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Acclarent Trial Media Monitoring 6/29/16
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Acclarent Didn't Tell FDA About Adverse Events, Jury Told
Jun 28, 2016 | Law360
By Brian Amaral
Medical device maker Acclarent Inc. never told regulators that half the patients in a 2007 study for a sinus clearing device developed infections, even though that information should have been turned over, a federal jury in Boston was told Tuesday.
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Acclarent Didn't Tell FDA About Adverse Events, Jury Told
Jun 28, 2016 | Law360
By Brian Amaral
Medical device maker Acclarent Inc. never told regulators that half the patients in a 2007 study for a sinus clearing device developed infections, even though that information should have been turned over, a federal jury in Boston was told Tuesday.
Dr. Anjum Khan, who helps study medical devices for U.S. Food and Drug Administrationclearance, testified that a preliminary study on Acclarent’s Stratus sinus-spacer shortly after it was approved included only information about one patient getting a nosebleed. But as she prepared for testimony in a trial of two former Acclarent executives, she said, she learned that seven of 14 patients got infected, and that in another case, the plastic device that was supposed to rest snugly in one part of a person’s sinus to battle infections migrated to another.
Acclarent, she said, never turned over that information.
“There were more adverse events that they didn’t tell us about,” Khan said on direct examination by Assistant U.S. Attorney Sara Bloom.
Turning over that information would have affected later studies, Khan said, because it would have been disclosed to patients who signed up to be experimented on. The informed consent documents for later studies never said that the Stratus spacer could cause infections. A later study also proved problematic when small steel wings used to keep the Stratus spacer in place kept falling off, Khan said, prompting the FDA to temporarily shut it down.
Tuesday was Khan's second day of testifying in the off-label promotion fraud case against ex-Acclarent CEO William Facteau and former Vice President of Sales Patrick Fabian. Federal prosecutors say that Facteau and Fabian oversaw a company that constantly misled the FDA, as well as Johnson & Johnson, which eventually bought out the company for a tidy sum.
The failure to fully disclose potential risks of the Stratus device was part of a pattern, prosecutors say, of fraudulent deception at Acclarent, and the company’s rush to get the product to market.
The company chose to get the Stratus spacer approved via the FDA's 510(K) process. Acclarent did so by certifying that the device was significantly similar to a sinus stent — essentially taking up space in a patient’s sinus to keep it open and clear the area from infections. The Stratus spacer was a tube-like device with a small balloon on the end.
For prosecutors, the trial will hinge on what was supposed to go into that balloon. Acclarent told the FDA again and again that it intended to fill it with saline — salt water. But all along, federal prosecutors say, Acclarent designed the device to be used with the steroid Kenalog.
If the company had been upfront about that, it might have needed to go through the much pricier premarket approval process, involving extensive clinical studies, rather than the 510(K) process, Khan testified Tuesday.
She only later discovered that the device was essentially useless, and perhaps even harmful, if filled with saline, she testified. The saline would run right out of the device in just a few minutes, even though the device was supposed to stay there for upwards of two weeks, which could have caused infections.
Prosecutors say that even as Acclarent tried and failed to get the device approved for use with the steroid Kenalog, the company continued to promote the device that way, creating a new intended use that had not been cleared by regulators.
On cross-examination, which began Tuesday afternoon, defense attorney Reid Weingarten ofSteptoe & Johnson LLP pressed Khan about the laws surrounding medical devices and their clearances.
Acclarent had gone back to the FDA repeatedly to try to expand on the device's use, Weingarten noted. And at no point did the FDA insist on reclassifying the device as more risky than class 1, the lowest level, he said.
But, Khan countered, the FDA had to rely on Acclarent’s representations, which she considered lacking.
Weingarten also pressed Khan to acknowledge that it is legal for a company to get a device approved for an intended use, even if the company has other intended uses in mind.
Defense attorneys say that any true and nonmisleading statements about the Sinus spacer, even for its off-label use, are protected by the First Amendment.
They also say that officials like Khan were well=aware that the company intended to expand on the original approval of the device as a sinus spacer to include use with the steroid Kenalog. It was part of the iterative or “building block” approach to device approval, Weingarten said Tuesday.
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 Sonsini 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 Edrienne Su.
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