Acclarent Trial Media Monitoring 6/28/16

Client Attorney Privileged/Attorney Work Product/At Request of Counsel

Online Sources

1. Acclarent Device Quickly Raised Alarms At FDA, Jury Told

   Jun 27, 2016 | Law360

   By Brian Amaral
   
   
   A doctor who helps oversee approval of medical devices for the Food and Drug Administration told a federal jury in Boston on Monday that within months of an Acclarent device's approval in 2006, the company came back to expand on its use — raising concerns among regulators in Washington.

Client Attorney Privileged/Attorney Work Product/At Request of Counsel

Client Attorney Privileged/Attorney Work Product/At Request of Counsel

Online Sources

1. Acclarent Device Quickly Raised Alarms At FDA, Jury Told

   Jun 27, 2016 | Law360

   By Brian Amaral

   A doctor who helps oversee approval of medical devices for the Food and Drug Administration told a federal jury in Boston on Monday that within months of an Acclarent device's approval in 2006, the company came back to expand on its use — raising concerns among regulators in Washington.
   

   The Stratus device was originally approved in August 2006 for use as a sinus spacer because of its purported similarity to a stent already on the market. The purpose of the device, Acclarent told FDA officials like Dr. Anjum Khan, was to occupy a space in a sinus to help clear out the area and battle infections, and to emit salt water to lubricate the area.
   

   By April 2007, however, the FDA and Acclarent were in communication about changing its indications for use. Acclarent came back with a suggested expansion: It wanted to inject the device with not just saline but also a “therapeutic agent,” possibly drugs.
   

   “We were concerned,” Khan testified Monday.
   

   The FDA quickly shot down the idea, Khan testified. Combining a drug with a medical device would need much more rigorous safety tests, because it would involve multiple departments in the FDA. And it likely couldn’t have dodged rigorous safety checks that Acclarent avoided by applying via the 510(K) process and saying that it was substantially similar to another device, Khan said.
   

   Monday’s testimony was an effort to underscore the government’s allegations that Acclarent CEO William Facteau and Vice President of Sales Patrick Fabian engaged in a scheme to mislead and defraud the FDA, as well as Johnson & Johnson, which later bought the company. Facteau and Fabian were indicted in April 2015.
   

   By telling the FDA that the device was substantially similar to another spacer — through the process known as 510(K) clearance — Acclarent was able to avoid pricey studies in the premarket approval process, including tests on animals, prosecutors say. All along, Acclarent’s intention was to sell the device as a way to deliver the topical device Kenalog, prosecutors say. It was, the government alleges, the path of least resistance, paved with lies and obfuscations.
   

   And even as the FDA told Acclarent that it couldn’t immediately get approval for use of the device with a drug, the company continued to baldly promote that off-label use, prosecutors allege.
   

   Accepting Acclarent’s proposal to use the device with therapeutics like steroids would likely have triggered the much more difficult path, Khan said. Instead of merely telling the FDA that the device was similar to something already on the market, and certifying that it posed no real safety risks, the dual use as a medical device and drug deliverer would have required safety tests, Khan said.
   

   The Stratus device was a straight tube, shaped somewhat like a pen, that was inserted by an ear, nose and throat surgeon into a patient’s sinus through the nose. It had a small balloon attached to the end, dotted with small holes so it could emit liquid. A key question has emerged at this trial: What kind of liquid? Was it saline, or was it the steroid Kenalog?
   

   Khan testified Monday that the FDA cleared the Stratus based on Acclarent’s representations that the device would emit salt water over two weeks. That would held lubricate the area and fight infections. Prosecutors, however, say that the saline came out in just minutes, and that nobody actually used the device that way.
   

   Khan, who will take the stand again on Tuesday for more direct examination, is the first FDA witness to testify in a trial that will be closely watched in the medical device world. Facteau and Fabian say that their employees’ true and not-misleading statements to doctors about off-label use of the device are protected by the First Amendment, and that the FDA knew all along that they envisioned using it with the steroid Kenalog. 
   

   Their attorneys have vigorously objected to some of the prosecution’s questions and attempts to admit evidence. For example, on Monday, defense attorney Reid Weingarten objected to questioning Khan about internal Acclarent documents that prosecutors hope will show that the company misled the FDA in another attempt to expand the use of the drug via a new 510(K) submission.
   

   Medical device companies are allowed to make small changes to their device with a letter to its own file, rather than going through the 510(K) process. And when it sent an updated, special 510(K) to the FDA to get the Stratus approved for all sinuses, rather than just the ethmoid sinus, it also attached those smaller update letters to the FDA. But, prosecutors hope to show, those “letters to file” that Acclarent sent to the FDA weren’t the actual letters that Acclarent had sent to its own file.
   

   The letter to file that Acclarent gave the FDA said that it changed the number of holes on the Stratus balloon from 30 to 40 to change the way saltwater leaked out of it. But internal documents show that the new design was to ease the flow of the topical steroid Kenalog, a therapeutic agent, prosecutors hope to show.
   

   U.S. District Judge Allison Burroughs said Monday that the documents are likely admissible, but agreed with the defense’s objections about using it to ask Khan how she may have reacted if she’d known about it at the time, a frequent theme of the government’s questions. Khan never saw the internal documents herself. 
   

   “I don’t think it comes in through this witness,” Judge Burroughs 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, 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 Patricia K. Cole.
   

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Client Attorney Privileged/Attorney Work Product/At Request of Counsel