Dive Brief:

• Olympus Corp. senior executives invoked the Fifth Amendment when lawyers asked them about internal company correspondence related to the safety of their duodenoscopes in a case brought on by the federal government against the device maker over recent superbug outbreaks, Kaiser Health News reports. 
• European customers were notified in January 2013 of a decontamination problem with the scope, but a February 2013 e-mail shows that 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. The two other executives that have been deposed are Hisao Yabe and Hiroki Moriyama.
• The scopes have been linked to at least 35 deaths in American hospitals since the outbreaks began being reported in 2013.

Dive Insight:

The company’s scopes dominate the U.S. hospital market, with an 85% market share. In a previous Senate investigation, the Olympus scope had been deemed difficult to clean, a problem the company agreed to address. The scope’s design could result in antibiotic-resistant bacteria remaining on the device after cleaning and allowing these “superbugs” to travel from one patient to another.

Nevertheless, in an email advising against notifying U.S. hospitals, Nishina stated that Olympus assessed the risk as “acceptable.” Next month U.S. Olympus executives will be deposed, including Laura Storms, vice president of regulatory and clinical affairs, who had sent Nishina the email asking whether to communicate with U.S. customers regarding the scope’s safety risks.

Olympus Corp. has been sued for wrongful death, negligence or fraud by no less than 25 patients and families. But scope safety is not only legal issue plaguing the Japanese device manufacturer. Earlier this year, Olympus agreed to pay $646 million to the U.S. government in the largest-ever settlement for violations of the U.S. Anti-Kickback Statute.