[Congressional Record Volume 144, Number 64 (Tuesday, May 19, 1998)]
[House]
[Pages H3377-H3392]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
RICKY RAY HEMOPHILIA RELIEF FUND ACT OF 1998
Mr. HYDE. Madam Speaker, I move to suspend the rules and pass the
bill (H.R. 1023) to provide for compassionate payments with regard to
individuals with blood-clotting disorders, such as hemophilia, who
contracted human immunodeficiency virus due to contaminated blood
products, and for other purposes, as amended.
The Clerk read as follows:
H.R. 1023
Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
(a) Short Title.--This Act may be cited as the ``Ricky Ray
Hemophilia Relief Fund Act of 1998''.
(b) Table of Contents.--The table of contents of this Act
is as follows:
Sec. 1. Short title; table of contents.
TITLE I--HEMOPHILIA RELIEF FUND
Sec. 101. Ricky Ray Hemophilia Relief Fund.
Sec. 102. Compassionate payment relating to individuals with blood-
clotting disorders and HIV.
Sec. 103. Determination and payment.
Sec. 104. Limitation on transfer of rights and number of petitions.
Sec. 105. Time limitation.
Sec. 106. Certain claims not affected by payment.
Sec. 107. Limitation on agent and attorney fees.
Sec. 108. Definitions.
TITLE II--TREATMENT OF CERTAIN PRIVATE SETTLEMENT PAYMENTS IN
HEMOPHILIA-CLOTTING-FACTOR SUIT UNDER THE MEDICAID AND SSI PROGRAMS
Sec. 201. Treatment of certain private settlement payments in
hemophilia-clotting-factor suit under the Medicaid and
SSI programs.
TITLE I--HEMOPHILIA RELIEF FUND
SEC. 101. RICKY RAY HEMOPHILIA RELIEF FUND.
(a) Establishment.--There is established in the Treasury of
the United States a trust fund to be known as the ``Ricky Ray
Hemophilia Relief Fund'', which shall be administered by the
Secretary of the Treasury.
(b) Investment of Amounts in Fund.--Amounts in the Fund
shall be invested in accordance with section 9702 of title
31, United States Code, and any interest on and proceeds from
any such investment shall be credited to and become part of
the Fund.
(c) Availability of Fund.--Amounts in the Fund shall be
available only for disbursement by the Secretary of Health
and Human Services under section 103.
(d) Termination.--The Fund shall terminate upon the
expiration of the 5-year period beginning on the date of the
enactment of this Act. If all of the amounts in the Fund have
not been expended by the end of the 5-year period,
investments of amounts in the Fund shall be liquidated, the
receipts of such liquidation shall be deposited in the Fund,
and all funds remaining in the Fund shall be deposited in the
miscellaneous receipts account in the Treasury of the United
States.
(e) Authorization of Appropriations.--There is authorized
to be appropriated to the Fund to carry out this title
$750,000,000.
SEC. 102. COMPASSIONATE PAYMENT RELATING TO INDIVIDUALS WITH
BLOOD-CLOTTING DISORDERS AND HIV.
(a) In General.--If the conditions described in subsection
(b) are met and if there are sufficient amounts in the Fund
to make each payment, the Secretary shall make a single
payment of $100,000 from the Fund to any individual who has
an HIV infection and who is described in one of the following
paragraphs:
(1) The individual has any form of blood-clotting disorder,
such as hemophilia, and was treated with antihemophilic
factor at any time during the period beginning on July 1,
1982, and ending on December 31, 1987.
(2) The individual --
(A) is the lawful spouse of an individual described in
paragraph (1); or
(B) is the former lawful spouse of an individual described
in paragraph (1) and was the lawful spouse of the individual
at any time after a date, within the period described in such
subparagraph, on which the individual was treated as
described in such paragraph and through medical documentation
can assert reasonable certainty of transmission of HIV from
individual described in paragraph (1).
(3) The individual acquired the HIV infection through
perinatal transmission from a parent who is an individual
described in paragraph (1) or (2).
(b) Conditions.--The conditions described in this
subsection are, with respect to an individual, as follows:
(1) Submission of medical documentation of hiv infection.--
The individual submits to the Secretary written medical
documentation that the individual has an HIV infection.
(2) Petition.--A petition for the payment is filed with the
Secretary by or on behalf of the individual.
(3) Determination.--The Secretary determines, in accordance
with section 103(b), that the petition meets the requirements
of this title.
SEC. 103. DETERMINATION AND PAYMENT.
(a) Establishment of Filing Procedures.--The Secretary of
Health and Human Services shall establish procedures under
which individuals may submit petitions for payment under this
title. The procedures shall include a requirement that each
petition filed under this Act include written medical
documentation that the relevant individual described in
section 102(a)(1) has (or had) a blood-clotting disorder,
such as hemophilia, and was treated as described in such
section.
(b) Determination.--For each petition filed under this
title, the Secretary shall determine whether the petition
meets the requirements of this title.
(c) Payment.--
(1) In general.--To the extent there are sufficient amounts
in the Fund to cover each payment, the Secretary shall pay,
from the Fund, each petition that the Secretary determines
meets the requirements of this title in the order received.
(2) Payments in case of deceased individuals.--
(A) In general.--In the case of an individual referred to
in section 102(a) who is deceased at the time that payment is
made under this section on a petition filed by or on behalf
of the individual, the payment shall be made as follows:
(i) If the individual is survived by a spouse who is living
at the time of payment, the payment shall be made to such
surviving spouse.
[[Page H3378]]
(ii) If the individual is not survived by a spouse
described in clause (i), the payment shall be made in equal
shares to all children of the individual who are living at
the time of the payment.
(iii) If the individual is not survived by a person
described in clause (i) or (ii), the payment shall be made in
equal shares to the parents of the individual who are living
at the time of payment.
(iv) If the individual is not survived by a person
described in clause (i), (ii), or (iii), the payment shall
revert back to the Fund.
(B) Filing of petition by survivor.--If an individual
eligible for payment under section 102(a) dies before filing
a petition under this title, a survivor of the individual may
file a petition for payment under this title on behalf of the
individual if the survivor may receive payment under
subparagraph (A).
(C) Definitions.--For purposes of this paragraph:
(i) The term ``spouse'' means an individual who was
lawfully married to the relevant individual at the time of
death.
(ii) The term ``child'' includes a recognized natural
child, a stepchild who lived with the relevant individual in
a regular parent-child relationship, and an adopted child.
(iii) The term ``parent'' includes fathers and mothers
through adoption.
(3) Timing of payment.--The Secretary may not make a
payment on a petition under this title before the expiration
of the 120-day period beginning on the date of the enactment
of this Act or after the expiration of the 5-year period
beginning on the date of the enactment of this Act.
(d) Action on Petitions.--The Secretary shall complete the
determination required by subsection (b) regarding a petition
not later than 120 days after the date the petition is filed
under this title.
(e) Humanitarian Nature of Payment.--This Act does not
create or admit any claim of or on behalf of the individual
against the United States or against any officer, employee,
or agent thereof acting within the scope of employment or
agency that relate to an HIV infection arising from treatment
with antihemophilic factor, at any time during the period
beginning on July 1, 1982, and ending on December 31, 1987. A
payment under this Act shall, however, when accepted by or on
behalf of the individual, be in full satisfaction of all such
claims by or on behalf of that individual.
(f) Administrative Costs Not Paid From Fund.--No costs
incurred by the Secretary in carrying out this title may be
paid from the Fund or set off against, or otherwise deducted
from, any payment made under subsection (c)(1).
(g) Termination of Duties of Secretary.--The duties of the
Secretary under this section shall cease when the Fund
terminates.
(h) Treatment of Payments Under Other Laws.--A payment
under subsection (c)(1) to an individual--
(1) shall be treated for purposes of the Internal Revenue
Code of 1986 as damages described in section 104(a)(2) of
such Code;
(2) shall not be included as income or resources for
purposes of determining the eligibility of the individual to
receive benefits described in section 3803(c)(2)(C) of title
31, United States Code, or the amount of such benefits, and
such benefits shall not be secondary to, conditioned upon
reimbursement from, or subject to any reduction because of
receipt of, any such payment; and
(3) shall not be treated as a third party payment or
payment in relation to a legal liability with respect to such
benefits and shall not be subject (whether by subrogation or
otherwise) to recovery, recoupment, reimbursement, or
collection with respect to such benefits (including the
Federal or State governments or any entity that provides such
benefits under a contract).
(i) Regulatory Authority.--The Secretary may issue
regulations necessary to carry out this title.
(j) Time of Issuance of Procedures.--The Secretary shall,
through the promulgation of appropriate regulations,
guidelines, or otherwise, first establish the procedures to
carry out this title not later than 120 days after the date
of the enactment of this Act.
SEC. 104. LIMITATION ON TRANSFER OF RIGHTS AND NUMBER OF
PETITIONS.
(a) Rights Not Assignable or Transferable.--Any right under
this title shall not be assignable or transferable.
(b) 1 Petition With Respect to Each Victim.--With respect
to each individual described in paragraph (1), (2), or (3) of
section 102(a), the Secretary may not make payment with
respect to more than 1 petition filed in respect to an
individual.
SEC. 105. TIME LIMITATION.
The Secretary may not make any payment with respect to any
petition filed under this title unless the petition is filed
within 3 years after the date of the enactment of this Act.
SEC. 106. CERTAIN CLAIMS NOT AFFECTED BY PAYMENT.
A payment made under section 103(c)(1) shall not be
considered as any form of compensation, or reimbursement for
a loss, for purposes of imposing liability on the individual
receiving the payment, on the basis of such receipt, to repay
any insurance carrier for insurance payments or to repay any
person on account of worker's compensation payments. A
payment under this title shall not affect any claim against
an insurance carrier with respect to insurance or against any
person with respect to worker's compensation.
SEC. 107. LIMITATION ON AGENT AND ATTORNEY FEES.
Notwithstanding any contract, the representative of an
individual may not receive, for services rendered in
connection with the petition of an individual under this
title, more than 5 percent of a payment made under this title
on the petition. Any such representative who violates this
section shall be fined not more than $50,000.
SEC. 108. DEFINITIONS.
For purposes of this title:
(1) The term ``AIDS'' means acquired immune deficiency
syndrome.
(2) The term ``Fund'' means the Ricky Ray Hemophilia Relief
Fund.
(3) The term ``HIV'' means human immunodeficiency virus.
(4) Unless otherwise provided, the term ``Secretary'' means
Secretary of Health and Human Services.
TITLE II--TREATMENT OF CERTAIN PAYMENTS IN HEMOPHILIA-CLOTTING-FACTOR
SUIT UNDER THE SSI PROGRAM
SEC. 201. TREATMENT OF CERTAIN PAYMENTS IN HEMOPHILIA-
CLOTTING-FACTOR SUIT UNDER THE MEDICAID AND SSI
PROGRAMS.
(a) Private Payments.--
(1) In general.--Notwithstanding any other provision of
law, the payments described in paragraph (2) shall not be
considered income or resources in determining eligibility
for, or the amount of--
(A) medical assistance under title XIX of the Social
Security Act, or
(B) supplemental security income benefits under title XVI
of the Social Security Act .
(2) Private payments described.--The payments described in
this subsection are--
(A) payments made from any fund established pursuant to a
class settlement in the case of Susan Walker v. Bayer
Corporation, et al., 96-C-5024 (N.D. Ill.); and
(B) payments made pursuant to a release of all claims in a
case--
(i) that is entered into in lieu of the class settlement
referred to in subparagraph (A); and
(ii) that is signed by all affected parties in such case on
or before the later of--
(I) December 31, 1997, or
(II) the date that is 270 days after the date on which such
release is first sent to the persons (or the legal
representative of such persons) to whom the payment is to be
made.
(b) Government Payments.--
(1) In general.--Notwithstanding any other provision of
law, the payments described in paragraph (2) shall not be
considered income or resources in determining eligibility
for, or the amount of supplemental security income benefits
under title XVI of the Social Security Act.
(2) Government payments described.--The payments described
in this subsection are payments made from the fund
established pursuant to section 101 of this Act.
Amend the title so as to read: ``A bill to provide for
compassionate payments with regard to individuals with blood-
clotting disorders, such as hemophilia, who contracted human
immunodeficiency virus due to contaminated antihemophilic
factor, and for other purposes.''.
The SPEAKER pro tempore. Pursuant to the rule, the gentleman from
Illinois (Mr. Hyde) and the gentleman from Virginia (Mr. Scott) each
will control 20 minutes.
The Chair recognizes the gentleman from Illinois (Mr. Hyde).
General Leave
Mr. HYDE. Madam Speaker, I ask unanimous consent that all Members may
have 5 legislative days within which to revise and extend their remarks
on the bill presently under consideration.
The SPEAKER pro tempore. Is there objection to the request of the
gentleman from Illinois?
There was no objection.
Mr. HYDE. Madam Speaker, I yield myself such time as I may consume.
Madam Speaker, I rise in support of H.R. 1023, the Ricky Ray
Hemophilia Relief Fund Act of 1998. This legislation has 270 cosponsors
in the House, including our distinguished Speaker; and I am informed
the Minority Leader also supports this legislation.
When communities in our great Nation are devastated by a natural
disaster such as floods or tornadoes, we rush to their aid, as well we
should. The hemophilia community has been devastated by another type of
natural disaster, the HIV contamination of the blood-clotting products
which they need to treat their hemophilia. This legislation provides
the disaster relief necessary to assist this community through a very
difficult time.
In the late 1970s and early 1980s, half of all people with blood-
clotting disorders in the United States were infected with HIV due to
their use of blood-clotting products which were on the market at that
time. During this period, people with blood-clotting disorders needed
to use these products to live a relatively normal life; and because
each dose came from a pool of
[[Page H3379]]
thousands of blood donors, it was almost certain that they would become
HIV infected.
{time} 1215
However, at that time HIV had not been identified and no tests were
available to detect its presence. Most people with blood clotting
disorders are already financially strapped by the medical costs they
incur to treat their disorder. With earlier medical costs of over
$150,000 and the added tragedies of an HIV infection, these families
have been emotionally and financially devastated.
In cases involving other types of blood and blood products, such as
transfusion cases, where a primary provider or a small child was
infected, settlements usually were for hundreds of thousands of
dollars. Many of the HIV infected people with hemophilia were young
fathers and children.
After many years of litigation, the manufacturers of these blood
clotting products containing HIV have set up a fund which provides
$100,000 to individuals and their families. However, when considering
the incredible financial burden placed on these families due to medical
costs and, in many cases, loss of the primary provider of the family,
this amount will not sufficiently lift this community out of the
financial crisis that has developed.
While no amount will completely alleviate the losses felt, H.R. 1023
provides a payment equal to that of the industry. The amount available
to these families would then be comparable to that potentially realized
by other HIV-infected blood victims through settlement.
There is a manager's amendment to this legislation. The bill as
reported by the committee included a provision of no more than 2
percent of these payments that may be used for attorneys' fees. Concern
was raised during committee consideration that should there be a
complication in the processing of an individual's application, 2
percent would be insufficient to address that concern, and the 2
percent limitation on attorneys' fees has been increased to 5 percent.
I know my budget-conscious colleagues may balk at this expenditure,
but when an extreme crisis hits an American community, we should as a
Nation respond to that community's need. That is what this bill does.
To aid this community in crisis, I urge a favorable vote on H.R. 1023.
Madam Speaker, I reserve the balance of my time.
Mr. SCOTT. Madam Speaker, I yield myself such time as I may consume.
Madam Speaker, I rise in support of H.R. 1023, the Ricky Ray
Hemophilia Relief Fund Act of 1998. The purpose of the bill is to
establish a fund to provide compassionate payments of $100,000 to
individuals with hemophilia who contracted HIV, the AIDS virus, from
contaminated blood-clotting products.
Hemophilia is a blood-clotting disorder genetically passed to sons by
their mothers. In the late 1970s and early 1980s approximately 7,200
boys and men were infected with HIV through the use of blood-clotting
products. That is nearly half of all people with hemophilia in the
United States.
Because these blood-clotting products were derived from pools made up
of literally thousands of donors, including prisoners, it has been
nearly impossible to conclude causation and liability to any one
manufacturer for selling contaminated blood products. Although, as the
chairman mentioned, many cases have been settled, of the dozen or so
cases that eventually went to trial, the manufacturers were only held
liable in two cases, one of which was reversed and the other is still
on appeal. To make matters worse, many of the States have passed so-
called blood shield laws to protect blood banks from liability when
blood-based diseases are passed on to users.
Notwithstanding the industry's courtroom success and new blood shield
laws, the industry recently established a fund to provide $100,000 to
individuals who contracted HIV through contaminated blood-clotting
products in exchange for signing waivers releasing the industry from
any future liability. Many hemophiliacs and their families have
accepted this offer. Unfortunately, the $100,000 industry payment is
insufficient to cover the enormous costs of blood-clotting drugs which
people with hemophilia must continue to have in order to live a
relatively normal life, and the enormous costs of drugs to combat the
AIDS virus. Accordingly, this legislation is necessary to provide
additional financial assistance.
The administration supports this proposal. We want to thank the
chairman for the manager's amendment to increase the attorneys' fee
provision from 2 to 5 percent, because we support this amendment,
because we believe that it will allow claimants greater access to legal
counsel in processing their applications under the bill.
Madam Speaker, I reserve the balance of my time.
Mr. HYDE. Madam Speaker, I am pleased to yield 8 minutes to the
distinguished gentleman from Florida (Mr. Goss), one of the driving
forces behind this excellent legislation.
(Mr. GOSS asked and was given permission to revise and extend his
remarks and include extraneous material.)
Mr. GOSS. Madam Speaker, I thank the distinguished gentleman from
Illinois (Mr. Henry Hyde), chairman of the Committee on the Judiciary,
with my great respect for him, and I thank him personally from my heart
for getting this legislation this far.
Madam Speaker, I rise today in support of H.R. 1023, the Ricky Ray
Hemophilia Relief Fund Act, which is designed to respond to the
tragedies of hemophilia-associated AIDS.
I first became involved in this issue some nine years ago when I met
the Ray family. Ricky Ray, like his two brothers, contracted HIV
through the use of contaminated blood products. Ricky, the eldest of
the three boys, died of AIDS in 1992 at the age of 15. Before his death
Ricky and his family courageously spoke out and became national symbols
of the terrible situation we are facing. He inspired many of his peers
to tell their stories and begin seeking answers from the Federal
Government and the blood product manufacturing industry.
I am saddened that he did not live to see the day when legislation
named in his honor would win the approval of this body. But we know his
brothers and sisters, his parents, and the extended family of friends
he established around the country recognize the enormous contribution
that he made in his very short life. It is appropriate that the
legislation before us bears his name, and I am pleased that Ricky's
mother Louise is here with us today.
Madam Speaker, hemophilia is an inherited blood-clotting disorder
causing serious internal bleeding episodes that, if left untreated, can
lead to disfigurement and death. People with hemophilia rely on blood
products, commonly called factor, which are manufactured and sold by
pharmaceutical companies.
Because these products are made from the pooled blood of thousands of
people, the potential for infection with a blood-borne disease among
those who use them is obviously very high, something that has been
known for decades. In fact, hemophilia sufferers have long been
described as the canaries in the coal mine, because when something goes
wrong with the blood supply it shows up in the hemophilia community
first.
Soon after the introduction of clotting factor in the 1970s, the
hepatitis virus swept through the hemophilia community. Largely as a
result of the hemophilia community's experience with the hepatitis
virus, the Federal Government adopted the national blood policy, which
charged the Public Health Service, including the Centers for Disease
Control, Food and Drug, and the National Institutes of Health with
ensuring the safety and adequacy of the Nation's blood supply. It is
worth noting that the Federal responsibility for blood and blood
products is indeed unique. No other product has a national policy.
In the early 1980s a much more deadly disease struck as approximately
one-half of the Nation's hemophiliacs, some 7,200 people at a minimum,
became infected with HIV through the use of contaminated blood
products. How did this happen? Why did the system that was established
to safeguard the supply of blood and blood products fail to heed the
early warning signs and prove so slow to respond to a dangerous threat?
In 1993 I joined with Senators Graham of Florida and Kennedy of
Massachusetts in asking the Department of Health and Human Services to
[[Page H3380]]
conduct a review of the events surrounding this medical disaster. The
results of that intensive and objective review are contained in a
report prepared by the Institute of Medicine, an arm of the National
Academy of Sciences.
The IOM found ``a failure of leadership and inadequate institutional
decision-making processes'' in the system responsible for ensuring
blood safety, concluding that ``a failure of leadership led to less
than effective donor screening, weak regulatory actions, and
insufficient communication to patients about the risk of AIDS.''
While the IOM report is important, it does not begin to quantify the
human dimension. For me, that is the most compelling part of this
tragedy. We cannot talk to these victims without being moved by what
they have gone through. It is important to keep in mind that the people
with hemophilia already have to manage a sometimes debilitating
disease. The average person with hemophilia spends approximately
$100,000 per year on clotting factor alone. Many people with hemophilia
have had a difficult time obtaining both health and life insurance,
understandably.
In addition to the difficulties associated with hemophilia itself,
the added complication of HIV AIDS has hit the hemophilia community
particularly hard. Each treatment costs somewhere in the range of
$10,000 to $50,000 per year, varying on the stage of the disease and
the course of the treatment.
As a result of these extraordinary costs and the disproportionate
impact of this tragedy on men, who most typically suffer from
hemophilia and who tended to be the head of many of these households,
many of these folks have been financially devastated. In some cases
entire generations have been wiped out: fathers, sons, uncles. Most
tragically, some men infected their wives with HIV before they became
aware that they had contracted the disease. We know of cases where
unborn children in these circumstances were also infected.
The emotional toll on all of these families has been immense. Madam
Speaker, the Federal Government cannot become involved in every tragic
case that occurs in this country, but this case is unique. I believe
the Federal Government can and should, for compassionate reasons, act
to help the hemophilia community.
While we cannot right all the wrongs in the world, we should pass
this legislation to acknowledge the unique responsibility of the
government to protect the blood supply and provide some measure of
compassionate assistance to these victims. While I am encouraged that a
final class settlement between the people of hemophilia and the blood
product manufacturing companies is in fact going forward, it does not
change my view that government also must act.
As my colleagues know, and as the hemophilia community has learned
firsthand, moving a bill through the legislative process is a slow,
difficult, and sometimes frustrating experience, amen. When I first
introduced the Ricky Ray bill, we had about two dozen cosponsors. Since
then support for the bill has swelled to 270 cosponsors, and we have
secured unanimous approval for all three committees with jurisdiction.
This incredible progress is the direct result of the courage,
diligence, and hard work of the hemophilia community. Of particular
notice is the work of a group of high school students from Robinson
Secondary School in Fairfax, Virginia. For several years these kids, as
part of a marketing education program called DECA, have lobbied to pass
this bill. Their efforts have been extraordinary, and they show that
democracy can and does work.
Finally, Madam Speaker, let me say thank you to the congressional
staff that have worked with me through the years to research and
understand this tragedy, explain it to the House, and get this bill
moving.
Madam Speaker, for too long the hemophilia community has felt that
government first let them down and later abandoned them. I sincerely
hope that the House action today will provide some measure of
reassurance that their voices do count, that the legislative process
does work, and that we have not forgotten them or the tragedy that
befell their community. I only wish we had a cure for AIDS.
I strongly urge my colleagues to support this important legislation.
Madam Speaker, I include for the Record the following CRS report.
The report referred to is as follows:
CSR Report for Congress--Blood and Blood Products: Federal Regulation
and Tort Liability
(By Diane T. Duffy and Henry Cohen, Legislative Attorneys, American Law
Division)
summary
Part I of this report, by Diane Duffy, Legislative
Attorney, provides an overview of the Federal government's
regulation of blood products. Part II, by Henry Cohen,
Legislative Attorney, examines tort liability for injuries
caused by defective blood or blood products.
The Food and Drug Administration (FDA) regulates blood and
blood products under two statutes which overlap to a certain
degree: the Federal Food, Drug and Cosmetic Act [FFDCA] and
the Public Health Services Act (PHSA). Regulations are issued
in order to implement the provisions of these statutes.
Current statutory and regulatory law operates to govern the
licensing, production, testing, distribution, labeling,
review and approval of all drugs and biologics. Specifically,
under the FFDCA, drugs, which include biologics such as blood
and blood components or derivatives, which are intended to
cure, mitigate, or prevent disease, are regulated. The
enforcement and penalties provisions of the FFDCA can be
applied to biological product manufacturers. Within the
agency, the Center for Biologics Evaluation and Review has
jurisdiction over the regulation of these articles.
Tort liability for injuries caused by defective blood or
blood products is a form of products liability, which is
governed primarily by state law. Products liability is strict
liability, which means that, to recover, the plaintiff does
not have to prove that the defendant was negligent, but need
prove only that the defendant sold a defective product and
that the plaintiff's injury resulted from the defect.
However, all 50 states--48 through ``blood shield''
statutes--provide that blood transfusions are not subject to
strict liability. The primary rationale for this is the
belief that holding suppliers of blood or blood products
strictly liability would make blood transfusions too
expensive.
Part I of this report, by Diane Duffy, Legislative
Attorney, provides an overview of the Federal government's
regulation of blood products. Part II, by Henry Cohen,
Legislative Attorney, examines tort liability for injuries
caused by defective blood or blood products.
part i: federal regulation of blood products
Issues relating to the regulation of blood products have
been raised in the context of individuals with hemophilia who
contracted Human Immunodeficiency Virus (HIV), the virus
which causes AIDS, through the use of contaminated blood
products. In the 104th Congress, bills have been introduced
by Rep. Goss and Sen. DeWine which would establish a trust
fund to compensate hemophiliacs, their spouses or estates,
who contracted HIV through tainted blood products. This part
of the report summarizes Rep. Goss' bill (H.R. 1023, 104th
Congress) \1\; discusses current Federal law that directs and
authorizes the regulation of blood products; and discusses
regulatory issues and events which are notable in this
context. In particular, it focuses issues which tend to
indicate that the regulation of blood products has been
different than the regulation of other articles which are
within the jurisdiction of the Food and Drug Administration
(FDA).
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Footnotes at end of article.
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Summary: The Ricky Ray Hemophilia Relief Fund Act of 1995
H.R. 1023, 104th Congress, introduced by Rep. Goss,
establishes procedures for claims for compassionate payments
with regard to persons with blood clotting disorders, e.g.,
hemophilia, who contracted HIV due to contaminated blood
products. The bill, entitled the Ricky Ray Hemophilia Relief
Fund Act of 1995, states that about half of all individuals
in the U.S. who suffer from blood clotting diseases like
hemophilia, were exposed to HIV through the use of blood
clotting agents. The bill finds that the Federal government
has a shared responsibility with the blood products industry
for protecting the safety of the blood supply and for
regulating blood clotting agents. H.R. 1023 finds that people
with blood clotting disorders were at a very high risk of
contracting HIV during the period beginning in 1980 and
ending in 1987, when the last mass recall of contaminated
anti-hemophilic factor (AHF) occurred. The bill states that
it was during this period that the Federal government did not
require the blood products industry to use means to ensure
safety of blood products that were marketed for sale to
people with blood clotting disorders. Moreover, it finds that
the government did not require that all available information
about the risks of contamination be dispensed and failed to
properly regulate the blood products industry. Based upon
these and other findings, the bill establishes a fund to
compensate individuals in this circumstance. The fund is
named after a child born with hemophilia who, like his two
younger brothers and others, became infected with HIV through
the use of contaminated blood clotting products.\2\
[[Page H3381]]
Specifically, the fund provides for partial restitution to
people who were infected with HIV after treatment, during the
period of 1980-1987, with contaminated blood products. The
fund is established in the Department of the Treasury, is to
be administered by the Secretary, and is to remain viable for
five years after the date of enactment. The bill authorizes
to be appropriated to the fund $1,000,000,000, to be
disbursed by the Attorney General. H.R. 1023 provides that
any person who submits to the Attorney General written
medical documentation that he has an HIV infection shall
receive $125,000 if each of these conditions is met:
(A) 1. The person has any form of blood clotting disorder
and was treated with blood clotting agency in the form of
blood components or blood products at any time during the
period of January 1, 1980 and ending December 31, 1987; or
2. The person is the lawful spouse of the infected person
or is the former lawful spouse of the infected person at the
time so described in the bill.
3. The person acquired HIV through perinatal transmission
from a parent who is an individual described in the above
paragraphs.
(B) A claim for payment is filed with the Attorney General.
(C) The Attorney General determines that the claim meets
the requirements under this bill, if enacted.
The Attorney General is required to establish procedures
for the claims and payments and must determine whether the
claim meets all the requirements. Claims are to be assessed
and paid, if appropriate, within 90 days of their filing. In
the case of a deceased claimant, the payment is to be made to
the deceased's estate or in the manner set forth in the bill.
Payments made from the fund shall be in full satisfaction of
all claims of or on behalf of the individual against the
United States that arise out of both the HIV infection and
treatment during the period of time noted. With regard to
judicial review, any person whose claim is denied may seek
judicial review in a district court of the U.S. The court
shall review the denial on the administrative record and hold
unlawful and set aside the denial if it was arbitrary,
capricious, an abuse of discretion, or otherwise not in
accordance with the law.
Regulation of blood products
The Food and Drug Administration (FDA) regulates blood and
blood products under two statutes which overlap to a certain
degree: the Federal Food, Drug and Cosmetic Act [FFDCA] \3\
and the Public Health Services Act (PHSA)\4\ and implementing
regulations.\5\ Current statutory and regulatory law operates
to govern the licensing, production, testing, distribution,
labeling, review and approval of all drugs and biologics.
Under the FFDCA, drugs intended for the cure, mitigation, or
prevention of disease, which include biologics such as blood
and blood components or derivatives, are regulated.\6\
Biological products are regulated by the FDA's Center for
Biologics Evaluation and Review under the authority of the
FFDCA, PHSA and implementing regulations.\7\ The FDA is the
primary agency for protecting the nation's blood supply and
it is directed and authorized to regulate blood-banking, the
handling of source plasma, and the manufacturer of blood
products. Investigations of a new biological product is done
under investigational new drug procedures found in the drug
section of the FFDCA because the PHSA specifically regulates
after the product is in the stream of commerce, not before.
The enforcement and penalties provisions of the FFDCA can be
applied to biological product manufacturers.
Under section 351 of the PHSA \8\, blood products are
regulated under the category of biological products. Current
law provides that no person may sell, barter, exchange or
offer to sell, barter, exchange or conduct interstate
commerce of the same or bring from a foreign country any
virus, therapeutic serum, toxin, antitoxin, vaccine, blood,
blood component or derivative, allergenic products, or
analogous products applicable to the prevention, treatment,
or cure of diseases or injuries of man unless the same has
been propagated or manufactured and prepared at an
establishment holding an unsuspended or unrevoked license,
issued by the Secretary, to propagate or manufacture and
prepare the biological product.
Moreover, the law provides that each package of the product
must be plainly marked with the proper name of the product,
the name, address and license number of the manufacturer and
the expiration date. The statute prohibits the false labeling
or marking of any package or container containing the
biological product and authorizes department officials to
inspect establishments. Current law governs licensing for
both the establishment and the product. For example, the
statute provides that licenses for the maintenance of the
establishment are issued after a showing that the
establishment and the products meet standards designed to
insure the continued safety, purity and potency of the
products. Further authority is provided for suspending and
revoking licenses. Also, when a batch, lot or other quantity
of a licensed product presents an imminent or substantial
hazard to the public health, the Secretary shall issue an
order, under 5 U.S.C. Sec. 554, immediately ordering the
recall of the quantity. The assessment of civil money
penalties is authorized for violations. Any person who
violates this section or aids in the violation of this
section may be punished upon conviction by a fine or
imprisonment or both. In sum, the agency is authorized to
enforce the law through various enforcement tools including,
seizure, application for recall, injunction, criminal
prosecution, or administrative techniques, e.g. suspension,
revocation of license.\9\
Implementing regulations governing blood and blood products
provide further detail. For example, 21 C.F.R. Part 600
addresses general standards for establishments that
manufacture a product subject to licensing as a blood
product. It defines critical terms, e.g., biological product,
sterility, purity, establishment, etc. These regulations
state that with respect to an establishment, a person shall
be designated as the ``responsible head who shall exercise
control of the establishment in all matters relating to
compliance with the provisions'' of these regulations.\10\
This part governs inspections with respect to time of
inspection, duties of inspectors and more. In addition,
regulations require other actions, for instance, the post-
market reporting of adverse experiences.\11\
Part 601 governs two types of licensing: the establishment
and the product.\12\ The FDA is charged with issuing licenses
only after all pertinent requirements and conditions are met.
The agency is authorized to enforce provisions of current law
through administrative measures to revoke or suspend a
license. Provisions for review of the agency's decision
regarding suspension or revocation are also addressed.
Section 601.25 establishes the review procedures to determine
that licensed biological products are safe and effective and
not misbranded under prescribed, recommended or suggested
conditions of use. Notably, Subpart E provides for the
accelerated approval of biological products for serious or
life threatening illnesses. This section permits the agency
to approve products on a fast track to provide meaningful
therapeutic benefit to patients over existing treatments,
that is, to treat patients unresponsive to or intolerant of,
available therapy.
To assist the agency in fulfilling its duty to evaluate the
safety and effectiveness and labeling of biological products,
Part 601 also authorizes the FDA to appoint advisory review
panels to (1) evaluate the safety and effectiveness of
biological products for which a license has been issued under
Sec. 351 of the PHSA; (2) review the labeling of such
biological products; and (3) advise the Commissioner on which
of the biological products under review are safe, effective
and not misbranded. The members of the panel shall be
qualified experts, appointed by the Commissioner, and shall
include persons from lists submitted by organizations
representing professional, consumer, and industry interests.
Such persons shall represent a wide divergence of responsible
medical and scientific opinion. The Commissioner designates
the chair of each panel (for each type of biological product)
and minutes of all meetings must be made. Additionally,
regulations provide that interested persons can participate
in the advisory panels sessions to the extent that the FDA
must publish a notice in the Federal Register requesting
interested persons to submit, for review and evaluation by
the advisory panel, published and unpublished data and
information pertinent to the biological products.
To a certain extent, the industry regulates itself through
the adherence to good manufacturing practices (GMPs). Part
606 sets forth these GMPs for blood \13\ and blood components
and provides uniform and industry-specific guidelines and
requirements to insure safety, effectiveness, purity and
other important features of blood products.\14\ These
regulations pertain to personnel of the establishment, e.g.,
requirement to designate person in control of establishment;
facilities maintenance, e.g., adequate space, quarantine
storage, orderly collection of blood, etc.; equipment, e.g.,
calibrated, properly maintained, etc.; and, supplies and
reagents, e.g., storage in a safe, sanitary and orderly
manner. The GMPs detail finished product controls, container
labels, records and reporting procedures and importantly, the
adverse reaction process.
Part 607 requires the registration of establishments which
include human blood and plasma donor centers, blood banks,
transfusion services, other blood product manufacturers and
independent laboratories that engage in quality control and
testing for registered blood product establishments. The
regulations also provide special standards for human blood
and blood products, some of which apply directly to those
being treated for hemophilia. For example, Part 640 addresses
the product known as Cryoprecipitated AHF, a preparation of
antihemophilic factor which is obtained from a single unit of
plasma collected and processed in a closed system. The source
material for this product is plasma which may be obtained by
whole blood collection or plasmapheresis.\16\ The regulations
establish procedures pertaining to the suitability of donors;
the collection of source material; the testing of blood;
processing; quality control; and further requirements. With
specific regard to donor testing, the regulations provide
that the blood from which the plasma is separated must be
tested as prescribed in Sec. Sec. 610.40 [Test for hepatitis
B], 610.45 [Test for HIV] and 640.5 [Test for syphilis, blood
group, and Rh factors]. The test must be conducted on a
sample of the blood collected at the time of donation and the
container must be properly labeled. Manufacturers of this
product are responsible for testing and record-keeping.
Moreover, quality control tests for potency of the
antihemophilic factor must
[[Page H3382]]
be conducted each month on at least four representative
containers of Cryoprecipitated AHF. The results must be
maintained at the establishment for inspection and review by
the FDA.
As soon from the above examination of statutory and
regulatory law, the legal requirements and procedures, as
well as industry GMPs, create a complex and far-reaching
regulatory structure for biological products and blood
products in particular. To a certain extent, under the FFDCA
and the PHSA, the licensing of biologics is more restrictive
than that for other regulated articles, e.g., new drug. For
example, a new drug under the FFDCA needs an approved new
drug application (NDA), however, a new biologic needs to
fulfill higher requirements. A generic biological product
such as a serum must be approved by the FDA under the PHSA
for its purity, potency and effectiveness based upon data
submissions.\16\ The PHSA states that licenses for new
products may be issued only upon a showing that meets these
express standards.\17\ Additionally, related regulations and
GMPs must be fully satisfied to ensure compliance.
Second, manufacturers of the product are individually
licensed as capable of making the product on the particular
manufacturing site.\18\ Regulations at Part 607, discussed
above, must be fully met for each establishment and for
each product. Enforcement and inspection authority under
the Act may be triggered to address alleged violations of
the law or regulations or to insure ongoing compliance.
Inspectors are authorized to examine records of the
licensed establishments while GMPs guide recordkeeping,
facility and equipment management, personnel regulations
and similar procedures. Moreover, the FDA inspectors are
granted special inspection authority for biological
products and special procedures apply. For instance, as
noted above, a specific person must be designated as being
in control of the facility for regulatory and compliance
purposes.\19\ Moreover, and particularly with regard to
blood clotting agents for hemophilia, extensive and
frequent testing of lots and batches is required after
initial production. The FDA may exercise its enforcement
authority under the FFDCA and PHSA to suspend or revoke
the license for either the product or the establishment,
to seize, to seek recalls, injunctions, assess penalties,
and to exercise a range of impressive enforcement
tools.\20\
The entire licensure process is complex and intended to
insure purity, potency and prevent misbranding. Some view it
as the functional equivalent to a NDA for a new drug.
Regulation of biological products is more restrictive in
scope and has appeared to evolve to meet the unique needs and
characteristics of biological products. While there are many
similarities in the regulation of the drugs, devices, and
biological products during pre-market and post-market phases,
there appears to be a greater emphasis on regulatory
standards and requirements for biologics at the manufacturing
level. Commentators have noted that the unique and separate
histories of the regulation of drugs and biologics may
account for the difference in regulatory approach.\21\ One
reason may be attributed to the fact that the Biologics Act
\22\ predates the FFDCA and that it was not enforced by the
FDA until 1972, when jurisdiction for these matters was
transferred to the FDA from the National Institutes of
Health. Extensive government involvement and regulation of
the manufacturing process grew out of early tragic incidents
when it was determined that microbes contaminated
vaccines.\23\ Thus, where the primary focus is on the final
product for drugs and devices, for biologics, it was
determined that government regulation was needed much earlier
and more strictly than for other articles under the various
pertinent statutes.
Additionally, blood and blood products are the subject of
an articulated national policy. Other articles under the
FFDCA and PHSA have not been focused upon nationally in such
a way. In 1973, the National Blood Policy was announced and
the Public Health Service, including the CDC, the FDA and
NIH, was charged with responsibility for protecting the
nation's blood supply. The Policy recognized that reliance on
``commercial sources of blood and blood components for
transfusion, therapy . . . contributed to significantly
disproportionate incidence of hepatitis, since such blood is
often collected from sectors of society in which
transmissible hepatitis is more prevalent.'' \24\ The Policy
encouraged efforts to establish an all-volunteer blood
donation system and to eliminate commercialized acquisition
of blood and blood components.
The Policy listed four goals: to provide an adequate supply
of blood; to ensure a higher quality of blood; to facilitate
maximum accessibility to services; and to achieve total
efficiency.\25\ According to the Institute of Medicine's
[IOM] 1995 study, the first actions under the policy included
adoption of an all-volunteer blood collection system;
coordination of costs; regionalization of blood collection
and distribution; and, an examination of standards of care
for hemophiliacs and other special groups. The Policy did not
address the commercialization of plasma, the preparation and
marketing of plasma derivatives, and the commercial
acquisition of blood for diagnostic reagents.\26\
Contaminated blood products and brief overview of Government
actions during the 1980's
In the context of blood products regulation and the
government's focus on the nation's blood supply, events
occurred in the 1980s which led hemophiliacs and others to
contract HIV from contaminated blood and blood products. The
IOM study indicates that in September of 1982, of the 593
cases of AIDs reported to the CDC, 3 were hemophiliacs.
Later, the CDC noted that the hemophilia patients who had
AIDS had all received large amounts of a commercially
manufactured anticoagulant known as AHF (antihemophilic
factor) \27\ Evidence seemed to indicate that children with
hemophilia were at risk for the disease.\28\ As more cases
were reported, the IOM report states that a national survey
indicated that 30% or more of all hemophiliacs had abnormal
immunological tests. By January 1983, evidence from CDC
investigations strongly indicated that blood and blood
products transmitted AIDS and that it could be transmitted
through sexual contact. It appeared that AIDS was occurring
in individuals with hemophilia who had received AHF
concentrate.\29\ In March, 1983, the PHS issued its first
formal recommendations on the prevention of AIDS and with
regard to hemophiliacs, the recommendation stated that
work should continue toward development of safer blood
products for use by hemophiliac patients.\30\ H.R. 1023
states that thousands became infected with HIV through the
use of contaminated blood clotting products.\31\
The IOM report indicates that numerous measures were
publicized and taken with regard to blood and plasma
donations, collection and use, e.g. quarantine and disposal.
The FDA announced that it approved a heat treatment to
inactivate viruses in AHF concentrate, which purported to
help protect individuals with hemophilia from Hepatitis B,
and perhaps, AIDs.\32\ The IOM report states that:
``Government and private agencies identified, considered, and
in some cases adopted strategies for dealing with the risk of
transmitting AIDs through blood and blood products. The
recommended safety measures were limited in scope. . . .''
\33\
In 1983, the FDA's Blood Product Advisory Committee (BPAC)
met to reconsider blood and blood products policies. One
company recalled AHF concentrate when it determined that the
concentrate was made from pools containing plasma from a
person diagnosed with AIDs. However the IOM report notes that
this recall was expressly not viewed as a recall of all such
products and that the agency did not initially initiate a
nationwide call of the concentrate.\34\ The BPAC stated in
mid-1983 that the criteria for deciding to withdraw lots of
AHF concentrate should be based on evidence that plasma from
a donor with AIDs had been present in the pooled plasma from
which the lot was manufactured and recommended to the FDA a
case-by-case decision regarding withdrawal for each lot that
included plasma from a person who had AIDS or was suspected
of having AIDS.\35\ Some physicians switched from AHF
concentrate to cryoprecipitate in those with less severe
hemophilia. The IOM concluded ``[b]lood safety policies
changed very little during 1983 [and that there] were missed
opportunities to learn from pilot tests to screen potentially
infected donors or implement other control strategies that
had been rejected as national policy.'' \36\ Inaction
relating to donor screening and surrogate marker testing was
emphasized in the report.\37\
BPAC served as an advisory committee for the FDA and was
the forum for industry and interested entities to participate
in and influence the FDA's policy regarding blood products
regulation.\38\ According to the IOM report, BPAC's
membership included blood and plasma organization
representatives, scientists, and physicians.\39\ The report
concluded that valuable screening measures were not
recommended by the BPAC due to uncertainties regarding
scientific data, i.e., data from CDC, and ``pressures from
the blood industry and special interest groups.'' \40\ Thus,
options that could have reduced infection were not pursued.
HIV testing and additional donor screening procedures were
implemented in 1985. The IOM concluded that the FDA relied
too heavily on BPAC and did not independently assess its
recommendations and statements, and did not observe
principles for proper management of advisory committees.\41\
Moreover, IOM concluded that the membership of BPAC limited
the information and points of view expressed to the agency
and found possible issues relating to conflicts of interest.
The report focused on the agency's role as being responsible
for protecting the nation's blood supply, providing
leadership and communication of information to those at
risk.\42\
Conclusion to Part I
In sum, the blood and blood products regulation under the
FFDCA and PHSA are restrictive and complex, governing
primarily licensing of products and sites, as well as the
final product, and authorize extensive enforcement actions.
The FDA is the lead agency responsible for regulation of
these articles and was charged with this responsibility in
1972. The products themselves seem to have been accorded
special status, to a certain degree, under the statutes
for regulation. Moreover, blood and blood products have
been part of an articulated National Blood Policy. Events
of the 1980s resulted in individuals with hemophilia, and
many others, to contract HIV through the use of
contaminated blood and blood products. This spurred
intense examination of the FDA, its regulatory actions,
and the use of its advisory committee BPAC, during this
period. H.R. 1023, and S. 1189, were introduced to provide
for payments from a trust fund to those with
[[Page H3383]]
blood clotting disorders who contracted HIV at this time.
part ii: tort liability for injuries caused by defective blood or blood
products
``Products liability'' refers to the liability of a product
manufacturer or subsequent seller for damages resulting from
an injury caused by a product defect. Products liability is
governed primarily by state common (i.e., court-made) law, as
modified by state statute, although federal statutes
occasionally preempt aspects of state products liability law.
For example, prior to filing suit under state law for
injuries caused by defective vaccines, one must file a claim
under the National Children Vaccine Injury Act of 1986, as
amended.\43\
Products liability differs from most other liability for
non-intentional torts because products liability is strict
liability, which means that, to recover, the plaintiff does
not have to prove that the defendant was negligent (i.e.,
failed to exercise due care). All the plaintiff generally
must prove in a products liability action is that the
defendant sold a defective product and that the plaintiff's
injury resulted from the defect.\44\
Products liability suits sometimes also allege a breach of
warranty, on the theory that the fact that the product was
defective constitutes a breach of the implied warranties that
goods shall be merchantable (fit for ordinary purposes) and
fit for any particular purpose for which they are required.
These implied warranties arise under Uniform Commercial Code
Sec. Sec. 2-314 and 2-315, which has been enacted into law in
every state but Louisiana. A suit for breach of warranty is
similar to one for strict liability in tort in that in
neither type of case need the plaintiff prove negligence.
Breach of warranty suits predate strict tort liability suits,
which came into being only in the 1960s.
One situation in which strict liability is generally not
applied is in suits involving unavoidably unsafe products,
among which, as noted below, some courts include blood.
Restatement (Second) of Torts Sec. 402A comment k, which
courts generally follow, provides: ``There are some products
which, in the present state of human knowledge, are quite
incapable of being made safe for their intended and ordinary
use. This is especially common in the field of drugs. An
outstanding example is the vaccine for the Pasteur treatment
of rabies, which not uncommonly leads to very serious and
damaging side effects when it is injected. Since the disease
itself inevitably leads to a dreadful death, both the
marketing and the use of the vaccine are fully justified,
notwithstanding the unavoidable high degree of risk which
they involve. Such a product, properly prepared, and
accompanied by proper directions and warnings, is not
defective, nor is it unreasonably dangerous'' [emphasis in
original].
Case law
The seminal products liability blood transfusion case was
Perlmutter v. Beth David Hospital, decided by the New York
Court of Appeals in 1954.\45\ It was a breach of warranty
case (as it predated strict tort liability), and the issue
was whether a transfusion constituted the sale of a product,
in which case a transfusion of contaminated blood would
constitute a breach of warranty, or whether it constituted
the provision of a medical service, in which case the
plaintiff would have to prove negligence to recover. This
distinction was critical because there was no means to detect
the presence of the hepatitis virus in blood, nor a practical
method to treat the blood to eliminate the danger of
hepatitis. Therefore, if the court deemed the transfusion a
sale, it would turn hospitals into insurers of the risk of
contaminated blood, but if it deemed it a service, then
plaintiffs in most cases would go uncompensated because of
the difficulty in proving negligence.
The court held that the transfusion should be treated as a
service, because, ``when service predominates, and the
transfer of personal property is but an incidental feature of
the transaction, the transaction is not deemed a sale. . .
.'' \46\ The Perimutter decision was widely followed by the
courts, and extended to blood banks as well as hospitals. In
Community Blood Bank, Inc. v. Russell, however, a Florida
court found it ``a distortion to take what is, at least
arguably, a sale, twist it into the shape of a service, and
then employ this transformed material in erecting the
framework of a major policy decision.'' \47\ This policy
decision, of course, is whether ``the social utility of an
abundant blood supply outweighs the risks to individuals''
\48\ The Florida court, needless to say, found the
transfusion to be a sale, and a transfer of contaminated
blood to be a breach of warranty.
``Community Blood Bank thus paved the way for the greatest
assault on the Perlmutter citadel, which came in Cunningham
v. MacNeal Memorial Hospital,\49\ where the defendant once
again was a hospital, not a blood bank.'' \50\ The plaintiff,
who had contracted serum hepatitis from defective blood
supplied by the hospital during a transfusion, asserted a
claim in strict liability and won, with the court refusing to
allow the hospital the defense that there was no means to
detect the existence of serum hepatitis in whole blood. The
court wrote: ``To allow a defense to strict liability on the
ground that there is no way, either practical or theoretical,
for a defendant to ascertain the existence of impurities in
his product would be to emasculate the doctrine and in a very
real sense return to a negligence theory.'' \51\
Some courts, even if they treated a transfusion as the sale
of a product and not as a service, found for the defendant
under Restatement (Second) of Torts Sec. 402A comment k,
mentioned above. They ``considered whether liability without
fault was applicable in view of a claim that blood containing
hepatitis is a product which is unavoidably unsafe and thus
is not an unreasonably dangerous product for which the blood
bank could be held liable without fault. With some authority
to the contrary, the courts have reasoned that blood infected
with hepatitis virus is such an unavoidably unsafe product,
since there is a great need for blood for operations and
surgical procedures, but the possibility of blood being
infected with hepatitis cannot be totally eliminated despite
due care being taken, and therefore they have held that a
blood bank cannot be held liable without fault for injuries
to a patient who contracted hepatitis from the blood it
supplied.'' \52\
Blood shield statutes; negligence suits
The Illinois legislature responded to the Cunningham
decision by enacting a statute that provides, in part: ``The
procuring, furnishing, donating, processing, distributing or
using human whole blood, plasma, blood products, blood
derivatives and products, corneas, bones, or organs or other
human tissue for the purpose of injecting, transfusing or
transplanting any of them in the human body is declared for
purposes of liability in tort or contract [i.e., breach of
warranty] to be the rendition of a service . . . and is
declared not to be a sale of any such items and no warranties
of any kind or description nor strict tort liability shall be
applicable thereto, except as provided in Section 3 [which
imposes liability for negligence].'' \53\
A subsequent Illinois case upheld the constitutionality of
this statute, writing: ``[I]t was predicted at the time
Cunningham was handed down that the imposition of liability
without fault on the distributors of blood would cause the
cost of transfusions to skyrocket. . . . Moreover, implicit
in the legislature's declaration of public policy is the fear
that the imposition of strict tort liability would cause the
financial considerations arising out of increased exposure to
tort litigation to impinge on the exercise of sound medial
judgment in a field where an individual's life might be at
stake.'' \54\
Illinois' approach is now the approach of all 50 states,
with 48 states having enacted blood shield statutes, and
Minnesota, New Jersey, and District of Columbia courts having
reached the same result on their own.\55\ Blood shield
statues ``expressly characterize blood transfusions as
services or explicitly state that blood transfusions will not
be subject to strict liability.'' \56\ A 1990 Washington
case articulated the policy justifications for blood
shield statutes: ``First, the societal need to ensure an
affordable, adequate bloody supply furnishes a persuasive
reason for distinguishing between victims of defective
blood and victims of other defective products. Second,
strict liability cannot provide an incentive to promote
all possible means of screening the blood for HIV. Third,
although the producers may be in a better position to
spread the costs, it is not in society's best interest to
have the price of a transfusion reflect its true costs.''
\57\
Blood shield statutes do not preclude all lawsuits alleging
injuries caused by contaminated blood. Even in a state with a
blood shield statute, one commentator notes, ``It seems
likely that an action in express warranty or innocent
tortious misrepresentation would lie if a supplier of a blood
product misrepresented the product's safety, and a plaintiff
relied on the misrepresentation to his detriment in the
purchase of use of the product.'' \58\
Another commentator addresses a different situation in
which strict liability may remain: ``So blood shield statutes
were expressly enacted to address only the threat of serum
hepatitis, and it was not until after it was discovered that
the HIV virus was transmittable through blood that
legislatures amended these statutes to deal with potential
AIDS liability. Courts have held that these amendments are
not to be applied retroactively. Consequently, plaintiffs who
received contaminated transfusions before the amendment are
not barred by the blood shield statutes from bring strict
liability actions.'' \59\
A blood shield statute was also held inapplicable in a suit
against a pharmaceutical company where the relevant statute
(Indiana Code 16-41-12-11) applied to the distribution of
blood by a ``bank, storage facility, or hospital.'' The
Indian Court of Appeals wrote: ``[W]e simply cannot conclude
that our legislature intended to include a pharmaceutical
company, which commercially produces blood products for mass
distribution, as an entity within the same class described as
an organ or a blood ``bank or storage facility.'' The
manufacture and distribution of blood products by
pharmaceutical companies is better characterized as the sale
of a product rather than the provision of a service. . . . It
is quite unlikely that our legislature intended to include
pharmaceutical companies in its definition of ``bank or
storage facility'' simply because the manufacture or
production of blood products incidentally involves their
storage.'' \60\
Finally, blood shield statutes do not, of course, preclude
suits for damages caused by negligence, and, ``[w]ith strict
liability effectively eliminated as a possible remedy [in
transfusion cases], negligence remains the only viable
alternative.'' \61\ ``To recover under a negligence cause of
action a transfusion-related AIDS victim must prove that
[[Page H3384]]
a standard of care existed, that the defendant's conduct fell
below that standards, and that this conduct was the proximate
cause of the plaintiff's injury. Plaintiffs who have
contracted AIDS through transfusions of blood and blood
products have alleged negligence in both blood testing and
donor screening.'' \62\
It is relevant to note here that, in 1985, the Food and
Drug Administration (FDA) licensed the enzyme-linked
immunsorbent assay (ELISA) test, which ``has proven 98.6%
effective in detecting exposure to AIDS [in blood], and when
coupled with a second test, the Western Blot Analysis, the
rate of detection rises to 100%.'' \63\ The existence of this
test enables plaintiffs to argue that a failure to use this
test constitutes negligence. A federal court of appeals
wrote: ``We believe that the FDA's recommendation of February
19, 1985, that blood facilities begin testing all donated
blood as soon as testing supplies become commercially
available imposed a duty on [the blood bank] to test all
its blood supplies for antibodies to the AIDS virus.''
\64\
One commentator reports: ``As the rampant spread of AIDS
continues and its devastating effects, both socially as well
as personally, are being publicized, courts are weighing the
consequences of the AIDS epidemic against the necessity of
assuring an adequate supply of blood. . . . In the past
several years, courts have started to rethink their position
on denying recovery to victims of AIDS-tainted transfusions.
Several approaches [to proving negligence] have been utilized
with some success. These approaches include: (1) failure of
the blood supplier or doctor to adequately warn the blood
recipient of the inherent dangers associated with a blood
transfusion [thus denying] the patient the opportunity to
make an informed choice; (2) inadequate screening of blood
donors [thus] allowing high-risk individuals to continue
donating blood; and (3) using a blood transfusion when an
alternate, safer method of sustaining life was available.''
\65\
Selected recommendations in the legal literature; The
National Childhood Vaccine Injury Act of 1986
One commentator writes: ``Although absolute protection for
these entities [blood banks and blood product manufacturers]
may have been logical or desirable when the HIV virus was
undetectable in blood, the better view based on current
medical and scientific knowledge would be to allow post-1985
recipients of contaminated transfusions to recover under the
theories of strict liability and breach of warranty. This
would place the burden on the blood banks and blood products
manufacturers to ensure the safety of the products they
distribute.'' \66\
The same writer adds: ``Moreover, court and legislatures
should distinguish between hospitals, blood banks, and blood
products manufacturers. Blood banks, and especially blood
products manufacturers, are active players in the economic
marketplace, selling goods rather than providing services.''
\67\
These views are echoed by another commentator: ``While
hospitals may be characterized as service-providers, it is
merely a legal fiction to so characterize blood and blood
products providers. To hold them liable only in negligence--
and then to allow the blood industry itself to set the
standard of care accepted in the community, thus requiring
innocent plaintiffs to shoulder an extraordinary burden of
proof--violates all notions of fair play. It is time that
blood products purchased for a price, and particularly
manufactured blood derivative products, be recognized for the
products they are. Even under the 402A comment k exception
for ``unavoidably unsafe'' products, it would be unthinkable
to term blood contaminated by the HIV virus as not
``unreasonably dangerous.'' It would be hard to think of
anything more unreasonably dangerous.''\68\
An advocate of the blood shield statutes could respond to
these arguments by quoting the justifications various courts
have proffered for the statutes.\69\
Finally, one commentator proposes: ``The National Childhood
Vaccine Injury Act (NCVIA) should serve as the structural
model for ``alternative legislation.'' . . . [P]otential
claimants should seek capped [no-fault] compensation in a
court of claims on waiver of potential tort claims against
blood products manufacturers. Petitions should receive
compensation from a fund financed by both congressional
appropriations and revenue raised through an industry tax
based on the sale of blood products.'' \70\
The National Childhood Vaccine Injury Act of 1986,\71\ was
enacted because Congress feared that some vaccine
manufacturers might leave the market, which could create a
genuine health hazard in the United States. The Act provides
federal no-fault compensation to persons who suffer injury or
death from specified vaccines. It allows more limited
recovery than is generally allowed against manufacturers
under state tort law, but it was hoped that ``the relative
certainty and generosity of the system's awards will divert a
significant number of potential plaintiffs from litigation.''
\72\
The Act established a National Vaccine Injury Compensation
Program funded by a manufacturers' excise tax on certain
vaccines. Persons injured by a vaccine administered after
October 1, 1988, with claims of more than $1,000, may not sue
the vaccine administrator or manufacturer unless they first
file a petition in the United States Court of Federal Claims
for compensation under the Program. Upon the filing of a
petition, the court must issue a decision within a specified
period. Under the Program, compensation is limited to actual
reimbursable expenses, up to $250,000 for pain and suffering
and emotional distress, $250,000 in the event of a vaccine-
related death, actual and anticipated loss of earnings, and
attorney's fees and other costs, but no punitive damages.
A petitioner dissatisfied with his recovery under the
Program may reject it and file a tort suit (state statutes of
limitations are stayed during the pendency of the federal
petition), which is governed by state law, with some
limitations, such as that there are rebuttable presumptions
that manufacturers who comply with federal regulations are
not subject to failure to warn suits or to punitive damages.
Treatment of blood and blood products in 104th Congress
products liability legislation
On May 2, 1996, President Clinton vetoed H.R. 956, 104th
Congress, the Common Sense Product Liability Legal Reform Act
of 1996. On May 9, the House failed to override the veto.\73\
The vetoed bill had been agreed upon in a House-Senate
conference, which adopted the Senate version of the provision
that dealt with blood and blood products.
Both the House and Senate versions addressed blood and
blood products in their respective definitions of
``product.'' Section 108(8)(B) of the House-passed bill
provided: ``The term [``product''] does not include . . .
``human tissue, human organs, human blood, and human blood
products.''
Section 101(13)(B) of the Senate-passed bill, by contrast,
provided: ``The term `products' does not include . . .
tissue, organs, blood, and blood products used for
therapeutic or medical purposes, except to the extent that
such tissue, organs, blood, and blood products (or the
provision thereof), are subject, under applicable State law,
to a standard of liability other than negligence. . . .''
The Senate bill, in others words, did apply to blood and
blood products in strict liability and breach of warranty
actions, although these actions are precluded by all state
laws, except apparently in the limited instances noted on
page 15 of this report.\74\ The Senate-passed bill did not
apply in blood and blood products that are the subject of
negligence actions. The House-passed bill did not apply in
any suits involving blood or blood products.
The committee report that accompanied the House bill states
merely, with respect to the exclusion: ``Tissue, organs,
blood, and blood products--that are human in origin--. . .
are explicitly excluded from the product definition.'' \75\
The committee report that accompanied the Senate bill goes
into more detail: \76\ ``Claims for harm caused by tissue,
organs, blood and blood products used for therapeutic or
medical purposes are, in the view of most courts, claims for
negligently performed services and are not subject to strict
product liability.\77\ The Act thus respects state law by
providing that, in those states, the law with respect to
harms caused by these substances will not be changed.\78\ In
the past, however, a few states have held that claims for
these substances are subject to a standard of liability other
than negligence, and this Act does not prevent them from
doing so.\79\ See, e.g., Cunningham v. MacNeal Memorial
Hosp., 266 N.E.2d 897 (Ill. 1970) (overturned by Ill. Ann.
Stat. Ch. 111\1/2\, sections 2 and 3).\80\ Such actions
would be governed by the Act. . . .''\81\
The conference committee version of H.R. 956, as noted,
adopted the Senate provision that dealt with blood and blood
products (renumbered as Sec. 101(14)(B)). The joint
explanatory statement of the conference committee, did not,
however, discuss the provision.\82\
Recent settlement \83\
On August 14, 1996, a federal judge gave preliminary
approval to a settlement between hemophiliacs infected with
AIDS and four pharmaceutical companies that allegedly had
manufactured blood clotting products contaminated with
HIV.\84\ Judge John F. Grady of the U.S. District Court for
the Northern District of Illinois tentatively certified a
settlement class, preliminarily approved the settlement
agreement, and authorized the parties to begin notifying
class members.
The plaintiffs contended that the companies sold tainted
blood clotting products from 1978 until 1985, when new heat
sterilization procedures came into practice. Under the
settlement, each class member would receive $100,000,
regardless of the number of class members; the total number
of class members reportedly could range as high as 10,000. A
fairness hearing is scheduled before Judge Grady on November
25, 1996.
____
footnotes
\1\ Sen. DeWine's bill is substantially similar to H.R. 1023.
\2\ The bill indicates that Ricky Ray died at age 15 of
hemophilia-associated AIDS.
\3\ 21 U.S.C. Sec. Sec. 301 et seq.
\4\ 42 U.S.C. Sec. 262.
\5\ FDA regulations pertaining to blood products are set
forth at 21 C.F.R. Parts 600 [Biological products; general];
601 [Licensing]; 606 [Good manufacturing practices for blood
and blood products]; 607 [Establishment registration and
product listing for manufacturers of human blood and blood
products]; 610 [General biological products standards]; and,
640 [Additional standards for human blood and blood
products].
\6\ 21 U.S.C. Sec. 321(g)(1) [Definitions; drug].
\7\ According to an intra-agency agreement that
differentiates drugs and biologics, biologics include:
vaccines, allergens and in vivo diagnostic allergenic
products; human blood and blood derived products;
immunoglobulin products; products composed of or intended to
contact intact cells or intact microorganisms including
viruses, bacteria, fungi, etc.; non-
[[Page H3385]]
antibiotic products that are proteins, peptides, or
carbohydrate products produced by cell culture; protein
products produced in animal body fluids by genetic alteration
of the animal; venoms and their constituents; synthetically
produced allergenic products intended to specifically alter
the immune response to a specific antigen or allergen; and
certain drugs used in conjunction with blood banking or
transfusion. ``FDA's Intercenter Agreement,'' Treatise on
Food and Drug Administration, James O'Reilly, Sec. 13.21
[Biological Products].
\8\ 42 U.S.C. Sec. 262.
\9\ The FDA is not authorized to mandate recalls.
\10\ 21 C.F.R. Sec. 600.10.
\11\ 21 C.F.R. Sec. 600.80.
\12\ This also includes the licensing of foreign
establishments and products.
\13\ Blood means whole blood collected from a single donor
and processed either for transfusion or further
manufacturing.
\14\ Component means that part of a single donor unit of
blood separated by physical or mechanical means.
\15\ Subpart F; 21 C.F.R. Sec. 640.50.
\16\ 42 U.S.C. Sec. 262(d).
\17\ Id.
\18\ Id.; Food and Drug Regulation, James O'Reilly,
Sec. 13.22.
\19\ 21 C.F.R. Part 606.
\20\ The FDA is authorized to act via the misbranding and
adulteration sections of the FFDCA and can take various
actions for enforcement under 21 U.S.C. Sec. 357.
\21\ See, for example, Regulation of Biologics Manufacturing:
Questioning the Premise, Food and Drug Law Journal, Vol. 49,
No. 1, 1994, pp. 213, 216.
\22\ The Act was originally enacted in 1902 and reenacted in
1944 when the PHSA was enacted; codified at 42 U.S.C.
Sec. 262.
\23\ FDLJ, infra, at 216.
\24\ Reprinted in the Institute of Medicine's [IOM] ``HIV and
the Blood Supply,'' National Academy of Sciences, 1995, p.
41.
\25\ Id.
\26\ Id.
\27\ IOM, at p. 68.
\28\ Id.
\29\ Id., at p. 70. AHF concentrate is manufactured from
pools containing plasma from donors.
\30\ Id., at p. 73.
\31\ H.R. 1023, Sec. 2 (10).
\32\ Id., at p. 73.
\33\ Id., at pp. 73-4.
\34\ Id., at p. 74.
\35\ Id., at p. 75.
\36\ Id., at p. 75-6.
\37\ IOM, at pp. 101-133.
\38\ The FDA is authorized, or at times directed, to use
advisory committees. The Federal Advisory Committee Act,
FACA, is applicable to the FDA and defines ``advisory
committee'' as any committee, board, commission, counsel,
conference, panel task force or, other similar group . . .
which is established by a statute, established or used by the
President, or established or utilized by the one or more
agencies in the interest of obtaining advice or
recommendations.'' 5 U.S.C. App. Sec. 3. As discussed above,
FDA regulations provide additional and specific requirements
for advisory committees, how they are constituted, meetings,
participation by interested persons, and similar issues.
\39\ IOM, at p. 121.
\40\ Id., at p. 127.
\41\ IOM, at p. 213.
\42\ Id., at p. 215.
\43\ 42 U.S.C. Sec. Sec. 300aa et seq., discussed infra, at
pp. 18-19.
\44\ To recover in a products liability suit, the plaintiff
must prove that the defect was present at the time it left
the hands of the defendant. If a defect was present at the
time of manufacture, but a plaintiff sues a seller instead of
the manufacturer, then the seller may recover from the
manufacturer any damages it pays to the plaintiff. In the
past decade, almost half the states have enacted statutes
making product sellers other than manufacturers strictly
liable only when the manufacturer cannot be sued or would be
unable to satisfy a judgment. See Fifty-State Surveys of
Selected Products Liability Issues (CRS Report No. 95-300 A).
\45\ 123 N.E.2d 792 (N.Y. 1954).
\46\ Id. at 794.
\47\ 185 So.2d 749 (Fla. Dist. Ct. App. 1966), aff'd as
modified, 196 So.2d 115 (Fla. 1967).
\48\ Terri S. Hall, Bad Blood: Blood Industry's Immunity From
Liability For Transfusion-Borne Disease, 12 Journal of
Products Liability 25, 33 (1989).
\49\ 266 N.E.2d 897 (Ill. 1970).
\50\ Hall, supra note 48.
\51\ Cunningham, supra note 49, at 902.
\52\ Annotation, Liability of Blood Supplier or Donor for
Injury or Death Resulting from Blood Transfusion, 34 ALR4th
508, 513.
\53\ 745 Ill. Compiled Stat. Ann. 40/2 (Smith-Hurd).
\54\ Glass v. Ingalls Memorial Hospital, 336 N.E.2d 495, 499
(Ill. 1975).
\55\ Andrew R. Klein, Beyond DES: Rejecting the Application
of Market Share Liability in Blood Products Litigation, 68
Tulane Law Review 883, 915 (1994). The citations to 44 of the
48 state blood shield statutes appear in M. Stuart Madden,
PRODUCTS LIABILITY (2d ed. 1988 & Supp. 1993) Sec. 6.19 n.1.
Minnesota repealed its statute, Minn. Stat. Sec. 525.928, in
1991.
\56\ Dana J. Finberg, Blood Bank and Blood Products
Manufacturer Liability in Transfusion-Related AIDS Cases, 26
University of Richmond Law Review 519, 524 (1992).
\57\ Howell v. Spokane & Inland Empire Blood Bank, 785 P.2d
815, 817 (Wash. 1990).
\58\ Robert E. Cartwright and Jerry J. Phillips, PRODUCTS
LIABILITY (1986 & Supp. 1992) at Sec. 4.03 (Supp. p. 127). Of
course, a blood supplier may avoid this liability simply by
not making warranties or representations as to a product's
safety.
\59\ Finberg, supra note 56, at 525-526.
\60\ JKB, SR., and VB v. Armour Pharmaceutical Company, 660
N.E.2d 602 (Ind. App. 1996).
\61\ Kathryn Glasgow Lofti, Suppliers of AIDS-Contaminated
Blood Now Face Liability, 34 Howard Law Review 183, 196
(1991).
\62\ Finberg, supra note 56, at 533.
\63\ Id. at 521.
\64\ Kirkendall v. Harbor Insurance Co., 887 F.2d 857, 861
(8th Cir. 1989).
\65\ Lofti, supra note 61, at 200, 197.
\66\ Finberg, supra note 56, at 537.
\67\ Id.
\68\ Hall supra note 48, at 43.
\69\ See, text accompanying notes 54 and 57, supra.
\70\ Klein, supra note 55, at 931, 932-933. The author of
this proposal, however, would not allow a petitioner to use
the no-fault compensation scheme unless he first
``demonstrate[d] a diligent, but unsuccessful, effort to
prove which manufacturer produced the product that caused his
infection. Thus, only plaintiffs unable to prove traditional
cause in fact would use alternative legislation.'' Id. at
933.
\71\ 42 U.S.C. Sec. Sec. 300aa et seq. The summary of the Act
that follows draws heavily from Lester S. Jayson, Handling
Federal Tort Claims: Administrative and Judicial Remedies
Sec. 1.25 (1996).
\72\ H.R. Rep. No. 99-908, Part 1, 99th Cong., 2d Sess. 13
(1986).
\73\ For additional information see The Products Liability
Conference Committee Bill (CRS Rep. No. 96-276 A).
\74\ See, text accompanying note 48, supra.
\75\ H.R. Rep. No. 104-64, Part 1, 104th Cong., 1st Sess. 30
(1995).
\76\ The footnotes that accompany the following quotation are
all by the author of this memorandum; they do not appear in
the Senate report.
\77\ This, of course, is because the blood shield statutes
generally preclude suits except in negligence.
\78\ This statement does not explain the reluctance to change
negligence actions involving tissue, organs, blood, and blood
products, when there is no reluctance to change negligence
actions involving other products. Section 102(a)(1) of the
bill provides that the bill would apply to any product
liability action (with exceptions not relevant here), and
section 101(14) defines ``product liability action'' as ``a
civil action brought under any theory [i.e., including
negligence] for harm caused by a product.''
\79\ This is true, but does not explain why the bill would
apply to strict liability actions involving tissue, organs,
blood, and blood products, but not to negligence actions
involving those products. Whether the bill would apply to a
particular type of suit is unrelated to the question of
whether that type of suit may be brought. This is because the
bill would affect only particular aspects of products
liability suit; it would not alter their nature as
negligence, breach of warranty, or strict liability suits.
\80\ This statute was renumbered as indicated in note 53,
supra.
\81\ S. Rep. No. 104-69, 104th Cong., 1st Sess. 24 n.86
(1995).
\82\ H.R. Rep. No. 104-481, 104th Cong., 2d Sess. (1996).
\83\ The following is based on an article in 24 Products
Safety & Liability Reporter 761 (Aug. 16, 1996).
\84\ Walker v. Bayer AG (N.D. Ill., MDL No. 93-C-7452).
[From the Committee to Study HIV Transmission Through Blood and Blood
Products, Division of Health Promotion and Disease Prevention,
Institute of Medicine, National Academy Press, Washington, D.C., 1995]
HIV and the Blood Supply: An Analysis of Crisis Decisionmaking
(By Lauren B. Leveton, Harold C. Sox, Jr., and Michael A. Stoto)
executive summary
A nation's blood supply is a unique, life-giving resource
and an expression of its sense of community. In 1993,
voluntary donors gave over 14 million units of blood in the
United States (Wallace, et al. 1993). However, the
characteristic that makes donated blood an expression of the
highest motives also makes it a threat to health. Derived
from human tissue, blood and blood products can effectively
transmit infections such as hepatitis, cytomegalovirus,
syphilis, and malaria from person to person (IOM 1992). In
the early 1980s blood became a vector for HIV infection and
transmitted a fatal illness to more than half of the 16,000
hemophiliacs in the United States and over 12,000 blood
transfusion recipients (CDC, MMWR; July 1993).
Each year, approximately four million patients in the
United States receive transfusions of approximately 20
million units of whole blood and blood components. The blood
for these products is collected from voluntary donors through
a network of nonprofit community and hospital blood banks.
Individuals with hemophilia depend upon blood coagulation
products, called antihemophilic factor (AHF) concentrate, to
alleviate the effect of an inherited deficiency in a protein
that is necessary for normal blood clotting. The AHF
concentrate is manufactured from blood plasma derived from
1,000 to 20,000 or more donors, exposing individuals with
hemophilia to a high risk of infection by blood-borne
viruses.
The safety of the blood supply is a shared responsibility
of many organizations including the plasma fractionation
industry, community blood banks, the federal government, and
others. The Food and Drug Administration (FDA) has regulatory
authority over plasma collection establishments, blood banks,
and all blood products. Since 1973, the FDA has established
standards for plasma collection and plasma product
manufacture and a system for licensing those who met
standards. The Centers for Disease Control and Prevention
(CDC) has responsibility for surveillance, detection, and
warning of potential public health risks within the blood
supply. The National Institutes of Health (NIH) supports
these efforts through fundamental research. During the
1950s and 1960s, blood shield laws were adopted by 47
states. These laws exempt blood and blood products from
strict liability or implied warranty claims on the grounds
that they are a service rather than a product. The laws
were developed on the premise that given the inherently
risky nature of blood and blood products, those providing
them required protection if the blood system was to be a
reliable resource.
As a whole, this system works effectively to supply the
nation with necessary blood and blood products, and its
quality control mechanisms check most human safety threats.
The events of the early 1980s, however, revealed an important
weakness in the system--in its ability to deal with a new
threat that was characterized by substantial uncertainty.
With intent to prepare the guardians of the blood supply for
future threats concerning blood safety, the Department of
Health and Human Services commissioned the Institute of
Medicine to study the
[[Page H3386]]
transmission of HIV through the blood supply. The Committee
to Study HIV Transmission Through Blood and Blood Products
undertook this assignment fully aware of the advantages and
dangers of hindsight. Hindsight offers an opportunity to gain
the understanding needed to confront the next threat to the
blood supply. The danger of hindsight is unfairly finding
fault with decisions that were made in the context of great
uncertainty.
HISTORY
The Risk of AIDS
Starting with the identification of 26 homosexual men with
opportunistic diseases in June 1981, the CDC's Morbidity and
Mortality Weekly Report became the source for reports of the
epidemic. By July 1982, enough cases had occurred with common
symptomatology to name the new disease ``acquired immune
deficiency syndrome'' (AIDS). By January 1983,
epidemiological evidence from CDC's investigations strongly
suggested that blood and blood products transmitted the agent
causing AIDS and that the disease could also be transmitted
through intimate heterosexual contact. The conclusion that
the AIDS agent was blood-borne was based on two findings.
First, AIDS was occurring in transfusion recipients and
individuals with hemophilia who had received AHF concentrate;
these patients did not belong to any previously defined group
at risk for contracting AIDS. Second, the epidemiologic
pattern of AIDS was similar to hepatitis B, another blood-
borne disease.
Immediate Responses to Evidence of Blood-Borne AIDS Transmission
In the first months of 1983, the epidemiological evidence
that the AIDS agent was blood-borne led to meetings and
public and private decisions that set the pattern of the
blood industry's response to AIDS, starting with a public
meeting convened by the CDC in Atlanta on January 4, 1983.
Later that month, the leading blood bank organizations, and,
separately, the National Hemophilia Foundation (NHF) and the
blood products industry, issued statements about preventing
exposure to AIDS. In March 1983, the Assistant Secretary for
Health promulgated the first official Public Health Services
(PHS) recommendations for preventing AIDS, and the FDA
codified safe practices for blood and plasma collection.
The government and private agencies quickly identified,
considered, and in some cases adopted strategies for dealing
with the risk of transmitting AIDS through blood and blood
products. The recommended safety measures, however, were
limited in scope. Examples include: questions to eliminate
high-risk groups such as intravenous drug users, recent
immigrants from Haiti, and those with early symptoms of AIDS
or exposure to patients with AIDS; direct questions about
high-risk sexual practices were generally not used. These
questions reflected a lack of consensus about the magnitude
of the threat, especially among physicians and public health
officials who had trouble interpreting the unique
epidemiological pattern of AIDS. The recommendations also
reflected uncertainty about the benefits of identifying and
deferring potentially infected blood and plasma donors,
treatment of blood products to inactivate viruses, recall of
products derived from donors known to have or suspected of
having AIDS, and changes in transfusion practice and blood
product usage. The costs, risks, and benefits of these and
other potential control strategies were uncertain.
Opportunities to Reformulate Policy
In the interval between the decisions of early 1983 and the
availability of a blood test for HIV in 1985, public health
and blood industry officials became more certain that AIDS
was a blood-borne disease as the number of reported cases of
AIDS among hemophiliacs and transfused patients grew. As
their knowledge grew, these officials had to decide about
recall of contaminated blood products and possible
implementation of a surrogate test for HIV. Meetings of the
FDA's Blood Products Advisory Committee in January, February,
July and December 1983 offered major opportunities to
discuss, consider, and reconsider the limited tenor of the
policies.
Despite these and other opportunities to review new
evidence and to reconsider earlier decisions, blood safety
policies changed very little during 1983. Many officials of
the blood banks, the plasma fractionation industry, and the
FDA accepted with little question estimates that the risk
of AIDS was low (``one in a million transfusions''), and
they accepted advice that control strategies (such as
automatic withdrawal of AHF concentrate lots containing
blood from donors suspected of having AIDS, or a switch
from AHF concentrate to cryoprecipitate in mild or
moderate hemophiliacs) would be ineffective, too costly,
or too risky. During this period, there were missed
opportunities to learn from local attempts to screen
potentially infected donors or implement other control
strategies that had been rejected as national policy.
Research Activities
From 1983 through 1985, research on AIDS included
epidemiological analysis to understand patterns of spread and
etiology, the search for methods to control or eliminate the
disease, and evaluation of the efficacy of potential safety
measures such as surrogate tests for the infection. Related
research on methods to inactivate hepatitis B virus in AHF
concentrate had begun in the 1970s and came to fruition in
the early 1980s.
Scientists at the Pasteur Institute in Paris first isolated
the retrovirus now known as HIV-1 in 1983. Investigators at
the National Institutes of Health (NIH) provided convincing
evidence that HIV-1 was the causative infectious agent of
AIDS in 1984, and were also able to propagate HIV-1 in the
laboratory, thus providing the basis for a blood test to
identify individuals infected by the virus. Scientists at NIH
isolated and characterized HIV in 1984. Viral inactivation
methods for AHF concentrate were developed in laboratories of
the plasma fractionators, and the FDA licensed the new
processes quickly. Although the pace of viral inactivation
research had been slow, it accelerated in the 1980s, largely
in response to hepatitis, and had identified effective
strategies by 1984. However, research into other potential
ways to safeguard the blood supply such as the use of
surrogate tests was not pursued vigorously, and there was
relatively little research on blood safety issues per se.
findings
The Committee framed its approach by examining four topics
that are essential components of a focused strategy for
ensuring the safety of the blood supply: blood product
treatment, donor screening and deferral, regulation of
removal of contaminated products from the market, and
communication to physicians and patients.
Product Treatment
Plasma products can be treated by a variety of physical and
chemical processes to inactivate viruses and thus to produce
a product free from contamination and relatively safe for
transfusion. Shortly after the development of the technology
to manufacture AHF concentrate, it was recognized that these
products carried a substantial risk of transmitting hepatitis
B. Although some blood derivative products had been treated
with heat to destroy live viruses since the late 1940s,
Factor VIII and IX concentrates in the United States were not
subject to viral inactivation procedures until 1983 and 1984.
If this technology had been developed and introduced before
1980 to inactivate hepatitis B virus and non-A, non-B
hepatitis virus, fewer individuals with hemophilia might have
been infected with HIV.
Overall, the record of the plasma fractionators and the FDA
with respect to the development and implementation of heat
treatment is mixed. The Committee's analysis focused on
whether the basic knowledge and technology for inactivating
viruses in AHF concentrate had been available before 1980 and
whether industry had appropriate incentives (from FDA, NIH,
NHF, or others) to develop viral inactivation procedures. In
the Committee's judgment, heat treatment processes to prevent
the transmission of hepatitis, an advance that would have
prevented many cases of AIDS in individuals with hemophilia,
might have been developed before 1980. For a variety of
reasons (e.g., concern about possible development of
inhibitors and higher costs), however, neither physicians
caring for individuals with hemophilia nor the Public Health
Service agencies actively encouraged the plasma fractionation
companies to develop heat treatment measures earlier. The
absence of incentives, as well as the lack of a
countervailing force to advocate blood product safety,
contributed to the plasma fractionation industry's slow rate
of progress toward the development of heat-treated products.
Once plasma fractionators developed inactivation methods,
however, the FDA moved expeditiously to license them.
Donor Screening and Deferral Policies
The purpose of donor screening and deferral procedures is
to minimize the possibility of transmitting an infectious
agent from a unit of donated blood to the recipient of that
unit, as well as to ensure the welfare of the donor. Donor
screening includes the identification of suitable donors; the
recruitment of donors; and the exclusion of high-risk
individuals through methods and procedures used at the time
of donation, such as questionnaires, interviews, medical
exams, blood tests, and providing donors with the opportunity
to self-defer. Donor deferral is the temporary or permanent
rejection of a donor based on the results of the screening
measures.
By January 1983, in addition to suggesting that the agent
causing AIDS was transmitted through blood and blood products
and could be sexually transmitted, the epidemiological
evidence also demonstrated that there were several groups who
had an increased risk of developing AIDS. The highest
incidence of the disease was in male homosexuals, who donated
blood frequently in some geographic regions. The Committee
found that organizations implemented donor screening measures
in different ways at different times. Plasma collection
agencies had begun screening potential donors and excluding
those in any of the known risk groups as early as December
1982, and CDC scientists suggested in January 1983 that blood
banks do likewise. Also in January, the blood-banking
organizations (the American Association of Blood Banks, the
American Red Cross, and the Council of Community Blood
Center) issued a joint statement that recommended the use of
donor screening questions to detect early symptoms of AIDS or
exposure to AIDS patients. The statement, however, did not
advocate directly questioning donors about their sexual
preferences. Blood banks did institute some screening
[[Page H3387]]
measures in early 1983, but only a few asked potential donors
questions about homosexual activities. At the same time, CDC
scientists also suggested that all blood and plasma
collection agencies employ an available surrogate test for
hepatitis B core antigen (anti-HBc). Most blood and plasma
collection agencies rejected this recommendation. Although
the precise impact of these two actions is not known, earlier
implementation of either probably would have reduced the
number of individuals infected with HIV through blood and
blood products. In March 1983 the PHS issued recommendations
that identified high-risk individuals for AIDS and stated
that these individuals should not donate plasma or blood.
Based on its review of the evidence, the Committee found
that decisionmakers involved with donor screening and
deferral acted with good intent in some instances. In other
instances, however, preference for the status quo under the
prevailing conditions of uncertainty and danger led
decisionmakers to underestimate the threat of AIDS for blood
recipients. The Committee concluded that when confronted with
a range of options for using donor screening and deferral to
reduce the probability of spreading HIV through the blood
supply, blood bank officials and federal authorities
consistently chose the least aggressive option that was
justifiable. In adopting this limited approach, policymakers
often passed over options that might have initially slowed
the spread of HIV to individuals with hemophilia and other
recipients of blood and blood products, for example, by
screening male donors for a history of sexual activity with
other males and screening donated blood for the anti-HBc
antibody. The Committee believes that it was reasonable to
require blood banks to implement these two screening
procedures in January 1983. The FDA's failure to require this
is evidence that the agency did not adequately use its
regulatory authority and therefore missed opportunities to
protect the public health.
Regulations and Recall
The FDA is the principal regulatory agency with authority
for blood and blood products, but it exercises its authority
largely through informal action. Recall--the removal of a
product from the market--exemplifies the relationship between
the FDA's potent formal powers and its informal modus
operandi. Recall is a voluntary act undertaken by the
manufacturer but overseen by the FDA, which has the authority
to seize or revoke the license of a product. Regulation of
blood and blood products has been generally based on
establishing a scientific consensus. Because the FDA's
resources are limited, it relies upon the blood industry and
others for cooperation. The FDA's Blood Products Advisory
Committee is a venue for consensus-building about blood
regulatory policy. In an industry in which firm and product
reputation is critical to market success, the FDA's collegial
approach is usually effective.
The Committee analyzed the FDA's exercise of its regulatory
powers by examining how it acted during four critical events:
(1) letters issued by the FDA in March 1983 requiring
particular practices related to donor screening and the
segregation of high-risk plasma supplies; (2) a July 1983
decision not to recall plasma products ``automatically''
whenever they could be linked to individual donors who had
been identified as having or as suspected of having AIDS; (3)
a decision not to recall nontreated AHF concentrate when
heat-treated AHF concentrate became available in 1983; and
(4) a delay of years in the FDA's formal decision to
recommend tracing recipients of transfusions from a donor who
was later found to have HIV. For each of these, the Committee
posed a series of hypotheses to explain the FDA's actions.
These focused on the reach of the agency's legal powers, the
information available at the time in relation to relevant
public health considerations, the agency's resources, the
FDA's institutional culture, the economic costs of particular
actions, and the prevailing political climate.
The analysis of these four events led the Committee to
identify several weaknesses in the FDA's regulatory approach
to blood safety issues. The agency's March 1983 letters may
have been unclear concerning whether all of their
recommendations were required to be implemented by the
addressed. Handling of the case-by-case recall decision
suggested that the agency lacked both the capacity to
structure its advisory process adequately and to analyze
independently the recommendations that were made to it. In
the Committee's judgment, these and other events indicate the
need for a more systematic approach to blood safety
regulation when there is uncertainty and danger to the
public.
Communication to Physicians and Patients
As evidence accrued on the possibility that the blood
supply was a vector for AIDS consumers of blood and blood
products and their physicians found themselves in a complex
dilemma about how to reduce the risk of infection.
Restricting or abandoning the use of blood and blood products
could lead to increased mortality and morbidity. On the other
hand, continued use of these products apparently increased
the risk of AIDS. The Committee investigated the processes by
which physicians and patients obtained information about the
epidemic and the costs, risks, and benefits of their clinical
options.
A wide range of clinical options were available by late
1982 and might, in some instances, have reduced or eliminated
dependence on AHF concentrate and there by reduce the risk of
HIV transmission. As often happens in times of intense
scientific and medical uncertainty such as in the early
1980s, individuals with hemophilia and transfusion recipients
had little information about risks, benefits, and clinical
options for their use of blood and blood products.
The dramatic successes of treatment with AHF concentrate in
the 1970s provided a context in which thresholds for
abandoning or radically restricting the use of these products
for individuals with severe hemophilia were high. both
physicians and individuals with hemophilia express reluctance
about returning to the era of clinical treatment before the
introduction of AHF concentrate. The National Hemophilia
Foundation (NHF) and physicians, in their effort to find the
right balance between the risks and benefits of continued use
of AHF concentrate, tended to overweight the well-established
benefits of AHF concentrate and underestimate the risks of
AIDS, which were still uncertain.
In addition, the Committee found that prevailing
assumptions about medically acceptable risks, especially
regarding hepatitis, led to complacency and a failure to act
with sufficient concern upon reports of a new infectious
risk. Ultimately, assumptions about medical decisionmaking
practices in which patient played a relatively passive role
led to failures to disclose completely the risk of using AHF
concentrate and thereby did not enable individuals to make
informed decisions of themselves. As the potential dimensions
of the epidemic among individuals with hemophilia became
clear, communication between physicians and patients was
further compromised by physicians' reticence to discuss the
dire implications of widespread infection with their patients
and families.
Institutional barriers to patient-physician communications
and relationships between relevant organizations also impeded
the flow of information. If the NHF had received input from a
wider group of scientific and medical experts, more explicit
and systematic dissemination of a range of clinical options
might well have been possible. In addition, the financial and
other relationships between the NHF and the plasma
fractionation industry created a conflict of interest that
seriously compromised the perceived independence of NHF's
recommendations.
No organization stepped forward to communicate widely the
risks of blood transfusions to potential recipients. Many
blood bank officials during this period publicly denied that
AIDS posed any significant risk to blood recipients. In this
context, and because many transfusions occurred on an
emergency basis, patients were typically not apprised of the
growing concerns about the contamination of the blood supply.
For both individuals with hemophilia and recipients of blood
transfusion, physicians concern that their patients might
refuse care deemed a ``medical necessity'' further
contributed to failure to inform them of the risks.
CONCLUSIONS
Decisionmaking Under Uncertainty
The events and decisions that the Committee has analyzed
underscore the difficulty of personal and institutional
decisionmaking when the stakes are high, when knowledge is
imprecise and incomplete, and when decisionmakers may have
personal or institutional biases. The Committee attempted to
understand the complexities of the decisionmaking process
during this uncertain period and to develop lessons to
protect the blood supply in the future. In retrospect, the
system did not deal well with contemporaneous blood safety
issues such as hepatitis, and was not prepared to deal with
the far greater challenge of AIDS.
Although enough epidemiological evidence has emerged by
January 1983 to strongly suggest that the agent causing AIDS
was transmitted through blood and blood products and could be
sexually transmitted to sexual partners, the magnitude of the
risk for transfusion and blood product recipients was not
know at this time. Policymakers quickly developed several
clinical and public health options to reduce the risk of AIDS
transmission. There was, however, substantial scientific
uncertainty about the costs and benefits of the available
options. The result was a pattern of responses which, while
not in conflict with the available scientific information,
were very cautious and exposed the decisionmakers and their
organizations to a minimum of criticism.
Blood safety is a shared responsibility of many diverse
organizations. They include U.S. Public Health Service
agencies such as the CDC, the FDA, and the NIH, and private-
sector organizations such as community blood banks and the
American Red Cross, blood and plasma collection agencies,
blood product manufacturers, groups like the National
Hemophilia Foundation, and others. The problems the Committee
found indicated a failure of leadership and inadequate
institutional decision making process in 1983 and 1984. No
person or agency was able to coordinate all of the
organizations sharing the public health responsibility for
achieving a safe blood supply.
Bureaucratic Management of Potential Crises
Federal agencies had the primary responsibility for dealing
with the national emergency posed by the AIDS epidemic. The
Committee scrutinized bureaucratic function closely and came
to the following conclusions about the management of
potential crises.
[[Page H3388]]
First, unless someone from the top exerts strong
leadership, legal and competitive concerns may inhibit
effective action by agencies of the federal government.
Similarly, when policymaking occurs against a backdrop of a
great deal of scientific uncertainty, bureaucratic standard
operating procedures designed for routine circumstances seem
to take over unless there is a clear-cut decision-making
hierarchy. An effective leader will insist upon coordinated
planning and execution. Focusing efforts and
responsibilities, setting timetables and agendas, and
assuming accountability for expeditious action cannot be left
to ordinary standard operating procedures. These actions are
the responsibilities of the highest levels of the public
health establishment.
Second, the FDA and other agencies in the early 1980s
lacked a systematic approach to conducting advisory committee
processes. These agencies should tell their advisory
committees what it expects from them, keep attention focused
on high-priority topics, and independently evaluate their
advice. Because mistakes will always be made and
opportunities missed, regulatory structures must organize and
manage their advisory boards to assure both the reality and
the continuous appearance of propriety.
Third, agencies should not rely upon the entities they
regulate for analysis of data and modeling of decision
problems.
Fourth, agencies need to think far ahead. They must monitor
more systematically the long-term outcomes of blood
transfusion and blood product infusion to anticipate both new
technologies and new threats to the safety of the blood
supply. The Committee believes that the Public Health Service
should plan what it will do if there is a threat to the blood
supply. It should specify actions that will occur once the
level of concern passes a specified threshold. The Committee
favors a series of criteria or triggers for taking regulatory
or other public health actions in which the response is
proportional to the magnitude of the risk and the quality of
the information on which the risk estimate is based. Taking
on small steps allows for careful reconsideration of options,
particularly as information about uncertain risks unfolds.
Not all triggering events need lead to drastic action; some
may merely require careful reconsideration of the options or
obtaining new information.
recommendations
The Committee's charge was to learn from the events of the
early 1980s to help the nation prepare for future threats to
the blood supply. From the record assembled for this study,
the Committee identified potential problems with the system
in place at that time and has identified some changes that
might have moderated some of the effects of the AIDS epidemic
on recipients of blood and blood products. The federal and
private organizations responsible for blood safety and the
public health more generally will have to evaluate their
current polices and procedures to see if they fully address
the issues raised by these recommendations.
The Public Health Service
Several agencies necessarily play important, often
differentiated, roles in managing a public health crisis such
as the contamination of blood and blood products by the AIDS
virus. The National Blood Policy of 1973 charged the PHS
(including the CDC, the FDA, and the NIH) with responsibility
for protecting the nation's blood supply.
The Committee has come to believe that a failure of
leadership may have delayed effective action during the
period from 1982 to 1984. This failure led to less than
effective donor screening, weak regulatory actions, and
insufficient communication to patients about the risks of
AIDS. In the event of a threat to the blood supply, the
Public Health Service must, as in any public health crisis,
insist upon coordinated action. The Secretary of Health and
Human Service is responsible for all the agencies of the
Public Health Service,\1\ and therefore the Committee makes--
Recommendation 1: The Secretary of Health and Human Services
should designate a Blood Safety Director, at the level of a
deputy assistant secretary or higher, to be responsible for
the federal government's efforts to maintain the safety of
the nation's blood supply.
---------------------------------------------------------------------------
Footnotes appear at the end of article.
---------------------------------------------------------------------------
To be effective in coordinating the various agencies of the
PHS, the Blood Safety Director should be at the level of a
deputy assistant secretary or higher, and should not be a
representative of any single PHS agency.
In considering the history of the contamination of the
blood supply with HIV and the current surveillance,
regulatory, and administrative structures for ensuring the
safety of our nation's blood resources, the Committee became
convinced that the nation needs a far more responsive and
integrated process to ensure blood safety. To this end, the
Committee makes--Recommendation 2: The PHS should establish a
Blood Safety Council to assess current and potential future
threats to the blood supply, to propose strategies for
overcoming these threats, to evaluate the response of the PHS
to these proposals, and to monitor the implementation of
these strategies. The Council should report to the Blood
Safety Director (see Recommendation 1). The Council should
also serve to alert scientists about the needs and
opportunities for research to maximize the safety of blood
and blood products. The Blood Safety Council should take the
lead to ensure the education of public health officials,
clinicians, and the public about the nature of threats to our
nation's blood supply and the public health strategies for
dealing with these threats.
The proposed Blood Safety Council would facilitate the
timely transmission of information, assessment of risk, and
initiation of appropriate action both during times of
stability and during a crisis. The Council should report to
the Blood Safety Director (see Recommendation 1). The Council
would not replace the PHS agencies responsible for blood
safety but would complement them by providing a forum for
them to work together and with private organizations. The PHS
agencies would be represented on the Council.
The Blood Safety Council should consider the following
activities and issues: to deliberate the need for a system of
active surveillance for adverse reactions in blood
recipients; to establish a panel of experts to provide
information about risks and benefits, alternative options for
treatment, and recommended best practices (see Recommendation
13); and to investigate methods to make blood products safer,
such as double inactivation processes and reduction of plasma
pool size.
When a product or service provided for the public good has
inherent risks, the common law tort system fails to protect
the rightful interests of patients who suffer harms resulting
from the use of those products and services. To address this
deficiency, the Committee makes--Recommendation 3: The
federal government should consider establishing a no-fault
compensation system for individuals who suffer adverse
consequences from the use of blood or blood products. \2\
For such a no-fault system to be effective, standards and
procedures would have to be determined prospectively to guide
its operations. There needs to be an objective, science-based
process to decide which kinds of adverse outcomes are caused
by blood-borne pathogens and which individual cases of these
adverse outcomes deserve compensation. As with vaccines, such
a system could be financed by a tax or fee paid by all
manufacturers or by the ultimate recipients of blood
products. However, had there been a no-fault compensation
system in the early 1980s, it could have relieved much
financial hardship suffered by many who became infected with
HIV through blood and blood products in the United States.
The no-fault principles outlined in this recommendation might
serve to guide policymakers as they consider whether to
implement a compensation system for those infected in the
1980s.
The Centers for Disease Control and Prevention
The CDC has an indispensable role in protecting our
nation's health: to detect potential public health risks and
sound the alert. In order to improve CDC's efficacy in this
critical role, the Committee makes--Recommendation 4: Other
federal agencies must understand, support, and respond to the
CDC's responsibility to serve as the nation's early warning
system for threats to the health of the public.
One way to begin to implement this recommendation is for
the Secretary of Health and Human Services to insist that an
agency that wishes to disregard a CDC alert should support
its position with evidence that meets the same standard as
that used by the CDC in raising the alert.
In order to carry out its early warning responsibility
effectively, the CDC needs good surveillance systems. The
Committee, believing that the degree of surveillance should
be proportional to the level of risk inherent in blood and
blood products and should include both immediate and delayed
effects, makes Recommendation 5: The PHS should establish a
surveillance system, lodged in the CDC, that will detect,
monitor, and warn of adverse effects in the recipients of
blood and blood products.
The Food and Drug Administration
The FDA has legal authority to protect the safety of the
nation's blood supply, and it is the lead federal agency in
regulating blood banking practice, the handling of source
plasma, and the manufacture of blood products from plasma.
The Committee's recommendations focus on decisionmaking and
the role of advisory committees in formulating the FDA's
response to crises.
In the Committee's judgment, a more systematic approach to
blood safety regulation, one that is better suited to
conditions of uncertainty, is needed. In particular, the
Committee recommends (see Chapter 8) that the PHS develop a
series of criteria or triggers for taking regulatory or other
public health actions for which the response is proportional
to the magnitude of the risk and the quality of the
information on which the risk estimate is based. In order
that the perfect not be the enemy of the good, the Committee
makes--Recommendation 6: Where uncertainties or
countervailing public health concerns preclude completely
eliminating potential risks, the FDA should encourage, and
where necessary require, the blood industry to implement
partial solutions that have little risk of causing harm.
In all fields, decisionmaking under uncertainty requires an
iterative process. As the knowledge base for a decision
changes, the responsible agency should reexamine the facts
and be prepared to change its decision. The agency should
also assign specific responsibility for monitoring conditions
and identifying opportunities for change. In order to
implement these principles at the FDA, the Committee makes--
Recommendation 7: The FDA should periodically review
[[Page H3389]]
important decisions that it made when it was uncertain about
the value of key decision variables.
Although the FDA has a great deal of regulatory power over
the blood products industry, the agency appears to regulate
by expressing its will in subtle, understated directives.
Taking this into account, the Committee makes--Recommendation
8: Because regulators must rely heavily on the performance of
the industry to accomplish blood safety goals, the FDA must
articulate its requests or requirements in forms that are
understandable and implementable by regulated entities. In
particular, when issuing instructions to regulated entities,
the FDA should specify clearly whether it is demanding
specific compliance with legal requirements or is merely
providing advice for careful consideration.
In the early 1980s, the FDA appeared too reliant upon
analyses provided by industry-based members of the Blood
Products Advisory Committee (BPAC). Thus the Committee
arrived at--Recommendation 9: The FDA should ensure that the
composition of the Blood Products Advisory Committee reflects
a proper balance between members who are connected with the
blood and blood products industry and members who are
independent of industry.
An agency that is well-practiced in orderly decisionmaking
procedures will be able to respond to the much greater
requirements of a crisis. This consideration leads to--
Recommendation 10: The FDA should tell its advisory
committees what it expects from them and should independently
evaluate their agendas and their performance.
Advisory committees provide scientific advice to the FDA,
but they do not make regulatory decisions for the agency. The
FDA's lack of independent information and an analytic
capability of its own meant that it had little choice but to
incorporate the advice of BPAC into its policy
recommendations. To ensure the proper degree of independence
between the FDA and the BPAC, the Committee makes--
Recommendation 11: The FDA should develop reliable sources of
the information that it needs to make decisions about the
blood supply. The FDA should have its own capacity to analyze
this information and to predict the effects of regulatory
decisions.
Communication to Physicians and Patients
One of the crucial elements of the system for collecting
blood and distributing blood products to patients is the
means to convey concern about the risks inherent in blood
products. In today's practice of medicine, in contrast to
that of the early 1980s, patients and physicians each
accept a share of responsibility for making decisions.
In instances of great uncertainty, it is crucial for
patients to be fully apprised of the full range of options
available and to become active participants in the
consideration and evaluation of the relative risks and
benefits of alternative treatments. To encourage better
communication, the Committee makes--Recommendation 12: When
faced with a decision in which the options all carry risk,
especially if the amount of risk is uncertain, physicians and
patients should take extra care to discuss a wide range of
options.
Given the inherent risks and uncertainties in all blood
products, the public and providers of care need expert,
unbiased information about the blood supply. This information
includes risks and benefits, alternatives to using blood
products, and recommended best practices. In order to provide
the public and providers of care with information they need,
the Committee makes--Recommendation 13: The Department of
Health and Human Services should convene a standing expert
panel to inform the providers of care and the public about
the risks associated with blood and blood products, about
alternatives to using them, and about treatments that have
the support of the scientific record.
One lesson of the AIDS crisis is that a well-established,
orderly decisionmaking process is important for successfully
managing a crisis. This applies as much to clinical
decisionmaking as to the public health decision process
addressed by earlier recommendations. As the narrative
indicates, there are both public health and clinical
approaches to reducing the risk of blood-borne diseases. The
Blood Safety Council called for in Recommendation 2 would
deal primarily with risk assessment and actions in the public
health domain that would reduce the chance that blood
products could be vectors of infectious agents. The primary
responsibility of the expert panel on best practices called
for in Recommendation 13 would be to provide the clinical
information that physicians and their patients need to guide
their individual health care choices. To be most effective,
this panel should be lodged in the Blood Safety Council (see
Recommendation 2) so that both bodies can interact and
coordinate their activities in order to share information
about emerging risks and clinical options.
Recommendation 14: Voluntary organizations that make
recommendations about using commercial products must avoid
conflicts of interest, maintain independent judgment, and
otherwise act so as to earn the confidence of the public and
patients.
One of the difficulties with using experts to give advice
is the interconnections that experts accumulate during their
careers. As a result, an expert may have a history of
relationships that raise concerns about whether he or she can
be truly impartial when advising a course of action in a
complex situation. One way to avoid these risks is to choose
some panelists who are not expert in the subject of the
panel's assignment but have a reputation for expertise in
evaluating evidence, sound clinical judgment, and
impartiality.
Financial conflicts of interest influence organizations as
well as individuals. The standards for acknowledging, and in
some cases avoiding, conflicts of interest are higher than
they were 12 years ago. Public health officials, the medical
professions, and private organizations must uphold this new,
difficult standard. Failure to do so will threaten the fabric
of trust that holds our society together.
references
Centers for Disease Control, Morbidity and Mortality Weekly
Report, July 23, 1993. Institute of Medicine, Emerging
Infections. Washington, D.C.: National Academy Press, 1992.
Wallace, E.L., et al. Collection and Transfusion of Blood and
Blood Components in the United States. Transfusion, vol. 33,
1993.
footnotes
\1\ In the 1980s and now, the PHS agencies report to the
Assistant Secretary of Health. As this report was being
written, the Department of Health and Human Services has
proposed to eliminate the office of the Assistant Secretary,
so that the PHS agencies would report directly to the
Secretary.
\2\ One Committee member (Martha Derthick) abstains from this
recommendation because she believes that it falls outside of
the Committee's charge.
Mr. SCOTT. Madam Speaker, I yield such time as he may consume to the
distinguished gentleman from Massachusetts (Mr. Delahunt).
Mr. DELAHUNT. Madam Speaker, I thank the gentleman for yielding me
the time.
Madam Speaker, I, too, rise in strong support of H.R. 1023, the Ricky
Ray Hemophilia Relief Fund Act. Before I begin my statement, I want to
acknowledge and commend the fine work of my colleague, the gentleman
from Florida (Mr. Porter Goss). He has truly provided outstanding
leadership in this particular issue.
Let me ask Members to imagine that they are the parent of three fine
sons, each of whom has inherited the gene for hemophilia. Now imagine,
if you can, that each of your sons acquires the AIDS virus through a
contaminated blood transfusion. Two brothers die before age 40, and the
third is very sick. Among them, they have 9 children, your
grandchildren, all of whom will be left fatherless.
At least one family in my district does not have to imagine what that
would be like, Madam Speaker. They know, because this is precisely what
is happening to them. Nor is their heartbreaking story, unfortunately,
unique. I have received letters from people in Abingdon, Weymouth,
Ducksbury, and other towns throughout Massachusetts who have lost
family members and friends to hemophilia-associated AIDS.
Every death from AIDS is a tragedy that touches many lives. Yet, who
can fathom the sheer devastation that is visited on families such as
these? The enormity of their experience becomes still more compelling
when one learns that the government, our government, could have acted
to prevent it.
In 1980 when the first Americans began to fall ill from the
mysterious ailment that would ultimately be called AIDS, the technology
became available to pasteurize blood-clotting agents. Yet, for 7 years
the government failed to require the blood products industry to make
use of this technology, nor did the government require the industry to
inform the public about the risks of contamination with HIV and other
blood-borne pathogens.
{time} 1230
As a result, at least 8,000 people with hemophilia and other blood-
clotting disorders contracted HIV/AIDS from transfusions of
contaminated antihemophilic factor or AHF between 1980 and 1987. This
means that as many as 50 percent of all individuals who suffer from
blood-clotting disorders were exposed to HIV through their use of AHF.
In 1995, an independent scientific review conducted by the Institute
of Medicine concluded that this tragedy occurred because the government
failed to take the steps that could have prevented it. Some might argue
that we cannot afford to do anything about that, but I believe we have
an obligation to acknowledge what happened and make restitution to the
victims of this disaster and their families.
This bill will not compensate them for the terrible harm that was
done to them, nor will it begin to cover their medical costs. But it
will mean a great
[[Page H3390]]
deal to them to know that their country has not abandoned them. I am
proud to be an original cosponsor of this bill and urge all of my
colleagues to join in supporting it today.
Mr. HYDE. Madam Speaker, I yield 1 minute and 30 seconds to the
gentleman Arizona (Mr. Hayworth).
Mr. HAYWORTH. Madam Speaker, I thank my colleague, the gentleman from
Florida (Mr. Goss), for his hard work on this legislation.
I am pleased to come to the well today to speak in behalf of passage
of this legislation because, Madam Speaker, I had a chance to listen to
a young man from my State recount the very real difficulties that he
confronted from receiving a transfusion of HIV-tainted blood. His name,
Jeremy Storms.
Jeremy lived the Scriptures in which he so fervently believed. He let
his light shine among men and, despite all the medical difficulties he
encountered, many times he traveled here to Washington to tell us of
the challenges he faced. He had a wisdom beyond his years. He would
joke, you know, I used to be upset that I was a hemophiliac. Now I wish
it was the only problem I had.
Jeremy passed away a few short months ago, but he did not live in
vain. For his mother and father and family and for countless other
families, this House on this day at this hour acknowledges the role of
the Federal Government in public health and, yes, in personal
responsibility.
I would urge this body, adopt this legislation in memory of Ricky
Ray, Jeremy Storms and so many others.
Mr. SCOTT. Madam Speaker, I yield 2 minutes to the gentlewoman from
Texas (Ms. Eddie Bernice Johnson).
Ms. EDDIE BERNICE JOHNSON of Texas. Madam Speaker, I rise in support
of this bill. Having functioned as a registered professional nurse, I
have observed over the years persons who are afflicted and need
frequent transfusions are more subjected to the risk of HIV than others
on a normal basis. This has been one of the viruses that has come along
in our history that we have not found any way to conquer it. That we
must always be mindful of.
Nothing is more important than assuring a family that when they have
a loved one that needs a transfusion it is free of viruses and any
other bacteria. We have gone a long way in that. We have had to deal
with the virus of the 1930s for pneumonia and the virus of polio for
the 1950s. Now we are having to deal with another major virus, the HIV
virus.
So many people are so unaware of their risk for this disease, for the
disease which the virus will cause. We must do all that we can to
protect the general public, and this bill goes a long way in protecting
the hemophiliacs because they can not get around having the
transfusions.
I have observed too many families, heterosexual, intact families be
destroyed by contamination from the young children and some young
adults getting transfusions, blood transfusions. I do think, and I
agree with the gentleman that there is a public health responsibility
of our Federal Government, and this is one of those major issues that,
until we find medical breakthroughs, we as a government need to take
the responsibility of ensuring the availability of safe, virus-free
blood.
Mr. HYDE. Madam Speaker, I yield 3 minutes to the gentleman from
Florida (Mr. Bilirakis).
Mr. BILIRAKIS. Madam Speaker, I, too, rise in strong support of H.R.
1023.
First and foremost, I want to commend my colleague, the gentleman
from Florida (Mr. Goss), for his tireless efforts to secure passage of
this important measure.
As chairman of the Subcommittee on Health and Environment of the
Committee on Commerce, I am pleased to be an original cosponsor of the
bill.
As my colleagues have already noted, H.R. 1023 provides compassionate
payments to individuals with blood-clotting disorders who contracted
HIV due to contaminated blood products. The National Hemophilia
Foundation estimates that nearly 8,000 individuals with hemophilia
contracted HIV from the Nation's blood supply which became contaminated
before the identification of and development of tests to detect its
presence.
These individuals and their families were already burdened by the
medical costs of treating their blood-clotting disorders, and many have
been financially devastated by the costs associated with HIV infection.
This is a tragedy, and I share the Foundation's view that passage of
this bill will serve to rebuild trust in the Federal Government in its
essential role of protecting the U.S. blood supply and blood products.
A number of my constituents, including Margie and Johnny Kellar of
Palm Harbor, have contacted me to urge enactment of this critical
legislation. I share the desire to secure prompt passage of the bill,
and I am pleased that the House is considering it today under a
suspension of the rules.
As Members know, provisions of H.R. 1023 which fall within the
jurisdiction of the House Committee on Commerce were enacted last year
as part of the balanced budget law. Those provisions exempted the
private settlement funds from the calculation of income for the
purposes of determining Medicaid eligibility. This language was
designed to ensure that those who accepted the private settlement would
not lose their eligibility under the Medicaid program.
My Subcommittee on Health and Environment has jurisdiction over the
Medicaid provisions, and I was pleased to secure their enactment as
part of the 1997 balanced budget law.
The measure before us today extends similar protections to recipients
of Supplemental Security Income benefits.
Again, I want to commend the gentleman from Florida (Mr. Goss) for
his leadership on this issue and his diligent efforts in bringing H.R.
1023 to the floor. I urge all of my colleagues to lend their
wholehearted support to passage of this important bill.
Mr. SCOTT. Madam Speaker, I reserve the balance of my time.
Mr. HYDE. Madam Speaker, may I inquire how much time remains?
The SPEAKER pro tempore (Mrs. Emerson). The gentleman from Illinois
(Mr. Hyde) has 5 minutes remaining.
Mr. HYDE. Madam Speaker, I yield 2 minutes to the gentleman from
Florida (Mr. Stearns).
Mr. STEARNS. Madam Speaker, I thank the gentleman for yielding me
this time.
I commend my colleague the gentleman from Florida (Mr. Goss) for his
vigilance in getting this legislation to the floor. I also am an
original cosponsor of the Ricky Ray Relief Act. I am deeply committed
to seeing this bill become public law.
Madam Speaker, my involvement in this issue began back in 1994 when
I, too, was contacted by Gale and Randy Ellman. The Ellmans lost their
son Eric Brandon when he was 14 years old. Eric died as a result of
infusing a clotting factor that was tainted with HIV. His death is a
double tragedy because it could have been avoided.
While we cannot bring back Ricky or Eric, we can try today to rectify
this wrong. According to best estimates, about 8,000 hemophiliacs have
been infected with HIV. This represents half the hemophiliacs in the
country. By passing this bill we are simply saying that we acknowledge
the government's failure, through the FDA, to protect our Nation's
blood supply and regulate the sale of blood products.
Will $100,000 make up for the pain and suffering these families had
to endure? The answer is no. But what it will do is say to thousands of
people so deeply affected by this tragedy that your government wants to
right the wrong.
The Ellmans called my office this morning to express their heartfelt
gratitude for my support for this legislation and for my other
colleagues' support. I say to the Ellmans and the many other families
so devastated by what has happened to them, it is the very least we can
do.
The SPEAKER pro tempore. The gentleman from Virginia (Mr. Scott) has
11\1/2\ minutes remaining.
Mr. SCOTT. Madam Speaker, I reserve the balance of my time.
Mr. HYDE. Madam Speaker, I yield 2 minutes to the distinguished
gentleman from Virginia (Mr. Davis).
(Mr. DAVIS of Virginia asked and was given permission to revise and
extend his remarks.)
Mr. DAVIS of Virginia. Madam Speaker, I rise today to voice my strong
support for H.R. 1023, the Ricky Ray Hemophilia Relief Fund Act.
As an original cosponsor in both this Congress and the 104th
Congress, I am
[[Page H3391]]
enormously proud that we have been able to bring this bill to the floor
in a bipartisan manner with the support and cosponsorship of over 270
Members.
The gentleman from Florida (Mr. Goss) has done a tremendous job in
garnering support for the Ricky Ray Act and ensuring that it come
before the full House today.
I also express my appreciation to the chairman of the Committee on
the Judiciary, the gentleman from Illinois (Mr. Hyde), as well.
I also want to recognize the hard work of the students at the
Robinson Secondary School in Fairfax, Virginia, on behalf of the
thousands of hemophiliacs suffering from AIDS. They have dedicated
themselves over the past couple of years to winning passage of this
legislation and are now witnessing that democracy does work.
As my colleagues know, this legislation is named for Ricky Ray, a
young boy from Florida who died in 1992 of hemophilia-related AIDS that
he contracted through the use of blood-clotting products. Approximately
one-half of all hemophilia sufferers were infected with HIV through the
use of blood-clotting products between 1980 and 1987. The Federal
Government has a shared responsibility for this tragedy because it
failed to fulfill its responsibility to protect the Nation's blood
supply and to regulate the safety of blood products.
The Ricky Ray bill gives a one-time payment of $100,000 each to about
7,200 hemophiliacs, about half of whom are still surviving, who were
infected with the AIDS virus from blood-clotting agents between July 1,
1982, and December 31, 1987. It also implements a sunset provision
after 5 years from the date of the bill's enactment.
Passage of this legislation will mark a defining and critical moment
in the lives of many innocent AIDS sufferers, not because of the
relatively small amount of money they receive but because of the peace
they and their families will have in knowing that their government has
taken responsibility for what happened to them and is attempting to
compensate them for their suffering to the extent that we are able to
do so.
I strongly urge all of my colleagues to vote in favor of the Ricky
Ray bill.
Mr. SCOTT. Madam Speaker, I yield 4 minutes to the gentlewoman from
California (Ms. Pelosi).
Ms. PELOSI. Madam Speaker, I thank my colleague from Virginia for
yielding me this time.
I rise in strong support of the Ricky Ray Hemophilia Relief Fund Act.
I want to commend our colleague, the gentleman from Florida (Mr. Goss),
for his leadership and compassion in bringing this legislation to the
floor as a sponsor of this bill.
The life of the boy who gave his name to this legislation should
remind all of us of the many different tragedies and demonstrations of
courage and compassion the AIDS epidemic has brought us.
In his short life, Ricky witnessed the prejudice and fear which
surrounded hemophilia, AIDS particularly, in its first decade but which
is still all too common today. He had hemophilia, but he contracted
AIDS and was the victim of much discrimination. He and his family
watched their home burn down because neighbors were afraid of his
illness.
{time} 1245
His family struggled with the tremendous financial burden of
providing for a child with hemophilia and AIDS. Ricky's parents saw
their son pass away as they confronted the limits of treatment to fight
the HIV disease.
Each of these aspects of Ricky's life is important to remember today:
The prejudice, the crushing financial burden, the hope for cures which
have yet to come, and the inspiring courage and compassion of this
young man, his family and friends. This was Ricky's story, and it is
the story of thousands of other people, many of whom have died, many
are living today with hemophilia, HIV and AIDS.
The resources that Congress can provide will not solve the tragedy of
hemophilia and AIDS for Ricky Ray and others like him, but they will
help individuals, families and communities begin to recover from the
calamity that has befallen them. Whether the Federal Government acted
appropriately to protect blood clotting products in the 1980s is not
the issue today. At issue now is providing assistance to individuals
and families who have been forced to confront a personal and financial
crisis brought by two debilitating diseases.
The Federal Government must do many things to respond to the AIDS
epidemic and to hemophilia. It must protect the Nation's blood supply;
provide prevention interventions; in the case of HIV-AIDS, fund
research to find a cure and a vaccine; and support health care and
needed services for those who are ill.
But as with other major catastrophes, the Federal Government also
must provide the resources which help families and communities take the
first steps toward recovery. For that I am grateful to the gentleman
from Florida (Mr. Goss) for his leadership, to the gentleman from
Virginia (Mr. Scott) for his participation in this, as well as the
gentleman from Illinois (Mr. Hyde) and others, and I urge my colleagues
to support H.R. 1023.
Mr. HYDE. Madam Speaker, I have no further requests for time, and I
yield back the balance of my time.
Mr. SCOTT. Madam Speaker, I yield myself such time as I may consume
just to thank the gentleman from Florida (Mr. Goss) for his hard work
on this, the gentleman from Illinois (Mr. Hyde) for his leadership, and
the gentleman from North Carolina (Mr. Watt), whose subcommittee
considered this.
Ms. CHRISTIAN-GREEN. Madam Speaker, I rise today in strong support of
H.R. 1023, a bill to provide compassionate payments to individuals with
blood-clotting disorders such as, Hemophilia, who contracted the HIV
virus due to contaminated blood.
My colleagues, children, especially minority children, are one of the
most rapidly increasing segments of our population being infected with
HIV. And, in all cases they are the innocent victims. Any legislation
which helps to improve the quality of life of these children is worthy
of all of our support.
Prevention programs, while available to all, often do not reach out
to the most needy populations. Where we most need to improve our effort
in this regard, is in making sure that the treatments which have been
developed and proven to improve lives and health, are made accessible
to all who need it. This bill does it.
As a family physician who has treated several patients with
hemophilia, I am pleased to support H.R. 1023 and urge all my
colleagues to do so as well.
Ms. JACKSON-LEE of Texas. Madam Speaker, as Chair of the Children's
Congressional Caucus, and a co-sponsor of this bill, I want to take a
few minutes to speak about the importance of this issue and this bill.
H.R. 1023 is named after Ricky Ray, a child victim of hemophiliac
associated AIDS. Like thousands of others, Ricky Ray became infected
with HIV through the use of contaminated blood products. Ricky brought
national attention to this tragedy before he died from AIDS at age 15,
1992.
The Ricky Ray Hemophilia Relief Fund Act will not only acknowledge
the federal government's unique responsibility to protect the nation's
blood supply, it will also provide recognition to and some small solace
to those living with hemophilia related HIV and their families. Almost
50% of the U.S. hemophilia population has been infected with HIV
through tainted blood products. This bill will also authorize a $750
million dollar fund to provide compassionate assistance to individuals
struggling with the emotional and financial costs of this disease.
In my home state of Texas, AIDS was the sixth leading cause of death
among young people aged 13-24, and currently worldwide approximately
775,000 Americans are infected with the HIV virus.
Although we can never fully compensate the victims and families of
those who are living with hemophilia related AIDS and HIV, we must show
our compassion and our recognition of their plight, through the
legislation here today.
Ms. FURSE. Madam Speaker, I rise today in support of H.R. 1023, the
Ricky Ray Hemophilia Relief Fund Act. I want to congratulate my
colleague, Mr. Goss, for his hard work and relentless efforts to pass
this bill through the House.
In 1994, shortly after I was first elected to the House, a
constituent of mine named Katherine Royer brought to my attention the
plight of people with hemophilia who became infected with HIV through
tainted blood products. Many of these people were children. Until I met
Katherine, I had no idea that over 7000 people with hemophilia had
become infected with HIV, and their already complicated lives were
getting even more difficult. Her family's story was powerful, and
Katherine has relentlessly pursued this issue in her community and with
her elected officials.
I strongly support H.R. 1023 because it acknowledges that the
government must protect
[[Page H3392]]
the nation's blood supply, and provides assistance to the victims of
this tragedy. With yearly medical costs of over $150,000, and a lack of
legal options, many of the affected families have been devastated
financially. While this bill can not bring back loved ones, it can
provide those who are still living with some degree of financial
relief. In addition, it recognizes, finally, the tragedy that occurred
and the impact it had on the entire hemophilia community.
I thank Katherine for bringing this issue to my attention, and am
pleased that H.R. 1023 is finally on the floor of the House. I strongly
urge all my colleagues to support it.
Mr. SHAW. Madam Speaker, I strongly support H.R. 1023, the ``Ricky
Ray Hemophilia Relief Fund Act of 1998.''
H.R. 1023, sponsored by my friend Porter Goss, is named for Ricky
Ray, a 15 year old Florida hemophiliac who died in 1992. This bill
represents the best of what government can do to help needy families
struggling to overcome personal tragedy. From some, including for the
bill's namesake, H.R. 1023 comes too late to provide help. But for many
others it will provide welcome relief, and I am proud not only to be an
original cosponsor, but also to have helped H.R. 1023 progress through
the Ways and Means Committee to the House floor today.
Even though the bill was first marked up by the Judiciary Committee,
an important component is the promise H.R. 1023 would keep by
continuing Supplemental Security Income (SSI) benefits to needy
individuals, which falls under the jurisdiction of the Committee on
Ways and Means and the Subcommittee on Human Resources that I chair.
These critical benefits will remain available despite a recent
settlement and also new federal funds that otherwise would disqualify
hemophiliacs who contracted the AIDS virus through tainted blood
products in the 1980s from continued SSI eligibility. There is ample
precedent for SSI to ignore such payments, and I can scarcely think of
a more worthy class than this limited number of hemophiliacs, many of
them children at the time, who have been afflicted with the AIDS virus.
The Congressional Budget Office has told us the cost is minimal,
especially when compared with the tragedy these individuals and their
families have already experienced.
Another important feature of the bill is that it would exempt the
payments from federal income taxes. Chairman Bill Archer summarized the
issue well when the Committee on Ways and Means unanimously approved
H.R. 1023 last month: ``No amount of money in the world can fix this
tragedy, but we want to make sure that the federal payments are treated
as tax-free, as they should be, and that SSI benefits stay unchanged
for these innocent victims. They've been through enough as it is.''
Madam Speaker, I commend Congressman Goss for his diligence in
pressing for passage of this important bill, and urge all of our
colleagues to support it.
Mr. ARCHER. Madam Speaker, I rise today in support of H.R. 1023, the
Ricky Ray Hemophilia Relief Act. As an original cosponsor to the
legislation introduced by my friend and colleague, Porter Goss, I
believe that H.R. 1023 takes a positive step in addressing a great
wrong that was committed affecting seven thousand Americans; over half
of the hemophilia community.
In 1995, the Institute of Medicine conducted an independent review
which concluded that the system designed to ensure the safety of blood
and blood products had been ill-prepared to deal with the dangers of
blood-borne viruses and had failed to protect the public health. As a
result, thousands of Americans with hemophilia became infected with HIV
through the use of these contaminated blood products.
The portion of the legislation that came before the Ways and Means
Committee ensures that payments to people with hemophilia who
contracted HIV from tainted blood products will be tax-free and not
threaten benefits under the Supplemental Security Income (SSI) system.
While no amount of money in the world can fix this tragedy, Congress
must do all it can to make certain that the SSI benefits of these
individuals living with two chronic and expensive diseases remain
unchanged.
Finally, I want to commend: Congressman Goss; Chairmen Hyde and
Bliley; the National Hemophilia Foundation (NHF); Ray Stenhope, a
Houstonian who is Past-President of NHF; Dr. Keith Hoots and the folks
at the Gulf States Hemophilia Treatment Center at Hermann Hospital in
Houston; and everyone else who worked long and hard to bring this
legislation before the House of Representatives. While I realize that
these courageous individuals and their families will have to continue
to live with the horrors of this tragedy, I hope that this bill will at
least bring them some comfort.
Mr. SCOTT. Madam Speaker, I have no further requests for time, and I
yield back the balance of my time.
The SPEAKER pro tempore (Mrs. Emerson). The question is on the motion
offered by the gentleman from Illinois (Mr. Hyde) that the House
suspend the rules and pass the bill, H.R. 1023, as amended.
The question was taken; and (two-thirds having voted in favor
thereof) the rules were suspended and the bill, as amended, was passed.
The title was amended so as to read: ``A bill to provide for
compassionate payments with regard to individuals with blood-clotting
disorders, such as hemophilia, who contracted human immunodeficiency
virus due to contaminated antihemophilic factor, and for other
purposes.''.
A motion to reconsider was laid on the table.
____________________