Olympus Cops a Guilty Plea x 3 for $85 M!! https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm628096.htm?utm_campaign=121018_Statement_FDA%20provides%20update%20on%20duodenoscope%20postmarketing%20studies&utm_medium=email&utm_source=Eloqua
And, as part of their PR yesterday, the FDA reports that Olympus pleads guilty to 3 criminal counts of failure to file adverse events reports and is fined $85,000,000:
“Finally, we rely on manufacturers to report infections associated with duodenoscopes, as well as other adverse events caused by medical devices, to the FDA in a timely manner – generally within 30 days of learning about the event. When this does not occur, patients’ safety and sometimes their lives may be put at risk. When this happens, the agency can and does take action. The FDA’s Office of Criminal Investigations recently worked with the U.S. Department of Justice to bring criminal action against Olympus for failing to adequately file adverse event reports involving infections that occurred in Europe in 2012 and 2013 that were associated with their TJF-Q180V duodenoscope. After pleading guilty to three counts of distributing misbranding devices in interstate commerce, the company was fined $80,000,000 and ordered to forfeit $5,000,000. As part of its plea agreement with the Justice Department, Olympus is also required to undertake enhanced compliance measures.”
While there is no mention in this statement of Olympus accepting liability for patient injuries and deaths that occurred subsequent to the OEM becoming aware of the issue of scope contamination, one expects the lawyers representing plaintiffs in the myriad cases now before the courts will seize on this plea deal with the DoJ as evidence of Olympus’s culpability.
As I noted previously, Olympus had already set aside money for this settlement, but they will likely be spending much much more to settle wrongful injury and death suits, now and in the future.
Again, one has to wonder why Olympus hasn’t taken a run at a hostile take-take-over of TSO3 for $2+ and thereby showing everyone that they are serious about mitigating the damages and taking control of the situation with an effective cost efficient solution to the scope contamination problem, not just for ERCP scopes, but for colonoscopes, bronchoscopes, and other scopes.