Viles & Beckman, file class action lawsuit against Guidant over faulty
defibrillators and pacemakers
4 October 2005
Fort Myers, Fla, USA. US law firm Viles & Beckman, LLC has filed a class
action product liability lawsuit against Guidant Corp., one of America's
largest manufacturers of medical devices. The complaint states that Guidant
Corp. learned well in advance of the recall that their devices were faulty,
but delayed notification to physicians and the general public hoping that
future models would correct any flaws. Subsequently, two cases of death
associated with Guidant's recalled pacemakers have already been reported to
the FDA.
On June 17th, 2005, Guidant Corp. announced that it would recall nearly
50,000 Implantable Cardiac Defibrillators distributed worldwide due to
faulty insulation in the wiring. Defibrillators, which are largely used by
people who suffer from life-threatening arrhythmia or an irregular
heartbeat, are designed to emit a life-saving electrical shock to the heart
to restore normal rhythm. Faulty insulation in the wiring of the
defibrillator has the potential to cause short circuits and prevent the
device from shocking the heart during a cardiac event.
The following defibrillator devices were affected by the recall:
- PRIZM 2 DR, Model 1861 (manufactured on or before April, 2002)
- CONTAK RENEWAL, Model H135 (manufactured on or before August 26, 2004)
- CONTAK RENEWAL 2, Model H155 (manufactured on or before August 26,
2004
On July 19, 2005, Guidant Corp. announced a second recall affecting
approximately 28,000 patients worldwide.
Pacemakers are also implantable devices that are designed to electrically
stimulate the heart. The difference is that pacemakers emit electrical
shocks to the heart causing it to contract and pump blood when the heart's
electrical system is dysfunctional, whereas defibrillators shock the heart
when an irregular heartbeat is sensed. The flaw resides in the hermetic seal
on some Guidant pacemaker devices, whereby moisture can seep in and
potentially cause damage to the device. There has been at least one death
thought to be attributed with this product failure. Guidant has also
identified that some of their pacemakers may have a defective magnetic
switch which may be stuck in the closed position, hindering the pacemaker
from delivering an electric charge when needed.
The following Guidant pacemaker devices, manufactured between November
25, 1997 and October 26, 2000, were affected by the recall:
- PULSAR MAX Models 1170, 1171, 1270
- PULSAR Models 0470, 0870, 0970, 0972, 1172, 1272
- DISCOVERY Models 1174, 1175, 1273, 1274, 1275
- MERIDIAN Models 0476, 0976, 1176, 1276
- PULSAR MAX II Models 1180, 1181, 1280
- DISCOVERY II Models 0481, 0981, 1184, 1186, 1187, 1283, 1284, 1285,
1286
- CONTAK TR Model 1241
- VIRTUS PLUS II Models 1380, 1480
- INTELIS II Models 1483, 1484, 1485, 1384, 1385, 1349, 1499
Potentially 78,000 persons may now require surgery to replace
defibrillators and pacemaker devices produced and subsequently recalled by
Guidant Corp. Some Guidant devices that were not recalled may be subject to
a memory error which can also lead to malfunction of the device.
Incorporated in 1994, Guidant quickly became the leading medical device
supplier in the United States, earning over 3.8 billion dollars in the past
11 years. Its medical devices were hailed as some of the most dependable
machines ever produced, until 2002 when they received some unfortunate news
regarding a potential problem with its Ventak Prizm 2 DR (model 1861),
indicating that faulty insulation in some of its wires could lead the device
to short circuit. Apparently, Guidant was sure this flaw would be corrected
in future models, and waited until May 2005 to notify doctors of this
potential malfunction. The Contak Renewal (models H135 and H155) made prior
to 2004 are also subject to this flaw.
Designated as a Class I recall by the Federal Drug Administration (FDA),
Guidant's products may fail to deliver the lifesaving shock during the time
when patients would need it most. Class I is the most serious category in
the recall system used by the FDA; it identifies a "reasonable probability
that the malfunctioning device will cause serious adverse health
consequences or death." ( www.fda.org/ )
Signs of a failing product may include sudden faintness, a loss of
consciousness, shortness of breath, dizziness, lightheadedness, prolonged
fast heart rate, and heart failure or death.
If you have a Guidant pacemaker but are not sure which model it is,
consult your physician with any questions or concerns that you may have.
Lastly, if you have experienced any problems with your pacemaker device,
please notify the FDA MedWatch program and Guidant Corp. Go to
www.fda.gov/medwatch to file
a report on the problem online or call 1-800-FDA-1088 (1-800-332-1088).
About Viles & Beckman, LLC
Viles & Beckman, LLC takes pride in making corporations accountable for
their actions. It was the first law firm in the U.S. to file a class action
suit against the manufacturers of the diet drug Fen-Phen. It helped lead the
successful effort to recall defective tires in the Ford/Firestone class
action and has been featured on CNN, MSNBC, Good Morning America and CBS
Evening News. They have also been featured in the Wall Street Journal, New
York Times, Washington Post and other publications. Viles & Beckman, LLC has
been nationally recognized for their extensive work towards defending the
rights of the consumer and demand that goliath companies take responsibility
for their actions. They hope to promote corporate accountability and to
protect the rights of consumers worldwide.
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