Medtronic to Pay $114 Million In Settling Heart-Device Suits

-Wall Street Journal

12/21/2007 -  Medtronic Inc. said it reached a $114.1 million settlement agreement to settle lawsuits related to its Marquis line of implanted cardiac defibrillators.

The Minneapolis-based implantable biomedical device maker will settle 2,682 cases for $95.6 million as well as $18.5 million in attorneys' fees, which will be recorded as a one-time charge in its fiscal third quarter ending in January.

Medtronic said the settlement does not mean it admits liability or the validity of any defenses in the litigation.

"We are pleased to settle these cases and put the matter behind us," said Pat Mackin, senior vice president and president, Medtronic Cardiac Rhythm Disease Management. "We know the Marquis line of defibrillators continues to provide life-saving therapy for thousands of people around the world, and they remain among the most reliable ICDs ever manufactured by Medtronic."

In November 2006, a federal judge denied Medtronic's motion to dismiss more than 350 product-liability lawsuits connected to a voluntary company recall of implantable defibrillator heart devices in February 2005.

Implantable cardioverter defibrillators, or ICDs, provide shocks to stop hearts from potentially dangerous rapid beating. They treat patients at risk for sudden cardiac death, which is the leading natural cause of death in the U.S.

At issue in the product-liability suits was Medtronic's announcement in February 2005 of a potential battery shorting problem in various Marquis-brand defibrillators. The failure rate was and remains extremely low, but Medtronic voluntarily notified doctors of the issue. In the U.S., 11,000 of the machines were surgically removed and replaced with a different device, and 2,000 more such removals took place overseas. 

The FDA did not take regulatory enforcement action regarding the matter but did classify Medtronic's action as a Class II recall.

Plaintiffs in the suits against Medtronic argued that the company knew for years that there was a potential for product defects but sold its stock of potentially defective devices and didn't advise patients that safer devices were available. The company has argued that it fulfilled every obligation in terms of reporting the problem, including seeking and receiving FDA approval in 2003 to implement battery design changes.

Medtronic is the largest ICD maker. The other manufacturers include rivals Boston Scientific Corp. and St. Jude Medical Inc.. Guidant Corp., which is now a Boston Scientific unit, also had a high-profile recall.

This fall, Medtronic issued a world-wide recall of heart-defibrillator wires. That drove down sales in its core defibrillator business, which reported a 16% sales drop during its fiscal second quarter to $639 million.

Medtronic pulled the wires, or "leads," from the world-wide market, a step that affected about 235,000 patients who have the leads implanted in their chests. The Sprint Fidelis lead, used to connect defibrillators to the patient's heart, has been fracturing at a rate of 2.3% in a 30-month period, more than twice that of an older Medtronic lead, the Sprint Quattro.

If you or a loved one have had the device replaced or plan to have it replaced you may be entitled to compensation regardless if you suffered as a result of complications from surgery or the device itself. Contact the Medtronic attorneys of Ennis & Ennis today for a free confidential case evaluation. Our on staff nurse and lawyers are standing by to answer any questions you may have regarding the Medtronic pacemaker defects, a possible Medtronic class action lawsuit, or any other type of Medtronic Pacemaker litigation.