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.
"Plaintiff has failed to allege any additional facts relating to the manufacture of the device in support of her claim," Brodie wrote, according to court documents. "This failure is fatal to plaintiff’s claim."
Burgos sued Satiety in 2009, appealing the case after it was dismissed by Judge John Gleeson in November 2010. Gleeson, however, allowed Burgos to file an amended complaint because her claim that the company violated its IDE was not preempted by federal statutes.
Burgos could not prove exactly when the TOGA device used in her surgery was destroyed, meaning she could not prove whether Satiety destroyed the device in violation of the IDE (which required the company to keep all devices used in non-commercial applications for 3 months), Brodie ruled.
Brodie also found that Burgos was made aware of the risk of esophageal tears when she signed on for the clinical trial, writing that she "signed a consent form that listed various risks of the surgery, including a tear within the esophagus."
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