Olympus Is in Yet Another Scandal


Olympus Endoscope Schematic Drawing

Olympus Endoscope Schematic Drawing

One of WC’s better decisions, after years fo frustration, back in April 2013 was to abandon Olympus cameras and switch to the Canon line. Not long after that, Olympus was mired in an accounting scandal that nearly killed the company and led to criminal convictions for several officers and former officers. The “re-focus” – heh – by Olympus, largely abandoning the high-end camera line, hurt a lot of photographers, and the financial losses hurt Olympus shareholders.

Now Olympus is mired in a new scandal, and this time it is accused of negligently killing people.

Olympus makes its real money on hospital equipment, and in particular the instruments used to peer up your colon and down your throat. Endoscopes and endosurgical instruments are the big profit center for Olympus.1

One such instrument is the duodenoscope, used for various procedures involving the general intestinal tract down as far as the duodenum. It turns out that Olympus duodenoscopes are difficult to impossible to fully disinfect. The scopes have tiny crevices near the camera at the tip of the device that can harbor microorganisms, and the FDA has warned that following the manufacturer’s instructions for cleaning does not ensure that bacteria will not be passed from patient to patient. As a result, the ‘scopes represent a vector for transmission of diseases, including infections by so-called “superbugs,” bacteria that are resistant to all antibiotics, passing the “superbugs” from patient to patient despite following the sterilization procedures recommended by Olympus, the manufacturer.2

Worse, emails among Olympus officials show that the top folks at Olympus knew of the problem and chose not to disclose it to customers. Susumu Nishina is chief manager for market quality administration at the Tokyo headquarters of Olympus. In 2013, a U.S. Olympus official asked Nishina whether American hospitals should be warned of the infection risk. 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.”

At least 35 patients in American hospitals have died since 2013 after developing infections tied to tainted Olympus duodenoscopes. Hundreds have suffered infections.

There are lawsuits. There have been depositions in those lawsuits. At those depositions, three different Olympus officials took the 5th Amendment. That is, they refused to answer questions on the grounds that the answers might incriminate them.

That’s their right, of course. But in a civil case – and these are civil, wrongful death cases – a claim of the 5th Amendment privilege is itself admissible into evidence. Imagine yourself a juror in the King County, Washington, case, alawsuit brought by the families of 25 patients who died of Olympus duodenoscope infections. As a juror, you get to see the emails fro the VP for quality control telling their mid-management in the U.S. not to warn hospitals of the infection risk. And then you learn those folks have taken the 5th Amendment?

Break out the checkbooks, folks.

 


  1. This scandal shouldn’t be confused with the other, earlier medical device bribery scandal. Olympus settled with the U.S. Department of Justice (DOJ) for $646 million over a series of criminal and civil charges that state it rewarded and won business by making illegal payments to doctors and hospitals. 
  2. It turns out that the FDA never approved the suspect duodenoscopes. The FDA had approved an earlier design, but Olympus never submitted the later designed to the FDA. 
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