Olympus Corp. is feeling the burn for manufacturing and selling specialized endoscopes without warning that they could transmit bacteria from patient-to-patient, leading to life-threatening superbug infections. Last week, the U.S. Department of Justice (DOJ) ordered the Tokyo-based medical-scope maker to pay $80 million in fines and $5 million in criminal forfeiture over its defectively designed duodenoscopes.
The company’s former executive, Hisao Yabe, also pleaded guilty for distributing the instruments and not filing reports with the U.S. Food and Drug Administration (FDA) about infections related to Olympus’ duodenoscopes.
On the heels of that announcement, Olympus also agreed to pay an undisclosed amount to two Seattle-area widows whose husbands died after contracting drug-resistant infections after being treated with the devices.
The lawsuit was filed by Theresa Bigler and Deborah Shawver. Their husbands were among the 18 people who were treated with Olympus’ TJF-Q180V duodenoscope at Virginia Mason Medical Center before developing infections severe enough to cause their deaths.
Bigler’s case originally went to trial in 2017. In that trial, a jury awarded the hospital $6.6 million and Bigler $1 million. But punitive damages were not awarded. A new trial was ordered in January after it was found that Olympus had failed to disclose internal emails dating back a decade that indicated the devices could spread disease.
Duodenoscopes are specialized endocsopes that are threaded down a patient’s throat to treat or diagnose conditions involving the pancreas and bile duct. The devices have small nooks and crannies that can harbor bacteria even after they have been cleaned, sterilized and disinfected.
More than 25 lawsuits have been filed against Olympus over the infections.