By George Bao Aug. 30, 2016
LOS ANGELES – U.S. Congressman Ted W. Lieu (D | Los Angeles County) has urged the U.S. State Department to request that Japanese authorities investigate and prosecute Olympus for civil or criminal misconduct in their mishandling of antibiotic-resistant bacteria infections caused by their medical devices.
Lieu sent a letter to U.S. Secretary of State John Kerry, asking the U.S. State Department to put pressure on the Japanese Government to investigate the case, Lieu’s office announced Tuesday.
“Reports indicate that Japanese device company Olympus Corp. knowingly failed to alert and warn American hospitals, doctors and patients about its defective medical scope, the duodenoscope,” the letter says.
“In doing so, Olympus deliberately endangered the lives of thousands of American patients undergoing procedures using its medical scope and killed scores of Americans,” the letter continues.
“Internal emails now reveal that Olympus executives in Japan purposely told U.S. executives to not issue warnings associated with its medical scope devices, leading to antibiotic-resistant ‘superbug’ outbreaks, infections, and deaths in hospitals all across the country,” the letter reads.
Internal emails now reveal that Olympus executives in Japan purposely told U.S. executives to not issue warnings associated with its medical scope devices, leading to antibiotic-resistant “superbug” outbreaks, infections, and deaths in hospitals all across the country, according to the letter.
“Because this issue poses both health and national security risks–and because Americans have died as a result of Olympus’ actions–it is imperative that the State Department coordinate with the appropriate Japanese authorities to have them investigate and prosecute Olympus,” Lieu asks in the letter.
According to the drugwatch.com website, two deaths and the possible addition of 200 more infections linked to the antibiotic resistant superbug carbapenem-resistant Enterobacteriaceae (CRE) that has put a spotlight on Olympus’ TJF-Q180V duodenoscope.
Olympus did not gain clearance from the U.S. Food and Drug Administration (FDA) before putting the scope on the market in 2010, according to the website. Now, a recent redesign may have made the scope difficult to disinfect, putting surgery patients at risk of infection.
Officials at the UCLA Ronald Reagan Medical Center, where one outbreak occurred, linked the infections to this particular duodenoscope, and they say infections developed during the months between October 2014 and January 2015, according to the website.
CRE is considered a “superbug” because it is notoriously difficult to treat. Roughly 50 percent of those infected do not survive. Now more hospitals across the country are finding infections linked to these scopes, according to the website.