Lawsuit originate from Vasca’s sale of the LifeSite System. Vasca, Inc., the developer, manufacturer and marketer of the LifeSite® Hemodialysis Access System, announced today that it has been named in a lawsuit filed in California on behalf of a LifeSite patient.
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
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.