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44–331 PDF 2008

S. HRG. 110–497 

SHORT-CHANGE FOR CONSUMERS AND SHORTSHRIFT FOR CONGRESS? THE SUPREME 

COURT’S TREATMENT OF LAWS THAT PROTECT 

AMERICANS’ HEALTH, SAFETY, JOBS AND RETIREMENT 

HEARING 

BEFORE THE

COMMITTEE ON THE JUDICIARY 

UNITED STATES SENATE 

ONE HUNDRED TENTH CONGRESS 

SECOND SESSION 

JUNE 11, 2008 

Serial No. J–110–99 

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 

STEPHANIE A. MIDDLETON, Republican Staff Director 

NICHOLAS A. ROSSI, Republican Chief Counsel 

(III) 

C O N T E N T S 

STATEMENTS OF COMMITTEE MEMBERS 

Page 

Coburn, Hon. Tom, a U.S. Senator from the State of Oklahoma, prepared 

statement .............................................................................................................. 57 

Feingold, Hon. Russell D., a U.S. Senator from the State of Wisconsin, prepared statement ................................................................................................... 71 

Leahy, Hon. Patrick J., a U.S. Senator from the State of Vermont .................... 1 

prepared statement .......................................................................................... 96 

Specter, Hon. Arlen, a U.S. Senator from the State of Pennsylvania ................. 3 

WITNESSES 

Anderson, Andy R., Of Counsel, Morgan, Lewis & Bockius LLP, Chicago, 

Illinois ................................................................................................................... 10 

Cooper, Richard M., Partner, Williams & Connolly LLP, Washington, D.C. ..... 14 

Kurtek, Maureen, Pottsville, Pennsylvania ........................................................... 8 

Lawless, Robert M., Professor of Law and Galowich-Huizenga Faculty Scholar, University of Illinois College of Law, Champaign, Illinois ......................... 15 

McGarity, Thomas O., Professor of Law, University of Texas School of Law, 

Austin, Texas ........................................................................................................ 12 

Robb, Bridget, Gwynedd, Pennsylvania ................................................................. 6 

QUESTIONS AND ANSWERS 

Responses of Richard M. Cooper to questions submitted by Senators Grassley 

and Specter ........................................................................................................... 27 

Responses of Robert M. Lawless to questions submitted by Senator Feinstein . 35 

Responses of Thomas O. McGarity to questions submitted by Senators Specter 

and Grassley ......................................................................................................... 40 

SUBMISSIONS FOR THE RECORD 

Anderson, Andy R., Of Counsel, Morgan, Lewis & Bockius LLP, Chicago, 

Illinois, statement ................................................................................................ 48 

Bartlett, Steve, President and CEO, Financial Services Roundtable, Washington, D.C., statement ........................................................................................ 53 

Cooper, Richard M., Partner, Williams & Connolly LLP, Washington, D.C., 

statement .............................................................................................................. 59 

Johnson & Johnson, New Brunswick, New Jersey, statement ............................ 73 

Kurtek, Maureen, Pottsville, Pennsylvania, statement ........................................ 77 

Lawless, Robert M., Professor of Law and Galowich-Huizenga Faculty Scholar, University of Illinois College of Law, Champaign, Illinois, statement ...... 82 

McGarity, Thomas O., Professor of Law, University of Texas School of Law, 

Austin, Texas, statement ..................................................................................... 98 

National Business Group on Health, Washington, D.C., articles ........................ 114 

Robb, Bridget, Gwynedd, Pennsylvania, statement and attachment .................. 117 

(1) 

SHORT-CHANGE FOR CONSUMERS AND 

SHORT-SHRIFT FOR CONGRESS? THE SUPREME COURT’S TREATMENT OF LAWS 

THAT PROTECT AMERICANS’ HEALTH, SAFETY, JOBS AND RETIREMENT 

WEDNESDAY, JUNE 11, 2008 

U.S. SENATE, COMMITTEE ON THE JUDICIARY, Washington, D.C. 

The Committee met, Pursuant to notice, at 10:02 a.m., in room 

SD–226, Dirksen Senate Office Building, Hon. Patrick J. Leahy, 

Chairman of the Committee, presiding. 

Present: Senators Leahy, Whitehouse, Specter, and Hatch. 

OPENING STATEMENT OF HON. PATRICK J. LEAHY, A U.S. 

SENATOR FROM THE STATE OF VERMONT 

Chairman LEAHY. Good morning. I am glad to see everybody 

here. I called this hearing today to shine a light on how the Supreme Court’s decisions affect Americans’ everyday lives. We sometimes see a headline, the Court rules this way or that way, and I 

recall when I was a law student, it was always an interesting thing 

to then discuss the pros and cons of a decision. But it is well beyond that. It goes into how it affects real people in those decisions. 

We know that the Court’s rulings will come into focus if they involve divisive cultural issues. But, lately, many Court observers 

have noticed that business interests have been the big winners 

over workers and consumers. In a worsening economy, mothers and 

fathers are struggling with health care coverage, the uncertainty of 

retirement, credit card payments, and mortgages, and, of course, 

gasoline prices that are going off the charts. Congress has passed 

laws to protect Americans in many of these areas, but in many 

cases, the Supreme Court, I believe, has ignored the intent of Congress in passing these measures, sometimes turning these laws on 

their heads and making them protections for big business rather 

than for ordinary citizens. 

For almost two decades, to give one example, Lilly Ledbetter 

worked as the sole female supervisor in a major national corporation. Her diligence helped send her children to college and helped 

her and her husband plan for the future. Before her retirement, 

Ms. Ledbetter received an anonymous note showing the salaries of 

her male counterparts, the men in her business that were doing 

the same work she was doing. And even the lowest-paid of the 

male supervisors was earning 20 percent more than she was, deVerDate Aug 31 2005 11:24 Sep 30, 2008 Jkt 044331 PO 00000 Frm 00005 Fmt 6633 Sfmt 6633 S:\GPO\HEARINGS\44331.TXT SJUD1 PsN: CMORC
2 

spite having far less experience and seniority than she did. She 

would later learn that the pay difference was even greater because 

she was also short-changed on bonuses, retirement benefits, and 

overtime pay. Now, she clearly proved to a jury that she had been 

illegally discriminated against. There was no question in the jury’s 

mind, no question in the lower court she was discriminated 

against. But the Supreme Court reversed the verdict and created 

a bizarre interpretation of the law. As a result, her employer is 

never going to be held accountable for the illegal discrimination 

against her. The Court’s ruling tells other corporations very clearly 

go ahead and discriminate because you can get away with it, as 

long as they keep their illegal activity hidden long enough. 

Now, a majority of Senators support overturning the Court’s decision, but we have 43 Senators who are preventing us from even 

proceeding to consider this remedy. They have filibustered having 

the ability to reverse what the Supreme Court did. And by filibustering the Lilly Ledbetter bill, those Senators are standing behind 

the Supreme Court’s terrible interpretation of our antidiscrimination laws. 

At today’s hearing, we are going to focus on several laws designed to protect Americans’ health, safety, and retirement. We will 

hear testimony today from two brave women who, like Ms. 

Ledbetter, have or will be denied relief and justice as a result of 

Supreme Court rulings. There are thousands more of them outside 

this hearing room who have been adversely affected by rulings that 

slam the courthouse door shut and encourage corporate misconduct. 

Years ago, Congress passed a landmark law known as ERISA. It 

was done to ensure that workers with employer- sponsored health 

insurance or retirement benefits could benefit from them when 

they needed them. But the Supreme Court has so distorted this 

law, so changed what was intended by Congress, that it provides 

no relief for individual beneficiaries when the companies and insurers entrusted with administering their benefit plans violate the law 

or the terms of the employees’ plans. Can you imagine? People are 

entrusted to handle these retirement plans, and if they violate the 

law, the Supreme Court has given them a get-out-of-jail-free card. 

Moreover, the Court has held that it was the intent of Congress 

to take away preexisting State law remedies for workers, even 

though Congress never intended that. The result: Congress’ bill 

passed with Republican and Democratic support, a monumental effort to safeguard workers and their families has literally left them 

more vulnerable than they were before the law was passed. Congress passed the law to protect them, and the Supreme Court says 

not only does it not protect them, but we are taking away any 

other protections you might have had. Great jurists from the late 

Justice White to Justice Ginsburg have decried how preposterous, 

unjust, and incompatible with Congress’ true intent this result is. 

The late Judge Ed Becker, former Chief Judge of the Third Circuit, 

a friend to many of us here in this Committee, best captured the 

impact of this line of cases when he observed that the interpretation had devolved from the protection of ordinary Americans that 

was intended into a catch–22 and ‘‘into a shield that insulates 

3 

HMOs from liability for even the most egregious acts of dereliction...directly contrary to the intent of Congress.’’ 

The Supreme Court has narrowly interpreted another law designed to protect Americans who rely on medical devices to keep 

them alive. Unfortunately, here again the Supreme Court’s interpretation has transformed the law into one that takes away protections from people by extinguishing longstanding State law remedies which hold corporations accountable when they are aware of 

potential dangers but hide them from consumers, and we are going 

to hear what happens in real life. 

The last set of laws to be examined here today involves lending 

institutions used by Americans to finance their homes and credit 

cards used for everyday purchases. In this context as well, the 

Court has interpreted Federal legislation in such a way that strips 

consumers of the right to benefit from more protective State laws. 

These decisions also serve to shield corporations from their misconduct. This is something that potentially affects the pocketbook 

of every working American man and woman in this country. 

Now, the Supreme Court rulings have occurred with little public 

attention, except for the lives of Americans that it impacted. There 

has been plenty of academic discussion about the radical changes 

that this Court is making to preemption and federalism. But the 

health and retirement guarantees provided by Congress were not 

meant to be merely rhetorical commitments. They are essential to 

give every American the chance to lead a rich and full life. 

So in light of the troubling Supreme Court rulings we are going 

to examine today, Congress may be again required to step in with 

remedial action to clarify our intent, as we did in 2006 with the 

Voting Rights Act reauthorization. Congress is seeking to do the 

same with the Lilly Ledbetter bill if we can get past the filibuster. 

And to paraphrase my friend and civil rights hero Congressman 

John Lewis, in our system of checks and balances we have to meet 

every judicial step backward with a legislative step forward. The 

problem, however, with any legislative fix is that the Supreme 

Court might again strip it of its purpose. 

So I hope today’s hearing will be a first step in contributing to 

the understanding of the impact the Supreme Court has on our 

daily lives. 

[The prepared statement of Senator Leahy appears as a submission for the record.] 

Senator Specter? 

STATEMENT OF HON. ARLEN SPECTER, A U.S. SENATOR FROM 

THE STATE OF PENNSYLVANIA 

Senator SPECTER. Thank you, Mr. Chairman. 

This is a very important hearing as a significant step for the 

Congress of the United States to establish the law on this subject 

contrary to what the Supreme Court has ruled. This is a matter 

of statutory interpretation, not a constitutional ruling. So it is a 

matter for congressional decision. 

This issue involves very fundamental questions of federalism on 

the tradition of leaving it to the States to make decisions which are 

particularly applicable for State court decisions as opposed to control out of Washington, D.C. 

4 

When we deal with the subject of the FDA and preemption, the 

FDA under the existing law will grant approval only if it finds 

there is a reasonable assurance of the device’s safety and effectiveness. The grave problem with that is that the FDA has become a 

joke. It does not have the funds to begin to carry out its responsibilities, and that has been highlighted in the course of the past 

several weeks on strenuous efforts by Members of Congress to find 

out from the FDA what money it needs. But the FDA will not tell, 

and the reason the FDA will not tell is because it is run by the Office of Management and Budget, and they have overall targets, and 

they do not want a needy agency communicating to Congress where 

Congress really needs to know what is going on. 

I have gotten to know Commissioner von Eschenbach well. Perhaps it is the Philadelphia connection. But I finally got from him, 

as a result of a letter I wrote on May 1st, a figure of $275 million. 

Now, that is a start, candidly, but not a very good start. Well, we 

have worked to put the $275 million in an emergency appropriation 

bill, supplemental appropriation. Yesterday I found out that the administration, Secretary Leavitt, HHS, has come in with a different 

approach, wants to have an amendment to next year’s budget. And 

Secretary Leavitt is quoted in the New York Times yesterday as 

‘‘urging Congress to act promptly.’’ 

Well, the emergency appropriation would put the money in 

FDA’s hands in the next week or two if we finally get around to 

acting on that bill, which involves Iraq funding. What the administration and Secretary Leavitt are doing is to defer it until next 

March or April. Really, it is an effort to sabotage getting the funds 

in hand at the present time. So it seems to me really ludicrous to 

talk about having preemption by an agency which is dysfunctional, 

does not have the capacity to pass on safety. 

We are dealing here with a wide variety of products, and I think 

back to my days as district attorney, and I think that Senator 

Leahy will agree and Senator Whitehouse may also, and I think 

Senator Hatch will as well. Malice is established when someone 

acts or fails to act in a context of subjecting an individual to the 

unreasonable risk of bodily injury or death. That is the definition 

for malice and murder in the second degree. And I believe if the 

Federal Government does not fund the FDA on matters like the tomatoes and others, harsh language, but I think it really does 

amount to criminal negligence. 

So it is hard for me to see how Congress can sit back and let preemption exist with the FDA when the FDA cannot do its job. And 

the administration is sabotaging under a cover of urging Congress 

to act, when the Secretary and the administration are submitting 

legislation which will delay it for 8 or 9 months. 

I was pleased to see the Chairman quote Judge Becker. Judge 

Becker was a preeminent jurist, did a lot of work with the Committee on asbestos, and I would like to quote Judge Becker a little 

more on the subject about preemption on ERISA, where he said, ‘‘A 

plan participant whose claim is denied by an HMO is often in the 

throes of a life-or-death medical crisis, hardly a feasible time to retain counsel and prosecute an injunctive lawsuit.’’ He concluded, as 

have many critics, that ERISA and its preemption provisions ‘‘have 

become virtually impenetrable shields that insulate plan sponsors 

5 

for any meaningful liability for negligent or malfeasance acts committed against plan beneficiaries in all too many cases.’’ 

So I do think it is high time that the Congress got into this field 

with both feet and undertook some significant action. 

Just one more point in passing, and I do want to agree with the 

Chairman on what he had to say about the Ledbetter case. Ms. 

Ledbetter was denied an opportunity to go to court on a claim of 

discrimination by a Supreme Court ruling that the statute of limitations of 6 months precluded her going to court when she did not 

even know she had a cause of action within the 6 months. But I 

want to differ with my distinguished colleague Senator Leahy on 

what is happening in the Senate on it. 

The bill was introduced, and I am for it, but a procedure was employed known as ‘‘filling the tree,’’ which is arcane within the Beltway, and nobody could offer any amendments. And I voted against 

cloture to go forward because I am not about to move ahead on the 

bill if I cannot offer amendments. The same thing happened with 

global warming. The same thing has happened repeatedly. And it 

is a procedure which has been employed by both Republicans and 

Democrats. One thing, when you find partisanship around here, 

you find an even 50–50 split. Senator Mitchell used it nine times 

years ago; Lott and Frist used it nine times; and Senator Reid is 

now up to 12. But we are going to have to revert to the days when 

a Senator could offer amendments on any subject, and we will take 

up Ledbetter, and we will reverse the Supreme Court decision, giving the woman a right to a remedy. 

We really are facing enormously serious issues here beyond any 

question. 

Mr. Chairman, I would ask consent that my letter to Commissioner von Eschenbach be included in the record and my letter to 

Secretary Leavitt yesterday be included in the record. 

Chairman LEAHY. Without objection. 

Senator SPECTER. Secretary Leavitt and I traded called. He 

called me twice, and I called him back twice, so I finally ended up 

writing him a letter in the afternoon to move ahead on the record. 

Chairman LEAHY. This falls in the category of strong letter. 

Senator SPECTER. Well, every now and then a strong letter is in 

order. 

Secretary Leavitt is a great public servant, and he is following 

the work of the administration. But there comes a time when the 

public interests are so pronounced that people in Congress ought 

to be told what is going on so that we can protect the public, and 

not hide behind a shield. But to say ‘‘urging Congress to act’’ when 

the administration is delaying it for 8 or 9 months is unconscionable. It is sabotage. 

Mr. Chairman, I regret that I cannot stay, but I have other commitments, one of which is to move ahead on this FDA funding, trying to get it into the emergency supplemental. And I am especially 

sorry not to stay because we have witnesses from Pennsylvania 

who have come a long way, and I would like to be here to question 

them. But I am leaving the Republican side in very goods hands 

with former Chairman Hatch. 

Chairman LEAHY. Thank you, Senator Specter, and I am glad to 

hear you quote Judge Becker. I know what a close friend he was 

6 

of yours, and he became a close friend of so many of the rest of us. 

Let us hope we can get over any procedural things because 57 Senators have voted to overturn Ledbetter. And let us hope before the 

year is out we find a way that all 100 can, because it was an egregious, egregious misstep on the part of the Supreme Court. 

Our first witness is Bridget Robb, who was diagnosed 4 years ago 

with congestive heart failure. To save her life, doctors implanted a 

medical device in her chest. A few months ago, she experienced a 

horrific malfunction of that device. I want to let her tell the Committee the story. 

Incidentally, there is a 911 call that she made. We have a tape 

of that. The 911 call is very disturbing. It may be difficult for many 

to hear, especially the sound of her child begging her not to die. 

I cannot think of an easier way of putting it, but that is basically 

it. Your child was begging, ‘‘Mommy, don’t die.’’ 

We will put an edited version of the transcript in the record, 

without objection, and I will make the audio recording available to 

all members of the Committee and their staffs. 

Ms. Robb, thank you very much for being here. Please go ahead 

with your testimony. 

STATEMENT OF BRIDGET ROBB, GWYNEDD, PENNSYLVANIA 

Ms. ROBB. Chairman Leahy and members of the Senate Judiciary Committee— 

Chairman LEAHY. Pull the microphone a little bit closer, please. 

We want to make sure that that little red light is on. 

Ms. ROBB. Is that better? 

Chairman LEAHY. Yes, that is better. 

Ms. ROBB. Chairman Leahy and members of the Senate Judiciary Committee, thank you for the invitation to speak on the topic 

of laws that protect Americans’ health and safety. In a time when 

big business and corporate profits seem to take precedence over individuals’ rights, we tend to forget the reasons why certain laws 

were, in fact, enacted and why it remains important for people who 

have been injured by defective products to be able to hold companies accountable and to have their day in court. I am here today 

not only because of my own tragedy, but also to protect the rights 

of those who have or may suffer similar events such as mine. 

My name is Bridget Robb. I am a 34-year-old mother and resident of Gwynedd, Pennsylvania. On December 31, 2007, I suffered 

greatly and thought I was going to die because of a defective heart 

device implanted in my body. I am thankful to be here today and 

to be able to share my experience with you. 

Approximately 4 years ago, I was diagnosed with non- ischemic 

viral cardiomyopathy and congestive heart failure. In May 2005, to 

prevent me from dying from a fatal arrhythmia, I had a Medtronic 

cardiac defibrillator with pacemaker implanted in my chest. This 

heart device is a small metal case that contains electronics and a 

battery. Its components work much like a pacemaker, but unlike 

a pacemaker, an ICD delivers an electrical shock to the heart when 

the heart rate becomes dangerously fast. My particular device combined a pacemaker and an ICD unit in one. 

On December 31, 2007, I was awoken from my sleep by a series 

of shocks to my heart which felt as if a cannon was being repeatVerDate Aug 31 2005 11:24 Sep 30, 2008 Jkt 044331 PO 00000 Frm 00010 Fmt 6633 Sfmt 6633 S:\GPO\HEARINGS\44331.TXT SJUD1 PsN: CMORC
7 

edly shot at my chest at close range. Along with these recurrent 

shocks was a strong electrical current racing through my body. 

After feeling the first shock, I immediately phoned 911 for help. My 

6-year-old daughter, Emma, had snuck into bed with me that night 

and was present during this horrific experience. I remember Emma 

being confused and scared. She crouched down in front of me hugging her cat, saying ‘‘Mommy’s dying.’’ She was present during the 

entire 7 minutes that I was on the telephone with the 911 operator 

until the EMS arrived. I cannot imagine how terrified she must 

have been to see her mother in such pain. 

The doctors have told me that I received a total of 31 inappropriate shocks to my heart in a matter of minutes that morning. 

Each time I was shocked, I saw my life flash before my eyes. At 

one point, I began to pass out, and I thought that I would never 

see Emma again. 

I later learned that the inappropriate shocking and electrical 

feeling throughout my body was caused by a defective cardiac lead 

implanted in my heart, the Sprint Fidelis lead manufactured by 

Medtronic. A lead is a thin wire which connects the ICD to the 

heart and delivers the actual shock to the heart when it is beating 

too fast. Medtronic’s Sprint Fidelis lead was recalled on October 15, 

2007, because of its potential to fracture. Unfortunately, Medtronic 

never notified me that my lead was recalled, and I did not learn 

of the recall until after this ‘‘life-saving’’ medical device seriously 

hurt me. 

Since this terrifying experience, my health has declined significantly. I have been visiting doctors almost weekly for followup appointments and testing and have suffered from severe anxiety. I 

have since undergone surgical replacement of my defibrillator and 

the defective lead, and a second surgery to revise the lead. My second surgery resulted in an extended hospital stay where I had to 

undergo a blood transfusion. As you would expect, I risk serious 

harm each time another procedure is performed. Even though 

Medtronic’s defective device caused my injuries, my health insurance plan has been paying for the cost of my medical care. 

I would like to have the opportunity to hold Medtronic accountable for the injuries that I suffered that day and the emotional 

aftereffects that I continue to experience on a daily basis. 

Medtronic knew that its Sprint Fidelis lead was faulty, yet the 

company never took responsible steps to notify me that this lead 

needed to be replaced. Instead, I suffered indescribable pain that 

day and continue to suffer from the emotional toll of my near-death 

experience. 

However, my attorneys tell me that a jury may never hear my 

case due to a legal doctrine known as ‘‘preemption,’’ which the Supreme Court recently discussed in another Medtronic medical device case, Riegel v. Medtronic. In that case, the Supreme Court 

found that any claims brought by people injured by another 

Medtronic device were preempted and that the company would 

have complete immunity from any claims brought against it given 

that the FDA approved the device. My attorneys are concerned that 

the Riegel decision also may apply to my case, and as a result, I 

would have no recourse for my injuries. I find this discouraging 

and demoralizing. 

8 

In addition, the considerable costs for my health care have been 

shifted from Medtronic, the company that knew about this problem 

but failed to take action, to my health insurance provider. This 

may result in an increase in the cost of my insurance. It is wrong 

to shift the cost of medical care from the responsible party to private insurers, patients, and in some cases to taxpayer-sponsored 

programs like Medicare and Medicaid. 

Therefore, I am asking Congress to pass legislation to ensure 

that victims of faulty medical devices, like me, will continue to 

have the ability to hold a medical device manufacturer accountable 

for their injuries. I find it hard to believe that Congress ever intended to prohibit me from having the opportunity to go to court 

to obtain justice. 

Thank you for your attention to this critical issue, and I am 

happy to answer any questions that you may have. 

[The prepared statement of Ms. Robb appears as a submission 

for the record.] 

Chairman LEAHY. Thank you very much, Ms. Robb. I would urge 

the Senators on this Committee and their staffs to listen to the 911 

call. It is chilling, to say the least. 

Maureen Kurtek—did I pronounce that correctly, Ms. Kurtek? 

She has been battling lupus for almost 20 years. She is here to tell 

her compelling story about an HMO that delayed approving health 

care treatment under the Supreme Court’s ERISA case law, which 

I believe is misguided, and I also believe not what was intended 

by either the Democrats or Republicans who voted for the ERISA 

law. Ms. Kurtek has no avenue of recovery for significant medical 

injuries. 

Ms. Kurtek, please go ahead, and make sure that is on. Go 

ahead, please. 

STATEMENT OF MAUREEN KURTEK, POTTSVILLE, 

PENNSYLVANIA 

Ms. KURTEK. Chairman Leahy and members of the Committee: 

A health insurance company should never be allowed to jeopardize 

a person’s health while they look for ways to save money. But 

when they do they should be held accountable. 

My name is Maureen Kurtek. I have lupus, and I was diagnosed 

in 1989. My doctors agreed that a therapy called IVIG would be 

beneficial to me. 

IVIG helps to fight infection by building up a patient’s resistance. 

People with autoimmune diseases such as myself do not have a 

normal resistance to germs, which is comparable to a person undergoing chemotherapy. 

Periodic IVIG therapy improved my condition. It raised my platelet count and boosted my immunities. My first series of treatments 

in 1998 cost about $14,000 and was paid for by Pennsylvania Blue 

Cross and Blue Shield through my husband’s employer. Although 

I had six treatments in 3 years, in January of 2003 my doctor recommended another IV treatment. At the time, my husband had 

changed jobs, and our health insurance company was now Capital 

Blue Cross. 

9 

I immediately called them to preauthorize the treatment, which 

according to the plan they would pay for as long as it was medically necessary. 

I first called Capital on January 17, 2003. The first representative wanted to look into whether the treatment would be provided 

at home health instead of in the hospital, which I had got it all the 

time before in the hospital. 

The next person told me she thought the treatment was experimental. Well, that put up a red flag to me. 

I repeatedly asked to speak with a supervisor and was told that 

Capital was continuing to look into this and would report back to 

me once a decision was made. 

Every time I called, I was told that ‘‘someone was working on it 

and that the supervisor had a note on her desk with my name and 

number on it. 

Capital did not call any of my doctors. It took the insurance company 53 days to authorize my treatment. By then I had nearly 

died. Due to not receiving my treatment, I became septic. I developed an infection my body that I could not fight, 

On March 1, 2003, I was taken by ambulance to the hospital for 

an acute flare-up of my lupus. According to my doctor, this condition could have been prevented or dramatically diminished if I had 

received the medically necessary IVIG treatment. 

The very first treatment I received after being admitted to that 

hospital was emergent IVIG. While at the hospital, I was in critical 

condition. The doctors told my husband I had a 5-percent chance 

of survival. 

After going into septic shock, I went into kidney failure. My body 

also started to throw clots at the same time as I was bleeding bled 

out. I had blood clots in my hands and feet. I also suffered uncontrollable hemorrhaging of the sinuses causing blood to enter my 

lungs. I was bleeding from every orifice in my body, including my 

eyes and mouth. 

I was in respiratory failure and required ventilation on a respirator and within 24 hours had an emergency tracheotomy due to 

bleeding from my sinuses into my lungs. I almost died because of 

this injustice, and parts of me actually did die: my fingertips; I lose 

half of my right foot. 

Eleven days after I was admitted to the hospital, the insurance 

company approved the treatment. As a result of the extraordinary 

delay in the approval of the IVIG therapy, like I said, I had lost 

half my right foot, amputated. I had developed osteomyelitis to that 

right foot. I had lost five fingertips. I had difficulty breathing 

through my nose and had undergone many surgeries. I am required to take Lovenox, two injections daily, and have developed 

peripheral neuropathy, and I am required to wear special shoes. 

I filed a lawsuit against the insurance company, but the judge 

decided my case was covered under the ERISA law, which does not 

allow people like me to sue for the harm the insurance company 

caused me. The ERISA law, as the late Judge Becker stated, ‘‘has 

evolved into a shield that insulates HMOs from liability for even 

the most egregious acts of dereliction committed against plan beneficiaries.’’ 

10 

Because of ERISA, there is a monetary incentive for insurance 

companies to mistreat people like me who have health problems. 

I am privileged to be here today to tell you about how the ERISA 

law has hurt me and my family. I am wearing a tear-shaped necklace given to me by my family members who had to watch me cry 

tears of blood. 

At the time I was sick, I had a 13-year-old son who did not know 

whether his mom would even make it through the night. I had a 

husband who didn’t know whether in a few days he would be a single parent and have to raise a child while trying to support a family on a modest income. And all of this pain and suffering was 

caused by an insurance company that failed to timely authorize the 

treatment that I had received six times before. This treatment was 

necessary for me. 

As I stand before you today, I can tell you that life ceased as I 

had known it. I am no longer able to jog or dance. I cannot wear 

stylish shoes on special occasions. And I have to wear an orthopedic shoe, which I can assure you is not any woman’s dream. During my time in the hospital, I missed my son’s spelling bee, piano 

recital, his confirmation at church, and many baseball games. 

These are events I can never get back. 

Due to this law, insurance companies can get away with denying 

care and delaying treatment without any consequences. This is 

wrong. We need to change this law so no families will have to suffer the way mine did. 

Thank you for your time. 

[The prepared statement of Ms. Kurtek appears as a submission 

for the record.] 

Chairman LEAHY. Thank you, Ms. Kurtek. I know it is not easy 

to tell your story, the same as Ms. Robb. 

Ms. KURTEK. I have pictures here if you would like to see them. 

Chairman LEAHY. Thank you. We will make sure they are available to all the Senators. 

Ms. KURTEK. Thank you. 

Chairman LEAHY. What I am going to do is go through the testimony of each of you, and then we will open it to questions. 

Andy Anderson is of counsel for the international law firm of 

Morgan Lewis. He is testifying today on behalf of the U.S. Chamber of Commerce. 

Mr. Anderson, welcome, and go ahead, please. 

STATEMENT OF ANDY R. ANDERSON, OF COUNSEL, MORGAN, 

LEWIS & BOCKIUS LLP, CHICAGO, ILLINOIS 

Mr. ANDERSON. Chairman Leahy and members of the Committee, 

I am pleased and honored to be here today. As you indicated, I am 

here to testify on behalf of the United States Chamber of Commerce regarding Supreme Court decisions under the Employee Retirement Income Security Act of 1974, commonly known as 

‘‘ERISA.’’ 

My name is Andy Anderson, and I am of counsel at Morgan 

Lewis. My practice focuses on advising single-employer and multiemployer benefit plans on employee benefits matters and specifically on their health benefit programs. I have worked in the area 

of employee benefits since 1984. I chair my firm’s Health and WelVerDate Aug 31 2005 11:24 Sep 30, 2008 Jkt 044331 PO 00000 Frm 00014 Fmt 6633 Sfmt 6633 S:\GPO\HEARINGS\44331.TXT SJUD1 PsN: CMORC
11 

fare practice, and I participate on the Chamber’s Employee Benefits Committee. 

ERISA uniformity and limited recovery is intended and necessary. All employers—except for certain religious and government 

organizations—who voluntarily choose to offer retirement or health 

benefits are governed by ERISA. 

ERISA was the subject of a long and detailed legislative process. 

Included among the myriad provisions of ERISA are two concepts 

that cut to the heart of today’s hearing. These concepts work in 

unison to encourage employers to voluntarily extend health benefits to their employees with a high degree of uniformity and without unnecessary exposure to liability. 

These provisions are ERISA Section 514, which generally preempts State jurisdiction over employer-provided health benefits, 

and ERISA Section 502 that outlines the rules associated with the 

civil enforcement of ERISA. 

The ERISA provisions in these sections have a long and detailed 

legislative, regulatory, and judicial history that extends all the way 

back to the initial legislative proposals that eventually became 

ERISA. It was no accident that resulted in these provisions but, 

rather, a careful balance of competing interests and incentives to 

encourage employers to voluntarily offer retirement and health 

benefits. 

Our judiciary, including the Supreme Court, has heard many 

cases related to ERISA uniformity and remedies. While sometimes 

chafing under the statutory provisions of ERISA or bemoaning yet 

another ERISA case on their docket, our judiciary has usually 

reached the correct decision regarding both the specific facts of a 

given case and the broader principles and tradeoffs embodied in 

ERISA. These decisions should be respected and upheld. 

Changes to ERISA will decrease employer-provided voluntary 

health care 

Employers engage in a complicated calculus when they determine whether or not to offer health benefits. Included in this calculus is whether they retain control over the fundamental provisions of their plans, such as eligibility and which benefits are covered under the plans. Employers are also concerned about the risk 

of liability associated with offering a health plan and the judicial 

forums and rules applicable to the plan. 

Of the 160 million Americans who have employer-provided 

health coverage, 132 million receive health benefits that are subject 

to the provisions of ERISA. The large numbers of Americans covered by ERISA-regulated health plans shows how successful ERISA 

has been at encouraging employers to voluntarily offer benefits. 

This success is due in large part to ERISA Sections 514 and 502, 

since these rules ensure that employers—and particularly employers who self-insure their health benefits—are able to provide uniform medical plans in every State in which they operate, that disputes associated with ERISA-governed health plans are heard in 

Federal court, and that successful litigants generally receive the 

benefits owed to them under the terms of their employer’s plans. 

I firmly believe that interposing the determination of a State legislature—or a State judge—regarding the eligibility and benefit 

rules for an employer’s health plan will begin to make this volVerDate Aug 31 2005 11:24 Sep 30, 2008 Jkt 044331 PO 00000 Frm 00015 Fmt 6633 Sfmt 6633 S:\GPO\HEARINGS\44331.TXT SJUD1 PsN: CMORC
12 

untary program much less appealing and far more complicated for 

employers. Further, if employers have to begin weighing the increased risk of broader participant recoveries, we will quickly see 

a number of employers stop providing health coverage to their employees or merely reimburse employees for individually purchased 

coverage. As a result, we will wind up with fewer Americans who 

are covered under traditional employer- provided health plans. 

While a few will benefit, many will lose. 

We are already witnessing the reduced retirement income security associated with the legislative, regulatory, and judicial environment surrounding defined benefit plans. This lesson is reason 

enough for Congress to build on the strengths of employer-provided 

health care, maintain ERISA uniformity and recovery rules, and 

encourage—rather than discourage—our system of voluntary employer-sponsored health plans. 

Mr. Chairman and members of the Committee, thank you for the 

opportunity to testify today and for your attention to this very important issue. I would be happy to answer any questions that you 

may have during the balance of this hearing. 

[The prepared statement of Mr. Anderson appears as a submission for the record.] 

Chairman LEAHY. Our next witness is Thomas O. McGarity. Professor McGarity teaches at the University of Texas School of Law, 

a leading scholar in the fields of torts, administrative law, and environmental law. He has written a number of influential books on 

Federal regulation, including the forthcoming book ‘‘The Preemption War: When Federal Bureaucracies Trump Local Juries.’’ 

Mr. McGarity, thank you for being here. Please go ahead, sir. 

STATEMENT OF THOMAS O. MCGARITY, PROFESSOR OF LAW, 

UNIVERSITY OF TEXAS SCHOOL OF LAW, AUSTIN, TEXAS 

Mr. MCGARITY. Mr. Chairman and members of the Committee, 

thank you for having me here. As mentioned, I hold the Long Chair 

in Administrative Law at the University of Texas School of Law. 

I am board member and immediate past president of the Center for 

Progressive Reform, which is an organization of legal scholars 

throughout the country that is working on preemption, among 

other issues. My forthcoming book, just mentioned, will be out in 

October, and is being published by Yale University Press. 

Although the Supreme Court quite correctly is insulated from the 

pulls and tugs of day-to-day politics, its decisions do have a powerful impact on the lives of ordinary Americans. Our written testimony highlights the serious injustices that can result when the 

Court exercises its power to interpret Federal statutes narrowly to 

reach a result that Congress never intended and then employs the 

doctrine of Federal preemption to impose that questionable interpretation on the State common law courts. 

An increasing number of sitting Justices, in my view, seem more 

willing to interpret laws that Congress enacted to implement protective social goals in ways that really advance their less protective 

views of public policy. For example, the longstanding presumption 

against preemption that the Supreme Court has honored for years 

seems more honored in the breach these days, as at least some sitting Justices, demonstrate their willingness to accommodate the inVerDate Aug 31 2005 11:24 Sep 30, 2008 Jkt 044331 PO 00000 Frm 00016 Fmt 6633 Sfmt 6633 S:\GPO\HEARINGS\44331.TXT SJUD1 PsN: CMORC
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terest of the business community in nationally uniform implementation of weak Federal regulations. Ms. Kurtek’s experience is 

sadly but one of hundreds of similar instances of medical benefit 

plan errors that have resulted in uncompensated mental damage 

and physical harm to the erstwhile beneficiaries of such plans. 

The injustice that Ms. Kurtek and Ms. Robb have felt here in the 

case of ERISA stems from two lines of Supreme Court precedent 

that were just moving off in different directions from each other 

and the Department of Labor’s failure to exercise its rulemaking 

power to address the problem of medical benefit plans. 

The first line of cases narrowly interpreted the clause Mr. Anderson just referred to, providing civil remedies, to exclude common 

law damages. So all you get by way of a remedy is the benefits that 

you would have otherwise been entitled to, no matter how negligent the health care provider. 

A second line of cases, broadly interprets the express preemption 

provisions of ERISA to displace all Federal laws, including, though 

not mentioned explicitly in the statute, State common law. 

The Department has consistently failed to fill the gap which it 

does have the power to do by promulgating regulations that would 

limit negligence on the part of health care providers. The net effect 

has been to substitute a virtually content-free Federal regulatory 

regime for what would otherwise be a rich body of State common 

law. The message to the HMOs and insurance companies is to ignore their fiduciary obligations and deny legitimate requests for 

coverage, and my testimony mentions where that has actually been 

instructed to the medical service folks. 

Justice Ginsburg, Judge Becker, Second Circuit Judge Guido 

Calabresi have all expressed concern about the state of ERISA law 

as interpreted by these two lines of Supreme Court cases. 

Now, ERISA is not the only Federal statute. My book goes into 

several Federal statutes where Federal agencies promulgate weak 

regulations that then preempt State common law actions. The Medical Device Amendments that resulted in the approval of the medical device—the full approval of the medical device that Ms. Robb 

described to you is another instance of injustice coming about by 

a recent Supreme Court case saying that all claims involving fully 

approved devices are preempted. 

The arcane law of Federal preemption has a profound effect on 

the rights of ordinary citizens. First, it deprives innocent plaintiffs 

of the corrective justice to which I believe all Americans are entitled. Second, it replaces the common law jury, perhaps that most 

democratic of legal institutions, with an unelected Federal bureaucracy. And, third, it undercuts the backstop role that State common 

law litigation can provide to back up the Federal law. 

Just in passing, the ERISA law preempts even claims based on 

violations of ERISA, not just claims that are inconsistent with 

ERISA. 

So when the Supreme Court concludes that Congress meant for 

the questionable judgment of Federal bureaucracies to supersede 

the common-sense wisdom of a common law jury, it leaves behind 

a hole in the law that has enormous potential for injustice. 

Thank you. 

14 

[The prepared statement of Mr. McGarity appears as a submission for the record.] 

Chairman LEAHY. Thank you, Professor. 

Richard Cooper, our next witness, was chief counsel of the FDA 

during 1977 to 1979. He is currently a partner at the Washington 

law firm of Williams & Connolly, where his principal area of practice is food and drug law, with an emphasis on medical products. 

Mr. Cooper, welcome. Please go ahead, sir. 

STATEMENT OF RICHARD M. COOPER, PARTNER, WILLIAMS & 

CONNOLLY LLP, WASHINGTON, D.C. 

Mr. COOPER. Thank you, Mr. Chairman. I thank you and the 

Committee for inviting me to testify here this morning. 

The fundamental question that is put at issue by preemption in 

the food and drug field is who gets to decide whether a medical device or drug is safe and effective and who gets to decide what information will be put into labeling to guide doctors in prescribing and 

administering the medical product. 

Under our Federal system, the supremacy of Federal law over 

State law is fundamental. The Riegel decision earlier this year involved express preemption. Congress in 1976, as part of the Medical Device Amendments, included a section that provides, in substance, that no State shall establish or continue in effect with respect to a device any requirement—any requirement—that is different from or in addition to a requirement with respect to the device under the Food, Drug, and Cosmetic Act and that relates to 

the safety or effectiveness of the device. 

As early as 1959, long before the current Supreme Court, the Supreme Court recognized that State common law damages remedies 

have a regulatory effect and, thus, in effect, impose requirements. 

That was 17 years before the Medical Device Amendments of 1976. 

That understanding was reiterated and applied to product liability, 

a part of the common law, in the Cipollone decision in 1992. And 

in the Sprietsma case, another product liability case, in 2002, that 

recognition was endorsed by a unanimous Court. 

In Riegel, the Supreme Court applied that established body of jurisprudence to FDA approval decisions with respect to a medical 

device. And although FDA has many problems, whether it is tomatoes or pharmaceutical factories in China, I am not aware of evidence that FDA is inadequately staffed or has inadequate resources 

to perform its review function with respect to medical devices or reviews of new drug applications. 

When FDA reviews a Pre-Market Approval application for a medical device, it reviews a vast amount of data. It assesses effectiveness and safety and makes tradeoffs between design features that 

affect safety or effectiveness. It decides on the basis of the medical 

needs in the best interest of all potential users of the product and 

takes into account, as far as can be foreseen, those who are likely 

to derive a net benefit from it, whether it is saving life, whether 

it is maintaining health, whether it is enhancing quality of life, as 

well as those who are likely to suffer adverse experiences with the 

device. It takes into account what is known and what is unknown. 

And when FDA approves a product, it approves it with conditions 

that, together with the applicable statutory and regulatory requireVerDate Aug 31 2005 11:24 Sep 30, 2008 Jkt 044331 PO 00000 Frm 00018 Fmt 6633 Sfmt 6633 S:\GPO\HEARINGS\44331.TXT SJUD1 PsN: CMORC
15 

ments, must be obeyed by the manufacturer with very, very limited 

exceptions. 

FDA could always hold the product off the market until there is 

more information to guide use, to make it safer and more effective, 

possibly to change design, or even to reveal new risks that might 

make one conclude that the product is unsafe. You could hold the 

product off the market forever until you had perfect information. 

If you waited for perfect information, if you insisted that no device 

ever malfunction, no drug ever cause an adverse reaction, we would 

have no devices and we would have no drugs. There are no perfect 

medical products. 

The PMA products are only a very small proportion of the medical devices on the market today. All Class I devices and Class II 

devices and the vast majority of even Class III devices do not go 

through the PMA process, and Riegel and the other preemption decisions have no effect on the ability of harmed patients to seek 

legal redress. 

Riegel is also consistent with the scope, the limited scope, for 

compensation from manufacturers under products liability law. 

Manufacturers are not insurers. In general, they are liable only if 

their product is defective or they are negligent, if they are at fault 

in some way. Once FDA has decided that a design is safe and acceptable and what is to be in the labeling, there is no fault in a 

manufacturer that markets that product with that design and with 

that labeling. Under the Supremacy Clause, State law requirements that would change the design or would change the labeling 

are preempted. 

In general, this system benefits consumers as the flow of life-saving and life-enhancing products used by people, some of whom may 

be in this room, this hearing room, most of whom, millions of 

whom, are not in this hearing room this morning. Preemption also 

gives full respect to Congress by taking fully seriously the words 

that Congress enacted in the preemption provision of the Food, 

Drug, and Cosmetic Act. 

Thank you. 

[The prepared statement of Mr. Cooper appears as a submission 

for the record.] 

Chairman LEAHY. Thank you very much. 

Our next witness is Robert Lawless. Professor Lawless teaches at 

the University of Illinois College of Law. He is an expert in bankruptcy and corporate law, has published numerous articles on these 

topics. Professor Lawless has previously testified before this Committee on the implementation of the Bankruptcy Abuse Prevention 

and Consumer Protection Act, and we welcome him back here 

again. 

Professor, please go ahead. 

STATEMENT OF ROBERT M. LAWLESS, PROFESSOR OF LAW 

AND GALOWICH-HUIZENGA FACULTY SCHOLAR, UNIVERSITY 

OF ILLINOIS COLLEGE OF LAW, CHAMPAIGN, ILLINOIS 

Mr. LAWLESS. Thank you, Mr. Chairman and members of the 

Committee. Thank you very much for inviting me to testify today. 

As Senator Leahy indicated, my name is Robert Lawless. I am 

a professor of law at the University of Illinois College of Law, 

16 

where I study bankruptcy and financial services law, and my research focuses especially on how those laws, how those legal institutions affect the American family. And I really commend the Committee for having this hearing today and shedding light on the 

many ways the U.S. Supreme Court has decisions that happen outside the blur of the usual media headlines, but that really can dig 

into the pocketbooks of everyday Americans. 

I am here today to talk about cases about credit cards, about 

bankruptcy, about consumer loans, some areas that we have not 

heard about yet this morning. But in the same way, what we have 

seen is a series of Supreme Court decisions that have centralized 

regulatory authority in the Federal Government and taken away 

the power of the States to provide protections for their citizens. 

In my written testimony, I refer to a citizen of Maryland who has 

written some comments to the Federal Reserve’s recent regulations 

on credit cards. And he complains about being charged an extremely high, exorbitant rate. Penalty default rates now on credit 

cards can run into the 30s. This gentleman was complaining about 

a rate, as he characterized it, in the ‘‘high 20s.’’ The State of Maryland prohibits a creditor from charging more than 24 percent interest. An interest rate higher than 24 percent is considered usurious. 

Why can’t a citizen of Maryland rely on their State law to protect 

them? Because of a decision of the U.S. Supreme Court known as 

Marquette. 

Why do we have so much consumer debt in this country? Why 

do we have over $50,000 in consumer debt for every man, woman, 

and child in the United States? Again, because of that same decision, because of the Marquette decision, involving an interpretation 

of something known as the National Bank Act, which gives a bank 

the authority to charge interest at the rate allowed where the bank 

is located. This law had been passed 114 years before the case had 

reached the Supreme Court. At the time it was passed, this country 

was in the midst of the Civil War. The purpose of the National 

Bank Act was to establish a strong national banking system. The 

purpose of that particular section was to prevent a State like Nebraska, as was involved in that case, from ganging up on a Federal 

bank and driving federally chartered banks out of the State in 

favor of State-chartered banks. 

What had been a section that was there to protect Federal banks 

was used in Marquette as now a sword for a bank in the State of 

Nebraska to go into the State of Minnesota and make consumer 

loans that were above the legal rate allowed by the State of Minnesota, but because they were within the rate of the laws of the 

State of Nebraska, the Supreme Court upheld the bank’s actions. 

Now, reasonable people can differ over whether this was a good 

idea or not. The effect of the Marquette decision was effectively to 

deregulate interest rates. But the important point here that we 

have been hearing over and over is that this ultimately was a decision for Congress to decide. By ruling in favor of the banking interest, Congress essentially locked in a regulatory policy. I do not 

think anybody realistically expected that consumer interests were 

going to be able to effectively come into Congress after the Marquette decision and seek to have it overturned. 

17 

I talked about some other decisions in my written testimony. Let 

me just focus on one more from last term, the Watters decision. 

Why can’t States right now, especially State Attorneys General, enforce their own State consumer laws against national banks, the 

Watters decision? The Office of the Comptroller of the Currency 

issued a regulation defining the scope of its own authority to displace State law. In that regulation, the Office of the Comptroller 

of the Currency preempted State consumer protections as they applied to national banks. The Watters decision upheld the authority 

of the OCC to do this. Again, reasonable people might differ over 

this, but, again, this would be a policy decision for Congress to consider. 

Because of the Watters decision, the New York Attorney General 

would not have been able to undertake an investigation into overbilling practices that was undergoing as that Watters case began its 

way through the Federal court system. The New York Attorney 

General was not investigating consumers who were trying to escape responsibility for loans, whether the New York Attorney General was trying to investigate cases of overbilling where the lender 

acknowledged receiving payments over and above the amount they 

were contractually entitled to. Such an investigation today would 

be preempted because of the U.S. Supreme Court’s decision. 

We have heard a lot about problems. Let me try to offer one solution, and that would be for Congress to start adopting an interpretive rule, either broadly or in particular statutes, that any ambiguity be resolved in favor of consumer interests. That would stop 

the problem of lock-in. That would stop the problem of having a decision from the Supreme Court that cannot effectively be overturned. If the tipping rule were to be adopted, then the burden of 

legislative change would rest with the financial services industry 

and the business interests were most able to come to Congress and 

have their interests represented. 

Thank you for letting me speak this morning, and I will be happy 

to answer any questions you have. 

[The prepared statement of Mr. Lawless appears as a submission 

for the record.] 

Chairman LEAHY. Thank you, Professor Lawless. Let me ask my 

first question of Professor McGarity, and I should note that each 

of you will have a copy of the transcript; if you want to expand on 

your answers, feel free to. We are also going to probably have some 

questions for the record afterward. 

Professor, you heard Ms. Robb’s testimony, and here she has this 

911 call, a malfunctioning device implanted in her chest, a malfunctioning device that the company knew could malfunction. She 

thought she was dying because of the severe pain, and probably as 

traumatically, her 6-year-old daughter thought her mother was 

dying. And yet she finds that nobody is accountable. The company 

knew the device was improper. They are not accountable. 

Now, I wonder—they know they are not accountable, they are 

given this kind of blanket immunity—what is out there that might 

give them the incentive to do something right? We have laws on 

the books that for your conduct. If you drive down the road, you 

have got speed limit laws, and most people will follow them. Some 

do not. But if you had a sticker on your license plate which said 

18 

Professor McGarity does not have to follow these laws, there is no 

real incentive to follow them. 

Now, some claim that the Supreme Court’s Riegel decision is 

going to allow an injured consumer to go to court to enforce Federal 

agency regulations. That should be sufficient to protect consumers, 

but there is no compensation. So do you really think that is going 

to allow consumers to be protected? Is there anything in there that 

gives a real incentive for corporations to even notify consumers 

when they know there is not a heck of a lot consumers can do to 

them? 

Mr. MCGARITY. I think there is very little—I mean, there is nothing there if there is no common law action available at all, which 

is the case now for fully approved devices. Now, what you have, of 

course, is the approval process so that the device is supposed to be 

shown to be safe and effective when it is approved. 

That could have happened years ago. It could have happened 

decades ago. In the case of some agencies, it did happen back in 

the 1950s. The agency has never gone back and revisited the regulation or the approval, even though we have lots more information 

that has come in by way of adverse event reports in the case of 

FDA and other such sources of information, including academia, 

that show that various aspects are unsafe and that safer technologies are there. Until the agency withdraws that regulation or 

takes some action, there is no incentive for the company to do anything to even come up with safer technology. 

Chairman LEAHY. Look at the results of this. I mean, Congress 

spent, I believe, a decade studying the problems of protecting workers’ pensions and benefits before passing a sweeping law intended 

to increase protection of the vulnerable American workers. But Justice Scalia has taken the lead and ignored congressional intent, 

gutted the law that is supposed to ensure that workers with employer-sponsored health insurance and retirement benefits can 

count on them. But listen to Ms. Kurtek’s testimony, we see what 

Judge Becker, the late Judge Becker, described as the ‘‘perverse effects’’ of Justice Scalia’s cramped interpretation. Doesn’t this, instead of protecting people within HMOs—as Mr. Anderson and others testify. Doesn’t this really create a strong incentive for HMOs 

to deny claims? There does not seem to be anything that can happen to them if they do. 

Mr. MCGARITY. Well, in fact, it can be a profit maximizer to deny 

the claims. The fact is that your employer and you have paid into 

the insurance company. The money is in their bank account drawing interest while they are denying the claim so that the entire 

time that that is happening, they are investing that money at the 

same time they are denying the claim. If there is no consequences, 

no accountability, as Ms. Kurtek pointed out, for doing that, there 

is exactly that. And I mentioned in my testimony a training session 

that was conducted in the late 1990s of these basically nurses who 

make the decision whether or not something is covered or not, and 

they train them that if it is an ERISA-covered claim, draw it out. 

If it is not ERISA, we might be held liable, so go ahead and get 

that thing taken care of. 

Chairman LEAHY. Well, you know, I think about last week, Colorado’s Governor, Bill Ritter, signed into law major crippling penVerDate Aug 31 2005 11:24 Sep 30, 2008 Jkt 044331 PO 00000 Frm 00022 Fmt 6633 Sfmt 6633 S:\GPO\HEARINGS\44331.TXT SJUD1 PsN: CMORC
19 

alties for health insurers who delayed or denied authorizing payments of a covered benefit without a reasonable basis for it. But 

doesn’t Justice Scalia’s line of ERISA decisions threaten to override 

such State laws? 

Mr. MCGARITY. That is not so different from the Texas law that 

President Bush signed when he was Governor of Texas that was 

at issue in the Davila case, which did give a private right of action 

when your claim was unreasonably denied. The Supreme Court 

held that that was preempted. I expect that the Supreme Court— 

one hesitates to predict always, but my prediction would be that 

this provision is DOA, dead on arrival. 

Chairman LEAHY. I am going to yield to Senator Hatch, and I 

have other questions. We could spend hours and hours with each 

one of you on this. I will submit questions to you. And Senator 

Whitehouse is going to chair. I must admit—and this, I agree, will 

be somewhat editorial commenting, but you hear this buzz word of 

‘‘activist’’ judges. I cannot think of any more activist judges than 

many on the Supreme Court who have overturned congressional actions that were intended to protect consumers, when basically they 

end up overturning them to protect multinational corporations, and 

that is one Senator’s opinion. But I thank each one of you for being 

here. 

Ms. Robb and Ms. Kurtek, you are not people who are used to 

testifying before congressional committees, and I thank you for 

being here. I hope your son, Ms. Kurtek, still goes to the spelling 

bees and does those things. Ms. Robb, I hope your daughter still 

wants to hug her mom. 

Senator Hatch? 

Senator HATCH. Well, thank you, Mr. Chairman. I appreciate you 

holding this hearing. It is an interesting hearing to me. And as 

many things in the law, we find a lot of situations that are very 

difficult to resolve. I empathize with both of you, Ms. Robb and Ms. 

Kurtek. Did either of you sue the doctors or the hospitals? 

Ms. KURTEK. No. 

Senator HATCH. Did you, Ms. Robb? 

Ms. ROBB. No, I did not. 

Senator HATCH. OK. Well, it seems to me there was some potential there, but, still, these issues are important issues. 

Now, Mr. Cooper, I want to thank you for your testimony. Reading your resume, and, of course, knowing a lot about you, it is obvious that you are not only the expert on FDA law, but you were 

chief counsel for the FDA during the Carter administration. And 

you have a real sense of how the FDA works, and it is a practical 

sense. So I want to commend the Chairman and the Ranking Member for inviting all of you to testify, but especially you since you 

have this broad background at the FDA. And this seems to be a 

major, major aspect of at least this one part of this problem. 

Now, Mr. Cooper, is there any way that Ms. Robb, based upon 

the statement that she made today, could have sued the insurance 

company under the Medical Device Act? 

Mr. COOPER. You mean the manufacturer? 

Senator HATCH. Yes, the manufacturer. Excuse me. The manufacturer. 

20 

Mr. COOPER. I cannot comment on the details of her case without 

knowing a lot more about it— 

Senator HATCH.—that she could not. 

Mr. COOPER. Yes, I can speculate. The preemption doctrine under 

Riegel applies to the FDA approval decision, so I think it protects 

against lawsuits challenging the design of the product or the labeling of the product. But if, for example, the malfunction she described resulted from a defect in manufacturing, if the product was 

not manufactured to its design specification— 

Senator HATCH. The law allows an opening for that, doesn’t— 

Mr. COOPER. Pardon? 

Senator HATCH. The laws allows an opening to sue for that. 

Mr. COOPER. That is a possible opening. I don’t know whether 

that happened, but that is a possible opening. 

Senator HATCH. I just wanted to make that clear, that there may 

be a cause of action there if there was negligence on the part of 

the manufacturer or a defect in the product that they— 

Mr. COOPER. In the manufacturing. 

Senator HATCH. Right, in the manufacturing, which bothers me 

a lot because she has gone through an awful lot of pain. It is more 

difficult to see how the ERISA laws would be overturned in the 

case of Ms. Kurtek, but, nevertheless, these are matters of great 

concern. 

Mr. Cooper, what would happen to a company if it ignored the 

requirements for use set by the FDA? The requirements the FDA 

set, would it be liable under State tort law? What would be its exposure under Federal law? 

Mr. COOPER. Well, if a company violated one of the conditions of 

approval of its product, it could be liable under both Federal and 

State law. If it manufactured a product that differed in a material 

way from the design that FDA had approved, the product would be 

adulterated. If it materially changed the labeling from what FDA 

had required in its approval, the product would be misbranded. It 

would also be—in the case of a device, an unapproved product and 

would be adulterated. In the case of a drug, if the company 

changed the formula for the drug, for example, without FDA approval, the drug would become an unapproved product, and there 

is a separate prohibited act in Section 301 of the Federal Food, 

Drug, and Cosmetic Act that would make the shipment of that 

drug in interstate commerce unlawful. In addition, the Supreme 

Court has been very clear in all of its FDA preemption decisions 

that a State law theory of liability that, in effect, enforces a Federal requirement is not preempted. 

Senator HATCH. Now, the distinguished Chairman kind of indicated that the Riegel case was an activist decision. After all the 

sturm and drang over the Riegel decision, I think it is important 

to keep in mind that it was an 8–1 decision. This was not some 5– 

4 decision. This was an 8–1 decision. 

Mr. COOPER. That is correct, and it was clearly foreshadowed in 

prior Supreme Court decisions and by the vast majority of courts 

of appeals decisions that had considered the question. It was not 

a bolt from the blue. 

21 

Senator HATCH. Well, could you elaborate on that decision, what 

it does and does not say? And also, in your view, did the decision 

come as a surprise to the experts in the legal community? 

Mr. COOPER. I think it was not a surprise, and I would emphasize that it protects only a very small percentage of the medical devices—the thousands and thousands of medical devices that are 

marketed. It protects only those that go through the PMA route to 

the market and have been approved by FDA in accordance with 

what the Supreme Court correctly described as a ‘‘very rigorous 

process,’’ backed up by lots of data. 

Senator HATCH. Could I ask one more question, Mr. Chairman. 

Senator WHITEHOUSE. [Presiding.] Of course. Please take your 

time. 

Senator HATCH. This is important stuff because, you know, I am 

one of the authors of some of the subsequent aspects of the Medical 

Device Act, and I want to have it right. I certainly do not want to 

see people suffer. And I would appreciate any advice you could give 

to the Committee as to whether we should change some aspect of 

the law to make this more workable and to make it more fair, if 

there is, in fact, unfairness. 

Now, I agree with you, there are millions and millions of people 

who benefit from these devices, and there is no way you could absolutely be sure that any device is perfectly harmless or that any 

pharmaceutical is perfectly harmless. They all have risks, and they 

all have adverse events to a degree, and this is part of this. 

But let me ask you this question: Mr. Anderson in his testimony—and I do not mean to not give you this question, Mr. Anderson, but I would like to—since I have been asking Mr. Cooper, I 

would like to just ask this of him. 

In his testimony, he stated that legislative efforts to undermine 

ERISA preemption would discourage employers from providing 

health benefits to their employees. 

Do you agree or disagree with that? 

Mr. COOPER. I am really not an expert on ERISA. 

Senator HATCH. OK. Well, then, let me ask the question of Mr. 

Anderson. I do not think there are very many experts on ERISA, 

I tell you. It is a very complicated set of laws. 

Mr. COOPER. We should treasure the one we have. 

Senator HATCH. Yes, that is right. But let me tell you, your testimony there is a matter of great concern to me. The fact of the matter is that we are finding that employer-provided health care is diminishing gradually in a rapid fashion, and there are many reasons for that. But I for one want to do everything we can to give 

incentives to employers to provide health care. So if you care to expand on your testimony there so that we all know exactly what you 

think will happen. 

Mr. ANDERSON. Thank you, Senator. I would be pleased to. 

As you point out, ERISA is a voluntary statute. Employers 

choose to offer employer-provided health coverage, and, unfortunately, in recent years, fewer and fewer employers have been able 

to afford to offer health coverage. There are a lot of costs associated 

with or bundled into delivering medical benefits—medical advances, liability concerns, so on and so forth. And I think anything 

that exposes employers to additional risk related to their employerVerDate Aug 31 2005 11:24 Sep 30, 2008 Jkt 044331 PO 00000 Frm 00025 Fmt 6633 Sfmt 6633 S:\GPO\HEARINGS\44331.TXT SJUD1 PsN: CMORC
22 

provided health coverage will lead to those employers beginning to 

exit the system. 

I would also like to clarify what I think was a misrepresentation 

earlier in today’s testimony. It is easy to demonize health insurers 

here, that they are looking to line their pockets or some such thing. 

But what is often overlooked is somewhere in the neighborhood of 

73 million Americans who have employer-provided health insurance enjoy self-insured health insurance. What that means is, 

while there may be an insurer who handles some of the paperwork 

or provides the doctors or the network, every single dollar associated with the cost of that employer-provided coverage comes exclusively out of the employer’s pocket. This is not a scheme to enrich 

insurance companies for those 73 million Americans. 

Senator HATCH. Well, let me interrupt you for a second. Ms. 

Kurtek’s case is the—I would hate to go through what she went 

through. I think anybody sitting and listening to this would just 

hate to have to go through the terrible pain, suffering, amputations, and so forth that she has gone through. Do you see no way 

that her case could be brought under ERISA? 

Mr. ANDERSON. Well, I see a couple things— 

Senator HATCH. Would it be preempted completely under the 

ERISA laws? Or is there some way around the ERISA laws that 

would give her a cause of action? 

Mr. ANDERSON. I think the United States in the—or the Supreme 

Court in the Davila case, which we heard before, unanimously concluded that cases like that should be the sole province of the Federal judiciary, not State law. 

Senator HATCH. Could she have brought her case in the Federal 

judiciary? 

Mr. ANDERSON. She sure could have, and while I am not aware 

of— 

Senator HATCH. Could she—OK. 

Mr. ANDERSON.—her case, there has been a lot of regulatory effort in this area recently by the Department of Labor. The last 5 

or 8 years has seen a huge expansion of the rules associated with 

ERISA claims and appeals in the area of health plans. Had a physician determined that a patient was suffering from some medical 

condition which rises to the level of urgent care, that claim has to 

be heard in 3 days; that appeal has to be heard in 3 days. On the 

seventh day, that individual could make their way to Federal court 

to receive an injunction to receive that benefit. 

I don’t know the particulars of this case. I just want to highlight 

that our Government has been very active in this area, ensuring 

that Americans have quick access to medical care and medical decisions when they are suffering from life-threatening illnesses or diseases. 

Senator HATCH. Could I just ask one more? Then I am going to 

have to leave. 

Senator WHITEHOUSE. Sure. 

Senator HATCH. The Chairman has been very gracious to me. I 

really appreciate it. But I would like to ask just one other question 

of Mr. Cooper, because I am concerned about these two women, and 

others who are like them. I agree the vast majority of cases probably could not be brought. But, Mr. Cooper, you were forthright in 

23 

your testimony acknowledging that no product goes to the market 

absent any risk. And you explained, however, that this risk does 

not emerge through the fault of the FDA or the manufacturer. If 

that is the case, it seems that negligence claims in State court 

might not be the best way to compensate persons injured by properly approved and used products. 

Now, have you given any thought and could you give us the benefit of your thinking here on this Committee to alternative remedies that Congress might pursue to provide compensation to these 

persons? 

Mr. COOPER. I have given it some thought, Senator, and have a 

couple of possible answers. One is a system of compensation quite 

different from most of our compensation system would be a no-fault 

system. We have that, I think, for some childhood vaccines. We 

may have that in some other circumstances. Under traditional tort 

law, the plaintiff has to show that the manufacturer was somehow 

at fault. Either the design, the manufacturing, or the labeling of 

the product had some defect—this is any kind of product, not limited to medical products—or that the manufacturer was negligent. 

That is a kind of fault. 

If the manufacturer was not at fault, then there is no recovery, 

and you could have people who go through these kinds of experiences, and the manufacturer is not at fault. It just happened, because no drug or medical device is perfect. There are always going 

to be some people who will have adverse experiences, and it is nobody’s fault. 

My father died in surgery or as a result of surgery, shortly after 

surgery. Something went wrong in the surgery. But it was not clear 

that anybody was at fault. So there was no lawsuit. That happens 

in life. And if you do not have a no-fault system, then you need a 

network or set of networks for insurance, for health insurance, for 

disability insurance, for life insurance, to cover the bad things that 

can happen to people. You need a social safety net, because, if you 

put it all on the manufacturer, then you are going to drive the 

prices of goods way up. 

Senator HATCH. Well, I apologize to you other two professors 

for—I have a couple questions I would like to ask both of you, and 

I appreciate the testimony you have given as well. This has been 

an extremely interesting hearing to me and one that causes me 

great concern on both sides of the equation. And I can easily see 

why this is—having worked on both of these laws, trying to get 

them right, we had to balance a lot of interests. There is no question about it. And we have an illustration here of where, you know, 

I wish we could have done a better job of solving these things. But, 

on the other hand, our current tort system does not solve a lot of 

things either. 

Thank you, Mr. Chairman. You were very gracious to allow me 

to ask these extra questions. 

Senator WHITEHOUSE. It is my pleasure. As the audience well 

knows, the distinguished Senator from Utah is a former Chairman 

of this Committee who served with great distinction. He is one of 

the leading trial lawyers in the history of Utah, and his thoughts 

and observations are most welcome. And I was very pleased to lisVerDate Aug 31 2005 11:24 Sep 30, 2008 Jkt 044331 PO 00000 Frm 00027 Fmt 6633 Sfmt 6633 S:\GPO\HEARINGS\44331.TXT SJUD1 PsN: CMORC
24 

ten and have you take the time that you needed, Senator, since 

there was nobody else competing for our attention here. 

Senator HATCH. If you would yield for just one further comment, 

I agree with Mr. Cooper that the FDA—I agree with Senator Specter that the FDA needs more money, that we really treat it like a 

wicked stepsister rather than doing what we should when it handles up to 25 percent of all consumer products in America. But I 

also agree with you, Mr. Cooper, that the FDA is very diligent and 

has the capacity and the ability to do the work in this area in an 

extremely refined and good manner. And I do not particularly go 

along with people who do not believe the FDA can do a high-quality job. I know it can, and especially if we get that—you know, I 

passed the FDA Revitalization Act back in 1992 to build the plaza 

out there, to get everything under one roof with the highest ability 

computer-wise and every other scientific instrumentation-wise so 

that we would attract the top people there. And we are gradually 

getting there, but we are still—now, that was in 1992, and we are 

still only beginning getting that whole White Oak plaza going. But 

I really appreciate people like you who have served so long and 

hard in these areas. 

Mr. COOPER. If I may just say, Senator, your work on FDA matters has been a very important contributor to such success as the 

agency has had. 

Senator HATCH. Thank you. 

Mr. COOPER. That should be acknowledged. 

Senator HATCH. Thank you. 

Senator WHITEHOUSE. I would like to start on a historical note, 

because the question of the role of the common law in this country 

is at issue when Federal administrative regulatory preemption is 

the topic, and so is the role of the American jury system. And I 

know that there are people who could go on at considerable and exhaustive length about this, and I am not inviting that at this late 

stage in the hearing. But I do think it is important that the hearing should in some fashion reflect the importance to the founders 

of this country of the American common law and of the American 

jury system. 

If you read from the Revolutionary Era of the various principles 

that America was fighting for, if you would ask any of the Founding Fathers to put together a top-ten list of the principles that they 

were willing to put their lives, their reputations, and their sacred 

honor—their lives, their fortunes, and their sacred honor on the 

line for, I suspect every single one of them would have had the 

common law and the jury system in that top-ten list. And I am not, 

however, a professor so, if I may, I will turn to Professor McGarity 

and Professor Lawless to see if they have an observation along 

those—in that context. 

Mr. MCGARITY. Well, I think you are absolutely right that the 

common law jury is written into the Seventh Amendment of the 

United States Constitution in civil cases, not just in criminal cases, 

and most State Constitutions recognize a right for a jury. So, yes, 

absolutely. And we trust juries. And the fact of the matter is the 

jury has been over the last 15 or 20 years severely maligned and, 

in my view, quite inappropriately so, too, usually through anecVerDate Aug 31 2005 11:24 Sep 30, 2008 Jkt 044331 PO 00000 Frm 00028 Fmt 6633 Sfmt 6633 S:\GPO\HEARINGS\44331.TXT SJUD1 PsN: CMORC
25 

dotes, like the McDonald’s case and things like that that just get 

repeated over and over and over again— 

Senator WHITEHOUSE. Often with critical relevant facts omitted. 

Mr. MCGARITY. That is right, omitting the fact that she was not 

in the car as it was driving down the street, that she was sitting 

in a parked car, and lots of other things. And the fact of the matter 

is, if you look at the objective evidence, that is, collected data on 

juries, one they do not vary that much from judges in their decisions on the merits. So there are very few instances of juries off 

the reservation, so to speak. And if they do go off the reservation, 

the judges can correct that by various procedural devices that are 

available. 

They tend to view plaintiffs quite skeptically these days—in fact, 

more skeptically these days than judges do, no doubt in part due 

to the advertisements that they have been hearing about all the 

abuse of the common law system that they get on their daily TVs. 

But the fact of the matter is the jury is a profoundly democratic 

institution. I, unfortunately, have never served on one because I always get excluded. I always go down and try. But my wife has 

served on them, and she was most impressed with the seriousness 

with which they take their job. 

Senator WHITEHOUSE. Well, as somebody who has been a lawyer 

through a significant portion of his life, I have developed a very 

strong confidence in the American trial jury as a collective group 

to sift through facts and legal arguments and come to, almost every 

time, a very fair and correct decision. But in addition to that, I 

think there is another point that is worth exploring a little bit, and 

that is that, again, those Founding Fathers who set up this country 

were keenly interested in the abuse of power. And they were keenly interested in the passions of politicians and containing them. 

They were keenly interested in trying to diffuse political power in 

such a way that Americans essentially were safe from their Government. 

I see the common law backdrop that they fought for and the jury 

system that they fought for as a part of that system of checks and 

balances. And a word that has not yet been mentioned, or at least 

I did not notice it if it was—I apologize—is ‘‘regulatory capture.’’ 

And I would like to talk about that just for a minute and ask for 

your thoughts. For people who are listening, to me, anyway, regulatory capture means when an agency that purports to be a public 

agency representing the general public in fact gets taken over politically by the organizations that it was designed to regulate. It is 

a widely known phenomenon through administrative law particularly because it is a little bit more under the radar then. And it 

strikes me that if you are doing your best to deprecate and to diminish the jury system, and if you are doing your best to eliminate 

the common law, and if you are doing your best to set as much 

power as you possibly can in the hands of an administrative agency 

that is not elected but is appointed by political actors, you are creating a very grave risk. And, indeed, it strikes me that special interests would be particularly encouraged to focus the full force and 

might of their political and economic strength on administrative 

agencies that enjoy preemptive authority, because they know that 

if they can capture that regulatory agency, they have won the day. 

26 

The prize is a tantalizing one: no more juries, no more liability, no 

more State regulation, no more accountability to the law, just a 

regulatory agency that you now own. 

And it is a horrible thing for the general American public, but 

from a highly self-interested point of view, there can almost be no 

greater prize for a special interest than to own or control or dictate 

terms to its regulatory agency. And that prize is even more valued 

and the risk of that happened I would think goes up even more 

once you have put all the eggs in that basket. 

Mr. LAWLESS. I completely agree with that, Senator. What we 

are talking about, the modern administrative state was unknown 

to the Founders, but you are absolutely right about their genius in 

that they set up checks and balances that are still with us today— 

Senator WHITEHOUSE. I am afraid—I am sorry. I have to interrupt this hearing. Certain checks and balances have just been deployed in the U.S. Senate. This hearing has gone beyond 2 hours. 

There is a rule that requires hearings to conclude within 2 hours 

unless unanimous consent, which is ordinarily provided as a matter 

of courtesy and formula, is given. A Republican Senator has invoked the 2-hour rule, which means that this Committee hearing 

cannot take place for more than 2 hours after the Senate was 

called into session, and the Senate was called into session at 9:30 

this morning. It is now just after 11:30. 

I regret that this tactic has been deployed again. It was done yesterday when a Committee was exploring questions of torture and 

of abusive interrogation techniques. It has now been employed 

here. But the hearing must be suspended due to an objection of an 

unnamed Republican Senator. 

This is an important hearing. I thank the witnesses for their testimony. I particularly thank Ms. Robb and Ms. Kurtek for this testimony. And I consider it an embarrassment on the part of my institution that after the effort that you have taken to come here 

today and after the nature of the testimony that you have given 

that we should be put in this position and obliged to interrupt the 

hearing. So on behalf of the U.S. Senate, I apologize to you. 

The hearing is now recessed. 

[Whereupon, at 11:33 a.m., the Committee was adjourned.] 

[Questions and answers and submissions for the record follow.] 

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