent panels. These 
witnesses are capable of answering your questions, and others 
that have been recommended by your side will be available, as 
well, to answer your questions.
    Mr. Souder. Mr. Chairman, did the minority ask if there 
would be a witness on the first panel?
    Chairman Waxman. The answer is no.
    Mr. Souder. So your position is the minority doesn't care 
if they have a witness on the first panel, or did you----
    Chairman Waxman. I didn't specify panel, but we have taken 
all the witnesses that were recommended. We have always taken 
recommendations of witnesses and accommodated the request.
    Mr. Souder. Thank you, Mr. Chairman. I have been on both 
sides of this as a staffer and a Member, and, quite frankly, I 
know the chairman is open to taking minority witnesses, but 
when you bury them further in the hearing, as a former staff 
director who knows how to set up hearings, I can see what is 
done in front of me, and it is frustrating. Of course I can ask 
questions later. Of course I can do this type of thing. The 
question is on the first panel that we have had, one approach 
here----
    Chairman Waxman. Mr. Souder, your time is going, and when 
you get the majority and become chairman you can design the 
hearings as you see fit. Regular order means Mr. Souder is 
recognized.
    Mr. Souder. Will I get the time that you used on my time?
    Chairman Waxman. Without objection, the gentleman will be 
given one additional minute.
    Mr. Souder. When we were in the majority we did have more 
balanced hearings, and we gave one-third of the witnesses, and 
I always included in my hearings on the first panel a minority 
witness unless there was agreement otherwise, and we did do 
that when we were governed.
    Here is the question. Here is my problem, that real 
concerns have been turned into simplistic, silly policy. I 
understand the concerns you are raising. It is not addressed, 
in my opinion, by proliferating lawsuits; that we have 
substantive questions here on labeling. It would be 
embarrassing. Mr. Quaid handled the question. It would be 
embarrassing for the others on the panel and it would be 
hypocritical self-interest if you didn't include doctors and 
nurses in the same charges that you do pharmaceutical companies 
and medical device companies. I didn't hear that.
    We have never seen cost containment or innovation come from 
lawsuits. Yes, lawsuits can discourage risk, but it does not 
address the fundamental question of whether you get innovation 
and cost control.
    In my District I met a man that was Lincoln Reinsurance 
because every doctor in every hospital knows this, as well as 
pharmaceutical companies, that the company only assumes part of 
it. They get insurance to cover this if there is not legal 
protection. And the insurance companies get protection through 
reinsurance. I met a man in a little office who is trying to 
figure out 40 years from now what the legal risk is of genetic 
modification drugs that are trying to get breakthroughs. Now, 
he is trying to set a cost. The greater you set the risk and 
the lawsuit risk and the proliferation of lawsuits and the 
negotiated settlements and trying to make all this proof and 
jury trials followed by appeals, the greater that insurance 
company charges the greater the reinsurance and you escalate 
the cost of health care, which reduces innovation and reduces 
this.
    We need fundamental questions of how to provide product 
safety, but it is silly to suggest that proliferating lawsuits 
and having 50 States address this in any kind of medicine, 
whether it is nurses, doctors, hospitals, or others, that yes, 
the ability to sue will, in fact, particularly if you think you 
can get to an executive, result in very over-reactive behavior, 
which helps some individuals, as I mentioned in Justice 
Breyer's point, will help some individuals, but it will also 
hurt thousands of individuals, because in the over-reaction and 
in the cost process of how things are made in America and how 
things are delivered in America in the real world of finances 
is an incredible risk.
    I also am frustrated that if there is willful neglect, 
clearly willful neglect, that I heard possible, that there may 
be damage and companies didn't pull something on, but willful 
neglect is not immunized. If you have deliberately provided 
false information to the FDA, you are accountable now.
    Let me ask, Mr. Kessler, isn't that true? Not debatable, 
but willful distortion by the companies of data can be 
prosecuted?
    Dr. Kessler. U.S. 1001, false statements are a crime.
    Mr. Souder. The debate here is what about the areas of 
tolerable risk, and is it going to be decided by the courts or 
the process, and if we have companies that are willfully--
everybody believes that. We are at the margins here.
    Dr. Kessler. Congressman, you ask a very good point, but 
rarely is this about willful, intentional, criminal behavior. I 
ran the agency for 7 years, and yes, we had an Office of 
Criminal Investigations, but I don't sit here and believe that 
the kind of cases that we are talking about are people--I mean, 
at these companies they want to do good. They don't sit there 
wanting to engage in criminal behavior. That is not what we are 
talking about.
    The issue is, though, where are the incentives. It is not 
only lying, but there is the issue. You heard this, ``If we 
don't know, we are OK.''-+ So where do you create the 
incentives? I mean, is the ostrich defense: I am not going to 
undertake those studies, I am going to be willfully blind.
    Mr. Souder. Isn't the FDA and consumer product safety and 
other types of advertising questions because you want to say 
that this should be solved at the lowest level courts appealing 
through four court processes in 50 States when these businesses 
are internationally doing it, taking capital risk, and you know 
full well it would be a disincentive, because when you were 
there we saw this in orphan drugs. We saw this in the medical 
license.
    Chairman Waxman. The gentleman's time has expired, but 
please go ahead and answer the question.
    Dr. Kessler. I wish I could sit here, Congressman, and tell 
you that with all the agency resources you gave the agency, the 
agency could ever be in a position as good as the company to 
deal with those risks.
    But the agency is always racing after, especially when one 
is talking about once the drug is on the market, new 
information comes. It is somewhere. The company knows about it. 
So the question is do you want to incentivize that behavior of 
the company. So it is not just FDA doesn't control all the 
behavior after a drug is on the market. I mean, how the company 
acts in that interval until the agency gets the information, 
until the agency has been able to review all that information, 
those are the kind of cases that I think that you are seeing, 
so it is that gray zone, Congressman, that really is--I mean, 
those are the hard questions, and that is what we are talking 
about today. It is not about criminal behavior.
    Chairman Waxman. Mr. Tierney.
    Mr. Tierney. Thank you, Mr. Chairman.
    Chairman Waxman. Mr. Quaid, did you want to say something?
    Mr. Quaid. Yes, sir, I just wanted to address that because 
he brought up about the hospital, and that is I certainly don't 
believe in frivolous lawsuits, myself, sir, but I do believe 
that the tort system that exists in States is a good balance 
between the drug companies and the FDA and what we are talking 
about today.
    The FDA, to my understanding, is, in part, funded by the 
drug companies who pay a fee sometimes to expedite the 
marketing of their product. That seems to me to be a conflict 
of interest, and the tort system has traditionally created a 
balance for this.
    What we are talking about really is a balance between 
business expediency and public safety, and the tort system does 
exist to inform the public about--that is where a lot of the 
public learns about what are the dangers of some products out 
there.
    Without the tort system, there is not going to be as much 
motivation and impetus, and certainly I don't believe the 
people at the drug companies are evil people, as well. 
Everybody is trying to do their job in the best way, but we are 
talking about business here.
    For instance, Baxter would answer to why didn't they recall 
the Heparin when they knew there was a problem with it, with 
the labeling, would say that it was because it was a very 
important drug and they did not want to create a shortage that 
was out there. But at the same time recently we had the events 
that happened in China with the tainted Heparin that was out 
there that was also a Baxter product, and what happened was 
that Baxter's competitor wound up taking up the slack and there 
was absolutely no shortage of the product.
    Chairman Waxman. Thank you.
    Mr. Tierney.
    Mr. Tierney. Thank you, Mr. Chairman.
    I thank all the witnesses so far.
    It is all very interesting what Mr. Souder was proposing 
over there, but I think the last two statements from witnesses 
hit it right on the head: this is really about who is going to 
bear the burden when a corporation isn't as careful as they 
should be or makes a bad decision. Is it going to be the family 
of the patient or is it going to be spread out on the party 
that had the most control over the information.
    There is pretty much agreement, the Government 
Accountability Office, which is Congress' investigatory arm, 
the Institute of Medicine, they all agree there is a problem 
with the safety of products that the FDA regulates, but I 
think, Dr. Kessler, you said it right: no matter how many 
resources we give the FDA, or no matter how much authority we 
give them--we can never give them unlimited authority or 
resources--the company is always going to have more information 
than the FDA has. Where should the burden fall on that?
    Let me just ask, please, Dr. Kesselheim, do you think 
preemption will help or harm drug and device safety?
    Dr. Kesselheim. I think preemption will harm drug safety, 
and that is what my conversation earlier was focused on. When a 
manufacturer is allowed to discharge their duty of safety to 
patients merely by presenting something to the FDA, which we 
know is under-staffed and which we know may not be able to pick 
up on safety signals that are masked in the presentation of the 
data, and meanwhile the company continues to promote its 
product, it doesn't do that with presenting the risk and 
benefits to physicians and patients that they need to do to 
make fully informed prescribing decisions.
    Mr. Tierney. Thank you.
    Dr. Kesselheim. So that would harm the public health.
    Mr. Tierney. Thank you.
    Dr. Maisel, do you agree?
    Dr. Maisel. I do agree that preemption would harm drug and 
device safety. And I think it is interesting to point out, in 
the Guidant example, for instance, the FDA actually conducted 
inspections, seven inspections of the Guidant manufacturing 
plant during the time period that these malfunctions were 
occurring. They had received reports of the adverse events, and 
they still were incapable of detecting the problem and 
reporting it publicly.
    So even with the best resources, the FDA is still not going 
to be able to pick up on all the important safety signals.
    Mr. Tierney. Dr. Kessler, I gather from your testimony, as 
well, that you don't think the FDA's oversight is so reliable 
that manufacturers should be given a free pass on any of this?
    Dr. Kessler. No, I don't believe the companies should be 
given a free pass, and I think if you go back and you look at 
what we said when general counsel, back in 1996, my general 
counsel, if I could just put it in the record, Congressman, 
Margaret Jane Porter, in 1996, said, ``FDA's view is that FDA 
product approval and State tort liability usually operate 
independently, each providing a significant yet distinct layer 
of consumer protection.''
    She was talking about devices, but I think it applies also 
to drugs. ``FDA regulation of a device cannot anticipate and 
protect against all safety risks to individual consumers. Even 
the most thorough regulation of a product such as a critical 
medical device may fail to identify potential problems 
presented by the product. Preemption of all such claims would 
result in the loss of a significant layer of consumer 
protection, leaving consumers without a remedy caused by 
defective medical devices.'' That was what my general counsel 
said in 1996 to the Food Drug Law Institute. I still think that 
is the wisest policy, Congressman.
    Mr. Tierney. Thank you.
    Somebody mentioned the word frivolous several times. I 
think there is nothing more frivolous that I can think of than 
any assertion that anyone believes in frivolous lawsuits. I 
mean, obviously that is not the case in general, but, Mr. 
Quaid, I understand you have done a number of things as a 
result of what happened to your twins. You have spoken out 
publicly, obviously made statements on that. You have created a 
foundation and you filed a lawsuit on that.
    Why are you suing Baxter, Mr. Quaid? Is it all about the 
money? Is it frivolous?
    Mr. Quaid. Yes, sir. Also, to answer Mr. Souder as far as 
the makeup of the panel, I, myself, have considered myself to 
be a Republican most of my life, but I am on the other side of 
this issue.
    Mr. Tierney. That may not be conservative enough for Mr. 
Souder. You may want to talk about that.
    Mr. Quaid. But we are pursuing Baxter because Baxter, like 
I said before, this was a chain of events in human error, and 
part of that human error was in the design and labeling of the 
bottle and the label of this Heparin. Even after the 
Indianapolis incident where three infants were killed and three 
others were severely injured, Baxter did send out a warning. 
They eventually, although not in a timely manner, changed the 
label of the bottle of Heparin, but 13 months after the fact. 
But they failed to recall the existing bottles that were 
already out there and that had already been proven to be 
dangerous and possibly lethal and almost were to my 12-day-old 
newborn twins.
    So we are going to the source, starting at the source, and 
that is why we are suing Baxter, sir.
    Mr. Tierney. Again, I thank all the witnesses for their 
testimony; Mr. Quaid, you for bringing your family's situation 
to a good cause. We are trying to get a resolution on that.
    I yield back, Mr. Chairman.
    Chairman Waxman. Thank you, Mr. Tierney.
    Mr. McHenry.
    Mr. McHenry. Thank you, Mr. Chairman.
    Mr. Quaid, I appreciate your being here. I know it is 
taking time out of your personal schedule, but it shows your 
commitment to the issue at hand. I certainly appreciate that.
    I think, regardless of where we stand on State preemption, 
your story is a very moving one, and I appreciate your taking 
your awareness. The American people know you. We all feel like 
we know you and your family to some degree, and so I appreciate 
your actually taking that for a proactive approach to something 
you feel very sincerely about, so thank you.
    Mr. Quaid. Thank you, sir. When the twins were in the 
hospital and they finally made it to the 41-hour period where 
their blood was basically turned to the consistency of water, 
and severely bruised and bleeding out of every place they had 
been poked or prodded, and they had made it, it made me feel 
that they had survived for a reason. First off, I really thank 
God that they had pulled through, but they had survived for a 
reason, that they were maybe going to change the world in a 
little way that might wind up saving more lives.
    We were lucky. Our twins survived. Those people in 
Indianapolis were not so lucky. I believe if preemption is 
allowed to prevail, it will basically make all of us, the 
public, uninformed and uncompensated lab rats.
    Mr. McHenry. Is a part of what you are advocating an 
awareness about medical errors, too, because in hearing your 
story certainly there is a component on legal action?
    Mr. Quaid. Yes, sir. It is not the issue that is before us 
today, but really we want to concentrate on one thing at a time 
in our foundation, and part of that is bringing some sort of 
recordkeeping and checks and balances and backups into the 21st 
century in medical care, and part of that would include bar 
coding in bedside and in pharmacies and in recordkeeping in 
hospitals by someone who is hospitals, sir, where by someone 
who is administering medicine to a patient when they are in the 
room, they could basically scan the bracelet of the patient, 
scan the medicine, itself, scan in their own i.d. tag, and 
there would be a record and there would be a warning if the 
wrong medication was being administered.
    There is resistance to this because a lot of people say it 
is way too expensive, especially people in the hospitals and 
medical industry, but yet my question is: there is a bar code 
reader in every checkout stand in every supermarket in America; 
why can't there be one in hospitals?
    Mr. McHenry. And so part of that is technology and making 
sure medical records are digitized and really in keeping with 
our society?
    Mr. Quaid. Yes, sir. There was a study done not too long 
ago where it was shown that, because a lot of times the doctors 
scribble down prescriptions that are sent to the pharmacy, and 
by using the bar code system and computerized technology they 
lowered the mistakes of pharmaceutical mistakes by more than 98 
percent.
    Mr. McHenry. Because I think beyond this issue I think 
medical errors and making sure hospitals and the medical 
industry updates in terms of technology, I think a lot of us 
can work together.
    Mr. Quaid. This is doable.
    Mr. McHenry. Yes.
    Mr. Quaid. This is something that would actually wind up 
saving the American public money. This is something that 
eventually I think the insurance companies, themselves, would 
welcome because it would lower their liability, because fewer 
mistakes would be made.
    I relate it to the airline industry, one of our safest. Why 
is it so safe? It is because every time there is a crash the 
NTSB goes out and they find out the exact cause of that crash, 
and usually always whether it is design or pilot or whether--it 
comes down to human error somewhere along the way, and they 
minimize the impact of human error in aviation to where it is 
the safest form of travel today.
    But if you relate it to what is going on with how many 
patients die needlessly every year because of medical mistakes, 
it is 100,000 patients. That is the equivalent of one major 
airline crash a day every single day of every year. Because it 
happens over such a broad, disconnected area, the public isn't 
really aware of it, but it is something that if people were 
really aware of we would not tolerate.
    Mr. McHenry. Thank you, sir.
    Mr. Quaid. Thank you.
    Chairman Waxman. Thank you very much, Mr. McHenry.
    Mr. Burton.
    Mr. Burton. Thank you, Mr. Chairman.
    In Indianapolis six children were injured at Methodist 
Hospital after receiving an adult dose of the blood thinner 
Heparin on September 15, 2006. That is correct, isn't it, 
September 15, 2006?
    [No audible response.]
    Mr. Burton. Well, I have already checked. It is.
    The new Baxter Pharmaceutical label was introduced in 
October 2007, which was 13 months later, and in November 2007 
your twins received the wrong dose at Cedars-Sinai Hospital?
    Mr. Quaid. Yes, sir.
    Mr. Burton. My question is I can't understand if anybody 
reads the newspapers, because the tragedy that took place in 
Indianapolis was all over the country in the newspapers and it 
seems to me that the FDA and Baxter Pharmaceuticals would have 
known immediately that this problem existed and they wouldn't 
have waited around from September 15, 2006 to October 2007 to 
start taking any action, and the action that was taken in 
October 2007 really wasn't known about when your twins were 
hurt in November.
    So this idea that people weren't informed and that is why 
this tragedy occurred with your twins just doesn't make any 
sense to me because it was publicized all over the country.
    If I were talking to the FDA right now I would like to ask 
them, don't you have some kind of a part of your agency that 
reviews these kinds of cases that are publicized in the 
newspapers, and if it does take place don't you act 
immediately?
    And I would also like to say if the pharmaceutical company 
has a product where someone is injured, I am sure they know 
about it right away, and it seems to me logically that they 
would want to move as soon as possible to preempt any further 
problems like that occurring.
    I can't understand why it was 14 months between the 
Indianapolis case and your case and nothing was done. I just 
don't understand it. That is not a question, it is just a 
statement.
    Mr. Quaid. Well, myself as a part of the general public, I 
have a lot more knowledge now than I did before. I wasn't aware 
of the Indianapolis case, myself. I am sure Baxter 
Pharmaceutical was aware of it.
    Mr. Burton. Mr. Quaid, I am sure you weren't, but the FDA 
was or should have been, and the pharmaceutical company I am 
sure was, because it was their product. That is the point I am 
trying to make. Action should have been taken much quicker, 
which would have preempted the problem which you faced.
    I would like to say this to Mr. Chairman. Mr. Chairman, we 
have been working for years to try to make the Vaccine Injury 
Compensation Fund more user friendly. We have about $3 billion 
in that fund. You were one of the authors of that, as I recall. 
I would like to work with you to make that more user friendly 
and maybe to expand it to take in cases that may occur similar 
to this one.
    I know you have legislation you are going to be introducing 
that would make tort reform changes, but the Vaccine Injury 
Compensation Fund, if it was properly handled and we expanded 
it to deal with these kinds of problems, would protect the 
pharmaceutical industry and yet still give people like Mr. 
Quaid recourse. I think that is extremely important. We are not 
doing that right now and we could legislatively.
    I am very sympathetic to your problem. It is 
incomprehensible to me that this kind of thing could occur in 
Indianapolis, in my area--I represent part of Indianapolis--and 
it was reported widely, and the FDA and the pharmaceutical 
company had to know about it, and no action was taken for 13 
months, and 14 months later your children were injured.
    I think that we need to hold them accountable for their 
inaction, but also, in order to protection the pharmaceutical 
industry so they aren't hit with thousands of lawsuits, we need 
to come up with an answer like the Vaccine Injury Compensation 
Fund which could take care of this kind of problem without 
going through the courts.
    With that, thank you very much.
    Mr. Quaid. Thank you, sir.
    Chairman Waxman. Some of our Members have responded to a 
vote that is pending on the House floor. We will take a short 
recess, probably around 10 minutes or so, and then we will 
reconvene so other Members may have their chance to ask 
questions.
    We stand in recess.
    [Recess.]
    Chairman Waxman. We would like to reconvene the committee 
hearing. We have the Members but we don't have all of the 
witnesses for the first panel, but I think they are going to be 
joining us now.
    Mr. Sarbanes, I would like to recognize you now for 
questions.
    Mr. Sarbanes. Thank you, Mr. Chairman. I do have some 
questions.
    Mr. Sarbanes. Ms. Schmitz has taken particular interest in 
this hearing because her own mother passed away in February 
2006 from an adverse reaction to a medical device. She was a 
healthy, active 74-year-old woman who went in for routine 
surgery, and tragically her surgeon used a medical device that 
the FDA's own data base revealed had been subject to several 
complaints. Unfortunately, that information never came to 
light. The manufacturer was never required to change its 
labeling of the device. If that had happened, Ms. Schmitz' 
mother would be alive today.
    Now, with the FDA's preemption of lawsuits regarding 
medical devices, Ms. Schmitz has no legal remedy at her 
disposal.
    This, Mr. Chairman, is another illustration of the need for 
Congress to act on this critical issue.
    Dr. Kesselheim, I wanted to ask you a few questions that 
relate to the importance of litigation, which, after all, is 
simply an individual or family's recourse when they have 
suffered a tragedy in many instances, the importance of that in 
terms of bringing information forward, when often the focus is 
on the damage end of the equation, and that is where we have a 
lot of the rhetoric that goes around, but in the process of 
these lawsuits moving forward there is a lot of very valuable 
information that does come to light.
    There have been some recent publications revealing safety 
problems with Vioxx for patients who suffer dementia. Your 
testimony I think indicated that the manufacturer delayed 
communication and known risks to the FDA and minimized those 
risks in its communication. How exactly did that happen? How 
did they sort of minimize that?
    Dr. Kesselheim. So what the litigation does in a number of 
circumstances is it brings to light both information that the 
manufacturer had kept internally and also brings to light the 
manufacturer's practices and the way that they address safety 
concerns, so it brings information to light in a number of 
different ways that can help affect both knowledge about drugs 
and knowledge about the proper use of drugs.
    In the specific case of Vioxx that I referred to earlier, 
the manufacturer had conducted a number of studies in using 
Vioxx in patients with cognitive impairment and had found in 
two different studies an increased rate of mortality in the 
Vioxx arm as compared to the placebo arm, and what they did was 
they chose a statistical method regarding the interpretation of 
the safety data that purposefully or, in the best case 
scenario, just improperly helped mask the risk that those 
studies resulted in when they presented that data initially to 
the FDA.
    FDA regulators in one case did pick up on the possibility 
that there might have been an increased mortality risk and 
directly queried the manufacturer about whether or not they 
should continue one of the studies on ethical grounds, and the 
manufacturer dismissed the FDA's concerns as simple chance 
fluctuations, when, as we found out later in the litigation, 
the manufacturer was internally very concerned about these 
safety risks and had done its own calculations indicating that 
they were legitimate.
    Mr. Sarbanes. So basically the manufacturer was able to 
present the data or manipulate the presentation of the data in 
a way that made it difficult to discern what some of the risks 
were. I gather FDA tried to piece some of that together. But it 
sounds like without the litigation that was involved we 
wouldn't have gotten a full picture of what the risk was.
    Dr. Kesselheim. I think that is correct, and I would just 
add that it isn't necessarily that the manufacturer's actions 
in this case rise to the level of fraud. These are just 
decisions that the manufacturer made in how to interpret and 
how to present risk. That may not rise to the level of fraud, 
and therefore would be preempted.
    Mr. Sarbanes. It is interesting because Mr. Quaid talked 
about bringing checks and balances into the hospital, but if 
you think about it, litigation is really a check and balance, 
itself, in its ability to bring to the surface information, two 
kinds of information, Mr. Chairman, and then I will stop 
because I know my time is out.
    There are two kinds of information that the litigation can 
help to surface. One is information that maybe folks know about 
but they are hiding, and that is an important result. But the 
other, frankly, is information that maybe nobody has yet 
realized is important, because in a particular case the facts 
of a particular case might be such that you would only see it 
in that instance, and so it is critical to bring that forward 
in the litigation context in order to promote safety going 
forward.
    Thank you, Mr. Chairman.
    Chairman Waxman. Thank you, Mr. Sarbanes.
    Mr. Issa.
    Mr. Issa. Thank you, Mr. Chairman.
    Mr. Chairman, I would ask unanimous consent to have a 
number of items, we have already given them to your staff and 
they have read them, included in the record, particularly one 
from the Manhattan Institute on Policy Research, and another 
one, a letter to Mr. Conyers from Leader Boehner.
    Chairman Waxman. Without objection, those will be made part 
of the record.
    [The information referred to follows:]

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    Mr. Issa. Thank you, Mr. Chairman.
    Dr. Kessler, I guess I will begin with you. Fairly 
straightforward. You have had a very long career at the FDA. 
This drug has been on the market since most people in the room 
hadn't been born. This basically goes back, I understand, to 
the 1950's.
    Dr. Kessler. This drug?
    Mr. Issa. Heparin.
    Dr. Kessler. Sure.
    Mr. Issa. If I believe what one side has given me, there 
has been somewhere north of 70 million uses, one confusion. 
When you became aware of that, when you were still at the FDA, 
would you have sponsored an immediate recall, since that was 
reported in a timely fashion within the 15-day rule?
    Dr. Kessler. Under the drug----
    Mr. Issa. I apologize. I just want to know your personal. 
You are no longer in that position. I really just want to know 
would you have recalled all the Heparin based on that event?
    Dr. Kessler. I don't believe I would have had the 
authority----
    Mr. Issa. No, no.
    Dr. Kessler [continuing]. Under the law.
    Mr. Issa. I am going to make you the chairman and CEO of 
Baxter. Would you have recalled it all based on that one event?
    Dr. Kessler. Again, the experience I have had is at FDA. 
You would have to give me a little more information and the 
context.
    Mr. Issa. Exactly what occurred. Three innocent children 
died, three more were severely hurt using a drug based on a 
misapplication of two different drugs at a hospital before Mr. 
Quaid's children suffered the same.
    Dr. Kessler. So if you made me CEO of Baxter and there were 
three deaths, and the labels looked like they look like on the 
screen, I would want those changed. I would want to make sure 
that no other nurses or doctors were put in that position.
    Mr. Issa. And I appreciate that, because they did just 
that. They began the process of making changes in labels. I 
asked you would you immediately recall and lead potentially to 
a shortage, immediately recall all these drugs.
    Dr. Kessler. Three deaths? I would certainly give it very 
serious consideration.
    Mr. Issa. When you were at the FDA did you ever recommend a 
recall based on products which were not defective but, in fact, 
if not read, could be misunderstood as to the two distinctly 
different drugs?
    Dr. Kessler. FDA doesn't have the authority, Congressman, 
to recall drugs.
    Mr. Issa. OK. I am going to make a small statement, which 
is I don't believe you would if you had the authority. I think 
when you look at decades of the use of this drug, the two 
different doses, and the fact that you would have to do every 
drug which had a similar label but different doses, if you were 
to do that, that you would have said that is Congress' 
authority or that is something which we could research. I don't 
think, in 15 or 30 or even 180 days, you would have recalled 
it.
    The reason I am bringing this up is that this is an 
important hearing. People died, and people die every day. More 
people die in hospitals, based on these kinds of mistakes, than 
die in car accidents, as you are well aware. They did that 
before you came to your office and they continued to do it 
after you leave this office. Mr. Sarbanes even noted one. 
People die in hospitals of the mistakes in hospitals very, very 
often, don't they?
    Dr. Kessler. People die in hospitals.
    Mr. Issa. OK. And this was a mistake to have this drug in 
the pediatric ward to begin with, wasn't it?
    Dr. Kessler. I don't know the answer.
    Mr. Issa. OK. Do either of the doctors know?
    Mr. Quaid. Sir, I can answer that question.
    Mr. Issa. OK. Just one more thing, and then I really would 
like to ask you. Do any of the doctors know? Is there a valid, 
common use of the full-strength drug in a pediatric ward?
    Mr. Quaid. Yes, sir.
    Mr. Issa. Yes, Mr. Quaid?
    Mr. Quaid. In a pediatric ward you are going to have 
children from infants all the way up to 18 years of age who are 
adult size, and those minors would take an adult dose, which is 
much more.
    Mr. Issa. Good. Well let me ask you a question, Mr. Quaid. 
And I am very sorry for what has happened to Zoe and Thomas. 
You came here because you want to make a change. Everyone on 
the dias, certainly myself, came here because we want to make 
changes. Is the change you want to make, separate from a 
lawsuit, is the change you want to make to get overall better 
labeling, clearer, and, with all due respect, places like 
Cedars-Sinai to use the bar coding that was already on this 
drug so as to prevent this mistake even if the person tries to 
carelessly read?
    I looked at both the bottles. They are both bar coded. I 
think you have probably long since over-studied this more than 
I have.
    Mr. Quaid. Yes, sir. I would like to see bar coding and all 
of that, what you just mentioned I would like to see changes 
in. But the real reason that I am here today is not because of 
our foundation or because of that issue, which is a separate 
issue which we are going to continue on with, but I am here 
today because of the preemption law that is coming up before 
the Supreme Court, which I believe in the end will be, if it 
goes through in favor of the drug companies, there will be less 
motivation to change certain problems that arise with drugs and 
their applications in the after-market process. That is why I 
am here today.
    Chairman Waxman. Thank you, Mr. Issa.
    Mr. Issa. Thank you. Thank you for being here.
    Chairman Waxman. Ms. Watson.
    Ms. Watson. I want to thank all the witnesses, and 
particularly you, Mr. Quaid, for coming today and putting a 
real face on what the dangers are of the kinds of labeling and 
the fact that we don't have enough people in the FDA to really 
followup and responsibilities of the manufacturers.
    It is very important that we, as policymakers, understand 
and thoroughly review so we can hold whichever the responsible 
parties are accountable so that we will protect the health and 
safety of the public.
    Thank you for being here, all of the witnesses, and your 
patience.
    I would like to deal with Vioxx, which was a product that 
all of you are aware of, was finally recalled, and a product 
that was highly advertised on television. You know, most people 
get their information today from television. That is why the 
ads are so frequent, because that is the way of giving the 
public their information.
    So, Dr. Kesselheim, I would like to talk about the 
importance of litigation in bringing information about drug 
safety to light. Recent publications have revealed safety 
problems with the drug Vioxx for patients with dementia. 
According to your testimony, the manufacturer delayed 
communications of known risk to the FDA and minimized those 
risks in its communication. So, Dr. Kesselheim, how did it do 
this? And can you respond, and then I will followup.
    Dr. Kesselheim. Sure. As I indicated in more detail in my 
written testimony, the manufacturer selected certain 
statistical tests that have been shown to mask the types of 
outcomes and the adverse events that were showing up in the 
trials of Vioxx in patients with cognitive disability, and by 
choosing those statistical tests in its presentation to the FDA 
led the risks of the drug to be under-estimated by the FDA 
regulators who would then read that report.
    Ms. Watson. All right. And what did the FDA do? Did they 
pick up on the risk?
    Dr. Kesselheim. The FDA did, at the end of 2001, send a 
note to the manufacturer asking them about the possibility that 
there were increased cardiovascular adverse events in one of 
the trials, and the manufacturer dismissed the FDA's qualms, 
calling the results chance fluctuations, when, in fact, the 
manufacturer, as the litigation files show, was internally 
concerned about these problems and had performed its own 
analyses suggesting that these were not simply chance 
fluctuations.
    In addition, the manufacturer had a whole separate second 
study. You know, in science when a result appears in a test and 
it might be a result of chance fluctuations, the normal course 
of action is to conduct a second test to evaluate it, and the 
manufacturer already had in front of them a second whole trial 
that showed the same results, an increased hazard ratio for 
cardiovascular adverse events of upwards of two to four times 
normal.
    Ms. Watson. Now, would this information come to light 
without litigation?
    Dr. Kesselheim. Well, ultimately 2 years later the 
manufacturer submitted to the FDA the full reports of the test, 
including the proper statistical tests, but that was 2 years 
later and very close to the removal of Vioxx from the market.
    Ms. Watson. Yes.
    Dr. Kesselheim. So the role of litigation after the fact 
was sort of to show both improper decisionmaking on behalf of 
the manufacturer and to reveal to the FDA the need to be more 
concerned in future instances when these sorts of cases occur. 
They need to be more vigilant and potentially try to dig 
deeper.
    Again, as we have heard from Dr. Kessler, the resources of 
the FDA in many circumstances, try as hard as they might, may 
be limited in terms of both their authority to require 
different statistical testing be done or different analysis to 
be done or to punish the manufacturers if they don't respond to 
the FDA's requests.
    Chairman Waxman. Thank you, Ms. Watson. Time has expired.
    Mr. Bilbray.
    Mr. Bilbray. Thank you, Mr. Chairman.
    You know, Mr. Quaid, this hearing is kind of tough for some 
of us, but your experience just brings back a lot of memories 
to me. With your two twins less than a year old, I am sure 
every time you go home and are able to pick up that baby, one 
of them or both of them, you will never take it for granted 
again.
    David, have you been able to talk to your staff about the 
Bendectin issue?
    Dr. Kessler. Bendectin was before my time, Congressman.
    Mr. Bilbray. I know. You are all so young, it is all before 
your time. I only point out here that there is a cost here not 
just in dollars and cents, but there is a cost here in lives we 
are talking about. The Bendectin during the 1970's was 
available to consumers, right, and then there was a lot of 
litigation. As far as I remember, the FDA looked at it, looked 
at it, looked at it, and never removed it. Is that fair to say?
    Dr. Kessler. I wasn't there, Congressman, so you know a lot 
more about Bendectin than I.
    Mr. Bilbray. Well, in the 1990's, when you were there, you 
did not remove Bendectin from the market?
    Dr. Kessler. I didn't deal with Bendectin. No, I did not.
    Mr. Bilbray. And in only want to say this because what 
happened with Bendectin is something we have to be very careful 
of. It is like what has happened with the implant issue that 
required the Titus bill, a young man who desperately needed to 
have shunts to be able to live. Annie Eschew and I actually 
authored a bill to hold the manufacturers of products harmless, 
because what happened was the litigation was going after the 
manufacturer of the material, like Union Carbide, the plastic 
that went into the implant, and was going after deep pockets 
that basically were going to deny the manufacturers, that the 
people making the product wasn't going to be able to get the 
product to make the implant, and thus it was not going to be 
available for the consumers, and young man like Titus and kids 
would then be doomed because somehow litigation had deprived 
them of what they desperately needed.
    I will say this, Mr. Quaid, in my situation my wife was 
acutely reactive to pregnancy. She had morning sickness so bad 
that when she had her first child in the 1970's she almost 
died. They gave her Bendectin and she learned that was what she 
had to have. When it came back to the 1970's, the product was 
taken off the market, not because the FDA ever found that the 
product was defective, but because of litigation after 
litigation was going after deep pockets.
    Sadly, when my first boy was born, the product wasn't 
available to my wife. My wife almost died, and thank God there 
was a doctor who was willing to find old product to be able to 
give to my wife. That was one of those things that it is sad 
that, not because of science, but because of litigation and the 
deep pockets my wife almost died then.
    Now, there is no way for me to say there was a nexus, but 3 
months later the baby didn't wake up, and physicians feel that 
the trauma of the first trimester contributes severely to crib 
death. I cannot prove it, but I know in my heart that my child 
died because the proper product wasn't available because the 
science wasn't driving the issue, but the greed for money was.
    I will say, Mr. Quaid, I totally feel where you are. Thank 
God you didn't end up in our situation. But I just hope as we 
look at this that we understand, just as we address the 
litigation limitations for implants, that we do not think that 
trial lawyers in a courtroom is the best way to maintain 
quality health care.
    I just want to say to be careful here, because there are 
two ways to kill somebody: inappropriate treatment, and denial 
of treatment. I will go to my grave believing my child is dead 
because he was denied the product that he desperately needed in 
his first trimester because of litigation.
    Mr. Quaid, I will open it up for your comments. I know this 
is basically between you and me today.
    Mr. Quaid. I certainly feel for you, sir, of the tragedy 
that occurred to you. My feeling is, of course, science should 
drive the products that are out there and they should become 
available to the general public. But at the same time, the 
general public needs to be protected, because really, after 
market, with the public, it is basically ongoing clinical 
trials only its out there and the public are the ones who are 
conducting the trials.
    I would say to that I don't believe that drug companies are 
evil people, but I do believe that some check and balance needs 
to be in place to motivate the drug companies that changes come 
about in the after-market or before-market process, that would 
be harmful to people, that they needed to be identified and the 
public needs to be informed about it.
    And, just like what we have in our system of Government 
where we have checks and balances between the three parts of 
our Government--Congress and the courts and the Presidential--
there needs to be, I think, the tort system, and the State tort 
system serves as a check and balance for sometimes the 
businesses, the drug companies, because sometimes decisions are 
made for business expediency. There also could be a conflict of 
interest between public safety and business expediency.
    Mr. Bilbray. Thank you, Mr. Chairman.
    I just wanted to say that the conflict of interest exists 
in the tort system, too, even more so in my opinion.
    I come from a family of lawyers that have never made life 
and death decisions and never had that, but the fact is I would 
rather see our resources going to the FDA to front end to avoid 
the problem than to depend on courts and lawyers and lawyers 
and rogues to make the quality issue settle down. There has to 
be a more cost-effective way of doing that.
    Mr. Quaid. I agree with you, sir, but, as I mentioned also 
before, the FDA is largely funded by the drug companies in 
order to expedite their products to the market. That seems to 
me to be a conflict of interest.
    Chairman Waxman. The gentleman's time has expired.
    Mr. Bilbray. Thank you, Mr. Chairman.
    Chairman Waxman. I want to recognize Mr. Lynch.
    Mr. Lynch. Thank you, Mr. Chairman. I thank the ranking 
member, as well.
    I want to thank, first of all, the panelists who have come 
here to help us with our work. Mr. Quaid, I want to thank you 
for the power of your example. I also appreciate the comments 
of the gentleman, Mr. Bilbray, in bringing his own personal 
experience here, as well.
    I want to just make a couple of quick observations. A 
number of Members have made the point today that Mr. Quaid did 
not name the hospital involved here as a defendant in this 
case. I, for one, am thankful for that, and I appreciate the 
spirit in which it was done, but I do want to point out it is a 
simple procedure of cross-claim by which the drug company can 
bring the hospital in as a defendant, so it is not a simple 
case where the deep pocket is being targeted here. The deep 
pocket can bring all the possible and likely parties on the 
basis of either superseding liability or shared liability. So I 
do not ascribe any motive on the part of Mr. Quaid other than 
not wanting to bring the hospital in on this occasion.
    Second, I just want to make another observation, and that 
is one about power, power here in this Congress. This is really 
a hearing on whether or not this whole liability and tort 
process should be Federalized. I just want to remind all the 
Members not too long ago--well, first of all I read recently 
that there are more pharmaceutical company lobbyists on Capitol 
Hill than there are Members of Congress, and if there is any 
doubt about the power of the drug companies, pharmaceutical 
companies, one only needs to look back to the last Medicare 
reform bill.
    It seems to me unbelievable, but the pharmaceutical 
companies were able to get a provision put in the Medicare 
Reform Act that said that the Secretary of Health and Human 
Services shall not negotiate lower drug prices with the 
pharmaceutical companies. Now, that was a provision that 
benefited a very small number of people, the pharmaceutical 
companies, and acted to the detriment of every senior citizen, 
the 32 million people without health care, and it was clearly 
against the best interest of consumers, but that happened.
    So any attempt here to Federalize this process lays itself 
open to the same disparity in power, I believe, that opened up 
that example. That is one of my main fears.
    The last issue I would like to touch on--and I want to 
leave this for the doctors--there was an argument made earlier 
today from a gentleman in the minority who I have great respect 
for who argued that acts of willful negligence would not be 
preempted. We have talked here at length this morning about the 
incentives for causing drug companies and these device 
companies to exercise the proper duty of care.
    Now, I just want to remind people we are talking about drug 
companies and people who manufacture medical devices. Their 
customer is almost always compromised health-wise. These people 
are either afflicted with a disease that requires them to need 
this drug, or, as in the case of Mr. Quaid, his two young 
children were unable to protect themselves, were unable to 
complain, and so in my opinion the drug companies and the 
device manufacturers have a tremendous duty of care here 
because of the people that they are treating and the quality of 
what they are providing.
    These drugs are going to be ingested or administered to 
people who are in a compromised position.
    I want to ask the doctors: is willful negligence where we 
want to set the bar here? In other words, the only time it 
won't be preempted is if the plaintiff's attorney can prove, 
which is very difficult, that the drug company acted or the 
defendant acted with willful negligence, they did it basically 
on purpose. That is New York Times v. Sullivan. That is just a 
very hard standard to meet.
    I just want to ask the doctors: is that where we are at 
here? Is this where we want to set the bar for incentives of 
providing safe products to consumers in America? Please?
    Dr. Kessler. I think the responsibilities of manufacturers 
do not end with the approval of their medical device. In fact, 
I think it would be much easier to argue that is really where 
they begin.
    There are a number of requirements that the FDA puts on 
manufacturers when their device or drug is approved, and I will 
talk about devices as a specific example, but post-approval 
studies, for example, oftentimes when a device is approved we 
don't know how it is going to behave in people over many years, 
and the FDA, recognizing that, requires manufacturers to 
complete studies.
    Well, if you go back and look at how many manufacturers 
actually complete the studies that they were ``required'' to 
complete, more than 20 percent of those studies aren't 
completed. At least that is data from 1998 to 2000. So is that 
willful neglect? Is that bad management at the company? I think 
there are a lot of factors that go into what causes a company 
not to meet the requirements that are expected of them or that 
are put on them by the FDA.
    I think other neglect, if you will, can be much more subtle 
than that. In the Guidant case that we talked about earlier 
with the implantable defibrillators, the independent analysis 
demonstrated that the company relied on product performance 
engineers to recognize safety issues within the company and the 
product line of implantable defibrillators. Well, during this 
period of time, at times only one of three positions were 
actually staffed, so they were under-staffed. Is that willful 
neglect? Is that bad management? I think it is a very murky 
line that we are trying to paint.
    Chairman Waxman. Thank you, Mr. Lynch.
    Mr. Shays.
    Mr. Shays. Thank you, Mr. Chairman, for holding this 
hearing.
    I used to chair the subcommittee, we had a Health 
Subcommittee. Dr. Kessler, you came before my subcommittee on 
many occasions, and I was taught not to like FDA 
Administrators, but I thought you did a really fine job and I 
thought you were always a very candid and helpful witness. So I 
appreciate your service with the FDA. Obviously, your 
participation here has particular import, even though you are 
not longer with the FDA.
    Mr. Quaid, let me say, as well, I can't imagine anything 
worse than seeing your children suffer, and then to think that 
they are suffering because of a mistake. I always appreciate 
people who have gone through this kind of experience to not let 
it die but to learn from it and try to be helpful.
    But I actually don't know where I come down on this issue, 
because it is almost to me like everything is on its head. 
Republicans are taking the absolute opposite view that they 
usually take, and the Democrats seem to be taking the exact 
opposite view they take. I mean, we are usually not for the 
central Government and the FDA, and usually my chairman and 
others have argued very strongly for the FDA and the role it 
plays.
    And then I will just say I wonder, in a trial with a jury 
of people that aren't experts, they say how should they have a 
role, but honestly, when I look at this, I say, you know, why 
in the world did they look so much alike. So I don't have to be 
a doctor, I don't have to be a researcher. I can apply my own 
logic and say this is pretty dumb, this here.
    But then again I think it could be dumb for there to be 
lots of different requirements in lots of different States. I 
think uniformity matters.
    So I wonder, and I will ask you, Dr. Kessler, to start. 
Kansas City, MO, Kansas City, KS, St. Louis, MO, St. Louis, IL; 
Washington, DC, and the metropolitan area of D.C., Virginia, 
Maryland. So you live in Virginia and your doctor is in D.C. 
How does the doctor prescribe the drug? I mean, how does that 
function? Let's say you have three different requirements in 
those three different locations, or at least two. Tell me how 
it works.
    Dr. Kessler. Congressman, I have been licensed in New York, 
Connecticut, Maryland, California----
    Mr. Shays. And all different requirements?
    Dr. Kessler. But I have not acted differently as a 
physician.
    Mr. Shays. Right.
    Dr. Kessler. I have been trained----
    Mr. Shays. But what I am wondering is, Does the 
manufacturer, if in one jurisdiction, Virginia, a trial of 
laymen determine that there needs to be a change, will the 
manufacturer make that change nationwide because they now 
expose themselves? So in essence would there be uniformity 
because in essence wherever you had a jury you just add to the 
label?
    Dr. Kessler. I think my colleague, David Vladeck, and I 
deal with that issue, because that is one of the arguments that 
are being used----
    Mr. Shays. Tell me the answer. I only have 5 minutes.
    Dr. Kessler [continuing]. For preemption. No, it doesn't. A 
jury's finding doesn't require that the label be changed; a 
jury's finding only deals with compensation for the individual.
    Mr. Shays. But in effect, though, they have been found 
guilty because they didn't warn, so in effect it would strike 
me that then they are going to have to put that label in every 
State.
    Dr. Kessler. Not necessarily.
    Mr. Shays. Well, it doesn't seem logical to me because they 
could be sued again.
    Dr. Kessler. They could look at the jury's finding. They 
can ask the FDA to opine, and if the FDA says, Boy, that is a 
stupid thing. We don't see that association. If I were the 
company, just because a jury does it----
    Mr. Shays. Let me ask you another question, and this gets 
to something that we have dealt with a lot with autism. The lay 
folks, me included, think that the immunizations have had an 
impact on autism. The medical community seems to disagree. If 
there was a court determination that it did, in fact, have an 
impact, what would be the impact on the supplier of these 
various drugs? And how would the FDA respond to that?
    Dr. Kessler. In general, Congressman, this is about 
information. If information comes to light in that trial, I 
would argue----
    Mr. Shays. But we may not have expertise.
    Dr. Kessler [continuing]. The FDA should look at that 
information and be able to bring the best science to bear on 
that information and be able to help answer the scientific 
issues that arise from that information that comes out at that 
trial.
    Mr. Shays. What I wrestle with, whether you win me over or 
not, is this: I am not sure that a trial of laymen, a jury of 
laymen, have the capability to decide whether immunizations 
have, in fact, caused autism, but they may make that decision 
in a court. The implication would be that somehow it would have 
a tremendous implication on the manufacturer and the labeling 
and so on.
    Dr. Kessler. This is a very important point.
    Chairman Waxman. Mr. Shays' time has expired, but if you 
want to answer that point.
    Dr. Kessler. It is a very important point that you raise, 
but it is important for the record to understand that jury, 
that trial is not a requirement and doesn't require that label 
to be changed. If you look at the Supreme Court in Bates v. Dow 
Agra Science, they say that a requirement is a rule of law that 
must be obeyed, and that is not the case with a jury verdict.
    If there is information that comes out of that trial--and I 
have been in that situation--I at FDA would want to be able to 
look at that and evaluate that, but it is FDA that has the 
ability to require what goes on the labels.
    Chairman Waxman. It is the science and not the jury's 
opinion that will dictate what will happen at FDA; is that 
correct?
    Dr. Kessler. As far as the requirement, yes, Mr. Chairman.
    Chairman Waxman. Thank you. Thank you, Mr. Shays.
    Ms. Norton, did you have questions?
    Ms. Norton. Not at this time.
    Chairman Waxman. OK. Well, that completes the questioning 
for this panel. You have been terrific and very patient, and I 
think it has been very helpful for Members as they think 
through this whole question and we look at this very important 
public policy discussion. Thank you so much for being here.
    For our second panel the Chair would like to call forward 
David Vladeck, professor of law and co-director for the 
Institute for Public Representation at Georgetown University 
Law Center. He also serves as the director of the Center on 
Health Regulation and Governance of the O'Neill Institute for 
National and Global Health Law. He will be providing an 
overview of the current legal landscape of preemption in the 
context of FDA-approved drugs and medical devices, as well as 
implications for the future.
    Dr. Gregory Curfman is an internal medicine physician, 
currently the executive editor of the New England Journal of 
Medicine. Dr. Curfman will be providing testimony regarding his 
views on the effect of preemption on the safety of FDA-approved 
drugs and medical devices.
    Christine Ruther is a biomedical engineer and the president 
and chief engineer of C&R Engineering, Inc. She will be 
testifying today regarding her views on the impact of 
preemption in medical device and product liability cases.
    Representative David Clark has served in the Utah State 
House of Representatives since 2001 and is currently a member 
of the National Conference of State Legislatures Executive 
Committee. As a State legislator he will be sharing his views 
on the impact of preemption on State interests.
    Dr. John E. Calfee is a resident scholar for the American 
Enterprise Institute for Public Policy Research, where he 
studies pharmaceuticals, the FDA, health care policy, 
advertising, the tort liability system, and tobacco. He will be 
testifying on his views regarding the preemption in the context 
of FDA-approved drugs and medical devices.
    Thank you all for being here. We are pleased that you have 
been willing to come and share your views on this subject with 
us.
    Your prepared statements will be in the record in full. 
What we would like to ask you to do is to, as you noticed with 
the previous panel, try to stay within the 5-minutes for the 
oral presentation.
    It is the policy of this committee that all witnesses that 
testify before us do so under oath, so if you would please 
stand and raise your right hands I would like to administer the 
oath.
    [Witnesses sworn.]
    Chairman Waxman. The record will indicate that each of the 
witnesses answered in the affirmative.
    Mr. Vladeck, let's start with you.

STATEMENTS OF DAVID VLADECK, J.D., PROFESSOR OF LAW, GEORGETOWN 
   UNIVERSITY LAW CENTER; GREGORY CURFMAN, M.D., EDITOR, NEW 
ENGLAND JOURNAL OF MEDICINE, ACCOMPANIED BY STEPHEN MORRISSEY, 
    M.D., MANAGING EDITOR, NEW ENGLAND JOURNAL OF MEDICINE; 
      CHRISTINE RUTHER, PRESIDENT AND CHIEF ENGINEER, C&R 
 ENGINEERING, INC.; STATE REPRESENTATIVE DAVID CLARK, NATIONAL 
 CONFERENCE OF STATE LEGISLATURES; AND JOHN E. CALFEE, PH.D., 
                 AMERICAN ENTERPRISE INSTITUTE

                   STATEMENT OF DAVID VLADECK

    Mr. Vladeck. Thank you, Mr. Chairman, members of the 
committee. I want to thank you for inviting me here today to 
present my views on FDA preemption.
    My view is this: FDA's new position on preemption, namely 
that the regulation of drugs and medical devices broadly 
displaces State liability law, is wrong both as a matter of law 
and a matter of policy. If accepted, it gives consumers the 
worst of both possible worlds.
    Why? First, preemption undermines safety. Experience has 
shown that, despite the FDA's claims to the contrary, the FDA 
alone cannot be counted on to keep dangerous drugs and devices 
off the market or to correct errors or mistakes once devices 
and drugs get on the market.
    Drug companies and device companies must do their part. 
They, too, must be kept accountable for their acts. Giving drug 
manufacturers and device manufacturers immunity from liability 
weakens their economic incentives to protect the public.
    Second, preemption leaves injured parties with nothing, no 
compensation, no recompense for the injuries, no medical 
expenses, nothing.
    FDA's policy is not a good one and will undermine public 
health. Fortunately, the courts have made clear that the 
ultimate choice is not for the courts, it is not for the FDA, 
it is for Congress to make.
    So first I would like to urge Congress to work to reverse 
the Supreme Court's ruling in Riegel v. Medtronic. As I have 
explained elsewhere, the ruling in Riegel v. Medtronic is wrong 
as a matter of law, but what I would like to do for a moment is 
focus on the policy issues underlying Riegel.
    Riegel should be overturned because it deals a body blow to 
people like Joshua Oukrop, who we have heard about today. 
Joshua was 21 years old. He had a heart condition that could be 
treated with a defibrillator. His defibrillator failed him and 
he died.
    Now, the manufacturer of the defibrillator knew back in 
2002 that this particular device was prone to malfunctioning. 
It did not tell the doctors who installed the defibrillator 
into Joshua's chest. It did not, as far as we know, alert the 
FDA of the fact other than to bury it in an enormous 
submission. And so by the time Joshua died in March 2005, 25 
other malfunctions had been reported with this particular brand 
of defibrillator. Guidant had continued to sell those that it 
knew were prone to malfunction, even though it knew of the 
defect and even though it had developed a new and more 
effective model.
    Seven other deaths have been linked to this particular 
defibrillator. There were probably others. Other people were 
injured.
    This manufacturer was sued and settled after a court 
rejected its preemption defense.
    Now fast-forward to today. In the wake of Riegel, Guidant 
would be immunized for its errors, no matter how egregious, no 
matter how knowing, and no matter how lethal. Riegel takes away 
the manufacturers' incentive to protect the public by 
preventing or correcting errors as soon as they become 
manifest. And Riegel deprives people like Joshua and his family 
of any remedy at all. That just isn't right. That is not the 
way we do things in this country.
    Congress should act to restore the rights of people injured 
by dangerous and defective medical devices like Joshua Oukrop 
to bring State liability actions.
    Let me turn briefly to drug preemption. In my view the 
argument for drug preemption is just as weak if not weaker for 
medical devices. The Federal Government has regulated drugs for 
100 years, tracing back to the Bureau of Chemistry in 1908. For 
all of that time there has been concurrent Federal regulation 
of drugs and State liability actions. Indeed, State liability 
actions for failure to warn predate Federal regulation by at 
least 60 years. So there is nothing new about product liability 
litigation, there is no argument that for the last 100 years 
product liability litigation has stifled innovation. We have 
the most robust medical device and drug industry in the world.
    Nonetheless, in 2002 the FDA, which had previously 
supported and encouraged the existence of State liability, 
litigation, as a way of promoting the values the Food, Drug, 
and Cosmetic Act served, reversed field and has now taken the 
position that there ought to be broad preemption.
    Now, what has changed other than the change of 
administrations? As far as I can tell, nothing. There is simply 
no public health justification for this about-face, as the 
examples of Heparin indicate.
    I want to take one more minute, if I may, Mr. Chairman, to 
talk a little about the change of being affected regulations 
that the FDA has proposed, which would weaken the ability of 
drug manufacturers like Baxter to quickly change their labels. 
If the FDA changes that rule, what Baxter did in changing its 
label in October 2007 would be forbidden by the FDA rule 
because it would not have been based on any newly discovered 
evidence.
    If you look at the time line that you put up on the 
monitors earlier, Baxter asked the FDA, notified the FDA that 
it wanted to change its rule in August 2007. It went ahead and 
changed the label in October 2007. The FDA did not approve that 
labeling change until December.
    So under the new proposed rules, the FDA will inhibit the 
ability of drug manufacturers to respond promptly to serious, 
urgent public health needs by changing labels and doing other 
things to protect the public.
    Thank you.
    [The prepared statement of Mr. Vladeck follows:]

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    Chairman Waxman. Thank you very much, Mr. Vladeck.
    Dr. Curfman.

                  STATEMENT OF GREGORY CURFMAN

    Dr. Curfman. Thank you, Mr. Chairman, members of the 
committee. My name is Greg Curfman. I am the executive editor 
of the New England Journal of Medicine. I am here with my 
colleague, Dr. Stephen Morrissey, the managing editor, to 
provide testimony from our Journal. We will argue that 
preemption of common law tort actions against drug and medical 
device companies is ill advised and will result in less-safe 
medical products for the American people.
    For nearly 200 years the New England Journal of Medicine 
has published articles on new drugs and medical devices. Some 
have succeeded, but others have failed, in most cases owing to 
problems with safety. We have learned that approval of a new 
product by the FDA by no means guarantees its safety, and FDA 
approval is just one step in the assessment of long-term 
safety.
    Let me give some specific examples.
    Now, we have heard a lot about Vioxx today, and I want to 
tell you a little bit more about Vioxx, a drug used to treat 
arthritis pain which was approved by the FDA in 1998. In 2000 
we published in the Journal a clinical trial showing that Vioxx 
relieved pain while causing less gastrointestinal bleeding than 
traditional pain killers; however, we were disturbed by 
something that we learned later. What was not revealed in that 
article was that for each episode of serious gastrointestinal 
bleeding prevented by the use of Vioxx, one heart attack, 
stroke, or other serious cardiovascular problem was caused by 
Vioxx.
    The FDA was provided with the missing data after the 
article was submitted, but it was not until 2002 that the label 
for Vioxx was revised to reflect these cardiovascular risks and 
it was not until 2004, 6 years after the drug was approved by 
the FDA, and after millions of people had taken it, that it was 
finally removed from the market, in part owing to the mounting 
threat of product liability litigation.
    Another example is the diabetes drug Avandia, which after 8 
years on the market was shown in a New England Journal article 
to be associated with an increased risk of cardiovascular 
problems.
    And tonight, Mr. Chairman, at 5, we will publish a study on 
our Web site showing that Trasylol, a drug that has been used 
for 15 years to control bleeding after open heart surgery, 
results in an increased death rate in heart surgery patients--5 
tonight.
    What do we learn from these examples? First, together the 
drugs I have described have placed millions of Americans at 
risk, but those who have been harmed have had the right to seek 
legal redress. Preemption would erase that right.
    Second, drugs are approved by the FDA on the basis of 
short-term efficacy studies, not long-term safety studies.
    Third, and importantly, manufacturers may not immediately 
make public information indicating safety problems with their 
drugs.
    Fourth, the FDA is hampered by a lack of resources and may 
be slow in resolving drug safety concerns. I say that with a 
lot of respect for the good work of the FDA.
    If drug and device companies are shielded against tort 
actions by preemption, medical products will surely be less 
safe. The possibility of litigation is a strong inducement for 
companies to be especially diligent about the safety of their 
products. If they are immunized against product liability 
suits, they will surely be less vigilant.
    The purported benefit of making drugs and devices available 
quickly should not outweigh the possibility of redress for 
patients when safety flaws are discovered later.
    Patients injured by unsafe drugs and devices should not be 
stripped of their right to seek redress through due process of 
law. Preemption will seriously undermine the confidence that 
doctors and patients have in the safety of drugs and devices, 
and preemption will have a chilling affect on the doctor/
patient relationship, which is built on a foundation of trust.
    Mr. Chairman, members of the committee, we urge you and 
your colleagues to pass legislation that will eliminate the 
possibility of preemption of common law tort actions for drugs 
and medical devices. Removing the right of legal redress is not 
only unjust, but will also result in less-safe drugs and 
medical devices for the American people.
    Thank you, Mr. Chairman.
    [The prepared statement of Dr. Curfman follows:]

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    Chairman Waxman. Thank you very much, Dr. Curfman.
    Ms. Ruther.

                 STATEMENT OF CHRISTINE RUTHER

    Ms. Ruther. Thank you. My name is Christine Ruther, and I 
am a medical device engineer with over 15 years experience in 
testing and designing medical devices, and in compiling 
information for regulatory submissions such as those filed with 
the FDA.
    I am appearing today to speak as an engineer and as a 
Republican in support of legislation to ensure that all medical 
devices are subject to market forces, including the possibility 
of lawsuits by injured patients, which I believe is critical to 
help ensure the safety and effectiveness of those medical 
devices.
    I have two main reasons for this position.
    First, the FDA has a prescribed list of information that 
must be provided for pre-market review. In very general terms, 
we provide a description of the device and its intended use, as 
well as top level engineering documents. It is important to 
note that FDA does not directly test our products, so we also 
provide safety testing data, as well as clinical data, to the 
FDA.
    The FDA reviewers inspect the data, ask questions, and then 
make the decision on whether our device can be sold in the 
United States.
    I believe manufacturers are generally being truthful and 
are not necessarily trying to hide information, and I believe 
the FDA reviewers are diligent in their duties; however, not 
all manufacturers understand the level of care that should be 
taken in testing and other areas, and sometimes seemingly 
irrelevant data is omitted that would make a difference to 
FDA's review.
    An analogy may help. Let's say that I am in a State where I 
am required to show that my car is safe to drive. In other 
words, that it is roadworthy. I select a mechanic to review the 
engine while I inspect the body and the tires. I send these 
reports off to the States Car Division where an inspector 
reviews the paperwork. After writing to ask me additional 
questions, the inspector makes a decision without having 
personally inspected my car that my car is, in fact, safe to 
drive.
    The inspector relies completely not only on my integrity, 
but also on my ability to select a competent mechanic, my 
ability to evaluate my own tires, and to make other judgments. 
And it is possible that some key information that I deemed 
irrelevant and the inspector never asked for was omitted. For 
instance, if it doesn't bother me if I only take short drives, 
I may not mention that the car tends to stall after it has been 
running for about an hour.
    The review is an excellent first step, but even the most 
rigorous review does not ensure that my car is safe, and a 
rigorous FDA review, unfortunately, cannot fully ensure that a 
device is safe and effective.
    On a second point, as designers and manufacturers we are 
constantly balancing conflicting goals. Getting to market 
quickly and maximizing profit creates a tension with taking 
sufficient time to consider and test for possible risks, and, 
when necessary robustly addressing issues.
    After arising at a resolution for such a conflict, a 
colleague of mine will generally ask us to proceed that 
argument with, Ladies and gentleman of the jury. He is not 
asking us to determine if the choice is legally defensible, but 
rather he wants to make sure that we are comfortable publicly 
defending our choices.
    We often collect data that FDA does not ask for and 
therefore we do not submit. I believe that it is vitally 
important to keep the possibility of public disclosure of all 
data and our decisionmaking processes, especially with regards 
to risk and remediation, in front of those of us who design and 
manufacture medical devices.
    The concept of preemption can cause a fundamental shift in 
the risk/benefit equation. We go from, Ladies and gentlemen of 
the jury, to potentially, What is the minimum the FDA will 
accept? And if we no longer need to consider the ladies and 
gentlemen of the jury, do we then diminish the regulatory 
manager's argument for testing beyond the FDA requirements to 
ensure that we really are selling a great product? Does 
Dilbert's pointy-haired boss see preemption as a get-out-of-
jail-free card and as a license to push for the minimum?
    Finally, the reality is that, despite the very best efforts 
of designers, manufacturers, and the FDA, not all device 
problems are identified in pre-market testing. The potential 
for being held liability is a key force in assuring the most 
conscientious testing and the prompt correction of hazards when 
they are identified.
    I hope this information allows you to better weigh the 
advantages and disadvantages of any proposed legislation, and I 
will remain at your disposal to answer any questions.
    Thank you.
    [The prepared statement of Ms. Ruther follows:]

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    Chairman Waxman. Thank you very much, Ms. Ruther.
    Mr. Clark.

                    STATEMENT OF DAVID CLARK

    Mr. Clark. Thank you. Good afternoon. I am Utah House 
Majority Leader David Clark and Chair of the National 
Conference of State Legislators Standing Committee. The 
standing committees of NCSL are the policymaking entities of 
that organization. I am grateful to Chairman Waxman, Ranking 
Member Davis, and other members of the House Oversight and 
Government Reform Committee for inviting me here to speak to 
you about the impact of regulatory preemption on States.
    From NCSL's vantage point and that of the States, Federal 
agencies have taken inappropriate liberties with the regulatory 
process. The preemptive regulatory actions of the Federal 
agencies have been steadily on the rise over the past several 
years and show no signs whatsoever of decreasing.
    There are many troubling aspects of this trend for States.
    First, unlike State legislatures, Federal agencies are 
comprised of unelected Federal bureaucrats with no 
constituency. Agency bureaucrats have no real accountability to 
those impacted by the agency's preemptive regulations. 
Conversely, State legislatures do answer to their constituents.
    Second, Federal agencies have gone so far to preempt 
established bodies of State law without even having enabling 
legislation passed by Congress to do so. FDA did this in the 
prescription drug labeling rule. This type of preemption is an 
affront to our Federalist system. It is dishonest and ignores 
the rules and the role of the States as implementers of these 
regulations.
    In my State, if an agency were to preempt local ordinances 
in the absence of State statutory authority, I, as a State 
legislator and majority leader of my chamber, would hear about 
it right away. My legislature would take immediate action to 
reign in that agency and correct the problem.
    In Utah we have a Legislative Review Committee whose job it 
is to examine rules submitted to it by our agencies. After 
examining each rule, this committee must present a report to 
the presiding office of the Utah House and Senate. If the rule 
is not proper, we act upon it.
    Third, agency preemptions have sought to regulate in areas 
that have traditionally been left by Congress for the States to 
address. Again, FDA prescription drug labeling rule falls into 
this category, as it seeks to prohibit State lawsuits and erode 
State tort and consumer protection laws.
    In Utah, State product liability law has been around for 
decades, and our products have careful consideration of court 
decisions and statutory laws. Unelected Federal bureaucrats in 
Washington, DC, should not--repeat, should not--get to tell my 
legislature and my judges how to address these topics.
    Finally, NCSL, in concert with other States and local 
government national associations, sought to increase 
communication between our Federal and State governments by 
refining the provisions of Executive Order 13-122, better known 
as the federalism Executive order. This Executive order 
requires agencies to consult with State and local elected 
officials or their national associations like NCSL whenever a 
proposed rule contains preemption provisions.
    The purpose of this consultation is for agencies to better 
understand the preemptive impact of a proposed regulation and 
to minimize the preemption. Agencies like FDA, however, have 
chosen to ignore it.
    I have written in length about NCSL's experience with the 
FDA during the promulgation of this prescription drug rule in 
my written testimony. That experience was not a positive one, 
and the State's impact of the FDA final rule has undermined 
State policy in several States. Federal agencies do not seem to 
care that the entire body of State law out there that has been 
passed by legislatures and handed down by State court judges 
that represents the balancing of competing interests on a 
particular subject.
    In the absence of congressional authority and without even 
knowing what the State impact of these actions would be, 
Federal agency bureaucrats should not have the authority to 
swipe laws out with a single stroke of the pen. However, and 
even moreover, Congress should not let them.
    Mr. Chairman, I sincerely hope that you will introduce and 
move the medical device safety act that you have drafted and 
will seek to restore some of the traditional State authority 
with agencies, and now even the Supreme Court has stripped 
away, move it back to the States.
    NCSL is prepared to work with you to pass this important 
first step legislation. My hope is that, with your leadership, 
more legislation to address the States' concern on preemption 
will be introduced and passed. Our States, your States deserve 
this respect.
    I would be happy to answer any questions that you might 
have and thank you for your time today.
    [The prepared statement of Mr. Clark follows:]

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    Chairman Waxman. Thank you very much, Mr. Clark.
    Dr. Calfee.

                  STATEMENT OF JOHN E. CALFEE

    Mr. Calfee. Mr. Chairman, I am honored to testify in 
today's hearings. I am John E. Calfee. I am an economist with 
the American Enterprise Institute here in Washington, DC, where 
I do research and writing on tort liability and FDA regulation 
and other topics. I am the ninth witness today. I would like to 
offer a different perspective.
    I support limited FDA preemption of State tort law, and I 
do so basically for three reasons: First is the issue of 
compensation. Contrary to what is often assumed, the liability 
system is an extremely inefficient way to provide compensation 
for harm from drugs, partly because of the increasingly 
important role of punitive damages and damages for pain and 
suffering. Attempts to use the liability system for 
comprehensive compensation essentially transforms the tort 
system into an insurance system, with corresponding increases 
in drug prices. Because this insurance tends to be worth less 
than its cost to consumers, the net effect can be to discourage 
the use of even very valuable drugs.
    This was demonstrated vividly in the 1980's when liability 
suits nearly destroyed the childhood vaccine market. Preemption 
would serve to ameliorate these adverse effects of liability 
litigation.
    Second is the issue of information. Liability litigation 
has proved to be a very poor tool for improving product 
information. Mass litigation for Vioxx, for example, has failed 
to improve public information about that drug, and here I 
depart somewhat from the views of some of the other witnesses.
    In the case of tobacco, where the product is essentially 
unregulated and where litigation has been massive, the result 
has not been to improve information about the product, itself.
    A particularly serious problem is liability litigation 
based upon allegations of failure to warn about the dangers of 
approved drugs. This kind of litigation is likely to trigger 
unnecessary contra-indications and other forms of over-warning 
to the detriment of patients.
    On the other hand, there is little evidence that litigation 
will actually improve the pharmaceutical information 
environment. This is partly because the FDA already tends the 
require excessively detailed safety disclosures and warnings.
    Finally, there is the issue of drug safety. Contrary to 
what is often assumed, there is no evidence of a drug safety 
crisis today, or even a decline of drug safety in recent years, 
nor is there evidence of the FDA's slighting of drug safety. In 
fact, there are compelling reasons to believe that, if 
anything, the FDA tends to be overly cautious in its emphasis 
on safety at the cost of delaying the approval of new drugs and 
new indications. This is mainly because the FDA is criticized 
far more for problems with approved drugs than it is for being 
too slow to approve new drugs or new indications.
    Liability suits tend to reinforce these adverse tendencies 
toward over-caution. Preemption, on the other hand, would tend 
to ameliorate this negative effect from liability litigation.
    On the whole then, I suggest that more liability litigation 
is not always a good thing. In certain situations, liability 
lawsuits could even cause harm. This is particularly likely to 
occur when juries are given the power to overrule FDA 
deliberations on label contraindications and other warnings. 
Preemption is a useful tool to prevent this from happening.
    Thank you, Mr. Chairman. My written testimony has 
considerably more detail on these three points.
    [The prepared statement of Mr. Calfee follows:]

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    Chairman Waxman. Thank you. Your written testimony, of 
course, is part of the record in full.
    Mr. Vladeck, let me start my questions with you. These 
lawsuits are by people who are injured, and they are claiming 
that the manufacturer of a drug or device didn't do what would 
be required of them, what a reasonable company would do. Isn't 
that what the issue is all about in these lawsuits?
    Mr. Vladeck. Right. That is the question that the jury or 
the judge would have to decide.
    Chairman Waxman. So there are two reasons for lawsuit, one 
for compensation. The company didn't do right, therefore the 
injured person should be compensated. The second reason for 
these lawsuits is that it makes companies concerned in advance 
that if they did something wrong they could be sued, and 
therefore incentivize them, as we might say, to make sure they 
are doing everything right.
    Mr. Vladeck. That is right. I think Ms. Ruther put it about 
as well as anyone has, which is it makes companies worry about 
suppose they don't play by the rules and they get caught. Is it 
going to cost them some money?
    Chairman Waxman. The question that I want to ask you is why 
don't we have all these lawsuits at the Federal level? Why 
should they be at the State level? If we had a Federal law, 
like FDA approving drugs, and there turns out to be a problem 
with the drugs or devices, why should we have this at the State 
level?
    Mr. Vladeck. Congress considered that very question 70 
years ago when the first Food and Drug Act was enacted, the 
Food, Drug, and Cosmetic Act was enacted. Congress decided not 
to put in a right of action in to the Federal food and drug 
laws because the States already permitted these kinds of suits, 
and so Congress made a deliberate decision 70 years ago to let 
Mr. Clark's State, or Senator Clark's State, to set its own 
liability rules.
    But let me make one quick point about that. Concerns about 
dis-uniformity, which have cropped up repeatedly, and I believe 
Congressman Shays raised that, that is a red herring. If the 
drug company loses a case, it doesn't have to change its label. 
Ultimately, of course, the FDA will exercise final control over 
the label. But what will happen is the company will have to go 
back and take a hard look and say, Is this a risk that needs to 
be warned about? And if so, how do we go about making sure 
there is no recurrence?
    Perhaps this is what Mr. Shays was driving about. If the 
company decides this is just an aberrational jury verdict that 
was wrong and the product is safe and it doesn't pose the risk, 
then the company will probably just ignore it.
    Chairman Waxman. What if I were concerned about the fact 
that 50 States are going to have different label requirements? 
Should I be concerned about this matter?
    Mr. Vladeck. It can't happen. The Food and Drug 
Administration does exercise final control, but the problem 
generally arises from the other direction. We talked a lot 
about Vioxx. It took the FDA over a year to force Merck to put 
a warning on Vioxx, a serious warning on Vioxx, about the heart 
attack and stroke risk. Why did it take the FDA a year? Because 
it didn't have the authority then to tell Merck that it had to 
place that warning on its label.
    Now, I know Congress has changed the law to explicitly give 
the FDA the authority, but even under the new legislation it is 
going to take months. Even if the FDA goes through the process 
and accelerates it, the way the new statute permits it to do, 
it will take months.
    Chairman Waxman. So preemption would say that we shouldn't 
just rely on FDA; we should hold the manufacturer accountable, 
and if we were going to rely on the FDA, there are going to be 
so many delays at FDA that we may not have a very good system 
at FDA to protect us, so we ought to be able to use the tort 
system, as well.
    Is all this premised on the idea that the FDA can be relied 
on and has the capacity to regulate drugs and medical devices 
effectively?
    Mr. Vladeck. The FDA does a great job, given its resources, 
but it is not perfect. Since this issue first surfaced 30 or 40 
years ago, the FDA consistently took the position that it 
needed State liability actions to give it information and to 
place an important discipline on the market that it could not 
possibly place.
    Chairman Waxman. And that has always been the position of 
the FDA until the Bush administration, hasn't it?
    Mr. Vladeck. Right.
    Chairman Waxman. So FDA is not complaining that their 
powers are being limited and they are not going to be able to 
make sure that the drugs are as safe as possible?
    Mr. Vladeck. Well, they are now complaining.
    Chairman Waxman. Well, now. It is interesting that they are 
now complaining, when at the same time we have seen a dramatic 
drop of enforcements by the FDA against drug companies. They 
used to send warning letters from the agency that there are 
violations of the Federal requirements, but these warning 
letters have fallen over 50 percent 2000 to 2005. It is a 15-
year low. During the same period of time the number of seizures 
of mislabeled, defective, and dangerous products declined by 44 
percent. A rational drug and medical device company would take 
a look at FDA's lack of diligence and say, Well, I shouldn't 
worry about it because the FDA is not ever going to go after 
me. They are not even enforcing the law.
    Mr. Vladeck. Right. The shrinkage of FDA enforcement is 
nothing short of stunning. In the last several years the FDA 
has brought no criminal prosecutions, the number of enforcement 
actions had declined more sharply than is imaginable, so the 
regulatory cop is off the beat.
    We have talked about a lot of regulatory failures here 
today, the Guidant heart defibrillator. We have talked about 
Vioxx. There has been no sanction imposed by the FDA. The only 
discipline on the marketplace that is meaningful these days is 
the tort system. The statistics are there for anyone to see. 
The report was commissioned by the FDA, and this part of it was 
written by a preeminent food and drug lawyer who represents the 
food and drug industry, and so these are the statistics he 
complied based on the FDA's own records. They are astonishing.
    Chairman Waxman. Thank you very much.
    Mr. Braley.
    Mr. Braley. Thank you, Mr. Chairman.
    We have a mutual friend who is a constituent of mine who 
shares your passion for oversight of the FDA, and that is 
Republican Senator Charles Grassley. Senator Grassley initiated 
an effort that led to Congress mandating that the Centers for 
Medicare and Medicaid Services sponsor a study by the 
Institutes of Medicine to address the problem of medication 
errors. It is the third publication in the quality chasm series 
that I was holding up earlier called Preventing Medication 
Errors.
    I was shocked when Dr. Calfee testified there is no 
evidence of a drug safety crisis, because this publication that 
was released on July 20, 2006 by the Institutes of Medicine 
reached a very different conclusion. It found that every year 
there are 7,000 deaths due to medication errors, and that the 
increased cost of preventable adverse drug events affecting 
hospitalized patients cost us $2 billion every year.
    They also talked in this Institutes of Medicine Study about 
the disparity of resources for new drug approval and monitoring 
of drug safety.
    So, Dr. Curfman, in light of that Government study, can you 
explain to us whether you believe that this is a serious 
problem and whether you are concerned about the safety of drugs 
and medical devices in a post-preemption world.
    Dr. Curfman. Well, Mr. Braley, I think that you have set 
the frame very beautifully here today by pointing out that in 
the last few years there has been a national effort to look at 
patient safety, hospital safety, drug safety. This is very much 
on the minds of physicians, hospital administrators. We have 
published in our own Journal numerous articles dealing with the 
issue of patient safety. So this is a national effort that is 
going on.
    Now, preemption of tort litigation is simply going to be a 
way of attempting to undermine what I see as a national effort 
that our Journal has been a part of to try to improve the 
safety of patients. So I want to thank you for having set the 
frame so nicely.
    Mr. Braley. Thank you.
    Ms. Ruth, you gave some eloquent testimony about your role 
in actually processing the medical devices that are some of the 
subject of the conversation here today. As an engineer and a 
potential patient, do you share Dr. Curfman's concerns about 
the fact that if there is no preemption, device manufacturers 
will be unable to innovate?
    Ms. Ruther. I disagree that the lack of preemption stalls 
innovation. We haven't had preemption, and if you look at the 
innovation of devices over the last 50 years it is stunning.
    What we don't want is that people look at innovation as 
just the next cool toy and how do we get it through the FDA. We 
really want the best, which is what we have always had in the 
United States. Starting with the FDA is a fantastic base. 
Keeping the liability there helps keep us on our toes.
    Chairman Waxman. Thank you, Mr. Braley. Your time has 
expired.
    Ms. Watson.
    Ms. Watson. I have no questions.
    Chairman Waxman. You pass. Ms. Norton, are you ready to ask 
your questions?
    Ms. Norton. Thank you very much, Mr. Chairman. Since I have 
been here I have heard some fairly frightening testimony. I am 
pleased I was able to come in for part of this hearing.
    I have a question for Mr. Vladeck.
    I want to thank all the witnesses. Mr. Vladeck is a 
colleague of mine at Georgetown, where I am still a member of 
the faculty, and I was drawn perhaps because, like him, I look 
at the legal implications of this, to the Riegel decision, 
which, of course, is the problem, preempting of Federal law and 
shielding medical devices from State suits, even without an up-
to-date warning. It seems to me pretty harsh.
    Let me ask you, first of all, it was decided eight-to-one. 
I would like to know, a court that tends to be fairly divided, 
I would like to know your view of that. And then, of course, 
the industry says, So what? It only applies to 1 percent of all 
devices. I would like to hear your view on that.
    Mr. Vladeck. Thank you very much.
    First, let me talk about the court's ruling in Riegel. What 
the court says in Riegel is that when Congress passed the 
Medical Device Amendments in 1976 it included a preemption 
provision that used the word requirements. The preemption 
provision was included because by 1976 there was already robust 
State regulation of medical devices, and Congress had to figure 
out how to allocate responsibility between the Federal and the 
State governments. So what Congress did was preempt State 
requirements that are different from or in addition to Federal 
requirements.
    The Supreme Court in Riegel said in the Medical Device 
Amendments the word requirements includes State tort law, and 
therefore Congress, not the courts, but Congress made a 
calculated decision back in 1976 to preempt State tort law.
    I think the court had it backward. I think the court 
intended to preserve, not to preempt, State tort law in 1976. 
But ultimately, of course, that is a question for Congress.
    The court makes it quite clear that the ball is in 
Congress' court, so this is a problem that Congress could fix 
tomorrow, assuming you could get the votes.
    Now, with respect to, Don't worry about Riegel, it only 
applies to PMA devices, these pre-market approval devices which 
are 1 percent, well, that is not a fair argument. PMA devices 
are the devices that are life-sustaining, life-supporting, or, 
if there is a problem with them, might kill people. These are 
the most important devices. These are the devices that sustain 
life. These are the devices that Ms. Ruther was talking about 
earlier. These are the devices we depend on to keep our loved 
ones safe and healthy.
    So to simply suggest that Riegel is somehow less important 
because it only applies to these is I think to get it backward. 
Riegel is especially important because it immunizes the people 
who make the most important medical devices from liability, and 
it removes the incentives to play straight.
    Ms. Norton. Yes, and I have a question, particularly since 
we have the Wyeth case now and Riegel can serve something of a 
precedent for the case that is now before the Supreme Court on 
drug labeling.
    By the way, concerning your last answer, very often, still 
to this very day, we will seek to leave intact State laws, 
because very often they are stronger than laws we are able to 
pass here. That has been a habit of Congress since long before 
I came, so I am not particularly surprised there. There may be 
some wording that has to be adjusted if they get it wrong, as I 
believe they did.
    But here we have the next step. We have a recent decision 
here. We are going to go on to a case to come before the court 
I believe in October. This case takes us to the next step, to 
the largest number of cases that would be involved, and that is 
whether or not the regulation of a drug's labeling preempts 
State law claims when the manufacturer failed to warn both the 
patients or either the patients or physicians.
    I would like to know your view on what you think will 
happen in this case.
    Mr. Vladeck. Well, I hope the court gets it right.
    Ms. Norton. Your testimony seemed to indicate that you 
thought we had a better chance in this case.
    Mr. Vladeck. Well, there are several reasons why I believe 
we do. First and foremost, there is no preemption provision in 
the drug part of the Food, Drug, and Cosmetic Act. The industry 
has long coveted preemption. It wants immunity, but Congress 
has never given it to it. This is a statute that has been 
repeatedly amended and reviewed by Congress. Congress is well 
aware of the backdrop of State liability litigation, and 
Congress has never acted to give the industry the immunity it 
wanted. In fact, when Congress added the efficacy requirements 
to the statute in 1962, it made clear that it would only cutoff 
State law that was positively and directly contrary to what the 
FDA did. So, to the extent there had been any signals in the 
statute from Congress, the signals had been strongly anti-
preemptive.
    The second thing is there is a long history of product 
liability litigation over failure to warn claims in State 
courts, dating back since 1852. This is an area that the States 
have historically exercised their police power in, and the 
court has, at times at least, been respectful of State 
prerogatives in this area.
    Third and foremost, I think the arguments for preemption 
are its absolute weakest here. If you take a look at the case 
before the court, this is a case in which a woman, a musician, 
lost her arm because of the way a drug was administered to it. 
Now, what the plaintiff said was there ought to be a warning to 
doctors, don't administer this drug directly into the veins, 
because it is incredibly corrosive to the veins. That is what 
caused the amputation.
    There is no such warning on the drug label. The FDA has 
never sat down and considered whether there ought to be. There 
were some proposed changes to the drug label that the 
manufacturer submitted, none of which would have done what the 
plaintiff asked for and what the jury said should have been 
done. So I think this is exactly the kind of case where State 
liability law complements, not thwarts, the achievement of the 
FDA's goal, which is to protect the American people.
    This kind of litigation simply calls for the disclosure of 
material safety information. It is hard for me to fathom that 
anyone thinks that is a bad idea.
    Mr. Braley [presiding]. Thank you.
    Mr. Shays is recognized for 5 minutes.
    Mr. Shays. Thank you.
    Attorney Vladeck and Professor Vladeck, you have great 
passion, but you are also, I think, someone who believes in 
fairness. We have eight witnesses who take your view, and we 
have one witness who doesn't, and it is a little frustrating 
because you are making certain claims that I am told by my 
staff are not correct, but I don't have the expertise. In other 
words, you are giving part of the story but not all of the 
story.
    Dr. Calfee, what would you want to say with the time I have 
allocated to counteract eight witnesses?
    Mr. Calfee. And I am not a lawyer.
    Mr. Shays. Use it wisely.
    Mr. Calfee. A further disadvantage.
    I think we have to bear in mind that, first of all, we 
don't want to confuse Institute of Medicine reports. There are 
reports showing that a lot of people die as a result of things, 
bad things that happen when they are given drugs in hospitals 
and clinics and so on, but that is not usually an inherent 
problem with the drug; the problem is with the way the drug is 
being used. That has happened with a number of people, 
including a Boston Glob columnist who died from an overdose of 
chemotherapy.
    The Institute of Medicine report that specifically 
addressed FDA oversight of drug safety said very clearly at the 
outset that they had made no attempt to determine whether or 
not there was a drug safety crisis or even whether drug safety 
is worse than it used to be. This has been a largely anecdote-
driven episode.
    Mr. Shays. Let me just jump in.
    Mr. Calfee. Sure.
    Mr. Shays. Professor Vladeck, where I have my problem first 
is I believe that we have a litigious society. I believe that 
lawyers get too freaking much. I don't think that the public 
ultimately benefits. That is the bias I take to the table. It 
just seems to me that if the FDA has made certain findings and 
those warnings are proper, and that in the end it is 
administered incorrectly, I don't know why the drug company 
should be the one to be liable. So just give me the short 
version.
    Mr. Vladeck. OK. The short version is this: the FDA does 
not have the capacity to keep up with the current information 
post-approval about the safety of a drug. For decades what the 
FDA has said----
    Mr. Shays. OK. That is a fine point. Now tell me this: how 
does a lay person have the expertise to do and know more than 
the FDA? How do they have that expertise, because you are 
basically having this decided by laymen.
    Mr. Vladeck. But, with all respect, I don't believe that is 
the way to frame the question. If I might answer this way, the 
FDA recognizes this, and what the FDA's regulations have said 
is that manufacturers have a duty to update their label without 
first securing the FDA's approval, without having this 
conversation with the FDA, when there is a safety problem, and 
that regulation has been in effect for a long time.
    Mr. Shays. Let me ask you this. In the case didn't the FDA 
deny the company the ability to change it, and doesn't the drug 
company have to get approval from the FDA to change its----
    Mr. Vladeck. Not with respect to safety issues. The drug 
company can make the change first and then get the FDA's 
approval.
    In the case before the Supreme Court, yes, the agency 
denied two suggestions by Wyeth about changing a label, but the 
courts and the jury found that the changes in the label were 
not the ones that would have addressed the issue. The issue in 
that case was a route of administration, and nothing in the 
labeling changes.
    Mr. Shays. I honestly don't know where I fall down on this 
issue, but my inclination is that to suggest that somehow if a 
court rules against you, you still don't have to change your 
label in other States to me sounds foolish, because you have 
been found guilty in a particular State. So tell me why I am 
looking at it incorrectly.
    Mr. Vladeck. I think that is a fair question. Let me answer 
it in three ways.
    First, it is very hard to find a case in which a drug 
company wanted to strengthen the warnings and the FDA said no. 
That is certainly not what happened in the case from Vermont.
    Second, in a case that came up like that where the company 
said, We want to add a stronger warning, and the FDA said no, 
no lawyer in their right mind would take that case because I 
would lose that case.
    Mr. Shays. Let me ask you one last question while I still 
have the yellow light. What happens if laymen make a 
determination that it is simply false?
    Mr. Vladeck. And they do, just like everybody makes 
mistakes.
    Mr. Shays. But, no, they are not just everybody; they are 
laymen.
    Mr. Vladeck. And that is why we have judges and that is why 
we have appellate courts.
    Mr. Shays. No, no. With all due respect, judges aren't 
medical experts. They are not experts on the issue. They are 
lawyers.
    Mr. Vladeck. But in a case like this, both sides puts on 
experts.
    Mr. Shays. I ask one question: what happens if they make a 
mistake?
    Mr. Vladeck. My answer to you is two-fold. First is there 
are error correction devices embedded in the judicial system to 
correct errors. Many jury determinations are set aside by trial 
judges or overturned on appeal, so one answer is trust the 
judiciary to do its job. That is the first answer.
    The second answer is assume for the moment your worst 
hypothetical, where a jury reaches a bad decision and it is not 
corrected on appeal. In that case the company would have the 
discretion to----
    Mr. Shays. I don't mean to be rude. I have 2 minutes to get 
to vote.
    Mr. Vladeck. Sorry.
    Mr. Shays. That is OK. Thank you.
    Mr. Braley. I want to thank all of the panel for coming and 
testifying today. Your testimony has been deeply appreciated.
    Before we adjourn this panel I just want to make a comment 
about the issue of appellate review, because there was a point 
brought up during the hearing about the role of punitive 
damages and tort liability. One of the things we know is recent 
U.S. Supreme Court decisions have restricted severely the right 
to recover punitive damages. They have set a very high bar in 
order to recover from punitive damages. They have limited the 
evidence that can be submitted in support of a punitive damage 
award and have required mandatory appellate review of State 
court determinations of punitive damages.
    So one of the things we want to do is continue to consider 
your helpful testimony as we go further.
    With that we will adjourn until 2:15. We have a series of 
votes. And then we will take up the third panel.
    [Recess.]
    Chairman Waxman [presiding]. The hearing will please come 
back to order.
    For our third panel we are pleased to welcome Dr. Randall 
W. Lutter, Deputy Commissioner for Policy at the U.S. Food and 
Drug Administration. Dr. Lutter will present the FDA's current 
view regarding preemption in the context of FDA-approved drugs 
and medical devices.
    We are pleased to have you with us today. Your full 
statement will be part of the record in its entirety. We are 
going to ask you to try to limit your presentation to 5 
minutes.
    It is the practice of this committee that all witnesses 
that testify before us do so under oath, so if you would please 
rise and raise your right hand.
    [Witness sworn.]
    Chairman Waxman. The record will indicate that the witness 
answered in the affirmative.
    I would like you to now commence your oral presentation.

  STATEMENT OF RANDALL LUTTER, PH.D., DEPUTY COMMISSIONER FOR 
              POLICY, FOOD AND DRUG ADMINISTRATION

    Mr. Lutter. Good afternoon, Chairman Waxman and members of 
the committee. I am Dr. Randall Lutter, Deputy Commissioner for 
Policy at the U.S. Food and Drug Administration. Thank you for 
the opportunity to discuss issues relating to the safety of 
medical products regulated by FDA and the importance of 
accurate information about those products.
    FDA is the public health agency charged by Congress with 
ensuring that drugs, biologics, and devices are safe and 
effective and that the labeling of drugs, biologics, and 
devices adequately informs users of the risks and benefits 
associated with the use of those products.
    We believe, based on the authority provided by Congress and 
the scientific expertise of the agency, that FDA's 
qualifications to make important judgments about the safety, 
effectiveness, and labeling of medical products are 
unsurpassed.
    We have heard today about the importance of balance in 
deciding the roles of Federal regulation by FDA and of State 
tort law, and I would like to speak to that.
    FDA is concerned that State product liability lawsuits that 
challenge the agency's careful determination of safety, 
efficacy, and appropriate labeling can have detrimental effects 
on public health in a number of ways, including limiting 
patient and doctor choices and decreased patient access to 
beneficial products and increased confusion over warnings or 
statements that can deter the use of beneficial medical 
products.
    Of course, if a plaintiff claims to have been harmed 
because a sponsor, meaning a manufacturer, did not meet the 
conditions of FDA's approval for a drug, biologic, or device, 
then State law liability on that basis wouldn't interfere with 
Federal law and manufacturers would get no protection from such 
claims. But both to protect the public health and as a matter 
of law, State law claims are preempted if they challenge a 
design or a labeling that FDA approved after being informed of 
the relevant health risk based on its expert weighing of the 
risks and the benefits of requiring additional or different 
warnings.
    A critical part of the FDA's mission is its review of the 
adequacy of labeling. The agency carefully controls the content 
and labeling of medical products because such labeling is our 
principal tool for communicating to health care professionals 
and consumers the risks and benefits of approved products so as 
to help ensure safe and effective use. FDA employs scientists 
and other experts to review the information submitted by the 
manufacturer on a product's risk and carefully calibrate 
warnings and other information that should be placed on the 
labeling.
    FDA continuously evaluates the latest available scientific 
information to monitor the safety of products and to 
incorporate new information into product labeling when 
appropriate. FDA takes care that labeling neither under-warns 
nor over-warns. We work to ensure that approved labeling not 
omit important risk information that patients and physicians 
should consider in making health care decisions.
    FDA engages in extensive post-market surveillance to detect 
and respond to emerging information about approved products 
after they have been on the market.
    After a drug has been approved and marketed, the 
manufacturer must investigate and report to FDA any adverse 
events associated with the use of the drug in humans, and must 
periodically submit any new information that may affect FDA's 
previously conclusions about the safety, effectiveness, or 
labeling of the drug.
    Device sponsors similarly have obligations to report 
certain adverse events. FDA is currently modernizing its post-
marketing surveillance and risk communication efforts through 
its implementation of the Food and Drug Administration 
Amendments Act of 2007 and other major initiatives. FDA 
believes its teams of scientists are unsurpassed in ensuring 
that labeling meets patients' needs.
    Congress authorized FDA to apply its scientific expertise 
to determine in the first instance whether a medical product is 
safe and effective and what labeling, including warnings, is 
appropriate and necessary for particular product; therefore, 
FDA's determinations about safety, efficacy, and labeling are 
paramount.
    FDA believes that the important decisions it makes about 
the safety, efficacy, and labeling of medical products should 
not be second-guessed by State courts. Recent documents clarify 
FDA's longstanding position that it has primary responsibility 
to review the safety, efficacy, and labeling of medical 
products.
    In particular, FDA has reiterated the basis for this 
position in its Supreme Court brief in Wyeth v. Levine, and 
before that in the preamble to the Physician Labeling Rule.
    Early regulation, preambles from 1982 dealing with tamper 
resistance, 1986 dealing with over-the-counter aspirin, and 
1994 on protecting the identity of adverse event reporters, all 
may be construed to extend to State tort judgment, although 
they are primarily directed to State legislative law.
    In the preamble to the Final Physician Labeling Rule, which 
has been discussed earlier today, FDA describes some examples 
of instances in which it believes preemption is appropriate; 
for example, where there are claims that a sponsor breached an 
obligation to warn but where FDA had considered the substance 
of the warning and decided that it shouldn't be required.
    FDA also recognized that FDA's regulation of drug labeling 
would not always preempt State law actions, noting that the 
Supreme Court has held that certain State law requirements that 
parallel FDA requirements may not be preempted.
    FDA is concerned that State product liability lawsuits that 
challenge FDA's careful determination of safety, efficacy, and 
appropriate labeling can have detrimental effects to public 
health, and such effects include decreased consumer access to 
beneficial products through decreases in availability, or even 
removal of beneficial products from the market, thereby 
limiting patient and doctors' choices, and the requirement for 
additional and conflicting warnings or statements that could 
cause confusion or deter the use of beneficial medical 
products.
    Of course, if a patient claims to have been harmed by a 
sponsor's failure to use the specific design or labeling 
approved by FDA, then State liability would not interfere with 
Federal requirements and preemption would not apply. But public 
health is not served if tort litigation has the unintended 
consequence of decreasing or eliminating access to a beneficial 
product.
    The agency is concerned that State tort actions, in 
conflict with FDA's authority, would create requirements on 
manufacturers to increase labeling warnings, to include 
speculative risk or warnings that do not accurately communicate 
FDA's careful evaluation of the risks and benefits of the 
product. Including warnings in a labeling without a 
determination by FDA that they are well grounded in science can 
have the effect of over-warning and confusion, as well as 
deterring use of a beneficial drug. Thus, FDA interprets and 
implements its responsibility under the act as establishing 
both a floor and a ceiling for risk information, and that 
additional disclosures of risk information by the manufacturer 
can violate the act if the statement is unsubstantiated or 
otherwise false or misleading.
    As FDA articulated in the Physician Labeling Final Rule, 
the public health risk associated with over-warning can be as 
great as the health risk associated with under-warning. Over-
warning can cause patients not to use beneficial medical 
products and doctors not to prescribe them.
    Over-utilization of a product based on dissemination of 
scientifically unsubstantiated warnings so as to deter patients 
from undertaking beneficial, possibly life-saving treatment, 
could well frustrate the purposes of Federal regulation as much 
as over-utilization resulting from a failure to disclose a 
drug's scientifically demonstrable adverse effects.
    [The prepared statement of Mr. Lutter follows:]

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    Chairman Waxman. Thank you very much, Dr. Lutter. Your 
whole statement is going to be in the record, and you have 
already taken over 7 minutes. We have some questions for you. 
And we have had an opportunity to review your statement in 
advance.
    I want to recognize Mr. Braley to start off the questions.
    Mr. Braley. Thank you, Mr. Chairman.
    Dr. Lutter, I want to talk to you about the change in FDA's 
position on preemption and your role in that change. Before 
2002, FDA took the position that the regulation of drugs and 
medical devices did not preempt State court product liability 
cases. The FDA's view was that State liability cases actually 
helped it to protect consumers from unsafe drugs and medical 
devices because they brought new safety information to light, 
information the FDA might not otherwise get.
    In fact, in 1997 former FDA Chief Counsel Margaret Porter 
stated, ``FDA's view is that FDA product approval and State 
tort liability usually operate independently, each providing a 
significant yet distinct layer of consumer protection. FDA 
regulation of a device cannot anticipate and protect against 
all safety risks to individual consumers. Preemption would 
result in the loss of a significant layer of consumer 
protection.''
    And your former FDA Commissioner David Kessler testified in 
a previous panel that this was the agency's longstanding view.
    Yet in early 2006 the FDA issued a final Drug Labeling Rule 
whose preamble announced a brand new position. The preamble 
declared that the agency now believed that FDA approval of 
labeling preempts State failure to warn lawsuits. And in that 
preamble the FDA claimed that the preemption is the agency's 
longstanding position.
    So you will have to forgive me, Dr. Lutter. I am a little 
confused. We know from our previous witnesses that the FDA's 
longstanding position was against preemption of State court 
cases, yet your agency now claims the opposite. Please tell us 
the date and time when the FDA decided to reverse its 
longstanding position on preemption and the persons involved in 
that decision.
    Mr. Lutter. The position on preemption has been articulated 
in a number of amicus briefs over the years and also in various 
regulations in their preambles. With respect to the positions 
pertaining to statutory law by States, these go back all the 
way to the 1970's, and there has been, I believe, no change 
with respect to FDA's position on preemption in that regard.
    I mentioned in my oral testimony several regulations where 
preambles have articulated a position on preemption that goes 
back a couple decades.
    Mr. Braley. Do you hold yourself out at this hearing as an 
expert in the Federal Doctrine of Preemption as it has evolved 
over time?
    Mr. Lutter. I am not an attorney by training. I have been 
briefed on the matter here and I come to you as a 
representative of FDA on its current policy position on 
preemption.
    Mr. Braley. Well, are you aware that long before the FDA 
was ever created by act of Congress that State tort liability 
claims involving medications and drugs and drug devices were 
already taking place?
    Mr. Lutter. Yes.
    Mr. Braley. Did you have to take an oath when you became 
Deputy Administrator at the FDA?
    Mr. Lutter. Yes.
    Mr. Braley. Did you have to swear to uphold the 
Constitution of this country?
    Mr. Lutter. Yes, sir.
    Mr. Braley. Are you familiar with the Constitution?
    Mr. Lutter. Yes, sir.
    Mr. Braley. Including the 7th amendment?
    Mr. Lutter. Yes.
    Mr. Braley. What does that provide?
    Mr. Lutter. I am sorry, I don't know the 7th amendment.
    Mr. Braley. The 7th amendment provides that suits at common 
law, which is what we are here talking about today, the right 
to trial by jury shall be inviolate. So can you explain to me 
how it is that the FDA has suddenly decided that it is going to 
completely turn the Doctrine of Federal Preemption on its head 
by having Federal agencies stand in the role of Congress, which 
normally has the exclusive jurisdiction to preempt State law 
claims?
    Mr. Lutter. I think there is also a Supremacy Clause, sir, 
in the Constitution that deals with the relationship between 
Federal law and State law, and the Supremacy Clause speaks also 
to the question of FDA's authority relative to other 
authorities exercised by State law.
    Mr. Braley. The Supremacy Clause of the U.S. Constitution 
you claim speaks to the FDA's authority?
    Mr. Lutter. It speaks to the relationship between Federal 
law and State law.
    Mr. Braley. Because you realize the FDA did not exist when 
the Supremacy Clause was added to the Constitution?
    Mr. Lutter. Yes, sir.
    Mr. Braley. And, in fact, that was one of the whole points 
of the Constitution and Bill of Rights was to distinguish those 
issues where the States had the right under the Savings Clause 
of the 10th amendment to exercise their control over things 
like product safety. Were you aware of that?
    Mr. Lutter. I am aware of the 10th amendment. Yes, sir.
    Mr. Braley. Now, one of the things that we are concerned 
about here is it seems to us that the FDA has changed its 
position on preemption 180 degrees, because we know that there 
was a preamble to the final rule on drug labeling, but the 
proposed rule was issued back in 2000, and there was absolutely 
nothing in the proposed rule that signaled that FDA intended to 
address preemption, much less that the agency was going to 
reverse its longstanding position. So can you tell us what 
happened between the issuance of the proposed rule and the 
later final rule and the change in the preamble?
    Mr. Lutter. We received public comments asking us to 
articulate a position in this regard, and we took those public 
comments into account and developed the language in the 
preamble based in part on those.
    Mr. Braley. And did some of those public comments come from 
Agencies or associations or trade groups who have been at the 
vanguard of the tort reform movement?
    Mr. Lutter. I presume they come from a variety of sources, 
including industry.
    Mr. Braley. Including bodies like the American Enterprise 
Institute that you worked for?
    Mr. Lutter. I don't know if the AEI filed a brief. I did 
work at AEI. I was not involved in any brief on this issue at 
the time that I was there.
    Mr. Braley. Were you aware that AEI had been influential in 
trying to push an agenda of tort reform?
    Mr. Lutter. I know that AEI has been involved in tort 
reform.
    Mr. Braley. Thank you. That is all I have at this time.
    Chairman Waxman. Thank you, Mr. Braley.
    Mr. Shays.
    Mr. Shays. Thank you. And, Mr. Chairman, thank you for 
inviting a representative from the FDA, as well.
    I want to just be clear. The FDA's position is that the FDA 
should be the ultimate decider, and that they should not have 
State courts, juries, override a decision of the FDA; is that 
correct?
    Mr. Lutter. Yes, sir. Our key position is that we have been 
entrusted by Congress to have expertise in the regulation and 
labeling of medical products in a manner that ensures that the 
communication through labeling of the safety and effectiveness 
of those products best protects and promotes public health. We 
believe we are uniquely well-qualified to do that, and our 
position with respect to preemption is that State law claims 
are preempted if they challenge a design or labeling that FDA 
has approved after being informed of the relevant health risks 
based on our expert weighing of the risks and the benefits of 
requiring additional or different warnings.
    Mr. Shays. So basically we are talking about experts making 
a decision versus a court, whether it is a judge who does not 
have expertise in the field or a jury of lay people who do not 
have expertise, and so your argument is that the experts should 
trump the lay officials and the judges, correct?
    Mr. Lutter. Yes. The labeling decisions made by FDA are 
made by teams of doctors, pharmacologists, scientists, 
epidemiologists who review the information about safety, who 
take it into account, often on public venues such as our 
Advisory Committee meetings, and then make decisions about what 
information should be conveyed on the label about risks and the 
effectiveness of the product.
    Mr. Shays. Yes. The irony of this hearing has been that 
Republicans usually are not great fans of the FDA, at times for 
a variety of reasons, and Democrats usually are there arguing 
that the FDA should be given more credibility than sometimes 
people on my side of the aisle want to do. I mean, that is the 
irony that I am saying. You are not saying that, I realize. But 
in asking the question of our first panel, the chairman said, 
well, we go where the science takes us, and that the courts are 
basing it based on science. But, without offending the 
chairman, how do you respond to that? And maybe I didn't say it 
correctly.
    Mr. Lutter. I don't remember exactly the chairman's remarks 
in that regard, but our view is that we look carefully at all 
the adverse events that are associated with the product.
    Mr. Shays. Let's look at the courts, though. The argument 
is the courts go where the science takes them. How do you 
respond to that?
    Mr. Lutter. They lack the technical, scientific, and 
medical expertise that we use in making decisions about the 
labeling of products that we regulate.
    Mr. Shays. What is the danger of having the courts or the 
jury basically override the FDA?
    Mr. Lutter. Well, fundamentally there is a conflict between 
law imposed by the courts and the law that we impose on the 
sponsors in terms of their labeling. In particular, if we say 
that a label must describe the risks in a particular manner and 
the State court reaches a conclusion that those risks were 
associated with the failure to warn and an alternative label 
was appropriate, there is a conflict between that legal 
judgment by the court and our judgment. And we think that, from 
a public health standpoint, we have more expertise in conveying 
and regulating those risks.
    Mr. Shays. Let me just say, Mr. Chairman, thank you for 
allowing a third panel, because I think it is important that we 
get the position of the FDA and I think it is very persuasive.
    I thank you, Doctor, for your testimony.
    Mr. Lutter. Thank you.
    Chairman Waxman. Thank you, Mr. Shays.
    FDA was set up in 1906, I believe. From 1906 to the present 
time, FDA has had responsibilities to make sure drugs are safe. 
That was the first job of the FDA. Then later FDA was empowered 
to decide whether drugs were effective.
    Now, throughout all that period of time there is always 
this dual system of FDA assuring drug safety by following the 
science and using their expertise, but we have always had 
during that same period of time a system where individuals 
could sue in State courts if they were injured.
    Now, in courts all the time experts come in and give their 
opinion. FDA isn't the only expert on drug safety; there are 
others who can give opinions on drug safety. Isn't that true?
    Mr. Lutter. There are other experts. The decisionmakers in 
State courts are the judges and the juries.
    Chairman Waxman. Yes, but the decisions that FDA is making 
is not in an individual case; the decision FDA is making is 
whether a drug ought to be approved and marketed as a safe 
product, and, after it is out, to review whether it still 
should stay on the market if there is a safety problem that 
arises. Isn't that correct?
    Mr. Lutter. Yes.
    Chairman Waxman. OK.
    Mr. Lutter. We make decisions on the safety for the 
population that is intended to use the drug.
    Chairman Waxman. So we have never had this preemption 
before. Suddenly FDA, under the Bush administration, has 
decided to insert FDA preemption in the law. This was done in a 
rather tricky way, it seems to me, because there was a proposed 
regulation that didn't mention it at all. In fact, it had a 
provision saying this won't affect preemption. And then at the 
last minute FDA put in a preamble that said, oh, by the way, we 
are preempting the States from even having court cases to 
resolve the disputes where people are injured and feel that the 
manufacturers didn't live up to their legal responsibilities.
    Now, I am offended by that. I am offended by it all the 
time by this administration because I know there is a unitary 
theory of the executive branch that you are the supreme branch, 
but there is a branch of Government under the Constitution that 
is supposed to make laws, and Congress was never asked to 
change the law. Suddenly FDA decided to change the law.
    Now, if FDA is going to say we are the only ones that can 
decide these things for the safety risks for individual 
consumers, you would have to work on the assumption that FDA is 
on top of tens of thousands of drugs and medical devices that 
it regulates, not only to have approved them, but to make sure 
that they continue to be safe.
    Now, FDA doesn't have the capacity to do that. There is 
just no way in the world FDA can do that, and to say that you 
are doing it is to accept the notion of the Federal Government 
bureaucracy being supreme over everybody else in the country in 
deciding whether an injured person has the ability to go in 
court and say that I was unfairly treated, and as a result I 
have lost my arm, I have lost my livelihood, I have suffered 
enormously. That person will be denied even the opportunity to 
go in and get redress from their injuries.
    Mr. Lutter. Sir, we are not opposed to all State lawsuits, 
and it is important to----
    Chairman Waxman. You are opposed to any lawsuit that is 
based on the manufacturer not living up to a reasonable 
standard of care that deviates once FDA has approved them.
    Mr. Lutter. State law claims are preempted if they 
challenge a design or labeling that we have approved after 
being informed of the relevant----
    Chairman Waxman. OK. After being informed. That is a very 
interesting point, because when we heard this morning about the 
Heparin that nearly killed the Quaid family children and, in 
fact, did kill some other children, what we learned was that 
the company knew about the problem but FDA didn't, and the 
company wanted to change its label and, in fact, did change its 
labels, and then wrote to the FDA or appealed to the FDA 
saying, We want you to approve that label.
    Now, if the company found out that its product was doing 
harm to children and they decided they wanted to change the 
label, under this Doctrine of Preemption they would have to 
wait for FDA to decide it is OK. That could take a long period 
of time, wouldn't it?
    Mr. Lutter. I can't speak to the specifics of that.
    Chairman Waxman. You can talk to the specifics of a 
situation where the company knows about the harm, FDA does not. 
The company wants to take action to prevent this harm from 
occurring again, and under the Doctrine of Preemption they 
would have to wait for FDA to decide to adopt a change in the 
label. The reason they would have to do that is otherwise they 
are not going to be protected against a State lawsuit.
    Mr. Lutter. We have a practice which has been in place for 
a couple decades called changes being affected, and we have 
issued a new proposed regulation that speaks a little bit to--
--
    Chairman Waxman. Where was FDA in September 2006 when three 
babies in Indianapolis died from an overdoes of Heparin? They 
didn't know about it. Why did it take FDA until December 2007 
to approve a label change to address this very serious and very 
real risk? That is over a year. If the company knew about the 
problem, they could have done something about it earlier. Why 
shouldn't they be held responsible if they didn't?
    Mr. Lutter. I would have to get back to you on the 
specifics of that case, sir.
    Chairman Waxman. Well, I am telling you the specifics of a 
case like that would mean that people in the interim would not 
be able to sue, even though FDA didn't act and the manufacturer 
didn't act. In effect, we are just telling them, Well, that is 
just too bad. You are out of luck. You pay the penalties. This 
seems to me a radical change in direction. From 1906 to 2008 we 
have never had preemption.
    Now, the medical device law, there was a specific reference 
to preemption, but never in the FDA law, and suddenly FDA is 
trying to do it by regulation. You don't have the power to do 
it by regulation. If you want it changed, come to Congress and 
make an argument. I think you have a weak one, and you 
certainly don't have the power to do it on your own.
    I have exceeded my time, and I will be glad to recognize 
any Members who want to ask further questions.
    Mr. Shays.
    Mr. Shays. Thank you, Mr. Chairman. Just for that basic 
point, to just say, though, that it might be wise to bring more 
officials of the FDA and the legal side of the office to 
respond to I think a question you raise, which I think is 
debatable.
    Chairman Waxman. What is the question that is debatable?
    Mr. Shays. Whether or not they have ever had preemption.
    Chairman Waxman. Well, you can answer that. Have you ever 
had preemption before?
    Mr. Lutter. I would like to speak a little bit, sir, if I 
may----
    Chairman Waxman. No, no. Have you ever had preemption 
before?
    Mr. Lutter. I am not sure exactly in what context you are 
asking it. I have alluded to different regulations going back 
to 1980 where we have articulated a Doctrine of Preemption 
against State statutes in the preambles and regulations going 
back into the 1980's. Yes.
    Chairman Waxman. Those were States' efforts to regulate the 
products or to design the label. Have you ever had preemption 
against State lawsuits by injured people against manufacturers 
of products?
    Mr. Lutter. In 2000 FDA issued an amicus brief in----
    Chairman Waxman. Amicus briefs do not make the law change. 
You might have asked the court to accept it. Did the court 
accept it in that case?
    Mr. Lutter. I don't know the decision of the court case.
    Chairman Waxman. OK. So it is 2008 that you are now 
suddenly deciding that the law is going to be preemption and 
people are out of luck, they can't go to the State courts. You 
may think that the preemption was always there, but it has 
never been acted upon in that way. Suddenly you are making the 
law out of FDA. Where were you before FDA? Were you at a think 
tank?
    Mr. Lutter. I was at the American Enterprise Institute 
before I joined the FDA.
    Chairman Waxman. That is a think tank with a particular 
point of view. And I don't care what the point of view is, but 
why should a think tank person come into Government and then be 
able to write laws when we have a Congress to do that?
    Mr. Shays. Mr. Chairman.
    Chairman Waxman. Yes, Mr. Shays. It is your time.
    Mr. Shays. I think that you feel very convinced about your 
argument. My point is it would strike me that we would get a 
number of folks from the FDA to respond. I think some of the 
power has been implicit for a very long period of time. I am 
just struck by your basic argument about----
    Chairman Waxman. Are you talking about me or him?
    Mr. Shays. I am talking about the FDA's arguments. I think 
the power is implicit in the powers we have given them. I think 
this has become an issue that has come to the forefront, but 
the fact that you are questioning whether they have this power 
or not and never had this power to me is a debatable issue. 
That is all. And I am just suggesting we bring in some of the 
legal folks in the FDA to make this argument.
    We have had eight people who have given testimony one way 
and we had one individual give testimony the other way, and now 
we have the FDA. I think we should bring in more from the FDA. 
I think it would be interesting.
    I just make this point to you: I don't have a dog in this 
fight, but as I listen to it I think it is a debatable issue. 
Then the next question is: what should we do about it? Should 
we pass a law to make it clear or not? I think that is 
something that is a debatable issue, as well.
    Chairman Waxman. Would the gentleman yield to me?
    Mr. Shays. Absolutely.
    Chairman Waxman. There is some strange notion I don't have 
a dog in this fight. If the products are less safe as a result 
of preemption, then you and I both have a vested interest in it 
in a personal way and also as a public policy matter, because 
it could turn out that you or I or our loved ones will go and 
need drugs and find out that the drugs are not as safe as they 
could be.
    Mr. Shays. Just reclaiming my time, because I wouldn't want 
you to distort what I mean by that, what I mean by that is that 
I am very open to this debate. Other than someone who has a 
very strong opinion one way, I don't have a strong opinion 
either way, but as I listen to this debate I don't think having 
eight witnesses who make your argument and having one witness 
who argues differently gives an accurate and fair presentation. 
I am just making the point to you. You have the FDA disagreeing 
with you.
    You are not a lawyer, correct, sir?
    Mr. Lutter. That is correct.
    Mr. Shays. Your capabilities is as an expert, and you are 
expressing your opinion as an expert.
    Mr. Lutter. I am representing FDA here and its positions, 
yes.
    Mr. Shays. Right. And all I am saying is we are getting 
more into a legal fight, and I think it is unfair to Dr. Lutter 
to be arguing the legal aspects of it. That is all.
    Chairman Waxman. Thank you, Mr. Shays.
    Mr. Braley.
    Mr. Braley. Well, Mr. Chairman, I may be the only person 
who is participating in these hearings today who has actually 
researched, briefed, and argued Federal preemption questions in 
Federal and State court, and this gets to the basic core of the 
Doctrine of federalism, and that is whether or not we are going 
to allow a Federal agency to substitute its judgment for the 
judgment of Congress in deciding whether or not to attempt to 
preempt State law claims.
    Now, Dr. Lutter, have you ever been a witness in a product 
liability case?
    Mr. Lutter. No.
    Mr. Braley. Drug you know what the standard of proof is in 
a State tort claim to recover damages for a defective product?
    Mr. Lutter. I think it varies State by State.
    Mr. Braley. Not usually, because it is based upon the 
restatement of torts, which are generally acceptable in State 
court cases all over the country. You have to prove that the 
product was defective, that there was something wrong with it, 
and then you have to prove that it was unreasonably dangerous. 
And in every case that I have ever been involved in involving a 
defective product the defense always comes in and presents 
every piece of evidence that they can to prove the product was 
not unreasonably dangerous at the time it was placed into the 
stream of commerce.
    If you have an FDA ruling on your warning, don't you think 
that would be a critical piece of evidence offered by the 
defense to try to avoid even any liability in those State tort 
claims?
    Mr. Lutter. I think that speaks to the issue at hand, which 
is what is the relationship by a State court's finding that 
products are unreasonably unsafe given that we have found that 
they are safe and effective. That is really the inconsistency 
between the----
    Chairman Waxman. Would the gentleman yield?
    Mr. Braley. Of course.
    Chairman Waxman. What troubles me is that you at FDA can 
agency this product appears to us, based on the science that 
has been presented to us by the manufacturer, that it is safe. 
And you approve it for use by the public. And then it turns out 
it is not safe, it is defective, and somebody is injured by 
this defective product, a drug let's say. Well, should we tell 
the injured person, you might have been injured by a defective 
product, but you can't go and sue the manufacturer, who might 
have even known it was defective, because the FDA said it was 
not defective when they approved it? That to me is an absurd 
position.
    Thank you for yielding.
    Mr. Braley. And, reclaiming my time, there is a doctrine 
that already exists in product liability law called post-sale 
duty to warn. It focuses on newly discovered information that 
has come to the knowledge of the manufacturer or potentially in 
this case to the FDA that raises concern about some information 
that was not known at the time that product was placed or 
approved. So I don't understand how the agency can contend that 
once you pass your Good Housekeeping seal of approval on a drug 
label that some subsequent problem, like the problem we saw 
today with the Heparin labels, could not bring about a change 
in the need for labeling requirements. Can you explain that?
    Mr. Lutter. We think there are already requirements on 
manufacturers to make label changes and recordkeeping and to 
report adverse events to us, and we think these go a long way 
toward ensuring the safety of the product.
    Chairman Waxman. Would the gentleman yield to me?
    Mr. Braley. Yes.
    Chairman Waxman. It is voluntary. A manufacturer of a drug 
does not have to report to you an adverse impact that they are 
informed of. It is voluntary.
    Staff person. It is voluntary for physicians.
    Chairman Waxman. Oh, I see. But the company is still 
required. So the physicians may know about an adverse impact of 
a drug.
    Mr. Lutter. It is mandatory, sir, the manufacturers must 
report to us the information that they collect. It is not 
mandatory that the physicians report to anybody. They may or 
may not do that.
    Mr. Braley. But getting to the point the chairman was 
raising, the manufacturer does not have a representative in the 
hospital room or the physician's office to monitor every 
adverse outcome, so how, if it is a voluntary reporting 
requirement for the people on the front line using the device 
or the medication, how is it possible that you can guarantee 
every adverse reaction or every adverse outcome with an 
approved medical device is going to get reported through your 
adverse system?
    Mr. Lutter. We cannot do that guarantee. Absolutely cannot.
    Mr. Braley. Isn't that the problem?
    Mr. Lutter. Well, that is the world that we live in, that 
we only have this information available to us. Given this 
information----
    Chairman Waxman. Would the gentleman yield?
    Mr. Braley. As soon as I finish this point I will be happy 
to.
    Mr. Lutter. But I think, given this information, the 
question is we are still asked, nonetheless, given the 
information that we have, to make judgments about adequate 
labeling of the products that we regulate.
    Mr. Braley. Let me put a fine point on this. Are you 
familiar with the Joint Commission on Accreditation of Health 
Care Organizations?
    Mr. Lutter. Yes.
    Mr. Braley. They are charged with collecting data on 
patient safety based upon the same type of medical mishaps we 
were talking about earlier in the hearing, and it is a 
voluntary reporting requirement, and they have had a system in 
place called a sentinel event reporting system that requires 
any sentinel event that results in serious injury or death to 
be reported, that a root cause analysis to be performed of what 
led to that event and an action plan be created to prevent that 
event from occurring in the future.
    In the 10-years that system has been in place, do you know 
how many sentinel event reports have been filed with JHACO?
    Mr. Lutter. I don't know.
    Mr. Braley. 3,000. That works out to 300 a year, and, given 
the numbers we were talking about, deaths only, 44,000 to 
98,000 a year due to preventable medical errors, I think you 
can appreciate how there is a huge gap between the number of 
adverse incidents and a voluntary reporting system. That is why 
some of us are so passionate about not allowing the FDA to be 
the last safeguard for these procedures.
    With that I will be happy to yield.
    Chairman Waxman. Will you yield to me?
    Mr. Braley. Yes.
    Chairman Waxman. And then I am going to yield to Mr. Shays.
    Look, you have companies that make these drugs. They have 
so much more resources to follow whether there are problems 
with their drugs. They have the marketers who talk to the 
doctors who can tell them about adverse impacts. They have 
reasons to want to improve their drugs, and they are following 
this information. They may know about it but FDA may not.
    Now, if someone is injured because a manufacturer decided, 
Well, I have already been approved by FDA, so therefore if 
somebody is hurt they can't sue me, they can't even get into 
court to sue me, why should I want to get so active in trying 
to do anything more to improve the safety of my drugs, and I 
will just take it, see if this is as big a problem as it may 
be.
    That is very little solace to somebody who is injured. 
Somebody who is injured by a drug that is defective has to be 
told the bureaucracy in Washington called the Food and Drug 
Administration approved this drug with the knowledge that we 
had at the time we approved it, and therefore you have been 
injured, you suffer. It is your hard luck. You pay for all the 
consequences.
    Now, that individual may pay for it, their insurance may 
pay for it, or all the taxpayers will pay for it. Who will not 
be liable and responsible is the manufacturer of the drug, who 
may have some culpability under all the tort laws in this 
country, which is not different from one State to another but 
generally the standard to which they are held.
    Mr. Shays.
    Mr. Shays. Thank you.
    My point in this is it is a fascinating debate, but, Mr. 
Sarbanes, you are making my point because you are saying you 
are the only one who has this expertise, that basically you 
have dealt with preemption issues, you have filed briefs, and 
so on, and you are dialoguing as a trial lawyer against a 
medical expert. All I am saying is I would learn more from 
having someone who has the same knowledge that you appear to 
have.
    And I would say to you, Mr. Chairman, when you were 
instrumental in 1986 in enacting the 1986 National Childhood 
Vaccine Injury Act, I don't want people to think that we don't 
want people to be dealt with fairly. There are just some of us 
who think this hearing today, with all due respect, is more 
about trial lawyers than it is about the health of our young 
people and our older people. That is the debate that we begin 
to wonder about.
    Shouldn't we find a way to compensate people without having 
to go through the courts, but do exactly what you did as it 
related to vaccines, which was landmark legislation. That, to 
me, is the kind of issue we should be debating.
    Chairman Waxman. Would the gentleman yield to me?
    Mr. Shays. Sure.
    Chairman Waxman. The Vaccine Compensation Act provided a 
system where, in rare cases, because it is mandated that every 
child be immunized, when there is an adverse impact, as there 
are going to be, very rare, but it is going to be, and we 
wanted to provide a compensation system for them, but we never 
ever precluded them from going to court. We never said now 
there is a preemption and the court cases will not be allowed, 
first of all.
    And second of all, you want to have a compensation system 
for everyone in this country with all the thousands of drugs 
and devices if anybody is injured without any showing of 
responsibility that suddenly they are going to be compensated? 
That is called universal health care. Great, but we don't have 
it, and a lot of people are going to be left in the lurch, 
injured, having to bear the burden of their injuries without 
any compensation from anybody.
    Mr. Shays. Let me just tell you what I wrestle with, 
though, because this is what you said in talking about the act. 
This is a quote I think that you made. ``No vaccine 
manufacturer shall be liable in a civil action for damages 
arising from a vaccine-related injury or death associated with 
the administration of a vaccine after October 1, 1988, if the 
injury or death resulted from side effects that were 
unavoidable, even though the vaccine was properly prepared and 
was accompanied by proper directions and warnings.''
    I think what you did was you took it out of the courts, you 
took it out of the trial lawyers, and you made sure that people 
would get the full benefit and not have to share it with anyone 
else. I think that made sense.
    Chairman Waxman. It is interesting you are quoting a 
statement from me from I don't know when, but I will tell you 
what the law requires, because that is the way I intended it to 
be. There is a compensation system because vaccines for 
children are a unique product. It is mandated that every child 
be immunized for childhood diseases, and because of that, in 
order to----
    Mr. Shays. I need to correct something. I am sorry. This 
was not your quote, it was taken directly from the act, itself. 
I apologize.
    Chairman Waxman. And the act provides that this 
compensation system will compensate a child who has an adverse 
impact, but it does not preclude that child from going into the 
courts and suing under tort law in the State in which that 
child resides. We did not preempt the courts in that 
legislation, even though we tried to provide another 
alternative. There is no other alternative for the adults and 
children who use drugs that are not vaccines. If they are 
injured and it is the fault of the manufacturer, they should be 
able to go into court and prove it. They have a job to prove 
it. And if they can't prove it, they don't recover it.
    If the drug has been approved by the FDA, that will be 
introduced in evidence. But this preemption idea precludes that 
person from ever getting into court in the first place. The 
manufacturer can just simply say, You can't sue me. There is a 
bureaucracy in Washington called the FDA. They approved this 
product, and even though there are problems with the product 
that they didn't know about, that means I am home free.
    Well, trial lawyers, people who are injured usually get 
lawyers to represent them. They don't have a good chance on 
their own to represent themselves. There is nothing wrong with 
people having representation. I am sure you will fight to the 
end to make sure that the rich and powerful are represented 
here in Washington and elsewhere. The poor often are 
represented by trial lawyers who take the case because they 
realize that they can recover damages and they should recover 
damages.
    This is not a trial lawyer issue, this is a consumer issue. 
I think it is a red herring to say the trial lawyers. It is the 
consumers who are going to be left out in the cold.
    And if you want to be mean about it you could say perhaps 
some postal are more concerned about--and I am not saying this 
about you--some people are more concerned about the drug 
manufacturers than they are about the people who may be injured 
by those products.
    Well, unless anybody else has another thought to throw into 
the stew, I think we have had an interesting hearing, a lot to 
think about, and I wish Congress had this before us to decide 
and debate, not the FDA Bureaucrats to make a decision on their 
own based on some ideology of power that they don't really have 
and an ideology to put in place their view of the world.
    We want to keep the record open for any other submissions 
that Members may wish to make. There are two statements, one by 
Dianna Wynn Levine, and I would like that statement to be made 
part of the record, and testimony of Cybil Nighten Goldrich, as 
well.
    [The prepared statement of Ms. Levine follows:]

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    Chairman Waxman. The record will be held open for other 
comments or any other items that Members wish to add to that 
record.
    We stand adjourned.
    [Whereupon, at 3:03 p.m., the committee was adjourned.]

                                 
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