Baxter Finds Filters’ Link to Deaths
Baxter International Inc. said Monday its filters used in kidney dialysis may be linked to 51 deaths in the U.S., Spain, Croatia and other countries. Baxter stopped making two models of the product.
Fluid used to test filters made at Baxter’s Ronneby, Sweden, plant probably caused the deaths, said Lee Henderson, a Baxter consultant. Baxter, the biggest maker of treatments for blood diseases, said costs of liability and discontinuing the filters, called dialyzers, will reduce fourth-quarter profit by $100million to $150 million.
The findings, which contradict Baxter’s statement a month ago that the filters didn’t cause 10 deaths in Spain, sent the company’s shares down $2.67, or 5.5%, to $46.33 on the New York Stock Exchange. The company widened the inquiry after more than 20 deaths were reported in Croatia.
The fluid is used to test whether the filters leak and is supposed to be removed after the safety check. The company is investigating how the solution remained on filters that were packaged and then used to treat patients.
Deerfield, Ill.-based Baxter has stopped making the A and AF series filters, which were investigated in the deaths. The chemical solution isn’t used to test other Baxter filters that remain on the market, the company said.
“With the recall of the dialyzers, our expectation is we will not see any more deaths,” said Henderson, Baxter’s former medical director, who is assisting with the probe.
Baxter purchased the dialyzers in its $130-million acquisition of Althin Medical last year. Sales of the two products were less than $20 million last year.
U.S. Food and Drug Administration spokeswoman Sharon Snider said the agency is investigating 21 deaths in Croatia, 10 deaths in Spain, seven in Taiwan, five in Germany, four in Italy, two in Texas and two in Nebraska.
Baxter’s statement last month that the filters didn’t cause the deaths in Spain was based on its own tests and tests by Munich-based TUV Product Service.
The fluid, made by 3M, wasn’t properly removed from the filters. Typically, the fluid evaporates from the filter, Henderson said.
Fibers used in the filters were made in Miami Lakes, Fla., the company said.
Dialysis cleans blood to remove toxins and fluids from patients whose kidneys don’t function or who have impaired kidney use.
After the deaths of at least 11 kidney dialysis patients in Spain were reported in late August, Baxter pulled 460 units of the product that were used in Spain and stopped shipments of the filters to other countries.
Croatia’s health minister, Ana Stavljenic-Rukavina, resigned in October after the deaths of 23 patients there, and Baxter said last month it was notified that two patients died in Texas. It had already recalled the A and AF series.
