Heart patients sue Medtronic over recalled device

A cardiac defibrillator manufactured by Medtronic.
Photo courtesy of Medtronic

(AP) - A man who claims he received 47 unneeded jolts from his implanted defibrillator is suing Medtronic over the broken wires the company is recalling.

Plaintiffs Leonard Stavish and Kelly Luisi seek class-action status in U.S. District Court in Minneapolis as representatives of people they say were hurt.

The lawsuit's allegations include emotional distress and negligence, and it seeks restitution, disgorgement of profits, and punitive damages.

Medtronic Inc., maker of pacemakers and other heart devices, has acknowledged that wires connecting its implantable defibrillators to patient hearts break more often than it expected. It said five deaths may be linked to the broken wires. Medtronic said some 235,000 people have the Sprint Fidelis lead wires.

"We would expect the litigation floodgates to open over the current recall."

Medtronic spokesman Rob Clark did not immediately return a phone message seeking comment.

Attorneys for Stavish claim his defibrillator had to be removed because he got 47 jolts he didn't need. They said the device was replaced with another defibrillator and a new set of Sprint Fidelis wires.

The lawsuit also said Luisi went to the emergency room after experiencing "frightening episodes of unnecessary shocks."

At the hospital, Luisi's defibrillator "began delivering unnecessary shocks over and over again," after someone from Fridley-based Medtronic used an instrument to check her device, according to the lawsuit. The lead was removed a month later.

Removing the leads can be dangerous because it may tear at scar tissue that builds up around the wires. The lawsuit said Luisi was forced to have her lead removed, "scarring her already fragile heart, and forcing her to undergo additional and unnecessary complicated surgery."

Hunter J. Shkolnik, an attorney for Stavish and Luisi, said they decided on Friday to file the lawsuit, and he said he has 25 more clients who will sue in coming days as their complaints are written up. He said he believes Medtronic disclosed the lead problems late Sunday because it knew the lawsuits were on the way.

Medtronic spokesman Rob Clark said the company did not have any immediate comment on the lawsuit. He denied the lawsuit affected the timing of Medtronic's disclosure.

"We made our decision and we moved forward based on our concern for patient safety, and our commitment to patient well-being," he said.

Carol Levenson, an analyst at Gimme Credit, wrote in a note on Tuesday that a 2005 Medtronic recall over defibrillator battery failures, which Levenson said was less severe than the new one, brought more than 1,000 personal injury cases.

"We would expect the litigation floodgates to open over the current recall as well," she wrote.

(Copyright 2007 by The Associated Press. All Rights Reserved.)

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