<DOC> [110 Senate Hearings] [From the U.S. Government Printing Office via GPO Access] [DOCID: f:44331.wais] S. Hrg. 110-497 SHORT-CHANGE FOR CONSUMERS AND SHORT-SHRIFT 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 U.S. GOVERNMENT PRINTING OFFICE 44-331 PDF WASHINGTON DC: 2008 --------------------------------------------------------------------- For Sale by the Superintendent of Documents, U.S. Government Printing Office Internet: bookstore.gpo.gov Phone: toll free (866) 512-1800; (202) 512ÿ091800 Fax: (202) 512ÿ092104 Mail: Stop IDCC, Washington, DC 20402ÿ090001 COMMITTEE ON THE JUDICIARY PATRICK J. LEAHY, Vermont, Chairman EDWARD M. KENNEDY, Massachusetts ARLEN SPECTER, Pennsylvania JOSEPH R. BIDEN, Jr., Delaware ORRIN G. HATCH, Utah HERB KOHL, Wisconsin CHARLES E. GRASSLEY, Iowa DIANNE FEINSTEIN, California JON KYL, Arizona RUSSELL D. FEINGOLD, Wisconsin JEFF SESSIONS, Alabama CHARLES E. SCHUMER, New York LINDSEY O. GRAHAM, South Carolina RICHARD J. DURBIN, Illinois JOHN CORNYN, Texas BENJAMIN L. CARDIN, Maryland SAM BROWNBACK, Kansas SHELDON WHITEHOUSE, Rhode Island TOM COBURN, Oklahoma Bruce A. Cohen, Chief Counsel and Staff Director Stephanie A. Middleton, Republican Staff Director Nicholas A. Rossi, Republican Chief Counsel 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 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, despite 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 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. 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 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 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 repeatedly shot at my chest at close range. Along with these recurrent shocks was a strong electrical current racing through my body. After feeling the first shock, I immediately phoned 911 for help. My 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. 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. 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.'' 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 multi-employer 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 Welfare 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 voluntary 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 interest 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. [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 requirements, 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, 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. 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 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 penalties 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. 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. 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 employer-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 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 listen 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 anecdotes, 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. 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.] [GRAPHIC] [TIFF OMITTED] T4331.111 [GRAPHIC] [TIFF OMITTED] T4331.002 [GRAPHIC] [TIFF OMITTED] T4331.003 [GRAPHIC] [TIFF OMITTED] T4331.004 [GRAPHIC] [TIFF OMITTED] T4331.005 [GRAPHIC] [TIFF OMITTED] T4331.006 [GRAPHIC] [TIFF OMITTED] T4331.007 [GRAPHIC] [TIFF OMITTED] T4331.008 [GRAPHIC] [TIFF OMITTED] T4331.009 [GRAPHIC] [TIFF OMITTED] T4331.010 [GRAPHIC] [TIFF OMITTED] T4331.011 [GRAPHIC] [TIFF OMITTED] T4331.012 [GRAPHIC] [TIFF OMITTED] T4331.013 [GRAPHIC] [TIFF OMITTED] T4331.014 [GRAPHIC] [TIFF OMITTED] T4331.015 [GRAPHIC] [TIFF OMITTED] T4331.016 [GRAPHIC] [TIFF OMITTED] T4331.017 [GRAPHIC] [TIFF OMITTED] T4331.018 [GRAPHIC] [TIFF OMITTED] T4331.019 [GRAPHIC] [TIFF OMITTED] T4331.020 [GRAPHIC] [TIFF OMITTED] T4331.021 [GRAPHIC] [TIFF OMITTED] T4331.112 [GRAPHIC] [TIFF OMITTED] T4331.023 [GRAPHIC] [TIFF OMITTED] T4331.024 [GRAPHIC] [TIFF OMITTED] T4331.025 [GRAPHIC] [TIFF OMITTED] T4331.026 [GRAPHIC] [TIFF OMITTED] T4331.028 [GRAPHIC] [TIFF OMITTED] T4331.029 [GRAPHIC] [TIFF OMITTED] T4331.030 [GRAPHIC] [TIFF OMITTED] T4331.031 [GRAPHIC] [TIFF OMITTED] T4331.032 [GRAPHIC] [TIFF OMITTED] T4331.033 [GRAPHIC] [TIFF OMITTED] T4331.034 [GRAPHIC] [TIFF OMITTED] T4331.035 [GRAPHIC] [TIFF OMITTED] T4331.036 [GRAPHIC] [TIFF OMITTED] T4331.037 [GRAPHIC] [TIFF OMITTED] T4331.038 [GRAPHIC] [TIFF OMITTED] T4331.039 [GRAPHIC] [TIFF OMITTED] T4331.040 [GRAPHIC] [TIFF OMITTED] T4331.041 [GRAPHIC] [TIFF OMITTED] T4331.042 [GRAPHIC] [TIFF OMITTED] T4331.043 [GRAPHIC] [TIFF OMITTED] T4331.044 [GRAPHIC] [TIFF OMITTED] T4331.045 [GRAPHIC] [TIFF OMITTED] T4331.046 [GRAPHIC] [TIFF OMITTED] T4331.047 [GRAPHIC] [TIFF OMITTED] T4331.048 [GRAPHIC] [TIFF OMITTED] T4331.049 [GRAPHIC] [TIFF OMITTED] T4331.050 [GRAPHIC] [TIFF OMITTED] T4331.051 [GRAPHIC] [TIFF OMITTED] T4331.052 [GRAPHIC] [TIFF OMITTED] T4331.053 [GRAPHIC] [TIFF OMITTED] T4331.054 [GRAPHIC] [TIFF OMITTED] T4331.055 [GRAPHIC] [TIFF OMITTED] T4331.056 [GRAPHIC] [TIFF OMITTED] T4331.057 [GRAPHIC] [TIFF OMITTED] T4331.058 [GRAPHIC] [TIFF OMITTED] T4331.059 [GRAPHIC] [TIFF OMITTED] T4331.060 [GRAPHIC] [TIFF OMITTED] T4331.061 [GRAPHIC] [TIFF OMITTED] T4331.062 [GRAPHIC] [TIFF OMITTED] T4331.063 [GRAPHIC] [TIFF OMITTED] T4331.064 [GRAPHIC] [TIFF OMITTED] T4331.065 [GRAPHIC] [TIFF OMITTED] T4331.066 [GRAPHIC] [TIFF OMITTED] T4331.067 [GRAPHIC] [TIFF OMITTED] T4331.068 [GRAPHIC] [TIFF OMITTED] T4331.069 [GRAPHIC] [TIFF OMITTED] T4331.070 [GRAPHIC] [TIFF OMITTED] T4331.071 [GRAPHIC] [TIFF OMITTED] T4331.072 [GRAPHIC] [TIFF OMITTED] T4331.073 [GRAPHIC] [TIFF OMITTED] T4331.074 [GRAPHIC] [TIFF OMITTED] T4331.075 [GRAPHIC] [TIFF OMITTED] T4331.076 [GRAPHIC] [TIFF OMITTED] T4331.077 [GRAPHIC] [TIFF OMITTED] T4331.078 [GRAPHIC] [TIFF OMITTED] T4331.079 [GRAPHIC] [TIFF OMITTED] T4331.080 [GRAPHIC] [TIFF OMITTED] T4331.081 [GRAPHIC] [TIFF OMITTED] T4331.082 [GRAPHIC] [TIFF OMITTED] T4331.083 [GRAPHIC] [TIFF OMITTED] T4331.084 [GRAPHIC] [TIFF OMITTED] T4331.085 [GRAPHIC] [TIFF OMITTED] T4331.086 [GRAPHIC] [TIFF OMITTED] T4331.087 [GRAPHIC] [TIFF OMITTED] T4331.088 [GRAPHIC] [TIFF OMITTED] T4331.089 [GRAPHIC] [TIFF OMITTED] T4331.090 [GRAPHIC] [TIFF OMITTED] T4331.091 [GRAPHIC] [TIFF OMITTED] T4331.092 [GRAPHIC] [TIFF OMITTED] T4331.093 [GRAPHIC] [TIFF OMITTED] T4331.094 [GRAPHIC] [TIFF OMITTED] T4331.095 [GRAPHIC] [TIFF OMITTED] T4331.096 [GRAPHIC] [TIFF OMITTED] T4331.097 [GRAPHIC] [TIFF OMITTED] T4331.113 [GRAPHIC] [TIFF OMITTED] T4331.099 [GRAPHIC] [TIFF OMITTED] T4331.114 [GRAPHIC] [TIFF OMITTED] T4331.115 [GRAPHIC] [TIFF OMITTED] T4331.116 [GRAPHIC] [TIFF OMITTED] T4331.103 [GRAPHIC] [TIFF OMITTED] T4331.104 [GRAPHIC] [TIFF OMITTED] T4331.105 [GRAPHIC] [TIFF OMITTED] T4331.106 [GRAPHIC] [TIFF OMITTED] T4331.107 [GRAPHIC] [TIFF OMITTED] T4331.108 [GRAPHIC] [TIFF OMITTED] T4331.109 [GRAPHIC] [TIFF OMITTED] T4331.110 <all>