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TRENTON
– Attorney General Anne Milgram announced
today that New Jersey has entered into a
multi-state settlement agreement with the
Guidant Corporation, maker and marketer
of electronic cardiac implant devices known
as Implantable Cardioverter Defibrillators
(ICD).
The settlement resolves allegations that
Guidant failed to disclose to the medical
community wiring failures in Guidant-made
ICDs called the Ventak Prizm 2 DR Model
1861. It also resolves allegations that
after making modifications to correct the
wiring problems in 2002, Guidant continued
to sell the original, unmodified devices
into 2003.
ICDs are devices that doctors surgically
implant in a patient’s chest to monitor
for abnormal heart rhythms. If a patient’s
heart stops, the ICD delivers an electrical
surge to start it again. The Indianapolis-based
Guidant is among the world’s three
largest makers of ICDs. Its related corporate
entities, Guidant Sales Corporation and
Cardiac Pacemakers, Inc., are also party
to the settlement.
Currenty, Guidant is conducting a warranty
program to provide consumers who wish to
replace their Ventak Prizms with a new device
at no cost, and to reimburse consumers up
to $2,500 for any out-of-pocket expenses
they incur with the replacement. As part
of the settlement, Guidant has agreed to
extend its warranty program for an additional
six months. Of the total $16.7million being
paid by Guidant to the states, approximately
$1 million will be used to reimburse warranty
program participants for expenses they incur
beyond the $2,500 threshold.
New Jersey will receive a total of $390,000
from the settlement payout. The money will
fund consumer awareness programs and consumer-protection-related
enforcement efforts.
“As
a result of this agreement, Guidant will create
the position of patient safety officer staffed
by a physician, and will take other steps
to ensure that patient safety is always a
priority,’‘ Attorney General Milgram
said. “Guidant will also be more accountable
concerning the performance of its products.’‘
Milgram said New Jersey and the other participating
states began investigating Guidant after learning
that the company made changes in 2002 to correct
a Ventak Prizm wiring problem that could cause
the device to short-circuit.
If the device short-circuited, it could
fail to deliver a life-saving jump-start
to a patient’s heart. Guidant, which
as part of the settlement admits no wrong-doing,
modified the Ventak Prizm twice to correct
the wiring difficulty. However, it continued
to sell unmodified Ventak Prizm devices
in 2002 and 2003. Guidant did not notify
physicians or the public of its continued
sale of unmodified Ventak Prizm devices
until May 2005.
Under terms of the settlement, Guidant has
agreed, among other things, to do the following:
-
Establish a patient safety advisory board
consisting of independent experts to evaluate
data concerning ICD performance;
- Establish
a patient safety officer position, staffed
by a physician whose primary responsibility
is to advance ICD patient safety;
- On
a quarterly basis, publicly disclose and
disseminate specific information, including
worldwide failure data, survival probability
estimates and current information in the
event of any U.S. Food and Drug Administration
recall of an ICD;
- Post
a notice on its Web site within 30 days
of any modification to any of its ICDs
to correct a failure pattern;
- Solicit
the return of out-of-service ICDs
- Maintain
a data system to track the serial numbers,
implant dates and removal dates of all
ICDs that Guidant distributes in the United
States.
Consumers
who apply for reimbursement under Guidant’s
extended warranty program and were rejected
in whole or in part, are urged to contact
the Division of Consumer Affairs’
Office of Consumer Protection. The Office
of Consumer Protection can be reached by
contacting the Division’s consumer
hotline at 1-800-242-5846.
Consumers may also obtain further information
at www.bostonscientific.com
.
Deputy Attorney General Jennifer Dougherty
of the Consumer Fraud Prosecution Section
represented the state in this matter.
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