[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
http://www.house.gov/reform
U.S. GOVERNMENT PRINTING OFFICE
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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:]
[GRAPHIC] [TIFF OMITTED] T6191.144
[GRAPHIC] [TIFF OMITTED] T6191.145
[GRAPHIC] [TIFF OMITTED] T6191.146
[GRAPHIC] [TIFF OMITTED] T6191.147
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.]