Baxter Says Its Dialysis Filters May Have Played Role in Patient Deaths
ap.tbo.com
By Dave Carpenter The Associated Press
Published: Nov 5, 2001
CHICAGO (AP) - Baxter International Inc. said Monday that its recalled dialysis filters appear to have played a role in recent patient deaths being investigated in several countries.
Baxter said it has idled two plants and decided to discontinue the products in question. Bracing for more lawsuits from patients' families, it also is earmarking $100 million to $150 million for litigation and related expenses.
The statement signaled a turnabout by the Deerfield, Ill.-based medical products maker, which previously said it found nothing to indicate its products were at fault in the dialysis patients' deaths under review, mostly in Europe.
The U.S. Food and Drug Administration and other health authorities are investigating 51 deaths from this summer and fall, including 23 in Croatia last month, 15 in Spain, seven in Taiwan, two in Colombia and two each in Texas and Nebraska. All were using dialysis filters, or dialyzers, which help remove waste from the blood of patients with failed kidneys.
Baxter, which recalled the filters in mid-October, said preliminary tests completed over the weekend led it to conclude that a chemical used in routine testing at its manufacturing plant in Ronneby, Sweden, may have played a role in many of the deaths.
The fluid, a chemical solution known as 5070, is used to test for leaks and somehow was not fully removed from all filters before being packaged and shipped, the company said. The chemical then evidently entered patients' bloodstreams, officials indicated.
"The solution should not be in the dialyzer after the safety check has been carried out," Lee Henderson, a Baxter dialysis expert and retired scientist, said during a conference call Monday. "We need further investigation to identify precisely how that has occurred."
Baxter said it is stopping production of all three dialysis product lines made at the Swedish plant, including the Series A and AF dialyzers, which it recalled last month.
The Ronneby facility and another Baxter plant in Miami Lakes, Fla., which makes fibers used in the filters have been idled; company officials said they have not yet decided whether to make other products there or close them for good. Together, the plans employ about 300 workers.
Harry Jansen Kraemer Jr., Baxter's chairman and chief executive, said the company is "greatly saddened" by the deaths and has a responsibility to make its findings public and take action.
"While a small number of our A and AF dialyzers appear to have played a role in some of these tragic events, we believe there remain substantive gaps in information about the facts associated with many of the patient deaths," he said.
In Spain, where a court case against Baxter is under way, the son of a kidney patient who died in August said the statement shows relatives were right to blame Baxter for the deaths. "They (the deaths) could have been avoided," said Enrique Ortego.
The Series A and Series AF dialyzers were made in Sweden by Althin Medical AB, a company acquired by Baxter last year. Production of the third line of filters in Sweden, the Series AX, had been halted since February for business reasons, Baxter said.
Baxter said it expects to take a charge of $100 million to $150 million in the fourth quarter to cover the cost of discontinuing the products and expected lawsuits by patients' families.
The company said the discontinued items represented about 30 percent of its dialyzer production and generated about $20 million in annual revenues.
Merrill Lynch in a research note said the announcement's impact on revenues and Baxter patients should be minimal.
In trading Monday on the New York Stock Exchange, Baxter shares fell $2.67, or 5 percent, to close at $46.33.
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On the Net:
baxter.com
AP-ES-11-05-01 1624EST |
