Three senior executives at medical scope maker Olympus Corp. repeatedly invoked their 5th Amendment right against self-incrimination when questioned recently about internal company emails dealing with its role in superbug outbreaks. The executives declined to answer questions in depositions taken in a U.S. civil case against Olympus filed by a Seattle hospital and the widow of a patient. The company emails – first reported by the Los Angeles Times and Kaiser Health News – are key evidence in several pending civil suits against Olympus. The emails also could be relevant to an ongoing federal investigation.
The emails 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 Dutch, French and U.S. hospitals. At least 35 patients in American hospitals have died since 2013 after developing infections tied to tainted Olympus duodenoscopes — flexible, lighted tubes used to peer deep inside the body. More than 25 patients and families, including the Seattle-area widow, have sued Olympus alleging wrongful death, negligence or fraud.
In addition to Nishina, the company’s chief manager for market quality administration at the Tokyo headquarters, the other two executives questioned were Hisao Yabe and Hiroki Moriyama. Yabe appears to be the highest ranking official among the three, serving as an executive officer in charge of the medical manufacturing improvement division. Moriyama is a key figure in the company’s regulatory affairs and quality assurance unit. He is listed on several company patents for endoscopes. Also, he was the manufacturer’s contact on numerous injury reports filed with U.S. regulators about scope-related infections.
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. Mrs. Bigler has sued 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. The focus of the probe was not specified. The emails could be relevant in both the civil case and the federal investigation because they show that a month after Olympus alerted European customers in January 2013 a scope it manufactured could become contaminated, the company decided not to issue a broad warning to U.S. customers.
For those who are not familiar with the procedure, duodenoscopes are threaded down a patient’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, with possibly life-threatening consequences. Although infections have been tied to scopes made by other companies, Olympus dominates the market and its scopes remain in wide use.
It would appear that Olympus in Japan knew of the dangers of the duodenoscopes not being able to be adequately disinfected, even when Olympus guidelines are followed. It appears Olympus failed to notify health care providers in the U.S. of this problem. This appears to be a very strong case. Rando Wick represents the hospital and John Gagliardi represents the Bigler family.
Source: Los Angeles Times
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