May 10, 1995 CONGRESSIONAL RECORD — SENATE S6453

move to bring to a close debate on the pending committee substitute amendment to S.

534, the solid waste disposal bill.

John H. Chafee, Bob Dole, Bob Smith,

Jim Jeffords, Hank Brown, Kit Bond,

Orrin Hatch, Spencer Abraham, Jon

Kyl, Larry E. Craig, Kay Bailey

Hutchison, Trent Lott, R.F. Bennett,

Pete V. Domenici, Dirk Kempthorne,

(During today’s session of the SenJesse Helms.

MORNING BUSINESS

fate, the following morning business

was transacted:)

PRODUCT LIABILITY FAIRNESS

fACT

Mr. DODD. Mr. President, today the

Senate passed the Product Liability

Fairness Act, which I have cosponsored, by an overwhelming vote of 61–

37. For those of us who have been working on this issue for a long time—my

involvement dates back to 1985—this is

an historic day. With passage of this

balanced measure, we have taken a

huge step toward improving the product liability system for everyone—for

the injured people who need fast and

fair compensation, for consumers who

need quality products to choose from,

for those American businesses who are

at the cutting edge of international

competition, and for workers who depend on a strong economy to support

their families.

I commend Senator ROCKEFELLER

and Senator GORTON, and their staffs,

for their heroic efforts on this measure.

From drafting the legislation, to skillfully guiding it through a lengthy debate on the Senate floor, they have

worked extremely effectively. Their

success is reflected in the broad bipartisan coalition that supported the bill.

I also commend Senator LIEBERMAN,

my colleague from my home State of

Connecticut. He authored an important

section on biomaterials. That provision

is designed to ensure that manufacturers of life-saving and life-enhancing

medical devices have access to raw materials. In recent years, the supply of

raw materials has been threatened by

litigation. This is a critical problem,

and I commend Senator LIEBERMAN for

crafting a promising solution.

Of course, like any compromise, this

bill will not please everyone in all respects. I had drafted, for example, an

amendment providing a different approach to punitive damages. under my

amendment, the jury would determine

whether punitive damages are appropriate, and the judge, guided by certain

factors, would determine the amount.

That procedure, in my view, offers a

better approach to punitive damages

than one which provides limits, or

caps. Senators ROCKEFELLER and GORTON incorporated some aspects of my

proposal in the final provision, and I

appreciate their efforts on this difficult

issue.

The final version of this bill does not

contain a provision that I have supported in the past—the Government

standards defense. One aspects of that

defense, related to approval of drugs

and medical devices by the Food and

Drug Administration, was passed by

voice vote in the House and will, I understand, be considered in conference. I

ask unanimous consent that a number

of letters supporting this provision be

printed in the RECORD at the end of my

remarks. As these letters point out, inappropriate punitive damages have

convinced many corporate researchers

to avoid the search for safer and more

effective drugs.

Once again, I commend my colleagues, particularly Senators ROCKEFELLER and GORTON, for their bipartisan efforts on the Product Liability

Fairness Act.

There being no objection, the letters

were ordered to be printed in the

RECORD, as follows:

PHARMACEUTICAL RESEARCH AND

MANUFACTURERS OF AMERICA,

Washington, DC, April 25, 1995.

Hon. CHRISTOPHER J. DODD,

U.S. Senate,

Washington, DC

DEAR SENATOR DODD: As a physician volunteer, I treat AIDS patients at the WhitmanWalker Clinic. The suffering that I see—and

the threat of an ever-wider epidemic—convince me that the greatest gift anyone could

give to society would be an AIDS vaccine. If

I were the chairman of a philanthropic foundation, I would invest every dollar in vaccine

research.

However, if I were CEO of a pharmaceutical company, knowing that the investment in my company represented the retirement and college savings of many of my

stockholders, I wouldn’t touch AIDS vaccine

research with a ten-foot pole—until the liability issue has been successfully addressed.

Even the safest, most widely accepted vaccines entail risks—and potentially bankrupting liability burdens. Childhood vaccines are

available in adequate supply only because

Congress passed the Childhood Vaccine Compensation Act. This came about only because

several manufacturers got out of the business of manufacturing childhood vaccines

due to liability concerns—raising fears of a

dangerous scarcity.

In 1975, a man who got polio after changing

his baby’s diaper sued the manufacturer of

the Sabin polio vaccine, which the baby had

received. The risk of polio transmission was

known, but small—about 1 in 1 million. Nevertheless, the jury awarded punitive damages. The award was later reversed, but only

by the narrowest possible margin. The very

fact that such a widely acclaimed health advance could expose a manufacturer to punitive damages would certainly give pause to

any manufacturer considering research on an

AIDS vaccine—which entails special liability

risks.

With a preventive AIDS vaccine, people

who are vaccinated will probably turn HIV

positive—with all the social stigma and

threat of job loss or insurance loss that this

involves. There is a risk that a very small

number of people will get AIDS from the vaccine. Additionally, there is the risk that the

vaccine won’t ‘‘take’’ in all cases and that

some people who think they are protected

may engage in risky behavior and come

down with AIDS. All of these eventualities

could result in lawsuits.

In the case of therapeutic vaccines for people who already have the disease, it would be

very difficult to distinguish the symptoms of

AIDS from any side-effects of the vaccine.

And people with AIDS, prodded by unscrupulous lawyers, might easily be tempted to sue

vaccine manufacturers.

Unless the liability threat is alleviated—at

least by exempting manufacturers of FDAapproved products from punitive damages—

developing an AIDS vaccine is decidedly a

‘‘no-win’’ proposition. This is outrageous,

unfair, tragic—but true.

Sincerely,

JOHN D. SIEGFRIED, M.D.

MAY 2, 1995.

Hon. CHRISTOPHER J. DODD,

U.S. Senate,

Washington, DC.

DEAR SENATOR DODD: We are writing to ask

that you vote in favor of a proposal that we

believe will have a positive effect on research and development of new medicines

and medical devices. American innovation is

in trouble in the courts particularly in the

high risk areas of reproductive health. Liability fears have caused the withdrawal of

new drugs and medical devices that the Food

and Drug Administration (FDA) considers

safe and effective. We understand that when

S. 565, the ‘‘Product Liability Fairness Act

of 1995’’ is considered on the Senate floor, an

amendment will be offered that would prevent juries from second-guessing the FDA’s

scientific decisions that a drug is safe insofar

as punitive damages are concerned.

The proposed FDA-approval defense to punitive damages would establish a defense to

punitive damages in tort actions involving

drugs or devices approved by the FDA and

subject to FDA regulation. The defense

would apply only to punitive damages, and

would not be available to a manufacturer

that has withheld or misrepresented information to the FDA, including all required

post-approval disclosure of unexpected adverse effects.

In the past twenty years, most companies

have halted U.S. research on contraceptives

and drugs to combat infertility and morning

sickness. As a case in point, Bendectin, a

morning-sickness drug, was removed from

the market by its manufacturer in 1984 after

more than 2,000 lawsuits were filed claiming

it caused birth defects. Merrell Dow has

spent over $100 million defending those suits

and is still doing so. Even though almost

every court which has looked at the issue

has determined that there is no scientific

evidence to support the contention that the

drug causes birth defects, and even though

Bendectin is still approved by the FDA for

use in pregnancy, no manufacturer will risk

making a morning sickness drug.

The 1970s brought more litigation over oral

contraceptives than any other drug. In the

early 1970s, there were 13 companies doing

research and development on contraceptives.

Eight of these were American. Today there

are only two major U.S. companies doing

such research. In 1990, a distinguished panel

of scientists put together by the National

Academy of Sciences noted that due to fear

of lawsuits, the United States is decades behind Europe and other countries in the contraceptive choices it offers women.

In early 1994, because it had spent tens of

millions of dollars defending against suits by

people claiming injury from tempero-mandibular joint implants, DuPont announced it

would no longer make polymers available to

the medical device industry in the United

States. These polymers are used in artificial

hearts, pacemakers, catheters, hip and knee

prostheses, and a host of other implantable

devices. We have not even begun to feel the

full impact of that decision.

The Senate is taking advantage of an unprecedented opportunity to fix a flawed product liability system. We ask that you include
S6454 CONGRESSIONAL RECORD — SENATE May 10, 1995

a reform that will encourage the development of better medical products without impairing the ability of people who are injured

from recovering just compensation.

Sincerely,

NANCY SANDER,

Allergy and Asthma Network/Mothers of

Asthmatics, Fairfax, Virginia.

PATRICIA TOMPKINS,

National Black Nurses’ Association, Washington, DC.

DOROTHY I. HEIGH,

National Council of Negro Women, Inc.,

Washington, DC.

ADELE BAKER,

Wright, Robinson, McCammon, Osthimer

and Taturn, Washington, DC.

SUSAN WALDEN,

Renaissance Women Foundation, Washington, DC.

NATIONAL FAMILY PLANNING & REPRODUCTIVE HEALTH ASSOCIATION,

Washington, DC, May 1, 1995.

DEAR SENATOR: As the Senate considers S.

565, ‘‘The Product Liability Fairness Act of

1995,’’ we urge you to support a provision

known as the FDA defense. With the FDA defense, companies would not be held liable for

punitive damages in a lawsuit if the drug or

medical device involved received pre-market

approval from the FDA, and if the company

fully complied with the FDA’s rigorous requirements, which include specifying the

warnings that companies must provide about

their products and furnishing post-market

reports on adverse reactions.

As an organization dedicated to expanding

medical research and increasing access to

products that can improve women’s reproductive health, we know firsthand the extent

to which the current liability system is impeding these important goals. In 1990, a distinguished panel of scientists put together

by the National Academy of Sciences noted

that due to U.S. Pharmaceutical companies

fear of lawsuits, the United States is decades

behind Europe and other countries in the

contraceptive choices it offers women. An

FDA defense would begin to turn the tide on

this disturbing trend by encouraging research and development of products women

need without impairing the ability of women

who are injured by drugs and medical devices

to recover just compensation.

We are deeply distressed that opponents of

reform are mounting a fear-based campaign

directed at women as their strategy to block

change. A great deal of misinformation has

been circulated concerning the impact of the

FDA defense on women. We certainly recognize that women have had a painful history

with medical products, such as DES and the

Dalkon Shield, which have caused tragic injuries to women and their children. Opponents of an FDA defense are mistaken, however, in claiming this provision would have

prevented plaintiffs from collecting punitive

damages in these cases. In fact, the Dalkon

Shield was on the market before the Medical

Devices Amendment was adopted in 1976, and

thus, was never approved by the FDA. As for

DES, various manufacturers involved are alleged to have defrauded or withheld information from the FDA, and therefore would not

be covered by the FDA defense.

The FDA defense would allow plaintiffs to

obtain full compensatory damages and noneconomic damages, including medical costs,

lost wages, loss of functioning, and pain and

suffering. We would not support the FDA defense if limited a plaintiff’s ability to obtain

full compensatory and non-economic damages in any manner. The FDA defense would

limit only punitive damages. Also, the FDA

defense would not be available to any company that is found to have lied or withheld

information from the FDA or otherwise

failed to comply with FDA rules.

The FDA defense is crucial given the current legal climate. A quick review of recent

events clearly points out the impact of current policies. During the 1970s, there were 13

companies doing research and development

on contraceptives. Eight of these companies

were American. Today, only two American

companies continue to conduct such research.

Given the current legal climate, it is easy

to understand why companies are increasingly reluctant to make available products,

despite their known therapeutic value. Two

cases in point:

Bendectin, a morning sickness drug that

was taken by over 30 million American

women, was removed from the market by its

manufacturer in 1984, after more than 2,000

lawsuits were filled claiming it caused birth

defects. The manufacturer has spent over

$100 million defending those lawsuits and is

still doing so. Even though almost every

court that has looked at the issue has determined there is no scientific evidence to support the contention that the drug causes

birth defects, and even though Bendectin is

still approved by the FDA for use during

pregnancy, no other manufacturer will risk

making a morning sickness drug.

Norplant, one of the most significant contraceptive developments of the past 20 yeas

in the United States, was approved by the

FDA in 1990. It is now the target of numerous

cookie cutter, mass-produced class action

lawsuits fueled by sensationalism and slick

advertising directed at women. Despite the

fact that Norplant continues to be supported

by the medical community—as recently as a

March 1995 endorsement by the American Society for Reproductive Medicine—many

women have been driven by unwarranted

fears away from a safe and effective contraceptive product.

Punitive damages are meant to punish

willful, flagrant, malicious or grossly illegal

behavior. A company that has compiled in

good faith with the FDA’s regulations cannot be guilty of such behavior and should not

be threatened with punitive damages. Nor

should juries be permitted to second-guess

the expert judgment of the FDA on whether

the benefits of a drug outweigh the risks.

Increasingly, the legitimate concerns for

the health and welfare of American women

are being sidelined in the pursuit of large financial settlements. It is our view that inclusion of a FDA defense, similar to the one

included in the House-passed product liability bill, would provide a much needed incentive for increased investment in women’s

health research and technologies. We believe

this is a measured response and we urge you

to adopt an FDA defense in any final product

liability legislation.

Sincerely,

JUDITH M. DESARNO,

President/CEO, National Family Planning

and Reproductive Health Association.

PHYLLIS GREENBERGER,

Executive Director, Society of the Advancement of Women’s Health Research.

DENNIS BARBOUR, J.D.

President, Association of Reproductive

Health Professionals.

LINDA BARNES BOLTON, DR.

P.H., R.N, FAAN,

President, National Black Nurses’ Association, Inc.

SUSAN WYSOCKI, RNC, NP,

President, National Association of Nurse

Practitioners in Reproductive Health.

MAY 1, 1995.

Hon. CHRISTOPHER J. DODD,

SR–444 Russell Senate Office Building, Washington, DC.

DEAR SENATOR DODD: We have been asked

to convey our views with regard to an

amendment to H.R. 956, the Product Liability Fairness Act, to establish a defense to

punitive damages for FDA-approved drugs

and devices. Each of the undersigned has

served at some time as Chief Counsel to the

Food and Drug Administration. Each of us,

in our current professional capacities, advises firms engaged in the manufacture of

drugs and devices. However, the views expressed in this letter reflect our shared personal judgment.

The proposed defense to punitive damages

for the marketing of medical products that

meet applicable federal regulatory requirements makes eminent sense as a matter of

public policy and can be expected to facilitate the development and continued availability of important products to treat and

prevent serious disease and to address other

significant health concerns. We describe

below FDA’s philosophy of new drug regulation and its powers in this area, which, we

believe, strongly support the defense.

FDA exercises sweeping authority over the

development, manufacture, and marketing of

pharmaceuticals. Indeed, no other industry

in this country is subject to such a comprehensive regulatory scheme. Pursuant to

its statutory mandate, FDA requires premarket approval of all new drugs. A new

drug may not be approved unless it has been

shown to be safe and effective under the conditions of use described in its labeling.

In making their approval decisions, FDA

physicians and scientists employ a risk-benefit standard. This standard recognizes that

all drugs have unavoidable risks, some of

them very serious. Therefore, FDA allows

drugs onto the market only when the benefits from using a drug outweigh those risks.

A drug’s labeling is an important factor in

making the approval decision. Once a drug is

available, the treating physician, apprised of

the recognized significant risks of a drug,

can make an informed decision whether a

drug is appropriate for use in a particular patient.

Inevitably, not all of the risks from a drug

can be discovered prior to approval. While

manufacturers are required to conduct extensive clinical trials, often in thousands of

patients, some adverse events are so rare

that they emerge only after a drug is in

widespread use after approval. FDA therefore

requires manufacturers to report all adverse

events to the agency. The most serious of

these must be reported within 15 days. FDA

and the Justice Department have vigorously

enforced the adverse event reporting requirements through a series of widely publicized

criminal prosecutions.

FDA has the power to act swiftly and decisively when postmarket surveillance does

identify a safety issue. The Secretary of

Health and Human Services can immediately

suspend approval of a drug that poses an imminent hazard, prior even to granting the

manufacturer a hearing. FDA also can compel labeling changes to incorporate new safety information. As a practical matter, formal action under any of these authorities is

rarely necessary because, in our experience,

companies generally comply voluntarily

with agency requests.

With this context, the desirability of the

punitive damages defense is readily apparent. Where manufacturers have complied

with all of FDA’s approval, labeling, and

safety reporting requirements, they should

not be open to punishment through the imposition of punitive damages. This defense

does nothing to restrict the availability of
May 10, 1995 CONGRESSIONAL RECORD — SENATE S6455

compensatory damages. Injured persons will

still be made whole for their losses under the

law. And they will even be able to recover

punitive damages in cases where their injuries were caused by violations of FDA regulations. The defense simply recognizes—as a

clear rule—that manufacturers who comply

with FDA’s comprehensive regulatory process do not manifest the type of willful misconduct that could merit punitive damages.

While we recognize that the imposition of

punitive damages is a comparatively rare

(but by no means unknown) event, the threat

of punitive damage awards skews the entire

litigation process and, with it, the process

for developing new drugs and making them

available to the public. Pharmaceutical

manufacturers have withdrawn beneficial

products from the market and have ceased

promising research because of this threat.

Congress is now in the position to remove

this obstacle and thereby to make a genuine

contribution to the public health. We therefore urge you to support the FDA approval

amendment to H.R. 956.

Sincerely,

THOMAS SCARLETT,

Hyman Phelps & McNamara, Chief Counsel—1981–89.

NANCY L. BUC,

Buc Levitt & Beardsley, Chief Counsel—

1980–81.

RICHARD A. MERRILL,

Covington & Burling, Chief Counsel—1975–

77.

RICHARD M. COOPER,

Williams & Connolly, Chief Counsel—1977–

79.

PETER BARTON HUTT,

Covington & Burling, Chief Counsel—1971–

CONGRATULATING SENATOR DOLE

ON THE EISENHOWER LEADER75.

fSHIP PRIZE

Mrs. KASSEBAUM. Mr. President,

last night my colleague from Kansas,

Senator DOLE, received the prestigious

Eisenhower Leadership Prize in recognition of his distinguished service to

the United States. I have long admired

Senator DOLE for his leadership and

dedicated service and am pleased that

the Eisenhower World Affairs Institute

and Gettysburg College recognized him

with such a high honor.

This prize is made all the more notable because Dwight D. Eisenhower, the

award’s namesake, is a fellow Kansan

and Senator DOLE’s hero. I add my

voice to the many who congratulate

him on this honor and ask unanimous

consent that the remarks Senator

DOLE gave last night be printed in the

RECORD.

There being no objection, the remarks were ordered to be printed in

the RECORD, as follows:

I want to thank the Trustees of The Eisenhower World Affairs Institute and Gettysburg College for this honor.

I am truly humbled to receive this award.

And I thank the Awards Committee for dipping down in the military ranks. The first

Leadership Prize went to General Scowcroft.

The second to General Colin Powell. Last

year you honored Major Lloyd Bentsen. And

this year, you’re down to Lieutenant Bob

Dole. I guess there’s still hope for all you

Privates out there.

A special word of thanks to my colleagues

from the 10th Mountain Division who joins

us this evening. I’ve always wondered why

they assigned a kid from the plains of Kansas to the 10th Mountain Division. But I’ve

never wondered about the men I served beside. You are all heroes in my book.

A few years back, the 10th Mountain veterans formed a national association. Over the

years, there have been five Presidents of the

Association, and I am honored that all five

are here this evening. At least they got to be

President of something.

I am also honored by the presence of many

friends and colleagues of President Eisenhower and of several members of the Eisenhower family.

I have been privileged to get to know John

on several occasions—including the Eisenhower Centennial in Abilene in 1990, and a

few years ago in the Capitol when we unveiled the sign which marks the Eisenhower

Interstate Highway System.

Elizabeth and I are very proud to call

David and Julie Eisenhower our friends.

We’ve also had the pleasure of meeting their

children, and can tell you that David and

Julie are as good as parents as they are authors.

And Mary Eisenhower Atwater was the one

who came to my office last year to inform

me of my selection as the recipient of this

prize. The only promise I had to make to her

was that my acceptance remarks would be

brief.

In fact, I am tempted to do this evening

what Ike did one evening when he was President of Columbia University. At the end of a

long evening of speeches, Eisenhower’s turn

came. After being introduced, he stood up

and reminded his audience that every speech,

written or otherwise, had to have a punctuation. He said, ‘‘Tonight, I am the punctuation. I am the period.’’ And he sat down. He

later said that was one of the most popular

speeches he ever gave.

It is a bit intimidating to talk about President Eisenhower and his legacy before family members and friends and who knew him

much better than I.

I can say, however, that, like countless

Kansans and countless Americans, I not only

‘‘liked Ike,’’ I regarded him as a hero. I will

never forget the first time I saw him. It was

the spring of 1952. I had just finished law

school, and was serving in the Kansas House

of Representatives. General Eisenhower had

come home to Abilene to officially launch

his Presidential campaign, and I was in the

rain-soaked audience that greeted him.

That campaign was, of course, wildly successful. And I took it as a good omen that

my official announcement in Topeka on

April 10 had to be moved indoors because of

rain.

I did have the privilege of meeting my hero

on several occasions during his lifetime, but

the truth is I knew him no better than the

countless soldiers who called him our general, and the millions of Americans who

called him our President.

Eisenhower succeeded as a soldier and as a

President for many reasons. Intelligence.

Courage. Honesty. Leadership. The ability to

place the right people in the right spots.

These were all qualities Ike possessed.

But as I look at the Eisenhower statue in

the reception area of my Capitol office, or

the painting of Ike that hangs behind my

desk, one word often comes to mind. And

that word is ‘‘Trust.’’

Ike inspired trust as no leader has before

or since. Millions of Americans may have

voted for Adlai Stevenson in 1952 and 1956,

but everyone trusted President Eisenhower

to do what was best for America.

And there’s a simple reason why America’s

citizens trusted Ike. And that’s because he

trusted America’s citizens. Don’t get me

wrong. President Eisenhower believed in government—our Interstate Highway System is

proof of that. But, moreover, Ike believed in

citizens. He believed in the wisdom of the

American people.

When Ike looked at America’s people he

saw himself. According to David Eisenhower,

the title that meant the most to his grandfather was not ‘‘Supreme Commander,’’ or

‘‘President;’’ rather it was the simple title

that all Americans share: The title of ‘‘citizen.’’

And David reminded me of a speech Ike

made in London the month after VE Day.

Ike said, ‘‘To preserve his freedom of worship, his equality before law, his liberty to

speak and act as he sees fit, subject only to

provisions that he trespass not upon similar

rights of others—a Londoner will fight. So

will a citizen of Abilene.’’

Throughout World War II, Ike saw himself

as someone who would do what any American citizen would do when freedom was at

risk. And throughout his Presidency, Ike

spoke of how all of us shared with him the

responsibility of guiding our country.

As Ike said in his first Inaugural address,

‘‘We are summoned to act in wisdom and in

conscience, to work with industry, to teach

with persuasion, to preach with conviction,

to weigh our every deed with care and with

compassion. For this truth must be clear before us: Whatever America hopes to bring to

pass in the world must first come to pass in

the heart of America.’’

What do those words mean in the America

of 1995? I believe they mean we should rededicate ourselves to remembering the duties of citizenship: To keep informed and to

become involved in the decisions that affect

the life and future of all the citizens of our

country.

And they also mean that government

should trust the American people with decisions that matter most—the decisions that

affect their families and their businesses.

To be sure, the 1950’s weren’t perfect. And

as we look to the 21st century, we should not

seek to return to those times. But what I

hope America can return to is a relationship

of trust between the people and their government. And if that’s to happen, then we must

rein in the federal government. It’s too big,

too intrusive, and makes too many decisions.

I carry a copy of the 10th Amendment with

me wherever I go. It’s only 28 words long.

And it basically states that all powers not

specifically delegated to the federal government should be given to the states, and to

the people. Dusting off that amendment, and

restoring it to its rightful place in the Constitution is my mandate as Majority Leader,

and I like to think that it’s a mandate that

Ike would have heartily endorsed.

Perhaps Ike said it best when he responded

to those who were urging bigger and bigger

government, all in the name of providing

Americans with security.

‘‘If all that Americans want is security,

they can go to prison,’’ Ike said. ‘‘They’ll

have enough to eat, a bed, and a roof over

their heads.

But he went on to say that citizens want

more than security. We also want freedom.

We want dignity. We want control of our

lives. We want our government to trust us.

And the lesson that Ike taught us is that if

the American people believe our government

trusts us, then we will trust our government

in return.

Americans also trusted Ike because he

trusted us with the truth. As Supreme Commander, Ike never hid the truth from his soldiers. If a mission was dangerous * * * if

some wouldn’t be coming home, then Ike laid

it on the line. And, with his Kansas candor,

he spoke about issues that many in Washington today shy away from. One of those was

the federal budget.