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Olympus Duodenoscopes: Failure to Warn “Disturbing”

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Seattle, WAMere days after the Los Angeles Times detailed allegations that endoscope manufacturer Olympus Corp. instructed its US executives to keep mum about endoscope-related infections, Representative Ted Lieu (D-Torrance) was renewing his push for the US Congress to get tough with medical device warnings. Plaintiffs, in the meantime, remain embroiled in endoscope infection lawsuits.

Endoscopes have long been suspected in superbug outbreaks in hospitals – especially duodenoscopes, complicated and intricate devices that are difficult to clean and thoroughly disinfect, even after procedures are followed to the letter. Numerous endoscope lawsuits have alleged design flaws in medical devices that promote the passage of infection from one patient, to another.

No fewer than 35 patients laid up in US hospitals have lost their lives in the three years since 2013 due to infection tied to unclean duodenoscopes, according to the Los Angeles Times (07/27/16).

“Olympus’ actions in this case were despicable,” Lieu said. “They knowingly failed to warn hospitals and patients of their defective scopes.”

Olympus, one of the largest manufacturers of endoscopes in the world, is accused of issuing emails in early 2013 that effectively muzzled and muted any opportunity to warn US hospitals about the possibility of infection. The Los Angeles Times identified email correspondence from a senior executive at the Tokyo headquarters of Olympus. It is alleged the senior executive, in emails sent to US-based Olympus managers in February, 2013, instructed recipients against issuing any kind of a broad warning to hospitals in the US with regard to endoscopic infections.

While managers were told they could, indeed respond to questions from a customer when asked, managers were told to keep mum otherwise. This, the Los Angeles Times reported, in spite of reports detailing endoscope and duodenoscope infections in US hospitals as well as facilities in Holland and France.

It was also reported that while Olympus issued a warning to European hospitals in January, 2013 – it waited two years before issuing any kind of similar warning to US hospitals.

Lieu, in July, called the revelation “despicable” and “incredibly disturbing.

“This is why Congress needs to act and pass legislation to make sure this doesn't happen again as well as hold a hearing,” Lieu said. “I believe it is now time for the decision-makers at Olympus to be held accountable and for Congress to hear what they have to say.

“Olympus’ actions in this case were despicable,” Lieu said. “They knowingly failed to warn hospitals and patients of their defective scopes.”

The fallout from Olympus’ Tokyo-based decision to fail to warn, translated to heartbreak for 18 families, and a serious situation for Seattle’s Virginia Mason Medical Center. Not long after the issuance of emails to US Olympus managers instructing against any proactive efforts with regard to a warning, Virginia Mason Medical Center discovered that a serious outbreak at the facility involved contaminated gastrointestinal scopes manufactured by Olympus.

Of 39 patients infected, 18 did not survive. Many an endoscopic infection lawsuit followed.

“We are very troubled by the now very clear facts that Olympus in Japan knew of the infection problems with their duodenoscopes long before the outbreaks we saw in America, and chose not to warn physicians,” said Dr. Andrew Ross, section chief of gastroenterology at Virginia Mason Medical Center.

“If they had done so, physicians could then determine what is best in how to treat and advise their patients,” Ross said.

The Los Angeles Times reports that Virginia Mason has launched a surgical infection lawsuit against Olympus, alleging fraud and misrepresentation.

Representative Lieu is pushing to have manufacturers notify the US Food and Drug Administration (FDA) when any safety warning is issued outside the US. He also wants manufacturers to notify the FDA of any change in device design or cleaning protocol, regardless of whether, or not the changes require government approval to implement.

The Device Act, a bill filed by Lieu this past April, would help to bring about these changes. The legislation, however, comes too late for the Seattle 18 victims felled by endoscope infection – or their families and various hospitals pursuing an endoscope negligence lawsuit.


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