The Olympus Colonoscope is only the latest in a seemingly endless parade of medical devices with design or manufacturing defects that are harming and killing patients.

Because of a design flaw that prevents the Olympus Colonoscope from being properly cleaned and sterilized between patient examinations, hundreds of patients have wound up contracting dangerous, antibiotic-resistant infections; which in some cases, have been fatal.

Individual plaintiffs began filing lawsuits last year. Chances are very good that these lawsuits will be successful, because behavior on part of Olympus Corporation executives last year strongly indicate that the company was fully aware of the dangers associated with its product.

The case involved Theresa Bigler, the widow of a man who died from an infection contracted following his colonoscopy at Seattle’s Virginia Mason Hospital in 2013. The hospital, where 17 other patients died from similar causes, joined the lawsuit. The device used for the procedure was the TJF-Q180V duodenoscope, which like so many other medical devices that have demonstrated to be defective, was approved by the FDA under the questionable 510(k) Pre-Market Clearance process.

In July 2016, the Los Angeles Times reported on company emails that had surfaced at the Tokyo-based company, in which management instructed U.S. executives not to warn American hospitals of the infection risks linked to the duodenoscope. Infections attributable to the duodenoscope had been reported in Europe, but when an Olympus executive in Pennsylvania reported concerns about a similar outbreak at a hospital in Pittsburgh, she was told by her boss in Tokyo that it was “not need [sic] to communicate to all the users actively.”

Later, as the lawsuit was underway, that senior executive was deposed, along with two of his high-ranking colleagues. The deposition took place at the U.S. embassy in Tokyo over two days. One of the individuals questioned, quality supervisor Susumu Nishima, was the author of the aforementioned email. The other two, Hisao Yabe and Hiroki Moriyama, were also mentioned in internal company emails. The latter was listed as the contact person on injury reports filed with the FDA – as well as on a number of company patents. When questioned by the plaintiffs’ attorneys, however, all three executives invoked their right under the Fifth Amendment not to incriminate themselves.

It’s not unusual for corporate executives to plead the Fifth during a civil lawsuit, as failure to exercise that right could leave them open to criminal charges. As it turns out, that could very well happen.

In 2016, Olympus agreed to pay a fine in the amount of $646 million to settle allegations that it paid kickbacks to doctors and hospitals in order to motivate sales of their products. Shortly before the Bigler case ended in a judgment for the plaintiffs, U.S. Senator Patty Murray (D-WA) began her own inquiry into Olympus and a “new and improved” version of the product, which according to the Senator, “reportedly fixed the device in question.”

If it turns out that Olympus executives were involved in a criminal conspiracy to withhold safety information that would have saved lives – even if it cost sales and revenue – it would not be the first time.

Tragically, it is unlikely to be the last.

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K.J. McElrath is a former history and social studies teacher who has long maintained a keen interest in legal and social issues. In addition to writing for The Ring of Fire, he is the author of two published novels: Tamanous Cooley, a darkly comic environmental twist on Dante's Inferno, and The Missionary's Wife, a story of the conflict between human nature and fundamentalist religious dogma. When not engaged in journalistic or literary pursuits, K.J. works as an entertainer and film composer.