Problems Continue To Plague Scope Manufacturers As Execs Plead The Fifth In Court
By Christine Kern, contributing writer
Japanese senior executives refuse to answer questions about internal correspondence.
When lawyers asked Olympus Corp. senior executives about internal company correspondence regarding the safety of their duodenoscopes in a civil case over recent superbug outbreaks, they invoked the Fifth Amendment. Olympus is under federal investigation for its role in the outbreaks.
The internal emails are considered key evidence in several pending litigations against Olympus and could also be significant in the ongoing federal investigation. Kaiser Health News and the Los Angeles Times first reported on the emails, which demonstrated Susumu Nishina told U.S. company managers there was no need to warn U.S. hospitals and healthcare providers about possible scope-related infections that had broken out in other hospitals.
The three Olympus officials were deposed in Tokyo, at the U.S. Embassy, by lawyers representing Virginia Mason Medical Center in Seattle and Theresa Bigler, whose husband Richard died in 2013 after being infected by a contaminated Olympus scope.
In February of 2015, the FDA issued a warning duodenoscopes are difficult to clean, even when healthcare workers follow the manufacturers’ own care instructions. In March, the FDA issued a list of final recommendations for the cleaning and sterilization of such scopes, as Health IT Outcomes reported.
Then, in October of 2015, the FDA ordered manufacturers of endoscopic devices to conduct post-market studies of their devices in healthcare facilities following a rash of outbreaks of life-threatening infections. At the heart of the investigations are the methods by which the scopes and cleaned and prepped for re-use in actual healthcare settings.
Olympus agreed to a voluntary recall and redesign of the scopes to correct the problem, but problems continued to plague the medical scopes.
A January 18 report blame manufacturers, hospitals, and the FDA for infections involving at least 250 individuals worldwide since 2012, including dozens of deaths. The report, from Senator Patty Murray, demonstrates there are systemic weaknesses in the FDA approach to protecting the public from potentially harmful medical technology, according to Insurance Journal.
It turns out European customers were notified in January of 2013 of a decontamination problem with the scope, but a February 2013 e-mail shows Susumu Nishina, chief manager at the company’s regulatory and quality assurance department, told a U.S. executive it was not necessary to issue a similar alert to American hospitals.
In an email on Jan. 31, 2013, vice president of regulatory and clinical affairs in Center Valley, PA Laura Storms asked Nishina at Japan headquarters about warning U.S. hospitals asking, “Should [we] also be communicating to our [U.S.] users the information that [Olympus Europe] is communicating to their European users?
In a Feb. 6, 2013 response, 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.”
After receiving the reply from Nishina, Storms wrote to Shapiro: “Donny, [Olympus Japan] has determined that a global communication is not required.”
Two other Olympus executives, Hisao Yabe and Hiroki Moriyama, have also been deposed. The scopes have been linked to at least 35 deaths in American hospitals since the outbreaks began being reported in 2013.