(CNBC: Published 07/25/2016, Mangan, Dan, Web)
Thirty-five people died in the United States after contracting infections from contaminated medical scopes made by Olympus Corp. in the years after a company official told American executives not to issue widespread warnings to U.S. hospitals “about potentially deadly infections from tainted medical scopes,” a new report says. That decision not to proactively issue warnings to U.S. hospitals was made despite the fact that Tokyo-based Olympus — which controls 85 percent of the American gastrointestinal scope market — was already warning 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.
An Olympus vice president in Pennsylvania in January 2013, knowing about the cases in Europe, and also knowing 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?” Olympus’s chief manager for market quality administration in Tokyo in a Feb. 6, 2013, email, replied to that query. “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, according to the email linked in the L.A. Times/Kaiser story. Nishina’s email continued, telling the American vice president that Olympus’ “risk assessment” had indicated that that risk was “acceptable.”
The story noted that in the three years after that email, at least 35 people have died in American hospitals after contracting infections from contaminated Olympus scopes. And the article said, “At the time of the safety alert in Europe, Olympus was already aware that design flaws could make it difficult to clean its duodenoscope for the next patient. Used in about 700,000 procedures annually in the U.S., the snake-like device is put down a patient’s throat to diagnose and treat problems in the digestive tract such as cancers and blockages in the bile duct.”
Olympus only announced a U.S. recall of its duodenoscopes, which is expected to be completed by next month, this past January.
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From the desk of Adam K. Levin, Esquire.