[Senate Hearing 110-300]
[From the U.S. Government Publishing Office]
S. Hrg. 110-300
REGULATORY PREEMPTION: ARE FEDERAL AGENCIES USURPING CONGRESSIONAL AND
STATE AUTHORITY?
=======================================================================
HEARING
before the
COMMITTEE ON THE JUDICIARY
UNITED STATES SENATE
ONE HUNDRED TENTH CONGRESS
FIRST SESSION
__________
SEPTEMBER 12, 2007
__________
Serial No. J-110-54
__________
Printed for the use of the Committee on the Judiciary
U.S. GOVERNMENT PRINTING OFFICE
40-883 WASHINGTON : 2008
_____________________________________________________________________________
For Sale by the Superintendent of Documents, U.S. Government Printing Office
Internet: bookstore.gpo.gov Phone: toll free (866) 512-1800; (202) 512�091800
Fax: (202) 512�092104 Mail: Stop IDCC, Washington, DC 20402�090001
COMMITTEE ON THE JUDICIARY
PATRICK J. LEAHY, Vermont, Chairman
EDWARD M. KENNEDY, Massachusetts ARLEN SPECTER, Pennsylvania
JOSEPH R. BIDEN, Jr., Delaware ORRIN G. HATCH, Utah
HERB KOHL, Wisconsin CHARLES E. GRASSLEY, Iowa
DIANNE FEINSTEIN, California JON KYL, Arizona
RUSSELL D. FEINGOLD, Wisconsin JEFF SESSIONS, Alabama
CHARLES E. SCHUMER, New York LINDSEY O. GRAHAM, South Carolina
RICHARD J. DURBIN, Illinois JOHN CORNYN, Texas
BENJAMIN L. CARDIN, Maryland SAM BROWNBACK, Kansas
SHELDON WHITEHOUSE, Rhode Island TOM COBURN, Oklahoma
Bruce A. Cohen, Chief Counsel and Staff Director
Michael O'Neill, Republican Chief Counsel and Staff Director
C O N T E N T S
----------
STATEMENTS OF COMMITTEE MEMBERS
Page
Feingold, Hon. Russell D., a U.S. Senator from the State of
Wisconsin...................................................... 5
Leahy, Hon. Patrick J., a U.S. Senator from the State of Vermont. 1
prepared statement........................................... 118
Specter, Hon. Arlen, a U.S. Senator from the State of
Pennsylvania................................................... 3
prepared statement and attachments........................... 131
WITNESSES
Dinh, Viet D., Professor of Law, Georgetown University Law
Center, Washington, D.C........................................ 12
Peddie, Collyn A., Attorney, Williams, Kherkher, Hart & Boundas
LLP, Houston, Texas............................................ 10
Stone, Hon. Donna, State Representative, Delaware General
Assembly, President, National Conference of State Legislatures,
Dover, Delaware................................................ 6
Untereiner, Alan E., Attorney, Robbins, Russell, Englert, Orseck
& Untereliner LLP, Washington, D.C............................. 8
Vladeck, David C., Professor of Law, Georgetown University Law
Center, Washington, D.C........................................ 14
QUESTIONS AND ANSWERS
Responses Viet D. Dinh to questions submitted by Senator Grassley 26
Responses of Collyn A. Peddie to questions submitted by Senators
Leahy, Grassley and Feingold................................... 28
Responses of Donna Stone to questions submitted by Senators
Feingold and Grassley.......................................... 38
Responses of Alan E. Untereiner to questions submitted by Senator
Grassley....................................................... 41
Responses of David C. Vladeck to questions submitted by Senators
Leahy, Feingold and Grassley................................... 48
SUBMISSIONS FOR THE RECORD
Conference of Chief Justices, resolution......................... 61
Dinh, Viet D., Professor of Law, Georgetown University Law
Center, Washington, D.C., prepared statement................... 63
Kessler, David A., M.D., Dean and Vice Chancellor for Medical
Affairs, Univorsity of California, San Francisco, and David C.
Vladeck, Professor of Law, Georgetown University Law Center,
essay.......................................................... 72
North American Securities Administrators Association, Inc.,
Washington, D.C., prepared statement........................... 120
Peddie, Collyn A., Attorney, Williams, Kherkher, Hart & Boundas
LLP, Houston, Texas, prepared statement........................ 123
Stone, Hon. Donna, State Representative, Delaware General
Assembly, President, National Conference of State Legislatures,
Dover, Delaware, prepared statement............................ 139
Untereiner, Alan E., Attorney, Robbins, Russell, Englert, Orseck
& Untereliner LLP, Washington, D.C., prepared statement........ 154
Vladeck, David C., Professor of Law, Georgetown University Law
Center, Washington, D.C., prepared statement................... 172
REGULATORY PREEMPTION: ARE FEDERAL AGENCIES USURPING CONGRESSIONAL AND
STATE AUTHORITY?
----------
WEDNESDAY, SEPTEMBER 12, 2007
U.S. Senate,
Committee on the Judiciary,
Washington, D.C.
The Committee met, Pursuant to notice, at 11:11 a.m., in
room SD-226, Dirksen Senate Office Building, Hon. Patrick J.
Leahy, Chairman of the Committee, presiding.
Present: Senators Leahy, Feingold, Whitehouse, and Specter.
OPENING STATEMENT OF HON. PATRICK J. LEAHY, A U.S. SENATOR FROM
THE STATE OF VERMONT
Chairman Leahy. Good morning. Unfortunately, with wrapping
up one last bill on the floor and with the Appropriations
Committee meeting one floor down on the defense appropriations
bill, a number of us on this Committee are also on that
Committee. Unlike members of the judiciary and other branches
of Government, the Senators are not able to set their schedule
with any kind of clarity in advance, and so we were delayed.
Today we will focus on a little-known abuse of Executive
authority that threatens devastating consequences for American
consumers. Diana Levine was a successful musician in Vermont.
She and her husband performed and recorded children's music. A
few years ago, when she sought medical treatment at a local
clinic for nausea, she was injected with an antihistamine. A
subsequent infection resulted in gangrene, and Diana, the
musician, had to have her arm amputated.
She filed a common law negligence claim at her local
courthouse against the drug's manufacturer. A jury awarded her
$2.4 million in economic damages and $5 million in non-economic
damages for her life-altering injuries--a figure that is
certainly much, much lower than it might have been in some
other States, but it seemed reasonable in our State. The drug
company defendant appealed. The Vermont Supreme Court upheld
the verdict and judgment upon review.
This tragic case demonstrates how our civil justice system
can work. It also, though, reveals a practice by this
administration to usurp laws through Federal regulations at the
expense of consumers. In this case, the drug company has
ignored the jury findings, ignored the Supreme Court finding.
Instead, it is seeking review from the U.S. Supreme Court
because it argues that Federal regulation--not Federal law but
a Federal regulation--of the drug's label should prevent even
the filing of the suit for these injuries, that somehow a
bureaucratic regulation should close the courthouse doors to
300 million Americans.
In this case, the Vermont Supreme Court held that the FDA
labeling rules create only minimum requirements, and that the
rules are not intended to and do not immunize drug companies
from liability. It would be one of the most amazing things in
the world if it did. And I agree with the Vermont Supreme
Court. But I fear that some on the U.S. Supreme Court will
follow the lead of the Bush administration and try to throw
Diana out of court--just as it did Lilly Ledbetter last year in
a terribly cramped legal opinion written by Justice Alito that
prevented redress for employment discrimination. It leads many
to ask what kind of an insulated, cosseted life some judges
lead, totally devoid from the realities of life of most
Americans.
Diana's story illustrates how an obscure legal theory
called ``implied preemption'' is being invoked to shield
corporations from culpability and prevent injured Americans
from obtaining redress for their injuries.
Today's hearing will examine the Bush administration's
efforts to assist corporations in this effort and the Bush
administration trying to override State laws that protect
Americans. Just yesterday, a judge appointed by this President
struck down a New York City law requiring fast food restaurants
to include calorie counts on their menus because local law
supposedly conflicted with Federal regulations. Ironically, of
course, it is different when you are out campaigning and
talking. President Bush once told a group of Governors whose
political support he needed that the role of the Federal
Government is ``not to impose its will on States and local
communities...it's to empower the States and people and local
communities to be able to realize the vast potential of this
country.'' Unfortunately, the reality catches up with the
rhetoric, and the rhetoric rings hollow when the record shows
clearly the administration's attempt to grant corporate
defendants blanket civil immunity by aggressively preempting
State law in the course of issuing administrative regulations.
Now, in addition to concerns about the administration's
actions threatening the principles of federalism, Senator
Specter and I joined to voice our concern about how the
administration's efforts in this regard violate the powers
assigned to Congress. On November 17, 2005, we wrote to the
National Highway Transportation Safety Administration about a
proposed agency rule on ``roof crush standards'' that sought to
preempt numerous State laws and ultimately, of course, weaken
consumer protections for Americans. Senator Specter and I
pointed out in our letter that it appeared the Federal agency
was plainly acting beyond the authority granted to it by
Congress in the Transportation Equity Act. But, unfortunately,
the Federal agency's response did nothing to address our
questions about its claimed authority to override State laws
that may compensate motorists critically injured in car
accidents. Those roof crush regulations are just one example of
at least a dozen issued by the Consumer Product Safety
Commission, the Department of Homeland Security, the Federal
Drug Administration, and other Federal agencies that are being
used not to protect consumers but to shield drug and other
product manufacturers.
The administration's concerted effort to thwart effective
consumer protection and to remove the incentive to improve
safety beyond the minimum standards set by regulatory agencies
reminds me of the politicization of the Justice Department.
Just as we have witnessed improper political considerations
undermine our Federal law enforcement, we are now witnessing
agency rulemaking turned into a mechanism to immunize powerful
corporations and political contributors at the expense of
ordinary Americans. Rather than issuing regulations based on
facts and science to benefit the American people, the process
has been hijacked. And the intended result of this politically
motivated version of rulemaking not only slams the local
courthouse door on injured victims, but it prevents State law,
State regulators, and State courts from acting.
I have gone way over my time. I will put the rest of my
statement in the record. But when this administration attempts
to override the efforts of State authorities to provide
meaningful health and safety and consumer protections, all
Americans are more vulnerable.
[The prepared statement of Chairman Leahy appears as a
submission for the record.]
Chairman Leahy. Senator Specter?
STATEMENT OF HON. ARLEN SPECTER, A U.S. SENATOR FROM THE STATE
OF PENNSYLVANIA
Senator Specter. Thank you, Mr. Chairman. This is an
important hearing to focus on the congressional role in
specifying whether there should or should not be preemption. We
have a large body of State law, common law, opening remedies,
and now we have the regulatory agencies coming in and on their
own authority saying that their regulatory process preempts the
State law. And it requires a very close look at precisely what
is going on and whether we are looking at the rule of law or
whether we are looking at the ideas of public policy which are
expressed by a specific administration.
We have the case of the Consumer Product Safety Commission
where the administration changes and there is a new Chairman
and there is a totally different policy--picking up cases which
had been decided, leading to very severe chastisement by the
administrative law judge on the retreat from what is the rule
of law. And we find that the Environmental Protection Agency
comes out with regulations which modify the Clean Air Act on
power plant emissions. You find the Children's Health Insurance
Program is affected by what regulations are issued reflecting
the policy position of the administration. And so often you
have the judgments based upon so-called scientific evaluations
which are highly suspect, whether the books are being cooked on
these matters to provide a basis for a different regulatory
process.
You have the global warming contest. Finally, there is an
acknowledgment--or at least so it seems--that there is a
problem on global warming. But a lot of tests were advanced of
dubious scientific value, and now the President has said there
is a problem on global warming.
You had the issue of the mercury pollution. You had the
Surgeon General Richard Carmona testify about the White House
directing him as to what to say about scientific findings. The
Surgeon General is a scientist, not the Office of Management
and Budget.
You have the Endangered Species Act. You have the Concerned
Scientists, 60 leading scientists, including Nobel laureates,
coming out with a very severe challenge to the findings of the
National Ambient Air Quality Standards, the regulations on
asbestos. And so it leads to the inference that there is
politicization. If you take the public policy determination by
one administration changing from another, that is what you call
politicization. And we really are a Nation where the rule of
law governs.
But you find the case involving 44,000 children riding in
all-terrain vehicles who were injured, 150 of them fatally. And
then you have groups like the National Association of
Pediatricians, the emergency room doctors coming out wanting a
change in the ATVs. And you have the agency with its general
counsel, former counsel on the defense of ATVs.
So I think we really have traditionally and wisely looked
to the courts to decide these matters as opposed to the
regulatory process. But it is a very deep and involved subject,
and if I had the time, I would read the very excellent
statement prepared by my staff as my opening statement, which I
will include in the record.
Chairman Leahy. I will read it.
Senator Specter. I said to my superb lawyer--I have got a
great law firm, by the way.
[Laughter.]
Senator Specter. And I said, after reading it, and taking
some time to read it, I said, ``What am I going to do with
this?'' I certainly cannot read it. And I am going to put it in
the record with the hope that somebody will read it. And it is
recommended reading--not for insomniacs. It will not put you to
sleep. But we are dealing on some very, very complex issues,
and I have tried to boil them down in the limited time allotted
to a comparison of the rule of law versus public policy as one
administration sees it. ``Politicization'' may be to harsh a
word, or it may be too accurate a word.
I do want to say this, Mr. Chairman. The schedule is just
extraordinary right now, as tough as I have seen it.
Senator Leahy and I were at the Appropriations Committee on
the defense appropriation bill, and it is a bad meeting to
miss. And I am sitting down with the military experts on the
Webb amendment as to whether we have rotation of troops. So I
am going to have to excuse myself early from the hearing, even
though it is a very, very important one. But I will be
following the transcript very closely.
Again, I thank you, Mr. Chairman, for your perspicacity in
scheduling this important hearing.
[The prepared statement of Senator Specter appears as a
submission for the record.]
Chairman Leahy. I never even try to say that word because I
get it all screwed up, but I thank you. And it is true, we do
have excellent lawyers on both sides of the aisle here, another
reason why some of us Senators consider ourselves
constitutional impediments to the staff running everything, and
we might be a lot better off if they did.
Senator Feingold, did you wish to add anything to this?
STATEMENT OF HON. RUSSELL D. FEINGOLD, A U.S. SENATOR FROM THE
STATE OF WISCONSIN
Senator Feingold. I would like to make a brief statement,
which my staff prepared for me.
[Laughter.]
Senator Feingold. I want to thank you, Mr. Chairman, for
holding this hearing. In recent years, this administration has
quietly undermined the longstanding relationship between
Federal public safety regulation and State common law. After
decades of recognizing that State common law is an
indispensable partner to Federal safety regulation, our Federal
agencies are suddenly taking the position that State lawsuits
and Federal regulation cannot coexist and that State lawsuits
intended to compensate the victims of defective products must
be preempted.
This is a 180-degree turnaround, and it is being
implemented through a deliberate end-run around Congress. In at
least one of these cases, Congress considered and rejected the
idea of preempting State law. Likewise, agencies are ignoring
their legal obligation under Executive order 13132 to avoid
preemptive regulations where possible and to consult with
States before they issue preemptive regulations.
This back-door dismantling of State tort law suggests that
this administration's rhetoric about States rights is really
just that--rhetoric. It also disserves the public. For all
their good points, Federal agencies react slowly to industry
developments and lack the power to subpoena product information
from corporations. Cases brought by consumers in State courts
can help ensure that safety standards keep up with the
industry, and they can provide an invaluable source of
information for regulators as well as for the public. They also
provide a critical safeguard against so-called ``agency
capture,'' the all-too-common phenomenon of agencies falling
under the influence of industries that they are supposed to
regulate.
Even if Federal agencies worked perfectly, Federal safety
standards are meant, in my view--and, I know, in the view of
the people in my State--to be a floor, not a ceiling. When you
prevent consumers from bringing cases in State courts, you
remove a key incentive for manufacturers to provide safety
features beyond the bare minimum. And make no mistake--people
will continue to be injured by defective products. The only
difference will be who pays the price. It will be the victim
and the taxpayers instead of the corporation that caused the
harm.
So I thank the witnesses for being here. And as Senator
Specter indicated, it is a very busy morning, so I regret not
being able to stay long, but I do feel strongly that this is an
important matter requiring our close attention.
Thank you, Mr. Chairman.
Chairman Leahy. Thank you.
Would the witnesses please stand and raise your right hand?
Do you solemnly swear that the testimony you will give in this
matter will be the truth, the whole truth, and nothing but the
truth, so help you God?
Ms. Stone. I do.
Mr. Untereiner. I do.
Ms. Peddie. I do.
Mr. Dinh. I do.
Mr. Vladeck. I do.
Chairman Leahy. Let the record show that all indicated yes.
We will go in the order they are there. Donna Stone is a
Republican member of the Delaware General Assembly and the
President of the National Conference of State Legislatures.
Alan Untereiner is a partner in the Robbins, Russell law
firm here in Washington, D.C., representing drug manufacturers
in product liability suits.
Collyn Peddie is an attorney at Williams, Kherkher in
Houston, Texas. She represents victims who have been injured by
prescription drugs.
Viet Dinh is a professor of law at my alma mater,
Georgetown University Law Center. He is a private consultant.
He served from 2001 to 2003 as Assistant Attorney General for
Legal Policy at the Justice Department and is no stranger to
this room.
David Vladeck is a professor of law at Georgetown
University Law Center--my alma mater, I add again, but that is
not why they are here--where he teaches classes in Federal
courts, civil procedure, and government processes.
Representative Stone, thank you very much for being here.
Let's begin with you. Go ahead.
STATEMENT OF HON. DONNA STONE, STATE REPRESENATIVE, DELAWARE
GENERAL ASSEMBLY, AND PRESIDENT, NATIONAL CONFERENCE OF STATE
LEGISLATURES, DOVER, DELAWARE
Ms. Stone. Thank you. Good morning. I am State
Representative Donna Stone, and the President of the National
Conference of State Legislatures. I am very grateful to
Chairman Leahy and Ranking Member Specter--I am so sorry. This
is my first time--and the members of the Senate Judiciary
Committee for inviting me to speak to you about the preemption
crisis that is facing States today. I ask that my written
testimony be incorporated into the record.
Chairman Leahy. Without objection, so ordered.
Ms. Stone. Thank you, sir.
NCSL is troubled by the growing trend in Congress and the
Federal agencies to pass legislation and promulgate rules that
have a detrimental impact on States because of their
intrusively preemptive nature. This trend is problematic. If
not curbed, it will undermine the genius of our Federal system.
I am particularly alarmed by the emergence of agency
regulatory actions that preempt without standing. Agency
bureaucrats are unelected and have no real accountability to
those impacted by an agency's preemptive regulations. This lack
of accountability was the reason behind the 1999 revisions to
Executive order 13132, better known as ``the federalism
Executive order.'' This order requires agencies to consult with
State and local elected officials and their national
associations, like NCSL, whenever a proposed rule contains
preemptive provisions. The goal of this consultation is for
agencies to better understand the preemptive impact of the
proposed rule and to minimize the preemption.
Unfortunately, the federalism Executive order does not have
the force of statute and cannot be enforced. Agencies
arbitrarily abuse and ignore it. Several recent rulemakings
serve to illustrate this point, and they share these common
elements:
One, enabling legislation contained no statutory authority
granting the agency permission to preempt the established
bodies of State law.
Two, there was no consultation conducted with State and
local officials.
And, three, the agency acts sought to preempt significant
areas of State law not within the purview of the Federal
regulation.
The first agency to attempt this recently was the National
Highway Traffic Safety Administration, or NHTSA. NHTSA tried to
promulgated a roof crush rule it claimed had no State impact,
warranting a consultation under the federalism Executive order,
but then went on brazenly to state that, if finalized, the rule
would preempt all conflicting State common law in this area,
including tort law. The rule has not yet been finalized.
Shortly thereafter, the FDA finalized its 5-year-old Notice
of Proposed Rulemaking on prescription drug labeling. Just
prior to finalizing the rule, but long after the public comment
period had closed, the FDA unilaterally decided to insert
policy language expressly stating that the rule would preempt
State product liability laws. Again, NCSL was not consulted,
had no opportunity at that point to comment against the
provision, and the FDA's enabling statute granted no authority
to the FDA to preempt in this area.
The most recent agency action occurred earlier in 2007 when
the IRS sought to issue a ruling that would have preempted
State Constitutions and statutes defining what constitutes a
legislative day. Once again, there was no consultation with
NCSL and no statutory authority.
The problem of unwanted preemption is not solely limited to
regulation, but is found also in recent acts of Congress.
Examples include the REAL ID Act; the vaccine liability
exemption, which prohibits any lawsuit under Federal law or any
applicable State law from being filed for any claim arising
from the use of the vaccine or the drug in question; and
pending election reform legislation that would preempt State
laws governing voting machine technology and election audit
procedures.
NCSL believes that the federalism Executive order should be
codified in statute to strengthen the intergovernmental
relations and to enhance transparency in legislative actions
undertaken by Congress. I have detailed a five-part legislative
proposal in my written testimony that I think will ameliorate
these preemption problems. The components of this solution
include:
One, enhanced consultation--can I finish up?
Chairman Leahy. Why don't you just name those parts? I have
read that. They make a lot of sense. But go ahead and just name
them.
Ms. Stone. Enhanced consultation with State and local
government officials prior to the consideration of preemptive
Federal legislation or regulation.
Two, a rule of construction that would pay due deference to
State law when there is no express intent to preempt present
law.
Three, an enforcement provision.
Four, legislative reporting of a bill's preemptive impact
on States.
And, five, an agency impact statement to ensure that
agencies engage in meaningful consultation with State and local
elected officials or their national organizations.
I will stop there. Thank you very much.
Chairman Leahy. Thank you very much, and your full
statement is part of the record, Ms. Stone.
Ms. Stone. Thank you.
[The prepared statement of Ms. Stone appears as a
submission for the record.]
Chairman Leahy. Mr. Untereiner?
STATEMENT OF ALAN E. UNTEREINER, ATTORNEY, ROBBINS, RUSSELL,
ENGLERT, ORSECK & UNTEREINER LLP, WASHINGTON, D.C.
Mr. Untereiner. Good morning Chairman Leahy, Ranking Member
Specter, other distinguished members of the Committee. Thank
you for the opportunity to testify today.
Chairman Leahy, you indicated that I was here today
representing drug companies and have represented them and am
currently representing them in litigation. That is not true. I
am actually here on behalf of the U.S. Chamber of Commerce as
well as the Chamber's Institute--
Chairman Leahy. Is your microphone on, Mr. Untereiner? Is
your microphone on?
Mr. Untereiner. It is on. I will try to speak up.
Chairman Leahy. Thank you.
Mr. Untereiner. I am here on behalf of the U.S. Chamber and
the Chamber's Institute for Legal Reform, and the views
expressed today are my own, based on my experience in private
practice and involvement in a wide range of preemption cases. I
have submitted a written statement that discusses the doctrine
of Federal preemption in detail and addresses a number of
proposals that have been made for limiting that doctrine in its
various forms, and I would like to ask that that written
statement be made part of the record.
Chairman Leahy. Without objection, it will be.
Mr. Untereiner. Thank you.
The doctrine of Federal preemption is critically important
to the business community, to the creation of unified national
markets, and to the health of our national economy. These
benefits are often overlooked in the heated debates over
whether a particular court decision that is controversial or a
particular agency action that is controversial is correct.
We live in a sprawling and large country that is rich in
many things, including Government. The multiplicity of
Government actors below the Federal level ensures that
businesses with national operations will be subject to
complicated, overlapping, and sometimes even conflicting legal
regimes.
These overlapping regulations have the potential to impose
undue burdens on interstate commerce. When Congress exercises
its unquestionable power to legislate preemptively, rather than
merely concurrently with the States, by prescribing a set of
uniform rules for the entire economy, it streamlines the legal
system. It also reduces the regulatory burdens on business,
lowers the barriers to new entry to small businesses, and helps
to create a unified national marketplace for goods and
services.
It is important to remember that many preemption schemes
created by Congress also vest additional regulatory authority
in an expert Federal agency. This ensures that preemption does
not result in a regulatory vacuum. It also means that the legal
rules governing complex areas of the economy or products are
formulated by expert regulators with a broad national
perspective and needed scientific or technical expertise rather
than by decisionmakers--such as municipal officials, elected
State judges, and lay juries--who have a far more parochial
perspective and limited set of information.
Federal preemption of State law is an ordinary and
ubiquitous feature of our scheme of Government. By virtue of
the Supremacy Clause, each new State statute, each new Federal
statute or regulation automatically preempts conflicting State
and local law. Also, Congress has passed scores of statutes
that contain express preemption clauses spanning a very wide
array of areas, including the design and labeling of many types
of specific products. These preemption schemes contain
carefully crafted limitations and other provisions that
accommodate the interests of State and local governments.
Reasonable people can and do disagree about such matters as
the regulatory function of tort law and liability judgments,
whether it makes sense to treat common law or tort law
differently under a preemptive Federal regime, and whether
preemption gives rise to serious federalism concerns or is
instead fully consistent with the Constitution's structure.
Because reasonable people disagree, the courts in express
preemption cases look to the actual language used by Congress
to discern how Congress has resolved these issues in each
particular case. There is no need to skew that inquiry with
special new default rules pointing one way or another.
Criticisms of so-called obstacle preemption are unfounded.
The Supreme Court has made clear that obstacle preemption flows
directly from the Supremacy Clause. Like ordinary conflict
preemption, obstacle preemption plays a vitally important role
in ensuring the supremacy and the full effectiveness of all
Federal laws against incursions by the States. Obstacle
preemption does not vest too much discretion in judges or
administrative agencies. True, it does require judges to
identify the relevant congressional purpose or purposes and to
decide whether those Federal purposes are being frustrated. But
Congress often declares its purposes explicitly in a statute or
in the accompanying legislative materials. In any event, the
Framers intended that the Supremacy Clause would be enforced by
the courts.
It makes little sense to disregard the views of an
administrative agency concerning whether State or local law
conflicts with or frustrates the purposes underlying a statute
the agency is charged with administering. As Justice Stevens's
opinion in Medtronic explained, an agency to which Congress has
delegated authority to implement the statute is ``uniquely
qualified to determine whether a particular form of State law
stands as an obstacle to the accomplishment and execution of
the full purposes of Congress.''
Finally, the Committee should keep in mind that the
doctrine of Federal preemption applies to all Federal laws and
the operation of all Federal agencies. Additional generalized
limits on preemption would impair the ability of Congress and
administrative agencies to bring about the many significant
benefits that flow from preemptive statutes and regulations.
Congress should not allow controversies over a limited subset
of preemption cases or administrative decisions to drive far-
reaching changes to this important area of law.
Thank you.
[The prepared statement of Mr. Untereiner appears as a
submission for the record.]
Chairman Leahy. Thank you. We will be getting back to that,
but keep in mind we are not--I am not as concerned about cases
where Congress very specifically preempts State law. It is
something we should do rarely. But there are times when we do.
I just do not agree when a Federal agency, not having been
given the authority to preempt, directly or indirectly,
suddenly does it on their own. At that point nobody is
responsible. Ms. Stone, Senator Specter, Senator Whitehouse,
and myself have to respond to our constituents, we have to
respond to our States if we do something, if we vote for
something. Somebody who has no responsibility to anybody other
than the administration in power, it worries me if they are
given too much authority. It is like these activist judges that
we all worry about, and currently with the most activist
Supreme Court I have seen in my lifetime.
Ms. Peddie?
STATEMENT OF COLLYN A. PEDDIE, ATTORNEY, WILLIAMS, KHERKHER,
HART & BOUNDAS LLP, HOUSTON, TEXAS
Ms. Peddie. Thank you. Chairman Leahy, Ranking Member
Specter, and members of the Committee, my name is Collyn
Peddie, and I am lead counsel in three ongoing preemption
battles in Texas and Pennsylvania involving thousands of Vioxx
and vaccine claims. I am grateful to the Committee for allowing
me this opportunity to give it a firsthand report from the
front lines of those battles.
With alarming frequency, those injured by prescription
drugs see their right to seek compensation and a day in court
eliminated entirely by the preemption doctrine. For 90 years,
the FDA maintained that its prescription drug regulations only
provided minimum standards; therefore, it did not consider
State actions which asserted higher duties to be in conflict
with those regulations or preempted by them.
Beginning in 2002, however, the FDA aggressively asserted a
new philosophy that FDA regulations provided both minimum and
maximum standards for prescription drugs. State tort claims
based on the failure to include in proposed warnings
information that the FDA considered and rejected would,
therefore, be impliedly preempted. In 2006, the FDA formalized
this policy in a preamble to its drug labeling regulations.
Although most courts have refused to defer to the FDA's
pronouncement, a handful of courts have ignored Federal law and
bedrock constitutional principles or relied upon the preamble
to apply the implied preemption doctrine to preclude thousands
of claims without trial or any consideration at all of their
merits.
Ruby Ledbetter's case is a good example. As a result of
taking Vioxx for a year and a half, this active, healthy
grandmother suffered heart attack. She sued Merck for failure
to warn her doctor of its potential cardiovascular effects.
Although Texas law would have permitted Ruby to show that Merck
had withheld from or misrepresented material information to the
FDA during the Vioxx approval process and, therefore, that
Merck was not entitled to assert FDA approval as a defense in
her case, Judge Wilson found that her ability even to try to
make that threshold showing was impliedly preempted and
dismissed her claim. In the name of Congress, then, he
immunized from suit in Texas even drug manufacturers who lie to
the FDA to gain approval and potentially locked the courthouse
door to thousands of pharmaceutical plaintiffs.
In Pennsylvania, Hannah Bruesewitz suffered a similar fate.
While a normal toddler, Hannah received DPT vaccine. Within 2
hours, she was in convulsions and has suffered from seizures
ever since. Ignoring language in the Vaccine Act that expressly
preserves suits like Hannah's that involve vaccines for which
there were safer alternatives, a Federal judge held that
Congress intended to preempt all design defect claims and
dismissed hers. Worse, a second Federal judge, relying in part
on the FDA Preamble, would have dismissed as impliedly
preempted Hannah's failure to warn claims too, even though
Congress expressly preserved those claims as well.
Ruby's and Hannah's cases, therefore, reveal an emerging
pattern of judicial and executive legislating, and
nullification of laws permitting them to assert tort claims
against drug companies. During the same period, however, the
FDA has increasingly failed to enforce regulations designed to
protect them. In one noteworthy instance, field inspectors
revealed a corporate-wide problem involving the substitution of
industrial nitrogen gas for medical oxygen. When nitrogen gas
was pumped into an Ohio nursing home's oxygen delivery system,
ten residents went into cardiac arrest and four died. Despite
strong recommendations from field staff and the indictment of
the company on negligent homicide charges, FDA officials
ignored the matter for almost 2 years and took no enforcement
action of any kind.
With FDA enforcement actions in free fall and private suits
increasingly preempted, what must be done to protect the
public?
First, Congress must make its intent clear. The FDA's
pronouncements on preemption will be entitled to little or no
deference in the face of clear expressions of congressional
intent.
Second, Congress must increase its oversight of the FDA and
other safety agencies. The U.S. Supreme Court in a Vermont case
is poised to review cases addressing the question of whether to
give agency assertions of preemption so-called Chevron or
conclusive deference. It is, therefore, critical that Congress
police such statements now.
Third, Congress should consider limiting legislation for
preemption. Congress should specifically define and restrict
the circumstances under which it will permit preemption to be
implied.
And, finally, Congress should consider passage of uniform
statutory interpretation rules, including those addressing
preemption. These laws are already in the common law. They
should be codified. By providing more guidance to the court and
agencies in interpreting Federal statutes, Congress can
increase the likelihood that State and Federal courts will
follow established principles and not legislate from the bench.
New studies released just this week reveal that injuries for
prescription drugs have increased dramatically in recent years.
Unless Congress acts, and acts now, more citizens like Ruby and
Hannah will be deprived of their day in court and any
compensation at all for their injuries. Instead, these costs
will be shifted entirely to the American taxpayer.
For these reasons, I urge Congress to adopt the
recommendations outlined here, and I ask that my more extensive
written testimony be included in the record.
Chairman Leahy. Without objection, the testimony will be
part of the record.
Ms. Peddie. Thank you.
[The prepared statement of Ms. Peddie appears as a
submission for the record.]
Chairman Leahy. Professor Dinh?
STATEMENT OF VIET D. DINH, PROFESSOR OF LAW, GEORGETOWN
UNIVERSITY LAW CENTER, WASHINGTON, D.C.
Mr. Dinh. Thank you very much, Mr. Chairman, members of the
Committee. Mr. Chairman, thank you for having me here and thank
you for being such a loyal alumnus of Georgetown University Law
Center.
I must start with a note of full disclosure since we are in
that spirit. My written statement, which is submitted for the
record, is based upon and in some cases recycled from a series
of articles I have written over the past decade on the question
of preemption, and many of which I co-authored with Paul
Clement, then my colleague on the Georgetown University Law
faculty. And so, Chairman and members of the Committee and
other witnesses, it is right to focus on this issue as one of
longstanding concern and potential great constitutional and
policy import in the past, present, and certainly in the
future.
A number of considerations I want to use my limited time in
order to highlight. That is, we all know Article VI of the U.S.
Constitution declares the laws of the United States to be the
supreme law of the land and that judges shall be bound thereby.
And so when we are talking about preemption, especially when we
talk about conflict preemption, what we are really talking
about is supremacy--that is, Federal law is supreme to conflict
State law. And so conflict preemption, true conflict
preemption--that is, it is impossible to comply with both State
and Federal law is simply a choice of law rule that is under
operation by the text of Article VI of the United States
Constitution.
The question of preemption, either express or implied, is,
properly conceived, a method of regulation which Congress may
employ pursuant to its power under Article I, Section 8, in
order to regulate areas of Federal concern, most notably the
regulation of interstate commerce. And so in that sense, when
we are talking about preemption, one thing that we should note
is that we start with a background, even though it was a very
significant intrusion into State legislative prerogatives, as
Ms. Stone has so cogently identified, but it works in the
background of supremacy--that is, the Constitution set forth
that Federal law shall be supreme. And as long as Congress acts
within the scope of its power enumerated under Article I,
Section 8, those laws would be supreme. I agree, however, that
when Congress so acts, it should be very careful and only
preempt when it deems necessary.
The next area of concern that the Chairman has raised is
the difference between regulatory preemption versus statutory
preemption. And here I think the unbroken line of Supreme Court
precedent is clear and unchallenged and correct. That is, so
long as Congress delegates the power to regulate generally to
the agencies in their organic statute, then that implication of
power, that grant of power also implies the methods with which
to regulate, including to preempt where necessary by express
provision within the regulation.
Of course, policies can change across agencies, across
administrations, across administrators. When those policies
change, they would be considered arbitrary and capricious
unless accompanied by a well-reasoned explanation and,
therefore, answering the Ranking Member's concern about the
politicization or unwarranted reversals in courses of action.
To this extent, I do not think that Congress has much to
worry about in terms of runaway agencies because Congress has
ample authority to correct such runaway action or to correct
the course on which the administrative train is headed. It can
revise the organic statute to deny the power to preempt, if
that is a specific area of concern. It can amend the underlying
text of a statute to make clear that the preemption action is
contrary to congressional intent. And, also, I would not object
to and, indeed, I would support the codification of the
federalism Executive order. As Paul Clement and I wrote in
1999, anything that forces--
Chairman Leahy. Professor, it is easy to say we can always
change the statute, but if they are following basically what is
either spoken or unspoken administration policy of whatever
administration, that means you have to get those changes past a
Presidential veto, which means a two-thirds vote in both
bodies. It is not quite as simple as--I agree with you on the
basic theory. The reality is a lot more difficult than the
theory.
Mr. Dinh. Bicameralism and presentment do work a rather
significant check on the legislative process, but I do think
that it remains for Congress to have that tool. Anything that
forces the Federal Government to stop, listen, and think about
whether or not it is the proper forum to regulate and to
displace State law I think is something to be advocated, which
is why I support the codification of the federalism Executive
order.
The only note with which I will end is that I think it is
profound constitutional policy and interpretive mistake to
adopt any type of clear statement rule that requires an express
statement of preemption. Otherwise, there would not be a
preemption of State law. As you have seen in the progression of
Federal regulation in the last 50 years, this era of Federal
regulation has brought a lot of great changes to our society
and a lot of the changes that many people on the opposite of
this argument would advocate. And I think that to throw the
baby out with the bath water because of a temporal fear of
abuse may be overreaching and an overreaction.
Thank you very much.
[The prepared statement of Mr. Dinh appears as a submission
for the record.]
Chairman Leahy. Professor Vladeck?
STATEMENT OF DAVID C. VLADECK, PROFESSOR OF LAW, GEORGETOWN
UNIVERSITY LAW CENTER, WASHINGTON, D.C.
Mr. Vladeck. Good morning. Mr. Chairman, Senator
Whitehouse, thank you very much for inviting me here to testify
before you today.
I want to begin by commending the Committee for grappling
with this important and timely question. The administration's
campaign to use regulatory agencies to broadly preempt State
law raises fundamental questions about federalism, the
allocation of power between Congress and the executive branch,
and the importance of State law in compensating people injured
through no fault of their own, and spurring innovation.
Recent assertions of preemption by Federal agencies are, in
the main, nothing less than an effort to arrogate to the
executive branch power that properly belongs to Congress.
Displacing State law is no trivial matter. Our federalist
system is based on the premise that Federal and State law can
comfortably co-exist, and for most of our Nation's history,
State tort law has served as an important backstop to both
Federal and State regulatory law.
At its core, tort law serves a complementary purpose to
direct Government regulation. Regulation seeks to prevent
injury and to weed out products that are unsafe. But there are
very few Federal statutes that provide compensation for injured
parties--very few--Price Anderson Act, the 9/11 Act. But
typically, when Congress regulates, it leaves it to the States
to compensate people injured through the fault of others. Tort
law serves that function. It informs the public about
unforeseen hazards, and it deters unwarranted risk taking.
Now, why should Congress care about this preemption
campaign? First and foremost, the administration's policy is
unsound. If you strip all the legalese that enshrouds the
debate, what is going on here is that the administration is
pushing silently and behind closed regulatory agency doors a
public policy campaign that I do not think they could get
through Congress.
Second, the Congress is being pushed as the party that is
responsible for these wholesale displacements in State law. If
you look at every agency pronouncement announcing broad
preemption, they blame Congress. The argument is that ``We are
simply carrying out the will of Congress.'' So when the FDA
preempts claims for drugs or medical devices and says that
people who are injured can no longer sue, Congress is the
culprit. The executive branch is placing the responsibility
squarely on your shoulders, where it ought not to be.
Third, in making these broad preemption claims, agencies
are repudiating decades, at times, centuries worth of practice.
These positions that are being set aside were set by their
predecessors, Republicans and Democrats alike. The FDA's new
position on failure-to-warn claims is contrary to the position
taken by every administration since at least 1962 when this
Congress passed the efficacy requirements of the Food, Drug,
and Cosmetic Act.
Fourth, the Constitution makes it quite clear that the
final say over when State law ought to be displaced is
Congress's to make, not the executive branch. This is plainly
an arrogation by the executive branch that Congress ought not
to stand by and tolerate.
There have been many discussions about what can be done
today. I do not share my colleague Professor Dinh's view that
the process will sort itself out. For one thing, no agency has
yet actually used the regulatory process as he describes to
preempt State law. What has happened here is that although in
the past agencies actually went through notice and comment
rulemaking to develop regulations that set forth the borderline
between State and Federal law, they are not doing that. They
are simply announcing their conclusions in preambles to final
rules. They are avoiding the notice and consultation
requirements of the Executive order. This is the Clinton
Executive order, but it is modeled on its predecessor Executive
order that was issued by President Reagan.
Since President Reagan, agencies have faithfully consulted
with States and local governments before preempting. This new
campaign is happening, by and large, behind closed agency
doors, without adequate consultation with the State and local
leaders like we have here today, and without any opportunity
for the public to participate in any meaningful sense.
I realize my time is up. Let me just say that I endorse
many of the proposals here today. Part of what Congress has to
do is wrest control of this question back to itself by being
much more specific when it legislates, by contemplating omnibus
legislation that will enshrine some of the substantive
components of the Executive order, and by holding the executive
branch feet to the fire. This problem has existed since 2002.
As far as I know, this is the first time that Congress has
tried to focus its attention on it.
[The prepared statement of Mr. Vladeck appears as a
submission for the record.]
Chairman Leahy. We have a new Congress.
[Laughter.]
Mr. Dinh. We are painfully aware of that, Mr. Chairman.
Chairman Leahy. People suddenly found out these things. We
realize Congress has the ability for oversight. I rather like
that, and we will do it.
As I listen to you, Professor Vladeck, I am struck by the
parallels between this and the whole question of signing
statements. Probably the most egregious was all this talk about
we are going to have a law against torture and the United
States will not be involved with torture. And I recall one
Senator, now running for President, who had great press
conferences on it, and the President had great statements on
it, and they signed the bill which had been passed virtually
overwhelmingly by the Congress, and then very quietly on a
Friday afternoon, put a signing statement saying we will not
have torture--unless we decide to torture. That is basically
what it said. And, you know, thus it goes.
There is a derogation on our part, on the Congress's part.
I was not in the majority at that time, but what we should have
done, of course, was immediately pass the law again making it
very clear that there are no exceptions.
But you have written extensively about the issue of
regulatory preemption. Your testimony, which is part of the
record, has a whole litany of preemption language that has been
put into Federal regulations.
It is interesting that a number of these agencies suddenly
decided almost at the same time to do this. Do you think this
is a coincidence, Professor?
Mr. Vladeck. No, it plainly is not. And we know this for
two reasons. One is this campaign sprung forth at many agencies
at exactly the same time, and that it came forward in
regulatory proposals, all of which had to be reviewed
extensively by the Office of Management and Budget. So the idea
that the White House somehow doesn't have its fingerprints on
this effort, writ large, is simply implausible.
Federal Register notices must be cleared by OIRA, the
Office of Information and Regulatory Affairs at OMB, before
they can be published. So this is not just a coincidence.
Chairman Leahy. Well, also, the Consumer Product Safety
Commission for the first time recently included language in its
mattress flammability rules to state that the Flammable Fabrics
Act necessitates the preemption of State law, including State
tort law. Why would they make such a change? What would this do
for product safety?
Mr. Vladeck. Well, as you know, Senator, there have been
many, many lawsuits brought and successfully prosecuted under
that statute. There have been many settlements of claims under
mattress flammability. So the current law today is that if you
or your children are injured in a fire with a mattress that
caught on fire--and they are not supposed to--you would have a
claim under State tort law and there would be no preemption. If
the courts agree with the Consumer Product Safety Commission's
interpretation, this would foreclose State claims across the
country, and manufacturers of mattresses would be insulated
from liability in the event that you or your loved ones or one
of your constituents was injured in such a fire.
Chairman Leahy. I am going to submit a question on the
National Highway Transportation Safety Administration, the
question that Senator Specter and I have raised. Representative
Stone, you are here speaking for all legislatures. You are a
Republican legislator. You have showed a lot of concern about
this. The administration has given great speeches about States
rights. But am I correct that this is preempting State laws,
the laws that you and the other legislators pass, or the
members of the Vermont General Assembly or Rhode Island's
Legislature or anybody else?
Ms. Stone. That is absolutely what is happening, sir, and
our biggest concern--and I mentioned this in my remarks, and
several other of the panelists have pointed it out as well. The
folks that write these regulations at the agencies are not
elected officials. They do not answer to a constituency. You
do, sir. I do. Senator Whitehouse does as well. I mean, it is--
I believe that they are operating in a vacuum. I believe that
oftentimes the draft rules are put out by staff. I am not sure
actually that always the agency heads are aware of what is
going out there. Or maybe they are very aware of it and it is
going out with their blessing.
Chairman Leahy. Either way it is bad.
Ms. Stone. Either way it is preempting our ability for
oversight and for taking care of our constituents.
We are not anti-preemption. There are many instances where
preemption has served all of our constituents well--the Civil
Rights Act, women's rights, fair housing. But what we are, sir,
is we are pro-process. We want to be included in the dialog. We
want a seat at the table because we are part of the
stakeholders.
Chairman Leahy. When you are talking about something like
the Civil Rights Act, we had years and years and years of
debate. It became a national issue and then was voted on.
Ms. Stone. Exactly. Exactly.
Chairman Leahy. Senator Whitehouse is with me, and I am
going to turn the gavel over to him in just a moment. But to
followup on what Senator Specter and I had raised about the
National Highway Transportation Safety Administration, we had
raised the question with them about their preemption language
they put in regulations to set the standards for the integrity
of car roofs, an obvious safety issue if cars overturn.
Now, they assert that their rules supplant all State laws,
but is that consistent with the clear presumption against
preemption that has been reiterated by even this activist
Supreme Court?
Mr. Vladeck. Not at all, Senator Leahy, and it is even
worse with respect to the Safety Act. The Safety Act contains a
savings clause that expressly preserves common law. But the
roof crush standard is an important for another reason, which
is this standard, once it takes effect, will amend the standard
that was adopted 37 years ago. And so if an agency revisits a
regulation every 37 years, in the interim that regulation
becomes out of date; it stultifies the development of stricter
and better rules.
And one of the ironies, of course, is the new NHTSA
standard will affect very few vehicles because tort
litigation--and we have had lots of rollover problems, the Ford
Explorer and so forth--has forced manufacturers over time to
innovate and to develop stronger roofs. So the new NHTSA
standard, which if the courts accept this view will preempt all
State tort law involving roof crush, will affect very few new
cars--very few new cars because most cars on the road today
already meet this new standard. But it will freeze product
liability law until NHTSA chooses to revisit the standard.
Chairman Leahy. Thank you.
Senator Whitehouse. [Presiding.] I would like to followup
on some of Chairman Leahy's questions, because I thought he was
right in the important area for discussion here.
Professor Vladeck, twice you have used the phrase ``the
administration's campaign'' to accomplish this. You are a
professor of law. You do not use terms unadvisedly. You said
more or less directly to the Chairman that you believe that
this is a deliberate political maneuver--that is my phrase, not
yours--by the administration. My question to you is: Would you
hazard an opinion as to why? What is the motivation for doing
this, and particularly in the context of a party that has
strongly, from the very tippy-top of the party, identified
itself with States rights for a long period of time? How do you
reconcile an affirmative campaign to do this by the Bush
administration with the principle of States rights that the
Republican Party has allied itself with for so many years?
Mr. Vladeck. That is a tough question. Let me answer it
this way. If I can talk about the consequence rather than the
motivation, I would prefer to do that. I do not know what is
pushing the administration to do this. I know what the
consequence is.
If you look up and down the products that every consumer
uses--drugs, medical devices, vehicles, the mattresses on which
they and their families sleep. We have not talked about
railroad safety or consumer finance issue. On each of these
issues, the administration has pushed and has pressed very
broad preemption of State law remedies, particularly consumer
remedies that go to compensation.
Now, one could argue that this is simply their view of how
the justice system ought to work. One could argue that this is
simply the administration showing that its allegiance really is
to the business interests that benefit enormously from having
State tort law withdrawn. But the loser, without any question
at all, is the American consumer who has had his or her right
to sue when a medical device fails, a right that pre-dated the
Medical Device Amendments of 1976, a right that has existed
indisputably until recently, taken away by the Federal
Government. And if you look--
Senator Whitehouse. Over and over again that is the common
theme of which side--
Mr. Vladeck. Over and over again--
Senator Whitehouse.--against the consumer and in favor of
the manufacturer.
Mr. Vladeck. Right. And if you look at my testimony--I just
collected a handful of cases. But if you do the math, those few
cases involve over 100,000 American consumers who have
defective heart valves, defibrillators, pacemakers, you know,
implants, hip and other prostheses. These are serious, serious
problems. And to tell a consumer who has got a defective heart
valve they have to go through open heart surgery to get it
replaced but, by the way, the manufacturer of that defective
product bears no liability or responsibility for your injury,
that is a blow to the American consumer.
Senator Whitehouse. Professor Dinh, we talked a little bit
about States rights already. Do you agree that this whole
question of States rights has been an issue or a cause that has
recently been strongly associated with the Republican Party?
Mr. Dinh. Absolutely. The Executive order was first issued
in 1982 by President Reagan. Preemption itself was the subject
of a Judicial Conference pamphlet written by then-Judge Starr
advocating the use of a presumption against preemption as a
second-best alternative to reinvigorating enumerated powers.
I happen to take a different view from Judge Starr in the
Judicial Conference report. I think that federalism is properly
protected by returning to the system of enumerated powers. And
where Congress acts, and acts properly, then there should be no
presumption one way or the other for or against preemption, but
let Congress's intent speak for itself; and the same goes for
the regulators.
Senator Whitehouse. But the very principle of federalism,
first of all, certainly implies a significant policymaking role
in our society at the State government level, does it not?
Mr. Dinh. Yes, it does, and that is why we have provisions
in the Constitution preserving to the States their autonomy,
and more significantly, the Ninth and Tenth Amendments and the
prohibition in Article--
Senator Whitehouse. And establishing the Federal
Government, indeed, as a Government of expressly limited
powers.
Mr. Dinh. Absolutely, sir.
Senator Whitehouse. Entirely apart from the structural
system which sets up policymaking and recognize policymaking at
the State level.
Mr. Dinh. Absolutely, with one significant--
Senator Whitehouse. That is an important backdrop in this
debate, isn't it?
Mr. Dinh. Right. It is--
Senator Whitehouse. It is not just the Supremacy Clause we
are talking about. If you look at the Constitution in toto, you
have to look also at the limited-government provisions and at
the whole principle of federalism.
Mr. Dinh. Absolutely. Two halves of the same coin.
Specifically enumerated powers in Article I, Section 8, where
it is properly exercised, those powers take supremacy over
conflicting State laws. And you are absolutely right in order
to point to both halves of our federalism, as the court has put
it.
Senator Whitehouse. I think back to Ronald Reagan and his
run for the Presidency and the extent to which in that run he
championed the idea that there was too much power in
Washington, that States rights needed to be recognized, that
Washington was out of touch, and that you needed to
disaggregated the power away from bureaucrats in Washington.
And now I see another Republican administration whose
procedures in this respect run directly contrary to that.
Is there anything other than irony that would explain that
contradiction?
Mr. Dinh. Two observations, Mr. Chairman. The first is that
there is a good reason why I strongly support the codification
of the federalism Executive order. To the extent that it has
been ignored and has not worked, I think we should amp it up in
order to make it truly enforceable and work, because the
process of consultation, assessment, and reflection on whether
or not we intrude upon State legislative prerogatives is one
that will simply result in better Federal policy.
My second observation is that there are--you know, I don't
think we--none of us in this room or in the Republican Party or
elsewhere is disagreeing with the system of our federalism.
There may be different questions asked to what is the proper
forum for a particular resolution of a public policy. Is it
through the rulemaking process with expertise--
Senator Whitehouse. But the forum is essential to
federalism, isn't it?
Mr. Dinh. It is, but not simply at the State versus Federal
level but, rather, rulemaking versus--general rulemaking versus
ad hoc jury decision, which is one example in relevance to--
Senator Whitehouse. You have provoked me with that.
[Laughter.]
Mr. Dinh. I didn't mean to.
Senator Whitehouse. Well, to remember a phrase in the
Washington Post article of yesterday on this subject, somebody
whose name is Darren McKinney, who is apparently a spokesman
for something called the American Tort Reform Association,
which apparently has about 300 businesses and trade
associations as its members, said this: ``Regulatory experts
are better arbiters of what is a potential threat to a consumer
than a judge or jury in Michigan.''
Now, I assume he means that across the board and he is not
making a complaint about the way judges or juries behave just
in Michigan. But as somebody who has been a lawyer most of his
life--I was the Attorney General in Rhode Island. I was the
U.S. Attorney. I have been in courtrooms pretty much my entire
professional life. I have got an awful lot of confidence in the
good common sense of judges and juries. In fact, the
Constitution really sets out the jury as a very special device
for making sure that people ultimately can be heard by
knowledgeable common-sense neighbors rather than, as Mr.
McKinney says, ``regulatory experts.''
So it is interesting to me that this individual would say
that regulatory experts are better than judges and juries. I
find that highly improbable. But setting aside on the merits
whether it is true or not, how do you think Ronald Reagan would
respond to the view that regulatory experts in Washington
bureaucratic agencies are better arbiters of what is a
potential threat to people in their homes and neighborhoods
across this country than their local judges and juries?
Mr. Dinh. I think President Reagan, as the recent
publication of his speeches and handwritten radio addresses,
had some fairly specific views about the litigation system and
the civil justice system, and I will not try to characterize
them here. But the fundamental question--and it is a very, very
good question that you ask, Senator, as you know--is the
following: Juries and judges in litigation must act also
according to law. Agencies in exercising their powers delegated
by you, by this Congress, must act according to the law set
forth by this Congress. And so ultimately it is a system of how
do we go about setting forth the best legal rules and are those
rules going to be followed.
One of the key elements that, you know, is lurking in this
room that nobody has put a face to it is this notion of
regulatory compliance. You know, is it OK for businesses and
individuals to rely upon the fact that if they comply with the
regulations issues, they are no longer in jeopardy of suit,
either criminal or civil? And I think that is a question that
fundamentally goes to the nature of regulation, be it by
Congress or by agencies or by State legislatures.
Senator Whitehouse. In the context of what you have been
saying about the principle of States rights and federalism and
the observation that Professor Vladeck drew that one side in
the political struggle seems inevitably to be the winner in
these determinations, as a general proposition wouldn't you
agree that one of the things that defines a principle as a
principle is that you are willing to stick by it even when your
team loses?
Mr. Dinh. Absolutely, and that is why I say that where
Judge Starr and I differ on preemption is we see different
paths to the mountaintop.
Senator Whitehouse. Ms. Peddie, we have been talking about
the role of judges and juries. You practice before judges and
juries. I think you and I probably share a view as to the
ability of judges and juries to get to the bottom of a matter,
to hash through evidence and to make a fair decision. So I am
not going to ask you about that because I suspect we agree.
Ms. Peddie. I think we would.
Senator Whitehouse. Let me ask you about a different though
related point, which is that it strikes me that our
Constitution goes to considerable effort to preserve judges and
juries from political interference or control. And entirely
apart from whether they are better quality decisionmakers, they
are protected as being independent decisionmakers. And,
clearly, a bureaucrat in Washington making these decisions,
being told what to do by the President or the White House
counsel or the Office of Management and Budget or the Office of
Information and Regulatory Affairs is in a very different
position. Would you comment on that distinction between the
independence of judges and juries versus the political control
over bureaucracies and how that bears on the rights of
Americans in these circumstances?
Ms. Peddie. Well, I think there is all the difference in
the world. In the case of political appointees, which in many
cases are the ones who are making these decisions, they change,
and they change with administrations. And so you may have a
very pro-preemption policy until 2008, and after 2008, you will
have a very anti-preemption policy. And so what leaving it to
political appointees does is to make things very unpredictable.
In the case of judges and juries, my experience, I think,
has been yours, that they usually reach the right result. Now,
a few judges in Texas and in Pennsylvania have missed that
goal, but on the whole, I think they try to do as best they
can.
Senator Whitehouse. The ones that are willing to give you a
clean shot usually--
Ms. Peddie. Absolutely. A level playing field and I am
there. That is what we are looking for. But when they are
hamstrung, as they are or will be in the case if something like
the FDA Preamble is given conclusive deference, Chevron
deference, they will not be able to exercise their independent
judgment and do what they want to do.
I think one of the examples that I would use here is in the
case of Vioxx. One of the purposes of FDA regulations that came
in a few years back when Vioxx was withdrawn from the market
and much of the reaction that has taken place to that is, oh,
we have got to get rid of all these claims because there are
too many, and, oh, some of them have been lost--I think that is
the best example of the value of jury systems. This is not a
case--the Vioxx cases are not cases in which, you know, runaway
juries have done, you know, horrible things. They have weighed
the evidence; and in some cases they have found for the
plaintiff, in some cases they have found for the defendant. It
has been about an even split. And so I think what that
illustrates is they are doing their job and there is nothing
that needs to be fixed by an agency coming in and saying, I am
sorry, you never even get to hear this.
Senator Whitehouse. There is a phrase we hear in politics
from time to time that politicians are obliged to ``dance with
the guy or girl that brung 'em.'' And when you have an
executive branch that is making its own rules through the
administrative process, is it not more likely that the
principle that that political entity has to dance with the
organizations that support it, that that will infiltrate and
affect the decisionmaking process than it is among, say, a jury
in Michigan?
Ms. Peddie. I think that is absolutely the case. For
example, the best example I can give you is the architect of
the preemption policy at the FDA was Daniel Troy, who was a
lawyer for Pfizer before he ever went into the Administration.
If the only voice that you hear is the voice of drug
companies--and I have represented them. I have no problem with
their exploiting the advantages given. I am here because I do
not think they should be given those advantages. But when the
only voice you hear is the voice of the drug companies, when
they are writing the legislation, when their lawyers are in
your agency, then, of course, you are going to get results that
favor those drug companies.
The people that I represent have no advocate. I am here on
their behalf, and there are a few organizations that try to
advocate on behalf of consumers. But we do not get in the halls
of power very often. And so there is a real disproportionate
access and voice, particularly in the prescription drug area,
that we think is very unfair and has resulted in a lot of
people losing their claims improperly.
Senator Whitehouse. Mr. Untereiner, there is a famous judge
who once referred to the States as ``laboratories of
democracy.'' If you accept that principle that the States are
laboratories of democracy and that we do not always get the
answer right away and it is sometimes worth kind of working
your way through a problem in the real world before you settle
on the final solution, isn't that an argument in favor of
Federal regulatory agencies standing back and letting the
States work this out on their own rather than having there be
central control out of a bureaucratic agency in Washington?
Mr. Untereiner. Sure, that is an argument in favor of that,
and I think the States do have substantial control over tort
law, and the common law develops in many different ways.
Preemption of State common law or State tort law is, I would
argue, rather limited if you look at Congress's handiwork. If
you look at the express preemption provisions that you have
passed, it is limited, sometimes only to labeling requirements,
sometimes only to labeling requirements that differ from the
Federal requirements so that an injured plaintiff can still
bring a tort suit under State tort law for violation of the
Uniform Federal Standard.
There are all sorts of federalism safeguards built into
many of Congress's preemption schemes. Those includes things
like the ability of States to go to the agency and ask for an
exemption from preemption. In some preemptive schemes--
Senator Whitehouse. It is a different kettle of fish, you
will agree, if Congress is going out and making a decision
about what preempts than it is if an Assistant Secretary of
something or other is doing that. Isn't it?
Mr. Untereiner. Yes, although these--
Senator Whitehouse. Constitutionally different and
practically different.
Mr. Untereiner. Yes, although these agencies are operating
under grants of authority from Congress to regulate health and
safety and to ensure that interstate commerce is not unduly
burdened and to ensure that there is some level of uniformity.
So imagine you are an agency regulator and you are asked by a
company that has a label that you have approved and that the
company is required to use going forward whether a new warning
should be added, and the agency looks at that and decides that
there is no scientific basis for that warning, that the risk
does not exist, the warning should not be given, and if it is
given, it is going to actually discourage people from using a
valuable product, and, in fact, you know, it is going to be
contrary to the public health.
I think a responsible regulator faced with that scenario
might well conclude that it would be contrary to Congress's
purposes and to a regulation requiring--or refusing to allow
that warning, to allow State civil liability judgments to
punish manufacturers to the tune of millions and millions--
Senator Whitehouse. Why does that get to be his call,
though? There are lots of things that, if you put the person in
power and you could have all the power in the world, they
would, in fact, make the right decision. But what characterizes
American democracy is the way to which we have divided and
subdivided power, both among the separated powers laterally and
in terms of federalism vertically. And I think it is a very
dangerous shortcut to say, well, because you can get to a good
result by violating those provisions, we should violate them. I
think they should and that the person who is in that position,
it is their job to go to Congress and ask for the appropriate
delegation, because that is the place where that authority
should lie rather than with an executive branch official acting
essentially unilaterally.
Mr. Untereiner. The background principle of law against
which Congress has acted since the early 1960s is that when it
gives regulatory authority to an agency, that includes the
authority of the agency to regulate preemptively. That does not
mean agencies should do it willy nilly. Obviously, agencies,
like Congress, should pay attention to the prerogatives of
State and local governments. Congress has, if you look at the
handiwork, if you look at the range of statutes. And I think
many of the examples that trouble the Committee involve rather
narrow instances of preemption where there is, in fact, a
conflict between a requirement imposed by State tort law and a
requirement imposed by a Federal agency.
Senator Whitehouse. Representative Stone, thank you so much
for being here. I appreciate it.
Ms. Stone. It is my pleasure.
Senator Whitehouse. I know that somebody with a position
like yours, both in the Delaware Legislature and with the
National Conference of State Legislatures, has a lot of demands
on their time, and I am grateful that you have taken the
trouble to be here.
I just would like to ask you to comment a little bit on the
process. You used an important phrase earlier. You are pro-
process.
Ms. Stone. Exactly.
Senator Whitehouse. And I spent my life before coming here
in State government, and, you know, I have seen how hard it is
to get elected Governor. I have seen how hard it is to get
elected Representative or Senator. I have seen how hard people,
once they are elected to those positions, work to fight their
way through issues. It is all done publicly. The galleries of
the Rhode Island General Assembly are usually filled. There are
press people scribbling away. There are microphones in the
hallways. The Governor operates under a similar level of
scrutiny and attention. Particularly where there is some
conflict, it gets even greater attention. An enormous amount of
the energy and the will of the people of my State and of the
people of Delaware has gone into electing people to those
positions, electing you to yours.
From a governmental point of view, isn't that entitled to a
lot more credit than a decision that may well have been the
result of a lobbyist's phone call to somebody in the White
House who called somebody at OMB who called the Director who
said this goes in and nobody ever saw any of that trail?
Ms. Stone. We are in agreement. I think that a lot of what
is happening is you have special interest groups who are not
able to push their agendas legislatively at the State level.
Senator Whitehouse. Because they do not have public policy
merit.
Ms. Stone. That is exactly right. And so they have found a
way to circumvent that process. They now have the opportunity
to do it through bureaucratic agencies, through regulations,
and that is not what the process should be. These folks are not
elected. They do not answer to a constituency like you do, like
I do. They are bureaucrats. And I do not--
Senator Whitehouse. They may answer to a constituency, but
it is not like the one that you or I answer to. It is a
narrower constituency.
Ms. Stone. A much narrower constituency. And as I said
earlier, we want to be part of the process. You have been a
legislator. I am still a legislator. When you are dealing with
issues, the absolute best way to deal with them is to involve
the stakeholders. And we in State government are every bit as
much a stakeholder as anyone else in the issues that we have
talked about here today.
We want a seat at the table. We want to be able to be part
of the conversation. We are where the rubber meets the road, so
to speak. And your constituents and my constituents are who we
are answerable to, and that is what we want. We want the best
for our constituents. That is who we swear an oath to protect
and to work in the best capability that we can. And that is not
what is happening. I mean, this is not the way I believe
federalism was ever intended to work, and we want to get back
to being included in the conversation and to be listened to,
not to have an agency make a decision that, oh, by the way, the
comment period is over and now we have decided that the rule
that we have put forth actually does preempt State law.
That is outrageous. It is absolutely outrageous. And we
would very much appreciate being partners with you. We believe
that an open process benefits everyone. It allows a better way
to share information. And I think ultimately it results in much
better policymaking.
Senator Whitehouse. Well, thank you, Representative Stone.
And I want to as I conclude the hearing--we all have places we
have to be, and I am late for the place I have next to be. But
I do want to say that I have found this a very, very
interesting hearing. All of the witnesses have been very
knowledgeable. I appreciate that they have shared their time
and their trouble with us. It is an important issue, I think,
for us to address the campaign that Professor Vladeck has
identified in this administration, to utilize this, what
Representative Stone has identified as highly non-democratic
process, is one that I think merits our attention as a matter
of genuine significance. And I want to commend Chairman Leahy
and the Ranking Member of this Committee, Arlen Specter of
Pennsylvania, for having had the wisdom to pull it together.
And I thank all of you for your testimony.
The record will remain open for a week for any further
comment or answers to questions that you wish, and with that,
if there is nothing further, we are adjourned.
[Whereupon, at 12:35 p.m., the Committee was adjourned.]
[Questions and answers and submissions for the record
follow.]
[GRAPHIC] [TIFF OMITTED] T0883.001
[GRAPHIC] [TIFF OMITTED] T0883.002
[GRAPHIC] [TIFF OMITTED] T0883.003
[GRAPHIC] [TIFF OMITTED] T0883.004
[GRAPHIC] [TIFF OMITTED] T0883.005
[GRAPHIC] [TIFF OMITTED] T0883.006
[GRAPHIC] [TIFF OMITTED] T0883.007
[GRAPHIC] [TIFF OMITTED] T0883.008
[GRAPHIC] [TIFF OMITTED] T0883.009
[GRAPHIC] [TIFF OMITTED] T0883.010
[GRAPHIC] [TIFF OMITTED] T0883.011
[GRAPHIC] [TIFF OMITTED] T0883.012
[GRAPHIC] [TIFF OMITTED] T0883.013
[GRAPHIC] [TIFF OMITTED] T0883.014
[GRAPHIC] [TIFF OMITTED] T0883.015
[GRAPHIC] [TIFF OMITTED] T0883.016
[GRAPHIC] [TIFF OMITTED] T0883.017
[GRAPHIC] [TIFF OMITTED] T0883.018
[GRAPHIC] [TIFF OMITTED] T0883.019
[GRAPHIC] [TIFF OMITTED] T0883.020
[GRAPHIC] [TIFF OMITTED] T0883.021
[GRAPHIC] [TIFF OMITTED] T0883.022
[GRAPHIC] [TIFF OMITTED] T0883.023
[GRAPHIC] [TIFF OMITTED] T0883.024
[GRAPHIC] [TIFF OMITTED] T0883.025
[GRAPHIC] [TIFF OMITTED] T0883.026
[GRAPHIC] [TIFF OMITTED] T0883.027
[GRAPHIC] [TIFF OMITTED] T0883.028
[GRAPHIC] [TIFF OMITTED] T0883.029
[GRAPHIC] [TIFF OMITTED] T0883.030
[GRAPHIC] [TIFF OMITTED] T0883.031
[GRAPHIC] [TIFF OMITTED] T0883.032
[GRAPHIC] [TIFF OMITTED] T0883.033
[GRAPHIC] [TIFF OMITTED] T0883.034
[GRAPHIC] [TIFF OMITTED] T0883.035
[GRAPHIC] [TIFF OMITTED] T0883.036
[GRAPHIC] [TIFF OMITTED] T0883.037
[GRAPHIC] [TIFF OMITTED] T0883.038
[GRAPHIC] [TIFF OMITTED] T0883.039
[GRAPHIC] [TIFF OMITTED] T0883.040
[GRAPHIC] [TIFF OMITTED] T0883.041
[GRAPHIC] [TIFF OMITTED] T0883.042
[GRAPHIC] [TIFF OMITTED] T0883.043
[GRAPHIC] [TIFF OMITTED] T0883.044
[GRAPHIC] [TIFF OMITTED] T0883.045
[GRAPHIC] [TIFF OMITTED] T0883.046
[GRAPHIC] [TIFF OMITTED] T0883.047
[GRAPHIC] [TIFF OMITTED] T0883.048
[GRAPHIC] [TIFF OMITTED] T0883.049
[GRAPHIC] [TIFF OMITTED] T0883.050
[GRAPHIC] [TIFF OMITTED] T0883.051
[GRAPHIC] [TIFF OMITTED] T0883.052
[GRAPHIC] [TIFF OMITTED] T0883.053
[GRAPHIC] [TIFF OMITTED] T0883.054
[GRAPHIC] [TIFF OMITTED] T0883.055
[GRAPHIC] [TIFF OMITTED] T0883.056
[GRAPHIC] [TIFF OMITTED] T0883.057
[GRAPHIC] [TIFF OMITTED] T0883.058
[GRAPHIC] [TIFF OMITTED] T0883.059
[GRAPHIC] [TIFF OMITTED] T0883.060
[GRAPHIC] [TIFF OMITTED] T0883.061
[GRAPHIC] [TIFF OMITTED] T0883.062
[GRAPHIC] [TIFF OMITTED] T0883.063
[GRAPHIC] [TIFF OMITTED] T0883.064
[GRAPHIC] [TIFF OMITTED] T0883.065
[GRAPHIC] [TIFF OMITTED] T0883.066
[GRAPHIC] [TIFF OMITTED] T0883.067
[GRAPHIC] [TIFF OMITTED] T0883.068
[GRAPHIC] [TIFF OMITTED] T0883.069
[GRAPHIC] [TIFF OMITTED] T0883.070
[GRAPHIC] [TIFF OMITTED] T0883.071
[GRAPHIC] [TIFF OMITTED] T0883.072
[GRAPHIC] [TIFF OMITTED] T0883.073
[GRAPHIC] [TIFF OMITTED] T0883.074
[GRAPHIC] [TIFF OMITTED] T0883.075
[GRAPHIC] [TIFF OMITTED] T0883.076
[GRAPHIC] [TIFF OMITTED] T0883.077
[GRAPHIC] [TIFF OMITTED] T0883.078
[GRAPHIC] [TIFF OMITTED] T0883.079
[GRAPHIC] [TIFF OMITTED] T0883.080
[GRAPHIC] [TIFF OMITTED] T0883.081
[GRAPHIC] [TIFF OMITTED] T0883.082
[GRAPHIC] [TIFF OMITTED] T0883.083
[GRAPHIC] [TIFF OMITTED] T0883.084
[GRAPHIC] [TIFF OMITTED] T0883.085
[GRAPHIC] [TIFF OMITTED] T0883.086
[GRAPHIC] [TIFF OMITTED] T0883.087
[GRAPHIC] [TIFF OMITTED] T0883.088
[GRAPHIC] [TIFF OMITTED] T0883.089
[GRAPHIC] [TIFF OMITTED] T0883.090
[GRAPHIC] [TIFF OMITTED] T0883.091
[GRAPHIC] [TIFF OMITTED] T0883.092
[GRAPHIC] [TIFF OMITTED] T0883.093
[GRAPHIC] [TIFF OMITTED] T0883.094
[GRAPHIC] [TIFF OMITTED] T0883.095
[GRAPHIC] [TIFF OMITTED] T0883.096
[GRAPHIC] [TIFF OMITTED] T0883.097
[GRAPHIC] [TIFF OMITTED] T0883.098
[GRAPHIC] [TIFF OMITTED] T0883.099
[GRAPHIC] [TIFF OMITTED] T0883.100
[GRAPHIC] [TIFF OMITTED] T0883.101
[GRAPHIC] [TIFF OMITTED] T0883.102
[GRAPHIC] [TIFF OMITTED] T0883.103
[GRAPHIC] [TIFF OMITTED] T0883.104
[GRAPHIC] [TIFF OMITTED] T0883.105
[GRAPHIC] [TIFF OMITTED] T0883.106
[GRAPHIC] [TIFF OMITTED] T0883.107
[GRAPHIC] [TIFF OMITTED] T0883.108
[GRAPHIC] [TIFF OMITTED] T0883.109
[GRAPHIC] [TIFF OMITTED] T0883.110
[GRAPHIC] [TIFF OMITTED] T0883.111
[GRAPHIC] [TIFF OMITTED] T0883.112
[GRAPHIC] [TIFF OMITTED] T0883.113
[GRAPHIC] [TIFF OMITTED] T0883.114
[GRAPHIC] [TIFF OMITTED] T0883.115
[GRAPHIC] [TIFF OMITTED] T0883.116
[GRAPHIC] [TIFF OMITTED] T0883.117
[GRAPHIC] [TIFF OMITTED] T0883.118
[GRAPHIC] [TIFF OMITTED] T0883.119
[GRAPHIC] [TIFF OMITTED] T0883.120
[GRAPHIC] [TIFF OMITTED] T0883.121
[GRAPHIC] [TIFF OMITTED] T0883.122
[GRAPHIC] [TIFF OMITTED] T0883.123
[GRAPHIC] [TIFF OMITTED] T0883.124
[GRAPHIC] [TIFF OMITTED] T0883.125
[GRAPHIC] [TIFF OMITTED] T0883.126
[GRAPHIC] [TIFF OMITTED] T0883.127
[GRAPHIC] [TIFF OMITTED] T0883.128
[GRAPHIC] [TIFF OMITTED] T0883.129
[GRAPHIC] [TIFF OMITTED] T0883.130
[GRAPHIC] [TIFF OMITTED] T0883.131
[GRAPHIC] [TIFF OMITTED] T0883.132
[GRAPHIC] [TIFF OMITTED] T0883.133
[GRAPHIC] [TIFF OMITTED] T0883.134
[GRAPHIC] [TIFF OMITTED] T0883.135
[GRAPHIC] [TIFF OMITTED] T0883.136
[GRAPHIC] [TIFF OMITTED] T0883.137
[GRAPHIC] [TIFF OMITTED] T0883.138
[GRAPHIC] [TIFF OMITTED] T0883.139
[GRAPHIC] [TIFF OMITTED] T0883.140
[GRAPHIC] [TIFF OMITTED] T0883.141
[GRAPHIC] [TIFF OMITTED] T0883.142
[GRAPHIC] [TIFF OMITTED] T0883.143
[GRAPHIC] [TIFF OMITTED] T0883.144
[GRAPHIC] [TIFF OMITTED] T0883.145
[GRAPHIC] [TIFF OMITTED] T0883.146
[GRAPHIC] [TIFF OMITTED] T0883.147
[GRAPHIC] [TIFF OMITTED] T0883.148
[GRAPHIC] [TIFF OMITTED] T0883.149
[GRAPHIC] [TIFF OMITTED] T0883.150
[GRAPHIC] [TIFF OMITTED] T0883.151
[GRAPHIC] [TIFF OMITTED] T0883.152
[GRAPHIC] [TIFF OMITTED] T0883.153
[GRAPHIC] [TIFF OMITTED] T0883.154
[GRAPHIC] [TIFF OMITTED] T0883.155
[GRAPHIC] [TIFF OMITTED] T0883.156
[GRAPHIC] [TIFF OMITTED] T0883.157
[GRAPHIC] [TIFF OMITTED] T0883.158
[GRAPHIC] [TIFF OMITTED] T0883.159
[GRAPHIC] [TIFF OMITTED] T0883.160
[GRAPHIC] [TIFF OMITTED] T0883.161
[GRAPHIC] [TIFF OMITTED] T0883.162
[GRAPHIC] [TIFF OMITTED] T0883.163
[GRAPHIC] [TIFF OMITTED] T0883.164
[GRAPHIC] [TIFF OMITTED] T0883.165
[GRAPHIC] [TIFF OMITTED] T0883.166
[GRAPHIC] [TIFF OMITTED] T0883.167
[GRAPHIC] [TIFF OMITTED] T0883.168
[GRAPHIC] [TIFF OMITTED] T0883.169
[GRAPHIC] [TIFF OMITTED] T0883.170
[GRAPHIC] [TIFF OMITTED] T0883.171
[GRAPHIC] [TIFF OMITTED] T0883.172