Olympus Medical Systems pleaded guilty to failing to file adverse event reports that detailed serious infections linked to its duodenoscopes as required by the FDA.
The Tokyo-based company was fined $80 million and ordered to forfeit an additional $5 million under the plea agreement, which involved three federal misdemeanor counts of distributing misbranded medical devices under the Food, Drug, and Cosmetic Act.
In addition, a former top Olympus regulatory executive in Japan—Hisao Yabe, manager of the company’s quality and environment division—pleaded guilty to one count, and could face up to one year in prison after being sentenced in March 2019. Olympus must also enact "extensive compliance reforms" under the agreement, according to the U.S. Department of Justice.
Olympus had previously admitted that it failed to file reports with the FDA in 2012 and 2014 related to three infectious outbreaks that involved at least 30 European patients and the potential superbugs Escherichia coli and drug-resistant Pseudomonas aeruginosa. The reports were linked to cleaned and reused models of its TJF-Q180V duodenoscope, which is used in endoscopic procedures within the gastrointestinal tract, pancreas and bile ducts.
Prior to that, Olympus received an independent analysis that noted problems with the Q180V scope’s design: Its tip had cracks, corners and crevices that were difficult to fully clean and could harbor bacteria. The report recommended investigating further, updating the cleaning instructions and improving seal quality, the DOJ said.
"Medical devices, such as the Olympus duodenoscope that is used in 500,000 procedures per year in the United States, can extend and improve the quality of life for many people," said Assistant Attorney General Jody Hunt for the DOJ’s civil division.
"But when a device manufacturer becomes aware of risks that could lead to illness, injury, or death, there is a statutory obligation to report that information to the FDA in a timely manner," Hunt said. "By failing to do so, Olympus and Mr. Yabe put patients’ health at risk."
Olympus first disclosed the DOJ investigation in May 2015, which the company said did not identify any direct harm to patients as a result of the disclosure failures. The settlement does not impact the availability of Olympus products and services.
Since then, the company has reformed its regulatory affairs functions, including reorganizing its global department, and brought in additional reporting and supervisory personnel while increasing training. Olympus has also agreed to retain an independent expert to inspect and review the company’s policies and procedures, who will report back to the FDA and the DOJ over the next three years.
"Olympus deeply regrets its failure to file and supplement the [medical device reports] identified in the plea agreement and accepts full responsibility for these failures," Hiroyuki Sasa, president and representative director of Olympus’ larger parent corporation, said in a statement. Sasa previously served as general manager of the company’s endoscope business planning department in the early 2000’s, and later as executive officer and director of Olympus Medical.
Between 2012 and 2014, Olympus’ misbranded duodenoscopes generated about $40 million in revenue and about $33 million in total gross profit in the U.S., according to the DOJ, with the $85 million fine representing more than two-and-a-half times the company’s total profit from sales.
The day the pleas were filed, the FDA issued a new safety communication to manufacturers and users updating them on an ongoing postmarket review of duodenoscope surveillance studies, which found "higher-than-expected contamination rates" following reprocessing. The agency urged them to closely follow manual cleaning, disinfection and sterilization procedures.
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