DOJ closes investigation of Medtronic’s controversial product Infuse

May 16, 2012 6:00 pm by Arundhati Parmar | 0 Comments

Infuse

In a short news release issued Wednesday afternoon, Medtronic(NYSE:MDT)disclosed that the U.S. Department of Justice has closed its civil and criminal investigation into the company’s former blockbuster and controversial product Infuse.

The investigation launched more than three years ago was into whether Medtronic illegally promoted the off-label use of the bone growth product. A spokesman said that the investigation found no wrongdoing in terms of Medtronic’s sales and marketing practices.

“After several years of investigation, we are pleased that the Department of Justice and the U.S. Attorney’s Office have come to the decision to close their investigation of the company related to Infuse bone graft,” said Chris O’Connell, executive vice president and group president, Restorative Therapies Group, which includes the company’s spinal business, in the release.

Yet, the company can’t fully exhale at this piece of good fortune.

Infuse sales have taken a battering as studies have been published alleging that the product is unsafe. To defuse the controversy, the medical device giant took the unprecedented step of providing a $2.5 million grant to Yale researchers to review Infuse data and vindicate the company.

Even as sales have faltered, expenses related to Infuse have mounted as a result of lawsuits. At the end of March, the company acknowledged that it was making an $85 million payment to settle a class-action securities lawsuit with lead plaintiff theMinneapolis Firefighters’ Relief Association.

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Related Topics: MDT, medical devices, Medtronic, Minnesota, publics, Twin Cities

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By Arundhati Parmar

Arundhati Parmar is the Medical Devices Reporter at MedCity News. She has covered medical technology since 2008 and specialized in business journalism since 2001. Parmar has three degrees from three continents - a Bachelor of Arts in English from Jadavpur University, Kolkata, India; a Masters in English Literature from the University of Sydney, Australia and a Masters in Journalism from Northwestern University in Chicago. She has sworn never to enter a classroom again.
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