REP LIEU STATEMENT ON $85 MILLION SETTLEMENT OVER MEDICAL SCOPES LINKED TO SUPERBUGS
WASHINGTON – Today, Congressman Ted W. Lieu (D-Los Angeles County) issued the following statement after Olympus Medical Systems Corp. reached a settlement with federal authorities over their failure to properly disclose instances when their medical scopes were linked to the spread of superbug infections. Mr. Lieu has long sought remedies for those impacted by Olympus’ actions, and has been working on the issue since it was reported in 2015 that superbug infections had occurred at Cedars-Sinai Medical Center in Los Angeles and at the Ronald Regan UCLA Medical Center.
“Olympus Corp. knowingly failed to alert and warn American hospitals, doctors and patients about its defective medical scope. In doing, Olympus deliberately endangered the lives of thousands of American patients and killed many others. Patients and hospitals deserve to know that the medical devices being used on patients are safe and effective. I thank the Justice Department for taking action and holding Olympus accountable and bringing justice to those who were affected by the company’s egregious decision to not report infections linked to their devices. As cases of antibiotic resistant bacteria continue to rise, it’s imperative we do everything we can to prevent and report any and all instances.”
MR. LIEU’S EFFORTS TO COMBAT THE SPREAD OF ANTIBIOTIC-RESISTANT SUPERBUGS
- In 2015, in response to news of superbug infections and deaths occurring at Cedars-Sinai Medical Center in Los Angeles and at the Ronald Regan UCLA Medical Center, Mr. Lieu called for a Congressional hearing to examine the outbreaks.
- Mr. Lieu sought answers from the Olympus Corporation of Americas, makers of the duodenoscopes that transmitted the deadly CRE bacteria to patients during a routine medical procedure. In the letter, he asked Olympus Corp. how they planned to prevent superbug outbreaks linked to contaminated medical scopes and about the effectiveness of their cleaning instructions.
- Mr. Lieu also sent letters to government agencies, including a letter to FDA Commissioner Margaret Hamburg seeking further information and ideas on how to best prevent fatal outbreaks of antibiotic resistant bacteria and a letter to the SEC Chair Mary Jo White to investigate Olympus for fraud and violations of U.S. securities laws.
- In August 2016, Mr. Lieu sent a letter to Secretary John Kerry urging the State Department to request that Japanese authorities investigate and prosecute Olympus for civil or criminal misconduct in their mishandling of antibiotic-resistant bacteria infections caused by their medical devices.
- After a yearlong investigation that Mr. Lieu requested, the House Committee on Oversight and Government Reform found significant gaps in existing law that contributed to a nationwide problem of superbug outbreaks due to tainted duodenoscopes. This led to Mr. Lieu introducing two pieces of legislation, H.R. 4965, the Disclosure; and Encouragement of Verification, Innovation, Cleaning, and Efficiency (DEVICE) Act and H.R. 4966, the Preventing Superbugs and Protecting Patients Act.
- On February 4, 2016, Senator Patty Murray (D-WA) introduced the Senate companion bill to Mr. Lieu’s H.R. 4966. It was included in Section 3059 of the 21st Century Cures Act, which was signed into law by President Barack Obama on December 13, 2016.