News tagged with 'Medtronic'

Two years after the Riegel decision by the U.S. Supreme Court, patients injured by medical devices still have no recourse in the court to hold the device maker accountable. The Riegel decision applies to medical devices that undergo FDA approval, many do not.

Medtronic has received a warning letter from the FDA about problems at its Mounds View, Minnesota facility where heart implants are made. This is the latest in a long line of problems found with the company's medical devices.

A review of the process that fast-tracks medical devices into the marketplace without a safety review will be undertaken by the Institute of Medicine. The review will take two years, long overdue say patients hurt by devices that have been fast-tracked.

Universities are often not told about the money their academics receive from device makers as consultants and product developers.

Two major shakeups at the Food and Drug Administration may be signs of how the agency is remaking itself to become more pro-consumer and less friendly to the industries it tries to regulate.

Dr. Tim Kuklo made $800,000 from medical device maker, Medtronic, for work as a consultant and during the time he shopped a professional article on a Medtronic product for publishing. The Army says the article was "falsified" by Kuklo, who is no longer an Army surgeon. 

A former surgeon at Walter Reed Army Medical Center made false claims about the Infuse bone-growth product sold by Medtronic Inc., a U.S. medical device maker.

President Obama will have an opportunity to shape future decisions from the highest court in the land.  Supreme Court Justice David Souter is retiring in June. Souter is one of the more liberal leaning justices and sided with the majority in the case of Diana Levine v. Wyeth and with the majority in the case of Riegel v. Medtronic, both tests of federal preemption.

After more than 30 years, the FDA is pushing to require that manufacturers of 27 medical devices, used to replace hips or make hearts beat, prove they  are safe. 

If you assumed that a medical device that's implanted to help hold up internal organs passed some safety review by the FDA, you'd be wrong.  Synthetic surgical mesh was approved for marketing only. Some in the medical profession suspect there's a problem - some women and men know there is.  

National Voices  - For years, Texas District Judge Michael Schattman sat on the bench in Fort Worth listening to product liability and personal injury cases.  Now he is a medical device injury victim who feels the Riegel decision prevents Americans from exercising an American right. 

Medtronic Sprint Fidelis Defibrillator Lead is implicated in more deaths than previously reported, admits the company.  That updated count was released after a federal judge dismissed about 700 cases against Medtronic citing the Riegel decision affirming federal preemption and a shield for device makers.

Lawmakers heard from those injured by medical devices in Washington, as a film and rally was held in support of the Medical Device Safety Act, currently before Congress. It would lift the shield devicemakers currently have from lawsuits. 

A federal judge, dismissed several lawsuits on behalf of thousands of patients with Medtronic heart-defibrillator wires citing a February decision that federal law “preempts” product-liability lawsuits under state law, effectively precluding such cases.

Two former employees of Medtronic Inc. have filed a whistle-blower lawsuit against the company, alleging it paid spine doctors to use a bone graft product in a way not yet approved by the FDA.