Guidant Class Action Lawsuit
Seeger Weiss is actively investigating claims on behalf of persons who have suffered injuries from defective heart pacemakers produced by the Guidant Corporation. Guidant Corporation is the second largest cardiac device manufacturer in the United States, but the company come under fire recently after many of its popular defibrillator and pacemaker devices have been recalled or ceased being used due to defects causing device failure. Some of the defects in the Guidant defibrillators and pacemakers have been found to be potentially fatal. The Associated Press has reported that an estimate by an A.G. Edwards & Sons analyst has found that approximately 80% of Guidant's heart products have been recalled or are under an advisory.
Defective Guidant Pacemaker Models
On July 18, 2005, Guidant announced problems with several of its implantable pacemaker models. Pacemakers are designed to use a mild electrical current to regulate a patient's heartbeat. Guidant announced that a subset of the following pacemaker devices made between Nov. 25, 1997, and Oct. 26, 2000, are affected by these problems and may need to be replaced:
- Pulsar Max;
- Pulsar;
- Discovery;
- Meridian;
- Pulsar Max II;
- Discovery II;
- Virtus Plus II;
- Intelis II;
- Contak TR.
 Contact us regarding Guidant Pacemakers; attorney consultations are free.
Guidant Pacemaker Defects
Reports have indicated that approximately 28,000 of these Guidant pacemaker devices are in use worldwide, the majority of which are in use in the United States (approximately 18,000). According to a letter from Guidant to the medical community, Guidant's Cardiac Rhythm Management Quality System determined that a hermetic sealing component utilized in these devices may experience a gradual degradation, resulting in a higher than normal moisture content within the pacemaker case late in the device's service life. According to the letter from Guidant, this may lead to one or more of the following problems:
? Premature battery depletion resulting in loss of telemetry and/or loss of pacing output without warning;
? Inappropriate accelerometer function (if programmed ON), resulting in sustained pacing at the programmed maximum sensor rate (MSR);
? Lack of appropriate accelerometer rate response during activity;
? Appearance of a reset warning message upon interrogation; and
? Inappropriate early display of replacement indicators.
Reported Failures of Guidant Pacemakers
Guidant has reported that examination of the device may be able to show if the pacemaker has already experienced any of these problems; however there is no reliable way to predict whether a Guidant pacemaker will have a problem in the future. According to Guidant, as of July 11, 2005, the company has identified failures in 69 of their pacemaker devices. The likelihood of a device failing is believed to increase over time as the failures all occurred after more than 44 months of use in the patients. Reports indicate that some of the patients have developed possible heart failure and several patients have reportedly lost consciousness.
New Warning for Insignia and Nexus Pacemaker Models
On September 22, 2005, Guidant issued another warning concerning two popular models of pacemaker, the Insignia and Nexus lines of devices. The warning from the company identified two failure modes for the devices where, according to the letter from Guidant, the pacemakers may experience intermittent or permanent loss of pacing output without warning, intermittent or permanent loss of telemetry, or reversion to VVI mode or appearance of a reset warning message upon interrogation. According to Guidant, loss of pacing output had been found in 36 Insignia and Nexus pacemaker devices out of 49,500 that had been distributed worldwide. The devices that were affected were shipped before March of 2004. It has been reported by Guidant, that device failures in these lines have not lead to any known deaths but the device failures are linked to nine emergency hospitalizations. Guidant indicated that there were three reports of syncope and six reports of bradycardia or heart block all linked to this failure mode. A second failure mode has been associated with sixteen failures out of 341,000 Insignia and Nexus devices distributed, with 145,000 of these devices active in the United States. Device failures were reported as far back as 2003 in these products, according to an FDA report. Guidant however, continued to manufacture the devices and users were not told of the failure reports.
Contact us regarding Guidant Pacemakers; attorney consultations are free.
Guidant Pacemaker Models Affected by September Warning
- INSIGNIA Entra SSI 0484, 0485
- INSIGNIA Entra DDD 0985, 0986
- INSIGNIA Entra SR 1195, 1198
- INSIGNIA Entra DR 1294, 1295, 1296
- INSIGNIA Ultra SR 1190
- INSIGNIA Ultra DR 1290, 1291
- INSIGNIA Plus SR 1194
- INSIGNIA Plus DR 1297, 1298
- INSIGNIA AVT SSI 482
- INSIGNIA AVT VDD 882
- INSIGNIA AVT DDD 982
- INSIGNIA AVT SR 1192
- INSIGNIA AVT DR 1292
- NEXUS ENTRA SSI 1325, 1326
- NEXUS Entra DDD 1425, 1426
- NEXUS Entra SR 1395, 1398
- NEXUS Entra DR 1466, 1494, 1495
- NEXUS Ultra SR 1390
- NEXUS Ultra DR 1490, 1491
- NEXUS Plus SR 1394
- NEXUS Plus DR 1467, 1468
- NEXUS AVT SSI 1328
- NEXUS AVT VDD 1428
- NEXUS AVT DDD 1432
- NEXUS AVT SR 1392
- NEXUS AVT DR 1492
Questions and Consultations
If you or a family member is using or has used one of the Guidant pacemakers at issue and would like to discuss your rights, are interested in more information on Guidant lawsuits, or if you have information about the cases that you would like to share with us, please click here to fill out a short evaluation form, and a member of Seeger Weiss LLP's experienced staff will call you to discuss your potential rights concerning Guidant. Attorney consultations incur no obligation on your part and all initial consultations are free of charge and do not create an attorney-client relationship. Seeger Weiss LLP has office locations in both New York and New Jersey and its attorneys practice in courts throughout the country.
Link To Lawyer Seek's Guidant Pacemakers Content:
<a href='http://www.lawyerseek.com/Practice/Product-Liability-C2/Guidant-Pacemakers-P61/'>Guidant Pacemakers: Lawyer Seek</a> |
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