A third patient is suing Olympus Corp. of the Americas, the company that makes the specialized duodenoscopes blamed for the CRE superbug outbreak at the Ronald Reagan UCLA Medical Center that claimed the lives of 2 patients.
What’s the Problem?
Plaintiff Domingo Gomez filed the lawsuit against Olympus Corp. in Los Angeles Superior Court on March 16, alleging product liability, negligence and fraud. Gomez claims he suffered “extraordinary pain and suffering” as a result of his CRE infection.
Olympus did not seek approval for changes made to its Q180V duodenoscope because the U.S. Food & Drug Administration (FDA) didn’t require it to do so, according to a company spokesperson. However, Gomez’s lawsuit states the device maker had a legal obligation to protect the patients.
“The manufacturer must ensure that the validated reprocessing protocol is disseminated to medical facilities and professionals,” the suit states. “Olympus failed to take these critical steps with the redesigned Q180V scope.”
Instead, Olympus provided hospitals and doctors a safety cleaning protocol for an earlier generation endoscope with a “significantly different design,” according to the complaint. “As a result, end-users were not able effectively to sanitize and clean the new redesigned scope.”
FDA Panel to Discuss Endoscope Cleaning Protocol
Under pressure to strengthen oversight on infectious diseases like CRE, the FDA has formed an advisory panel in an attempt to curb the spread of bacteria via contaminated duodenoscopes. FDA’s Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee meets May 14-15 to examine the threat posed by superbugs like CRE.
“FDA is convening this committee to seek expert scientific and clinical opinion related to reprocessing of duodenoscopes and other endoscopes, as well as automated endoscope reprocessors, based on available scientific information,” the agency said.
Consumer watchdog groups have criticized the FDA’s failure to regulate devices like the Olympus duodenoscope. The agency admitted it didn’t know until late 2014 that the scope had been on the market since 2010 without being approved. It also acknowledged that Olympus and other device manufacturers twice failed to prove their duodenoscopes can be effectively cleaned to a reasonable level of safety.
How Endoscopes Got Dirty: NBC News Video
More CRE Infections Linked to Olympus Endoscope
March 31, 2015 – More patients may have been infected with the CRE superbug via contaminated Olympus endoscopes than previously thought, health officials have warned. Many feel the recent outbreaks would’ve gone unnoticed if health departments hadn’t gone the extra mile to gather samples of CRE bacteria and investigate the links. Few states have conducted such research to detect potential outbreaks.
“We suspect endoscope-associated transmission of bacteria is more common than recognized and not adequately prevented by current reprocessing guidelines,” said Kristen Wendorf, a doctor at King County’s public health department in Seattle.
Superbug Lawsuit Filed in California
May 11, 2015 – The husband of a Diamond Bar woman who died after being infected with the CRE superbug at a UCLA hospital has filed a lawsuit against Olympus Corp., alleging that a contaminated endoscope passed the bacteria during a routine medical procedure. According to the Los Angeles Times, 41-year-old Silvia Aroche “suffered significant injury and died” in January after undergoing several ERCP procedures which involved the use of an Olympus duodenoscope at the UCLA Ronald Reagan Medical Center.
Virginia Mason Joins Lawsuit Against Olympus
Virginia Mason Medical Center has joined a lawsuit against Olympus America, claiming the device maker put patients at risk by failing to disclose design flaws in endoscopes suspected of passing drug-resistant bacteria in several recent outbreaks. Richard Bigler was among those who died of a bacterial infection caused by an Olympus duodenoscope, according to a lawsuit filed by his widow Theresa. In a rare move for a hospital, Virginia Mason joined Bigler’s lawsuit on May 11.