Acclarent trial media monitoring 6/13/16

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1. Medical executives face criminal charges for “misbranded” devices

   Jun 10, 2016 | The British Medical Journal

   By Jeanne Lenzer
   
   
   Two US medical device executives are facing criminal charges for off-label promotion of a device to treat nasal sinus problems.

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

Online Sources

1. Medical executives face criminal charges for “misbranded” devices

   Jun 10, 2016 | The British Medical Journal

   By Jeanne Lenzer

   Two US medical device executives are facing criminal charges for off-label promotion of a device to treat nasal sinus problems.

   William Facteau, former chief executive officer, and Patrick Fabian, vice president for sales, of the ear, nose, and throat medical device company Acclarent, have been charged with “distributing adulterated and misbranded medical devices” and securities fraud related to their promotion of the Status medical device to open up nasal sinuses.1 Acclarent was sold to Johnson & Johnson for $785m (£542m; €690m) in 2010.

   The Food and Drug Administration had cleared the device under its “510(k)” scheme, which allows devices to be marketed on the basis of the existence of a “substantially equivalent” product (known as a predicate device) already on the market. The predicate device cited by Acclarent was intended to keep sinuses open mechanically. However, the Status device was manufactured in such a way that it could be used to deliver steroid medicine—and not saline as the company stated in its 510(k) notice.

   Documents, videos, and emails obtained by the US Attorney’s Office in Massachusetts showed that the holes in the device were so large that saline would run out immediately and were instead sized to deliver the more viscous steroid, which the company openly promoted in a video and “educational” meetings with doctors and in other materials distributed or discussed by Acclarent.

   Prosecutors said that Facteau made an estimated $30m and Fabian $4m from the merger with the Johnson & Johnson subsidiary Ethicon. They face maximum prison terms of 20 years for each count of wire fraud and securities fraud.

   Facteau is currently the chief executive officer of the company EarLens, while Fabian is the chief operating officer of NxThera, another device manufacturer.

   This was not the first time that a device cleared through the 510(k) pathway made it on to the market despite being manufactured in a manner intended to enable off-label use rather than the original use in the predicate device cited.

   Robert Vaage, an attorney in California, has brought a civil suit against Medtronic and surgeons at the University of California, Los Angeles, as well as UCLA itself, for implanting Infuse, a mechanical device containing bone morphogenetic protein, in a client who experienced life threatening complications from the overgrowth of the protein after the device was implanted in his cervical spine.2 The device, known as the Verte-Stack Anatomic PEEK, won a 510(k) clearance on the basis of a predicate device that was approved by the FDA for use only in the thoracolumbar spine. However, the Verte-Stack PEEK device is made in a size that can be used only in the cervical spine, where the effects of bone morphogenetic protein are known to cause serious complications, including spinal cord compression and respiratory distress. The surgeons and UCLA are included in the lawsuit for several reasons, including their failure to reveal financial conflicts of interest related to the device.

   Although the FDA said that it was misled by Acclarent regarding the Status device, the agency’s failure to stop “misbranded” devices from reaching the market has been under fire for years. A 2011 report by the Institute of Medicine said that the problem was so serious that the entire 510(k) system should be scrapped.

   The Status case is considered important because it is holding corporate executives criminally responsible, a rarity in most cases of drug or device misbranding. Last September the US attorney’s office issued a memo3 for what it hoped would be more aggressive actions against companies that violated the law.

   AdvaMed, the trade association that represents medical device manufacturers, told The BMJ that prohibiting companies from off-label promotions violated manufacturers’ right to provide healthcare professionals with “needed information relating to on- or off-label uses through appropriate scientific exchange” and that the prohibition interfered with the right of a healthcare provider to “exercise his or her medical judgment in the best interest of their patients.”

   The FDA has concurred with the industry in a recent case, saying that the drug manufacturer Amarin was not in violation of the prohibition against off-label promotion of its prescription fish oil pill, Vascepa, when it disseminated reprints of a study regarding off-label use of the drug, as the agency “would not consider the dissemination of most of that information to be false or misleading.”4

   Vaage told The BMJ that inappropriate devices made it on to the market because, “Like Wall Street and the SEC [Securities and Exchange Commission], the FDA and medical device manufacturers are too closely connected.”

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