It turns out the superbug lawsuits aren’t the only legal problems for the manufacturer of duodenoscopes. Olympus has now reserved almost $450 million to settle claims of illegal marketing of its products from 2006 to 2011. These allegations involve the payment of kickback to doctors in violation of the False Claims Act, which is among the type of cases that our whistleblower attorneys handle.
The investigation may not be confined to the US. It looks like Olympus has also reported problems to the DOJ with payments to doctors in Brazil for travel, meals and entertainment. I haven’t done any research into the Brazil health care system, but if these doctors work for state-owned enterprises, I suspect the investigation is into potential FCPA violations.
Olympus has also been sued in Pennsylvania state court by two women accusing the company of spreading cancer with their device for laparoscopic power morcellation. The lawsuits accuse the company of failing to design the PKS PlasmaSORD Bipolar Morcellator to reduce the risk and argues that the company should have known about the problem.
Also in the news from Olympus, but related to its scopes and superbug contamination:
A two day advisory committee meeting declared duodenoscopes unsafe but did not instruct the FDA to stop their use by doctors. Instead, the 16 member panel of doctors, health experts and consumer representatives recommended that the FDA require the devices be redesigned.
Olympus and the two other scope manufacturers declined to participate in the two-day FDA panel. They haven’t released safety data about the effectiveness of their new, revised cleaning instructions, either.
Yet, Olympus is now claiming that human errors in the reprocessing of duodenoscopes may be at least partially to blame for the superbug infections. Physicians have contended that a design flaw in the devices makes them difficult to clean.
In early May, the FDA disclosed that it has received 142 reports of contaminated devices and possible patient infections since 2010. Approximately 50% of those came in 2013 and 2014.
Photo Credit: Kitmondo LAB.