News tagged with 'Riegel'

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, with a history of defective heart products, has had a catheter-placed heart valve approved by the FDA on humanitarian grounds because it will be used by fewer than 4,000 patients annually.

Two separate studies find that the approval of medical devices is not as rigorous as that of many drugs, especially dangerous considering many medical devices are implanted.

The FDA issues a recall notice for the ev3 catheter, but the company says it has collected all defective medical devices. Meanwhile, consumers injured or their survivors still cannot pursue litigation under the existing U.S. Supreme Court Riegel decision.

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.

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.

About 13 million American women experience stress urinary incontinence and the Ethicon TVT vaginal mesh is the gold standard for treatment. While the company reports an 84 to 95 percent success rate, doctors who deal with mesh complications say the number of problems appear to be vastly underreported and a national registry is needed now. 

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.