A New York federal judge rules that plaintiff Lucia Burgos fails to prove that her torn esophagus was caused by negligence by Satiety Inc.'s transoral gastroplasty stapling system.
Satiety Inc. can put a 4-year personal injury lawsuit in its rearview mirror now that the case has been dismissed by a federal judge.
The plaintiff, Lucia Burgos, failed to prove that the Palo Alto, Calif.-based medical device company's stomach stapling device violated the protocols of its investigational device exemption from the FDA.
Burgos suffered a torn esophagus while enrolled in a clinical trial in November 2008 for Satiety's transoral gastroplasty stapling system. Judge Margo Brodie of the U.S. District Court for Eastern New York ruled that Burgos couldn't prove that Satiety violated the terms of its IDE.