Atherton resident convicted of violating Food, Drug and Cosmetics Act

Former Acclarent CEO convicted of 10 misdemeanor counts but acquitted of 14 felony charges

A press release from the U.S. Attorney's Office says that Atherton resident Bill Facteau, 47, the former CEO of Menlo Park medical device company Acclarent, has been convicted by a federal jury in Boston of 10 misdemeanor charges connected to the sales of Acclarent medical devices.

He was acquitted of 14 more serious felony charges of conspiracy, wire fraud, and adulteration and misbranding.

Bill Facteau. (LinkedIn photo)
Convicted of the same misdemeanor charges was Patrick Fabian, 49, of Lake Elmo, Minnesota, a former vice president of sales for Acclarent.

Acclarent was sold to Johnson & Johnson in 2010 for $785 million.

According to a press release from a public relations firm, Mr. Facteau's lawyer, Reid Weingarten, said he will appeal the conviction.

The maximum sentence for each count is one year in prison, one year of supervised release and a fine of $100,000 or twice the gross gain or loss.

The statement from the U.S. Attorney's Office says the jury concluded that the two men "caused the unlawful distribution of a medical device known as the Relieva Stratus Microflow Spacer ("Stratus") for uses not cleared or approved by the U.S. Food and Drug Administration."

Prosecutors said the men wanted "to create a projected revenue stream that would make Acclarent an attractive business for either an initial public offering or acquisition."

The public relations firm's press release says "the jury specifically found the product's labeling was not false or misleading, and that the product in question did not lack adequate directions for use. Proof at trial made clear no injuries were associated with use of the device, which was widely used by surgeons to treat patients with chronic sinus problems."

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1 person likes this
Posted by Lawyer up
a resident of Woodside: Emerald Hills
on Jul 22, 2016 at 1:16 pm

Best defense money can buy. If ya got it, spend it. Worked for OJ, $50k a day in legal fees

It's a great country!

1 person likes this
Posted by Srini?
a resident of another community
on Jul 22, 2016 at 6:43 pm

Interesting dilemma. The guys certainly need to be held accountable, mostly for stupidity. If the product is proven to work, and do exactly what theyy claimed it would do, then the only harm is that they did not follow protocol. Rules are made for a reason, especially when it comes to medical devices and products. Chances are that this would have been approved, and with a litle patience, they wouldn't be in this mess. The other part of this is the doctors who used this device for their patients. Did it occur to them to check and see if this was a certified or approved product? Was the bill of goods they were sold worth compromizing their patients well being?

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