New York Times Article:  Baxter Dialyzer Recall

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Baxter Finds Possible Link in 53 Deaths

November 6, 2001

By MELODY PETERSEN with EMMA DALY

Baxter International (news/quote) said yesterday that a chemical that it used to manufacture filters for dialysis patients might have played a role in dozens of deaths around the world.

The Food and Drug Administration is investigating the deaths of 53 patients who used the Baxter devices, called dialyzers, which filter toxins out of the blood of patients whose kidneys have failed.

Baxter became aware of possible problems with the filters in August, after several patients died in Spain, but a company investigation had failed to find anything wrong with the devices. The company, which recalled the filters worldwide in mid-October and continued to study them, said it uncovered the probable cause of the deaths over the weekend.

Four of the deaths occurred in the United States, two in Austin, Tex., and two in Kearney, Neb. Federal regulators said yesterday that a doctor at the Nebraska dialysis center was questioning whether the company's filters were to blame.

Twenty-one of the deaths being reviewed by the F.D.A. occurred in Croatia. At least 10 deaths occurred in Spain, 7 in Taiwan, 5 in Germany, 4 in Italy and 2 in Colombia, according to the F.D.A.

The company voluntarily recalled all of its dialyzers in the series A, AF and AX on Oct. 18, sending letters to doctors and asking them to return any unused filters of that type.

Yesterday, Baxter said it had decided to permanently cease manufacturing the dialyzers. They were made by Althin Medical, a company Baxter acquired last year, at a factory in Ronneby, Sweden.

Baxter said it planned to compensate the families of patients who died.

"We are greatly saddened by the patient deaths, and I would like to extend my personal sympathies to family members," Harry M. Jansen Kraemer Jr., Baxter's chairman and chief executive, said in a statement. "We have a responsibility to make public our findings immediately and take swift action, even though confirmatory studies remain under way."

Dr. David W. Feigal, director of the F.D.A.'s center for devices and radiological health, said yesterday that the problem appeared to be that the chemical, a fluid called perfluorohydrocarbon that Baxter uses to manufacture some of the filters, is liquefied at room temperature but becomes a gas if it is warmed to body temperature.

That means the liquid could have created gas bubbles in the bloodstream, Dr. Feigal said.

Regulators are investigating whether the chemical fluid, which Baxter began using in December, is used by other filter manufacturers and whether other patients might have been affected.

"We want to make sure this is not a hidden problem in some other products," Dr. Feigal said.

Baxter, which is based in Deerfield, Ill., said yesterday that it began an internal investigation of the filters after Spain reported that 10 people using its filters had died.

The company said that an early series of tests on the filters had found no problems. Perfluorohydrocarbon is a nontoxic substance, the company said, but it is not labeled for human use.

Sally Benjamin Young, a spokeswoman for Baxter, said the fluid was used in fewer than 10 percent of the filters, those that had been set aside after they failed a quality control test.

The fluid was used to retest the filters, she said.

To cover the cost of recalling the filters and compensating families, Baxter said yesterday that it was setting aside $100 million to $150 million. The cost could exceed the $130 million that Baxter paid for Althin in March 2000.

In Spain, a report by the Ministry of Health that is expected to be released this week will tie the deaths of more than 10 people to Baxter's filters, according to Fernando Garcia Lopez, an author of the report.

Autopsies on five of those who died found evidence of multiple organ failure "which is not among the usual causes of sudden death" in kidney patients, Mr. Garcia Lopez said.

Manuel Mata, a lawyer who represents the families of eight people who died in Spain, said his clients were considering filing lawsuits against Baxter in the United States.

Families of people who died after Aug. 18 are especially angry, Mr. Mata said, because hospitals in the city of Valencia continued to use Baxter's dialyzers, despite four deaths in Madrid between Aug. 15 and Aug. 18 and after hospitals in that city stopped using the filters. "There is something very important that must be investigated," Mr. Mata said. "What happened after Aug. 18 when the dialyzers were removed in Madrid for fear they were connected to the deaths?"

"Baxter did not withdraw the dialyzers from Valencia," Mr. Mata said. "They could have pulled the products in that time. Those deaths were avoidable."

Ms. Young, the Baxter spokeswoman, said the company had been told that the deaths in Madrid were not related to the filters. When it learned of the deaths in Valencia, she said, Baxter immediately recalled the filters in Spain and stopped selling them worldwide.

Copyright 2001 The New York Times Company