Defective Guidant Pacemaker Attorneys

July 11, 2005 - Guidant Announces 69 of its Older Pacemakers May Have Failed

Guidant Corporation, a leading company in the design of medical devices for over ten years, recently announced that another Guidant implantable heart may be defective. This increased the number of older model pacemakers which may have failed to 69, all of which may pose extreme hazards to the implanted patients. As many as 78,000 of the devices were distributed and some 28,000 remain implanted in patients.

Although there have not been any reports of failures in its first four years on the market, the pacemaker may degrade over time causing serious health complications. Specifically, the hermetic sealing component may degrade over time, causing higher-than-normal moisture within the pacemaker.

The brand names of the pacemakers involved are:

• Pulsar
• Pulsar Max
• Discovery
• Meridian
• Pulsar Max II
• Discovery II
• Virtus Plus II
• Intelis II
• Contak TR

If you have been implanted with one of the above devices, Guidant recommends you seek medical attention immediately if you experience shortness of breath, dizziness, lightheadedness or a prolonged fast heart rate.

Reports indicate that 20 patients experienced loss of pacing output, five of whom experienced syncope (temporary loss of consciousness and posture). Loss of pacing output may also cause presyncope (lightheadedness) and may require hospitalization. There have also been two reports of sustained maximum sensor rate pacing in which the heart failure may have developed. One patient's device exhibited sustained MSR pacing causing multiple health issues in the patient that led to the death of the patient.

Companies that manufacture or sell products must be held accountable for their actions including the sale of defective products. The Law Offices of Nadrich & Cohen is a national products liability law firm with extensive experience fighting large corporations who have unnecessarily caused injuries and deaths to patients and consumers. Our team of skilled product liability lawyers are investigating cases involving Guidant pacemakers that may have failed when needed. We are aggressively representing Guidant pacemaker defect victims.

If you or a loved one currently has a Guidant pacemaker implanted, please contact a defective medical device attorney immediately at the Law Offices of Nadrich & Cohen for a free case review. We are actively investigating many Guidant pacemaker cases throughout the country. Our experienced injury attorneys have recovered tens of millions of dollars on behalf of injured clients. Please allow our team of defective medical device lawyers to help you recover damages for the pain and suffering caused by a defective Guidant pacemaker. It would be an honor for us to represent a Guidant victim.

Please immediately contact us by calling our Guidant recall hotline number (800) 722-0765 or click here to submit your potential claim.

Guidant Pacemakers In The News

Guidant adds to heart-device alerts
By Julie Schmit, USA TODAY

Guidant (GDT) on Monday issued another warning about its heart devices, this time involving older pacemakers in 28,000 patients.
The nine types of pacemakers, which correct irregular heartbeats, may fail suddenly or cause a high rate for too long, Guidant says. It said a sealing component can degrade, allowing body fluids into the device.

Guidant last month issued two alerts for 11 implantable defibrillators (ICDs). The Food and Drug Administration classified them as recalls, although it did not recommend replacement for the estimated 81,000 devices in use. That decision was left to doctors and patients.

The affected pacemakers were built between Nov. 25, 1997, and Oct. 26, 2000. They haven't been sold in four years, Guidant says. Only 28,000 of the original 78,000 devices, including 18,000 in the USA, are still in use.

The biggest risk is to the minority of patients who rely on pacemakers to keep their hearts beating. "It's a very serious issue" for them, says Kenneth Ellenbogen, cardiac electrophysiologist at the Virginia Commonwealth University School of Medicine. He recommends replacement for those patients.

Monday's news revived concern that Guidant's $25.4 billion merger with Johnson & Johnson could be renegotiated. Guidant shares sank 3% Monday to $67.31. The company has lost more than $2 billion in market value since April.

The news also shook doctors, who have largely lauded Guidant as a company that makes reliable devices, and who say pacemakers and ICDs, which shock hearts back to normal heartbeats, save more lives than the rare malfunction endangers. "But it concerns me when a device maker has two recalls," says Philip Oranburg, a Florida cardiologist.

Guidant predicts the rate of failure for the pacemakers to be between 0.17% and 0.51% over their remaining lifetime. Pacemakers last seven to 10 years. No failures were found in devices younger than 44 months, but Guidant warned that the failure rate may rise with the device's age and may be higher because of under-reporting of adverse events.

The FDA said Monday it will decide "within days" whether to classify the latest warning as a recall, says Daniel Schultz, medical device chief.

Guidant says 69 of 78,000 pacemakers may have failed because of the seal issue. One patient died. It is unknown whether the device was to blame.

J&J refused to comment Monday on its $76-per-share offer. In June, it said it still hoped to close the deal this year.

Guidant will replace the pacemakers at no cost. Doctors and patients may call 866-GUIDANT (866-484-3268) for more information. The 40 affected models are listed at www.guidant.com.

Read the story.

Guidant Issues Pacemaker Warning
From Associated Press

Guidant Corp. on Monday warned physicians that replacements might be needed for nine pacemaker models made from 1997 to 2000, of which some 28,000 remain implanted in patients worldwide.

The Indianapolis-based company, which last month recalled almost 109,000 defibrillators, released a warning that said a sealing component in the pacemakers had degraded in some cases, resulting in higher-than-normal moisture in the devices and possible malfunction.

About 78,000 of the pacemakers were distributed, with about 18,000 remaining in U.S. patients, the company said. The devices, which send electrical pulses to the heart to accelerate a slow heartbeat, have a 7- to 10-year life span before they must be replaced.

Guidant said it had identified 69 failures among the pacemakers — all after they had been used for at least 44 months. The models are: Pulsar Max, Pulsar, Discovery, Meridian, Pulsar Max II, Discovery II, Virtus Plus II, Intelis II and Contak TR.

The company told physicians they should consider replacing the pacemakers for patients who are dependent on the devices.

Several patients implanted with the devices have lost consciousness or developed possible heart failure, Guidant said. It reported the death of one person whose pacemaker might have failed, but it said the role of the device could not be confirmed as it was not returned for testing.

Food and Drug Administration spokeswoman Julie Zawisza said the agency was evaluating Guidant's warning. The company said the FDA might classify the warning as a recall. Guidant issued two safety warnings last month for 11 models of defibrillators that were later classified by the FDA as recalls.

Defibrillators, three times the size of pacemakers, are also implanted. Almost 88,000 of the Guidant devices that were recalled remain implanted worldwide.

The problem with Guidant's pacemakers poses less of a risk for patients than that of its defibrillators, said Dr. Angel Leon, chief of cardiology at Emory Crawford Long Hospital in Atlanta. That's because of the relatively small number of pacemakers implanted and because the degradation that can occur does so gradually, allowing patients more time to seek help.

Guidant said that it would replace the pacemakers at no charge through the end of the year, even though the warranty on many had expired, and that it would reimburse patients as much as $2,500 for medical expenses.

The company, which has faced a barrage of criticism from patients and physicians on its handling of the recalls and warnings, also said in its statement Monday that it planned to set up an "independent panel of experts to recommend guidelines for when to disseminate information" on its devices.

Guidant shares fell $2.10 to $67.31. They have traded in a 52-week range of $49.95 to $75.15.

Those levels compare with a $76-a-share offer from Johnson & Johnson that Guidant shareholders voted to accept in April. The $25.4-billion cash-and-stock deal is pending.

Jeffrey Leebaw, a spokesman for New Brunswick, N.J.-based Johnson & Johnson, said Monday that the company stood by its June 17 statement that it was working to close the acquisition in the third quarter. It called the initial safety advisories "serious matters."

If you or a loved one have suffered injuries or have legal concerns related to these products, please immediately contact us at (800) 718-4658. You may be legally entitled to recover medical expenses, lost earnings, as well as compensation for physical pain and suffering, mental anguish and physical impairment. For persons who have died, their surviving spouse or other family members often can bring a wrongful death action. We are actively seeking Guidant cases for patients who have been injured or killed by a defective pacemaker. Our experienced injury attorneys have recovered millions for our injured clients. Let our team of defective product lawyers help you recover damages for the suffering and injury caused by your defective pacemaker.