Italian medical device maker Sorin Group said it reached a tentative, $10 million settlement with the U.S. Dept. of Justice in case accusing its ELA Medical subsidiary of running an illegal kickbacks scheme.
The Justice Dept. opened an investigation into the case in 2006, examining whether the Plymouth, Minn.-based subsidiary orchestrated a scheme using its sales force to provide kickbacks to doctors who bought its pacemakers. The settlement, in which the company admits no wrongdoing, is expected to become official during the third quarter.
"We welcome this comprehensive settlement in order to close this chapter of our past, and avoid the uncertainty of protracted litigation," Sorin CEO Andre-Michel Ballester said in prepared remarks. "Over the past three years, the company has committed itself to cooperating fully and openly with the government’s investigation and taking any remedial steps needed. ELA Medical Inc. now has in place a compliance program that we believe could serve as a standard for the industry."
It’s not the first time the company has run afoul of federal regulators. Late last year the Food & Drug Administration warned Sorin that it must notify the agency of any adverse events related to its products, even if they occur overseas.