St. Jude, Medtronic sued for alleged defibrillator problems

By Michelle Massey, East Texas Bureau | Aug 23, 2007

Implantable Cardiac Defibrillator

TEXARKANA – Two major manufacturers of cardiac defibrillators have been sued by patients claiming the devices had to be removed because of ongoing problems.

Many patients have received an implantable cardiac defibrillator (ICD) in order to restore an irregular heartbeat or rapid heartbeat.

To restore the normal heart rhythm, the medical device can deliver an electrical shock to the heart and typically are only implanted in patients whose heart conditions are considered life-threatening.

After two years of reported problems with an implantable cardiac defibrillator, Richard Smith had a new one implanted late 2005.

Richard Smith and his wife, Julie Smith, filed suit against St. Jude Medical for its implantable cardiac defibrillator Atlas DR V-240 on August 22.

St. Jude Medical's 2005 news release states Richard's model can be affected by background atmospheric radiation (cosmic rays). The release states an incidence rate of only .00257 over the five year life of the device. St. Jude notified the FDA regarding this advisory.

"St. Jude Medical has taken a conservative, proactive approach in notifying the medical community of this anomaly," said Dr. Mark Carlson, professor of medicine and a member of an independent panel of physicians that reviewed the issue.

"St. Jude Medical's recommendation for monitoring at three-month intervals will be appropriate for the vast majority of patients," said Dr. Bruce Wilkoff, member of St. Judge Medical Independent Advisory Board in the 2005 news release. The remote monitor was offered at no charge.

According to the suit against St. Jude, in addition to the problems associated with the device, the plaintiff had problems healing from the implantation and removal surgeries.

Claims of action against St. Jude include products liability, breach of express and implied warranties and negligence. The Smiths are seeking damages for medical expenses, lost wages, physical impairment, pain and suffering, mental anguish, prejudgment interest and punitive damages. Judge John Ward will preside in the Texarkana U.S. District Court.

St. Jude Medical is the third largest medical device manufacturer in the United States.

In a similar suit, three plaintiffs filed a product liability lawsuit against Medtronic Inc., another defibrillator manufacturer, on Aug. 22.

Plaintiff Eunice Henderson had her Medtronic Thera Dr 7960 ICD for eight years before having it replaced. In 1996, plaintiff Alice Gaston had a Medtronic Thera DR 7960 ICD implanted, but has not had it replaced. Plaintiff Charles Bishop had a Medtronic SDR 303 ICD implanted in 2003 and also has not had it replaced with a new device.

According to the lawsuit, Medtronic misrepresented the safety of Thera, DR, and Sigma defibrillators.

"The devices malfunctioned, and therefore failed to operate in a safe and continuous manner, causing serious medical problems, and in certain patients, catastrophic injuries and deaths."

Claims of action filed against Medtronic, Inc. include products liability, breach of express and implied warranty and negligence.

Plaintiffs are seeking damages for medical expenses, pain and suffering, costs of suit, lost wages, physical impairment, mental anguish, prejudgment interest, and punitive damages.

Judge David Folsom will preside in the Texarkana U.S. District Court.

Medtronic is self described as the global leader in medical technology. According to Medtronic's website, "every five seconds, somewhere in the world, a person's life is saved or improved by a Medtronic product or therapy."

Marcus Stevenson from the Houston law firm of Sandford, Stevenson, and Riff is representing all plaintiffs. Both cases have demanded a jury trial.

Case No.:5:07cv00129
Case No.:5:07cv00130

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