Grilled About “Superbug” Outbreaks, Olympus Execs Take the Fifth

Duodenoscope maker on hot seat for patient deaths

Three senior executives at scope manufacturer Olympus Corp., which is under federal investigation for its role in “superbug” outbreaks, repeatedly invoked their Fifth Amendment right against self-incrimination when questioned recently about internal company emails, according to a report from Kaiser Health News (KHN). The Tokyo executives declined to answer questions about the correspondence during two days of depositions in a civil case against Olympus.

The company emails, first reported by KHN and the Los Angeles Times, are key evidence in several pending civil suits against Olympus and could be relevant to the ongoing federal probe. They show that Susumu Nishina, one of the three executives deposed, told the company’s U.S. managers in February 2013 not to issue a broad warning to American hospitals despite reports of scope-related infections in U.S., Dutch, and French facilities.

At least 35 patients in U.S. hospitals have died since 2013 after developing infections linked to tainted Olympus duodenoscopes. More than 25 patients and their families have sued Olympus for wrongful death, negligence, or fraud.

The three executives were recently deposed at the U.S. Embassy in Tokyo by lawyers representing Virginia Mason Medical Center in Seattle, Washington, 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 is 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. He did not specify the focus of the probe.

The emails could figure in both the civil case and the federal investigation because they show that one 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 February 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.”

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

Source: Kaiser Health News; December 19, 2016.