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FOLLOWING
EXTENSIVE INVESTIGATION, BAXTER IDENTIFIES PROBABLE CAUSE OF RECENT HEMODIALYSIS
PATIENT DEATHS
DEERFIELD, ILL, November
5, 2001 - A Baxter International Inc. subsidiary announced today a key
finding from its comprehensive dialyzer investigation that could account
for many of the unexplained recent hemodialysis deaths reported in several
countries. Preliminary tests completed over the weekend lead Baxter to
believe that a processing fluid used in the manufacturing operation in
its Ronneby, Sweden, facility may have played a role.
"We are greatly
saddened by the patient deaths and I would like to extend my personal
sympathies to family members of those patients. We have a responsibility
to make public our findings immediately and take swift action, even though
confirmatory studies remain under way," said Harry M. Jansen Kraemer,
Jr., Baxter chairman and chief executive officer. "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. Therefore,
we have decided that in the interest of patient safety, the most prudent
course of action is to permanently cease manufacturing these dialyzers."
The A and AF series dialyzers, which were part of Baxter's acquisition
of Althin Medical AB in March 2000, are manufactured in Ronneby, Sweden.
While a number of confirmatory tests are being conducted, Baxter has taken
immediate actions, extending beyond the global product recall already
implemented. Baxter has advised the U.S. Food and Drug Administration
(FDA), independent scientific testing laboratory TÜV Product Service,
and other health authorities of its findings. In addition, the company
has conveyed its findings to the manufacturer of the fluid, as well as
other dialyzer producers in case they may use the same or a similar kind
of fluid and manufacturing process.
The processing fluid,
a perfluorohydrocarbon, is used in the manufacturing process of certain
dialyzer fibers. The process, used only in Baxter's Ronneby, Sweden, facility,
is used in the manufacture of fewer than 10 percent of the A and AF series
dialyzers produced - specifically those dialyzers that require additional
manufacturing steps to ensure the integrity of the fibers. This fluid
is not used in the manufacturing process for other dialyzers that Baxter
manufactures or distributes.
Baxter initially put
a worldwide hold on the A series dialyzer following reports of patient
deaths in Spain in late August. Results of standard internationally recognized
safety and toxicity tests conducted by Baxter and TÜV Product Service
showed no linkage between the dialyzers and patient deaths in Spain. Following
reports of patient deaths in Croatia, Baxter immediately initiated a voluntary
global recall of the A, AF and AX series dialyzers and established an
independent panel of world-renowned dialysis experts to aid in the investigation.
Since first learning of a potential problem with the dialyzers, Baxter
encouraged a thorough investigation by international health authorities
and independent medical experts, in addition to conducting its own in-depth
analysis. The testing process included the examination of dialyzers from
centers where the deaths were reported, as well as an analysis of the
manufacturing process, including all raw materials and production materials
used. Throughout the process, Baxter has fully cooperated with all investigating
agencies.
Baxter expects to
take a fourth-quarter after-tax charge of approximately $100-$150 million
to cover the cost of discontinuing this product line and other related
costs. The after-tax cash impact is estimated to be no more than $50 million.
Excluding this charge, Baxter expects to meet the full-year 2001 financial
commitments of sales growth in the low double-digits, earnings growth
in the mid-teens and operational cash flow of more than $500 million.
In addition, Baxter reiterated it will also meet its 2002 full-year commitments
of sales growth in the low-teens (at current foreign exchange rates),
earnings-per-share in the mid-teens and operational cash flow of at least
$500 million.
Baxter International
Inc. is a global medical products and services company that, through its
subsidiaries, provides critical therapies for people with life-threatening
conditions. Baxter's products and services in the areas of bioscience
(including biopharmaceuticals, vaccines, biosurgery products and transfusion
therapies), medication delivery and renal therapy are used by health-care
providers and their patients in more than 100 countries.
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This news release
contains forward-looking statements that involve risks and uncertainties,
including technological advances in the medical field, product demand
and market acceptance, the effect of economic conditions, actions of regulatory
bodies, results of ongoing product testing, the impact of competitive
products and pricing, foreign currency exchange rates and other risks
detailed in the company's filings with the Securities and Exchange Commission.
These forward-looking statements are based on estimates and assumptions
made by management of the company and are believed to be reasonable, though
are inherently uncertain and difficult to predict. Actual results or experience
could differ materially from the forward-looking statements.
FOR ADDITIONAL
INFORMATION:
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- Media Contacts:
- Sally
Benjamin Young, 847-948-2304
Deborah Spak, (847) 948-2349
Patricia O'Hayer,
011-322-650-1924
- Investor Contacts:
- Neville
Jeharajah, 847-948-2875
Mary Kay Ladone, 847-948-3371
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