For More Information On The Gammagard Issue Explore This Website - http://www.drugs.com  - Place Gammagard into the search box.

Reuters Medical News

Baxter Agrees to Settle Hepatitis C Claims Related to Use of Immune Globulin

WESTPORT, Dec 22 (Reuters Health) - Baxter Healthcare has agreed to the terms of a proposed class action settlement brought by individuals who contracted or were exposed to hepatitis C virus through use of Baxter's immune globulin therapy, Gammagard, between January 1, 1993 and February 24, 1994.

Financial terms of the settlement were not disclosed by Baxter or the plaintiffs' class counsel.  However, the Deerfield, Illinois medical products firm said that members of the class would receive financial compensation.

Baxter voluntarily withdrew the immune-boosting product from the market in February 1994 after receiving reports from more than 200 patients who claimed that they were infected with hepatitis C virus after using Gammagard.

In the November 1996 issue of the Journal of the American Medical Association, Dr. Joseph S. Bresee of the US Centers for Disease Control and Prevention and colleagues reported on a study of nearly 300 patients who received immune globulin between March 1993 and February 1994.  As reported by Reuters Health, the researchers found that 11% of the patients who received Gammagard had contracted hepatitis C virus compared with none who received other products exclusively.

In may 1994 Baxter launched Gammagard S/D, whose manufacture includes an additional processing step that inactivates viruses such as hepatitis C.  There have been no reports of hepatitis C virus associated with Gammagard S/D, according to the company.

According to terms of the proposed settlement, patients who received Gammagard during the class action period could receive free test to determine whether they  have contracted hepatitis C virus.  Those who are infected with the virus are eligible to receive payments based on progression of the illness.  Those who did not contract the virus are also eligible for payment, according to Baxter.

John Evans of Specter, Specter, Evans & Manogue, the Pittsburgh, Pennsylvania-based lead counsel for the plaintiff class, said that the settlement "...was designed with individual patients' needs in mind, providing financial relief based on specific medical symptoms of hepatitis C they may exhibit today or in the future."

Baxter noted that the estimated cost of the settlement will be covered by previously established financial reserves.  The settlement must receive approval from the judge overseeing the class action

Immune Globulin Products

Immune Globulin IVIG

Immune Globulin intravenous IVIG is a protein found in the plasma component of blood.  Plasma is collected and pooled by domestic fractionators such as Bayer Corporation, Baxter Corporation and American Red Cross.  Igiv is prepared as a sterile solution, contains no preservatives and is treated to prevent transmitting viruses.  The U.S. Food and Drug Administration regulates its preparation, distribution and use.

Immune globulin is used to treat primary immunodeficiency's. It is especially useful when high levels or elevation of circulating antibodies are desired.  Immune globulin comes in sterile solution or lyophilized powder and is administered intravenously. 

Immune Globulin Intramuscular IGIM

Immune globulin tramuscular IGIM is for measles, hepatitis A, varicella, and rubella.

Other Immune Globulins

a)  Immune globulin is for passive, transient protection against tetanus in individuals.

b)  Immune globulin is for passive, transient post-exposure prevention of hepatitis B infections.

c)  Immune globulin is for passive, transient post-exposure prevention of rabies infection.

d)  Immune globulin is for prevention of Rh hemolytic disease of the newborn.