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Guidant Technology to stop producing device
Aortic graft associated with 12 deaths
INDIANAPOLIS - A subsidiary
of medical device manufacturer Guidant Corp. is ending production
of an aortic abdominal
graft, only days after the unit pleaded guilty to criminal
charges for covering up problems involving the product
that may have led to 12 deaths.
The guilty plea spawned at
least two competing lawsuits against Guidant seeking class-action
status for those injured
by
the device or from relatives of loved ones who died.
But in a hearing later this month regarding nine pending injury
and wrongful death cases against Guidant, the Indianapolis
medical-device maker will ask a California federal judge
to toss the suits.
Guidant's argument: Notwithstanding
that it admitted in criminal court to hoodwinking the FDA
about the safety
of the Ancure
system, it is contending in civil court that it is
immune to lawsuits under California product liability laws
because
the FDA approved the device in 1999.
Endovascular Technologies
Inc., a subsidiary of Indianapolis-based Guidant, pleaded
guilty to 10 felonies last week involving
its Ancure "stent-graft" device, including
shipping misbranded products and making false statements
to government
regulators.
Endovascular faces $92.4 million in federal
penalties for actions surrounding the device.
Guidant officials said yesterday that Menlo Park-based
Endovascular would continue to ship the device
and provide support to
patients until October. The company then will cease
ongoing operations other than continuing to provide
long-term
services for patients who have received the device.
The
problems with the device, used during operations to treat
abdominal aortic aneurysms, were resolved
after the
device
was voluntarily recalled in March 2001 and before
it was reintroduced five months later, the company
said.
The device, inserted through the groin, was designed
to let doctors patch the aneurysm without requiring
risky surgery
to open the abdomen.
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