(Reuters) — A Washington state woman filed a lawsuit against a hospital and Olympus (TYO:7733), claiming her husband died from a drug-resistant “superbug” he contracted from a contaminated endoscope, her lawyer said yesterday.
Theresa Bigler is seeking unspecified monetary damages for the death of her husband Richard Bigler, 57, who died in 2013 after a battle with pancreatic cancer. Bigler’s attorney, Joel Cunningham, said his death certificate also lists a drug-resistant form of E. coli bacteria as contributing to his demise.
Bigler was among 31 people infected in an outbreak at Seattle’s Virginia Mason Medical Center between 2012 and 2014 that was spread through medical devices called duodenoscopes that the hospital said harbor the germs even after being cleaned to manufacturer and federal guidelines.
Bigler’s lawsuit says Olympus America has known its product was unsafe but failed to act.
“For several years, Olympus America has known that its instructions for cleaning its duodenoscopes were ineffective and had resulted in severe infections and deaths,” the complaint reads.
The lawsuit, filed in King County Superior Court, said Virginia Mason Medical Center did not know of the hazards linked to the scopes, but was negligent in not informing infected patients after the E. coli outbreak was pinpointed.
Eleven of those people eventually died. All were critically ill when they were infected, and it was unclear if the bacterial infection contributed to their deaths, Seattle public health officials said.
A top Los Angeles hospital, Cedars-Sinai Medical Center, said this week that 4 patients had been infected with bacteria from a contaminated scope and 67 more were at risk, weeks after UCLA Ronald Reagan hospital reported 7 patients were similarly infected and scores more potentially exposed.
Across the country in Connecticut, Hartford Hospital has also reported a similar outbreak involving at least five infections and more than 280 potential exposures.
Between 2013 and 2014, the FDA said it received reports of 135 possible microbial transmission from reprocessed duodenoscopes. The federal safety watchdog has been under pressure to review current protocol of sterilizing the instruments after a string of superbug outbreaks at hospitals across the country.
Although the FDA this week said Olympus put its TJF-Q180V duodenoscope on the market without the agency’s clearance, Olympus claimed that, based on the FDA’s policy, a modified version of its previously approved scope did not require a new marketing approval. The rebuttal pushed Olympus shares to a 1-week high of ¥4,415, a 5.8% gain as of the Tokyo market’s close today.
Top makers of the devices include Olympus, Fujifilm Holdings (TSE:4901) and Hoya Corp.‘s (TYO:7741) Pentax subsidiary. Neither Olympus America nor Virginia Mason responded to requests for comment about the lawsuit.