A federal appeals court on Thursday upheld the convictions of two former executives of Acclarent Inc, a medical device maker now owned by Johnson and Johnson, for distributing a product for unapproved uses.
BOSTON, Dec 14 (The Justice Now) – On Thursday, the federal appellate court upheld the case of two former top executives of Acclarent Inc., a medical device manufacturer currently part of Johnson & Johnson, for distribution of a product that was not approved for purposes.
The 1st U.S. Circuit Court of Appeals in Boston denied arguments by lawyers representing William Facteau and Patrick Fabian that their convictions violated their freedom of expression and due process rights defined by the U.S. Constitution.
In the interim, U.S. Attorney Joshua Levy, in a statement, said that the ruling was in line with what he called the “central legal theories” of the case involving Facteau, the former chief executive officer, as well as Fabian, the former vice sales president.
“These issues are fundamental to the work that the FDA does every day to protect patients and ensure that they receive safe medical devices,” Levy stated.
Reid Weingarten, a lawyer for Facteau at Steptoe LLP, and Frank Libby, a legal counsel on behalf of Fabian of Libby Hoopes Brooks & Mulvey, have yet to respond to requests for comments.
Prosecutors claimed Facteau and Fabian were in charge of the development of a device that the company was planning to use to administer steroids, which the U.S. Food and Drug Administration did not approve.
The product was known as the Relieva Stratus MicroFlow Spacer or Stratus. In 2006, the FDA 2006 approved Acclarent to sell it as a saline-only product to help keep the sinuses open following surgery.
Prosecutors have alleged Facteau and Fabian were in charge of the illegal production of Stratus as a drug delivery device to deliver steroids, such as Kenalog-40.
In 2016, they were found guilty of misdemeanor charges for infusing medical devices branded as impure and not labeled adequately into commerce between states. However, they were cleared in 2016 of severe fraud charges.
After a delay of four years, Facteau and Fabian were sentenced to fines of $500,000 and $1 million each. Acclarent was a company that J&J purchased in 2010. In 2016, it settled the civil lawsuits for $18 million.
When they appealed, the company’s lawyers argued they were not prosecuted correctly based on honest, truthful public statements regarding their product. They were also found guilty based on an original interpretation of a constitutionally unclear FDA regulation.
They claimed that prosecutors applied retroactively the new understanding of an FDA regulation that requires manufacturers to inform the FDA of the gadget’s “intended use” before marketing the device.
But U.S. Circuit Judge Kermit Lipez ruled that the defendants could not clarify how “the law lacked sufficient clarity to apprise them of when they would be criminally liable for distributing a device with an unapproved intended use.”
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