↑ Grab this Headline Animator

Class Action Filed Against Medtronic For Faulty Leads

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.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.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.khhte.com

Seth Lesser

Locks Law Firm

110 E. 55th Street

New York, NY 10022

(212) 838-3333

slesser(at)lockslawny.com

↑ Grab this Headline Animator

---

This article has been robotically scanned and tagged by Prnewsnow with the following search tags. No human manipulation of these tags take place.
| Aquarium | Vancouver Aquarium | forward looking statements |

---

4902 readers online...

, Local News