News Archive

Two exceptional attorneys in the area of health law policy and regulation discussed the impact of the Acclarent settlement during the first Hall Center Grand Rounds event of the Fall 2016 semester. The program, “The Acclarent Settlement: Lessons Learned,” took place at IU McKinney on October 6.

Norman Tabler, Jr., and Suzanne O’Shea discussed the topic from the perspective of their individual expertise. Tabler is former general counsel at IU Health and now counsel at Faegre Baker Daniels. He worked at the law firm immediately upon graduation from Columbia Law School, and was chair of the first health law practice before serving at IU Health. O’Shea is a director at Navigant Consulting, where she leads the FDA Regulatory Pharmaceutical practice. She was regulatory counsel at the FDA for over two decades, serving in the Center for Drug Evaluation and Research, the Office of the Chief Mediator and Ombudsman, and the Office of combination Products.

Acclarent Inc. agreed to pay $18 million to resolve allegations that it caused health care providers to submit false claims to Medicare and other federal health care programs by marketing and distributing one of its devices for an off-label use. In a sign of increased federal government interest in holding corporate insiders responsible that settlement was announced shortly after two former Acclarent executives were convicted of misdemeanor counts involving the introduction of a misbranded and adulterated device into interstate commerce.

In the photo from left are Professor Terry, O’Shea, and Tabler.