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 Also withdrawn at the same time was a companion drug, Polygam®, also an IGIV product.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 have a one year statute of limitations. California has a two year statute. 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.
If you or a family member have been wrongfully injured call us at 1.888.777.1776 or use this form, delays can hurt your case, so please don’t hesitate to contact us.