[Congressional Record Volume 140, Number 85 (Wednesday, June 29, 1994)]
[Senate]
[Page S]
From the Congressional Record Online through the Government Printing Office [www.gpo.gov]


[Congressional Record: June 29, 1994]
From the Congressional Record Online via GPO Access [wais.access.gpo.gov]

 
                     PRODUCT LIABILITY FAIRNESS ACT

  The Senate continued with the consideration of the bill.
  The ACTING PRESIDENT pro tempore. Who yields time?
  Mr. HEFLIN. Parliamentary inquiry; what is the remaining time for 
each side?
  The ACTING PRESIDENT pro tempore. The time remaining to the Senator 
is 9 minutes, I am told.
  Mr. HEFLIN. How much is on the other side?
  The ACTING PRESIDENT pro tempore. They have 18 minutes.
  Mr. HEFLIN. I will yield 3 minutes to the Senator from Iowa [Mr. 
Harkin].
  The ACTING PRESIDENT pro tempore. The Senator from Iowa is recognized 
for 3 minutes.
  Mr. HARKIN. Madam President, I thank the Senator for yielding me the 
3 minutes. I did have a longer statement in opposition to this bill.
  Let me just summarize it very briefly. I will take time, hopefully 
after this next cloture vote at 10 o'clock, to expound more fully upon 
my opposition to the elements that are in this so-called product 
liability reform bill. And I am hopeful, of course, that at 10 o'clock, 
when the vote occurs, we will have sufficient votes to, again, keep the 
debate going.
  For many years, there have been those who want to take away the 
centuries-old protections that the little person has against powerful 
forces. The centuries-old doctrine that people have to act wisely and 
prudently and with due care and concern, and that people will be held 
responsible if they act recklessly and carelessly in their manufacture 
of articles is to be thrown out the window with this bill.
  For years, the proponents, who want to do that, have been saying we 
have not had a chance to debate it. Now we have a chance to debate it. 
Now they want to cut off debate. They want to invoke cloture so those 
of us who have amendments to offer to the bill, and Senator Lautenberg 
and I do have a very meaningful amendment to offer to this bill, will 
be foreclosed from offering those amendments and debating them because 
of the rules under cloture.
  So I find that just one of the double standards that the proponents 
of this bill are using. Because, Madam President, this bill in itself 
sets up a double standard. There is one standard if you are a 
manufacturer, if you are a business concern, a corporation; another 
standard if you are just one of the little people of this country who 
happens to get injured by a product.
  Under this bill, as it is designed right now, let us say an airliner 
crashes and the next of kin sues. There are limits on what that person 
can recover for surviving family members, for example. But let us say 
if it was, to use an example, American Airlines--I hate to pick them 
out; I just picked out an airline--they could go back and sue Boeing 
Aircraft with no limits. So in terms of a business suing another 
business, there are no limits as to what they can sue for in terms of 
product liability. But for the little person, they put the limits on.
  The ACTING PRESIDENT pro tempore. The Senator has spoken for 3 
minutes.
  Mr. HARKIN. That is just one of the double standards in this bill. I 
have several more. I hope after the 10 o'clock vote, I will be able to 
expound more fully on the double standards in this bill.
  The ACTING PRESIDENT pro tempore. Who yields time? The Senator from 
West Virginia.
  Mr. ROCKEFELLER. Madam President, I did not hear entirely the words 
of the Senator from Iowa, but those that I did hear were stunning 
because he indicated that it was the proponents of the bill who were 
trying to stall debate and cause a filibuster.
  Everybody knows and has known from the beginning, and the opponents 
of this bill have made known from the beginning--the Senator from 
Alabama and the Senator from South Carolina have made it clear from the 
beginning--that they were going to filibuster the bill. In fact, we had 
a meeting yesterday in the majority leader's office in which one of the 
Senators on the opponents' side was asked what would they do now that 
we had agreed to try to remove the FDA amendment and the FAA amendment, 
thus taking away many of the issues that women in particular were 
concerned about. The majority leader asked what will this particular 
opponent do? And he said: I will continue to talk.
  This is a classic, absolute, ultimate, total filibuster on the part 
of the opponents. My dear friend from Iowa, whom I am devoted to, made 
one of the most remarkable statements I have ever heard. I hope 
everyone in this body will take some time to think again about the 
question that we have to answer at the cloture vote scheduled for 10 
o'clock. It is really very simple. That is, will we reward 
obstructionism? Or will we not? Obstructionism equals filibuster. 
Filibuster is what this bill has been facing for the last 8 years since 
I have been in the Senate, and 13 years that this bill has been a 
matter of hoped-for discussion.
  This Senator said almost nothing yesterday in the debate because 
there was not any debate. The Senator from Alabama referred to this 
being an extended debate. There has been no debate. There has been no 
debate. The Senator from Washington has not debated. He is a master 
debater. He knows the bill. He has not debated at all. I have not 
debated. I have said almost nothing. The Senator from Connecticut has 
debated hardly at all. He simply has made some points about the bill. 
And the reason is because there is a filibuster against this bill.

  The question is, Will the Senate be able after 13 years to understand 
that this is a filibuster that we are trying to vote down so that we 
can get to the bill to discuss amendments which might improve the bill 
and defeat amendments which would hurt the bill, where the Senator from 
Connecticut and this Senator, and the Senator from Washington would be 
very helpful?
  The question in this vote is not whether to say a flat yes or a flat 
no to the bill before us today, which is the Product Liability Fairness 
Act. That can only be answered if and when the Senate can undergo an 
open, straightforward process in which any of our colleagues can offer 
suggestions on a way to improve the legislation. We are not at the 
point of even putting amendments to the bill. Even the FDA amendment, 
which is cared about so strongly by so many, cannot be removed until we 
obtain cloture. So I just hope that my colleagues really do understand 
our situation.
  To be clear about the situation we are in right now, the chief 
sponsors of this bill realized in the course of yesterday's debate on 
this bill that the prevailing sentiment on one of the provisions known 
as the FDA-FAA section, section 203, was that it would be deleted from 
the bill. We acknowledged the view--those of us who support the bill--
and the reasons that those views are felt so strongly. As a result, we 
entered into discussions with our colleagues, the distinguished Senator 
from North Dakota and the distinguished Senator from Illinois, who have 
led the effort steadily, stoutly, steadfastly and with great value to 
remove this section from the bill.
  When we, the sponsors, decided we should support that change, we 
worked out an understanding that we would support their motion to 
strike FDA and FAA. But, once again, we were thwarted even on yesterday 
and prevented from making the change to the bill pending before us 
until we came to another cloture vote, which ripens at 10 o'clock. We 
could not even debate the bill yesterday.
  Mr. DORGAN. Will the Senator yield?
  Mr. ROCKEFELLER. I yield to the Senator from North Dakota.
  Mr. DORGAN. Madam President, I appreciate the Senator yielding for a 
comment and a question. As I understand the position of the Senate at 
this point, we are discussing the amendment which I offered last 
evening, along with my colleague, Senator Moseley-Braun. That is the 
business before the Senate at this point, and the Senate is scheduled 
to take a cloture vote at 10 a.m.; am I correct, Madam President?
  The ACTING PRESIDENT pro tempore. The Senator is correct.
  Mr. DORGAN. Let me just make a couple of additional points--if the 
Senator will continue to yield--about this amendment. It was November 
when this piece of legislation moved through the Commerce Committee. 
That is some long while ago. When it did, the day it moved through the 
Commerce Committee, I spoke to the Senator from West Virginia and told 
him then that I would not support this piece of legislation on the 
floor, with section 203 as drafted in it.
  I felt very strongly, as I do now, about saying to someone we are 
going to set up a new shield and a new test, if you are, God forbid, 
injured somehow by a medical device or a pharmaceutical drug, and you 
seek compensation for that because you believe someone else was 
responsible--in this case the manufacturer of the device or drug--and 
you file a suit under this legislation as it is currently written, the 
response is, ``Well, the FDA approved it. We have no further liability 
here.''
  I could give you a notebook full of cases where the FDA has approved 
a drug or medical device that was later found to be defective or 
faulty. We ought not injure the rights of individuals in this country 
with a new shield and a new protection for manufacturers. This bill 
says we are going to increase the height of the bar now and requires 
victims to prove fraud and misinformation has occurred by the 
manufacturer with respect to FDA approval or the FAA approval. That 
makes no sense to me. My position remains that I will not support this 
legislation with this section in it.
  I inquire of the Senator from West Virginia. We are in a catch-22 
position now. I have offered an amendment to strip this section of the 
bill, a section that I think is a terrible section. The amendment 
apparently is not to be acted on before 10 o'clock. I would ask 
unanimous consent, but I will not because I understand it has already 
been requested, that we hold the vote on this amendment before the 
cloture vote. My understanding is that has been requested and there was 
an objection.
  The ACTING PRESIDENT pro tempore. That is correct.
  Mr. DORGAN. It really does no good to repeat that. My point is, we 
have an amendment that, as I understand, the manager of the bill and 
the ranking member have said they will accept.
  Mr. GORTON. That is correct.
  Mr. DORGAN. So as this bill advances, if it advances, they will 
accept stripping section 203 from the bill and the bill will advance 
without this section in it.
  Mr. GORTON. The Senator from North Dakota is correct.
  Mr. DORGAN. My preference would, obviously, be that we dispose of 
this amendment before the cloture vote. I understand the legislative 
procedure that we now follow and the cloture vote is going to occur at 
10 and we are not able to dispose of this.
  But I want to be certain of the discussion we had yesterday that the 
manager and the ranking member understand what I understand: That if 
this bill advances, that this bill will advance with a legislative 
provision that will strike section 203 because this amendment that I 
have offered is germane, so it will exist even after cloture and must 
be disposed of by the Senate.
  My understanding is if the bill advances and if we dispose of this 
legislation that the ranking member and the manager of the bill are 
going to be supporting the striking of section 203.
  Mr. GORTON. If the Senator will yield, the Senator's amendment 
strikes sections 203 (b) and (c) of the amendment and not only the 
Senator from West Virginia and I----
  Mr. ROCKEFELLER. I have yielded to the Senator.
  Mr. GORTON. We will support that amendment, but I have undertaken to 
persuade members on this side who will agree with me to do so as well. 
I think I can say with confidence that the amendment will be 
successful.
  The ACTING PRESIDENT pro tempore. Senator Rockefeller is controlling 
the floor at this moment. He is recognized.
  Mr. ROCKEFELLER. I thank the Senator from North Dakota. I would like 
to make a point that the majority leader, Senator Mitchell, 
acknowledged on Friday--this is in the Congressional Record--that the 
proponents of the bill were asked to file the cloture motion because of 
the certainty that the bill would be filibustered. That is what the 
majority leader said.
  So for my colleagues who are listening and to their associates 
throughout this and other buildings, let me reiterate that this bill 
would reduce the average 5 years that a person waits to get compensated 
for a crippling injury of some sort. We are trying to reduce that, we 
are trying to help the victims and take some of the money away from the 
lawyers to give it to the victims, and we are being filibustered.
  In any event, I would like at this point to yield 2 minutes to the 
Senator from Pennsylvania.
  The ACTING PRESIDENT pro tempore. The Senator from Pennsylvania is 
recognized for 2 minutes.
  Mr. SPECTER. Madam President, I thank my colleague from West 
Virginia.
  I believe that the filibuster should be very, very sparingly used. In 
a democracy, we function on 51 percent or a simple majority. But as we 
all know, some may not understand watching on C-SPAN or in the 
galleries, where there is a filibuster in the U.S. Senate, it requires 
60 votes to shut off debate to move ahead to consideration of the 
merits of legislation.
  I believe that a filibuster ought to be very, very sparingly used on 
major policy matters and constitutional issues to protect the rights of 
the minority from an unfair majority.
  I believe on the current face of this bill with a commitment by the 
managers to eliminate the provisions restricting punitive damages from 
the Food and Drug Administration and the Federal Aviation 
Administration, that we ought to proceed to consider the bill.
  I voted against cloture yesterday to continue the debate because I 
thought it was important that those provisions be removed.
  I wish to say that I have some substantial reluctance to see 
legislation in any area which involves case law determination where the 
courts for decades and really centuries have in a form of incrustation 
made decisions in an area like product liability. I have litigated in 
the field and have had occasion to read extensively in the field. There 
is a wisdom, a common law wisdom, which comes from the judicial process 
that really cannot be matched by what we do in the legislature. In 
Congress, where we have bills and hearings and markups, very frequently 
only a Senator or two at the hearings, which is a very difficult 
process to have the kind of analysis which the courts have rendered.
  I have great reservations about the underlying bill. I make no 
commitment how I am going to vote on the underlying bill. I have filed 
a series of amendments.
  I am very concerned about the provisions with respect to workman's 
comp and subrogation interests, very concerned especially in the area 
of catastrophic injury and to the joint and several liability issue. I 
have had some indications from the managers of a willingness to 
consider my amendments. But I think in this posture on this matter we 
ought not to require 60 votes but ought to go back to the democratic 
process of 51 votes. With the managers' assurances that these 
provisions as to punitive damages will be removed, I intend to support 
the cloture motion.
  The ACTING PRESIDENT pro tempore. The Senator's time has expired.
  Who yields time? The Senator from West Virginia.
  Mr. ROCKEFELLER. I yield to the Senator from Connecticut--how much 
time do the proponents have?
  The ACTING PRESIDENT pro tempore. Four minutes.
  Mr. ROCKEFELLER. Two minutes.
  Mr. LIEBERMAN. Fine.
  The ACTING PRESIDENT pro tempore. The Senator from Connecticut is 
recognized for 2 minutes.
  Mr. LIEBERMAN. I thank the Chair and I thank my colleague.
  Madam President, one of the most ill-understood aspects of our 
product liability system is how it affects the international 
competitiveness of our American manufacturing companies. I want to set 
aside, for a moment, the effect on innovation, and just focus on how 
our product liability system, which is uniquely generous, affects U.S. 
manufacturers simply with respect to sales of existing products.
  It is often argued by opponents of this bill that our product 
liability laws cannot be a competitive disadvantage to U.S. firms 
because, in this country, all competitors here are subject to our laws, 
and abroad, all competitors are subject to foreign laws. The problem 
with this argument is that it is not true. The underlying assumption of 
a level playing field in each market is false.
  As Prof. Aaron Twerski, one of the Nation's premier scholars in tort 
law, told the Senate Commerce Committee, under so-called modern or 
interest analysis choice of law doctrines, a U.S. manufacturer can be 
sued in the United States, under U.S. laws, for injuries resulting from 
a product manufactured here, even if the product was sold abroad in a 
foreign country and the person injured was a foreign citizen in that 
country. As Professor Twerski testified, ``U.S. manufacturers may be 
held to higher and more costly product liability standards in both U.S. 
and foreign markets than their foreign counterparts.'' Obviously, this 
puts U.S. companies at a cost disadvantage when selling in foreign 
markets since they will have to insure against the possibility of 
lawsuits brought by foreign purchasers in U.S. courts, while foreign 
competitors do not have to bear similar insurance costs with respect to 
sales in that country.
  In addition, it is simply much harder to take discovery--and hence to 
obtain a successful judgment--against a foreign manufacturer. While a 
U.S. court can obtain documents and testimony easily from a U.S.-based 
manufacturer, discovery procedures in foreign countries are much more 
limited, and usually involve replies to written interrogatories. 
Ironically, the less U.S. presence a foreign manufacturer has, the 
easier it will be to shield its documents.
  The same can be said when it comes time to enforce judgments. In the 
United States, a U.S. claimant can obtain a judgment against a U.S. 
company simply by getting a court order. The court can even order 
seizure of assets to enforce payment. U.S. claimants and courts do not 
have similar tools available against the assets of foreign 
manufacturers abroad. Foreign courts can refuse to honor U.S. judgments 
by finding that the U.S. court lacked jurisdiction or that insufficient 
evidence existed to support the judgment. The practical expense of 
hiring a foreign lawyer to attempt to collect a U.S. judgment further 
frustrates collection. This gives foreign manufacturers a real 
advantage vis-a-vis U.S. manufacturers when it comes to avoiding 
collection of tort damages.
  Our tort liability system has had one other impact on the ability of 
claimants to collect judgments from foreign manufacturers. Professor 
Twerski told the Commerce Committee that the United States has been 
unable to get foreign countries to agree to a treaty to enforce 
American judgments abroad because of foreign countries' low regard for 
U.S. tort judgments, which they view as out of control. Ironically, our 
supposedly proplaintiff system may actually be hurting claimants when 
it comes to suing and collecting from foreign companies.
  One other point needs to be made. When our product liability system 
drives manufacturing offshore or even into thinly capitalized U.S. 
based companies, claimants do not necessarily come out ahead. The risk 
of covering the cost of an injury will be transferred from the 
manufacturers to the purchasers in both settings, either because the 
assets of the foreign manufacturer are not subject to U.S. jurisdiction 
or because the thinly capitalized company seeks protection in 
bankruptcy. Either way, all our product liability system has 
accomplished in that setting is to reduce the amount of compensation 
available to injured claimants. That can hardly be considered a pro-
consumer result.
  Passage of S. 687 would help to mitigate these disadvantages for 
American companies and American consumers. A fair and balanced product 
liability system is in the best interests of all Americans.
  Madam President, we are coming again to one of those moments of truth 
which test not only the issue at hand but the openness and fairness of 
this body. The fact is we saw it last year in this Chamber and we saw 
it again yesterday. The majority of Members of the Senate want to 
reform the product liability laws of our country. They understand that 
too many consumers are not treated fairly under these laws. They have 
to wait too long; that if their injuries are small, they tend to be 
overcompensated because of the pressures in the system to settle. If 
their injuries are large, they are too often undercompensated; that the 
current system eats away at our competitiveness and our manufacturing 
base and the creation of jobs.
  We can disagree or argue about the particular remedies, but a clear 
majority of the Senate wants to reform our product liability laws. The 
question that we are going to answer at 10 o'clock in this cloture vote 
is whether we are going to give that majority the opportunity to work 
together and do just that. It has consequences for people's lives, 
people's jobs and the future of our economy.
  Second, we are in a posture now that I think suggests the 
difficulties and unreasonableness. The sponsors of this bill have tried 
to be fair every inch of the way, and yesterday as the vote went on and 
as we heard from our colleagues and we listened to them, we understood 
that there is substantial opposition to section 203. Senator Dorgan has 
a motion to strike. We wanted it voted on.
  The ACTING PRESIDENT pro tempore. The Senator's time has expired.
  Mr. LIEBERMAN. I ask my colleague for an additional 30 seconds.
  The ACTING PRESIDENT pro tempore. The Senator from Connecticut has 
asked for an additional 30 seconds.
  Mr. ROCKEFELLER. The Senator has that time.
  Mr. LIEBERMAN. I thank the Senator.
  Senator Dorgan's motion to strike, to take this objectionable 
provision out of the bill, is before us. All of us who are sponsors 
support that motion. We are trying to be reasonable, and yet those who 
oppose the bill are blocking a vote before 10 o'clock because they 
think in that way some who want this section out of the bill will not 
vote for cloture. I say to my friends, if cloture is adopted, the 
pending issue will be the motion to strike 203 and we will adopt it, so 
please vote for cloture.
  I thank the Chair.
  The ACTING PRESIDENT pro tempore. Who yields time?
  Mr. ROCKEFELLER. I yield the remainder of the proponents' time to the 
Senator from the State of Washington.
  The ACTING PRESIDENT pro tempore. The Senator from Washington is 
recognized.
  Mr. GORTON. Madam President, the vote we are about to take is the 
crucial vote on product liability for this Congress. The product 
liability bill which would very likely be passed if cloture is invoked 
is certainly not all this Senator would have liked, but he and others 
have given their assurances of support for the motion to strike and 
those assurances will be kept.
  Even so, this bill will represent a step forward toward greater 
fairness, toward greater productivity in our American economy and 
toward a greater degree of justice, less spent on transactional costs, 
less of the costs of the system going to actual victims. It is a good 
and forward looking proposal to reform our legal system. It should be 
passed. It can only be passed if 60 members vote in favor of cloture.
  The ACTING PRESIDENT pro tempore. The Senator's time has expired.
  Mr. HEFLIN. Parliamentary inquiry, Madam President.
  The ACTING PRESIDENT pro tempore. The Senator from Alabama will state 
it.
  Mr. HEFLIN. How much time remains?
  The ACTING PRESIDENT pro tempore. The Senator has 5 minutes.
  Mr. HEFLIN. What about the opponents' time?
  The ACTING PRESIDENT pro tempore. Their time has expired.
  The Senator is recognized.
  Mr. HEFLIN. I yield myself such time as I may need. Senator Hollings 
I think may want to make some remarks.
  I look around. It gets down to this--and I have said this before, but 
I want to reemphasize it and maybe say it a little differently. It is 
basically, is this a fair bill? And when you consider the overall 
situation, see the language that is in it, and how this word or that 
word is changed with an idea of giving an advantage, giving an 
advantage to the defendant, the manufacturing company, the insurance 
company, it just comes to it that it is an unfair bill.
  Basically, No. 1, if it is a fair bill, why do they exclude 
businesses and eliminate commercial loss? The biggest verdicts have 
been in the business arena, punitive damages and others--Texaco, 
Pennzoil, for example. But this bill does nothing about that. But the 
fellow who loses a finger, who is a violinist, or who loses a leg who 
is a soccer player, about which we hear so much today, whose livelihood 
is taken away from him, the provisions of this bill apply to him, and 
they are designed throughout to restrict his rights to recover.
  It is almost inconceivable that someone would come up with an idea 
that they can take your life insurance policy proceeds away from your 
widow and your children if you are killed as a result of an accident. 
Now, that is just unconscionable, but there is unconscionable language 
throughout.
  You pay health insurance. Maybe you work for the Government or are an 
employee and pay a portion or maybe you work and pay it all, and you 
have spent over the years thousands and thousands of dollars. You are 
in a hospital today, with costs like they are, for a month recovering, 
or you can pass away, yet they are allowed to deduct--not the jury. The 
jury knows nothing about this and are told nothing about it--but the 
court, after the verdict is rendered, is obligated under the law, under 
the provisions that are applicable, to deduct that $100,000 or whatever 
the hospital bill is from your economic damages. Then, if you had a 
disability payment or anything else, they eliminate that under these 
provisions and deduct it from you.
  Now, what is fair about that? It is just unconscionable to me that 
people would write that in it, but they do it under collateral 
benefits. They think nobody will read the definition of what collateral 
benefits means, so therefore they get by in the fine print.
  Now, arguments have been made here, very forcefully--and he has done 
a remarkable job, Senator Rockefeller, in his advocacy, Senator Gorton, 
Senator Lieberman and others, but they argue, all right, what we need 
to do takes 5 years.
  I support procedures to bring about the expeditious handling of 
cases. I support alternate dispute resolutions. But let us do that 
separate and not have all of this garbage and unfairness that is in the 
bill.
  Thank you, Madam President.
  Mr. MITCHELL addressed the Chair.
  The PRESIDING OFFICER (Mrs. Murray). The majority leader.


                           Order of Procedure

  Mr. MITCHELL. Madam President, I ask unanimous consent that there be 
5 minutes more of debate equally divided between Senator Heflin and 
Senator Rockefeller and that the vote occur at 10:05 a.m.
  The PRESIDING OFFICER. Is there objection? Without objection, it is 
so ordered.
  Who yields time?
  Mr. ROCKEFELLER. Madam President, we have 2\1/2\ minutes for each 
side.
  Mr. HEFLIN. Madam President, I yield 30 seconds to the Senator from 
Iowa.
  The PRESIDING OFFICER. The Senator from Iowa, Mr. Harkin, is 
recognized.
  Mr. HARKIN. Madam President, I thank the Senator for yielding 30 
seconds.
  I want to respond to my friend from West Virginia on the issue of the 
cloture vote. I ask my friend from West Virginia, are we not debating 
the bill? Are we not offering amendments? This bill was brought up on 
Friday. We have offered amendments. We are offering amendments. Also, 
we are voting on them. But, no, the proponents of this bill filed a 
cloture motion right at the beginning.
  Give us a week to debate it. Give us a week to offer amendments. The 
proponents of this bill know that, if cloture is invoked, we have 30 
hours total to debate and amend this bill. We can spend a week to 10 
days on Whitewater, can we not? We can do that. But we cannot spend a 
little bit of time amending this bill. That is why we ought to vote to 
sustain the debate.
  Mr. ROCKEFELLER. Madam President, I again defer to the majority 
leader. The Senator knows full well that the majority leader said the 
reason the cloture petitions had to be filed was because there would be 
a filibuster by the opponents.
  Mr. HARKIN. We are just simply amending the bill.
  The PRESIDING OFFICER. Who yields time?
  Mr. ROCKEFELLER. I yield myself 2\1/2\ minutes, or whatever time is 
left.
  I really do urge my colleagues to reject the obstructionism, to 
reject the filibuster. I think that this is a test of the Senate. Do we 
have the will to stand up to a small minority in a democracy when we 
have more than a majority of the Senate which wants to act its will on 
this bill? Will our Senators say to the people of our respective States 
that now you are limited to only 2 years from the point of your injury 
in order to bring suit and that, under this bill which we are 
advancing, that would be changed entirely to the advantage of the 
victim?
  Our bill will allow injured persons to sue up to 2 years from the 
point of the discovery of the injury and the cause of the injury. Many 
injured people would benefit from this change.
  Our bill will give more attention to the victims than to the pockets 
of lawyers. Facts have shown clearly over the years that the trial 
lawyers and the defense lawyers are getting more money in this process 
than are the victims who are injured and who have to wait an average of 
5 years to receive compensation. Even after 5 years, 39 percent of 
these injured parties will receive no financial reward whatsoever.
  This is a terrible injustice. It is being blocked by a few people who 
have tremendous power, who are able now for the 13th year to bring the 
business of this Senate to an absolute halt on this subject, to 
filibuster the Senate.
  I appeal to my colleagues, to their sense of fair play, to their 
sense of reason, to their sense of fairness to the victims, that we 
support the motion for cloture.
  I thank the Chair.
  Mr. HEFLIN. Madam President, the issue that Senator Rockefeller and 
others make is expedited court procedures. Let us cut back the backlog 
and the congestion and the time that it takes. That is an issue that we 
ought to agree on. We can support it, and we can take measures to 
approach it.
  He mentions alternate dispute resolutions. I think we are agreeable 
to most alternate dispute resolutions. But let us do that separately 
and not with all of this unfair language, this fine print, this design 
to take away the rights of the poor person, the injured person, the 
woman, the child, the elderly. Let us put all of the unfairness that 
exists herein, let us separate this. It has one or two good points in 
it. You have that combined with all of the damage and other things that 
it does. It is just not a bill that ought to be adopted at all.
  There is no issue here pertaining to savings on business because, 
clearly, the insurance premiums are not going to be affected. Clearly, 
it shows in the studies that there is no competitiveness problem here. 
The whole issue comes down to fairness. And I say to you that this is 
an unfair bill.
  The PRESIDING OFFICER. The time of the Senator from Alabama has 
expired.
  Mr. SIMPSON. Madam President, I want to commend the sponsors of this 
legislation for their tenacity. Senator Gorton and Senator Rockefeller 
have been absolute stalwarts in their efforts to bring this bill to the 
floor. Both are very effective legislators.
  However, I counsel my colleagues to consider carefully the 
consequences of our vote today.
  If cloture is invoked, this bill or a similar version will very well 
be enacted into law. That disturbs me greatly.
  Each Congress which has considered this, or similar proposals, has 
chosen not to enact such sweeping changes to existing law. I think that 
such a prudent course has been due to the realization that there are 
simply these areas of State law into which the Federal Government 
should not intrude.
  We have heard a great deal of thoughtful and powerful debate on the 
floor of the Senate today and yesterday. It should be clear, Madam 
President, that for each example that has been given of an ``abuse'' in 
the current system, there are equally persuasive and powerful examples 
of how the system has worked quite well.
  The current products liability laws do result in efforts to make 
products safer and do ensure that people have proper recourse to 
damages when and if they are injured.
  Certainly, there are occasions to ``fix'' a problem.
  I am concerned, however, that this ``fix''--S. 687--is far too 
extreme for what amounts to variance in the laws of some States.
  That is an important distinction, Madam President.
  Some States' products liability laws may, in fact, lead to unfair 
results. However, the debate on this legislation has fallen far short 
of convincing me that ``all'' State laws are flawed.
  Madam President, we do not need a ``Federal fix'' for this area of 
State law.
  I would conclude my comments today by asking my colleagues a simple 
and direct question: Are we prepared to tell the State juries in our 
own States that we do not have faith in their common sense and 
judgment?
  If we allow this legislation to be enacted, that is just what we will 
be doing. We will be telling our own constituents that we know better--
we, not they, know best how to achieve ``fairness'' in the State 
courts. I do not believe we can, in good faith, make or believe in that 
statement.
  I urge my colleagues to vote against cloture on this legislation.
  Mr. MATHEWS. Madam President, for some time now, it has been clear 
that the present product liability system is in need of serious reform. 
In fact, there is serious question whether this hodgepodge of law, 
questionable claims, outrageous judgments, and economic roadblocks can 
be called a system in any commendable sense. I want to compliment 
Senator Rockefeller for his leadership in addressing the product 
liability morass. And I urge all our colleagues to join with him to 
pass S. 687.
  In taking this legislation up, Madam President, we must acknowledge 
that much of the quarrel generated by this bill is between defendants' 
lawyers and plaintiffs' lawyers. I believe we should avoid taking sides 
in that argument by concentrating on what the current product liability 
situation does to society, business, injured consumers, and the 
economy.
  It seems to me, Madam President, that product liability statutes 
ought to facilitate three general goals. First, to enable consumers 
injured by manufacturers' negligence to be compensated promptly and 
proportionally. Second, to penalize manufacturers and sellers who 
perpetuate faulty merchandise upon consumers, who as a rule know less 
about the product than the people who make it. And third, to reign in 
the unscrupulous manufacturer with the jeopardy of legal action.
  In other words, statutes should join and clarify responsibility and 
liability for both consumer and manufacturer. To a great extent, the 
system that exists now does neither.
  What we have is a self-perpetuating, self-feeding litigation machine 
that devours billions of dollars a year. These costs drain resources 
that could be used to advance our economy. But even worse, they are 
only one aspect of the economic penalties inherent in our product 
liability predicament. Others include closed plants, laid-off workers, 
discontinued products, and products that are never developed because of 
actual and anticipated liability litigation. In dozens of industries 
ranging from aviation to pharmaceuticals, the United States is losing 
part of its competitive advantage and part of its incentive to innovate 
because the threat of untamed product liability damages is forever at 
our throats.
  In many cases, that threat amounts to what I call graymail of 
American business. Take the case of Polyloom Corp. in my native 
Tennessee. Polyloom makes carpet yarn. The company was added to a 
product liability suit involving a schoolboy who tripped over a floor 
covered by a carpet containing its yarn.
  Polyloom's president put the situation very well:

       Our lawyer advised us that we could not have any liability 
     in such a case, but he also told us that we likely would not 
     be able to extract ourselves from the lawsuit until just 
     prior to trial or at the trial. When we approached the 
     plaintiff's lawyer with the facts, we were asked to 
     pay several thousand dollars for the privilege of getting 
     out of something in which we did nothing wrong.

  The company refused to be extorted and eventually was dropped from 
the suit--after it had incurred the expense of depositions, petitions, 
and litigation. Regrettably, Madam President, this kind of jobbery is 
common in the product liability process. Plaintiffs threaten a company 
with the expectation of higher insurance premiums, punitive damages, 
and loss of reputation unless it pays up to make the case go away. 
Graymail is becoming part of the cost of doing business in America.
  Let me be clear: Firms that produce and sell products which do harm 
should compensate those who are harmed. But graymail does not penalize 
or restrain unscrupulous manufacturers and sellers. It encourages 
lawyers, acting in the interest of their clients, to case their biggest 
net into the widest pool of potential defendants. It encourages a 
fishing expedition to find the deepest pockets for liability awards. It 
expands beyond any reasonable definition the notion of responsibility 
and liability on the part of consumer and manufacturer.
  This legislation helps to restore reason to a situation that is 
becoming unreasonable for consumer and manufacturer alike. It benefits 
injured consumers by starting the statute of limitations for filing 
complaints according to a discovery rule rather than a time-of-injury 
rule. It promotes expedited settlement of claims by giving both parties 
incentives to make and accept reasonable reparations out of court. It 
encourages dispute resolution by an arbitrator, reducing the expense 
and time of litigation.

  In particular, Madam President, this measure establishes a clear 
standard to which manufacturers can be held in assessing punitive 
damages. It calls for liability to be determined by acts that show 
conscious, flagrant indifference to consumer safety. I believe that 
this provision is especially worthy of note and support.
  It establishes a clear, no-excuses rule that determines whether 
manufacturers have gone over the line. When firms violate that 
standard, courts and society are reassured that punishment by punitive 
damages is warranted. I believe that this standard will result in 
tougher punishments for firms that truly deserve them.
  Overall, Madam President, I am convinced that this measure is worthy 
for many reasons. It preserves the right of justified claimants to 
compensation for injury and it enhances their right to swift and 
appropriate compensation. It reduces tremendous direct and indirect 
costs to business and our economy. It removes the speculation and 
ambiguity that plague the current system. And it establishes a much-
needed clear standard for punishing firms that act in flagrant 
disregard of their responsibilities.
  I will vote for this legislation, and I urge my colleagues to do 
likewise.
  Mr. DORGAN. Madam President, I rise today to offer an amendment to S. 
687, the Product Liability Fairness Act. As my colleagues know, this 
legislation would reform tort laws on the Federal level and make rule 
changes that relate to product liability cases. I believe that some 
kind of reform with respect to product liability cases is necessary and 
I am willing to support Federal action in this area. I share the 
concerns that many small businesses have with the current system. Small 
businesses are asking for some sort of attention to product liability 
issues and I want to respond to those concerns, namely that fear of 
liability inhibits their ability to conduct their business and create 
jobs. I hope the Congress will pass legislation to address these 
concerns.
  However, I have very serious reservations about provisions in S. 687 
which would provide certain manufacturers with a defense against any 
punitive damages if their product has received Food and Drug 
Administration [FDA] approval or Federal Aviation Administration [FAA] 
certification. It seems to me that the Congress would be making a grave 
error if we gave large pharmaceutical companies and aircraft 
manufacturers a defense against punitive damages and expect that the 
FDA and the FAA can provide absolute and perfect protection to 
consumers. Agency approval and certification of products is meant to 
compliment our tort system, not replace it. This is especially true in 
the area of punitive damages. It is unacceptable to consumers, 
especially to those concerned with women's health and the safety of 
aircraft, and would seriously weaken their rights to challenge 
manufacturers who market defective products. Notwithstanding the issue 
of compensating victims, punitive damages serve as a necessary check in 
consumer product regulation. My conscience cannot accept this provision 
in the bill and I cannot support this legislation if this provision 
remains in the bill.


         punitive damages are not part of the liability problem

  That is why I am offering an amendment that would delete the FDA and 
FAA defense provisions on punitive damages. Although punitive damages 
are rare, they are very necessary when imposed. The bill in its present 
form would protect manufacturers from punitive damage exposure if their 
product is approved by the FDA or the FAA. The fact is that punitive 
damages are not a problem in the present tort system. The problem that 
needs to be addressed is that there are too many frivolous cases filed 
and settled simply to avoid a nuisance rather than resolve whether or 
not there was fault on the part of a manufacturer. The nuisance problem 
is draining resources and burdening small businesses. I want to address 
this problem and I believe other provisions in the bill address this 
issue. But the FDA and FAA provisions have no relation to the product 
liability problems that need to be addressed. Rather, they raise 
serious concerns about the ability of consumers to 
rectify unjustifiable behavior by a manufacturer.

  Punitive damages are imposed in cases where there is a need to punish 
and deter manufacturers whose fault is conscious or reckless. Punitive 
damages are necessary to impose a threat on manufacturers whose 
negligence or disregard for safety are almost criminal, or worse and 
are intended to force dangerous products either off the market or 
require manufacturers to redesign bad products. By eliminating the 
exposure to punitive damages for certain classes of products as the 
bill provides, a critical regulating device which has been used to get 
bad products off the market would be diminished.
  At issue with this provision is not simply a matter of individual 
compensation for negligence. Rather, a broader social objective is at 
stake where the tort system plays a necessary role to hold 
manufacturers and Federal agencies in check. The FDA and FAA provisions 
in S. 687 provide protection to manufacturers in the kinds of cases 
where it is in the best interest of the public to fight for consumer 
protection. Examples of where the FDA and the FAA have failed to remove 
dangerous products are legion. If companies are given a defense from 
punitive damages because a Federal agency provides marketing approval, 
we are throwing public health concerns with respect to drugs, medical 
products, and aircraft manufacturing to the wind.


                       burden of federal agencies

  It would be naive of the Congress to believe that any government 
regulatory agency or system could prevent, stop, or control the 
marketing of harmful products. At best, Government safety standards 
establish minimum levels of protection for the public. The FDA and the 
FAA have been slow to act in the face of evidence of harm and have 
failed to catch dangers in the marketplace in the past. Certainly, 
similar failures will happen in the future, especially if these 
agencies are not given increased resources and enhanced authority to 
monitor product safety. Even if the FDA and the FAA were dramatically 
improved, there will be cases where harmful products are approved and 
negligent behavior on the part of manufacturers will be the cause. We 
need the trot system to help identify these situation.
  A 1990 GAO report found that between 1976 and 1985, 51.5 percent of 
the drugs approved by the FDA had serious post-approval risks that 
could lead to hospitalization, increases in length of hospitalization, 
severe or permanent disability, or death. There are multiple factors 
contributing to this phenomenon. One is that the FDA approval process 
is inherently limited; another is limited resources. However, given 
understood limitations, the agency is very overburdened. In 1979, FDA 
had a staff of 8,000. In 1989, after enactment of 24 new laws 
increasing the agency's responsibilities, the staff levels dropped by 
1,000.
  In this debate, it is important that we understand how the FDA 
approval process works. The fact is that the FDA does not do any of its 
own testing. Rather, it must rely entirely on data and test results 
conducted by the manufacturer. On top of that, the FDA is one of the 
very few Federal agencies that does not have subpoena power--an 
important enforcement tool possessed by all the Federal departments and 
dozens of boards and commissions. Despite the fact there have been 
attempts in the Congress to grant subpoena power to the FDA, the big 
drug companies have fought his legislation vigorously. The 
pharmaceutical industry that is now seeking immunity from liability 
from punitive damages in this legislation has fought hard to deny 
effective enforcement tools to the FDA that would give us more 
assurance that companies are marketing safe products. It seems strange 
to me that commissions like Floral Research and Information, Watermelon 
Research, and Vesting and liquidation of Bulgarian, Hungarian, and 
Romanian Property International Claims would have subpoena power yet 
the FDA does not and the pharmaceutical industry would continue to 
fight the same enforcement powers for the FDA--where much more is at 
risk with respect to public safety.


                  dangerous products with fda approval

  Examples of cases where the FDA has permitted a manufacturer to 
knowingly market a dangerous during or medical device are many. Most of 
us are aware of the problems caused by the Copper-7 IUD's and silicone 
breast implants--both FDA sanctioned products which were not only 
harmful to the public but are cases in which the FDA had knowledge of 
the products' dangers. There are numerous other examples where either 
because of manufacturer negligence or because of agency oversight 
failure, medical drugs and devices were marketed despite serious health 
concerns:
  Bjork-Shiley heart valve, was sold with FDA permission between 1981 
and 1986 even though both the FDA and the manufacturer of the valve had 
evidence of strut fractures that led to the death of many patients;
  Albuteral, an asthma drug that has recently been recalled when it was 
discovered that millions of vials of the drug were contaminated with 
bacteria;
  Theratronics radiation equipment. Therac 25, a cancer treatment 
device, was found to be associated with five deaths in 1984 and 1988. 
Inadequate FDA bookkeeping allowed the product to be used until is 
prohibited its importation in 1991;
  Zomax, versed, and accutance are examples of drugs where the FDA 
ignored data showing potentially serious health risks; and
  The list goes on. But the point of mentioning these examples is not 
to assert whether or not the manufacturers of these products have 
engaged in behavior worthy of punitive damage awards--that issue needs 
to be left to a court. Rather, I raise these examples to point out that 
the FDA approval process cannot be used as a shield for manufacturer 
disregard for public safety. Under the FDA approved process, the agency 
must rely upon the data and clinical trials supplied by the 
manufacturer seeking approval. The FDA approves a product based upon 
the weighing of risks versus benefits. It is always understood that 
many risks cannot be detected in the pre-market approval process and 
often information about serious safety concerns arise after approval. 
The relevant question here is whether or not a manufacturer has engaged 
in behavior that warrants liability for harm caused by their product, 
despite agency approval. It makes no sense to me to say that we should 
exclude a role for the tort system to provide this ``check'' on product 
safety regulation. The FDA has numerous responsibilities, the most 
important of which is to protect public safety by doing its best to 
identify unsafe products. It should not be shouldered with the 
responsibility as the prime enforcer of reckless behavior that is in 
flagrant disregard of public safety.


                the fraud exception means escape clause

  The FDA and FAA defense provisions include a clause which would 
eliminate the defense if the manufacturer received product approval 
through fraud or has not complied with information sharing requirements 
to the appropriate agency. However, this ``escape clause'' is far from 
adequate and does not change the fact that the actual impact of these 
provisions will mean simply that negligent manufacturers will have more 
protection in a law suit and in turn a substantially larger burden will 
be placed on the consumer to win damages. Under this legislation, the 
burden is placed on the injured individual to prove what is required to 
be submitted to the agency, and what information is relevant and 
material. Further, the FDA and the FAA are not adequately equipped to 
take on the additional and judicial functions of determining when 
corporations will be liable for punitive damages. In the last analysis, 
the consumer will bear the burden and responsibility to prove that a 
company defrauded a Federal agency with a product before they even have 
the opportunity to pursue damages. Furthermore, consumers will have the 
additional burden of having to demonstrate causation between the fraud 
and the harm caused under this legislation. The fraud exception simply 
places more and more hurdles in front of victims.
  The results of the fraud exception and the so-called increased 
reporting requirements in this legislation will be that companies will 
flood FDA with massive amounts of information as to cover their tracks 
in the event problems do arise with their product. There is no 
requirement that this information is usable; companies can just dump 
boxes of information and leave it up to the agency to devote staff to 
dig through it. It seems to me that this exception will create more 
litigation and create more battles for lawyers to fight in liability 
cases, including an onslaught of litigation against the FDA and the FAA 
when plaintiffs are seeking to determine whether or not fraud was 
involved in the approval process.
  How can we expect victims to identify fraud and prove it when the 
agency itself cannot? According to an FDA official quoted in a January 
1992 article in the New York Times, the agency has no effective way of 
identifying fraud or serious misrepresentation of test data by 
companies. Madam President, I ask unanimous consent to include this 
article in the Record. What assurances will consumers have that fraud 
or information withholding has occurred? It seems to me that advocates 
of the FDA and FAA defense provisions need to demonstrate what is going 
to change overnight at the FDA or the FAA that will improve the ability 
of these agencies to identify the fraud and misinformation so that this 
exception would have any meaning at all.

  It must be kept in mind that this legislation would significantly 
increase the burden of proof for punitive damages as well as establish 
a tighter definition of behavior subject to punitive damages than what 
is currently used in most States. Under S. 687, a plaintiff would have 
to show, by ``clear and convincing evidence'' that ``the harm suffered 
was the result of conduct manifesting a manufacturer's or product 
seller's conscience, flagrant indifference to the safety of those 
persons who might be harmed by the product.'' My amendment does not 
affect this provision. However, it is important to point out that the 
FDA and FAA defense provisions in the bill is designed to protect 
manufacturers who would otherwise be found guilty of this very high 
standard--except for the fact that their product was approved by a 
Federal agency such as the FDA or the FAA.


           FDA DEFENSE IS NOT NEEDED TO ENCOURAGE INNOVATION

  One of the false claims being made about S. 687, the Product 
Liability Fairness Act, is that one of the bill's provisions, section 
203 which would grant manufacturers of drugs and medical devices 
immunity from punitive damages if their products are approved by the 
Food and Drug Administration, will actually encourage innovation and 
increase availability to new drugs and medical devices. It is being 
asserted that because of liability exposure, new pharmaceutical drugs 
and medical devices are withheld from the market and suppressing 
innovation. There is no basis in fact for these claims.
  It is not true that liability exposure is preventing people from 
obtaining safe and effective life-saving or life-enhancing medical 
devices. None of the products now being cited as examples of products 
that have been withheld because of liability concerns should be 
considered fully safe and deserving of immunity from product liability 
claims. In the Committee Report of the Senate Committee on Commerce, 
Science, and Transportation on S. 687 (November 20, 1993), Senator 
Hollings rebuts a number of these the claims, including Copper-7 IUDs, 
which proponents claim is safe despite overwhelming evidence to the 
contrary; Puritan-Bennett Anesthesia Gas Machines, which were actually 
recalled by the manufacturer and the FDA for causing deaths and 
injuries; and Ortho contraceptives, over which punitive damages were 
awarded because the manufacturer ignored substantial evidence that the 
product cased renal failure.
  Similar concerns have arise about another example: implanted shunts 
which are used to drain excess fluids from the brain. The shunt is made 
from Silastic tubing, a type of silicone, and has been implicated in 
intense inflammatory reactions in patients. Madam President, I ask 
unanimous consent that his article be printed in the Record.
  Finally, proponents has also asserted that an AIDS vaccine could not 
be marketed because of fears about products liability. According to a 
recent Washington Post, the vaccine manufactures are racing to get an 
AIDS vaccine to market. The problems vaccine manufacturers are facing 
in getting their products to market are a lack of volunteers for 
clinical trials, NOT supposed fears about product liability. According 
to the article, there is no shortage of vaccine candidates; however, 
the AIDS community did not feel that these vaccines were promising 
enough to justify clinical trials in high-risk populations. In 
addition, a recent letter from Project Inform lays to rest that claims 
of liability exposure is hampering the development of an AIDS vaccine. 
Madam President, I ask unanimous consent that the Washington Post 
article and the letter from Project Inform be printed in the Record.

  The fact is that drug manufacturers do not need additional incentives 
in order to invest more in innovation. According to a Senate Aging 
Committee report, U.S. drug manufacturers spend far more on marketing 
and advertising, 22.5 percent of revenues, than on research and 
development, 16 percent of revenues. The pharmaceutical industry in the 
United States does not have an innovation problem--the problem is with 
inflated prices and protecting consumers from dangerous products. The 
bill's provisions that would shield drug manufacturers, under the veil 
of innovation, is not the kind of response the American people want 
Congress to give the big drug companies.
  Clearly, the FDA punitive damage defense provisions in S. 687 
jeopardize health and safety. These provisions do nothing to improve 
availability of safe medical products. Rather, these provisions remove 
big pharmaceutical companies and medical device manufacturers from 
accountability for defective products.


                FAA CERTIFICATION IS SELF-CERTIFICATION

  The FAA certification protection for manufacturers raises similar 
concerns. A recent study by the General Accounting Office was very 
critical of the FAA's certification process and found that the FAA has 
delegated so much of its responsibilities for certification that it has 
``lost its ability to effectively oversee or add value to the 
certification process as well as understand new technologies.'' If the 
FAA has such serious weaknesses with its certification process, why 
should it be used as a protection by a manufacturer? Madam President, I 
ask unanimous consent that a copy of this GAO study be printed in the 
Record.
  FAA regulation is ostensibly self-regulation by aircraft 
manufacturers. To rely upon the FAA certification process as a defense 
against liability exposure is nothing less than falling for the ``fox 
guarding the henhouse'' problem.


                               CONCLUSION

  Why is it that in cases where a company may be guilty of near 
criminal behavior with respect to showing blatant disregard for public 
safety, we would want to favor tort rules to benefit the manufacturer 
and make it substantially more difficult for the consumer? That is what 
these provisions in section 203 of this legislation accomplish.
  If the FDA and FAA provisions remain in S. 687, I cannot support the 
bill. As I mentioned above, I want to support some sort of product 
liability reform. That is why I voted favorably to report this 
legislation from the Commerce Committee last fall. But the FDA and FAA 
provisions in the bill do not address the liability concerns that 
should be part of this legislation. The major beneficiary of these 
provisions is the large pharmaceutical companies that want to be 
protected from liability if they show disregard for public health. 
Let's not give them that break at the expense of victims and public 
safety.
  I hope that my colleagues will realize the danger these provisions 
cause to public health and support my amendment to remove them from the 
legislation. If that is done, I believe that S. 687 will be a bill that 
those of us who want to support product liability reform which benefits 
small businesses will be able to support.
  I urge my colleagues to support this amendment.
  There being no objection, the material was ordered to be printed in 
the Record, as follows:

                [From the New York Times, Jan. 26, 1992]

          Questions Raised on Ability of FDA To Protect Public

                            (By Gina Kolata)

       Consumer groups and Federal officials are raising 
     disturbing questions about whether the Food and Drug 
     Administration has adequate powers to protect the public from 
     dangerous drugs and devices. Recent cases involving silicone 
     breast implants, the sleeping pill Halcion and the sedative 
     Versed suggest that the agency and the public are sometimes 
     the last to learn of reports of dangerous side effects.
       The Federal agency does no testing of its own, and in 
     making decisions it must rely entirely on the test results 
     submitted by manufacturers. Officials of the agency and 
     consumer advocates both say that the F.D.A. lacks the 
     subpoena power, which virtually every other Federal agency 
     has, to obtain drug company documents when suspicions are 
     aroused.
       Even when people who are harmed by drugs go to court and 
     their lawyers discover reports of side effects in the 
     companies' files, the companies may settle the case on 
     condition that the reports are sealed. As a result, years may 
     pass before the drug agency gets to hear of vital information 
     about hazards.
       In the case of silicone breast implants, the data that 
     caused the Commissioner of Food and Drugs, Dr. David A. 
     Kessler, to ban implants this month pending a review of their 
     safety had long been known to the Dow Corning Corporation. 
     The details were disclosed to trial lawyers eight years ago, 
     but the drug agency learned about them only recently because 
     a court agreement had kept them confidential.
       ``In view of the recent history with generic drugs and the 
     data that are reported with Halcion and that are about to 
     come out with breast implants, it is hard to say there's not 
     a problem,'' said Dr. Alan Lisook, who is chief of the 
     clinical investigations branch at the drug agency. He said he 
     did not see any immediate solution. Among the disclosures 
     that have shaken the agency are findings that some generic 
     drug companies falsified the tests that enabled them to get 
     their drugs marketed. Within the last six months there have 
     also been allegations that major drug companies withheld 
     safety data from the F.D.A. In one instance, questions were 
     raised about the safety of the sedative Versed after the 
     disclosure of internal documents from Hoffmann-La Roche Inc., 
     which makes the drug. In addition, researchers who were 
     witnesses in a lawsuit and had seen internal company 
     documents accused the Upjohn Company, which produces the 
     sleeping pill Halcion, of falsifying and failing to report 
     data on adverse reactions in its clinical tests. In another 
     lawsuit, against Dow Corning, the maker of silicone breast 
     implants was accused of misrepresenting its safety data to 
     the F.D.A.


                       companies deny wrongdoing

       The final verdicts on Halcion and the breast implants have 
     not been reached. The companies that make them vehemently 
     deny any wrongdoing and say their data support their 
     products' safety and efficacy.
       The Pharmaceutical Manufacturers Association, which 
     represents makers of brand-name drugs, said it did not 
     perceive a problem in the F.D.A.'s ability to learn whether 
     companies misrepresented or failed to report data. ``To the 
     extent that problems exist, the F.D.A. can detect them,'' 
     said Dr. John Petricciani, the director for medical and 
     regulatory affairs at the association.
       But officials at the F.D.A. and consumer advocates say the 
     recent cases spotlight the agency's limitations in accurately 
     assessing the safety of drugs and devices. Adverse data about 
     both Halcion and silicone breast implants were provided by 
     their manufacturers to plaintiffs' lawyers but reached the 
     F.D.A. only by chance.
       Drug industry experts say there was no good way of 
     determining whether the few cases that have appeared are 
     anomalies or the tip of an iceberg. But some consumer 
     advocates have voiced grave concerns that the companies may 
     have hidden adverse data on other drugs.
       Arthur Bryant, executive director of Trial Lawyers for 
     Public Justice, a national public interest law firm, said the 
     situation had seriously endangered patients. ``The entire 
     system, where secrecy is permitted, works to enable companies 
     to maximize profits by sacrificing peoples' lives,'' he said.
       Dr. Sidney Wolfe, director of the Health Research Group, 
     which is part of Ralph Nader's Public Citizen consumer 
     advocacy group, agreed. The F.D.A., he added, ``is 
     extraordinarily dependent on the companies to be honest.''
       ``But as the line increases of companies that have pleaded 
     guilty to criminal charges, maybe the default position is not 
     to trust the companies,'' he said.
       It might seem that any company that marketed an unsafe drug 
     or device would be found out as adverse reactions 
     accumulated. Yet F.D.A. officials say they have seen 
     companies minimize or ignore adverse reactions in their 
     reports to the agency, even though those side effects 
     eventually forced the company to pull the drug from the 
     market and incur heavy costs.
       Dr. Robert Temple, director of new drug evaluations at the 
     F.D.A., speculates that companies might grossly play down 
     adverse reactions to their drugs because of ``wishful 
     thinking, hopes and dreams'' on the part of companies that 
     the reactions are not serious. ``The most striking thing 
     we've seen is companies not appreciating the wild horses they 
     were riding,'' he said.
       In addition, he said, he believes companies may fear that 
     ``if they tell us about it, we'll get hysterical and we won't 
     make a reasonable judgment.''
       Dr. Henry Grabowski, an economist at Duke University who 
     has studied the drug industry, said financial considerations 
     could sway a company to play down adverse data. ``Sometimes 
     you can have a mindset that a drug will be very commercially 
     important,'' he said. ``You don't want to hear bad news about 
     it. You don't really develop or acknowledge some problems.''
       F.D.A. officials and consumer advocates say that the F.D.A. 
     stands virtually alone among Federal agencies in its lack of 
     subpoena power. The Department of Agriculture, the 
     Environmental Protection Agency, the Department of 
     Transportation and the Federal Trade Commission all have 
     subpoena power. Without it, the F.D.A.'s only stick is to 
     threaten criminal prosecution by the Justice Department if it 
     finds critical data have been withheld.
       Dr. Lisook said subpoena power would certainly help the 
     agency to investigate possible withholding of data about 
     adverse drug reactions. ``We can only pursue some cases to a 
     certain point because there is information we can't obtain 
     because we lack subpoena power,'' he said. Instead of forcing 
     companies to produce documents and internal memorandums to 
     establish whether there is any wrongdoing, the F.D.A. has to 
     be certain enough that something is wrong to persuade the 
     Justice Department to begin a criminal prosecution.


                         subpoena power fought

       The Pharmaceutical Manufacturers Association, however, 
     opposes giving the F.D.A. subpoena power and heavily lobbied 
     against it when a bill to give the agency that power was 
     introduced in Congress last year. The bill failed to win 
     approval after the Secretary of Health and Human Services, 
     Dr. Louis W. Sullivan, said it would be vetoed.
       The F.D.A. also has no good way of finding fraud or 
     serious, if inadvertent, misrepresentation of data by 
     companies. In its fraud investigations, Dr. Lisook said, the 
     F.D.A. scrutinizes the records of individual investigators 
     who perform studies for drug companies. On occasion, it has 
     found that the investigators cheated, even making up all of 
     their data. This happened with one independent researcher who 
     studied Halcion, for example. But the agency cannot easily 
     detect the next level of misrepresentation or negligence, a 
     company's failure to properly report and analyze researcher's 
     data, Dr. Lisook said.
       A discrepancy between case report forms and company 
     analyses would not ordinarily be apparent to the F.D.A., Dr. 
     Lisook said, partly because the agency does not even receive 
     most case report forms. Since 1984, when F.D.A. regulations 
     were revised, companies have not been required to submit most 
     case report forms to the F.D.A.
       Dr. Lisook said the F.D.A. has stumbled upon companies that 
     accidentally or purposely overlooked adverse reactions in 
     their reports to the agency. ``We can't go to a company and 
     say, `Tell us if there are adverse reactions you didn't 
     submit,''' Dr. Lisook said. ``We don't have any good method 
     to determine whether what is on the case report forms is 
     identical to what is on the tabular summaries.''
       In the case of Halcion, critics who have examined case 
     report forms in connection with a lawsuit against Upjohn 
     charge that the company left out information about adverse 
     reactions reported on those forms when it prepared its data 
     analyses for the F.D.A. Upjohn denies the charges and the 
     F.D.A. is currently examining the forms and comparing them to 
     the company's data analyses.
       Another source of frustration for the F.D.A. is the growing 
     tendency of companies to obtain secrecy orders that seal 
     potentially damning company documents that are produced in 
     product liability suits. These orders prevent the plaintiffs, 
     their expert witnesses, and their lawyers from ever 
     disclosing what they learned. The Halcion data were uncovered 
     in a product liability lawsuit that was settled with a 
     secrecy order.
       The Pharmaceutical Manufacturers Association opposes 
     changing secrecy orders to enable the F.D.A. to be guaranteed 
     access to company data.
       Secrecy orders that keep information on the safety of drugs 
     and devices from the public and the F.D.A., ``are an outrage, 
     a total outrage,'' said Mr. Bryant, the public interest 
     lawyer. ``These standards for keeping data from the eyes of 
     the public should be far higher than they are now,'' he said. 
     ``Yes, there should be secrecy for certain things like the 
     formula for Coca-Cola. But we are talking about matters that 
     involve threats to the public health and safety, matters that 
     allow the public to evaluate whether the courts and 
     regulatory agencies are doing their jobs.''
                                  ____


                    [From the Lancet, Aug. 29, 1992]

         Antibodies to Silicone Elastomers and Re- actions to 
                      Ventriculoperitoneal Shunts

  (By Randall M. Goldblum, Ronald P. Pelley, Alice A. O'Donell, Debra 
                      Pyron, and John P. Heggers)


                              introduction

       Elastomers formed of cross-linked polydimethylsiloxane, 
     commonly called silicone elastomers, are widely used to make 
     medical implants and prostheses. Silicone elastomers are 
     generally believed to be biologically inert, since tissue 
     responses are usually limited to mild foreign-body reactions. 
     However, over the past 10 years, there has been increasing 
     suspicion that rare, severe inflammatory reactions to 
     silicone elastomer implants have an immunological basis. 1, 2 
     We report evidence that specific antibody reactivity to 
     polydimethylsiloxane develops in some patients after repeated 
     exposure to Silastic (Dow-Corning Wright, Midland, Michigan, 
     USA) shunt tubing.


                              case reports

       The first patient was a caucasian girl who had a low lumbar 
     myelomeningocele repaired on the first day of life. A 
     ventriculoperitoneal (VP) shunt was inserted at 19 days and 
     revised at 4 months. When the patient was 6 years old an 
     abdominal pseudocyst formed around the shunt. A year later a 
     neck wound from a shunt revision became red, exuded clear 
     fluid, and separated, exposing the underlying shunt tubing. 
     This process recurred eleven times over the next 4 years. 
     Similar reactions were seen at sites of silicone-coated 
     sutures. Cultures from the wound sites, collected many times 
     over 3 years, and four tissue samples failed to show any 
     microorganisms, despite use of many special stains and 
     electronmicroscopy. Histology of the inflamed tissue showed 
     granulomatous inflammation with many lymphocytes, 
     macrophages, giant cells, epithelioid cells, and occasional 
     plasma cells. There was mild 
     hypergammaglobulinaemia (IgA 3.24 g/l/ IgG 15.9 g/
     l). Serum samples taken when the child was 9-11 years old 
     were stored frozen until analysis. At the ninth shunt 
     replacement (age 14 years) precautions were taken to cover 
     the track with intact tissue; it has been well tolerated for 
     longer than 3 years.
       The second patient was a Latin American girl who developed 
     hydrocephalus at 9 months. Computed tomography confirmed 
     hydrocephalus and showed partial agenesis of the corpus 
     callosum and a Dandy Walker deformity. A VP shunt was placed 
     and revised when she was 5\1/2\ years. 2 months later the 
     shunt was extruded in the same way as in the first patient. A 
     few months later an abdominal pseudocyst was noted. Local 
     reactions developed along the shunt, but no microorganisms 
     were found by culture or histology. Serum concentrations of 
     IgG (15.4 g/l) and IgM (4.6 g/l) were moderately high and 
     there was unexplained eosinophilia (1.2 10. sup. 9/l). The 
     reactions gradually resolved over 10 days. Serum samples were 
     taken at the time of admission to our hospital and a year 
     later.


                                methods

       These intense inflammatory reactions surrounding recently 
     implanted Silastic tubing, in the absence of infection, 
     suggested an immunological reaction, possibly to the tubing. 
     To investigate this possibility, we developed an assay to 
     detect antibodies to Silastic tubing. We also collected 
     samples from five patients with VP shunts (aged 5-37 years) 
     who had had no clinically apparent reactions. Four of these 
     patients had had malfunction of their shunts, requiring at 
     least one surgical revision. The assay was a modified enzyme-
     linked immunosorbent assay (ELISA) 3 with Silastic tubing as 
     the solid-phase antigen. 1 ml volumes of serial ten-fold 
     dilutions (1/10-1/1000) of serum in 0.05 mol/1 phosphate-
     buffered saline, pH 7.1, with 0.05% (by volume) Tween 20 
     (Sigma Chemical Co, St Louis, Missouri, USA) were incubated 
     overnight at 20 degrees C in polystyrene test-tubes with 1 cm 
     sections of surgical Silastic tubing, sliced linearly to 
     allow full exposure of inner and outer surfaces. The pieces 
     of tubing were washed three times with 3-4 ml buffer, then 
     incubated for 4 h with rabbit antibody to human IgG 
     conjugated with horseradish peroxidase (Dako, Carpinteria, 
     California, USA), washed again, then transferred to clean 
     polystyrene test tubes. 1 ml enzyme substrate (0.2 g/l 
     orthophenylenediamine dihydrochloride in citrate 
     buffer with 0.25% hydrogen peroxide) was added to each tube 
     and the enzyme reaction was allowed to continue for 20 min, 
     then it was stopped by acidification. The optical density at 
     492 nm was measured (EIA reader, BioRad, Richmond, 
     California). Each experiment contained one serum sample from 
     patient 1 and a buffer control. Assays were run in duplicate. 
     Optical densities for the buffer controls were always less 
     than 7% of the maximum value for serum from patient 1.
       To find out whether the IgG binding to Silastic tubing was 
     specific, IgG was separated from the serum of patient 1, by 
     means of a protein A column (BioRad), and cleaved into Fc and 
     Fab fragments with papain immobilised on Sepharose beads 
     (Pierce Chemicals, Rockford, Illinois). Fab fragments were 
     separated from intact IgG and Fc fragments, concentrated, 
     and checked for purity by sodium dodecyl sulphate 
     polyacrylamide gel electrophoresis. The binding of Fab 
     fragments to Silastic tubing was measured by means of the 
     rabbit anti-IgG or a mixture of anti-kappa and anti-1 
     ambda conjugates (Dako) diluted 1/500 and 1/3000, 
     respectively.
       We investigated the specificity of IgG binding to Silastic 
     tubing further by assaying serum samples previously exposed 
     to tubing or methylsiloxane-conjugated proteins. 1/10 
     dilutions of serum were exposed to 1 cm or 2 cm sections of 
     Silastic tubing, as described above. The tubing was then 
     removed and a fresh section of tubing was added to each 
     absorbed serum. Both sets of Silastic tubing were processed 
     to determine the amount of IgG bound.
       Methylsiloxane-conjugated proteins were made by mixing 1 mg 
     crystalline bovine serum albumin or ovalbumin (Sigma) with 1 
     ml pyridine in glass tubes previously treated 
     (``siliconised'') with a reactive oligodimethylsiloxane 
     (Sigmacote, Sigma). The crystals were sonicated in a bath for 
     90 min at 56 degrees C and the mixture was left at 23 degrees 
     C overnight to allow the pyridine to infiltrate the protein 
     crystals. Varying amounts (10-1000 mu l) of the silylating 
     agents orthobis- (trimethylsilyl) -trifluoroacetamide 
     (Pierce) or N-trimethyls ilylimadazole (Supelco, Bellefonte, 
     Pennsylvania) were incubated with the protein/pyridine 
     suspension for 2 h at 56 degrees C with sonication. The 
     mixture was evaporated to dryness under nitrogen, and the 
     residue was suspended in 1 ml Tween-phosphate buffer. Control 
     protein complexes were prepared in the same way, but no 
     silylating agent was added; these samples were exposed to 
     pyridine in ``siliconised'' glass tubes.
       The oligomethylsiloxane-protein complexes were then used to 
     absorb serum from patient 1. About 50 mu g of the complex 
     mixture was incubated with 10 mu l serum for 15 min at 37 
     degrees C in a total volume of 1 ml. The absorbed serum was 
     then used in the Silastic tubing ELISA.


                                results

       In the ELISA for IgG binding to Silastic tubing, binding of 
     serum IgG from patients 1 and 2 was easily shown at all three 
     dilutions; serum from VP shunt patients without inflammatory 
     reactions and from 9 healthy adults showed much lower or 
     undetectable IgG binding (fig 1). To show that the binding to 
     Silastic was attributable to specific antibody, IgG and Fab 
     fragments from patient 1 were compared. Binding of the Fab 
     fragment (anti-light-chain conjugate) approached that of 
     intact IgG (fig 2). Fig 3 shows the effect of incubating 
     serum from patients 1 and 2 and a normal adult with tubing 
     before assaying the serum for IgG antibodies to Silastic. In 
     both patients, most of the IgG able to bind to Silastic 
     tubing was removed by the preincubation, though the 
     concentration of total IgG determined by rate nephelometry 
     did not change. The amount of IgG able to bind to Silastic 
     tubing was also reduced substantially (22-56%) by 
     preincubation of the serum with protein that had been 
     subjected to pyridine treatment in silicone-treated 
     glasswear (fig. 4). Incubation of serum with proteins 
     treated with increasing amounts of either silylating 
     reagent resulted in further decreases in IgG binding. 
     Proteins conjugated with a large molar excess (680-1400 
     moles of trimethylsiloxane per mole of hydroxyl residues 
     of protein) removed from the serum 72-81% of the binding 
     activity for Silastic tubing (fig. 4). The results for the 
     two different proteins and two different silylating 
     reagents were pooled, since they showed no significant 
     differences by ANOVA.


                               Discussion

       Temporary and long-term implantation of various devices 
     made from silicones has become common medical therapy. 
     Reactions to there foreign materials are usually restricted 
     to mild fibrosis, 4 but immune mechanisms were proposed for 
     some cases of obstruction of VP shunts, when inflammatory 
     cells were detected in the tubing lumen. 5,6 Other evidence 
     from patients and from experiments in animals suggests that 
     the silicones may not be immunologically inert 2, 3, 7-10 and 
     may elicit inflammatory reactions.
       The two patients described here probably represent unusual 
     complications of VP shunt placement, but similarities in 
     their histories suggest common mechanisms. Their VP shunts 
     were well tolerated at first, but after surgical revision of 
     the abdominal pseudocysts and intense subcutaneous reactions 
     developed at the sites of silicone implants and silicone-
     coated sutures, which could not be attributed to infections. 
     All serum samples from both patients contained IgG that bound 
     to the tubing in greater quantities than did IgG from normal 
     adults or other VP shunt patients without inflammatory 
     reactions.
       The bound immunoglobulin seemed to be specific antibodies, 
     since the Fab fragment of IgG also bound to the tubing and 
     most of the binding IgG was removed by preincubation with 
     similar tubing or siloxane-conjugated proteins. However, we 
     cannot attribute the local inflammatory reactions to these 
     antibodies. The granulomas observed in patient 1 are more 
     consistent with T-cell-mediated immune lesions than with 
     antibody-mediated reactions. 11 We have not yet found a form 
     of polydimethylsiloxane adequate for in-vitro testing of 
     cellular immunity in these patients, though the 
     oligomethylsilane-protein complexes we used may be useful. 
     The nature of the silicone antigen that elicits the immune 
     response is not known.
       Because therapeutic use of 
     polydimethylsiloxane is widespread, the 
     frequency of immune responses to these materials and their 
     relation to adverse reactions to silicone implants should be 
     studied further. Better understanding of the mechanisms by 
     which patients become sensitised to polydimethylsiloxane 
     could facilitate the selection of patients for implantation 
     procedures, and aid in the development of new synthetic 
     polymers that reduce the risk of adverse reactions to 
     implantation of important medical devices.
                                  ____


               [From the Washington Post, June 18, 1994]

        NIH Delays Full-Scale Testing of Potential AIDS Vaccine

                            (By David Brown)

       The National Institutes of Health yesterday decided to put 
     off sponsoring a full-scale AIDS vaccine trial until more 
     promising vaccines are developed or the two versions now 
     ready for testing show more laboratory evidence that they are 
     likely to work.
       As a result, vaccine testing in thousands of high-risk 
     people almost certainly will not occur for at least two 
     years. By then, entirely different strategies for 
     immunization could compete head-to-head, something that would 
     not be possible if the nearly identical ``candidate'' 
     vaccines were tested now.
       An advisory committee of the National Institute of Allergy 
     and Infectious Diseases (NIAID) reached the decision after an 
     eight-hour public meeting yesterday. The recommendation was 
     passed on to Anthony S. Fauci, the institute's director, who 
     immediately accepted it. NIAID oversees virtually all of 
     NIH's clinical studies of AIDS.
       The decision will erode the lead that two biotechnology 
     companies, Genentech and Biocine, have in the race to be the 
     first to develop an effective vaccine to prevent infection by 
     the human immunodeficiency virus (HIV). The 28-member 
     advisory panel concluded there was neither compelling 
     scientific evidence nor sufficient enthusiasm in high-risk 
     communities where volunteers would be recruited, to justify a 
     trial now.
       In a sea change from their familiar role of urging early 
     testing of AIDS drugs, several AIDS activists advised against 
     starting a large vaccine trial until there is greater 
     scientific consensus that the candidates are very strong.
       ``Once we go down this road with a mediocre product . . . 
     we may never have the chance to recruit a large number of 
     people again,'' said Martin E. Delaney of Project Inform in 
     San Francisco, a member of the advisory committee. He said 
     much of the AIDS-ravaged gay community is discouraged by poor 
     results of AIDS treatment drugs, and is much less likely to 
     volunteer for clinical experimentation now than in the past.
       ``We have only one chance to test a vaccine in a large 
     randomized trial, and this is not that chance,'' he said.
       At a news conference after the meeting, however, Fauci 
     emphasized the decision was essentially to delay testing the 
     two vaccines, not to reject them as worthless.
       ``It is clear that the recommendation of the [advisory] 
     group is not that there should be an abandonment of this 
     concept [of immune protection that Genentech and Biocine have 
     developed],'' he said.
       Both vaccines employ a protein from the virus's shell, or 
     ``envelope,'' to stimulate an uninfected person's immune 
     defense against HIV. Those defenses are antibodies--
     biochemicals that specifically target the virus--and a class 
     of white blood cells that attacks and kills cells the virus 
     invades immediately after infection.
       The protein in the vaccine, called gp120, is made by 
     genetic engineering techniques and is incapable of causing 
     HIV infection itself. It is like the crystal of a watch. The 
     watch's works--in this case, the reproductive machinery of 
     the virus--form no part of the vaccine.
       Numerous other vaccines are now in development. Some 
     involve splicing HIV genes into another carrier (``vector'') 
     virus, such as vaccine, which is the one used for smallpox 
     vaccination. Replication of the vector then releases large 
     amounts of harmless HIV protein into the body. Some 
     scientists believe this strategy more closely resembles the 
     real mechanism of HIV invasion, and will elicit a more robust 
     defense.
       Several panel members said they felt that a large trial 
     testing a vector vaccine against an envelope vaccine would be 
     a better use of time and money than a large trial testing 
     only two envelope vaccines.
       The two gp120 products have been used in small studies that 
     allowed researchers to test their safety and to run numerous 
     blood tests on volunteers to determine immune-system effects.
       Those studies have shown that gp120 can stimulate a person 
     to make antibodies and can case proliferation of certain 
     types of white blood cells. In laboratory experiments, 
     however, those antibodies have not been able to prevent 
     infection of cells by ``wild'' HIV virus.
       Seven chimpanzees who were given the vaccines subsequently 
     resisted infection when HIV was injected into their 
     bloodstreams. Company representatives pointed to these 
     experiments as proof of their products' promise. Many panel 
     members, however, were unsure how much could be extrapolated 
     from such a small sample of animals--and from a species known 
     to respond very differently from human beings.
       The largest of the gp 120 studies done so far enrolled 
     several hundred people at high risk for HIV infection because 
     of their sexual practices or drug use. During the study, 
     three persons--none of whom had gotten the full course of 
     three shots--developed HIV infection through known routes of 
     exposure. This did not prove that the vaccines were useless, 
     but only that a single dose of them was not protective.
       Numerous members of the advisory panel said that before 
     moving to a larger trial, information should be learned about 
     these ``breakthrough'' cases: what subtype of virus caused 
     them; what their tests of immunity showed; and how their 
     infections progress.
       The panel considered two possible trials it could have 
     recommended for starting later this year. One would have 
     required 9,000 high-risk volunteers, divided equally into 
     three groups who would receive one of the two vaccines or 
     placebo. It would have had the power to determine with a high 
     degree of certainty whether a vaccine's effectiveness was 50 
     percent or greater. Such a study would take 3\1/2\ years to 
     run, at a cost of up to $18 million a year.
       The other option, enrolling 4,500 people, could reliably 
     identify a useful vaccine only if it was protective 70 
     percent of the time. There seemed to be little confidence 
     among panel members the gp 120 candidates would perform that 
     well. They concluded such a study (with a price tag as high 
     as $9 million a year for two years) was not worth the money.
       A recent survey of a community network of potential vaccine 
     trial volunteers, set up under NIH auspices, showed that only 
     36 percent of gay men and injection drug users were ``very 
     willing'' to participate in a vaccine trial.
                                  ____



                                               Project Inform,

                                                San Francisco, CA,
       To whom it may concern: Some groups have suggested that 
     product liability laws are the principal reason we don't yet 
     have a vaccine for AIDS. In response, they suggest that 
     greatly relaxing such laws would result in quick or immediate 
     marketing approval of such a vaccine. This is simply not the 
     case. The principal reason that we don't yet have an approved 
     AIDS vaccine is that no such vaccine has demonstrated the 
     ability to protect humans against the normal routes of 
     infection by HIV, the virus which causes AIDS, and no vaccine 
     has yet been proven to be completely safe. No vaccine has yet 
     reached the stage of testing where product liability issues 
     are even a significant concern.
       Last week, as a member of the NIAID AIDS Research Advisory 
     Committee, I voted against initiating widescale human testing 
     of two proposed vaccines for AIDS, products of Genentech and 
     Biocene, a division of Chiron Corporation. Liability issues 
     never once entered the discussion. Instead, the committee 
     voted against approval of wide scale testing primarily 
     because the vaccines hadn't shown sufficient evidence of 
     efficacy in initial trials, and secondarily because some 
     safety questions remain, principally the question of whether 
     such a vaccine might accelerate the course of disease in 
     someone who became infected despite vaccination. Because 
     these concerns remain unanswered, and because of the 
     financial and human resources costs of the proposed trials, 
     it was felt that the public interest would be best served by 
     waiting for the availability of additional promising vaccine 
     candidates which might be tested comparatively. These two 
     vaccines, despite their weaknesses, are the products in the 
     most advanced stage of testing and development of AIDS. 
     Questions of safety and efficacy are thus larger still for 
     any other vaccine candidates, which have not yet had even the 
     level of human testing of these two.
       There are many possible ways to build a vaccine for AIDS 
     and I am no position to argue that one approach is inherently 
     better than another. Only a graduated, step-by-step testing 
     process can determine which is the safest and most effective 
     approach. Product liability concerns are not presently an 
     obstacle to such testing, which must precede any marketing 
     approval of a vaccine. Regardless of product liability 
     concerns, the availability of a vaccine for AIDS is many 
     years away.
                                                  Matthew Delaney,
                                                Founding Director.
                                  ____


       GAO Report--FAA's Certification Process, Executive Summary


                                purpose

       The Federal Aviation Administration (FAA), which is 
     responsible for certifying that new aircraft designs and 
     systems meet safety standards, is faced with the daunting 
     task of keeping abreast of increasingly complex technologies. 
     Douglas Aircraft Company's MD-11 aircraft, for example, 
     relies on sophisticated software systems to continuously 
     monitor and adjust the hydraulic, electrical, and fuel 
     systems without any action by the crew. Stating that it is 
     crucial for FAA to understand new technologies to certify the 
     safety of commercial aircraft, the Chairman, Subcommittee on 
     Aviation, House Committee on Public Works and Transportation, 
     asked GAO to determine if FAA staff are (1) effectively 
     involved in the certification process and (2) provided the 
     assistance and training needed to be competent in these 
     technologies.


                               background

       Before introducing a new type of aircraft into commercial 
     service, a manufacturer must obtain FAA's certification that 
     the aircraft meets safety standards. Over what is typically a 
     5-year process, the manufacturer must supply FAA with 
     detailed analyses as well as produce a prototype of the 
     aircraft. The Federal Aviation Act allows FAA to delegate 
     activities, as the agency deems necessary, to approve 
     employees of aircraft manufacturers. Although paid by 
     manufacturers, these designees act as surrogates for FAA in 
     examining aircraft design. FAA is responsible for overseeing 
     the designees' activities and determining whether the designs 
     meet FAA's requirements. A 1980 review by the National 
     Academy of Sciences found that this delegation system was 
     sound but warned that FAA was falling behind the industry in 
     competence. The Academy recommended that FAA define a 
     structured role for itself in the certification process and 
     hire 20 to 30 experts to assist staff. FAA concurred with the 
     findings, noting that it was developing a program employing 
     experts and was committed to improving its training program.


                            results in brief

       FAA has not ensured that its staff are effectively involved 
     in the certification process. Despite the National Academy of 
     Sciences' recommendation in 1980 that FAA develop a more 
     structured role in the process, the agency has increasingly 
     delegated duties to manufacturers without defining such a 
     role. FAA now delegates up to 95 percent of the certification 
     activities to manufacturers without defining (1) critical 
     activities in which FAA staff should be involved, (2) 
     guidance on the necessary level and quality of the oversight 
     of designees, and (3) standards to evaluate staff members' 
     performance. As a result, FAA staff no longer conduct all of 
     such critical activities as the approval of test plans 
     and analyses of hypothetical failures of systems. Because 
     faa has increased delegation over the last 13 years, its 
     ability to effectively oversee or add value to the 
     certification process as well as understand new 
     technologies has been questioned by internal reviews and 
     faa and industry officials.
       faa has also not provided its staff the assistance and 
     training needed to ensure competence in new technologies. 
     While many faa and manufacturing officials gao interviewed 
     stated that faa's hiring of experts to assist staff is an 
     excellent concept, faa never fully implemented the program. 
     faa identified a need for 23 experts but has staffed only 8 
     positions. In addition, faa has not identified critical 
     points in the certification process that require experts' 
     involvement. As a result, the experts are sometimes not 
     sought for advice and are often involved in the process too 
     late for them to be most effective. Also, faa's training has 
     not kept pace with technological advancements. gao found, for 
     example, that between fiscal years 1990 and 1992, only 1 of 
     the 12 faa engineers responsible for approving aircraft 
     software attended a software-related training course. faa 
     officials acknowledged that inadequate training over the last 
     decade has limited the certification staff's ability to 
     understand such areas of dramatic technological advancement. 
     As a result, faa is developing a new training program. 
     However, the program may not have the structure necessary to 
     improve the staff's competence. The program does not, for 
     example, establish specific training requirements for staff 
     in their areas of responsibility.


                           Principal Findings

  FAA has increased delegation without ensuring an effective role for 
                                 staff

       Since 1980, faa has delegated most certification activities 
     to designated manufacturing employees without defining or 
     measuring an effective role for its own staff. Between 1980 
     and 1992, the number of designees rose from 299 to 1,287 (330 
     percent), while the number of faa engineers and test pilots 
     increased from 89 to 117 (31 percent). faa has increasingly 
     relied on designees because of a dramatic growth in its work 
     load caused by more complex aircraft systems and an increase 
     in such higher-priority duties as issuing directives to 
     ensure the safety of already certified aircraft. faa 
     estimated, for example, that it delegated approximately 95 
     percent of the certification activities for the Boeing 747-
     400 aircraft. An faa review in 1989 concluded that the amount 
     of work delegated to designees had reached the maximum for 
     properly managing the certification process and that further 
     delegation would reduce FAA's ability to understand new 
     technologies. Another internal review found that staff 
     were not sufficiently familiar with the Boeing 747-400's 
     flight management system to define requirements for 
     testing it or verifying regulatory compliance. Both FAA's 
     and Boeing's Certification Directors acknowledged that 
     FAA's approach is too ad hoc and unmeasured to ensure a 
     minimum effective level of involvement by FAA.
       The National Academy of Sciences raised similar concerns in 
     1980. However, FAA has yet to identify critical activities in 
     which staff should be involved, set standards governing the 
     level and quality of the oversight of designees, or develop 
     measures through which staff members' performance can be 
     evaluated. For example, FAA has not established the extent to 
     which it needs to be involved in the development and approval 
     of test plans for key aircraft systems. The Academy concluded 
     that the delegation system was sound, in part because FAA 
     retained the approval of test plans. GAO found, however, that 
     FAA has delegated the approval of as many as 95 percent of 
     test plans to designees. FAA's Aircraft Certification Service 
     Director has acknowledged the need to better define and 
     measure an effective role for FAA staff in the certification 
     process and stated that the agency will initiate an effort to 
     define such a role. Until FAA completes this effort, 
     questions will remain about the value that the agency's 
     employees add to the process.

     Staff's competence limited by lack of assistance and training

       FAA has not provided the technical assistance needed to 
     ensure the staff's competence in evaluating the latest 
     technologies. FAA did not fully implement a program in which 
     experts assist staff during the certification process. In 
     1979, FAA identified a need for over 20 experts in such areas 
     as advanced avionics but authorized only 11 positions and 
     staffed only 8. FAA officials stated that the agency could 
     not attract qualified people but acknowledged that (1) FAA 
     has not formally examined the need for additional experts 
     since 1979 and (2) recent layoffs by manufacturers may have 
     increased the pool of qualified individuals. Furthermore, 
     because FAA has not identified key points in the process 
     requiring the involvement of experts, their knowledge is not 
     optimally used. For example, two experts were not involved in 
     crucial early junctures in the certification of the Boeing 
     777. After discovering that Boeing was employing new designs, 
     the two raised concerns about test requirements. Because of 
     these concerns, Boeing modified its test procedures in one 
     case and is currently reviewing them in the other.
       In 1991, a contractor hired by faa found that the agency 
     does not have adequate training for its certification staff 
     in such areas as composite materials and software systems. 
     gao found that his lack of training has occurred despite a 
     1987 internal study that recommended faa establish annual 
     training requirements. Citing the increasing inexperience of 
     faa staff--over half of the engineers with primary 
     responsibility in the certification of the Boeing 777 have 
     never participated in a major certification project--faa is 
     developing a new training program. While supporting this 
     effort, gao is concerned because it does not establish 
     specific training requirements or identify technical training 
     available from universities, private industry, and other 
     government agencies.


                            recommendations

       gao recommends that the Secretary of Transportation direct 
     the Administrator, faa, to define a minimum effective role 
     for the agency in the certification process by identifying 
     critical activities requiring faa's involvement or oversight, 
     establishing guidance on the necessary level and quality of 
     the oversight of designees, and developing measures through 
     which staff members' effectiveness can be evaluated. gao also 
     recommends that the faa Administrator formally examine the 
     need to hire experts in areas of technological advancement, 
     require experts' involvement early in the certification 
     process and at other key junctures, establish specific 
     training requirements, and identify training in new 
     technologies that is available at universities, industry, and 
     other government agencies.


                            agency comments

       Although the Department of Transportation (DOT) takes the 
     position that faa staff and experts are effectively involved 
     in the certification process, it concurred in part with gao's 
     recommendations. DOT did not fully concur with the 
     recommendations because it felt that they would impose rigid 
     requirements dictating the sequence and participants at each 
     juncture of the process. gao's recommendations are not 
     designed to impose rigid requirements, but rather to enhance 
     the technical competence of faa staff and ensure that they 
     add more to the certification process. gao found that faa 
     needs to establish basic guidance that describes the critical 
     activities requiring staff members' involvement, establishes 
     measures to evaluate staff members' performance, and defines 
     when experts should be consulted. The lack of such guidance--
     combined with inadequate training--has brought into question 
     the value added by faa's activities. An advisory group of 
     individuals with distinguished aviation backgrounds agreed 
     with gao's conclusion.
       dot also stated that the delegation system has been 
     effective. gao agrees. The current process results in safe 
     designs largely because of the efforts and expertise of the 
     designees. What is less clear, however, is the extent to 
     which the contributions of faa staff materially add to this 
     level of safety. Finally, dot maintained that annual training 
     requirements would be too ``rigid.'' gao acknowledges dot's 
     concern and has deleted its reference to annual requirements 
     in recommending that staff receive the training needed to 
     fulfill their certification mission.

  Mr. WOFFORD. Madam President, I rise to oppose S. 687, I believe this 
legislation would unjustly limit the ability of consumers to receive 
full and just compensation for negligent conduct on the part of 
manufacturers, while unnecessarily interfering with State authority in 
the area of tort law.
  Since I came to the Senate in 1991, I have consistently opposed 
effort to federalize tort laws. Under the principles of federalism, 
States have historically established their own tort rules. The Product 
Liability Fairness Act would change that historic practice by 
establishing national rules for some, but not for all, aspects of 
product liability law.
  For example, S. 687 would prohibit punitive damages in most cases of 
products that receive FDA approval. Such an exemption would preempt 
existing State laws that allow for punitive damages, like 
Pennsylvania's. This bill presents the greatest threat to woman, the 
elderly, and the poor. Women would be severely affected because many of 
the more dangerous drugs and medical devices produced have a major 
impact on woman's health.
  Just recently I received a letter from Karen M. Hicks of Bethlehem, 
PA, who like almost 4 million other women, was the victim of the Dalkon 
shield, IUD. Ms. Hicks writes:

       I began using the Dalkon Shield in 1972. Over the next 10 
     years, I suffered many medical problems. However, the [* * *] 
     Company had skillfully and deliberately suppressed the facts 
     about the havoc it was wreaking on women's bodies. Neither I 
     nor my doctors were able to pinpoint the cause of my damage 
     for more than a decade. In 1984, one week after I was 
     married, I had to have an emergency total hysterectomy from 
     the cumulative damages I had suffered for so long. That time 
     bomb finally exploded and robbed me of my fertility. For all 
     those years, I was told that my problems were ``all in my 
     head'' The emotional wreckage is too painful to talk about. 
     If Congress cares about the health and safety of women, it 
     will defeat this legislation.

  Proponents of S. 687 will argue that we must pass this bill to end 
the litigation explosion from frivolous lawsuits resulting in runaway 
jury verdicts. To that end, S. 687 would impose the more difficult 
standard of clear and convincing evidence before a jury could impose 
punitive damages. Before we impose such a standard we must first have 
clear and convincing evidence that there is a problem that needs to be 
fixed. I am not convinced that that evidence exists.
  Madam President, before we take this step down the road to making it 
more difficult for consumers to receive full compensation for their 
injuries and remove important levers of accountability that deter 
manufacturers from unsafely cutting corners, we must listen to the many 
Americans like Ms. Hicks. And we must respect the important strides 
made by State legislatures in the area of tort law. We should not pass 
this bill.

  Mr. COHEN. Mr. President, I rise in opposition to S. 687, the Product 
Liability Act. The bill is an unnecessary and unwise encroachment on 
the States in an area in which they possess abundant legislative and 
judicial experience. The legislatures of each State have debated 
product liability issues, enacted laws, and refined these laws in 
accordance with the will of the people who live under them. 
Additionally, the courts of each State have interpreted these laws, 
wrestled with the legal nuances, and developed sound bodies of case 
law.
  This legislative and judicial experience has produced laws that 
strike a careful balance between the needs of plaintiffs and 
defendants, between the needs of consumers and businesses. These laws 
ensure that plaintiffs are redressed for injuries caused by defective 
products and ensure that defendants are protected from unwarranted 
lawsuits. S. 687 fails to strike the proper balance.
  Congress may, of course, impose its will on the States. As shown by 
Chief Justice Marshall's landmark opinion in Gibbons versus Ogden and 
by Justice Holmes's classic dissent in Hammer versus Dagenhart, the 
Commerce Clause is a source of great power for the Federal Government. 
Indeed, the Commerce Clause empowers Congress to preempt State law to 
ensure a coherent structure to the national economy--but Congress must 
exercise this power with great care. In ``The Federalist,'' James 
Madison notes the delicate balance between the Federal Government and 
the States, and he warns against ``ambitious encroachments of the 
Federal Government on the authority of the State governments.'' S. 687 
is such an encroachment.
  For over 200 years, principles of federalism have prevailed as tort 
law has remained the province of the States. During this time, State 
legislatures have examined the issues and worked to pass laws that are 
fair and just. Similarly, State courts have scrutinized these laws and 
developed a significant expertise as well as a solid body of 
jurisprudence. This legislative and judicial experience has produced 
systems that are, on the whole, knowledgeable, stable, and equitable.
  Absent an overwhelming need to alter this time-tested structure, it 
should be left alone. The Conference of Chief Justices agrees. Speaking 
on behalf of the Conference of Chief Justices at a recent Judiciary 
Committee hearing, Chief Justice Carrico of the Supreme Court of 
Virginia said: ``[T]he response [to any defects in the system] should 
be left to the States where the power to decide local questions has 
remained for more than 200 years. There is no reason to believe that 
the States will not exercise the power wisely.''
  The United States is a nation of States. The need for the States to 
exercise their autonomy can be traced from the Constitutional 
Convention and the early days of the Union to the present day. States 
play a vital role in promoting the public good and, as in the case of 
product liability, are often in a better position to fashion a system 
that is attentive to the needs of the people. Thomas Jefferson once 
wrote, ``Our country is too large to have all its affairs directed by a 
single government.'' This statement applies with particular force to 
the field of product liability.
  Proponents of S. 687 argue that uniformity is essential to product 
liability law. Although uniformity is beneficial in many areas of the 
law, in the area of product liability it is not. The federalism 
embodied in the present system of product liability law should be 
valued, not disparaged. The vague promise of uniformity should not lead 
us to lay waste to State statutes and State common law. The diversity 
of State rules of liability is a strength, not a weakness.
  Rather than have the Federal Government create rules for product 
liability, it would be better to continue to let each State experiment 
and devise a system for dealing with the problems particular to that 
State. As Justice Louis Brandeis stated:

       There must be power in the States * * * to remould, through 
     experimentation, our economic practices and institutions to 
     meet changing social and economic needs. * * * To stay 
     experimentation in things social and economic is a grave 
     responsibility. Denial of the right to experiment may be 
     fraught with serious consequences to the Nation. It is one of 
     the happy incidents of the federal system that a single 
     courageous State may, if its citizens choose, serve as a 
     laboratory; and try novel social and economic experiments 
     without risk to the rest of the country.

  Entering the field of product liability may be tempting for some, but 
we must resist the temptation or, like Pandora and her husband 
Epimetheus, we will regret our actions. If S. 687 is passed, the 
Federal Government will become forever ensnared in the field of product 
liability. In the next Congress, we will almost certainly have to 
revisit the very same issues that we are debating today. Interest 
groups will be clamoring for changes. At a time when the crush of 
legislation is already great, members of Congress will have to spend 
more time on product liability, leaving less for health care, crime, 
education, and other pressing Federal concerns.

  One provision of S. 687 is particularly striking and particularly 
troubling. Under section 4(e), decisions of a U.S. Court of Appeals 
interpreting this act would be binding on all Federal and State courts 
within the judicial circuit. Although the decisions of the Federal 
appellate courts should, obviously, bind the lower Federal courts, it 
is an affront to State sovereignty to have the decisions of Federal 
courts bind State courts.
  Such a provision is unprecedented. Two State chief justices have 
written that they know of no other congressional legislation using the 
language contained in section 4(e). Again, Chief Justice Carrico of 
Virginia has stated that section 4(e) is ``a serious threat to 
federalism'' and ``would reduce State supreme courts to second class 
citizens in the field of products liability law.'' Also, Chief Justice 
Feldman of Arizona, has stated that ``The suggestion that section 4(e) 
be included in the product liability bill is almost offensive to State 
courts.'' He added, ``It is one thing * * * to defer and another to be 
told to obey.'' Additionally, Federal judges whom I consulted have 
advised me that section 4(e) is both unseemly and unnecessary, and it 
has severe implications for federalism.
  Section 4(e) and the litigation engendered by the rest of S. 687 
would add to the Supreme Court's case load at a time when its docket is 
already full. In the field of tort law, State courts have proven to be 
sound arbiters. There is no need to burden the Supreme Court with cases 
involving complex questions of State and Federal law.
  Section 4(e) was included to ensure uniformity in the field of 
product liability. But by supplanting State statutory and common law 
governing the substantive rules of product liability, S. 687 would 
cause uncertainty and complexity rather than certainty and clarity. The 
Conference of Chief Justices has even commented that ``If the search is 
for * * * settled law, the goal will not be achieved through Federal 
product liability legislation. S. 687 would preempt all related State 
law and substitute Federal standards, with changed and untested terms 
and concepts. * * * A legal thicket is inevitable.''
  The Product Liability Act would thwart one of the primary goals of 
the civil justice system which, as stated in Rule 1 of the Federal 
Civil Rules of Procedure, is ``to secure the just, speedy, and 
inexpensive determination of every action.'' Both claimants and 
defendants would be harmed.
  We need a legal system that benefits all Americans: Consumers, 
manufacturers, workers, and sellers. S. 687 would not create such a 
system. It would unnecessarily intervene in an area best left to the 
States.
  From the beginning of the Republic to the Civil War to the present 
day, federalism has played in important role in the balance of power in 
the Nation--in the ability of the people to express their will. The 
federalism embodied in the current system of tort law is valuable and 
necessary. I am not convinced that S. 687 will make the field of 
product liability more equitable, predictable, or efficient. It is 
better for States to have the flexibility to tailor their product 
liability laws without Federal preemption.
  Finally, Mr. President, I want to briefly discuss the so-called 
liability crisis. For years proponents of Federal product liability 
legislation have claimed that the present system is to blame for 
skyrocketing costs, lawsuits running rampant, and a suffering economy. 
They say that this legislation is necessary because there is a crisis 
in product liability cases, but there is not a crisis.
  In reality, product liability claims declined by 36 percent in the 
Federal courts between 1985 and 1991, excluding the unique claims of 
asbestos. In State courts, all tort cases amount to less than 10 
percent of the total case load and only three-tenths of 1 percent of 
all civil cases.
  Critics of the present system also claim that there has been an 
explosion in punitive damage awards. It is important to note that the 
vast majority of States have reformed punitive damage rules. In the 
last 25 years, punitive damages have only been awarded 353 times in 
product liability cases; 25 percent of these awards were reversed or 
remanded on appeal.
  While proponents of Federal product liability standards assert that 
product liability cases costs American business $100 billion a year, 
the National Association of Insurance Commissioners pegs the actual 
figure at about $4 billion. This figures includes insurance premiums 
paid by businesses, actual damage awards and legal fees. As others have 
point out, $4 billion is less than what Americans spend annually on dog 
food. This is well under one-fifth of 1 percent of retail sales.
  In conclusion, Mr. President, after weighing the claims that a 
uniform body of Federal product liability law would promote 
competitiveness against the costs of abandoning our well-established 
decentralized system, I have concluded that Federal preemption of State 
product liability laws would be unnecessary and unwise. It would 
trample the rights of States, disregard their vital experience, impose 
blanket rules on regions that have different needs, abrogate the 
sovereignty of State courts, and unnecessarily entangle Congress in the 
field of product liability. The States have the experience and have 
demonstrated the ability to handle product liability claims.
  Mr. HEFLIN. Madam President, as we conclude debate on S. 687 relating 
to product liability legislation, I would especially like to thank all 
of those who have contributed to our efforts to get the facts before 
the Senate on this bill.
  I would like to recognize the staff members of those Senators who 
joined our cause and who assisted their particular Senators. Their 
tireless efforts to assist us in researching the various issues, which 
were often difficult and complex, should be recognized and appreciated. 
I know that they put in a great deal of overtime at night and on 
weekends as we prepared for the floor debate which has just ended.
  I want to thank Kevin Curtin, Moses Boyd, Claudia Simons, and Jim 
Drewry of Senator Hollings' staff; Gene Kimmelman and Mike Lenett of 
Senator Metzenbaum's staff; Sean Moylan of Senator Biden's staff; Jeff 
Neterval of Senator Feingold's staff; Pam Smith of Senator Moseley-
Braun's staff; Phil Buchan of Senator Harkin's staff; Ken Boley of 
Senator Wellstone's staff; Cathy Smith of Senator Shelby's staff; 
Thomas Moore of Senator Breaux's staff; Greg Rohde of Senator Dorgan's 
staff; Judy Applebaum of Senator Kennedy's staff; Laura Schiller of 
Senator Boxer's staff; Carlos Angulo of Senator Simon's staff; and 
Winston Lett of my subcommittee staff. Each should be recognized for 
the superb staff work they contributed on behalf of their individual 
Senators.
  Ms. MOSELEY-BRAUN. Madam President, whether the sponsors of S. 687 
had been successful in invoking cloture today or not, it is highly 
unlikely that this bill would have made its way to President Clinton's 
desk for his signature this year. The House of Representatives has not 
yet acted on its product liability legislation. This is a very busy 
year, and we are rapidly approaching the end of this Congress. All of 
these facts worked to undermine the prospects for completing action on 
S. 687 before we adjourn.
  The amendment pending to S. 687 when the motion for cloture failed 
was an amendment proposed by Senator Dorgan and I, to strike the ``FDA 
and FAA excuse'' provisions from S. 687. I very much regret that the 
procedural posturing on this legislation made it impossible for a vote 
to occur on our amendment, as well as on a number of other amendments 
that had been proposed prior to the cloture vote. Unfortunately, the 
U.S. Senate was put in the position that this bill could not get the 
time it deserved.
  While the time shortage and the procedural maneuvering made it 
impossible for me to vote for cloture today, I want to make it very 
clear that I have voted against cloture on this issue for the last 
time. The problems present in our product liability system are problems 
that this body must address.
  The current system is too slow. The transaction costs are to high. 
Given the fact that markets for products are now national and global in 
scope, there is a good case to be made for a Federal approach.
  That is not to say that I agree with every provision of S. 687 as 
currently drafted. I do not. Senator Dorgan and I proposed one 
amendment to strike the FDA excuse, and I daresay that had cloture been 
invoked I may have sponsored or cosponsored amendments to strike or 
modify other portions of the legislation.
  Unfortunately, the majority of the product liability debate this year 
focused on whether the Federal Government should get involved in this 
area. Our focus in the future must not be limited to whether the 
Federal Government should be involved in product liability reform, but 
should also address what standards are appropriate to apply in product 
liability actions.
  Before I close, Madam President, I want to thank Senators Rockefeller 
and Gorton for this willingness to address the issue of the FDA and FAA 
excuse. I greatly appreciate their willingness to listen to and act on 
the concerns Senator Dorgan and I raised, and I deeply regret that we 
were not able to vote on this issue.
  Finally, I simply stress that this issue--the issue of product 
liability reform--has been before the Senate for over a decade now. I 
want to state for the Record that I am committed to seeing that the 
next Congress acts on a bill that addresses the problems present in our 
current system, that is fair to consumers, employers, product sellers, 
and manufacturers. I believe that everyone who is interested in our 
civil justice system should come to the table and work with the 
Commerce Committee, Senator Rockefeller and the entire Congress to 
address and resolve the underlying issues.

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