Devices

Olympus Paying $646 Million to Settle Kickback Charges

The Justice Department says that Olympus Corp. of the Americas, the nation’s largest distributor of endoscopes and related equipment, will pay $623.2 million to resolve criminal charges and civil claims relating to a scheme to pay kickbacks to doctors and hospitals. A company subsidiary also will pay $22.8 million to resolve criminal charges relating to the Foreign Corrupt Practices Act in Latin America.

A department news release says that a criminal complaint filed in New Jersey federal court charged the company with conspiracy to violate the anti-kickback statute. Olympus has entered into a three-year deferred prosecution agreement that will allow it to avoid conviction if it complies with reform and compliance provisions in the agreement, the department says.

The release says that the payment of $312.4 million in a criminal penalty and an additional $310.8 million to settle civil claims is the largest total amount paid in U.S./ history for medical device company violations of the anti-kickback statute.

The civil settlement resolves a whistleblower suit filed by the company’s former chief compliance officer, John Slowik. He will receive more than $51 million from the combined federal and state shares of the settlement.Olympus also has executed a corporate integrity agreement with the HHS Inspector General.

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

Read more

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