Olympus Corp., was hit with $85 million in fines and forfeiture by the U.S. Department of Justice (DOJ) for distributing specialized endoscopes in the United States without disclosing that the device could spread infections in patients.
Both Olympus and the Japanese medical technology’s former top regulatory official, Hisao Yabe, pled guilty to the charges in separate suits in New Jersey federal court. The instruments, called duodenoscopes, are threaded down the throats of patients to treat or diagnose problems with the bile ducts and pancreas. They had been linked to a number of infections in Europe in 2012 and 2013. By not disclosing this information, both Olympus and Yabe were in violation of the Federal Food, Drug and Cosmetic Act, the DOJ said.
Duodenoscopes are complex instruments with nooks and crannies where tissue and bacteria can hide. Tissue or fluid from one patient can remain on the devices even after they are disinfected and sterilized. When the devices are reused, they can lead to patient-to-patient transmission of infections.
Both Olympus and Yabe admitted that they were aware of this design flaw, but they failed to file adverse event reports with the FDA. Instead, between August 2012 and October 2014, the company shipped duodenoscopes into the U.S., generating about $40 million in revenue.
Not only was Olympus hit with an $80 million fine and $5 million in forfeiture, it also agreed to extensive compliance reforms. Yabe faces a year in prison and a $100,000 fine. His sentencing is scheduled for March 2019.
In 2015, outbreaks of drug-resistant superbug infections in patients who underwent procedures using duodenoscopes were reported at several hospitals in the U.S. The FDA ordered Olympus, as well as Fujifilm Medical Systems USA Inc. and Pentax of America, which also distributed duodenoscoes in the U.S., to conduct post-market surveillance studies so that the agency could better understand the contamination issues with the devices.
In March 2018, the agency issued Warning Letters to all three manufacturers for failing to provide sufficient data to address the issue. All three responded to the letters and submitted plans on how they would achieve the study milestones. This week, the FDA announced that the study revealed there was a higher-than-expected rate of contamination due in part to the devices not being cleaned efficiently.
FDA Safety Communication