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40–883 PDF 2008

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

(

(II)

COMMITTEE ON THE JUDICIARY 

PATRICK J. LEAHY, Vermont, Chairman 

EDWARD M. KENNEDY, Massachusetts 

JOSEPH R. BIDEN, JR., Delaware 

HERB KOHL, Wisconsin 

DIANNE FEINSTEIN, California 

RUSSELL D. FEINGOLD, Wisconsin 

CHARLES E. SCHUMER, New York 

RICHARD J. DURBIN, Illinois 

BENJAMIN L. CARDIN, Maryland 

SHELDON WHITEHOUSE, Rhode Island 

ARLEN SPECTER, Pennsylvania 

ORRIN G. HATCH, Utah 

CHARLES E. GRASSLEY, Iowa 

JON KYL, Arizona 

JEFF SESSIONS, Alabama 

LINDSEY O. GRAHAM, South Carolina 

JOHN CORNYN, Texas 

SAM BROWNBACK, Kansas 

TOM COBURN, Oklahoma 

BRUCE A. COHEN, Chief Counsel and Staff Director 

MICHAEL O’NEILL, Republican Chief Counsel and Staff Director 

(III)

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

(1)

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 

2

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 

3

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. 

4

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 

5

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 

6

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 

7

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. 

8

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. 

9

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 frusVerDate 0ct 09 2002 13:17 Mar 05, 2008 Jkt 040883 PO 00000 Frm 00013 Fmt 6633 Sfmt 6633 S:\GPO\HEARINGS\40883.TXT SJUD1 PsN: CMORC
10

trates 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 

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empted. 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 

12

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. 

13

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. 

14

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 

15

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 failureto-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 

16

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? 

17

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. 

18

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 secondbest alternative to reinvigorating enumerated powers. 

19

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 parVerDate 0ct 09 2002 13:17 Mar 05, 2008 Jkt 040883 PO 00000 Frm 00023 Fmt 6633 Sfmt 6633 S:\GPO\HEARINGS\40883.TXT SJUD1 PsN: CMORC
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ticular 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 

21

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 

22

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 inVerDate 0ct 09 2002 13:17 Mar 05, 2008 Jkt 040883 PO 00000 Frm 00026 Fmt 6633 Sfmt 6633 S:\GPO\HEARINGS\40883.TXT SJUD1 PsN: CMORC
23

jured 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. 

24

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 hapVerDate 0ct 09 2002 13:17 Mar 05, 2008 Jkt 040883 PO 00000 Frm 00028 Fmt 6633 Sfmt 6633 S:\GPO\HEARINGS\40883.TXT SJUD1 PsN: CMORC
25

pening. 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 nondemocratic 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.]

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