Johnson & Johnson's Acclarent Unit in $18 Million U.S. Settlement
July 22 2016 - 5:10PM
Dow Jones News
Johnson & Johnson's Acclarent unit paid more than $18
million to resolve U.S. claims of illegally marketing a medical
device, a case that led to two senior executives being convicted of
related charges.
The agreement, which Johnson & Johnson disclosed in
regulatory filings without giving specifics, includes a one-time
payment of $18 million, plus interest, according to documents
released on Friday by the Justice Department.
The case, which had been kept under seal until the criminal case
against the executives was resolved, stems from a so-called
whistleblower claim filed in 2011 by Melayna Lokosky, who had been
a saleswoman for Acclarent, a medical-device startup that Johnson
& Johnson bought in 2010.
A spokeswoman for Johnson & Johnson said the company has
since put in place tighter compliance controls. She noted the
agreement, which didn't include an admission of liability or
wrongdoing, resolves alleged conduct that took place almost
entirely before Johnson & Johnson acquired Acclarent.
According to court documents, Acclarent senior managers directed
salespeople to promote one of its products as a drug delivery
device even though U.S. health regulators had rejected the use. The
device, Stratus, had only been cleared as a spacer to maintain an
opening to the sinus for 14 days after surgery.
Under the terms of the agreement, Ms. Lokosky received $3.5
million, plus interest, and Acclarent paid her legal expenses.
Write to Maria Armental at maria.armental@wsj.com
(END) Dow Jones Newswires
July 22, 2016 16:55 ET (20:55 GMT)
Copyright (c) 2016 Dow Jones & Company, Inc.
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