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“The only thing necessary for these diseases to the triumph is for good people and governments to do nothing.”


Hepatitis C from Gammagard®, 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
Gammagard®, 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Also withdrawn at the same time was a companion drug, Polygam®, also an IGIV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.
Gammagard® 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. Polygam®
differs only to the extent that it is made from American Red Cross plasma.
Gammagard® was most commonly used in the treatment of children with leukemia.
Beginning in early 1994 Baxter learned that Gammagard® 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 Gammagard® or Polygam®. 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 Gammagard®." The
Center is actively seeking people who have received Gammagard® or Polygam®
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 Gammagard® 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
Gammagard® now labeled as Gammagard® 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.