Santa Clara, CAAccording to news reports from CNBC and the LA Times, contaminated Olympus duodenoscopes
are linked to the deaths of 35 people in the US. Further, the 35 people died in the years following a series of emails that show a company official told American executives not to issue widespread warnings to US hospitals "about potentially deadly infections from tainted medical scopes." LA Times
The decision to keep American hospital s in the dark was made by officials in Japan, and despite the fact that the Tokyo-based company had already issued warnings to its European customers.
It wasn’t until January 2013, when an Olympus vice president in Pennsylvania who was aware of the cases in Europe, and also aware that Olympus was investigating a similar case in a Pittsburgh hospital, asked in an email, "Should [we] also be communicating to our users the information that [Olympus Europe] is communicating to their European users?" (CNBC)
Olympus, which controls 85 percent of the American gastrointestinal scope market, had warned its European customers that a scope made by the company had a risk of contamination after two dozen infections were reported in hospitals in France and Holland, according to the joint Los Angeles Times and Kaiser Health News story that cited internal company emails.
The email reply from Olympus's chief manager for market quality administration in Tokyo, on a February 6, 2013, states "Although it is not need[ed] to communicate to all the users actively, you should communicate with the user who has asked a question" wrote the manager, Susumu Nishina. Further, Nishina's email went on to state that Olympus' "risk assessment" had indicated that that risk was "acceptable."
According to CNBC, the emails, and others cited in the article by the LA Times and Kaiser, are part of the court documents in a pending lawsuit against Olympus brought by a patient. Olympus is also under investigation by federal prosecutors in New Jersey.
The defective Olympus duodenoscopes were recalled by the company in February. Since Olympus learned of the issue, more than 140 patients in the United States have reportedly developed serious infections, mostly the deadly carbapenem-resistant Enterobacteriaceae. Prior to announcing the recall, Olympus had blamed improper hospital cleaning procedures for the outbreaks.
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