The U.S. Securities & Exchange Commission settles civil charges against a banker implicated in the $2 billion accounting scandal that nearly sank Olympus.
Lawyers for 2 patients, 1 of whom died, sue Olympus over the so-called 'superbug' infections they allegedly picked up from its endoscopes during surgical procedures.
(Reuters) — Attorneys for 2 patients infected with a drug-resistant bacterial "superbug" during medical procedures in a Los Angeles hospital, 1 of whom died, have sued the maker of the devices used in their care.
Federal regulators will speed label changes for medical devices linked to the 'superbug' outbreak
(Reuters) - The U.S. Food and Drug Administration is working to speed label changes for medical devices linked to a "superbug" outbreak in California, possibly to include new warnings and more stringent cleaning and disinfecting instructions, a senior official said.
The FDA warns ERCP endoscopes may allow for the transmission of certain drug-resistant "superbugs," even if the devices are properly cleaned.
The FDA is warning that ERCP endoscopes may allow for the transmission of certain drug-resistant "superbugs," even if the devices are properly cleaned.
The advisory was issued in the wake of news that contaminated endoscopes are suspected of causing a deadly outbreak of the superbug CRE, or carbapenem-resistant enterobacteriaceae (CRE), among patients at the UCLA Ronald Reagan Medical Center in Los Angeles.
Regulators have known since at least 2009 that the medical devices at the center of the "superbug" outbreak at UCLA
(Reuters) - U.S. health regulators have known since at least 2009 that the medical devices at the center of the "superbug" outbreak at UCLA can transmit lethal infections but have not recommended any new safety requirements, a lapse that threatens patient safety, experts in hospital-acquired infections said.
Olympus says it's negotiating with the U.S. Justice Dept. to settle a fraud and kickbacks probe into its medical division.
Here's a look at some of the top legal news stories for medical device companies this week: Olympus goes after ex-sales manager, ArthroCare; Stryker alleges Medtronic colluded with patent troll for Kyphon IP; Investors fire life science VC Burrill from his own fund; Patient group wants J&J probe over pelvic mesh