Tuesday, June 16, 2009

Synthes Indicted over Norian

The SpineBlogger knew it was coming, it was only a matter of time. At 4:27 p.m. today, June 16th Reuters reported that the US Attorney Michael Levy for the Eastern District of Pennsylvania filed a 97 count (ouch!) indictment against Synthes and Norian for conducting unauthorized clinical trials using Norian SRS and Norian CRS between 2002 and 2004. Allegedly, the companies encouraged the use of Norian on patients with Vertebral Compression Fractures without approval by the Food and Drug Administration, aka "off label use."

If one knows the history of Norian, it was initially intended for General Orthopaedic Surgery. The initial sites included Mass General where Dr. Jesse Jupiter published a few "White Papers" on the efficacy of Norian in distal radius fractures. Over 200 patients were treated with Norian and after the third death, the company decided to withdraw the product from the market (exemplary judgement).

If the company had generated little revenue from the use of this product, how STUPID was the management team at Synthes? It's a wonder that some of those Harvard graduates continue to exhibit some poor judgement, what a waste of an education.

Norian which is based in West Chester, Pennsylvania faces a $26 million dollar fine, while Synthes faces an $8.8 million dollar fine. The fines themselves are a joke. Hansjoerg Wyss has endowed Harvard with more than what the potential penalties total. When is the government going to get serious about making an example out of the Wild Wild West environment that exists in the US Spine Market? Sounds to me like Mr. Levy and the Grand Jury are as soft on Synthes like the NJ Attorney General. Who knows maybe they are related? The Spineman wants to know what you think?

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