Class Action Filed Against Medtronic For Faulty Leads

A class action suit was filed Monday against Medtronic by patients injured by defective leads attached to their pacemaker / defibrillators.

Minneapolis, Minnesota (PRWEB) October 16, 2007 -- Two patients complaining of faulty leads attached to pacemakers/defibrillators implanted in them filed a class action lawsuit Monday in federal court in Minneapolis. The patients complain that the Sprint Fidelis lead, manufactured by Medtronic, is unsafe and violates a number of consumer and product liability statutes. In particular, they complain that Medtronic misrepresented the safety of the Sprint Fidelis leads and negligently manufactured, marketed, promoted, advertised and sold the leads. The patients also allege that Medtronic concealed the dangers of the leads to the public. The class action is on behalf of every one who was implanted with the allegedly defective leads.

The lawsuit comes on the heels of Medtronic's announcement that it would stop selling the Sprint Fidelis lead and that it was encouraging over 235,000 patients implanted with the lead to see their doctors to ensure that their lead had not developed a fracture. Such a fracture would cause the device to be unable to accurately measure heart rhythm data. Such a malfunction could also cause shocks, like the one complained of by Ms. Kelly Liusi, a plaintiff in the lawsuit. Medtronic has estimated that 4,000 to 5,000 patients would have leads that experience some failure.

A lead is part of an implantable heart defibrillation system that has three main parts: the defibrillator, leads, and programmer. Two parts of this system are placed inside the body.

• The defibrillator is a small metal case that contains electronics and a battery. It is similar to a pacemaker in that it is designed to correct arrhythmias. But while a pacemaker increases a slow heart rate, a defibrillator detects and corrects fast and slow heart rates.
• Leads are specialized, thin, insulated wires that are attached to the defibrillator. Leads sense the heart's rhythm and deliver therapy to the heart (as directed by the defibrillator).

The third part, the programmer, is kept at the hospital or clinic. A doctor or nurse uses this specialized computer to monitor and change the instructions of the implanted defibrillator. If any part of the system fails to function as indicated, a patient is at great risk for serious injury.

Because of their respective cardiac conditions, both patients claim that they were implanted with a Sprint Fidelis lead, model number 6949. One of the patients, Kelly Liusi, claims that less than four months after being implanted with the lead, she experienced "frightening episodes of unnecessary shocks." When she went to the emergency room, the device continued to shock her while a Medtronic representative attempted to "interrogate" the device. When Ms. Liusi's lead was removed, it was found to have been fractured and a surgery to implant a new lead and pacemaker/defibrillator was necessary. Ms. Liusi complains that this procedure led to "scarring of [an already fragile heart and forcing her to undergo additional and unnecessary complicated surgery." Like Ms. Liusi, the other patient to file suit, Len Stavish, had a Sprint Fidelis lead implanted to assist with a cardiac condition. Less than two years later, Mr. Stavish had to undergo another surgery to replace the lead and pacemaker/defibrillator.

Hunter Shkolnik, a member of the group of lawyers who filed suit on behalf of the patients, complained about the slow pace of Medtronic's action.

"As we allege in the complaint, researchers have been sounding the alarm that something was wrong with these leads. Some studies show that the Sprint Fidelis lead was more likely to fracture than earlier models. This announcement to protect patients is long past due."

In addition to money damages, the patients seek medical monitoring for all patients implanted with the leads. The lawsuit is entitled Liusi v. Medtronic, Inc. and is pending in the United States District Court for the District of Minnesota in Minneapolis, Minnesota. Judge Richard Kyle has been assigned the case. The docket number is 07-04250. Medtronic has not responded to the allegations and no court hearings have been set.

Contact Information:
Daniel Gustafson
Gustafson Gluek, PLLC
650 Northstar East
608 Second Avenue South
Minneapolis, MN 55402
(612) 333-8844
dgustafson(at)gustafsongluek.com
www.gustafsongluek.com

Hunter Shkolnik
Rheingold, Valet, Rheingold & Shkolnik
113 East 37th Street
New York, NY 10016-3042
(212) 684-1880
hshkolnik(at)rheingoldlaw.com
www.rheingoldlaw.com

Nick Drakulich
Jennings & Drakulich LLP
2002 Jimmy Durante Blvd., Suite 400
Del Mar, CA 92014
(858) 755-5887
jenndrak(at)sbcglobal.net
www.jenningsdrakulich.com

Richard J. Arsenault
Neblett, Beard & Arsenault
P.O. Box 1190
Alexandria, LA 71309-1190
(318) 487-9874
rarsenault(at)nbalawfirm.com
www.nbalawfirm.com

Elizabeth Cabraser
Wendy Fleishman
Lieff, Cabraser, Heimann & Bernstein, LLP
Embarcadero West
275 Battery Street, 30th Floor
San Francisco, CA 94111-3339
(415) 956-1000
ecabraser(at)lchb.com
WFLEISHMAN(at)lchb.com
www.lieffcabraser.com

Silvija Strikis
Kellogg, Huber, Hansen, Todd, Evans & Figel, P.L.L.C.
Sumner Square
1615 M Street, N.W., Suite 400
Washington, D.C. 20036
(202) 326-7900
sstrikis(at)khhte.com
www.khhte.com

Seth Lesser
Locks Law Firm
110 E. 55th Street
New York, NY 10022
(212) 838-3333
slesser(at)lockslawny.com
www.lockslaw.com

Source: PRWeb: Legal / Law