http://www.yourlawyer.com/topics/overview/Lifesite_dialysis Sat, 21 Nov 2009 05:45:49 -0800 pixel-app en http://www.yourlawyer.com/articles/read/10408 Wed, 26 Jun 2002 00:00:00 -0700 http://www.yourlawyer.com/articles/read/10408
The suit asserts claims arising out of Vasca’s sale of the LifeSite System, including claims based on matters raised in an FDA Warning Letter issued to the company in November 2001.

The November 2001 Warning Letter includes issues on the complaint handling system and the timing of reported product complaints to the FDA. Many of these complaints were related to clinical issues seen with end stage renal disease patients and not to the LifeSite System.

Vasca has been working with the FDA, and the FDA has indicated that the company has taken appropriate corrective actions to address the concerns raised in the Warning Letter.

"We are continuing our review of this suit and will vigorously and confidently defend against the claims, particularly any allegation that questions the safety and efficacy of our product," said William "Mo" Cowan, counsel for Vasca.]]> http://www.yourlawyer.com/topics/overview/Lifesite_dialysis Wed, 26 Jun 2002 00:00:00 -0700 http://www.yourlawyer.com/topics/overview/Lifesite_dialysis Lifesite Dialysis A kidney dialysis device made by Vasca Inc. has been the subject of 129 complaints involving death or injuries since it went on the market in 1998, federal regulators say. In a letter sent to the Tewksbury-based company on Nov. 29, the Food and Drug Administration accused the company of reporting some incidents late and not investigating some deaths properly, The Patriot Ledger reported Thursday.

The device, LifeSite, is implanted under the skin and connects a dialysis machine to the patients blood vessels so the machine can remove wastes from the blood and return cleaned blood to the patient. LifeSite reduced including infection and blood clots side effects that are associated with dialysis, the company said. But in its letter, the FDA said it found 129 complaints in the company's files involving deaths or serious injuries. Thomas Glover, president of Vasca, said patients eligible to use the device are extremely ill.

But in 20 cases, FDA investigators ``found information to reasonably suggest'' the device ``may have caused or contributed to a death or injury'' or that the device malfunctioned in a way that could hurt a patient if the problem recurred, the letter said.

The company filed 14 of the 20 reports with the FDA after a 30-day time limit and did not file six reports at all, the FDA said. The letter, which was posted on the FDA's Web site, warned that the agency will take regulatory action if the company doesn't address the problems.

Glover said the company has responded to the letter and is in discussions with the FDA. He said the paperwork problems came from a misunderstanding of agency regulations. "There were things that we didn't think had to be reported,'' he said. ``So some of our reports were late.'' About 3,000 patients in the United States have used LifeSite since the FDA approved it last year, Glover said. The device was approved in Canada in 1999 and in Europe in 1998.

If you or a loved one suffered injuries from a Lifesite dialysis machine, please fill out the form at the right for a free case evaluation by a qualified defective medical device attorney.]]>