Class action filed over heart defibrillators

By Cara Bailey | Nov 23, 2007


CHARLESTON - A class action lawsuit has been filed against the manufacturers of a heart defibrillator, who claim at least five people have died from lead fractures in the device. The suit seeks $5 million for each member of the class.

Attorneys from the law firms Wexler Toriseva Wallace LLP and Motley Rice LLC filed the case Nov. 19 in the United States District Court of the Southern District of West Virginia.

The suit names West Virginia resident Ted Carter as the plaintiff, on behalf of himself and others similarly situated. The case was filed by Wheeling attorney Teresa C. Toriseva, president of the West Virginia Association for Justice which formerly was known as the West Virginia Trial Lawyers Association.

The suit is against Medtronic Inc., which distributes Sprint Fidelis Defibrillator Leads. The defibrillator is implanted into the body of the patient, and the leads present can cause injury or death.

Medtronic is located in Minneapolis, Minn. The Cardiac Rhythm Disease Management Division produces the defibrillator.

A defibrillator is implanted in patients who have abnormal heart rhythms. They deliver an electrical shock or rapid pacing to restore the normal rhythm when irregular heartbeats are detected. They are surgically implanted into patients who are at risk for sudden cardiac arrest.

According to the suit, the Sprint Fidelis Leads Models: 6930, 6931, 6948 and 6949 were placed on the market in September 2004.

According to the suit, Medtronic estimates that 2.3 percent of the devices will fail within 30 months of implantation.

The Sprint Fidelis Leads were recalled Oct. 15, 2007, because of the potential for lead fractures. The suit says Medtronic believes at least five people have died due to the lead fractures, and others have been seriously injured.

One of those injured is Monongalia County resident Ted Carter. Carter was a Medtronic defibrillator implanted Dec. 16, 2004, at Monongalia General Hospital in Morgantown. The device implanted was a Sprint Fidelis Lead Model Number 6949581D, which was recalled.

According to the suit, the Sprint Fidelis Lead in Carter's body presents a serious ongoing health risk due to its defective design and manufacture.

According to the suit, the defibrillator can fracture and malfunction, and is defectively designed. It also fails to perform as safely as an ordinary patient would expect.

"Upon information and belief, as of Oct. 15, 2007, roughly 235,000 Sprint Fidelis Leads have been implanted," the suit says. "172,000 of the leads have been implanted inside patients residing in the Unites States."

The suit claims Medtronic knew of the dangers the defibrillator presented, and should have exercised reasonable care. The suit says the Sprint Fidelis Leads are uniformly defective because they possess the same potential for fracture or malfunction and, as a result, are subject to risk of resulting injury.

In the three-count suit, the class members, including Carter, seek to be compensated for negligence, breach of implied warranty of merchandise and medical monitoring. The medical monitoring program, funded by Medtronic, would provide testing, screening, services, research and education and a medical/legal registry to ensure the class members receive prompt and proper medical treatment.

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