- Olympus Corporation of the Americas (OCA) agreed Tuesday to pay the U.S. government $646 million to resolve accusations of kickbacks and bribery.
- The settlement stems from cases involving OCA operations in New Jersey and Latin America.
- As part of the settlement, OCA is entering into a corporate integrity agreement, which sets compliance benchmarks and requires an independent auditor.
An investigation by the U.S. attorney’s office in New Jersey found that between 2006 and 2011 OCA paid providers to purchase its medical scopes, in violation of the U.S. Anti-Kickback Statute and the U.S. False Claims Act.
Federal prosecutors said Tuesday's settlement is the largest ever for violations of the U.S. Anti-Kickback Statute, according to Kaiser Health News.
The Department of Justice investigated claims that the firm’s subsidiary, Olympus Latin America, violated the U.S. Foreign Corrupt Practices Act by bribing doctors at government-owned hospitals to press their procurement departments to purchase its products.
The Latin American misstep will cost OCA another $22.8 million, and a deferred prosecution agreement, which includes certain compliance measures.
OCA President and CEO Nacho Abia acknowledged the firm’s “responsibility for the past conduct” and said it was committed to complying with all laws and regulations in a prepared statement. OCA has implemented a “robust” compliance program, he added.
Federal regulators have slammed OCA for not informing them sooner about life-threatening infections linked to its duodenoscopes. The infections have led to a number of deaths, resulting in new FDA warnings and congressional hearings.