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Hepatitis C from GammagardŽ, An Intravenous Immunoglobulin [IGIV]
By Richard Alexander, Esq.
San Jose, California attorney Richard Alexander, a National
Honor Scholar at
The Law School, University of Chicago, was certified as a
civil trial advocate
by the National Board of Trial Advocacy in 1980, has been
specially recognized
as a Trial Lawyer by the California Trial Lawyers Association,
is a former
member of the Board of Governors of The State Bar of
California, currently
serves as Vice President of Consumer Attorneys of California
and is a founding
member of the National Association of Consumer Advocates. He
is the founder of
The Alexander Law Firm [http://www.alexanderlaw.com],
a medium size law firm
specializing in individual and class action litigation arising
from negligence,
toxic chemical, defective product, mass accident,
environmental and fraud cases
on behalf of consumers and small businesses. The firm holds
Martindale-Hubbell's highest rating and is recognized in the
List of Preeminent
Law Firms in the United States. The firm sponsors The Consumer
Law Page
[http://consumerlawpage.com]
on the World Wide Web. Copyright Richard Alexander
1996.
In February, 1994 Baxter Healthcare Corporation withdrew from
world markets
GammagardŽ, an immunoglobulin administered intravenously to
those with acquired
or congential immune disorders, after 112 people in the U.S.
were reported
having symptoms of hepatitis C, the most fatal form of the
this liver disease.
Also withdrawn at the same time was a companion drug, PolygamŽ,
also an IGIV
product. Hepatitis C is the leading cause of liver failure and
is a recognized
precursor to cancer of the liver, taking nearly 10,000
Americans every year.
The virus is particularly dangerous because even though a
person is infected
he/she may show no signs of any disease until many years
later. In the
meantime, the virus can be transferred to others, primarily by
sexual
intercourse. Anyone with hepatitis C is a considered a
lifelong carrier.
GammagardŽ was introduced to the U. S. in 1986. It is made by
extracting human
proteins from plasma. Plasma is obtain from blood donors by
centrifuging
donated blood, separating the plasma and returning the red
blood cells to the
donor. Plasma donors can sell or provide plasma several times
a week. PolygamŽ
differs only to the extent that it is made from American Red
Cross plasma.
GammagardŽ was most commonly used in the treatment of
children with leukemia.
Beginning in early 1994 Baxter learned that GammagardŽ
recipients were being
diagnosed with hepatitis. At that time Baxter withdrew both
drugs due to
possible contamination with hepatitis C virus. Reports of
hepatitis C
infections in the U.S. spiked dramatically in March, 1994
among persons who had
received GammagardŽ or PolygamŽ. The Center for Disease
Control reports that
the "absence of other risk factors among these
patients" indicates that
hepatitis "was most likely transmitted by administration
of GammagardŽ." The
Center is actively seeking people who have received GammagardŽ
or PolygamŽ
between September 1992 and February 1994 and who probably have
been exposed to
contaminated product. Not everyone who received either gamma
globulin product
will develop hepatitis. Those who have been exposed to the
Hepatitis C Virus
through contaminated Gammagard have a 60-70% probability of
suffering chronic
hepatitis, which can be fatal. For those who have been
exposed, early diagnosis
and treatment increases the chances for a positive outcome.
The CDC has written
medical care providers to notify GammagardŽ patients to be
tested for
hepatitis. It is unknown how successful that notification
effort has been. In
May, 1994 Baxter was authorized by the FDA to sell a new,
purified version of
GammagardŽ now labeled as GammagardŽ S/D. The
"S/D" designation refers to
treatment of gamma globulin with solvents and detergents that
sterilize the
drug of viruses, including HIV and hepatitis. Nationwide
litigation has
developed as a result of the injuries and exposures caused by
this contaminated
drug. Anyone who received Gammagard, whether or not that
person has tested
positive for hepatitis, probably has a claim and should not
delay in taking
action once they discover the IGIV they received was a Baxter
product. In all
cases of delayed injury, the statute of limitations presents a
serious concern.
By way of a general explanation, which is not intended to be
legal advice since
that can only come from a lawyer who knows all the facts
concerning a
particular case or claim, statutes of limitations are in
effect in every state
in the United States. These laws require that a person who
knows, or reasonably
should know, that they have been injured must file suit within
a limited time
frame. The most common limit is two years, although several
states, including
California, have a one year statute of limitations. In cases
where an action
for damages is filed one day after the allowable period for
filing suit, the
wrongdoer is judgment proof because the statute provides a
complete and total
defense. Anyone believing they may have a valid claim should
take immediate
action to make sure they have filed suit before the running of
the statutory
period.
Journal of American Medical Association 1997;277:627-628
JAMA Letters - February 26, 1997
Hepatitis C Virus and Intravenous Immune Globulin
To the Editor.--The diagnosis of common variable
immunodeficiency (CVI) is made
by demonstrating the lack of the ability to generate new
antibody responses or
recall antibody responses against protein antigens, such as
tetanus and
diphtheria, coupled with low serum immunoglobulin levels and
recurrent
infections. It is interesting that in the cohort described by
Dr Bresee and
colleagues,[1] 26 of 29 immune-deficient patients (the bulk of
whom appear to
have CVI) who were documented to be positive for hepatitis C
virus (Hepatitis C Virus)
nucleic acid were able to generate an antibody response
against Hepatitis C Virus proteins.
Is there some special feature on the protein constituents of
Hepatitis C Virus that enables
it to overcome the profound immune dysfunction characteristic
of CVI?
Eric Macy, MD;Kaiser Permanente Health Care Program;San Diego,
Calif
References
1. Bresee JS, Mast EE, Coleman PJ, et al. Hepatitis C virus
infection
associated with administration of intravenous immune globulin:
a cohort study.
JAMA. 1996;276:1563-1567.
(JAMA. 1997;277:627)
To the Editor.--Dr Bresee et al[ 1] reported an epidemic of
Hepatitis C Virus infection among immunodeficient persons treated with Gammagard intravenous
immune globulin
(IGIV). The aggregate of 23 cases in 1 clinic was convincingly
attributed to 9
or more lots. Related cases are known elsewhere in the United
States, as well
as in the United Kingdom, Sweden, and Spain. Investigators of
the Boston, Mass,
aspect of the epidemic concluded that the introduction of more
sensitive donor
screening for the antibody to Hepatitis C Virus (anti-Hepatitis C Virus) resulted in
increased amounts of
uncomplexed virus entering the IGIV fraction.[2] However,
other factors may
have been equally or more important for this product.
The Hepatitis C Virus cases in 1983 associated with Gammagard from a pilot
plant[ 3] provoked
only a brief postmarketing surveillance study, interpreted as
showing safety.
The subsequent absence of reported cases until 1994 associated
with any US
Gammagard IGIV preparation does not mean that none occurred.
For the Boston
lots, Gammagard had an infection rate of just 11%. At that
level in more
typically sized immunology clinics, no more than a single case
might occur and
be dismissed as community acquired. Suspicion about Gammagard
IGIV would be low
because of the usual safety of all immunoglobulin
preparations. Only routine
monitoring of aminotransferase levels demonstrated the
Gammagard-spread cases
in the United Kingdom.[4]
The investigators suggest differences in manufacture may have
contributed to
Gammagard transmission, but they believe that no single
manufacturing error
would persist over several months. The latter statement,
however, deserves
scrutiny. The investigators similarly mention but fail to
discuss any
coinciding changes in paid plasmapheresis donor sources that
could have
increased the Hepatitis C Virus load in plasma pools. In addition, the
manufacturer's Polygam
IGIV, made for the American Red Cross from voluntary
donations, did not
transmit to the study population. The Food and Drug
Administration (FDA) stated
that the same manufacturing process was used for both
Gammagard and Polygam.[
5] In Boston, Polygam was given to 129 persons without
implication in Hepatitis C Virus
transmission.
The lack of Hepatitis C Virus cases from other IGIV brands, particularly
Polygam, must mean
epidemiologically that there were other factors that placed
Gammagard beyond
the margin of safety compared with other brands. The present
use of viral
inactivation steps in all products should not end the inquiry
into manufacture
and viral burden, because all contributions to virus
transmission must be
identified to minimize them in the future.
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