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It may be a matter of State's rights, particular as to your intervention in an individual case, and then, seemingly, to be in a contradictory position with some of the previous actions of other members of the Department of Justice, in saying that you should not be intervening in tort claim actions.

Now one of the most fundamental problems I have with the recommendations of the administration, and the provisions of this bill, is that it would place an arbitrary cap on the amount a person could recover for pain and suffering, no matter how severe the injury.

As I understand, you support this bill with a cap of $100,000. As a practical matter, that puts a cap of $250,000 on recovery for pain and suffering. Now in my own State of Ohio, there is a little boy by the name of Tyler White. My guess is that Tyler White is probably about the age of one of your children at the moment.

This is Tyler White's picture. Tyler White was given an injection of DPT vaccine. Today, as a result, he is severely and permanently retarded. He is 4 years old now. He has to be restrained by an attendant who has to be with him so he does not injure himself.

He has to wear a protective helmet over his little head. He sleeps in an enclosed crib and may always have to do that. He has severe autistic symptoms. He does not recognize his own family, his parents, his brothers, or his sisters.

Tyler White will never read or write. He will never have a job. A jury in a State court case awarded Tyler $2.1 million, the jury did not say how much was for pain and suffering, but persons knowledgeable about the case say it is a major portion of the award. Under your proposal, and with your support, this little boy would receive about $4 a day as compensation for the terrible suffering, based on a normal life expectancy. Under this bill, he would receive about $10 a day for pain and suffering. Do you really think that that is fair?

Do you really think that that is a fair amount of compensation and that we in the Federal Government ought to stick our nose in and say what the amount should be for the pain and suffering of this little child, who will never have a normal life?

Do you think that, Mr. Willard? Mr. WILLARD. Senator, our proposal does not place any limit at all on what can be recovered for medical treatment, rehabilitation; therapy, loss of income, or any other economically ascertainable element of damages.

We do suggest that there should be some limit on the amount awarded for pain and suffering in these cases because that is an intangible award that is not subject to any kind of objective proof.

In one case a jury might award $50,000; in another case a jury might award $5 or $10 million for essentially the same injury.

This unpredictability produces a sort of lottery-like aspect to our civil justice system, in which the amount of money people receive depends upon the way their case is presented emotionally to a jury and what a jury happens to do in a case.

Senator METZENBAUM. This is an administration that prides itself on keeping the Federal Government's nose out of the individual's rights. How can this administration say that this little boy ought to get either $4 or $10, and take away that right from the jury?

Where do you get the prerogative to say this is the right amount? Would it be the right amount for your child, or my child, or my grandchild? You know very well it would not be the right amount.

But you have the audacity to come in here and support a bill, throwing a picayune amount of money at some suffering child or some suffering adult.

I admit there is a problem. I recognize there is a problem, but all you want to do is put the total burden on the injured child, or the injured individual. I just wonder, where do you get that authority? What makes you feel that you are so right, that you are smarter than the jury? That you have the right, from an autocratic standpoint, to say, “This is the amount,” that a child, or an individual, ought to receive for their pain and suffering.

Where does it come from? What makes you think you are so right about that?

Mr. WILLARD. Senator, the Constitution authorizes Congress to regulate interstate commerce. The administration's Tort Policy Working Group found that product liability law was having a significant impact on interstate commerce.

Senator METZENBAUM. Your study group was loaded to begin with.

Mr. WILLARD. In the area of vaccines, in particular, we did look at the effect of liability awards on the availability of vaccines such as the DPT vaccine.

We found that many of the companies that had formerly made this vaccine had stopped doing so because of the high cost of liability.

At a couple of points in the last 2 years we were down to one company in the entire country making the vaccine. Officials at the Department of Health and Human Services were concerned that there would be a serious health problem in our country because of excessive liability, if this vaccine were not manufactured by anyone and not available for children.

The DPT vaccine has saved many thousands of children's lives by preventing them from contracting pertussis or whooping cough. That is a very substantial benefit to public health that is endangered by the liability system.

Senator METZENBAUM. I agree with you, that withdrawing vaccine manufacture from the marketplace would indeed be a problem. But is the only solution to that problem to take away the rights of those who are injured, to obtain fair redress in the courts? Is that the only solution you can think of? Is that all the innovative thinkers in this administration can come up with?

Mr. WILLARD. Senator, the question is whether or not the vaccine that is currently being made is a defective vaccine.

Senator METZENBAUM. That is not for you to decide. The jury has decided that in the cases. That is not for you to decide. You do not have that information. You do not have that intelligence to be able to say if it is defective. The jury has said it is and who are you to say it is not?

Mr. WILLARD. Well, Senator, the Food and Drug Administration has only approved one vaccine to use for pertussis, and that is the one that was made, and was challenged in this litigation.

If juries find that the one vaccine that the FDA is willing to approve as safe and effective creates excessive liability for the vaccine's manufacturer, then there will not be any vaccines available for DTP.

Senator METZENBAUM. That is correct. But is the only way you can solve the problem to take away the right of the plaintiff, or the injured child, to recover? Mr. WILLARD. Senator, in our

Senator METZENBAUM. Is that the only solution you can think up?

Mr. WILLARD. In our view, the role of the tort system is to allow recovery where there has been some wrongful conduct on the part of the defendant, where they have made a defective or unsafe product. The role of the tort system is not to provide compensation for all of the injuries or illnesses that occur in our society.

The Consumer Federation of America estimated, for example, that there are about 30 million product-related injuries in America every year. Yet, of this amount, there are only about 70,000 product liability lawsuits.

So our tort system does not now, nor properly should it ever, serve as a basis to compensate everyone who is injured in connection with a product.

Senator METZENBAUM. It does not. Many cases are lost. As a matter of fact, according to an article in Business Week, in a nation of 240 million people, there have only been 1,642 awards of $1 million, or more, in the last 14 years.

And what about the gleeful winners? According to the jury verdict-and this is from the article in Business Week

And how about the gleeful winners? According to Jury Verdict Research, Inc., the Ohio concern that tracks big awards, they were hardly in shape to enjoy the spoils. In more than two-thirds of the cases they suffered permanent paralysis, brain damage, amputations, or deaths.

Many of the cases are lost. Many times a jury does not conclude that there should be an award. You only win the case if you can prove fault, and you are saying that there is no fault because the FDA has approved the vaccine, as I understand your testimony. Is that your point?

Mr. WILLARD. It is our position, and the position of the officials of the Food and Drug Administration who are responsible for licensing drugs—that the particular DPT vaccine in question is safe and effective, that it is not a defective drug, and that there is not any other vaccine currently available on the market that is approved for use.

Senator METZENBAUM. You think therefore, that because they concluded it, that the jury and the judge, who came to a contrary conclusion, should be overriden by the Congress? Is that your point?

Mr. WILLARD. In our view, any determination of a defect in a case like that would be wrong. Part of the problem with the system, though, is that in many States, the trend has not been towards requiring a showing of fault but rather toward a de facto sort of no-fault liability.

Senator METZENBAUM. Res ipse loquitur. You learned about that in college. The thing speaks for itself. And is that what you are saying the theory is in some cases.

Mr. WILLARD. Well, it has actually been an extension of strict liability doctrine to create a kind of an absolute liability.

Senator METZENBAUM. Mr. Willard, your division has decided to get involved in the Tyler White case that I described. The Department filed a request with the court to delay the case, so the Department could decide if it wanted to argue against the award.

The Department filed a statement saying it is considering the filing of an amicus curiae brief in support of the Appellant who in this case is the company that made the vaccine.

As far as I know, this is the only time the Department of Justice has seen fit to meddle in a State court civil case, to try to overturn a jury award in a personal injury case.

In my opinion, I would guess that the Department of Justice has plenty of things to do with the taxpayers' money besides interfere in a State court case, to try to argue against an award in a case such as this.

Can you give me any other examples, where the Department tried to get involved, or has become involved in a State personal injury case, after the jury had made an award to someone who was severely injured? Have you done that before?

Mr. WILLARD. Yes, Senator. We did it last year in a case in Kansas in which a jury had awarded $10 million in damages, $8 million of it punitive damages, against the manufacturer of the oral polio vaccine. The award was based, on the theory that they should have used the old Salk vaccine instead of the newer Sabin vaccine. It was argued that the Sabin vaccine was defective. We filed a friend of the court brief with the Kansas Supreme Court on behalf of the Food and Drug Administration, pointing out, that as a matter of Federal health policy, the Sabin vaccine had been determined to be more effective in preventing polio.

Recently, by a four to three vote, the Kansas Supreme Court overturned a lower court's award of damages in that case.

I regard that as being similar to the case you have referred to involving the DPT vaccine.

Senator METZENBAUM. And S. 2760. Well, that is the only time. Before this administration, did the Federal Government ever get involved in a State court case after an award had been made?

That was last year you got involved in the Kansas case. What about before that? In other words, is this a new incursion by the Federal Government into State's rights issues, by giving the State the right to decide the amount of a jury verdict?

Now this is the administration which prides itself upon recognizing State's rights. Has that occurred in previous years? I do not know of it; maybe you do.

Mr. WILLARD. We frequently participate as a friend of the court in State court proceedings of various kinds. Obviously-

Senator METZENBAUM. I am not talking about that. I am not talking about that. I am talking about personal injury cases. Before this administration came into office, has there ever been a case where the Federal Government came in and said a jury verdict is too high?

Mr. WILLARD. I do not know, Senator. I was not here then.

Senator METZENBAUM. Well, you would know by the record of the Department. I mean, you are not going to tell me that you only know the things that have occurred while you have been in office.

You know the record of the Department. I am sure somebody has told you that it has, or has never happened before, and that this is precedent making?

Mr. WILLARD. I do not know whether it has or has not happened before, Senator.

Senator METZENBAUM. Do you find it at all uncomfortable, that under your leadership, the Department refused to prosecute in a case that you and I have discussed before? I think it was the company that manufactured vaccines. Baby formula. You refused to prosecute the baby formula manufacturer even though the Food and Drug Administration about which you spoke so highly of a couple of moments ago, asked you to prosecute, and you, Mr. Willard, decided not to prosecute and drop the case. I think you gave them some very small fine. Does this give you any kind of a message? The kind of message that I talked with you about in my office, when I was concerned as to what kind of leadership you would provide in this role, and what kind of human being you are, in order to always wind up on the side of the pharmaceutical companies, and never on the side of those who have children?

Mr. WILLARD. Senator, your request in that particular matter is now under review and I am not in a position to comment on it.

Senator METZENBAUM. What particular matter? You mean my request with reference to going forward with prosecution in that case?

Has not the statute expired in that case?

Mr. WILLARD. Senator, as you may recall, you wrote, asking for further review of that case, and the matter is now under review in the Department.

Senator METZENBAUM. When may I expect an answer?
Mr. WILLARD. I do not know.
Senator METZENBAUM. How long ago did I write to you?
Mr. WILLARD. Several months ago.
Senator METZENBAUM. Taking a long time to review?

Mr. WILLARD. The review is not being conducted in my office, Senator.

Senator METZENBAUM. Let me go a little bit further with you on this matter. S. 2760 allows manufacturers of drugs and medical devices to escape punitive damages, altogether, if they receive premarket approval from FDA.

To my knowledge, this defense for compliance with government standards is not the rule under any State tort law. How will this rule affect victims of medical devices such as the artificial heart valve manufactured by Shilies, Inc., a California corporation?

Over 120 people have died after their valves failed. There were recalls of valves because of structural weaknesses and we have not succeeded in getting all faulty valves off the market.

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