Synthes Statement Regarding Indictment by U.S. Government

Synthes (SWX: SYST.VX) learned today that the U.S. Attorney for the Eastern District of Pennsylvania has charged the company in connection with alleged off-label promotion of «Norian XR», a Spine product the company stopped selling in 2004. Off-label promotion involves marketing a product in a manner not approved by the FDA.

Synthes has fully cooperated with the government’s investigation, which began in 2006, and believes that its marketing practices in connection with «Norian XR» were proper. The company intends to vigorously defend itself against the charges.

«Norian XR» is a calcium phosphate based bone void filler that was cleared for sale by the U.S. FDA (Food and Drug Administration) in 2002 as a medical device to treat bone voids or defects in the skeletal system. Synthes marketed «Norian XR» from 2002 to 2004, having sold approximately 200 units, realizing total net sales of approximately US$ 400,000 only.

As a global leader in the medical device industry, Synthes has a long reputation for setting the highest legal and ethical standards in the development and commercialization of medical products focused on improvement in patient care. Synthes maintains a comprehensive legal and ethical compliance program, which is regularly reviewed and updated.

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Josh Sandberg

Josh Sandberg is the President of Ortho Spine Partners and Partner for The De Angelis Group. He also serves as Co-Founder and Editor of OrthoSpineNews.

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  1. Based on what was written in the indictment it's quite evident that there was an alleged, yet conscious cover up by the powers to be, especially when the government names the co- conspirators. No need to name them its already an embarrassment to the company and their careers. In addition a surgeon involved in the indictment even recommended an IDE with clinicians that had no financial ties to Synthes. Unfortunately Person #7 didn't want to go down that road. Synthes is no longer perceived as that once respected and revered company. Look at the Management Team and what transpired with Globus. Hansjoerg has made too much money, has gotten complacent and has is too old to care. He has surrounded himself with his Harvard Executive Educated Management Team……. Now it's up to the government to prove their case and stop behaving like a Paper Lion

  2. Oh, how fun it will be to see these people finally get the pressure and scrutiny that they deserve. Let us hope that the justice is swift and severe…

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