Grilled About Deadly Superbug Outbreaks, Execs At Scope Maker Olympus Takes Fifth

Moriyama is a key figure in the company’s regulatory affairs and quality assurance unit. He’s listed on several company patents for endoscopes. And he was the manufacturer’s contact on numerous injury reports filed with U.S. regulators about scope-related infections.Nishina fielded numerous emails containing questions from Olympus executives in the U.S. and helped shape their response to infections at American hospitals. Yabe and Moriyama were included on some of those emails, court documents show.

The three executives were recently deposed at the U.S. Embassy in Tokyo by lawyers representing Virginia Mason Medical Center in Seattle and Theresa Bigler. Her 57-year-old husband, Richard, died in 2013 after he was infected by a contaminated Olympus scope, according to the family’s lawsuit in King County Superior Court in Washington. Bigler is suing Olympus for wrongful death and seeking damages.

The separate federal investigation into Olympus surfaced in March 2015, when the company said it received a subpoena from investigators that “seeks information relating to duodenoscopes that Olympus manufactures and sells.”

A year later, in March 2016, Paul Fishman, the U.S. Attorney for the District of New Jersey, said the scope-related investigation was continuing. The focus of the probe was not specified, and a spokesman for the U.S. attorney’s office declined to comment further for this story.

The emails could figure in both the civil case and federal investigation because they show that a month after Olympus alerted European customers in January 2013 that a scope it manufactured could become contaminated it decided not to broadly warn U.S. customers.

In a Feb. 6, 2013 response to a question from a U.S. Olympus executive about whether American hospitals should be warned, Nishina replied it is “not need[ed] to communicate to all the users actively,” because a company assessment of the risk to patients found it to be “acceptable.”

Nishina said, however, that a U.S. executive could respond to inquiries from a customer. Nishina, Yabe and Moriyama didn’t respond to requests for comment sent through their lawyers.

Olympus said it doesn’t comment on pending litigation. Previously, the company has said that patient safety is a top priority and it’s working with the proper authorities to address any scope-related issues. The company recalled its duodenoscopes in January and did repairs over several months to reduce the risk of infection.

Duodenoscopes are threaded down a person’s throat to diagnose and treat digestive tract problems such as gallstones, cancers and bile duct blockages. The tip of the snake-like device has proven difficult to clean even when following the manufacturer’s instructions, and antibiotic-resistant bacteria known as superbugs can spread from one patient to another.

Although infections have been tied to scopes made by other companies, Olympus dominates the market and its scopes remain in wide use.

In California, Ronald Reagan UCLA Medical Center and Cedars-Sinai Medical Center in Los Angeles, as well as Huntington Memorial Hospital in Pasadena, have reported infections linked to Olympus scopes.