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Acclarent Trial Media Monitoring 6/21/16
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Ex-Acclarent Execs Slam Gov't's Tactics At Fraud Trial
Jun 20, 2016 | Law360
By Brian Amaral
Two former Acclarent executives on Monday asked the federal judge overseeing their off-label promotion fraud trial in Boston to “admonish” government lawyers “with increasing sternness” about what they view as hearsay testimony and forays into areas previously ruled out of bounds.
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Ex-Acclarent Execs Slam Gov't's Tactics At Fraud Trial
Jun 20, 2016 | Law360
By Brian Amaral
Two former Acclarent executives on Monday asked the federal judge overseeing their off-label promotion fraud trial in Boston to “admonish” government lawyers “with increasing sternness” about what they view as hearsay testimony and forays into areas previously ruled out of bounds.
Ex-Acclarent CEO and vice president of sales Patrick Fabian, in a renewed motion in limine, asked U.S. District Judge Allison Burroughs to crack down on federal prosecutors for bringing up safety concerns with the Stratus medical device, now at the center of a trial that accuses the two men of fraud on the Food and Drug Administration.
“For reasons known only to the government, the prosecutors elected to bring criminal charges in a purported off-label promotion case where: (a) patients benefitted from the alleged off-label use (which use was, of course, completely legal); (b) no patient ever was harmed from that use; and (c) the FDA never deemed it necessary to warn anyone about any potential risk of harm,” lawyers for Facteau and Fabian wrote. “Having made that decision, the government should not be permitted to raise the specter of safety risks to try to frighten the jury into a factually and legally unjustifiable conviction.”
Lawyers for the government have also improperly asked witnesses about their “understanding” of what other people were telling them, even though those statements were often written, and have not stopped asking leading questions, leading to numerous objections and sidebars that might confuse jurors, the executives said.
At issue is the Stratus, touted as a revolutionary device in the ear, nose and throat field. Acclarent, which was later acquired by Johnson & Johnson, sought FDA approval of the device for use in patients with chronic sinus infection. The company told the FDA that the device was substantially similar to devices already on the market that are used to make a space in the sinuses to clear an area from excess mucus.
But all along, federal prosecutors say, the “intended use” of the device was much different: It was inserted into a patient’s sinus not just to provide breathing room, but to deliver the topical steroid Kenalog, which fights sinus infections. Acclarent sales reps have testified that they received no training on the use of the device as a so-called spacer; the small balloon at the tip of the device was never filled with saline, as the company told the FDA, always with the steroid Kenalog.
But bringing up purported safety issues — like the breaking of wing attachments that help keep the device rooted in the patient’s sinus for several weeks — has no place in the trial, Facteau and Fabian said.
“The government’s repeated efforts to make this trial a referendum on whether defendants placed a 'dangerous' product into the stream of commerce constitute not only a variance from the indictment but also an improper attempt to inflame the passions and prejudices of the jury,” Facteau and Fabian wrote.
For example, a doctor from Virginia, Michael Armstrong, testified that the Stratus spacer was inserted by puncturing part of the sinus with a “nail.” It’s really just a needle, the ex-execs said.
Government prosecutors are also raising issues that were never previously disclosed and not at issue in this trial, the executives said, like the FDA telling Acclarent explicitly that the device couldn’t be used with steroids.
The case has also been marked with frequent hearsay evidence, and the government can’t just say that it’s not being introduced for the truth of the utterance, defense attorneys said. Prosecutors just don’t want to call the people who made the statements because they’d then be subjected to cross, Facteau and Fabian said. The statements should no longer be allowed at trial on the “state of the mind” of the witness exemption, they said.
For example, Armstrong, the Virginia doctor, was asked about what an unnamed sales representative told him about how the Stratus spacer should be used and also testified about conversations with unnamed doctors.
“The government plainly intends for the jury to believe the truth of the matters asserted; the witness’s state of mind is wholly irrelevant; and the government’s repeated invocation of that exception is causing the exception to swallow the rule — in a manner that is robbing defendants of their Confrontation Clause rights,” lawyers for Facteau and Fabian said. “It should be stopped.”
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 Patricia K. Cole.
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