ELA Medical, a subsidiary of Italian medical device maker Sorin Group, reaches a tentative, $10 million settlement with the U.S. Justice Dept. over charges that it ran a kickbacks scheme to drive pacemaker sales.
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.
With the Rise of AI, What IP Disputes in Healthcare Are Likely to Emerge?
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
“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.
The Massachusetts Medical Devices Journal is the online journal of the medical devices industry in the Commonwealth and New England, providing day-to-day coverage of the devices that save lives, the people behind them, and the burgeoning trends and developments within the industry.
