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Acclarent trial media monitoring 6/10/16
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Off-Label Use Was Focus Of Training At Acclarent, Rep Says
Jun 9, 2016 | Law360
By Brian Amaral
A former Acclarent sales representative testified Thursday that when she started working there in 2008, the focus of her training and her sales pitch was on the off-label use of a new device that is now the focus of the fraud trial of two company executives in Massachusetts federal court.
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Off-Label Use Was Focus Of Training At Acclarent, Rep Says
Jun 9, 2016 | Law360
By Brian Amaral
A former Acclarent sales representative testified Thursday that when she started working there in 2008, the focus of her training and her sales pitch was on the off-label use of a new device that is now the focus of the fraud trial of two company executives in Massachusetts federal court.
The Stratus, which was inserted into a patient’s sinus through the nose to relieve sinusitis, gotU.S. Food and Drug Administration approval in 2006 to essentially occupy space and moisten the area with saline, allowing the sinus to air out and clear infections. But as her former bosses William Facteau and Patrick Fabian looked on from the defense table in a Boston courtroom, Mary Vanderkarr testified that she received very little training beyond giving a doctor a passing mention of that FDA-approved use.
Instead, the sales materials were mostly about delivering the topical steroid Kenalog directly to the ethmoid sinus, a difficult-to-reach area right between the eyes, Vanderkarr testified. Drug delivery had not been approved by the FDA.
Their focus on the drug and the sales reps’ desire to lead doctors to discuss it was so stark that they often joked about wearing pins that said, “Ask me about Kenalog.” That way, the doctor would technically be the first one to bring it up, at least orally, keeping them on the right side of FDA guidelines.
“I was told that it was approved for use with saline and that surgeons could use it how they want,” Vanderkarr testified. “And that they probably wouldn’t use it with saline.”
Her testimony will continue Friday morning with more direct examination and the defense’s cross-examination. The beginning of direct examination was at times rocky and marked by failure to remember specifics.
For example, prosecutor Sara Bloom asked Vanderkarr about mock sales sessions during training with Fabian, who would play the role of a surgeon. Bloom asked Vanderkarr whether she remembered who brought up the off-label use of the Stratus first during those sessions, Vanderkarr or Fabian, but Vanderkarr said she could not remember, even when presented with her previous testimony.
Vanderkarr received immunity from criminal prosecution to testify in the case.
Federal prosecutors say Acclarent’s off-label promotion defrauded doctors, the FDA andJohnson & Johnson, which bought the company for $800 million in 2010 but had to pull the product from shelves in 2013.
Acclarent knew all along that it intended to market the device to administer Kenalog, prosecutors say, and only said that it was a spacer because that required fewer regulatory hurdles and safety tests.
Facteau and Fabian argue that off-label promotion is protected by the First Amendment if it’s true and not misleading, and that while some sales reps might have gone too far for regulators’ comfort — for example, by bringing up off-label uses of the Stratus before doctors did — they did so in good faith, hoping to improve patient care. The FDA knew that Acclarent wanted to get the device approved for Kenalog, and only maddening red tape stood in the way, lawyers for Facteau and Fabian have said.
Earlier on Thursday, defense attorneys tried to poke holes in the testimony of a doctor whoraised issues with the safety of the Stratus and the way it was being marketed.
Ear, nose and throat specialist Michael Armstrong has criticized Acclarent’s studies on the device, calling them cursory, but his own studies on unrelated matters also did not use randomized samples, defense attorney Michael Pineault of Clements & Pineault LLP said during cross-examination. Armstrong also didn’t deviate much from Acclarent’s proposed research when he put forward his own ideas to study the device’s safety and usefulness, Pineault said.
Also, even though Armstrong had testified that he was concerned about the safety of the device, the only potential risks were in the device itself, not the drug Kenalog, Pineault said. The device itself contained a small needle that sliced through tissue near the eyes, which might damage the optic nerve. Kenalog, on the other hand, is available over the counter in drugs like Nasacort.
“All the risks — those all have to do with the Stratus as it was cleared by the FDA?” Pineault asked on cross-examination.
“Yes,” Armstrong responded.
The government is represented by Sara Bloom, Patrick Callahan, William Weinred and Raquel Toledo of the U.S. Department of Justice.
Facteau is represented by Reid Weingarten, William Hassler and Jessica Urban of Steptoe & Johnson LLP, Michael J. Pineault of Clements & Pineault LLP and Leo Cunningham and Lisa Davis of Wilson Sosini Goodrich & Rosati PC.
Fabian is represented by Kristen A. Kearney, Frank A. Libby Jr., Daniel LaPenta and Brian J. Sullivan of LibbyHoopes PC.
The case is U.S. v. Facteau et al, case number 1:15-cr-10076, in the U.S. District Court for the District of Massachusetts.
--Editing by Brian Baresch.
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