Japanese medical scope manufacturer Olympus Corp. instructed its U.S. executives not to issue a warning to American hospitals about potentially deadly infections tied to its Olympus medical scopes that ultimately resulted in 35 U.S. deaths, according to a Los Angeles Times story.
Olympus has an 85% market share in the U.S. for its duodenoscopes used to diagnose gastrointestinal illnesses. Following an outbreak of deadly superbug infections in 2013 outside the U.S., the company warned European hospitals of the potential for contamination from its scopes. According to the Times, internal company emails from 2013 revealed that Japanese executives instructed the U.S. division not to warn American hospitals, saying that a company assessment of risk to patients found that risk to be “acceptable.”
Superbug outbreaks tied to the scopes have occurred in several U.S. cities since 2013, and at least 35 people have died after suffering infections from contaminated Olympus scopes. Olympus placed the blame on hospitals, saying the reusable scopes were not being cleaned correctly between uses.
In February 2015, the U.S. Food and Drug Administration (FDA) issued a safety alert, saying that even when cleaned according to the manufacturer’s instructions, the scopes still posed an infection threat. The FDA said that as many as 350 patients at 41 U.S. medical facilities had been infected or were exposed to tainted scopes over a nearly five-year period, from January 2010 to October 2015.
A January 2016 Congressional investigation into the tainted scopes criticized Olympus for failing to warn U.S. patients, medical facilities and physicians about the safety hazard. Following the release of the Congressional report, Olympus announced a recall of its duodenoscopes for repairs. However, some medical experts have called for a redesign of the product to prevent bacteria from being trapped in tiny crevices at the tip of the scope.
Lawsuits against Olympus have been filed in Pennsylvania and North Carolina by patients injured by the company’s duodenoscopes.
If you have suffered injuries from an unsafe or defective medical product, the experienced product liability legal team at Roberts & Roberts is here to help with compassionate, aggressive representation. Please call 800-248-6000 or contact us for a free consultation.