Devices

Olympus Pays $85 Million for Failing to File Device Reports

Olympus Medical Systems and a former senior executive in Japan pleaded guilty 12/10 in Newark, NJ federal court for failing to file required adverse event reports involving its duodenoscopes and associated infections, and continuing to sell the devices knowing the likely failures, according to a Justice Department release. U.S. District Court Judge Stanley R. Chesler imposed an $80 million fine and $5 million criminal forfeiture against Olympus. The company has also agreed to implement “extensive compliance reforms,” the government says. Former quality and environment manager Hisao Yabe, who is scheduled to be sentenced 3/27/2019, faces a maximum penalty of a year in prison and a $100,000 fine, or twice the gain or loss from the offense.

“Olympus and Yabe failed to file important FDA reports regarding adverse events,” Justice said in the release. “It is especially troubling that they remained quiet when they received additional information from an independent expert questioning the safety of Olympus’ device. Patient safety must always be a paramount concern for medical device companies, and these defendants simply failed to treat that concern with the gravity it deserves.”

Meanwhile, FDA 12/10 issued a safety communication reporting on preliminary findings from studies it ordered that showed “higher-than-expected contamination rates after reprocessing, with up to 3% of properly collected samples testing positive for more than 100 colony forming units of low concern organisms that are unlikely to cause serious infections (but an indication of a reprocessing failure) and an additional 3% of properly collected samples testing positive for ‘high concern’ organisms.”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome