Defective Cardiac Defibrillators Being Investigated by Napoli Kaiser Bern the Nationally Known Products Liability Attorneys
Defibrillator manufacturer’s recall of defective products last week spurs investigations by Napoli Kaiser Bern, LLP on behalf of hundreds of worried patients. Concealment of defects by the manufacturers prompts Napoli Kaiser Bern, LLP the renowned products liability attorneys to lead the investigations.
New York (PRWEB) July 5, 2005 -- Napoli Kaiser Bern, LLP announced today that
it is investigating claims and concerns raised about defective cardiac
defibrillators. Among those included in the investigation are defibrillators
manufactured by Guidant Corporation and Medtronic. This investigation was
spurred by recent news reports and calls from hundreds of worried patients
following Guidant's recall of thousands of defective defibrillators in recent
weeks. Of particular concern for patients is the fact that known defects in the
defibrillators were not immediately reported to doctors or
patients.
Guidant's decision to issue the recall came last week, after
urging by the Food and Drug Administration. On June 17, 2005 Guidant Corp.
issued a worldwide recall of nearly 50,000 cardiac defibrillators. These devices
are surgically implanted in patients to prevent death from cardiac arrhythmias.
The recall was necessary because of defects that could lead to serious injury
and death.
"It is troubling to see that companies who are in the business
of creating and marketing products for health care can be so cavalier about
concealing known defects that threaten the very patients who depend on them,"
said Marc Jay Bern, a Senior Partner at Napoli Kaiser Bern. "We intend to
investigate these claims thoroughly and in doing so, we will remind these
corporate decision-makers that serious consequences will result from putting the
bottom-line before the value of their patients' health and quality of
life."
Cardiac defibrillators are used to shock the heart into normal
rhythm after patients suffer irregular heartbeat or fibrillation, which are
rapid, life-threatening arrhythmias, originating in the lower chambers of the
heart. The defibrillators are implanted surgically in the patient's chest.
Defibrillators emit an electrical jolt to restore rhythm to a chaotically
beating heart. When a cardiac arrhythmia occurs, the capacitor is charged and
the device delivers the appropriate shock.
Approximately 38,000
defibrillators have been implanted in patients in the United States. The
defective Guidant models are: Prizm 2 DR, the Contak Renewal and Contak Renewal
2, the Ventak Prizm AVT, Vitality AVT, Renewal 3 AVT and Renewal 4 AVT ICDs.
Guidant Corp. failed to inform doctors or patients for three years that some of
their defibrillators had a defect that caused the affected devices to
short-circuit.
Within a week of their initial recall announcement,
Guidant issued a second safety advisory about its implantable defibrillators.
Guidant told doctors to stop using five of the models because they could
malfunction due to a defective switch. The latest warning applies to Guidant's
Contak Renewal 3 and 4 models, Renewal RF model and the Renewal 3 and 4 AVT
devices, which were included in the June 17 safety advisory.
Guidant did
not tell doctors for over three years about the electrical flaw in one model,
the Ventak Prizm 2 DR Model 1861, that it has recalled. It also kept selling
older versions of it after developing a version not prone to short-circuiting.
As noted in a recent New York Times report, Guidant's failure to disclose this
problem to physicians has caused some patients to feel a sense of betrayal.
Earlier disclosure might have spared these patients the tough choice they now
face: to have risky surgery to replace the units or take the chance that their
unit will not fail at a critical moment when defibrillation is needed.
Guidant's recall follows on the heels of Medtronic's recall of two of
its defibrillators because they have been linked to at least four deaths and one
injury. Medtronic said that some of these defibrillators have failed to charge
properly which can result in the late delivery or nondelivery of cardiac shock
therapy. The charging problem involves the Medtronic Micro Jewel II Model 7223Cx
and the Medtronic GEM DR Model 7271 implanted cardioverter-defibrillators.
Medtronic said that most of these devices were implanted in 1997 and
1998. About 1,800 are thought to be still in use. Medtronic said that with the
suspect defibrillators, the capacitors may take longer than normal to charge
near the end of the battery service life and could cause a delay in delivery or
nondelivery of shock therapy. A delay or nondelivery of shock therapy can be
life threatening.
The surgery to replace a defibrillator, which is the
size of a pager and is implanted under the skin of the upper chest near the
shoulder, takes an hour, and many people go home immediately afterwards. Full
recovery takes about 7 to 10 days. Like any surgical procedure, the surgery
carries a risk of infection. Infection occurs in 1 percent or less of
operations, several physicians said. But patients with certain conditions, such
as a weakened immune system, or who take certain drugs, such as blood thinners,
may face a higher than average risk of infection, serious bleeding or other
problems. Defibrillators normally have to be replaced every five to six years
due to battery life; the decision as to whether to replace the defective units
sooner depends on the patient's age, physical condition, and the nature and
severity of the cardiac problem that led to the unit being implanted in the
first place.
About Napoli, Kaiser & Bern
Napoli, Kaiser &
Bern, LLP is a law firm experienced in prosecuting personal injury actions on
behalf of its clients. The firm’s litigation practice is focused on mass tort,
medical malpractice, products liability, and negligence actions. Their office
has been instrumental in the development of new law in the area of personal
injury law and consumer rights. Napoli, Kaiser & Bern has law offices in New
York City, New Jersey, Philadelphia and Oklahoma. For more information visit www.nblawfirm.com
or call 1-888-LAW-IN-NY.
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Source : http://www.prweb.com/releases/2005/7/prweb257574.htm