Bad blood: contaminated plasma sickens users of Gammaguard.

A blood product designed to help people with compromised immune systems fight infection instead made them sicker, according to more than a dozen lawsuits recently consolidated into a multidistrict litigation (MDL).

The common thread among patients in a 1993-94 outbreak of potentially deadly hepatitis C was use of Gammagard, an intravenous immunoglobulin manufactured by the Hyland division of Baxter Healthcare Corp., based in Glendale, California. As of July 1994 - the latest date for which figures are available - the Centers for Disease Control and Prevention (CDC) had received 111 reports of hepatitis C virus (HCV) in people treated with Gammagard from 24 states and Puerto Rico.

Mary Thomas, a Baxter spokesperson, said the company has received about 300 reports of HCV infection associated with the product worldwide. She said Baxter does not expect that number to go higher than 350. The company voluntarily took Gammagard off the market in February 1994.

Intravenous immunoglobulins, which are produced by several manufacturers, are collections of antibodies culled from the plasma of many donors. They are prescribed for "anyone who needs a jump start to their immune system," said Donna Miller-Slade, an attorney and nurse in Durham, North Carolina, who cochairs ATLA's Gammagard Litigation Group.

Intravenous immunoglobulins have been effective in treating patients with a variety of immune system disorders, babies at risk for Group B strep infection, and some leukemia patients. They may also help shore up the immune systems of people with AIDS.

But in the case of Gammagard, some recipients discovered they had been infected with HCV, which affects the liver. Some patients suffer only mild symptoms like nausea, fatigue, and headaches. Others develop chronic hepatitis, which may lead to cancer or cirrhosis of the liver.

Attorneys representing injured patients allege that Baxter's faulty manufacturing process allowed the vim to contaminate the product. In June, 16 lawsuits against Baxter were consolidated in the Central District of California. Judge Manuel Real will oversee pre-trial proceedings. (In re Baxter Healthcare Corp. Gammagard Products Liability Litigation, MDL No. 1060 (C.D. Cal. consolidated June 9, 1995).)

Richard McGowan, a New York City attorney and cochair of the plaintiffs' interim steering committee, said 40 to 50 suits have been filed in federal district courts and as many as 20 in state courts. Those not named in the MDL will be treated as "tag-along actions" and will share discovery, he said.

One of McGowan's clients, a salesman in the garment industry, received monthly Gammagard treatments for idiopathic neurological disease. The disease had not prevented him from working and living a normal life, McGowan said. But after becoming infected with hepatitis C, the client suffers from chronic fatigue and can work only three to four hours daily.

"That's a pretty standard story" for Gammagard clients he said adding that many will become sicker in the future. According to the CDC, more than 60 percent of people infected with HCV from all sources will develop chronic hepatitis. McGowan said the percentage is likely to be higher among Gammagard recipients because of their weakened immune systems.

Miller-Slade said the number of cases is likely to grow because people with HCV may not display serious symptoms until long after infection.

"Unless people were notified [by their doctors] that they might have been contaminated, they don't even know" that they might be carrying the virus, she said. And according to the CDC, it may take longer to detect the virus in people with impaired immune systems because it takes longer for them to produce antibodies.

Missing Step

When the HCV outbreak occurred, eight different intravenous immunoglobulins were available on the market. Only Gammagard and a nearly identical product called Polygam, which Baxter manufactured for the American Red Cross, have been found to contain the virus. (As of July 1994, the CDC had received only one report of HCV transmission linked to Polygam.)

Attorneys involved in the litigation say the company omitted a crucial step in the manufacturing process that would have ensured that the product was virus-free.

When Gammagard went on the market in 1986, a process to kill viruses in blood products was available and used by most other manufacturers of intravenous immunoglobulins. This solvent-detergent treatment was not required by the FDA, and Baxter manufactured Gammagard without it.

The company says it followed all the FDA's rules for manufacturing intravenous immunoglobulins and that this, ironically, may have led to the contamination. Thomas, Baxter's spokesperson, said a test that screened donated plasma for HCV antibodies was probably the culprit.

There is no direct test for the hepatitis C virus. Instead, the FDA required manufacturers to test the plasma for antibodies to HCV. The presence of the antibodies would indicate that the plasma may be infected with the virus. Any plasma with the antibodies was to be eliminated from the pool.

However, the virus could still slip through in newly infected plasma that had not yet produced antibodies, Thomas said. With the antibodies removed, the plasma pool was defenseless against the undetected virus.

Nevertheless, Thomas denied that Baxter was at fault. After the HCV out-break, she said, "the FDA did review our manufacturing process and found no errors or procedure deficiencies."

But attorneys say if Baxter had used the solvent-detergent treatment, any virus that made it into the plasma pool would have been rendered harmless. The process "virtually eliminates the possibility of HCV transmission," McGowan said.

Baxter received FDA approval in May 1994 for Gammagard S/D, which includes the virus-killing step in the manufacturing process. There have been no reports of HCV transmission linked to the new version of the product.

The MDL remains in its early stages. At TRIAL press time, Judge Real had scheduled a mid-August hearing to discuss the status of the litigation, particularly how to begin discovery.