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Unauthorized testing leads to unusual consequences

Tuesday, October 5th, 2010



A medical device company with U.S. headquarters in West Chester has pleaded guilty to using its product in unauthorized human experiments.

In an unprecedented move, the U.S. Attorney in Philadelphia signed a plea agreement with the company Synthes that it must sell off its subsidiary, Norian.

Norian was responsible for testing its bone repair-product on patients without approval from the FDA.

Aarti Shetty, an industry analyst at Frost and Sullivan, says she’s never seen a deal like it before where a company had to sell off a piece of itself.

“It’s going to be a big hurdle to sell the company as such,” says Shetty. “It’s a product in an emerging space, but there have been so many problems with it that I’m just worried as to who would come up to the table and buy Norian.”

Shetty says a sale depends on what Norian has to offer, such as manufacturing facilities or distribution platforms.

Synthes must sell Norian by May 24, or start paying fines.


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