Antonia Torres Cerda, 48, died at UCLA Ronald Reagan Medical Center after she allegedly was infected with a “superbug” bacteria transmitted into her body by medical equipment. The Fresno Bee reports that the family is now suing the equipment maker for wrongful death, negligence and fraud. Cerda’s family is asking for punitive and exemplary damages of an unspecified amount. The University of California at Los Angeles is not named in the lawsuit.
Cerda had been given a procedure for ERCP, or endoscopic retrograde cholangiopancreatography, before the transplant and a second procedure afterward, said Peter L. Kaufman, a Los Angeles lawyer who is representing Cerda’s husband, Armando Cerda, her four children and her mother. The procedures were done using a duodenoscope manufactured by Olympus Medical System Corp. of Japan and marketed and sold by Olympus Corp. of the Americas and Olympus Medical System Corp. The scopes are flexible tubes inserted down the throat into the small intestines. About 500,000 people in the U.S. undergo procedures with the scopes every year, according to the federal Food and Drug Administration.
Antonia Cerda needed the transplant because she had nonalcoholic liver cirrhosis, said her oldest daughter Cynthia, 18, a freshman at the University of California at Santa Cruz. She said her mother, who was a field worker, became ill seven or eight years ago and was on the transplant list for about five or six years. Following the transplant, her mother had started to recover but then grew ill from the infection and died. The doctors said there were no antibiotic medications that would have killed the bacteria and saved her mother.
Cerda’s is one of two patient deaths that have been connected to an antibiotic-resistant bacterial outbreak at UCLA. The outbreak is believed to have spread through the use of endoscopes. Five others were infected with the bacteria after having procedures to diagnose and treat pancreatic and bile duct problems between October and January, and UCLA notified 179 people that they may have been exposed. UCLA spokeswoman Dale Tate said seven different scopes were used at the hospital during that time but five had no sign of bacteria. “There were only two that were impacted,” she said. Both were made by Olympus.
The lawsuit alleges that Olympus failed to develop and validate an effective way to clean a redesigned Q180V Scope. Kaufman said a device manufacturer that makes and markets a reusable medical instrument has “an obligation to figure out how to clean it, and they have to prove that their cleaning method works.” Otherwise, he said, they would have to sell it as a “single-use device.” According to the lawsuit, Olympus knew the complex design of its duodenoscope “renders some part of the device extremely difficult to access” and as a result, difficult to clean. An elevator mechanism within the scope contains microscopic crevices that can’t be reached with a brush, and material can remain inside, the suit said. Olympus should have known that these “residual fluids contain microbial contamination, multiple patients would be exposed to serious risk of harm, including lethal infection,” the suit alleges.
Olympus redesigned the TJF-Q180V duodenoscope in 2014, the suit alleges, but failed to update cleaning protocols. But before the redesign, the company allegedly knew the devices were difficult to clean. In 2013, Olympus was allegedly informed of infections to patients in the state of Washington, and “at least four patients who were infected as a result of exposure to contaminated duodenoscopes died.” The suit said Olympus continued to aggressively market the devices “with conscious disregard of the extreme risks to the public of serious infection, pain, suffering and death.”
The lawsuit also includes an allegation of fraud and names three Olympus sales and marketing representatives from Southern California. The lawsuit said the three made false representations to UCLA doctors and staff between July 2014 and January 2015 about the device’s safety and risks associated with its reuse. In seeking punitive damages, the lawsuit said the family believes that Olympus “acted with ‘malice’ “.
Olympus officials did not return telephone calls or email requests from the Fresno Bee for comment.