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RECENT CASES |
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GENERAL INFORMATION |
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Guidant Defibrillator Recall and Lawsuit |
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| On June 1, 2005, Lieff Cabraser
filed a lawsuit against Guidant Corporation in
federal court in Indianapolis, Indiana, on behalf
of a proposed nationwide class of patients implanted
with the Guidant Ventak Prizm defibrillator. This
was the first lawsuit filed against Guidant based
on its faulty defibrillator. The complaint alleges
that Guidant misrepresented the safety of its defibrillator,
which is subject to short circuiting and malfunctioning. |
| On June 17, 2005, Guidant
recalled more than 50,000 of its cardiac defibrillators
implanted in patients because of potential
malfunctions in the devices. The recall includes
the Ventak Prizm 2 DR (model 1861), Contak
Renewal (model H135) and Contak Renewal 2 (model
H155), Ventak Prizm AVT, Vitality AVT, Renewal
AVT, Contak Renewal 3 and 4, Renewal 3 and
4 AVT and Renewal RF. Guidant said it has determined
that a magnetic switch in these devices may
get stuck in the closed position, which in
some cases inhibits their ability to treat
ventricular or atrial tachyarrhythmias and
can accelerate battery depletion. |
| Boston Scientific,
which bought Guidant in 2006, announced in
June 2006 the recall of more defibrillators
and pacemakers. The recalled devices include
Ventak Prizm 2, Vitality, and Vitality 2
cardioverter defibrillators. On June 23,
2006 Guidant issued a warning letter to physicians,
informing them of the recall expansion and
urging patient exams and possible removal
of the defective devices. |
| The suspension affects
46,000 of these devices, Guidant said, without
specifying how many have been surgically implanted
in people's chests and how many may be on supply
shelves. |
| As of June 2005, Guidant
admitted that it was aware of 43 reports of
device failures, and two patient deaths. Guidant
has acknowledged that the actual rate of failure
may be higher than the reported rate and that
the number of associated deaths may be underreported,
since implantable cardio-defibrillators are
not routinely evaluated after death. The FDA
and Guidant have advised physicians and patients
to make individual decisions about whether
to remove and replace the affected defibrillators
on the basis of the specific medical situation
of the patient. |
| The recall came shortly
after Guidant issued a safety advisory to physicians
concerning its heart defibrillator, reportedly
after the company learned an article by the New
York Times was being prepared. The New
York Times reported that Guidant did not
tell doctors or patients that since 2002 it
knew that a small number of its defibrillators
contained a flaw that caused them to short-circuit
and stop working. |
| On July 1, 2005, the
FDA classified the recall of certain Guidant
defibrillator models as a Class 1 recall, the
most serious level of product recall. |
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GUIDANT
DEFIBRILLATORS: POSSIBLE DANGER
Class I (most serious)
recall: Ventak Prizm 2 DR (model 1861), Contak
Renewal (model H135) and Contak Renewal 2
(model H155.)
Class
II (any injury caused by a malfunction should
be temporary or reversible) recall: Guidant
models Ventak Prizm AVT, Vitality AVT, Renewal
AVT, Contak Renewal 3 and 4, Renewal 3 and
4 AVT and Renewal RF. |
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Our Guidant
defect lawyers have years of experience
successfully representing patients
with faulty or defective medical implants. |
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There is no
charge or obligation for our review
of your case. |
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We are pleased
to visit Guidant patients, or families
of loved ones who died, at or near
where you live and at no cost, to discuss
your legal rights and answer your questions. |
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To assist
our clients with their claims, we have
on staff nurses with cardiac training
and have retained physicians to provide
expert advice. |
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| In June of 2006, a
U.S. Food and Drug Administration analysis
dated a year earlier on June 16, 2005 was
released, revealing that Guidant’s
implantable heart devices may fail 10 times
more frequently than the company projected.
The FDA found that “most” of
the 16,000 Contak Renewal defibrillators
had damaged insulation within five years
of use and that 40% of those devices would
fail to produce an adequate shock in an emergency. |
| To read copies of "Urgent Medical Device Safety Information" letters sent to physicians and Guidant patients regarding Guidant defibrillators and pacemakers, click here. |
| Battery-powered defibrillators
are used to shock an erratically beating heart
back into normal rhythm. The devices typically
are replaced about every five years. |
| A short circuit in the defibrillator
can occur when the device builds a charge to deliver
the type of high-energy shock needed in emergency
situations. In three cases, when doctors intentionally
induced abnormal heart rhythms during routine checkups,
the Guidant device failed to work, forcing doctors
to rescue those patients by jolting them with the
type of external defibrillator used in emergency
rooms. |
| Lieff Cabraser, with co-counsel,
filed a lawsuit in early June against Guidant Corporation
on behalf of a proposed nationwide class of patients
implanted with the Guidant Ventak Prizm defibrillator.
This was the first lawsuit filed against Guidant
based on its faulty defibrillator. |
| The complaint alleges that
Guidant misrepresented the safety of its defibrillator,
which is subject to short circuiting and malfunctioning.
Plaintiff and the class are seeking a declaratory
judgment that Guidant is liable for all medical
care and corrective surgery caused by Guidant's
alleged misconduct, along with other damages. |
| Guidant has also issued
an advisory warning physicians that replacements
might be needed for nine pacemaker models made
between 1997 and 2000, of which some 28,000 remain
implanted in patients worldwide. To learn more
about this warning, click
here. |
| The law in most states provides
individuals with legal claims and the right to
compensation for injuries they suffer as a result
of a defective product or the negligence of another.
The injured person may file a lawsuit seeking compensation
for his or her pain and suffering, medical expenses,
lost past and future wages and punitive damages. |
| Damages sought against manufacturers
of an allegedly defective medical device typically
include damages for: |
- Physical pain and suffering, mental anguish
and physical impairment;
- Medical expenses associated with the allegedly
defective product; and
- Loss of earnings and/or earning capacity.
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| Founded in 1972, Lieff Cabraser Heimann & Bernstein,
LLP is an over fifty attorney
law firm with offices in San Francisco, New York and Nashville. For the last five years,
the National Law Journal has recognized Lieff Cabraser
as one of the top 20 plaintiffs’ law firms in America. |
| For our personal injury cases, we bring a team of experienced
lawyers. Each client is assigned an individual lawyer. In addition, we have
on staff multiple nurses, legal assistants, scientific analysts and case
clerks to assist the attorneys. To learn more about our firm, click
here. |
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| Trademark
Notice: Personal Injury Lawyer America is an electronic newsletter
from Lieff Cabraser Heimann & Bernstein, LLP. Lieff Cabraser
represents clients in a wide range of cases, including personal
injury and wrongful
death lawsuits. Our personal injury attorneys
| lawyers are committed to providing the very best representation
and support possible for our clients. This website provides information
on the legal rights of the injured and the latest news on product
defects and related lawsuits. |
Lieff Cabraser
is not affiliated in any way with any trademark owner. The use of
any trademarks on this site is for product identification and information
purposes only.
About Lieff Cabraser: We have
offices in San Francisco, New York and Nashville. Our lawyers have
represented clients in personal injury, wrongful death and
rollover crashes and product defect lawsuits across America, including
residents of Alaska, Alabama, Arkansas, Arizona, California,
Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho,
Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland,
Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, North
Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada,
New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South
Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin,
West Virginia and Wyoming.
Among the cases our personal injury
attorneys are prosecuting are the Medtronic heart lead recall, the
AMO contact lens solution recall, the Peter Pan peanut butter recall, Guidant
pacemaker defects, SUV
rollover accidents, popcorn
workers lung injuries, and Ford
switch fires.
Disclaimer: The hiring of legal
professionals is an important decision that should not be based on
advertising alone. Please read our disclaimer. |
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| Copyright © 2008 Lieff Cabraser Heimann & Bernstein, LLP |
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