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Acclarent Trial Media Monitoring 6/14/16
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Rep Touted Acclarent Device After Promotion Ban, Jury Told
Jun 13, 2016 | Law360
By Brian Amaral
Acclarent Inc. employees developed plans to tell doctors about the benefits of a sinus-clearing device, even after the company agreed to stop promoting it amid questions about its safety and efficacy, a company sales representative testified Monday in Massachusetts federal court in the fraud trial of two former executives.
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Rep Touted Acclarent Device After Promotion Ban, Jury Told
Jun 13, 2016 | Law360
By Brian Amaral
Acclarent Inc. employees developed plans to tell doctors about the benefits of a sinus-clearing device, even after the company agreed to stop promoting it amid questions about its safety and efficacy, a company sales representative testified Monday in Massachusetts federal court in the fraud trial of two former executives.
Mary Vanderkarr told jurors that in April 2011, another sales representative developed marketing materials that touched on the benefits of, among other things, the Stratus device. A year earlier, Ethicon Inc., the Johnson & Johnson subsidiary that bought Acclarent, had ordered the company to put the device on a catalog list over questions about its off-label promotion, meaning doctors could buy it but the company would not promote it.
The representative suggested on a conference call and in related slides that they tell surgeons that “they could use the Stratus,” Vanderkarr testified Monday in direct examination during herthird day of testimony.
In the trial’s second week, federal prosecutors are trying to establish continued promotion of the device as evidence that former CEO William Facteau and Vice President of Sales Patrick Fabian intended to skirt U.S. Food and Drug Administration laws and commit fraud against the FDA, doctors, and Johnson & Johnson.
At issue is the intended use of the Stratus device. Acclarent told the FDA that it was substantially similar to other sinus devices: It occupied a space in the sinus to allow breathing room, clearing mucus and infections. By saying it was substantially similar, prosecutors say, Fabian and Facteau were able to rush it to market without expensive but necessary tests.
All along, prosecutors say, Acclarent intended the device not for use as a spacer, as they’d said, but as a way to deliver the topical steroid Kenalog, which it was not approved to do.
Vanderkarr also testified that she wasn’t trained to tell doctors that the FDA had suspended a study of the device’s ability to remain in the sinus, or to tell doctors about some of the device’s off-label precautions, side effects and dosage.
On cross-examination, however, Vanderkarr agreed repeatedly with defense attorneys that she did not believe she was doing anything wrong and that doctors found the device helpful.
“You never thought you were part of a criminal conspiracy, right?” said Reid Weingarten ofSteptoe & Johnson LLP, an attorney for Facteau.
“Correct,” Vanderkarr testified.
Fabian attorney Frank Libby of LibbyHoopes PC also challenged prosecutors’ contentions that Acclarent never even bothered to train its employees on the approved use of the Stratus as a spacer with saline, based on an early revision of a training document. That document posed hypothetical prompts from hypothetical doctors, and mentioned the unapproved benefits of Kenalog but not the approved benefits of saline. Later revisions, though, did mention that the saline was used in the device to make it easier to remove after two weeks.
Prosecutors say that saline didn’t even work in the Stratus at all, proof that Facteau and Fabian misled regulators about its true intended use.
Defense attorneys, however, argue that Facteau and Fabian cannot be prosecuted for their sales reps’ true and non-misleading statements about off-label use because of the First Amendment.
That argument got a boost on Monday when Vanderkarr repeatedly said she never lied or misled to doctors about the use of the Stratus, even off-label.
“There’s nothing untruthful or misleading that you told doctors about the Stratus, right?” Libby said.
“Correct,” Vanderkarr testified.
Libby also quizzed Vanderkarr on FDA rules on the medical device field. It is her understanding, she said, that it’s not a crime in and of itself to provide truthful, non-misleading information about off-label use. It’s also true that a company can sell a medical device even if it knows the doctor is going to use it off-label, she said.
But other edicts led to confusion, she testified: Where was the line between the FDA guideline that said not to bring up off-label use with the doctor first, and the training that encouraged employees to lead the doctors to bring up off-label discussions first?
“Much of this is completely confusing and chaotic, is it not?” Libby said.
“Yes,” Vanderkarr said.
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 and Michael J. Pineault of Clements & Pineault LLP.
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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