As the FDA gears up for a panel meeting regarding duodenoscope devices linked to deadly bacterial infections, a U.S. hospital is joining forces with a patient's family to sue the largest manufacturer of the product.
The Olympus problem with one of its duodenoscopes has cropped up again with another major suit in the United States and new assertions the device also was linked to hospital superbugs in Europe.
Olympus is plowing ahead on its medical device strategy, opening a new surgical innovation center in Brooklyn Park, MN. The move comes despite the company's recent problems with difficult-to-clean duodenoscopes that are resulting in the spread of antibiotic-resistant bacteria that can cause disease and even death among some patients.
As Olympus faces mounting backlash for endoscope devices linked to the recent superbug outbreaks, Sony, the company's largest shareholder, is selling off half its stake to raise funds for strategic investments.
Olympus will pay as much as 11 billion yen ($92 million) to settle two lawsuits based in a 2011 accounting scandal. This comes just as the camera and medical imaging company has been identified as one of several companies whose dirty duodenoscopes have infected some patients with antibiotic-resistant bacteria.
Olympus revealed updated cleaning instructions for duodenoscopes linked to a recent superbug outbreak at UCLA, weeks after the FDA warned that the devices' complex design may contribute to the spread of deadly bacteria and called for label modifications.
Rep. Ted Lieu (D-CA) is calling for a federal investigation into the duodenoscope safety scare that has claimed lives and spread the dangerous pathogen CRE to patients across the nation. And he just sent a letter to Olympus asking the company why it did not seek FDA clearance for a 2010 redesign of its duodenoscope, if it plans to redesign the device in the future, and when the company first learned of the risk posed by the device.
Olympus Medical Systems has received its fifth suit filed by a patient claiming to have been infected with the hospital "superbug" as a result of inadequate sterilization of its duodenoscope.
Olympus was slapped with two new lawsuits over endoscope devices tied to a recent superbug outbreak at UCLA, adding to a mounting heap of litigation from patients and families affected by the devices.
A review of Olympus presentations to the U.S. FDA over its duodenoscopes suggests the Japan-based medical-device maker may have been "hoist with his own petard" in its attempt to have cleaning guidelines watered down.