Yourlawyer.com (Guidant Multi-Link Vision Stent News)

Defective Guidant Defibrillators Continue to Haunt Boston Scientific

Mon, 11 Sep 2006 00:00:00 -0700

According to recent SEC filings, Boston Scientific Corp. now faces about 477 individual and 72 class-action lawsuits over recalled Guidant defibrillators. Boston Scientific purchased Guidant earlier this year for $27 billion, after outbidding Johnson & Johnson. Both companies pursued Guidant even though the company had just recalled thousands of defibrillators and pacemakers. J&J’s decision not to match the higher offer appears to have been fortuitous, as Boston Scientific has already reserved $381 million to fund Guidant related lawsuits, and some legal experts believe the company’s liability could actually be much greater.

The first trial surrounding defective Guidant defibrillators is set to begin in Corpus Christi, Texas on September 18, 2006. The plaintiffs in this are two patients who had Guidant’s Ventak Prizm 2 defibrillator implanted 2001. While both plaintiffs are still alive, they live with the fear that the devices can fail at anytime. Many patients in their same situation have elected to have the defective devices removed and replaced with new models. The removal and insertion of these devices does require risk, making it a difficult decision for patients to decide on the best course of action.

Plaintiffs argue that Guidant knew about the defects in their defibrillators for three years before they informed doctors about the problems. The defibrillator defects didn’t come to light until the death of a 21-year-old college student was reported. The student had a Guidant defibrillator implanted because he suffered from heart disease. Guidant acknowledged that the defibrillator short circuited causing his death. The company also told his doctors that it was aware of 25 other cases in which the defibrillator had been affected by the same flaw. However, Guidant’s executives said the company did not see a compelling reason to issue an alert to physicians because the unit’s failure rate was very low and replacing the devices might pose greater patient risks.

The Guidant defibrillator recall included the following models:Guidant Prizm 2 DR, Model 1861, Guidant Contak Renewal, Model H135, Guidant Contak Renewal 2, Model H155, Guidant Prizm AVT Vitality AVT Renewal 3, Guidant AVT Renewal 4 AVT, Guidant Contak Renewal 3 and 4, Guidant Renewal 3 and 4 AVT and Guidant Renewal RF.

The recalled defibrillators are known as implantable cardioverter-defibrillators or ICD’s. These devices are implanted under the skin of patients to manage sudden cardiac death due to ventricular fibrillation. ICD’s are used to treat patients at risk of recurrent, sustained ventricular tachycardia or fibrillation. When an ICD detects ventricular tachycardia or fibrillation, it shocks the heart to restore the normal rhythm. When working properly, ICD’s have been very useful in preventing sudden death in patients with known, sustained ventricular tachycardia or fibrillation. New studies are being conducted to learn if ICD’s can be used to prevent cardiac arrest in high-risk patients who haven’t had, but are at risk for, life-threatening ventricular arrhythmias.

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Boston Scientific Announces Physician Communication Related to Products in Its CRM Group

Mon, 26 Jun 2006 00:00:00 -0700

Contact:
Paul Donovan
508-650-8541

Boston Scientific Corporation (NYSE: BSX) today announced that it is providing safety information and retrieving a specific subset of pacemakers, cardiac resynchronization pacemakers and implantable cardioverter defibrillators from its sales force and hospital inventories. The specific subset of devices includes INSIGNIA and NEXUS pacemakers, CONTAK RENEWAL TR/TR2 cardiac resynchronization pacemakers, and VENTAK PRIZM 2, VITALITY, and VITALITY 2 implantable cardioverter defibrillators. These products are manufactured by the Company's Cardiac Rhythm Management (CRM) Group, formerly Guidant's CRM business. Boston Scientific acquired Guidant on April 21.

Boston Scientific CRM has recently identified a supplier's low-voltage capacitor that is not performing to the company's expectations. A capacitor is an electrical charge storage component. Some capacitors from specific lots may perform in a manner that leads to device malfunction, including intermittent or permanent loss of therapy or premature battery depletion. To date, a total of five confirmed events have been reported out of approximately 27,200 implanted devices from this subset. One event involved a device malfunction discovered at the time of implant. The other four events involved devices that were implanted and subsequently required replacement.

Patients with affected pacemakers may experience intermittent or permanent loss of output or telemetry, or premature battery depletion. Patients with affected defibrillators may experience inappropriate sensing or premature battery depletion. There have been no reported patient deaths associated with this issue. There have been two reports of pacemaker patients experiencing syncope associated with loss of pacing output.

Engineering analysis is ongoing and the company will further communicate on this issue when it has additional information. Implanting and following physicians are being asked to schedule an in-clinic follow-up visit as soon as possible for all patients with implanted devices from this subset to assess device function. At this follow-up visit, physicians should look for behaviors that may be indicative of capacitor malfunction such as premature battery depletion, intermittent or permanent loss of therapy or telemetry, fault codes, pacing or sensing abnormalities, or loss of daily measurements.

"Boston Scientific believes in notifying physicians in a timely, transparent and responsible manner," said Jim Tobin, Boston Scientific President and Chief Executive Officer. "This action reflects Boston Scientific's industry-leading commitment to implementing recommendations made by both the Heart Rhythm Society and the Independent Panel Commission chaired by Dr Robert Myerberg. Boston Scientific is the only CRM company that has committed to implementing these recommendations, which it believes are in the best interest of patients and physicians."

Physician communications can be viewed in their entirety at http://www.guidant.com/physician_communications/.

Guidant Settles Lawsuits

Sat, 18 Oct 2003 00:00:00 -0700

The owner of a Menlo Park company that made a medical device linked to dozens of deaths has reached an out-of-court settlement of nine lawsuits that claimed malfunctions of the product.

The lawsuits had been filed over the past two years against EndoVascular Technologies, a Menlo Park subsidiary owned by medical-device giant Guidant and were dismissed late last month.

Terms of the settlement weren't disclosed. The cases had been filed with U.S. District Judge Jeremy Fogel in San Jose.

``I am not at liberty to talk about the cases at all or what occurred. We did resolve them, in a mutually satisfactory manner,'' said Rachel Abrams, an attorney at Hersh & Hersh, the San Francisco law firm that brought the lawsuits on behalf of nine families, including relatives of two dead patients.

A telephone call to the media spokesman for Guidant, the Indianapolis medical company that owns EndoVascular, was not immediately returned Friday afternoon.

None of the patients who filed the nine suits alleging they were injured by the device lived in the Bay Area. But people who sued the company included Helen Gaines of Missouri, who has suffered chronic pain and the loss of all sensation in her right foot since her procedure to implant the device, called the Ancure endograft, in 1998.

The Ancure device was made by Guidant's subsidiary, EndoVascular Technologies. That division pleaded guilty in June to 10 felonies involving the Ancure device, including making false statements to government regulators. The subsidiary agreed to pay a $92.4 million fine to the government in the largest settlement of its kind to date for failing to report medical device malfunctions to the FDA, as required by law.

The device was made to patch weak spots in a major blood vessel, called the aorta, that runs from the heart through the abdomen. Without reinforcement, weak spots in the aorta can swell like a balloon and burst, potentially causing death from internal bleeding.

In its settlement with the Justice Department, EndoVascular admitted to concealing more than 2,600 incidents where the device malfunctioned or caused serious injury or death from 1999 to 2001.

A Mercury News examination earlier this year found that the numerous Ancure malfunctions that went unreported to the FDA were widely known within the subsidiary. Overall, at least 75 patients died and 991 were injured after receiving the implant, the examination found. The lawsuits charged that, in some cases, the implant was at fault.

At the time Guidant announced it would no longer sell the Ancure device, the company said it would continue to offer long-term assistance to patients with the implants and their physicians. Guidant officials have insisted that the device itself is safe, saying any malfunctions were caused by equipment used to insert the Ancure and those problems were corrected in 2001.

Abrams said another lawsuit asking to be certified for class-action status also is pending before Fogel that asks the company to pay for the cost of mandatory lifelong monitoring for patients implanted with the Ancure device.

Guidant Voluntarily Recalls Artery Stent

Wed, 08 Oct 2003 00:00:00 -0700

Guidant Corp. has begun a voluntary, partial recall of a stent that won federal approval less than three months ago, the company disclosed Wednesday.

The Indianapolis-based medical device maker is recalling certain lots of its three millimeter-diameter Multi-Link Vision stent because some of the devices failed in quality tests. A stent is a metal-mesh tube inserted into a coronary artery to prop it open after a blockage has been cleared.

Patients who already have received the stents are not affected by the recall, but doctors have been notified, the company said.

The recall involves stents shipped in the United States and to Europe and Australia. Guidant received U.S. approval for the stents on July 16 from the Food and Drug Administration.

At the time of FDA approval, Guidant said the new stent could be used to treat more challenging blockages and did not seem to allow reclogging as much as other stents.

Guidant said it was working with the FDA and other regulatory bodies on the recall.

Information on how many stents were involved in the recall and the defect was not immediately available.

Guidant Initiates Voluntary Recall of 3.0mm-Diameter MULTI-LINK VISION Coronary Stent System

Wed, 08 Oct 2003 00:00:00 -0700

Guidant CorporatioN, a world leader in the treatment of cardiac and vascular disease, today announced that it has initiated a voluntary recall of certain manufacturing lots of the 3.0 mm diameter MULTI-LINK VISION(TM) Coronary Stent System.

The action will affect customers in the United States, Europe and Australia. Working with the Food and Drug Administration and other regulatory bodies, Guidant has taken action to address this matter and is currently shipping 3.0 mm diameter MULTI-LINK VISION stents to customers worldwide.

Patients who have received the MULTI-LINK VISION Stent are not affected by this action. The safety and effectiveness of the implanted product is supported by positive long-term clinical data. This action is due to a limited amount of product that did not meet Guidant's manufacturing specification for stent retention. Affected physicians and regulatory bodies have been notified.

Guidant Multi-Link Vision Artery Stent Recall Lawsuit

Wed, 08 Oct 2003 00:00:00 -0700

Guidant Multi-Link Vision Stent

On October 8, 2003 Guidant announced that it initiated a voluntary recall of certain manufacturing lots of the 3.0 mm diameter MULTI-LINK VISION Coronary Stent System.

Guidant Corp. has recalled some of the devices because they failed to stay in place and failed in quality tests. The recalled Guidant stent is a metal-mesh tube inserted into a coronary artery to prop it open after a blockage has been cleared.

The recall involves stents shipped in the United States and to Europe and Australia. Guidant received U.S. approval for the stents on July 16, 2003 from the Food and Drug Administration.

The recall of the Multi-Link stent comes just a few months after Guidant recalled its Ancure stent and pleaded guilty to 10 felonies and agreed to pay $92.4 million in civil and criminal penalties, to settle the federal charges that it withheld information about 2600 Ancure stent malfunctions. Ancure has been linked to at least 12 deaths and has failed 2400 times.

If you or a loved one suffered injuries from a Guidant Multi-Link Vision stent, please fill out the form at the right for a free case evaluation by a qualified defective medical device attorney.