Guidant & Class Action Suit
EndoVascular Technologies, a subsidiary of Guidant Corporation,
recently agreed to pay $92.4 million to settle criminal and
civil charges, including 10 counts of fraudulently shipping
a misbranded product and making a false statement to the Food
and Drug Administration. The $92.4 million is purportedly the
largest penalty ever given for failing to report a faulty medical
product to the FDA.
Guidant has plead guilty to covering up malfunctions of its
Ancure Endograft System, used to treat abdominal aortic aneurysms,
which may have led to 12 deaths and 57 emergency surgeries
nationwide.
The criminal complaint alleges that Guidant reported only
172 cases of malfunction since the product was introduced in
September of 1999, but the company actually had records of
2,628 incidents where the device malfunctioned.
The device was withdrawn from the market in March of 2001
after the FDA and Guidant received seven anonymous letters
from employees warning about the device. Patients with the
devices currently implanted are not at risk and should not
be alarmed because the malfunction only occurs during the insertion
of the device.
The devices were used to keep weak artery walls from rupturing
and were once considered groundbreaking because surgeons inserted
the device through an artery in the leg which is much less
invasive than having to cut open a patient ’s abdomen.
Since its withdrawal, Guidant has modified the stent-graft
and the FDA reports that the devices are safe now and being
sold on the market once again.
Related News:
» Guidant
to Discontinue Product for Treating Abdominal Aortic Aneurysms
» Guidant
faces possible class-action shareholders lawsuit
» Class
action suit coming after Guidant fined $92M in coverup
» Heart
device maker pleads guilty to cover-up
Your Legal Rights
If you or someone you know has suffered serious side effects
or injury that you believe may be related to Guidant Heart
Device, you may be eligible to file a claim.
CONTACT
THE MEDICAL DEVICES LEGAL GROUP NOW FOR A FREE CASE EVALUATION,
OR CALL US AT 1-800-955-0815.
» top
