|Olympus TJF-Q180V Duodenoscope--Courtesy of Olympus Australia|
The U.S. Department of Justice subpoenaed Olympus Medical Systems in the latest portion of the long-unfurling saga of how and why duodenoscopes routinely used in colonoscopies and upper gastrointestinal tract examinations have continued to be a problematic source for the spread of deadly bacteria for years.
The company revealed in a regulatory filing earlier this month that in March the DOJ issued a subpoena to Olympus Medical Systems, a subsidiary of Olympus Corp. The company already has been named in a series of civil lawsuits in the United States alleging harm from its duodenoscopes.
An FDA panel earlier this month recommended that the devices should be subject to sterilization, rather than high-level cleaning. That process has been adopted by the UCLA Medical Center, a recent site of the device-related infections, but it required that the facility purchase 20 additional duodenoscopes at a price of $38,000 each.
The agency is working with companies to develop an official protocol for duodenoscope cleaning. It said that it has received reports of at least 142 contaminated duodenoscopes involving subsequent patient infection since 2010.
Olympus remains uncertain of the financial implications of the federal investigation and the civil lawsuits. It simply stated in the filing: "Depending on the developments in these matters, our consolidated results of operations and financial condition may be affected."
This isn't the company's only brush with the DOJ; it recently settled two lawsuits for as much as 11 billion yen ($92 million) based in a 2011 accounting scandal. The claims of kickbacks and false statements were also the result of a DOJ investigation.
- here is coverage from Bloomberg