The family of Antonia Torres Cerda hoped the liver transplant she received in October would let her return home and resume her life as a mother of four and wife of a hard-working husband.
Instead, it cost her life.
Cerda, 48, died Nov. 8 at UCLA Ronald Reagan Medical Center after she allegedly was infected with a “superbug” bacteria transmitted into her body by medical equipment.
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, Ramona Vargas Martinez. 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, Cynthia said. About three weeks after the transplant, she said, her father urged her to come to the hospital because her mother had become very ill. That was Halloween weekend. About a week later, Antonia Cerda died.
When a doctor called later to tell the family how her mother had gotten the superbug, Cynthia was home and took the call.
“They said the company gave them equipment that had bacteria on it,” she said. “For me, it was heartbreaking.”
The doctors said there were no antibiotic medications that would have killed the bacteria and saved her mother, she said. The University of California at Los Angeles is not named in the lawsuit, and on Wednesday a UCLA Health Sciences spokeswoman said the university could not confirm Cerda was a patient because of confidentiality.
Antonia Cerda was buried in Pénjamo in the Mexico state of Guanajuato. Family and friends donated money for burial.
Now Armando Cerda, a field worker who is employed by J.G. Boswell in the winter and works for a farm labor contractor in spring and summer, is caring for three of the couple’s children — Yenifer, 17, a senior at Corcoran High, Joanna, 13, a seventh-grader at John Muir Middle School, and Jessica, 7, a second-grader at John C. Fremont Elementary.
“It’s hard,” he said Wednesday from the family home in Corcoran. “I have to be father and mother — it’s overwhelming. It’s hard to cope with the idea she’s gone.”
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.
Cerda’s lawsuit says Olympus failed to develop and validate an effective way to clean a redesigned Q180V Scope.
Olympus officials did not return telephone calls or email requests for comment.
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 said.
Olympus redesigned the TJF-Q180V duodenoscope in 2014, the suit said, but failed to update cleaning protocols. But before the redesign, the company knew the devices were difficult to clean, the suit said. In 2013, Olympus was 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.
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’ ”.
The Cerdas are a close family, Kaufman said. “They fully expected her to pull through” from the liver transplant, he said. “This is an unspeakable tragedy for them.”