Plasma Sold by Red Cross Tied to Deaths of 6 Liver Transplant Recipients at Cedars-Sinai

"All six patients died due to thrombotic events or excessive bleeding during the transplant procedure," the manufacturer of the plasma, V. I. Technologies, Inc., advised doctors in October 2000.

Four more deaths tied to the blood plasma, called Plas+SD or SD plasma, occurred at different hospitals between August 2000 and March 2001, according to the U.S. Food and Drug Administration. The additional deaths involved three liver transplant patients and a fourth with liver disease. The FDA declined to identify the hospitals involved.

The FDA said a warning was sent to doctors in October 1999 after the first six deaths occurred, and a stronger warning was sent this past March advising doctors that a "black box warning" had been issued for the plasma because of concern over the deaths.

The "black-box warning," the FDA's most serious, means that new containers of the plasma must now be labeled: "Should not be used in patients undergoing liver transplant or in patients with severe liver disease and known [clotting problems.]"

The FDA did not follow its customary practice of posting the letter on its public Web site until this week, after Newsday published the second of two reports about the deaths linked to the plasma.

The SD plasma is created by pooling plasma from thousands of donors and then cleansing it of dangerous viruses -- a technique that some medical experts fear may allow certain pathogens to linger and infect patients with suppressed immune systems

While production of the plasma was suspended last year, the existing plasma still in stock in hospitals around the country doesn't contain the warning.

Christopher Lamb, vice president of plasma operations at the American Red Cross, which was the sole distributor of the plasma, told Newsday in mid-April that there was only "a temporal association with the product in these incidents."

But Lamb, acknowledging the "black-box warning," said it was decided sometime in March that the plasma required further safety measures.

The warning does not state where the deaths occurred, but Newsday found in government documents that they occurred at Cedars-Sinai.

Cedars-Sinai spokeswoman Grace Cheng said the hospital stopped using the plasma in December 1999 after contacting the FDA and the Centers for Disease Control and Prevention to report the deaths, but never told relatives of those who died of its concern or the investigation that has followed.

"We do not want to alarm our patients' families," she said.