A federal jury on Wednesday convicted two former top executives at medical device company Acclarent, a unit of drug giant Johnson & Johnson (JNJ), for improperly marketing a sinus-opening device.
The Boston jury found Facteau and Fabian guilty on 10 misdemeanor counts of “introducing adulterated and misbranded medical devices into interstate commerce,” the U.S. Attorney’s Office in Massachusetts announced, but cleared them of 14 more serious felony counts of conspiracy and fraud.
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The defendants were former Acclarent CEO William Facteau and former VP of Sales Patrick Fabian. Justice Department attorneys alleged that the two executives knowingly promoted an Acclarent device called the Relieva Stratus Microflow Spacer, which is approved for opening up sinuses, for use as a delivery device to inject steroids. The Food and Drug Administration (FDA) had explicitly rejected approving the device for those purposes.
Prosecutors had said that the two executives’ alleged marketing for unintended uses was meant to maximize revenue in a bid to “make Acclarent an attractive business for either an initial public offering or acquisition.” J&J acquired the company in 2010.
Facteau’s lead attorney, Reid Weingarten, and Fabian’s lead attorney, Frank Libby, released a joint statement after the jury verdict praising their clients’ acquittal on the felony charges while promising to appeal the misdemeanor convictions, which did not require prosectors to prove criminal intent.
“It is difficult to understand how someone in America could be convicted of even misdemeanor crimes without a finding of intentional wrongdoing,” said Weingarten.
The appeals process will also add to an ongoing debate about the legality of preventing marketers from making truthful and non-misleading statements about medical products, even if the statements don’t reflect uses that have received FDA approval, Libby told Coins2Day in a telephone interview. “Due process and the First Amendment are at the heart of this case,” he said.
Last year, the FDA lost an off-label marketing case against pharma company Amarin because the firm’s promotional claims were truthful.