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Acclarent trial media monitoring 6/9/16
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Marketing Came Before Research At Acclarent, Doc Testifies
Jun 8, 2016 | Law360
By Brian Amaral
An ear, nose and throat specialist told a Massachusetts federal jury Wednesday at the fraud trial of two Acclarent Inc. executives that he repeatedly raised concerns about the company’s marketing of a new medical device, saying it differed from its FDA-approved label.
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Marketing Came Before Research At Acclarent, Doc Testifies
Jun 8, 2016 | Law360
By Brian Amaral
An ear, nose and throat specialist told a Massachusetts federal jury Wednesday at the fraud trial of two Acclarent Inc. executives that he repeatedly raised concerns about the company’s marketing of a new medical device, saying it differed from its FDA-approved label.
Michael Armstrong of Richmond, Virginia, told the Boston jury that while he was excited about the possibilities of the Stratus device to help people with sinus infections, he was also concerned that it had not been properly studied. He was the first witness in the fraud case against former Acclarent CEO William Facteau and Vice President of Sales Patrick Fabian, who are accused of defrauding the U.S. Food and Drug Administration, doctors like Armstrong, and Johnson & Johnson, which eventually bought Acclarent for $800 million in 2010, by lying about the intended use of the device.
Prosecutors say the Stratus was billed it as a spacer to give a sinusitis suffer breathing room but was actually a drug delivery device.
Armstrong, whom Acclarent targeted as a customer after the device was cleared in 2006, began raising questions about the Stratus two years before the buyout at a medical junket in Chicago called Sinus Forum, he testified.
“I felt the marketing had jumped years ahead of the research,” Armstrong testified.
At issue is the intended use of the device — a short tube wrapped with a balloon attached to a long, sharp pin that is inserted into a patient’s sinus. The tube and balloon are left there for more than two weeks. Acclarent, federal prosecutors say, told federal regulators that it was substantially similar to other devices that are intended to create space to air out a patient’s sinus to clear an infection. By claiming it was substantially similar, it avoided expensive clinical tests.
But all along, prosecutors say, Acclarent intended to use the device to deliver the topical steroid Kenalog, which is found in over-the-counter medications like Nasacourt.
Armstrong testified Wednesday that throughout Sinus Forum in 2008, there was little mention of filling the balloon with just salt water to slowly release and lubricate the area, as Acclarent said. Instead, it was all about delivery of Kenalog, Armstrong testified. That differed substantially from the 510(k) forms that Acclarent submitted to the FDA to get premarket approval, he said.
“That is not the same as how it was presented” to doctors at Sinus Forum, he said.
Training materials showed the small balloon filled with a white liquid that appeared to be Kenalog, Armstrong testified. Prosecutors showed a video from Sinus Forum of a doctor using the Stratus. The doctor said that it was used for drug delivery. Kenalog, when applied directly to the sinus, can help reduce symptoms, but it’s particularly hard to reach the ethmoid sinus.
According to Armstrong, when someone in the audience brought up clinical studies at a forum presented by an Acclarent consultant doctor, the doctor responded, “You are my researchers. Go home and try it.”
“It was shocking,” Armstrong said Wednesday.
Armstrong said that a few days after Sinus Forum, he emailed Acclarent executives and told him he’d like to take part in a clinical study testing the efficacy and safety of the Stratus as a drug delivery device.
A few days later Acclarent sent him draft clinical studies, but they were woefully insufficient, he said; they were not randomized and not blinded, important steps to ensure the worthiness of a study.
“I felt like it would really invalidate the results,” Armstrong said.
The case could have ramifications for some unsettled areas of the law and an ongoing debate about promotion of off-label drugs — for example, when a sales rep is pitching a drug to a doctor, who can bring up off-label uses first?
Facteau and Fabian say that their sales reps’ off-label promotion of the Stratus is protected by the First Amendment because it was true and not misleading, and that doctors were within their rights to use the drug off-label. Nobody was killed, blinded or seriously injured by the device, and no lawsuits came as a result, they've argued.
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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