BOSTON, July 20, 2016 /PRNewswire/ -- Bill Facteau, former CEO of medical device company Acclarent, has been unanimously acquitted on all 14 felony counts pending against him in federal court from an April 2015 indictment. These included one count of conspiracy, three counts of wire fraud, and 10 counts of felony adulteration and misbranding. Four additional counts were dismissed before trial.
In acquitting Facteau of the felonies, the jury found him guilty of ten misdemeanor counts of misbranding and adulteration under the strict liability provisions of the Food, Drug & Cosmetic Act (FDCA), which do not require proof of any wrongful intent. 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.
Reid Weingarten, Mr. Facteau's lawyer, immediately informed the Court he would move to set aside the misdemeanor charges on multiple grounds, including the lack of due process associated with the non-intent misdemeanor convictions, and the fact that instructions received by the jury permitted the defendants----- in violation of the First Amendment and recent Court of Appeals decisions---- to be convicted based on truthful, non-misleading statements by sales personnel.
Mr. Facteau said, "I'm gratified the jury rejected the Department of Justice's attempt to tarnish Acclarent's hard won reputation and that of its former employees. We are confident the misdemeanors will also be successfully addressed."
Mr. Weingarten said, "I am grateful that the jury exonerated Mr. Facteau of all charges requiring criminal intent and affirmatively concluded that the case did not involve false or misleading statements. It is difficult to understand how someone in America could be convicted of even misdemeanor crimes without a finding of intentional wrongdoing. We will fight vigorously to overturn these few remaining charges and will not rest until Mr. Facteau is completely vindicated."
Acclarent, recognized as the leader in the development of Balloon Sinuplasty (BSP) products, was acquired by Johnson & Johnson (JNJ) in 2010 for $785 million. The Department of Justice (DOJ) contended that employees at the company conspired to defraud the FDA and JNJ by commercializing a 510k cleared device called Stratus, in a manner in which DOJ unsuccessfully argued exceeded the FDA clearance that Acclarent had obtained. As noted, the jury rejected the conspiracy claims.
Kevin Knight, Media
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SOURCE Kevin Knight