Nov 4, 2009 02:00 PM
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A company called Stryker Biotech was in court last week defending a bone-growth product it sold for years, despite reports that it would "drift" in the body, causing bones to grow in random locations.
To boost sales of a product called OP-1 Implant with a bone-setting filler called Calstrux. The mixture was not approved by the FDA, and in fact OP-1 was only supposed to be used on a rare bone disease, not on people who simply needed to have their bones knit together fast. Surgeons were urged by Stryker to shape the OP-1/Calstrux paste into a "tootsie roll" or "vienna sausage" shape and implant it. Unfortunately, the substance often broke down and drifted through patients' bodies. Bids of sprouting bone that looked like "oatmeal" or "white sesame seeds" would appear far from the site of injury where the substance had been implanted.
According to NPR:
When those wayward bits bit landed in places they shouldn't have, bone sprouted and, in some patients, had to be surgically removed. According to the papers, then-president of the company, Mark Philip, touted the combination at sales meetings as "perfect" even while knowing it wasn't FDA approved and that the company was receiving complaints about nasty side effects.
The indictment say the president and sales team continued to promote the illegal mixture for two more years, until Feb. 2008, without informing surgeons of the side effects to keep sales rolling.
Stryker and some of its partners have been indicted on several counts of wire fraud and conspiracy.
via NPR (thanks, Kle!)
Send an email to Annalee Newitz, the author of this post, at annalee@io9.com.
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