Medtronic Heart Lead Recall -
News Articles

News Articles on the Medtronic Heart Lead Recall

August 17, 2009

Minneapolis Star-Tribune, "On mission to sue med-tech makers"

As Michele Meyer navigated the hallways of Congress earlier this month, meeting lawmakers and telling her story, she felt as though her daughter Katie was beside her, urging her on. "She would have been right there," said Meyer, of Cambridge, Minn. "She was very outgoing, exuberant, true to herself and her own beliefs." But Katie, 30, died in 2008 after surgery to remove a heart defibrillator wire made by Medtronic Inc. that had been recalled for safety reasons. More...

August 11, 2009

New Jersey Courier News, "Belle Mead woman pitches Medical Device Safety Act to Congress"

Several years ago, Jan Beadling received a defibrillator as a "safety net" in case her heart stopped. Everything seemed fine until New Year's Eve 2007. On what was supposed to be a celebratory night, Jan's husband, Walt, gave her a kiss on her cheek. Without warning, she jumped, having felt some sort of an electric shock course through her body. Something was not right, and doctors later confirmed that the defibrillator lead had fractured and needed to be replaced. More...

August 4, 2009

Des Moines Register, "Iowan to testify on medical device lawsuits"

An Iowan with a harrowing story to tell is scheduled to testify today on Capitol Hill as a U.S. Senate committee discusses manufacturers' liability when medical devices fail. Mike Mulvihill, 64, of Bettendorf was driving through Ohio en route to the East Coast two years ago when his internal defibrillator went off repeatedly. The jolts of electricity into his chest were excruciating, making it difficult for him to guide his car - with his wife alongside him - through a construction zone and to the shoulder. More...

August 4, 2009

Quad City Times, "Bettendorf man testifies in Washington about medical device failure"

Two years ago, Michael Mulvihill was driving through a construction zone in western Ohio when he saw a blue flash and felt a jolt. At first, the Bettendorf man said, he thought that he had hit something in the road. Instead, he said, it was something in his chest - the defibrillator that had been implanted a little more than a year earlier for an irregular heart beat and pulse rate. "I was scared to death," Mulvihill said. Twenty-two times over nearly the next hour, he said, the defibrillator shocked him, sending spasms of pain through his body. More...

August 4, 2009

Talk Radio News, "Families Harmed By Faulty Medical Devices Demand Justice"

A number of a families adversely affected by malfunctioning medical equipment gathered on Capitol Hill Tuesday to voice their support for the Medical Device Safety Act, a bill that would allow consumers to file lawsuits against their devices' manufacturers. "I think it's important that this bill is passed. There is a major injustice in the situation," said Mike Collins of Georgetown, Texas during a press conference. Collins, who is afflicted with the heart condition hypertrophic cardiomyopathy, received six improper shocks from an implanted defibrillator in 2007. More...

August 2, 2009

Northwest Herald, "McHenry family takes dispute to U.S. Senate"

Molly DeGroh had never heard her daughter scream so loudly, so intensely before. "She told me that the monsters were attacking her," DeGroh said. "I grabbed her to hug her, and I could feel all the electricity jolting back and forth, cycling through her body." About 10 months before, when she was 2½ years old, Avery had a defibrillator implanted to correct a hereditary disorder called Long QT Syndrome. DeGroh has the same condition, as does her 2-year-old son, Oliver, who also will need a defibrillator. More...

April 6, 2009

New York Times, "Removing Medtronic Heart Cables Is Hard Choice"

Consider the Sprint Fidelis, a heart defibrillator cable. In 2007 its maker, Medtronic, stopped selling it after five patients who had the cables died. More...

April 2, 2009

National Law Journal, "In wake of high court's 'Wyeth' ruling, legal groups throw support behind Medical Device Safety Act"

Several legal groups, including the American Bar Association, are voicing their support for passage of the Medical Device Safety Act of 2009, which was introduced on March 5 in the wake of the U.S. Supreme Court's decision in Wyeth v. Levine, No. 06-1249. Last year, the Supreme Court found that products liability claims against medical device manufacturer Medtronic were pre-empted by the Medical Device Amendments to the federal Food, Drug and Cosmetic Act. Riegel v. Medtronic, 128 S. Ct. 999 (2008). But on March 4, the Supreme Court ruled that federal law governing warnings on prescription drug labels does not pre-empt state claims asserting that pharmaceutical companies failed to warn of risks associated with the medication. More...

March 17, 2009

New York Times Supports Rights of Patients to Sue Makers of Defective Medical Devices

On March 15, 2009, the New York Times ran an editorial supporting the idea that patients victimized by defective medical devices should have their rights to sue manufacturers restored. These historical rights were invalidated last year when the U.S. Supreme Court ruled that device makers could not be sued for damages in state courts if the device was approved by the F.D.A. More...

March 9, 2009

New York Times, "Medtronic Links 13 Deaths to Faulty Heart Device"

Medtronic said Friday that at least 13 people might have died in connection with a heart device that it recalled in 2007 but was still in widespread use, including four patients whose deaths were related to efforts by doctors to surgically remove the product. The new data reflect the first fatality update by Medtronic since October 2007, when it recalled the device - a thin electrical cable that connects an implanted defibrillator to a patient's heart. The company cited five deaths when it recalled the product, saying fractures in the cable could cause a defibrillator to fail to deliver a lifesaving shock to an erratically beating heart, or to fire for no reason. More...

February 23, 2009

New York Times, "Study Finds More Failure of Heart Device"

A widely used heart device recalled two years ago by Medtronic may be failing in patients at a rate significantly higher than previously known, a new report by two prominent cardiac specialists indicated. The Medtronic device, known as the Sprint Fidelis lead, is an electrical cable that connects an implanted defibrillator to a patient's heart. More...

February 22, 2009

New York Times, "Medical Device Ruling Redraws Lines on Lawsuits"

The Supreme Court's decision Wednesday protecting many types of medical device makers from personal injury lawsuits began rippling through the courts and law offices almost immediately. Hours after the decision in the case, Riegel v. Medtronic, was announced, lawyers involved in a group of Florida state court cases related to Johnson & Johnson’s drug-coated Cypher heart stent received an e-mail message from Judge Mary Barzee Flores asking for briefs on whether the lawsuits should be allowed to continue. More...

February 21, 2009

New York Times, "Justices Shield Medical Devices From Lawsuits"

Makers of medical devices like implantable defibrillators or breast implants are immune from liability for personal injuries as long as the Food and Drug Administration approved the device before it was marketed and it meets the agency's specifications, the Supreme Court ruled on Wednesday. The 8-to-1 decision was a victory for the Bush administration, which for years has sought broad authority to pre-empt tougher state regulation. More...

February 20, 2009

New York Times, "Lawmakers Seek to Return Right to Sue Device Makers"

On the same day last month that a federal judge in St. Paul threw out hundreds of lawsuits against the maker of a faulty heart device, a man entered a nearby hospital to have one of those flawed products surgically removed. The risky operation went terribly wrong. As doctors extracted the device, a thin electronic cable, from the patient's heart, a vessel was punctured, causing extensive bleeding. The 33-year-old patient, Mark Turnidge, died two days later, leaving behind a wife and two young sons. More...

January 8, 2009

"District Court Finds Statute Grants Manufacturer Total Immunity For Producing Medical Devices"

On January 5, 2009, U.S. District Court Judge Richard H. Kyle Court found that under the Medical Device Amendments to the Federal Food, Drug and Cosmetic Act, the Food and Drug Administration has exclusive authority to make all decisions as to the safety and effectiveness of medical devices. The Court concluded that Medtronic, Inc., is completely shielded from having to account for severe injuries suffered by patients who received its Sprint Fidelis heart lead, and dismissed all actions against Medtronic. Plaintiffs' Counsel believe the Court erroneously interpreted federal law and intends to file a motion for reconsideration and seek other relief.

January 3, 2008

Inside Bay Area.com, "Fremont man sues medical firm; Class-action lawsuit could affect thousands of Californians"

A Fremont man has filed a class-action lawsuit against Medtronic Inc., a Minnesota-based medical technology company whose defibrillator wires for heart patients were recalled in October. In a complaint filed in a San Francisco federal court late last month, plaintiff Rashid Hunter alleged that four types of wires, or leads, sold under the Sprint Fidelis label were prone to bending or kinking.

The New York Times, "Medtronic Patients Wonder Whether to Replace a Wire That Might Fail"

For one heart patient, there will be no more agonizing over whether the implanted device meant to save his life might kill him instead. On Tuesday, two months after Medtronic warned doctors and nearly a quarter-million patients that a wire, or lead, connecting their electronic defibrillators to their hearts might break, the 48-year-old patient had the lead and defibrillator removed and replaced. It required a painstaking 90-minute operation here at Morristown Memorial Hospital. More...

October 30, 2007

News Inferno.com, "Defective Medtronic Sprint Fidelis Lead Fracture Reports Ignored by Company, FDA for Months Prior to Recall"

Medtronic Inc. knew that its Sprint Fidelis Defibrillator Leads were fracturing at higher-than-usual rates for months. Yet, the company appears to have dragged its feet in getting the defective Sprint Fidelis Lead off the market. Medtronic even went so far as to blame physicians for the problems, claiming that they weren't implanting the defective Sprint Fidelis Lead properly. What's even worse, the Food & Drug Administration (FDA), which never required the defective medical device to undergo clinical testing, was oblivious to the increasing reports of Sprint Fidelis Lead problems. More...

October 30, 2007

Law & Settlements.com, "Patients Concerned about Medtronic Sprint Fidelis Leads"

Patients who have been implanted with [Medtronic Sprint Fidelis Leads] are understandably concerned after learning that the leads have been linked to five fatalities. Some patients have undergone risky surgeries in order to have the leads removed after they malfunctioned. Meanwhile, [lawsuits] have been filed on behalf of patients who were injured by fractured leads. More...

Southeast Texas Record, "On heels of class action, Medtronic sued for civil theft"

In the midst of a recent Minnesota class action lawsuit over faulty defibrillator wires, Medtronic, Inc. is facing allegations in Texas that include civil theft of a previously implanted Medtronic device. Fort Worth residents, David and Elisha Kuhn filed suit on Oct. 19 against Medtronic in the Marshall Division of the Eastern District of Texas. More...

Associated Press, "Device Woes Said Reported Before Recall"

Hundreds of injuries linked to a brand of heart defibrillator wires were reported to the government by last winter, a consumer advocate said Tuesday in asking why the wires weren't recalled until this week. Medtronic Inc. pulled its Sprint Fidelis defibrillation wires off the market Monday, after identifying five patient deaths in which broken wires may have played a role. More...

October 16, 2007

Associated Press, "Medtronic Sued Over Recalled Heart Device"

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. More...

Associated Press, "Medtronic Recall: Medtronic sued for Faulty Lead"

Recalls had already battered the heart device industry when Medtronic warned doctors that the wires connecting a patient's heart to its implantable defibrillators break too often. Medtronic told doctors to stop using the Sprint Fidelis wires after linking five deaths to breaks in them. The company said the Fidelis wires failed slightly more often than the thicker wires they were meant to replace. More...