Olympus Told Executives Not to Issue Alert About Tainted Medical Scopes
An investigation of emails from Japanese medical device manufacturer Olympus Corp. shows that the company knew about the deadly super-bug risk associated with use of their duodenoscope devices. The emails reveal that executives chose not to inform hospitals in the United States about the infection risk.
In January 2013, Olympus warned European customers that its scopes were possibly contaminated after Dutch and French hospitals reported more than 20 infections. However, no information was disclosed to American hospitals, even though Olympus representatives were investigating such an infection at a Pittsburgh area hospital.
An email sent on January 31, 2013, from the vice president of regulatory and clinical affairs to the Tokyo headquarters questioned whether Olympus should be communicating the same information about outbreaks to its American users. On February 6, 2013, the chief manager for market quality administration responded “No, that’s not necessary.” She went on to explain that it was not chief manager for market quality administration necessary to “communicate to all the users actively” because it was found to be an “acceptable” risk.
This failure to timely transmit information to American facilities about the known infection risk resulted in multiple patient deaths. More than 35 people have died from super-bug infections caused by Olympus’ contaminated endoscopes. Related infections have been reported at hospitals in several cities, including Los Angeles, Denver and Milwaukee.
Now, survivors of victims are filing lawsuits in an attempt to recover compensation for Olympus’ failure to warn American facilities and medical providers of the known risk. The emails that have been uncovered are now being used to prove that the company was negligent and could have prevent the subsequent outbreaks – and fatalities – had it disclosed this important information.
When lab results showed bacteria on the medical scopes, Olympus’ response was that the contamination likely occurred during testing. The company failed to take the blame for the infections, choosing instead to blame the hospitals for improperly cleaning the devices.
Olympus, which controls 85% of the United States market for medical scopes, was aware that the endoscope’s design would make cleaning and disinfecting difficult. The device has a design that makes it difficult to completely remove all tissue and blood from the device, allowing infections to be spread from one patient to the next. In fact, an investigator hired by Olympus documented in a June 2012 report that the design flaw could lead to contamination issues. The investigator also suggested that Olympus conduct a worldwide investigation and initiate a recall if any problems occurred. The company failed to follow the investigator’s suggestions, putting patients’ lives at risk.
If you or a loved one developed a serious or life-threatening infection following an endoscopic procedure, immediately contact the Olympus scope recall attorneys of Nadrich & Cohen, LLP. We will provide a no-risk, 100% free consultation. Call us now at 1-800-718-4658.