[Congressional Record Volume 141, Number 77 (Wednesday, May 10, 1995)]
[Senate]
[Pages S6453-S6455]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
PRODUCT LIABILITY FAIRNESS ACT
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 Whitman-Walker 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 FDA-approved 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
[[Page S6454]] 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 non-economic 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
[[Page 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--1971-75.
____________________