[House Hearing, 111 Congress]
[From the U.S. Government Publishing Office]
H.R. 1346, THE MEDICAL DEVICE SAFETY ACT OF 2009
=======================================================================
HEARING
BEFORE THE
SUBCOMMITTEE ON HEALTH
OF THE
COMMITTEE ON ENERGY AND COMMERCE
HOUSE OF REPRESENTATIVES
ONE HUNDRED ELEVENTH CONGRESS
FIRST SESSION
__________
MAY 12, 2009
__________
Serial No. 111-39
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COMMITTEE ON ENERGY AND COMMERCE
HENRY A. WAXMAN, California, Chairman
JOHN D. DINGELL, Michigan JOE BARTON, Texas
Chairman Emeritus Ranking Member
EDWARD J. MARKEY, Massachusetts RALPH M. HALL, Texas
RICK BOUCHER, Virginia FRED UPTON, Michigan
FRANK PALLONE, Jr., New Jersey CLIFF STEARNS, Florida
BART GORDON, Tennessee NATHAN DEAL, Georgia
BOBBY L. RUSH, Illinois ED WHITFIELD, Kentucky
ANNA G. ESHOO, California JOHN SHIMKUS, Illinois
BART STUPAK, Michigan JOHN B. SHADEGG, Arizona
ELIOT L. ENGEL, New York ROY BLUNT, Missouri
GENE GREEN, Texas STEVE BUYER, Indiana
DIANA DeGETTE, Colorado GEORGE RADANOVICH, California
Vice Chairman JOSEPH R. PITTS, Pennsylvania
LOIS CAPPS, California MARY BONO MACK, California
MICHAEL F. DOYLE, Pennsylvania GREG WALDEN, Oregon
JANE HARMAN, California LEE TERRY, Nebraska
TOM ALLEN, Maine MIKE ROGERS, Michigan
JAN SCHAKOWSKY, Illinois SUE WILKINS MYRICK, North Carolina
HILDA L. SOLIS, California JOHN SULLIVAN, Oklahoma
CHARLES A. GONZALEZ, Texas TIM MURPHY, Pennsylvania
JAY INSLEE, Washington MICHAEL C. BURGESS, Texas
TAMMY BALDWIN, Wisconsin MARSHA BLACKBURN, Tennessee
MIKE ROSS, Arkansas PHIL GINGREY, Georgia
ANTHONY D. WEINER, New York STEVE SCALISE, Louisiana
JIM MATHESON, Utah PARKER GRIFFITH, Alabama
G.K. BUTTERFIELD, North Carolina ROBERT E. LATTA, Ohio
CHARLIE MELANCON, Louisiana
JOHN BARROW, Georgia
BARON P. HILL, Indiana
DORIS O. MATSUI, California
DONNA M. CHRISTENSEN, Virgin
Islands
KATHY CASTOR, Florida
JOHN P. SARBANES, Maryland
CHRISTOPHER MURPHY, Connecticut
ZACHARY T. SPACE, Ohio
JERRY McNERNEY, California
BETTY SUTTON, Ohio
BRUCE L. BRALEY, Iowa
PETER WELCH, Vermont
(ii)
Subcommittee on Health
FRANK PALLONE, Jr., New Jersey, Chairman
JOHN D. DINGELL, Michigan NATHAN DEAL, Georgia,
BART GORDON, Tennessee Ranking Member
ANNA G. ESHOO, California RALPH M. HALL, Texas
ELIOT L. ENGEL, New York BARBARA CUBIN, Wyoming
GENE GREEN, Texas HEATHER WILSON, New Mexico
DIANA DeGETTE, Colorado JOHN B. SHADEGG, Arizona
LOIS CAPPS, California STEVE BUYER, Indiana
JAN SCHAKOWSKY, Illinois JOSEPH R. PITTS, Pennsylvania
TAMMY BALDWIN, Wisconsin MARY BONO MACK, California
MIKE ROSS, Arkansas MIKE FERGUSON, New Jersey
ANTHONY D. WEINER, New York MIKE ROGERS, Michigan
JIM MATHESON, Utah SUE WILKINS MYRICK, North Carolina
JANE HARMAN, California JOHN SULLIVAN, Oklahoma
CHARLES A. GONZALEZ, Texas TIM MURPHY, Pennsylvania
JOHN BARROW, Georgia MICHAEL C. BURGESS, Texas
DONNA M. CHRISTENSEN, Virgin
Islands
KATHY CASTOR, Florida
JOHN P. SARBANES, Maryland
CHRISTOPHER S. MURPHY, Connecticut
ZACHARY T. SPACE, Ohio
BETTY SUTTON, Ohio
BRUCE L. BRALEY, Iowa
C O N T E N T S
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Page
Hon. Frank Pallone, Jr., a Representative in Congress from the
State of New Jersey, opening statement......................... 1
Hon. Henry A. Waxman, a Representative in Congress from the State
of California, opening statement............................... 4
Prepared statement........................................... 6
Hon. John D. Dingell, a Representative in Congress from the State
of Michigan, opening statement................................. 12
Hon. Steve Buyer, a Representative in Congress from the State of
Indiana, opening statement..................................... 14
Hon. Bruce L. Braley, a Representative in Congress from the State
of Iowa, opening statement..................................... 15
Hon. Joseph R. Pitts, a Representative in Congress from the
Commonwealth of Pennsylvania, opening statement................ 25
Hon. Michael C. Burgess, a Representative in Congress from the
State of Texas, opening statement.............................. 26
Hon. Marsha Blackburn, a Representative in Congress from the
State of Tennessee, opening statement.......................... 28
Hon. Anna G. Eshoo, a Representative in Congress from the State
of California, prepared statement.............................. 132
Witnesses
David Vladeck, J.D., Professor of Law, Georgetown University Law
Center......................................................... 30
Prepared statement........................................... 32
William H. Maisel, M.D., M.P.H., Director, Medical Device Safety
Institute, Department of Medicine, Beth Israel Deaconess
Medical Center, Boston......................................... 58
Prepared statement........................................... 60
Gregory Curfman, M.D., Editor, New England Journal of Medicine... 66
Prepared statement........................................... 68
Bridget Robb, Gwynedd, Pennsylvania.............................. 73
Prepared statement........................................... 75
Richard Cooper, Partner, Williams & Connolly LLP................. 94
Prepared statement........................................... 96
Michael Kinsley, Seattle, Washington............................. 114
Prepared statement........................................... 115
Submitted Material
Ruling of U.S. District Court of Minnesota, dated May 12, 2009,
submitted by Mr. Braley........................................ 17
Letter of May 11, 2009, from Albert J. Dahm to Committee,
submitted by Mr. Shimkus....................................... 133
Letter of May 11, 2009, from Vietnam Veterans of America to
Committee, submitted by Mr. Shimkus............................ 135
H.R. 1346, THE MEDICAL DEVICE SAFETY ACT OF 2009
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TUESDAY, MAY 12, 2009
House of Representatives,
Subcommittee on Health,
Committee on Energy and Commerce,
Washington, DC.
The subcommittee met, pursuant to call, at 2:12 p.m., in
Room 2123, Rayburn House Office Building, Hon. Frank Pallone,
Jr., [chairman of the subcommittee] presiding.
Present: Representatives Pallone, Dingell, Matheson,
Christensen, Castor, Sarbanes, Murphy of Connecticut, Braley,
Waxman (ex officio), Deal, Shimkus, Blunt, Buyer, Pitts,
Burgess, Blackburn, Gingrey, and Barton (ex officio).
Staff Present: Rachel Sher, Legislative Counsel; Sarah
Despres, Legislative Counsel; Eric Flann, FDA Detailee; Alvin
Banks, Special Assistant; Lindsay Leshin, Special Assistant;
Ryan Long, Minority Chief Health Counsel; Clay Alspach,
Minority Counsel; and Chad Grant, Minority Legislative Analyst.
OPENING STATEMENT OF HON. FRANK PALLONE, JR.
Mr. Pallone. Good morning. I am so out of it. I have been
having too many speeches and too many meetings. I apologize.
Good afternoon.
The subcommittee today is a meeting to review H.R. 1346,
the Medical Device Safety Act of 2009. We have made huge
advances in medicine over the last few decades. New and
emerging technologies hold promises that our great grandparents
could never have imagined. Many illnesses that were once a
death sentence are now preventable, curable, or are at least
manageable through modern medical treatments. However, though
these medical advances offer huge benefits, they also present a
certain amount of risk.
For example, there have been recent stories of patients who
have suffered serious injuries from defective FDA-approved
devices like implantable cardiac defibrillators and pacemakers.
To use an example from my home State of New Jersey, there was a
young girl who was 14 years old who was one of the victims
affected by a faulty medical device. Last year, she felt a very
strong pain through her body that she described as ``a horse
trampling me.'' Eventually, she realized that her implantable
cardiac defibrillator was shocking her, and it continued to do
so 18 times. When the paramedics arrived at the scene, they
found this little girl lying on the floor, begging for someone
to remove the device from her body. She spent the next 4 days
at a Children's Hospital, waiting to have the surgery to remove
the device. Though the faulty device is no longer inside her
body, she still suffers from significant anxiety triggered by
the slightest heart palpitation or any beeping sound she hears.
The medical costs this family in New Jersey now bears as a
result of the surgery and side effects are tremendous.
Unfortunately, I use that example of the little girl from
New Jersey, but the problem is that she and her family have no
opportunity for legal recourse, and she is not alone in this
problem.
In February of last year, the U.S. Supreme Court
deliberated the Riegel v. Medtronic case and made a decision
that, in effect, relieved medical device companies from the
responsibility of ensuring the safety of their products. The
Supreme Court ruled that patients could not receive
compensation for their injuries--medical expenses and lost
wages--caused by defective premarket approval, PMA devices, or
inadequate safety warnings. Now, this decision, in my opinion,
ignores congressional intent and is contrary to the Medical
Device Amendments or at least the way they have been
interpreted since the legislation was passed in 1976.
For the past 30 years, Federal regulation through the FDA,
together with tort liability, played crucial roles in
protecting consumers from risky devices. Already, this Supreme
Court decision has had a devastating impact on patients who
have been harmed by defective medical devices. For example, a
Federal judge in Minnesota threw out more than 1,400 lawsuits
filed by patients who had defective heart defibrillator wires
or leads implanted. Many of them died as a result. The judge
based his decision on the Riegel case and noted that the only
way to remedy the situation was for Congress to step in.
It is crucially important that all of the major
stakeholders involved in manufacturing medical devices make
patient safety their main priority. We must be certain that we
are taking every step necessary to ensure that the technologies
designed to save lives are not placing people in danger. Much
of the data used by the FDA in premarket approvals for both
drugs and devices is limited in the number of individuals who
are monitored as well as in the time frames that they are
collected. These studies are vital in making safety and
efficacy determinations while, at the same time, getting life-
saving treatments to patients in a timely fashion.
However, the Institute of Medicine has recommended that the
risk and benefits of these treatment options should be
monitored through the entire life cycle. This means that the
manufacturer has a responsibility for the safety of their
product for as long as it is being used by patients, not just
during pre-approval trials.
Until last year, the State court system provided an
additional incentive for companies to actually follow this
recommendation. Unfortunately, the Riegel v. Medtronic case and
its effects have removed that incentive and have provided
medical device companies with blanket immunity. The court
premised its decision on the theory that FDA approval
adequately protects patients from unsafe medical devices. That
theory, in my opinion, has proven false time and again.
So that is why I, along with Mr. Waxman, our full committee
chairman, introduced the Medical Device Safety Act of 2009, the
bill we are examining today. This bill protects patients from
dangerous and defective devices by correcting the Court's
flawed interpretation of the Medical Device Amendments of 1976.
The bill explicitly clarifies the State product liability
lawsuits are preserved and puts safety first by eliminating the
blanket immunity that medical device companies currently enjoy.
There is precedence for this as the Supreme Court just a
few months ago ruled in favor of a plaintiff in a case against
a drug company. In that case, the Court upheld congressional
intent and placed the responsibility for making the safe
products squarely within the company's purview; and it is
crucial, in my opinion, that we act now to provide patients in
need of a medical device with that same certainty.
So I want to thank all of you. I will introduce you after
we have the opening statements from the rest of the committee.
I now recognize my colleague from Georgia, Mr. Deal.
Mr. Deal. Thank you, Mr. Chairman. Thank you for having
this hearing today; and thanks to the witnesses who have come
to share their positions and opinions on this legislation, H.R.
1346.
Although the legislation is less than one page in length,
the legislative impact of the legislation is significant and I
think cannot be discontinued based on its own brevity.
The United States is and should remain at the forefront of
medical device innovation, a position which I believe would be
undermined by this bill. The medical industry in the United
States has grown as a worldwide leader in innovation and
development, providing therapeutic advances for patients and
their physicians to treat complicated medical conditions as the
advance of science and medicine in our country continues to
grow. This has been shared around the world.
Critical life-saving devices such as neurostimulation
devices, cardiac defibrillators, and pacemakers have improved
the longevity and the quality of life for countless Americans
who depend on these technologies every day. What must be
considered when evaluating the merit of legislation to
eliminate preemption of State tort claims with respect to these
critical devices is the resulting impact which will occur on
the development of new products.
Eliminating preemption will stifle innovation. In my
opinion, it will increase the risk among manufacturers who are
on the cutting edge of medical device development; and it will
prove detrimental to patients in dire need of innovative
solutions to complex, hard-to-treat medical conditions.
In the case that the chairman referred to of Riegel v.
Medtronic, the United States Supreme Court, as well as six out
of seven Federal circuit courts, confirmed the widely held view
that the Medical Device Amendments Act, MDA, does indeed
preempt State common law claims with respect to devices
approved through the premarket approval process, which is the
most rigorous approval process for medical devices. What seems
to have been forgotten is that the vast majority of State
common law claims involving most medical devices are still
permitted.
First, the preemption provision provided under the MDA
applies to approximately 2 percent of devices approved by the
FDA each year, those which are approved under the premarket
approval pathway. The majority of medical devices each year,
those which are approved through the 510(k) process, are not
preempted under current law.
Second, it is also important to remember that if a device
is improperly manufactured or the source company withholds
information from the FDA or it misleads the FDA and consumers
about the safety and effectiveness of the product, the MDA does
not preclude common law tort liability cases in State court.
Patients who incur harm are fully capable of pursuing such just
recourse for their harm.
I urge the members of this subcommittee to take the same
approach which the FDA takes in approving these devices by
evaluating the risk versus benefits of this legislation. Given
the detrimental impact H.R. 1346 will likely pose on the
development and innovation of promising new technologies
promoted by heightened litigious environments surrounding these
products, we will be instituting roadblocks contrary to the
overall mission of this committee and of the Food and Drug
Administration, which has the responsibility of improving the
health of American patients across the country.
Thank you, Mr. Chairman. I look forward to the testimony of
the witnesses, and I yield back.
Mr. Pallone. Thank you, Mr. Deal.
Chairman Waxman.
OPENING STATEMENT OF HON. HENRY A. WAXMAN
Mr. Waxman. Thank you very much, Mr. Chairman.
I welcome the witnesses to today's hearing as well.
Until February of last year, when Americans were injured by
defective medical devices they had a remedy. In most States,
they were able to sue the manufacturer of that product for
damages in State court. In fact, the only way patients could
obtain compensation was to bring a lawsuit under State law.
But in February, 2008, the Supreme Court dramatically
altered this landscape in its Riegel v. Medtronic decision. The
court ruled that, so long as the FDA has approved a medical
device, patients injured by that device could no longer seek
compensation to help them deal with their permanent
disabilities, their inability to work, and their costly medical
procedures.
Ironically, the decision applies only to the most dangerous
and most complex devices, the kind of devices that, when they
malfunction, often result in death or in severe physical
impairment. This decision has already had a devastating impact
in the over 1,400 cases brought by injured patients that have
been thrown out. We learned that another 300 cases were
terminated under Riegel and that countless other lawsuits will
never be brought.
In the wake of the Court's decision, it does not matter how
badly a defective device has harmed a patient. It does not
matter how egregious the device manufacturer's conduct was in
marketing a defective device. Patients have no recourse and no
ability to be compensated for their injuries.
The Court's decision was bad for Americans in another way,
too. It has destroyed one of the most powerful incentives for
safety, the possibility of liability. We know that some device
companies have hidden and have manipulated important safety
data. Some have failed to report serious adverse events. Some
have failed to disclose known defects. Yet, under the Court's
decision, even if a company withholds information about
potentially fatal defects from physicians, patients, or the
FDA, it is still immune from any liability for its actions.
In the absence of liability, all of the financial
incentives will point medical device companies in the wrong
direction. Tragically, the end result is that these abusive
practices will undoubtedly multiply.
Now, some would counter the FDA will be there to protect
against these abuses. The FDA approved these devices, so why
should we have juries second-guessing the FDA's expert
judgment? Well, as a result of chronic underfunding and weak
leadership, the FDA's ability to protect the public has
plummeted. In fact, the FDA's own science board issued a report
saying that the agency is so starved of resources that
``American lives are at risk.''
Even if we were to give the FDA every penny it needs, there
would still be a compelling argument for our system of State
liability laws. That is because we operate on a model that
relies on the industry to innovate, research, develop, and
market their products. The FDA is not the only one playing this
role, so the device companies themselves will always know more
about their products than will the FDA.
Here is another problem. The clinical trials upon which the
FDA relies to approve drugs or devices are often too small to
detect less frequent risks. Some risks can only be detected
when the drug or medical device is used in the population at
large.
I was here, as well as Mr. Dingell and very few others on
the committee, when the medical device law was adopted; and at
no point in the consideration of that legislation did we expect
that the preemption language, which was that the FDA has the
sole responsibility to approve a product, meant that we were
trying to preempt the States from the liability laws. Liability
laws have always been in place to serve a very important role;
and I was disappointed to see the Supreme Court come up with
the decision it did, using that language, which of course they
did not find in the medical drug section, to preempt the State
liability laws.
I hope that we will overturn the decision of the Supreme
Court and will allow State laws to continue to play an
important role in protecting consumers.
Thank you, Mr. Chairman.
[The prepared statement of Mr. Waxman follows:]
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Mr. Pallone. Thank you, Chairman Waxman.
The gentleman from Illinois, Mr. Shimkus.
Mr. Shimkus. Thank you, Mr. Chairman.
We are going to hear many difficult, tough stories today,
but I know we have Mr. Kinsley here to talk about the other
side, and I would just plead for people to remember the
thousands of people who have greatly benefited from--the one
aspect I know is the cerebellar or the spinal cord stimulators.
Now, I had a chance to visit with a couple of individuals
today--Mike Roman from Des Peres, Missouri, and Adam Homhammon,
who was an Army guy. I had a chance to visit with them, and
their stories are just as compelling of the serious pain which
they were under, to a point where they were of no benefit, only
to the pharmaceutical companies who had to medicate them
severely to ease their pain. They were not able to function in
today's society. Because of this technological advance, one
walked into my office. The other one jumped off the wheelchair
and talked to me about how his life had been changed for the
good.
Now, the doctors have the Hippocratic oath, which says,
``first do no harm.'' We had better be very, very, very careful
that, in trying to fix the problems of some, we do not turn
over the opportunity for this really new, life-giving
technology to be available for people who desperately need it.
So, Mr. Chairman, I would preach caution and concern for
both sides as we move forward; and I yield back the balance of
my time.
Mr. Pallone. Thank you, Mr. Shimkus.
Chairman Dingell.
OPENING STATEMENT OF HON. JOHN D. DINGELL
Mr. Dingell. Mr. Chairman, I thank you for holding today's
legislative hearing on H.R. 1346, the Medical Device Safety Act
of 2009. I am an original cosponsor of this legislation, and I
strongly believe that it is necessary to reinforce
congressional intent on a very important policy matter.
I want to thank the witnesses who have joined us today, and
I look forward very much to hearing their testimony.
Prior to 1976, in the absence of Federal regulation, States
enacted their own laws governing medical devices. So, in an
effort to streamline medical device safety policy, the Congress
acted. In 1976, we passed the Medical Device Amendments. Our
legislative intent was to give the FDA the power to regulate
the approval of medical devices for U.S. consumers. We
concluded that it was necessary to include a preemptive clause
to make sure that Federal regulation, through the FDA,
preempted State regulation on medical devices. We included no
other preemptions. We did not, I note, however, expressly nor
implicitly do away with State liability actions.
Unfortunately, the U.S. Supreme Court in Riegel v.
Medtronic, Inc. in 2008 decided to create legislative intent
where there was none and immune medical devices from State
product liability law. Now, people complain about activist
judges. Here is a fine example of people who are running out to
find congressional intent where none existed.
I urge my colleagues to remember that there are three
coordinate and coequal branches of the Federal Government with
distinctive duties and responsibilities. The appropriate
application of Federal preemption should be determined by the
Congress, not concocted in preambles to Federal regulations or
decided through case law. Though, in 2008, with the Riegel
decision, an activist judiciary decided to constrict State
authority in the way Congress never intended. Therefore, it is
time for the Congress to act properly, to exercise our
authority, and to correct this clear judicial overreach.
In this instance, the use of tort litigation is beneficial,
because it will protect consumers where Federal regulation
fails to anticipate latent danger in medical devices. When the
Congress wants to preempt, I think it has the great talent in
saying so in the legislation. None, I repeat, is here to be
found.
The Food and Drug Administration, I want to note, has been
starved for resources for a number of years. This has made it
almost impossible for them to adequately ensure the safety of
the products they regulate. All you have to do is look back at
the flood of unsafe foods, commodities, pharmaceuticals, and of
other things coming in from China and elsewhere abroad, as well
as things that are slipping into our American economy because
of the total inability of the FDA to properly protect American
consumers.
It is to be noted that the FDA does not have the ability to
ensure the safety of the products they regulate. The FDA's IT
systems are antiquated, its science base has eroded, its
laboratories are a joke, and it does not have adequate
personnel or, quite honestly, adequate authority to deal with
its responsibilities.
I will note, parenthetically, I have a good bill, H.R. 759,
that will go a long way in addressing this issue, and we can
get back to protecting our people in the way we should. Until
this can be done, we, very frankly, need to see to it that
citizens and Attorneys General have the capacity to properly
protect American consumers. So, until we properly equip the FDA
with the resources to do its job, consumers should have the
ability to seek redress under the law.
I would note that, as of late, we have seen many instances
where a lot of do-gooders have run out and have stripped
Federal agencies of the authority to regulate either
legislatively or in courts. We saw it in securities, and we saw
Enron follow, and a lot of other bad things happened. We have
seen them do it with regard to banks in the repeal of Glass-
Steagall, in the deregulation of the securities industry, and
in the deregulation of banks. Then, all of a sudden, we found
that we had a magnificent depression on our hands because of
the abuses of the banks in their repeating the same things that
they did in 1920 and in 1929.
Having said this, there may be a day come when we will no
longer need State liability to protect consumers from defective
medical devices. Unfortunately, that day is not here, and it is
not likely to come until we have dealt with the weaknesses of
the FDA in its inadequate budget and in its total inability to
properly protect American consumers.
For those who paid attention in 1976, we made our intent
clear. For those unfortunates needing clarification, we can
point to H.R. 1346. It tells people what we had in mind then
and what we have in mind now.
Thank you, Mr. Chairman, for holding this hearing. I look
forward to receiving the testimony of our witnesses.
Mr. Pallone. Thank you, Chairman Dingell.
The gentleman from Missouri, Mr. Blunt.
Mr. Blunt. Thank you, Mr. Chairman. Thank you for holding
this hearing on the Medical Device Safety Act of 2009.
It is certainly important that we carefully consider the
possible impacts this legislation could have on patients and on
the companies that produce life-saving and life-changing
devices for those patients. It is extremely important that any
medical device on the market undergoes a thorough and
appropriate approval process to ensure the safety of the
patients who need them.
If a company fails to ensure they are manufacturing the
highest quality devices and that there are adverse impacts on a
patient, then they should be held responsible. On the other
hand, if the manufacturer has done everything in its power to
put a device through the proper approval processes, to
correctly manufacture the device and to properly inform its
customers, it cannot be held responsible for situations beyond
its control.
We need to make sure, as we look at this bill and this
subject, that companies are not subject to overly burdensome
regulations, because this would ultimately cause patients to
suffer in the form of decreased access and decreased innovation
of medical devices.
I look forward to working with you, Mr. Chairman, with Mr.
Deal, and with the subcommittee as we move forward on this
issue. I also look forward to the panel today.
Mr. Pallone. Thank you, Mr. Blunt.
Mr. Murphy of Connecticut.
Mr. Murphy of Connecticut. Thank you very much, Mr.
Chairman.
Just very briefly, I would like to thank you for holding
this hearing today. I understand that the focus of much of our
discussion today is going to be the precedence set in Riegel,
but, as someone new to this debate, I look forward to hearing
from the panel about their ideas on how to truly make the
fundamental reforms to the FDA process that Mr. Dingell and
many others have referenced.
I absolutely believe that tort law can be an effective
check against unsafe products, but I also understand that it
can be a patchwork check on those products. So I look forward
to hearing today both about the precedent that has been set and
about our opportunity to transform it, but I also look forward
to hearing from this panel and from those who will come before
this committee in the future to hear about how we can truly put
teeth into the FDA. There is no reason to give up on that
process; and I stand ready, at the very least, to be part of a
process by which we can make that approval process work once
again.
Thank you, Mr. Chairman.
Mr. Pallone. Thank you.
The gentleman from Indiana, Mr. Buyer.
OPENING STATEMENT OF HON. STEVE BUYER
Mr. Buyer. Thank you, Mr. Chairman.
I want to comment on two points. One came from my dear
friend, Mr. Waxman. The reason I need to make this point is
that he talked about how the FDA, right now being an
underfunded agency, is ill-equipped to protect the public
because it has been woefully underfunded. All right. Let us
stop and think about that for a moment: woefully underfunded.
Mr. Waxman, what did you just do and this committee just do
with regard to tobacco legislation? You gave it a new mission
on top of a core mission that is counter to its culture. If, in
fact, we have an agency that is underfunded, we should be
funding the agency and should be making sure that it does its
job so that the best minds in the world can assess these
products to make sure that we have the gold standard of safety,
not to turn it over to juries and to judges and to the
cleverness of trial lawyers. That is the wrong place. That is
the wrong venue. It is the wrong jurisdiction to have the
supervision of medical devices. So that is a bizarre logic for
me.
The second point is with regard to my other dear friend,
Mr. Dingell, who was talking about activist judges. Boy, this
is in the hands of the beholder when conservative courts are
now considered to be activist courts because of their
interpretation of the law. Now whom are they embracing? No, who
they are embracing is the circuit, the 11th circuit that is out
of step with all other circuits is who Mr. Waxman is embracing.
For the years that I served on the Judiciary Committee, I
sought to sever the 11th circuit. I would break it into six
parts if I could. It is the most bizarre circuit with regard to
its judgments for the country. So for us as a committee to
embrace the 11th circuit as though that is, in fact, the
judgment that should be made for the whole of the country, I
think it is twisted logic.
Now, I agree with the judgments of the Supreme Court. I
think they made the right decision. I think they brought
clarity to the issue.
The other point I want to make is that, in the Court's
decision in Riegel, it confirmed, yes, that the MDA does
preempt State common law with respect to devices approved for
the premarket approval process, but it further confirmed that
the manufacturer, if it engages in wrongful conduct, can be
held liable.
Now, think about if some of us wanted to go to the
marketplace at risk, pool our capital, and push the bounds of
science. We have created something. We go through the approval
process, and we do everything that the FDA says we are supposed
to do. Yet what? We want to turn that over, even though we have
done everything we are supposed to do, to all of these State
court jurisdictions?
If I am the manufacturer and I have got a State out there
that is out of step and bizarre, I will not market that product
in that State. Then the people who live in that State will
suffer.
Is that the type of equity we bring to America? I do not
think so.
I yield back.
Mr. Pallone. Mr. Braley of Iowa.
OPENING STATEMENT OF HON. BRUCE L. BRALEY
Mr. Braley. Thank you, Mr. Chairman, for holding this
important hearing.
It is a very important distinction to draw that what we are
talking about today is a restoration of rights that existed in
this country for over 100 years, not the creation of some new
cause of action. In fact, Justice Ginsburg, in his dissenting
opinion, referred to this as a radical curtailment of State
common law remedy.
As someone who has not only researched, briefed, and argued
Federal preemption cases in both State and Federal courts, I
can tell you from personal experience that the key issue in
every Federal preemption case is the original intent of
Congress as expressly stated and that, in the application of
the law to that issue, the question is always a presumption
against preemption, because it is such an extraordinary action
to take.
In fact, the Court, in its opinion, cited the legislative
history, which is always one of the first things you look at in
determining congressional intent, and it referred specifically
to the Senate sponsor of the bill, Senator Kennedy, who noted
at the time the bill was introduced that the legislation is
written so that the benefit of the doubt is always given to the
consumer. After all, it is the consumer who pays with his
health and with his life for medical device malfunctions.
It also quoted Chairman Waxman, who I am sure would be
surprised that he was being cited as one of the contributing
members whose congressional intent shaped the Court's eventual
outcome.
One of the things that was also mentioned in the dissenting
opinion was the perverse effect of immunity. The Court focused
on fact that, at the time this Act was brought before Congress
in 1976, it was at a time when the entire industry, according
to the judgment of Congress, needed more stringent regulation.
If you look at Justice Scalia's opinion, he notes that, when
these devices enter the market, they have never been formally
reviewed under the MDA for safety or efficacy.
Mr. Chairman, I would like to note, as Chairman Waxman
referred to earlier, that just today, in the United States
District Court for the District of Minnesota, 300 additional
people who were injured or killed by defective medical devices
had their cases thrown out because of this decision.
I would ask unanimous consent for the ruling that was
handed down today to be included as part of the record.
Mr. Pallone. Without objection, so ordered.
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Mr. Braley. Now, one of the things we often hear about are
reasons that this bill should not be passed. Let me give you
four conservative reasons to support the passage of this bill.
Number one, it holds corporate wrongdoers accountable when
they injure or kill people with defective devices.
Number two, when you provide immunity to medical device
manufacturers, you create greater exposure for the physicians
who install them and for the hospitals where they are
installed.
Number three, as Dr. Maisel noted last year during our
hearing, it results in the cost shifting to U.S. taxpayers, who
end up paying for the care of these patients who have no other
remedy.
Number four, we see a flood of defective medical devices
flowing in from overseas.
Those are conservative reasons right there, and that is why
we need to pass this bill.
Mr. Pallone. Thank you.
The gentleman from Pennsylvania, Mr. Pitts.
OPENING STATEMENT OF HON. JOSEPH R. PITTS
Mr. Pitts. Thank you, Mr. Chairman. Thank you for convening
this hearing.
The bill we are discussing today, H.R. 1346, would overturn
the 8-1 Supreme Court decision in Riegel v. Medtronic. In this
2008 decision, the Court held that the preemption clause
contained in the Medical Device Amendments Act bars common law
claims challenging the safety of a medical device granted
premarket approval by the FDA. This decision is extremely
limited in scope. Only those devices that receive premarket
approval, or PMA--approximately 2 percent of the new medical
devices marketed per year--have express preemption.
Riegel also makes it clear that preemption does not apply
to PMA devices if the manufacturer withholds information from
the FDA, if it misleads the FDA about the safety or
effectiveness of its product, or if the company manufactures a
product improperly. In such case, a company can be sued for its
wrongful behavior.
The PMA process is scientifically rigorous. The FDA spends
an average of 1,200 hours reviewing each application, including
a device's proposed labeling. In granting PMA, the FDA has
determined that the probable benefit to help from the use of
the device outweighs any probable risk of injury or of illness
from use.
Once a device is approved through the PMA process, the
manufacturer is subject to reporting requirements, including
informing the FDA of new clinical or scientific studies
regarding a device and reporting incidents in which the device
failed or contributed to significant injury.
The FDA can withdraw its approval if a device is found not
to be safe or effective. The FDA can order a recall if it is
determined that a reasonable probability exists that a device
could cause serious injury or death.
What would the consequences be if these life-saving,
complex devices did not receive express preemption as would be
the case if H.R. 1346 became law?
Companies that manufactured and labeled their products
according to FDA-approved standards could be sued in State
courts and found at fault if a device causes injury or harm. A
lay jury would be presented with a case in which an individual
was harmed by a device, and its judgment would be substituted
for that of the FDA's. Fifty courts in fifty States could each
determine what standard a device should meet. Innovation would
be stifled. Venture capital could dry up with the threat of
litigation once a product hits the market. Manufacturers could
pull products from the market or could refuse to sell them in
certain States as a result of court cases. People who
desperately need these life-sustaining devices may not have
access to them.
No device, no matter what the approval process, will ever
be 100 percent safe and effective, but when the FDA grants
premarket approval, it has judged that the benefits of the
population at large outweigh the risk to the population at
large.
The Riegel case was decided properly, and H.R. 1346 is
simply bad policy. We all want only those medical devices that
are safe and effective to be on the market. H.R. 1346 will not
help us to achieve that.
I look forward to hearing the witnesses today.
I yield back.
Mr. Pallone. Thank you, Mr. Pitts.
The gentleman from Texas, Mr. Burgess.
OPENING STATEMENT OF HON. MICHAEL C. BURGESS
Mr. Burgess. I thank the chairman. I thank our witnesses
for being here with us today and for listening to our opening
statements. We will listen to yours in just a moment.
Certainly, the Food and Drug Administration categorizes
devices into three categories: Class I devices are subject to
minimal requirements. Some easy examples of that would be latex
gloves, bedpans, and urinals. Class II devices are subject to
more requirements that include such items as hearing aids.
H.R. 1346 is not aimed at Class I and Class II devices. It
is aimed at high-risk devices known as Class III. Class III
devices are considered high risk because they are complex and
are used to support or to sustain human life or whose use is of
substantial importance in preventing the impairment of human
health. They are most certainly life-changing devices with no
100 percent guarantee of safety or efficacy. With Class III
devices, there are calculated risks involved.
Now, when weighing the interests of a manufacturer against
the life of a human being, there is no question about what side
you would come down on. You would come down on the side of the
human being. But preemption does not do that, nor does
preemption bar State common tort laws. Preemption is not a get-
out-of-jail-free card for bad actors taken to court. If a
medical device manufacturer violated the essential premise of
producing a safe product, there are still remedies, despite the
Supreme Court's 8-1 ruling in Riegel v. Medtronic.
What the Supreme Court recognized in Riegel v. Medtronic
are two things:
First, the Supreme Court found that premarket approval for
devices by the Food and Drug Administration is rigorous, even
arduous, with 1,200 hours or more of review for each potential
device and with the undergoing of clinical trials, and a
company must give countless pages of documentation to the
scientific experts of the Food and Drug Administration.
A review by the Food and Drug Administration does not end
with the premarket studies. Postmarket approval is continuous
and frequent. If a manufacturer fails to maintain the Food and
Drug Administration's standard of approval by being
disingenuous or by the failure to be transparent, then approval
can be rescinded.
The strenuous nature of the premarket approval process is
evident in the exponential rise in the 510(k) applications
where a device is allowed to go to market if there are what are
known as ``substantially equivalent devices.''
Now, Mr. Chairman, I requested a hearing on the 510(k)
process in March of this year. I am concerned about how devices
are being approved at the FDA. If the FDA is broken, if the FDA
is under-resourced, as Chairman Waxman suggested, if the FDA is
understaffed and underwater, if the FDA is ill-equipped,
inadequate or severely underachieving in its Class III medical
device process, then let us do what is within our power and fix
the FDA.
This subcommittee is not tasked with fixing the legal
system. H.R. 1346 is tort reform, but it is tort reform at its
very worst, utilizing the worst possible mechanism. H.R. 1346
would create a haphazard system, a virtual patchwork of device
standards where lay jurors are elevated to the same standard of
expertise, knowledge, and grasp of science as someone on an FDA
advisory panel.
Furthermore, an Attorney General in California or an
ambitious Attorney General in New York or an even-keeled
Attorney General in Alabama could each create their own
sensational trial with sensational damage figures, regardless
of what the Food and Drug Administration does.
If there ever were congressional intent in the enactment of
the Medical Device Act of 1976, it would be this: Federal
ceilings to tort liability, as it relates to medical devices,
must exist as a necessity to encourage innovation and healthy
progress in medicine. Without a ceiling, no doctor will ever
use a medical device and risk his or her entire professional
future to a jury, and no manufacturer will ever undertake the
risk of producing a single device where a single error will
result in the destruction of the entire livelihood of that
company.
The science of devices should not be in the judicial
branch. The judicial branch should determine the law, and the
law here is written by Congress. So the solution regarding
medical devices is to give the Food and Drug Administration the
resources that they need to do the job that they have been
tasked to do and not to enact H.R. 1346.
I thank you, and I will yield back the balance of my time.
Mr. Pallone. Thank you.
The ranking member, the gentleman from Texas, Mr. Barton.
Mr. Barton. Thank you, Mr. Chairman.
I am going to submit my full statement for the record, but
I do want to read one paragraph from the Republican staff
committee brief for this hearing about H.R. 1346.
Before I do that, let me say I do appreciate that we are
having a legislative hearing. I wish it were on another bill,
but at least we are having a hearing.
Let me just put in a nutshell what my position is and what
I think the positions are of most of the Republicans on this
subcommittee.
Enacting H.R. 1346 will not only overturn the Supreme
Court's 8-1 decision in Riegel v. Medtronic. It will also
severely disrupt the innovation in the medical device industry
that has existed since the enactment of the Medical Device
Amendments Act of 1976 and of the Federal Food and Drug and
Cosmetic Act.
This disruption will decrease patient access to life-saving
medical devices, threaten the U.S.'s status as a global leader
in medical device innovation, and it will dramatically increase
the number of lawsuits against device companies.
So, Mr. Chairman, again, thank you for holding the
legislative hearing. We will certainly listen to our witnesses,
but I would hope that you have no intention of moving this
bill. There are more important bipartisan issues that we can
work on together for the good of the country. This is not one
of them.
With that, I yield back.
Mr. Pallone. Thank you, Mr. Barton.
Next is the gentlewoman from Tennessee, Mrs. Blackburn.
OPENING STATEMENT OF HON. MARSHA BLACKBURN
Mrs. Blackburn. Thank you, Mr. Chairman; and I thank our
witnesses for their patience today. We have had a lot of
conversation so far about the bill that you are going to
testify on. I think it is important to make just a couple of
notes as we move forward to your testimony.
I will submit my full statement, Mr. Chairman.
As Chairman Dingell said, it was over 30 years that
Congress enacted the Medical Device Amendments. They were there
to create a uniform national process for evaluating the medical
devices. They have done that.
Subsequently, the FDA successfully implemented the
premarket approval process, which gives to the medical
technology companies specific guidance that they follow to
ensure the safety of those devices. They have spent an average
of 1,200 hours reviewing every single application. That is a
lot of time on every one of those applications.
Now, common sense would dictate that the FDA and the
medical technology companies are committed to making available
the safest devices possible to save lives. Anyone who believes
that these companies are out to purposefully make poor
performing products ought to return to Business 101 and realize
that companies know if you put bad products into the
marketplace it will eventually lead to a company's collapse.
So, in order to stay competitive, medical technology companies
like Medtronic, Smith & Nephew, and Wright Technologies, which
are all in my district, continue to develop and to produce
innovative technologies in order to save lives.
Also, I am troubled that some in Congress would weaken the
current device review system in the name of consumer safety. I
do think that Act is misnamed. It would be a boon for trial
lawyers at the expense of public safety.
I think the other provision we have to look at is that the
device sector is responsible for almost two million jobs, for
thousands of jobs in my district alone. I have personally
toured many of the facilities and am continually impressed by
the innovation, by the research, and by the commitment to
saving and to bettering lives that I have found at each one of
the facilities.
Thank you, Mr. Chairman. I yield back.
Mr. Pallone. Thank you.
The gentleman from Georgia, Mr. Gingrey.
Mr. Gingrey. Thank you, Mr. Chairman.
Today, as a result of advances in medical technology,
Americans enjoy access to a quality of health care that most
nations do not. While some countries restrict or ration the
types or the amounts of drugs and devices that patients can
access, American patients can receive the latest and the most
advanced medical technology, such as an artificial hip or the
latest cancer medication, that will drastically improve and
extend their lives.
Mr. Chairman, ensuring the safety of medical devices is an
absolute necessity for our continued access to quality health
care. The FDA is charged with making certain that all medical
devices have been thoroughly tested for safety and
effectiveness before coming to the market. It is one of the
FDA's primary responsibilities, and I support increased efforts
in this area.
Unfortunately, modern medical procedures inherently have
risks associated with them, regardless of advances in
technology or of effective oversight. It goes without saying
there are very few absolutes in this world. With this thought
in mind, I look forward to the testimony of our witnesses
today.
I yield back. Hopefully, we will use some of this
additional time for questions. Thank you, Mr. Chairman.
Mr. Pallone. Thank you, Mr. Gingrey.
That is the end of our opening statements, so we are now
going to turn to our witnesses. We have just one panel, and I
want to welcome you all for being here today. Let me introduce
each of you, from my left to right.
First is Professor David Vladeck, who is a Professor of Law
at Georgetown University Law Center here in D.C.
Next is Dr. William Maisel, who is Director of the Medical
Device Safety Institute for the Department of Medicine at Beth
Israel Deaconess Medical Center in Boston.
Then we have Dr. Gregory Curfman, who is Editor of the New
England Journal of Medicine.
And Bridget Robb, who is--I know that is that Welsh name. I
always get it wrong. Gwynedd.
Ms. Robb. Gwynedd.
Mr. Pallone. Gwynedd, Pennsylvania.
Then we have Mr. Richard Cooper, who is a partner at
Williams & Connolly.
Finally, we have Michael Kinsley from Seattle, Washington.
Thank you all for being here today.
Now, the way we work it is we have 5-minute opening
statements. They become part of the hearing record. You may, at
the discretion of the committee, submit additional statements
in writing for inclusion into the record after your testimony.
STATEMENTS OF DAVID VLADECK, J.D., PROFESSOR OF LAW, GEORGETOWN
UNIVERSITY LAW CENTER; WILLIAM H. MAISEL, M.D., M.P.H.,
DIRECTOR, MEDICAL DEVICE SAFETY INSTITUTE, DEPARTMENT OF
MEDICINE, BETH ISRAEL DEACONESS MEDICAL CENTER, BOSTON; GREGORY
CURFMAN, M.D., EDITOR, NEW ENGLAND JOURNAL OF MEDICINE; BRIDGET
ROBB, GWYNEDD, PENNSYLVANIA; RICHARD COOPER, PARTNER, WILLIAMS
& CONNOLLY LLP, AND MICHAEL KINSLEY, SEATTLE, WASHINGTON
Mr. Pallone. I am going to start on my left again with
Professor Vladeck.
STATEMENT OF DAVID VLADECK, J.D.
Mr. Vladeck. Mr. Chairman and members of the committee,
thank you very much for inviting me to be here today.
The bill, H.R. 1346, proposes to restore consumers injured
as a result of defects in life-supporting or life-sustaining
medical devices the right to sue medical device manufacturers.
My views are these:
Mr. Pallone. Professor, just move the mike a little closer;
and I am going to ask everyone to do the same. It will be
easier to hear you.
Mr. Vladeck. I think it is on.
Mr. Pallone. It is on, but it is better to speak a little
closer to it.
Mr. Vladeck. All right.
My views are these:
Riegel v. Medtronic provides very broad immunity from tort
liability to manufacturers of medical devices, and the ruling
gives consumers the worst of both worlds.
On the one hand, the FDA cannot single-handedly ensure the
safety of the thousands of medical devices on the market today.
Too many serious defects have emerged with FDA-approved
devices, and too many patients have been killed or injured by
defective devices to contend otherwise.
On the other hand, in the aftermath of Riegel, patients
injured by devices are left with no remedy at all, with no
compensation for the pain and suffering they endure, with no
reimbursements for the costs of surgery and of medical care,
and with no recompense to their loved ones should they die.
Making matters worse, manufacturers have little economic
incentive to swiftly recall devices or to repair defective
devices in their market since they are immunized from liability
in tort.
I recognize that Riegel ruled that Congress, in passing the
Medical Device Amendments, conferred immunity from tort
liability to device manufacturers. In my view, Riegel is wrong
as a matter of history, as a matter of law, and as a matter of
policy, and Congress ought to swiftly overrule it.
First, Riegel is wrong as a matter of history. As Chairman
Waxman and Mr. Dingell confirmed, the Members of Congress who
enacted the Medical Device Amendments know that Congress never
intended the Medical Device Amendments' very narrow preemption
provision to restrict the rights of injured parties to sue for
compensation. Cutting off tort liability was not Congress' goal
in that statute.
Second, it is wrong as a matter of law. The Medical Device
Amendments were passed to strengthen consumer protection. The
statute was passed in the wake of the notorious failure of the
Dalkon Shield, an intrauterine device that harmed and killed
many women. The legislation was intended to strengthen consumer
remedies, and it is odd in the extreme to say that Congress
intended to insulate manufacturers from the tort liability that
was instrumental in bringing justice to people injured by
defective medical devices.
The last point and the most important point is that Riegel
is wrong as a matter of policy. Immunizing device
manufacturers--and device manufacturers alone in terms of the
manufacture of medical products--harms the public in several
ways:
First, immunity removes the incentive to manufacturers to
fix devices quickly and to get defective devices off the
market. Time and again, we have seen device manufacturers find
defects in their devices, make important safety improvements,
and yet continue to sell their older, riskier devices until
they sell out their inventory. Tort law would constrain that
practice.
Second, immunity weakens the incentives to disclose defects
to physicians and to patients without delay. Again, time and
again, we have seen device manufacturers fail to do that.
Again, tort liability would constrain that practice.
Third, immunity eliminates the compensatory justice role
served by the civil liability system. It shifts all of the
costs of injuries and deaths from the manufacturers on to
consumers, who can ill afford it, to insurance companies and,
ultimately, to taxpayers. What we have done is simply shift the
burden of risk off the manufacturer onto the shoulders of the
taxpayers.
The arguments that defend Riegel are off target, and
history proves this point. Life-saving and life-sustaining
medical devices have been marketed for decades. For all but a
very brief period, there has been no preemption. Preemption is
a fleeting phenomenon. It has not been the norm with respect to
medical devices, yet for virtually all of the time FDA
regulation and State tort litigation have coexisted, each
placing an important but complementary discipline on the
marketplace without impairing the FDA's function and without
any of the harms the defenders of Riegel fear.
For instance, the United States' industry for medical
devices remains and has always been the most innovative in the
world. The American manufacturers of medical devices dominate
the international market, even though there has long been a
backstop of tort liability.
I see my time is up. Let me just make one last point.
The Supreme Court in Riegel said that preemption was
decreed by Congress. Congress has the power to fix it. I urge
that, without delay, Congress restores consumers to the place
they were prior to Riegel. Thank you very much.
Mr. Pallone. Thank you, Professor.
[The prepared statement of Mr. Vladeck follows:]
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Mr. Pallone. Dr. Maisel.
STATEMENT OF WILLIAM H. MAISEL, M.D., M.P.H.
Dr. Maisel. Thank you, Chairman Pallone and distinguished
members of the committee. Thank you for the opportunity today
to speak about the importance of the Medical Device Safety Act
of 2009.
My name is Dr. William Maisel. I am a practicing
cardiologist at Beth Israel Deaconess Medical Center and am
Assistant Professor of Medicine at Harvard Medical School in
Boston. I am also Director of the Medical Device Safety
Institute, an industry independent, nonprofit organization
dedicated to improving the safety of medical devices. I have
served as a consultant to the FDA's Center for Devices and
Radiological Health since 2003, and I have previously chaired
the FDA's Postmarket and Heart Device Advisory Panels.
I hope that by the conclusion of my brief remarks today you
will appreciate that the FDA marketing approval of a medical
device does not guarantee its safety. In particular,
manufacturers' responsibilities for product safety extend well
beyond initial FDA approval, and it is apparent that additional
consumer safeguards are needed if we are to improve the safety
of medical devices for the millions of patients who enjoy their
benefits.
We are fortunate to have the preeminent medical regulatory
system in the world. The U.S. Food and Drug Administration
regulates more than 100,000 different medical devices that are
manufactured by more than 15,000 companies. They receive
several thousand new and supplemental device applications
annually, and they are mandated by Congress to complete their
premarket evaluations in a timely fashion.
Mark Gleeson is a man whose very life depends on one of
these implantable medical devices--in his case, a pacemaker.
Pacemakers are implanted to treat dangerous slow heart rhythms;
and, in Mr. Gleeson's case, every single beat of his heart
comes from his device. The pacemaker itself consists of a
battery and of computer circuitry and is sealed together in a
metal housing. Although pacemaker batteries typically last 5 to
10 years, Mr. Gleeson required the surgical replacement of his
pacemaker after just 12 months due to a short circuit that
caused the battery to wear out prematurely.
St. Jude Medical, the manufacturer of Mr. Gleeson's
pacemaker, had become aware of the short-circuit problem 2
years earlier because other faulty devices had been returned to
the manufacturer. St. Jude asked for and received FDA approval
for a modified version of the device that corrected the
problem, although they continued to distribute already
manufactured, potentially faulty pacemakers with the FDA's
knowledge but without public disclosure.
When Mr. Gleeson needed his faulty pacemaker replaced, he
received another potentially faulty device, even though
corrected pacemakers had been built and were available.
Ultimately, St. Jude Medical issued a recall of 163,000
pacemakers, including Mark Gleeson's new unit, but not until
nearly 2-1/2 years after initially learning of the problem.
As Mr. Gleeson wrote to me, ``It is unacceptable that St.
Jude Medical was permitted to continue to sell known defective
inventory of a device with impunity.'' One possible conclusion
is that St. Jude Medical weighed the likelihood of death or of
serious injury against the cost of pulling defective inventory
off the market.
While Mr. Gleeson's case occurred several years ago, it is
not an isolated event. Other manufacturers have also knowingly
sold potentially defective devices without public disclosure.
The FDA annually receives reports of more than 200,000 device-
related injuries and malfunctions and more than 2,000 device-
related deaths, and it is challenging for them to identify
patterns of malfunction among the deluge of adverse event
reports. In the majority of cases, the FDA relies on industry
to identify, to correct, and to report the problems, but there
is obviously an inherent financial conflict of interest for the
manufacturer that is sometimes measured in the billions of
dollars.
The U.S. Supreme Court, with their February, 2008, decision
of Riegel v. Medtronic, removed an essential consumer
safeguard--the threat of manufacturer liability. Implanted
medical devices have enriched and have extended the lives of
countless people, but device malfunctions and software glitches
have become modern diseases that will continue to occur. The
failure of manufacturers to provide the public with timely
critical information about device performance and malfunctions
enables potentially defective devices to reach unwary
consumers. Patients like Mark Gleeson are sometimes forced to
make life-changing decisions with insufficient and sometimes
inaccurate information.
We have consumer protections for airline passengers, for
cable television customers, and for cellular telephone users
but surprisingly few for patients who receive life-sustaining
medical devices. The Medical Device Safety Act of 2009 provides
important and necessary consumer safeguards that will minimize
adverse health consequences and will improve the safety of
medical devices for the millions of patients who enjoy their
benefits.
Thank you.
[The prepared statement of Dr. Maisel follows:]
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RPTS KESTERSONDCMN MAYER[3:10 p.m.]Mr. Pallone. Thank you.
Dr. Curfman.
STATEMENT OF GREGORY CURFMAN, M.D.
Dr. Curfman. I want to thank you for inviting me to
participate in this important hearing. My name is Gregory
Curfman. I am the executive editor of the New England Journal
of Medicine. I will argue that preemption of common law tort
actions against medical device companies is ill-advised.
Preemption puts the interest of corporations before the
interest of patients. It denies patients their rights and will
result in less safe medical devices for the American people.
For nearly 200 years, the New England Journal of Medicine
has been publishing articles on innovative drugs and medical
devices. We strongly support medical innovation. We are a
medical journal. But we are a patient-focused medical journal,
and we are committed to patient safety.
Now, Mr. Chairman, innovation and safety are not mutually
exclusive. We can and we must have both. Patient safety is a
national concern. Major stakeholders throughout our health care
system agree that every step must be taken to ensure that
medical interventions are as safe as possible.
Unfortunately, one major stakeholder, the medical device
industry, has been shielded from the potential consequences of
failing to adequately disclose risks. This was the result of
the U.S. Supreme Court decision in Riegel v. Medtronic. Until
that ruling, the possibility of litigation for failure to warn
or design defect served as a strong incentive for device
companies to be vigilant about the safety of their products.
Medical devices are often approved on the basis of only
small, short-term clinical trials, and a number of devices have
been approved through a fast-track process that does not
require any clinical testing at all. The approval process
leaves patients vulnerable to safety problems that have gone
unrecognized during the premarketing period only to emerge
during the postmarketing period. Since the Riegel ruling, as
Chairman Waxman has mentioned, thousands of lawsuits against
medical device manufacturers have been tossed out of court by
judges following the Supreme Court's lead.
Now, litigation or the threat of litigation has been
effective in removing potentially harmful medical products from
the market, and there are a number of examples. They include
the diet pill, dexfenfluramine, or Redux; the COX-2 inhibitor,
Rofecoxib or Vioxx; and the cholesterol-lowering drug,
cerivastatin or Baycol.
But the examples are not limited to drugs. A number of
medical devices have been removed from the market after
injuries and litigation, among them, the Dalkon Shield that
Professor Vladeck mentioned, the Bjork-Shiley heart valve and
recently the Sprint Fidelis cardioverter defibrillator lead
that we will hear more about.
Mr. Chairman, let me be clear, I am not here to promote
lawsuits. I am here to promote the interest of patients. I
oppose preemption because it removes a legal mechanism by which
patients who have been harmed can be compensated, and because
it will inevitably result in less safe medical devices for the
American people. The way to prevent lawsuits is to put safe
medical products on the market.
The Supreme Court's ruling in Riegel was not based on
considerations of what is best for the health of the public,
but rather on a point of statutory law. In marked contrast to
Riegel, the Supreme Court ruling last March in the drug
preemption case, Wyeth v. Levine, dismissed Wyeth's argument
that failure-to-warn suits against drug companies are preempted
by FDA approval of the drug's label.
Now, as the law stands, failure-to-warn and design-defect
lawsuits are preempted from medical devices, but not from
drugs. This perplexing state of affairs defies all logic.
The Medical Device Safety Act of 2009 addresses this legal
inconsistency. The bill would nullify the Court's ruling on
Riegel and would thereby place medical devices and drugs on a
level playing field with respect to patients' rights. I urge
you and your colleagues in Congress to swiftly pass this
legislation. The critical issue of preemption should be decided
by officials elected by the people.
Mr. Chairman, I hope that this testimony is informative and
I look forward to answering any questions that you may have.
Mr. Pallone. Thank you, Doctor.
[The statement of Dr. Curfman follows:]
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Mr. Pallone. Ms. Robb.
STATEMENT OF BRIDGET ROBB
Ms. Robb. Chairman Pallone and members of the Health
Subcommittee, thank you for inviting me to speak to you about
my personal experiences with the faulty medical device and my
reasons for supporting the Medical Device Safety Act, H.R.
1346.
My name is Bridget Robb, and I am a 35-year-old mother and
resident of Gwynedd, Pennsylvania. On December 31, 2007, I
suffered greatly and thought I was going to die because of a
defective heart device implanted in my body. I am thankful to
be here today, and I am pleased that Chairman Pallone has
reintroduced medical safety--the Medical Device Safety Act
which would restore the right of patients like me to hold
manufacturers accountable when their products cause injury and
sometimes even death.
Approximately 5 years ago, I was diagnosed with nonischemic
viral cardiomyopathy and congestive heart failure. In May of
2005, to prevent me from dying from a fatal arrhythmia, I had a
Medtronic cardiac defibrillator implanted in my chest. This
heart device is a small metal case that contains electronics
and a battery. Its components work much like a pacemaker, but
unlike a pacemaker, an ICD delivers an electrical shock to the
heart when the heart rate becomes dangerously fast.
On December 31, 2007, I was awoken from my sleep by a
series of shocks in my heart which felt as if a cannon was
being repeatedly shot at my chest at close range. Along with
these recurrent shocks was a strong electrical current racing
through my body.
After feeling the first shock, I immediately phoned 911 for
help. My then 6-year-old daughter, Emma, had snuck into bed
with me that night and was present during this horrific
experience. I remember Emma being scared and confused. She
crouched down in front of me, hugging her cat and saying, Mommy
is dying. She was present during the entire 7 minutes I was on
the telephone with the 911 operator until the EMS arrived. I
cannot imagine how terrified she must have been to see her
mother in such pain.
My doctors have told me that I received a total of 31
dangerous shocks to my heart in a matter of minutes that
morning. Each time I was shocked, I saw my life flash before my
eyes. It was excruciating pain. At one point I began to pass
out and thought that I would never see Emma again.
Every day since then, I have been unable--ever since that
day, I have been unable to sleep in my own bed due to the
trauma that I have experienced. I later learned that the
agonizing shocks and electricity coursing through my body was
caused by a defective cardiac lead implanted in my heart, the
Sprint Fidelis lead manufactured by Medtronic. A lead is a thin
wire that connects the ICD to the heart and delivers the actual
shock to the heart when is beating too fast. Medtronic's Sprint
Fidelis lead was recalled on October 15, 2007, because of its
potential to fracture. Despite receiving over 1,000 complaints
about the defective lead, it took Medtronic 3 years to issue
this recall.
Since this terrifying experience, my health has declined
significantly. I visit doctors weekly because of my ongoing
health issues due to this event. After the inappropriate
shocking from my lead, I underwent surgical replacement of my
defibrillator and defective lead and a second surgery to adjust
the new lead. My second surgery resulted in an extended
hospital stay where I had to undergo a blood transfusion.
Most recently in September of 2008, my incision ulcerated
and became extremely painful. I was hospitalized a series of
times, once for 2 weeks straight, in an effort to cure this
problem. To prevent an infection to the hardware in my chest,
my doctors ultimately decided to remove my defibrillator
altogether. Right now, my doctors continue to try and stabilize
my decreased heart function, and I take various medications
that carry serious health risks which I never took before.
As you would expect, I risk serious harm each time another
procedure is performed. From the time between my diagnosis in
2004 and the horrifying shocking in December of 2007, I was
never hospitalized for my heart failure except to have my
defibrillator implanted. My heart function had significantly
increased due to my medications, and I had a good outlook from
my doctors. However, since my defective lead misfired, I have
been hospitalized at least 8 times, mostly for 1 to 2 weeks at
a time, and my heart function is much lower than it used to be.
I am a single mother, so as you can imagine, this has been
trying for both my daughter Emma and myself. Each time I am
hospitalized, it becomes more difficult on my daughter, since
she is afraid that one of these times I won't come home.
Even though Medtronic's defective device caused my injury,
my health insurance plan has been paying for the cost of my
medical care. It is wrong to shift the cost of medical care
from the responsible party to private insurers, patients and,
in some cases, to taxpayer-sponsored programs like Medicare and
Medicaid.
I would like to have the opportunity to hold Medtronic
accountable for the injuries that I suffered that day and the
physical and emotional aftereffects that I continue to
experience on a daily basis. I find it discouraging and
demoralizing that I have no recourse for my injuries and that a
company that manufactured a defective product that has harmed
me and thousands of other individuals has no accountability.
I encourage Congress to act quickly and pass the Medical
Device Safety Act. It is extremely important that injured
patients have a remedy for their injuries and that the cost of
their medical expenses and other needs are not borne by
Medicare, private insurance, employees and patients themselves.
The medical device industry should be accountable for their
products just like the drug companies or any other industry.
Thank you for your commitment to this critical issue. I am
happy to answer any questions that you may have.
Mr. Pallone. Thank you, Ms. Robb. Thanks so much for being
here.
[The statement of Ms. Robb follows:]
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Mr. Pallone. Mr. Cooper.
STATEMENT OF RICHARD COOPER
Mr. Cooper. Thank you, Mr. Chairman, members of the
subcommittee for inviting me to testify here today. I am here
on my own, not representing any organization.
I would like to make three points. The first is, a number
of the opening statements refer to what the members called
defective devices. The fundamental issue here is who ultimately
decides whether a device is defective. Is it the physician, the
engineers, the material scientists, the chemists, the
statisticians and other experts at FDA; or is it juries and
judges in the 50 States and other jurisdictions that will hear
products-liability cases?
By what process should that decision be made? By people who
review enormous volumes of data, who over time, even after
approval, receive reports from manufacturers of malfunctions or
injuries, who can commission special studies, who can send
inspectors into manufacturing plants to review all of the
manufacturing records and interview the employees who design
and manufacture the products? Or should it be people who listen
to a couple of lawyers rant at them and observe witnesses being
examined and cross-examined?
And what perspective should guide that decision-making? The
perspective of people who look at all those who will use a
device, those who will benefit from it as well as those who
will suffer from malfunctions? Or a group that spends day after
day in court observing an injured plaintiff?
I submit to you that the ultimate decision should be made
by the Food and Drug Administration which, if properly funded
and subject to proper oversight, is a national treasure.
Second, products-liability law is not insurance; it is
about fault. And a manufacturer that puts on the market a
product with a design approved by the Food and Drug
Administration with the perspective I have described, by the
experts I have described and with the procedure I have
described is not at fault for marketing a device with that
design and, similarly, for other aspects of a device that FDA
approves.
Third, the concern about the effect of products-liability
litigation on incentives for innovation is not mere theory. It
is real.
A number of years ago, I served on a committee of the
Institute of Medicine that issued a report. The report came out
in 1990, called Developing New Contraceptives: Obstacles and
Opportunities. And one of the principal obstacles to innovation
in that medical field that the committee, which included
primarily physicians--that the committee identified was
products-liability.
It summarized its conclusion from its analysis as follows;
I quote from its report: ``Without changes in the products-
liability rules and procedures, it appears likely that even
fewer firms will allocate even fewer resources to contraceptive
research and development,'' closed quote. That is just one
small medical field, and indeed a field that probably doesn't
involve devices to which preemption under Riegel would apply.
But the effects of products-liability risks are great. Most
medical device companies are small. To develop a product in a
field that has great risks of litigation is to bet the company
on every product, and that is imprudent when there are other
things that can be done.
Since 1990 and this report was issued, there hasn't been a
lot of innovation in contraception. And there are other medical
fields which are underserved due to liability risks. So that is
something I would suggest you consider.
This isn't corporations versus people. This is how best to
serve people, how best to serve patients who need medical
devices, whose lives are supported or sustained by medical
devices and whose adverse health conditions can be greatly
alleviated by them if companies have the incentive to develop
them and they are presented to FDA for its review.
Thank you.
Mr. Pallone. Thank you, Mr. Cooper.
[The statement of Mr. Cooper follows:]
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Mr. Pallone. Mr. Kinsley.
Mr. Kinsley. Does this work?
Mr. Pallone. Good idea to switch seats.
STATEMENT OF MICHAEL KINSLEY
Mr. Kinsley. Thanks for this opportunity to testify, Mr.
Chairman. I am here because I was approached last week by
Medtronic, but I am here representing myself. I am not
accepting anything from this except for Xeroxing of copies of
my testimony.
I also have--I am not an expert on Federal preemption
issues, and I don't even have a view about the question of
whether standards should be similar between drugs and devices.
I also have no view about the goings-on in the 11th Circuit,
although it sounds pretty exciting.
I am here for two reasons, first, as a grateful customer of
the pharmaceutical and medical device industry. I have had
Parkinson's, and I have had it for over 15 years. As I hope you
can see for yourself, my symptoms are pretty mild. After all
that time they have not affected my ability to work, to travel
or to enjoy life.
This is true thanks in part to drugs, including many that
have just come on the market in the years since I was
diagnosed. And it is true especially because of the surgery I
had 3 years ago called deep brain stimulation. Now I walk
around with wires in my head and two pacemaker-type batteries
in my chest. But thanks to these devices and these pills, I am
walking around, which is encouraging to me.
I am also here as a journalist who has written quite a bit
about the damage done to our economy and to our country by
excessive litigation in general and product and medical
liability lawsuits in particular; and with all due respect to
Dr. Curfman, if he thinks that companies can avoid litigation
simply by producing safe products, I think he is naive. We all
want the government to protect us from dangerous drugs and
devices, but we don't want the government to prevent us from
getting helpful or life-saving drugs and devices.
And the central problem is that those are the same devices,
the ones that threaten us with harm sometimes and the ones that
help us most of the time. And you do not want a system even if
you could have it, that only allowed safe devices to be
produced because that would be too far over on the scale.
You need to have--in order for maximize the benefit, you
have to tolerate some risk. And the danger of using litigation
to solve these problems is that we--it forces us as a society
to be overcautious.
I think I will even stop there.
Mr. Pallone. Thank you, Mr. Kinsley.
[The statement of Mr. Kinsley follows:]
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Mr. Pallone. Thank you all. We are going to proceed to
questions from the members of the committee now, and I will
start with my own questions and I guess I will start with
Professor Vladeck if I may.
Many people looked at the fact that the Riegel decision was
decided with an 8-to-1 vote by the Supreme Court in favor of
preemption as evidence that it is clear that all FDA product
liability cases should be preempted. I wanted to ask you, how
could the court be wrong about that when it was such an
overwhelming margin?
Can you explain why the Riegel decision was 8-to-1?
Mr. Vladeck. I can take the Court at its word. What the
Court said was--and this goes back to an earlier decision by
the Court in a case involving cigarette labeling alone.
Many statutes that have preemption provisions use the same
language, and the language is, requirements are different from
or in addition to those proscribed by Federal law. And the
battleground since 1992, if you can believe it, has been over
the word ``requirement.'' And in Cipollone, where Congress
itself wrote the warning label, the Court said that it would be
odd to hold a tobacco company liable for failing to add a
warning that Congress itself did not write. And so there in
Cipollone the Court said the word ``requirement'' could, in
some cases, include common law remedies under tort. And since
then there has been a series of decisions discussed in both my
testimony and Mr. Cooper's testimony which the Court has
vacillated on what the word ``requirement'' meant.
Finally--and Justice Stevens' concurrence makes this quite
clear. Finally, in Riegel, the Court simply gives up the ghost
and says, going forward, the word ``requirement'' should be
understood to include common law tort remedy.
Mr. Pallone. What about--some of my colleagues made
statements that they were here at the time, that wasn't the
intent. Was that--any of that information, they just ignored it
or what?
Mr. Vladeck. Yes, the Court just ignored it and this is
part of the Court's new practice pushed by some of the justices
on the Court to look simply the attacks to the statute and not
to look at the statute's purpose or the underlying legislative
history.
The legislative history of the statute is quite clear.
Congress did not mean to wipe away tort remedy for people
injured by medical devices. And there is no argument on that
score.
Mr. Pallone. I appreciate it. I think it is important.
Now, the device industry is arguing that a bill overturning
the Riegel decision like mine would dramatically change the
legal and financial landscape for device companies.
But would this bill really change the status quo? My
understanding is that the device companies faced State tort
suits right up until the Riegel decision. So what is your
opinion on that?
Mr. Vladeck. Right. I think that is true with a caveat.
Prior to Riegel, the courts were divided on whether there
was preemption of these kinds of cases. The majority of the
Federal circuits had ruled that there was preemption, but none
of these decisions however, came before the mid-1990s. All of
them are post-Cipollone, post-1992 decisions. None of the
device manufacturers even argued preemption until post-
Cipollone. So it is true that in some jurisdictions and in many
circuits from maybe the mid-1990s through 2008, there was a
preemption defense available to these kind of devices.
But if you look at the history of medical devices in the
United States, they predate by decades the medical device
amendments of 1976. We have had life-supporting and life-
sustaining medical devices on the market for 50 or 60 years,
and only in that one brief interval, that maybe 10 years post-
Cipollone and pre-Riegel was their real preemption available.
And even then there was no guarantee because device
manufacturers could be sued in some jurisdictions, including
what some have colorfully referred to as the ``crazy 11th
Circuit.''
Mr. Pallone. Let me ask you this. You have heard some of my
colleagues say that the most frequently repeated objection to
my bill is that it will create 50 State FDAs, and the devices
will be regulated differently in different States. And then I
think Mr. Cooper stated that products-liability cases
constitute a kind of regulation in disguise.
What is your opinion about that?
Mr. Vladeck. I think that is an overstated argument. For
every other consumer product, except where Congress has
expressly preempted State tort law, we see parallel enforcement
of State regulation--excuse me--of Federal regulation of
products--car, cell phone, virtually any other consumer product
that complements State tort law. They serve distinct functions
although they are somewhat overlapping.
I think it is an overstatement to say that a State tort
judgment is regulation in my meaningful sense. It isn't. It is
not device specific. It doesn't tell the manufacturer that they
must do anything, and for that reason, we have seen tort law
and Federal regulatory law coexist in virtually every sphere of
government and private industry that we have in the United
States.
And this complementary role serves an important purpose.
One is, it compensates people injured through no fault of their
own; and second, it deters excessive risk-taking.
We can go up and down the list in terms of massive recalls
of medical devices; and here, remember, most of these recalls
are where--Mr. Cooper talked about who makes the decision about
defect. In virtually all of these cases, it is the manufacturer
and the FDA.
The Sprint Fidelis lead is being recalled because both
agreed it should be recalled; Bjork-Shiley, the heart valve,
55,000 people; the Sulzer heart valve, another 35,000 people;
the Medtronic pacemakers. All of these products were recalled
after serious defects emerged, and both the FDA and all of the
experts there and the company agreed it was time to get the
product off the market.
That serves--in most of these instances tort law served an
incredibly important informational function. That is, we
learned about the severity and pervasiveness of the defect
through tort litigation, not through the imperfect, adverse
reporting mechanisms that the FDA has.
Mr. Pallone. Thank you, Professor. Thank you for your
enthusiasm too.
The gentleman from Illinois, Mr. Shimkus.
Mr. Shimkus. As much as you don't want to go to me--no.
Thank you for the panel and compelling testimony.
I left--one of the challenges of our jobs as a Member of
Congress is we hear tough stories all the time, especially in
the Health Subcommittee. I left here to go to--it is ALS
lobbying day. I had folks in my office. So we are--these are
things we deal with on a daily basis, maybe multiple times. So
we appreciate you all being here.
Ms. Robb, can you give me a time line? You were diagnosed--
the implantation occurred in 2005?
Ms. Robb. I was diagnosed in February of 2004, and the
implantation was in May of 2005.
Mr. Shimkus. What would have been your health condition if
you had not had implantation?
Ms. Robb. The device was implanted simply as a safety net;
it didn't do anything on a daily basis. I didn't use the
pacemaker portion of it. It just was simply there in case I was
to have a fatal arrhythmia to, hopefully, shock me out of it
and save my life.
I was on a course of medication that was increasing my
heart function, and I was doing really well.
Mr. Shimkus. Yes, good. I think that is helpful, and I
appreciate that.
Let me turn to Mr. Kinsley from the St. Louis area, a
Member of Congress from Illinois. Of course, those of us who
follow the St. Louis Cardinals are huge Jack Buck fans, who
suffered from Parkinson's; and you would not have known that
had you not seen him and--because his voice was still strong.
When you moved from your chair from where your seat was to
Mr. Cooper's seat, had you not had the implantation, how long
would that have taken you to do?
Mr. Kinsley. Well, it would have taken a few seconds longer
probably. I mean, I can't be more specific than that.
Mr. Shimkus. So the implantation for you has been pretty
much as you stated in your testimony, very helpful in obtaining
a livelihood and your standard of living?
Mr. Kinsley. Yes. It has been essential, I would say.
Mr. Shimkus. In your testimony, you also talk about the
problem of having two independent systems, the FDA and tort
law, for making the decision on whether a device should be on
the market.
Can you talk about this and explain this analysis of the
problem?
Mr. Kinsley. Well, you have got the FDA ruling and you have
got tort law essentially trying to do the exact same thing,
which is to balance the risks against the benefit. And I was
amazed to hear that--well, let me start again.
I think that surely tort law does draw a line under the
behavior effect--affects the behavior of companies that
manufacture devices. And any company that loses a case and
then--and then continues to manufacture the device anyway would
lose--would do very badly both in the market and before this
committee. That would be crazy.
So I think it is undeniable that these are both systems
that affect the decisions of medical device companies; and I
think, in effect, the company does whatever, between the two,
is the most restrictive.
Mr. Shimkus. Thank you. Let me go to Mr. Cooper real quick.
Does a patient have a right to sue the device company if it
fails to follow FDA requirements in manufacturing the device?
Mr. Cooper. Yes. The Riegel decision, following the lower
decision, made it absolutely clear that States----
Mr. Shimkus. Let me go to the next one. That is fine. Does
a patient have the right to sue if the device labeling is
inconsistent with FDA requirements?
Mr. Cooper. Yes.
Mr. Shimkus. Let me go to the next one. Does the patient
have the right to sue if the company withholds data from the
FDA?
Mr. Cooper. Probably not.
Mr. Shimkus. Does the patient have the right to sue if the
company misleads the FDA as to the device's safety and
effectiveness?
Mr. Cooper. Same answer. But the FDA has tools, including
criminal prosecution, to deal with that kind of problem.
Mr. Shimkus. And I was going to follow up, Mr. Chairman,
with a question for Mr. Cooper.
Can you expound on the small business implications of this
legislation?
Mr. Cooper. Yes. I will give you an example.
One of the areas that at least some years ago was grossly
underserved was medical devices, including breathing
instruments and the like for prematurely born babies. That is a
high litigation risk area, a company that develops a product--
and there are some products. But a company that develops a
product in that area is taking an enormous risk of litigation
because nothing that humans make is perfect, nothing in
medicine is perfect.
I am not a doctor, but that is my understanding. Not
medical device, not drugs, not surgical procedure, not
laboratory test, nothing is perfect. They all fail sometimes.
And if you get failures in that area, you are going to get
litigation, and you are going to get enormous judgments. And
small companies, that doesn't--that is where the innovation is,
mostly in small companies.
Mr. Shimkus. Thank you.
Thank you, Mr. Chairman. If I could ask unanimous consent
to submit two letters one from the Vietnam Veterans of America
and also from a Mr. Albert Daum, who is in a similar situation
of the benefits of this type of technology.
Mr. Pallone. Without objection, so ordered
[The information appears at the conclusion of the hearing.]
Mr. Pallone. Mr. Braley of Iowa.
Mr. Braley. Thank you, Mr. Chairman. One of the comments
that was made earlier in the hearing was that preemption is not
a get-out-of-jail card.
Professor Vladeck, that is not true, is it? That is exactly
what preemption is; it is a bar to the courthouse door. In
fact, Justice Ginsberg mentioned that in the concluding
paragraph of her dissent where she writes the Court's broad
reading of section 360(k)(A) saves the manufacturer from any
need to urge these defenses. Instead, regardless of the
strength of a plaintiff's case, suits will be barred as an
issue; that means before they are even filed.
Mr. Vladeck. They will be dismissed as soon as they are
filed.
Mr. Braley. Exactly. And if this is a well-known legal
doctrine, then people aren't going to take those cases and they
are not going to file them.
One of the other comments was, this was going to
dramatically increase the number of lawsuits against medical
device companies, but until the Riegel decision clarified this
conflict within the circuit, there was nothing that prohibited
somebody from pursuing this type of relief.
So the same pace of claims is likely to occur whether or
not this act is passed?
Mr. Vladeck. Right, which is why we are seeing so many
cases dismissed in light of Riegel.
Mr. Braley. Exactly.
Now, one of the other comments that was made--I think it
was by Ranking Member Barton, who was quoting from the
Republican staff committee brief. And he would--he mentioned
that this act, if passed, would severely disrupt innovation in
a medical device industry that has existed since 1976.
But you pointed out this same dual enforcement mechanism
has existed literally since the act was passed. So any
innovation that has been proceeding at pace since 1976, should
not in any way be affected by this.
Mr. Vladeck. That is correct. And even well prior to 1976
we had medical devices prior to Congress' passage of the
medical device amendment.
Mr. Braley. Thank you.
Mr. Kinsley, I want to ask you a little bit about what your
concerns are, specifically related to the role that tort
liability litigation plays in medical device and pharmaceutical
claims.
Based upon your background, I assume that you are a firm
believer in the Constitution.
Mr. Kinsley. Yes.
Mr. Braley. That includes the Bill of Rights which, as we
know, includes the right to free speech and the right to
freedom of the press which gives you the ability to do what you
do for a living?
Mr. Kinsley. Right.
Mr. Braley. Are you supporter of the 7th amendment of the
Bill of Rights?
Mr. Kinsley. Which one is that?
Mr. Braley. It is the one that says, in suits at common
law, where the value in controversy exceeds $20, the right to
trial by jury shall be preserved.
Do you believe in that amendment?
Mr. Kinsley. Well, it doesn't--it is not one that gets my
heart beating faster.
Mr. Braley. Well, let us talk about that, because you
understand the historical perspective that led to the passage
of the Bill of Rights.
Mr. Kinsley. Well, let me say something about the Bill of
Rights.
I am the one in the street that is protected from
malpractice lawsuits which are called libel suits in the world
of the press. And the Supreme Court, as I am sure you know, has
said that because of the First Amendment, we are protected even
when we have committed malpractice by making a mistake, New
York Times v. Sullivan. Every other industry does not have that
advantage.
This is just the opposite of most countries, such as in
England where journalists live in terror of lawsuits, and
everybody else is rather calm about it because they somehow or
other manage to have a system that brings justice in most cases
without a lot of the absurdities that, in my view, attach to
product liability in this country.
Mr. Braley. Well, you understand that even journalists are
subject to liability under certain circumstances when they
engage in libel and slander, and there are differing degrees of
proof, whether you are a public figure or not; and that all
factors into determining whether there is accountability that,
in fact, some journalists have been held accountable because
they took unreasonable risks in what they say about people.
Mr. Kinsley. Yes, you have to try really hard to be sued.
Mr. Braley. Let's talk about that. Because one the things
we know is, if you are going to sue the manufacturer of a
defective medical device, not anybody can do that. Did you
realize that?
Mr. Kinsley. What do you mean?
Mr. Braley. In order to bring that claim, you have to prove
the manufacturer made a defective device that was unreasonably
dangerous, that caused direct harm to someone. And even if you
can prove that and you are the device manufacturer, you have an
absolute defense to those claims if you can prove that the
product you introduced into the stream of commerce conformed to
the state of the art at the time that product was manufactured.
Mr. Kinsley. As I said in the beginning, I am not an expert
in this field. But I do think that, as a general rule, our
society is overly risk averse; and we pay for that.
Mr. Braley. But in this case, if you are the device
manufacturer and this state of the art is an affirmative
defense that gives you complete immunity, you can walk into
court and say, Hey, the FDA preapproved my product. That was
state of the art at the time that manufacture--that product was
introduced, that is my get-out-of-jail-free card.
Mr. Kinsley. Well, that seems like a good get-out-of-jail-
free card to me.
Mr. Pallone. We are a minute over.
Mr. Braley. Thank you, Mr. Chairman.
Mr. Pallone. You two were having such a good time here that
I didn't really want to stop you. But thank you.
Mr. Burgess.
Mr. Burgess. Thank you, Mr. Chairman. I was enjoying it. It
took me back 15 years ago when I was a physician in practice
and every night would tune in Crossfire and watch you and Bob
Novak go at each other; and I used to enjoy those exchanges as
well. What concerns me today is, I agree with you more than I
recall agreeing with you 15 years ago. I must admit I guess
things have changed in 15 years.
Let me start with Dr. Curfman. I probably need to ask Dr.
Maisel the same question, both physicians.
Can you help us understand the physician's role in helping
to evaluate and helping an appellant understand the risks and
benefits associated with any complex medical technology? That
role does fall to the physician, does it not?
Dr. Maisel. It is a common role for physicians to serve as
counsel for patients when determining the risks and benefits of
any therapy, whether it is a medical device, a drug or some
procedure. I think it is incumbent upon physicians to have
accurate and timely information, and one of the things I, as a
physician, have struggled with is dealing with medical device
malfunctions with incomplete information, inaccurate
information or a lack of timely information in handling these
cases.
Mr. Burgess. And, of course, we all rely upon the Food and
Drug Administration to help us with those determinations.
Do you ever find yourself in the course of clinical events
reviewing court cases to find out if a device--if you should be
counseling your patient based upon what has happened in the
legal system?
Dr. Maisel. I am not sure I am the right person to ask that
question. I do review the court cases. I find them extremely
interesting. I think there is a lot of very interesting
information about device reliability that is in those court
cases. I think a lot has been learned from those court cases,
and there are things in those court cases that are released
because of the court cases that otherwise wouldn't be released,
including FDA documents.
Mr. Burgess. Let me ask Professor Vladeck, in response to a
question posed by Chairman Pallone about the 8-to-1 decision of
the Supreme Court, was this consistent with what had been the
decisions of lower courts or did they depart from lower court
decisions?
Mr. Vladeck. I think it is fair to say that many lower
courts had reached the same conclusion that the Supreme Court
did. I think it is also fair to say that there were many
courts, particularly State courts that did not. And so you had
a deep division within our judicial system about the proper
reading of the preemption provision of the medical device
amendment.
Mr. Burgess. But it was not inconsistent with what the
lower courts had ruled, so in that aspect did not alter the
regulatory environment?
Mr. Vladeck. Remember, no court had ruled that there was
preemption under the medical device amendments until the mid-
1990s. So to the extent there was preemption during this
period, one is, it was recent; and second, it was incomplete
because plaintiffs could engage in forum shopping, and where
possible they would sue in the jurisdictions that permitted
these cases to go forward.
So it is not as though prior to Riegel any medical device
manufacturer had an assurance that a claim would be preempted.
Mr. Burgess. Who would engage in the forum shopping?
Mr. Vladeck. The plaintiffs, yes.
It is only bad when the other side does it.
Mr. Burgess. Mr. Cooper, let me ask you a question if I
could. There is some suggestion that the effect of the Riegel
decision to provide broad-based immunity in instances where the
medical device failed, a get-out-of-jail-free card, versus a
don't-get-out-of-jail-free. So do you agree with that? Do you
think that is true?
Mr. Cooper. No, I would not agree with it, Mr. Burgess. The
Riegel decision applies only to devices that have gone through
the PMA approval process. That is about 30 products a year,
less than 1 percent of all the devices on the market.
Mr. Burgess. Under current law, does the patient have the
right to sue the manufacturer if the device fails?
Mr. Cooper. People can always sue. Whether they will win is
another matter. And if a manufacturer has--as I discussed
earlier in answering some question, if a manufacturer fails to
comply with FDA requirements and the conditions on the PMA
approval or the manufacturing process, Riegel would not provide
any defense.
The real problem, I think we are grappling with here, is
that medical devices are going to fail even if they are the
best that human beings can make; and how do we take care of the
people in whom they fail or for whom they fail? And that is
matter of health insurance, disability insurance or life
insurance. It is an insurance system.
And the products-liability system is not intended to be an
insurance system. It is based on fault or defect. And if the
product isn't defective, if the manufacturer is not at fault,
then the plaintiff should lose. That is our legal system.
Mr. Burgess. And just in the brief time I don't have left,
if, on the physician's part--the physician utilizing the
device, if they commit an error either in diagnostics or in
application of the device, under Riegel, can they be sued?
Mr. Cooper. Yes. And in Levine, for example, the doctor--
the clinic, I guess it was--settled.
And if you look at the facts in the Riegel case, the
physician who was applying the catheter, the balloon catheter,
misapplied it in violation of the labeling. Nevertheless, the
plaintiff sued the device manufacturer.
Mr. Pallone. OK. We are going to move on. Thanks.
The gentlewoman from Florida, Ms. Castor.
Ms. Castor. Thank you, Mr. Chairman.
Thank you all very much for being here today. Some device
companies have argued that the premarket--that the impact of
the Riegel decision is limited numerically because it only
applies to PMA devices. Mr. Cooper just made the argument that
it only represents 1 percent of all medical devices reviewed by
the FDA.
But is this a fair representation of Riegel and all of the
devices? Dr. Maisel, does that 1 percent figure accurately
represent the actual usage and importance of PMA devices?
Dr. Maisel. The best term I can come up with to describe
that number is ``propaganda.'' The repeated use of the 1
percent we heard or the 2 percent number is fuzzy math.
The devices that we care about are not tongue depressors
and bedpans and stethoscopes which are included in the 99
percent. We care about the important, life-sustaining devices
whose safety patients rely on.
And those devices--we have also heard a number of
approximately 30 new PMA applications a year. The FDA actually
sees over 1,000 PMA and PMA supplement applications each year,
so it is much higher than that number. And if you think about
the number of patients affected by these devices, it is in the
millions.
There are more than 10 million Americans living with
permanent implanted devices right now, and there are hundreds
of thousands if not millions implanted each year.
Ms. Castor. What type of injuries and what type of
patients?
Dr. Maisel. Well, these devices are--in many cases are
life-sustaining devices. We have heard from a patient today
here on our witness stand that received painful shocks.
There are devices that can fail to deliver life-sustaining
therapy when needed. There are pumps that can underdeliver or
overdeliver medication. There are stents that can malfunction.
Every product has the potential to malfunction.
I would like to clarify. I don't think a malfunction should
equal liability for a manufacturer. That is not what we are
talking about here. We are talking about a manufacturer that
fails to meet their--the standard of care, that fails to
produce a product that is as reliable as it should be.
Ms. Castor. And, Professor Vladeck, it is unclear to me,
does the preemption apply even when the corporation or folks in
the company knew or had knowledge that the device was defective
even after they received the FDA approval?
Mr. Vladeck. Yes. Even where the companies misleads the
FDA, it fails to provide information to the FDA.
There would be preemption not under Riegel, but under
Buchman v. Plaintiffs.
Ms. Castor. So, Mr. Kinsley, I would ask you about those
cases when folks in the corporation, or the corporation or
personnel knew of the danger; does it make sense that consumers
are barred from seeking compensation from their injuries and
lost wages?
Mr. Kinsley. When you say ``knew of the danger,'' if this
company has met FDA standards and what they knew was that there
is something--I mean, either it meets the standards or it
doesn't. And if it meets FDA standards, then you shouldn't have
to meet a whole other set of standards.
Ms. Castor. Even if they knew that the device was faulty
and could cause injuries, you are saying if the FDA signed off
on that----
Mr. Kinsley. Yes.
Presumably what they knew was--well, if what they knew was
that the device didn't meet FDA standards, yes, of course, they
should be liable.
Ms. Castor. I think the case is that if they receive the
premarket approval and approval from the FDA, that it is
supposed to mean something. But even in the cases they had
knowledge that the device could cause injury?
Mr. Kinsley. Well, I think some things I have heard today
and things I knew even before suggest, then I think everyone
here agrees that the FDA could use a little bit of improvement.
But----
Ms. Castor. It would seem to me that the companies in
those--in that case, have a responsibility to be truthful in
the FDA process.
Mr. Kinsley. Well, sure. I would say if the company is
lying, even if it is lying about a product that does meet FDA
standards, that is not good, and they should maybe lose this
immunity they get.
Ms. Castor. Thank you very much.
Mr. Pallone. Thank you.
The gentleman from Indiana, Mr. Buyer.
Mr. Buyer. Mr. Kinsley, I will be your lifeline.
Mr. Kinsley. Thank you.
Mr. Buyer. I will be your lifeline because I disagree with
the professor's testimony. The professor's testimony said that
Federal preemption will give protection to a manufacturer if,
in fact, they voluntarily withhold information, i.e., that is
wrongful conduct or lying, that is wrongful conduct.
So if a corporation is involved in wrongful conduct, they
are outside of the Federal preemption as according to the
Supreme Court decision. Is that not correct, Professor?
Mr. Vladeck. The decision I was referring to----
Mr. Buyer. Or is my analysis not yet--is that not correct?
Mr. Pallone. Professor, do you have the mic on?
Mr. Vladeck. I do. It would be correct under the Supreme
Court's prior ruling.
Mr. Buyer. Professor, time out.
The analysis that I just gave according to Riegel; is that
not yet correct?
Mr. Vladeck. Preceding Riegel is Buchman. Every lower court
to address what I believe is the question you are posing has
said that that is essentially a fraud on the FDA claim, which
is preempted.
And maybe I am misunderstanding your question.
Mr. Buyer. It is clear--I believe it is clear after Riegel
that if a manufacturer of a device, in fact, commits wrongful
conduct, it can be held liable. That is my lifeline to you,
sir, that if somebody is lying, they voluntarily withhold that
information, you do not get the shelter of the law.
If you participate in wrongful or criminal or conduct that
would be harmful to our society, you don't get the shield of
the law. That is Riegel; is it not?
Mr. Vladeck. I would hope you are right. Let me just make
two caveats. With all respect, I think the lower courts have
not read Riegel to overrule or to in any way affect Buchman.
And if you look at the cases cited at footnote 25 of my
testimony, many of them discuss precisely that issue.
I would agree with Mr. Cooper that the sanction that would
be available would be the FDA bringing an enforcement action
against the company. And the FDA plainly would have the
authority to go after the company for doing that conduct and
could proceed criminally. I am sorry.
Mr. Buyer. Is your background in tort law?
Mr. Vladeck. I have done tort law, yes, sir.
Mr. Buyer. Under products-liability law--now, help me. I am
just a country lawyer. So under products-liability law, a
device manufacturer's liability must be based on some type of
fault; is that not true?
Mr. Vladeck. That is correct.
Mr. Buyer. Some type of fault. So if a manufacturer,
though, abides by the rules, the regulations, the procedures,
the law, where are they then at fault?
Mr. Vladeck. They are not at fault.
Mr. Buyer. Right. And that, in fact, is the importance of
the preemption, the shield to that manufacturer in the
premarket approval process, correct?
Mr. Vladeck. I think I understand you. Yes.
Mr. Buyer. Yes. So that is basically--that is why I am say,
All right, Supreme Court, I understand why you then have made
that as a ruling, to bring clarity then to all of the other
courts and jurisdictions around the country, excepting the
hiccup of the 11th Circuit.
Mr. Vladeck. You are correct that only the 11th Circuit in
the Federal courts----
Mr. Buyer. I am referring to the Federal courts. And you
agree with that?
Mr. Vladeck. I am sorry?
Mr. Buyer. You would agree with what I just said, with
regard there is one circuit out of balance?
Mr. Vladeck. That is correct.
Mr. Buyer. So back to my lifeline to you.
I just want to be very clear to you here that if, in fact,
there is a manufacturer, Mr. Kinsley, that in fact has lied,
they don't get the protection of the law. And I don't think any
good manufacturer out there wants there to be protection
against anyone who is not playing by the rules.
If they play outside the foul line, they should feel the
full wrath of the law. Do you not agree?
Mr. Kinsley. Thank you. Thank you for that lifeline.
Mr. Buyer. I just don't remember that on Crossfire. I will
remember that.
Here is the other point that I make in my opening. It
really does concern me because in the year, the 17 years I have
been up here, I have been a strong advocate of our country
being able to attract great minds from all over the world to
place--come to the marketplace, at risk capital, push the
bounds of science for the benefit of our society and then under
the world.
If, in fact, we pass a law like this, what are the
consequences--let me turn to you, Mr. Cooper--what are the
consequences going to be upon not only innovation, but what--
will there be a quilt, sort of a patchwork in the marketplace
with regard to where manufacturers are going to go to sell
their products for fear that one State may, in fact, have a
different litigious environment?
Mr. Cooper. There may well be some of that.
I think the major impact would be lack of development of
products where there is great need but also great liability
risk. The--I think the experience of lawyers who try products-
liability cases is that juries will do what they need to do to
compensate an injured plaintiff. Even if the manufacturer had a
warning that said, Don't do this, it will kill you, the jury
will find that that was inadequate because it could have said,
It will kill you for sure.
That is a natural human reaction and it is a problem. And
the effect of it is on people who need medical devices and they
are not there. Or they haven't been improved to the extent that
they could be if more investment were made, but the
manufacturers decided to put the investment somewhere else,
which presents less liability risk.
Mr. Buyer. Thank you. Thank you, Professor.
Mr. Pallone. Thank you.
The gentleman from Utah, Mr. Matheson.
Mr. Matheson. Thank you, Mr. Chairman. I think this topic
is certainly an important issue. It represents an intersection
of a number of key dynamics, including patient safety and
health care and innovation. And while we all agree that patient
safety should be a top priority, I think it is also--I think we
all probably agree that if the device maker has done something
wrong, they should be held accountable.
What I am concerned about is that a blanket approach could
have some far-reaching consequences. If the problem lies
elsewhere, say, with the review process at FDA, then this
committee needs to have a larger conversation beyond this
preemption discussion we are having today. I don't think we
should take this issue very lightly, and I think we ought to be
really careful and not rush to legislative action.
I had a number of questions, all of which have all been
covered except one, and I will ask real quickly to Mr. Cooper.
How should we address this issue with the FDA? Do they need
more power, more authority? Do we need to change the way they
are structured to protect consumer safety related to medical
devices?
Mr. Cooper. I think they need additional resources. I
think, as several members have said, the Agency has been
underfunded for a very long time. The President's budget makes
some headway on that with some substantial increase, including
for safety-related projects. More needs to be done, and there
also needs to be good oversight.
My experience at the FDA was that nothing concentrates the
mind like an upcoming congressional hearing, particularly one
by the Oversight Subcommittee or by the Health Subcommittee of
this committee, which has a long and distinguished record of
very effective oversight of the agency. I think that is needed
as well.
The FDA has wonderful public servants, dedicated career
people, who could make a lot more money doing something else
but derive much value in their lives from serving the public.
On the whole, I think they do a very good job. It still could
be improved, because the problems they deal with are immense.
Mr. Matheson. Thanks, Mr. Chairman. I yield back.
Mr. Pallone. Thank you.
The gentleman from Georgia, Mr. Gingrey.
Mr. Gingrey. Mr. Chairman, thank you.
I want to address my first question to Mr. Cooper.
The medical devices we are talking about and how they are
regulated by the FDA, if you would just walk me through the
process to approve one of these new devices and would discuss
the types of postmarket surveillance that is typical of these
devices in order to identify higher-than-expected complication
rates and to notify patients and physicians of any failures.
Mr. Cooper. Well, to try to do it very briefly----
Mr. Gingrey. Yes, please.
Mr. Cooper.--as has been stated, the applications tend to
be voluminous. The FDA needs to understand the ingredients or
materials, the components of the device, the principle of
operation, what its intended use or uses are, and what kinds of
problems it has to deal with. There will be clinical studies,
preclinical studies. There will be laboratory studies.
The raw data of all of that and the analyses all go to the
FDA. The FDA does its own review, its own statistical analyses.
It can require the companies to do additional studies, to
propose labeling as submitted. The FDA can ask for samples. So
it does a truly comprehensive review of all that is known.
As has also been pointed out, the studies are limited in
terms of the number of patients and of the duration of the
studies. If you waited forever, you would never have any
devices approved. So you have to cut it off and make a
reasonable judgment at some point.
Then the FDA has to conclude and people have to sign their
names and be accountable--and they are accountable--for
concluding that there is an assurance, a reasonable assurance,
that the device is effective for its intended use and that it
is safe. And ``safe'' means not that it is harm-free or risk-
free but that the benefits of the product outweigh those risks.
Then it approves it; and it can approve it with various
kinds of conditions, including the conditions for further
studies as the patient population using the device expands,
sometimes exponentially, beyond the limits of the clinical
trials, which are the primary bases for the approval.
Manufacturers are required to submit promptly to FDA
reports of malfunctions or adverse events associated with the
use of the device. Device user facilities--hospitals, clinics
and the like--are also required to report. Physicians, patients
and others are encouraged to report. Then you can go to the FDA
Web site and do that. The medical literature is reviewed both
by the manufacturer and by the FDA; and, in their annual
reports, the manufacturers are supposed to update the FDA in
that area.
Mr. Gingrey. Mr. Cooper, thank you. I will reclaim my time.
Thank you for that response.
Ms. Robb, I wanted to ask you--and thank you so much, of
course, for being a witness. I am sure it is very difficult for
you to describe that harrowing experience that you went through
several years ago, but let me understand:
As to the defibrillator that was implanted, I am assuming
that the physician--your cardiologist--decided that you were at
great risk, because of this cardiomyopathy and, I guess,
because of some congestive heart failure as well, of going into
what we in the medical field call ``ventricular fibrillation,''
not atrial fibrillation, not super-ventricular but ventricular
fibrillation, and I am sure you were told that this could
result in sudden death. So you had this surgical procedure.
You had this defibrillator inserted because if, all of a
sudden, you went into ventricular fibrillation, without that
device to give you that shock, which was a pretty good jolt, as
you described, when it started shocking you, maybe
inappropriately--but if it had shocked you in the appropriate
manner that would have been because, truly, your heart would
have gone into ventricular fibrillation. That device would have
or it certainly was intended to save your life, was it not?
Ms. Robb. It was definitely implanted in me to save my
life. I had never been shocked before December 31 when it
malfunctioned. That was the first time that I had ever been
shocked, and it was 31 times, but it was put in as a safety net
in case I were to go into V-tach.
Mr. Gingrey. Would you agree that you had that put in
because it was better to have it not needed than to need it and
not have it?
Ms. Robb. Definitely. I would say that, you know, at the
time, I knew that--they have sort of a cutoff limit with your
heart function. When it gets below a certain level, you are at
an increased risk to go into V-tach, and they recommend to get
a defibrillator as a life-saving safety net.
Mr. Gingrey. Well, let me reclaim my time. Thank you for
that.
Mr. Chairman, I just want to say that this is a great
hearing, and it was an opportunity to hear from some real
experts and to hear anecdotal testimony from Ms. Robb and,
actually, from Mr. Kinsley as well.
It is not easy. This is tough. I am a physician member.
Some of my colleagues on this panel or on this committee and
subcommittee are physician members, and we understand that this
is a tough issue, so I appreciate your being here and for
giving testimony and for helping us weigh the pros and cons of
this legislation.
With that, Mr. Chairman, I will yield back.
Mr. Pallone. Thank you.
I think we have finished with our questions, but I do want
to thank all of you for being here today. I agree with what Mr.
Gingrey just said, that this is, you know, something that we
obviously take very seriously, and we have to decide what is
the best course of action. I think all of you have really
helped us in, you know, commenting on this legislation as we
move forward. So thank you all very much.
What happens procedurally is, if members have questions,
they can submit them in writing, and you should be notified
within the next 10 days if there are questions of that nature.
Then we would ask you to respond in writing. That is the way we
proceed.
Again, thank you so much.
Without objection, the meeting of the subcommittee is
adjourned.
[Whereupon, at 4:16 p.m., the subcommittee was adjourned.]
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