Boston Scientific Warns Of Problems With Battery In Implantable Guidant Defibrillators
On April 9, 2007, Boston Scientific notified doctors that some of the implantable heart defibrillators produced by its Guidant Unit contain batteries that could deplete early. Included in this warning are the ?Vitality? family of implantable cardioverter defibrillators (ICDs) and the ?Contak Renewal? line of cardiac resynchronization therapy devices (CRT-Ds). Boston Scientific estimates approximately 2 percent of these devices are at risk for early battery depletion and advises patients with these devices to have them monitored every month instead of every three months.
Boston Scientific states that no patient deaths or serious injuries have been associated with this problem. Boston Scientific bought Guidant in 2006. Previous problems have been noted with Guidant defibrillators. Between 2005 and 2006 more than 100,000 Guidant Heart rhythm devices were recalled.
Seeger Weiss LLP is investigating claims on behalf of persons who have had suffered injuries from defective heart defibrillators produced by the Guidant Corporation. Guidant Corporation, based out of Indianapolis, is one of the largest producers of medical technology in the world and has come under increasing scrutiny after some of its defibrillator products have been found to contain defects that are potentially fatal. The Guidant defibrillators are produced in order to be surgically implanted in persons who have had a heart attack or suffer from a type of heart disease that creates the risk of a life-threatening heart arrhythmia. The devices are designed to monitor the heart for irregular heart rhythms. If an irregular heart rhythm occurs, the defibrillator will deliver an electrical shock to the heart in an effort to restore normal heart rhythm.
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Guidant and Medtronic Defective Defibrillators Announcement
In February and May of 2005, two of the major companies in the medical technology industry, Medtronic and Guidant, announced that they manufactured and distributed defective ICDs and CRT-Ds to patients. In each instance, the devices have been implanted in patients for months, if not years, before the companies notified patients of the defects. In the case of Guidant, the company has allegedly admitted that it knew about defects in some devices as early as 2002, yet failed to disclose those defects to consumers until May 2005. The Guidant defects came to light only after a 21 year old college student died when his Guidant device failed. Perhaps just as alarming, since the student's death, it has come to light that Guidant allegedly continued to distribute an allegedly defective ICD after Guidant knew of the defect and had repaired it in newer models. Chris Seeger, named partner of Seeger Weiss LLP, has said, "If this allegation proves true, Guidant's decision to continue to sell the devices can be described as nothing short of a coldly calculated decision by Guidant officials to put company profits ahead of public safety; this decision and the failures of Guidant and Medtronic generally have rattled the public's confidence in ICD and CRT-D devices and raises serious doubts about the ability of these companies to fully inform their patients about problems with such devices."
Guidant Defects
The problems with Guidant?s defibrillators began to unfold on May 24, 2005. On May 24, Guidant notified doctors about a design flaw in the Ventak Prizm 2 DR implantable defibrillators manufactured prior to November 2002 that has caused some units to malfunction and short circuit. According to the company, there have been 26 reports of failure including one death regarding these devices. The company estimates that there are some 24,000 people who currently have the defibrillators implanted. On May 24, 2005, the New York Times reported that Guidant notified doctors about these defects only after learning that the New York Times was preparing an article about the devices. The New York Times further said that Guidant acknowledged that it knew about the defective design and waited 3 years before telling patients and their doctors about the problem.
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Guidant Defibrillator Recall
On June 17, 2005, the FDA announced that Guidant was recalling the Ventak Prizm 2 DR Implantable Defibrillators manufactured before April 16, 2002 and various other defibrillator models because of the defect that may cause the device to short circuit and fail. Guidant announced that the following devices would be recalled:
- PRIZM 2 DR, Model 1861, manufactured on or before April 16, 2002;
- CONTAK RENEWAL, Model H135, manufactured on or before August 26, 2004;
- CONTAK RENEWAL 2, Model H155, manufactured on or before August 26, 2004
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Guidant further announced at the same time that it had recently informed the FDA that it would be recalling another set of defibrillator devices because of a memory error defect that may affect the performance of the devices. The FDA is evaluating the information concerning this defect. The defibrillator models in this category include:
- PRIZM AVT;
- VITALITY AVT;
- RENEWAL 3 AVT;
- RENEWAL 4 AVT
Shortly after the June 17 announcement, Guidant made another announcement on June 24, 2005 concerning the company's defibrillator products. Guidant advised physicians to halt the use of five additional models of cardiac defibrillators. Guidant said it was advising doctors about safety problems with its Contak Renewal 3 and 4, Renewal 3 and 4 AVT, and Renewal RF ICDs. The Renewal 3 and 4 AVT models were also included in Guidant's June 17 recall. Guidant said it had 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. 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. The Indianapolis-based company said it found four cases of an electrical failure that can prevent the devices from shocking an irregularly beating heart back into a normal rhythm, and a fifth is suspected. No injuries or deaths were reported.
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Guidant Lawsuit Filed by Seeger Weiss LLP
Seeger Weiss, along with co-counsel, has already taken action on behalf of Guidant ICD and CRT-D patients by filing a medical monitoring program and fund class action lawsuit in the United States District Court for the Eastern District of New York on behalf of thousands of patients who were implanted with defective Guidant defibrillators. Seeger Weiss and co-counsel originally filed the class action on June 10, 2005 and they intend to file an Amended Complaint adding additional ICDs and CRT-Ds manufactured by Guidant that were the subject of disclosures and/or recalls by Guidant on June 17, 2005. The devices at issue in the Guidant class action include the Guidant Ventak Prizm 2 DR, Model 1861 ICD manufactured prior to November 2002; the Guidant Contak Renewal, Model H135 CRT-D and Contak Renewal 2 Model H155 CRT-D manufactured on or before August 26, 2004; and Guidant Ventak Prizm AVT, Guidant Vitality AVT and Guidant Renewal AVT (all series numbers).
Questions and Consultations
If you or a family member is using or has used one of the Guidant defibrillators cited 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 Boston Scientific/ Guidant Content:
<a href='http://www.lawyerseek.com/Practice/Product-Liability-C2/Guidant-Defibrillators-P62/'>Boston Scientific/ Guidant: Lawyer Seek</a> |
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