Opinion ID: 4110875
Heading Depth: 3
Heading Rank: 2

Heading: Axium

Text: Because clinical trials involving Onyx in the treatment of aneurysms evinced numerous complications, the defendants in 2007 launched a new medical device, Axium.1 Put simply, Axium provides another means of generating an embolism to facilitate the surgical treatment of anomalies in blood vessels in the brain. Surgeons use the device to place a small, detachable coil at a desired spot to generate a blockage of blood flow to an abnormality such as an aneurysm. Following the initial launch in 2007, the defendants redesigned the device several times in response to reports that it malfunctioned during procedures. They did not, however, recall earlier generations or relabel any devices. Problems persisted, notwithstanding frequent modifications. On top of these design challenges, irregularities during manufacturing resulted in defective lots of the devices that the defendants nonetheless sold. D'Agostino, who also promoted Axium, attended a February 2009 meeting where top brass admonished the 1The proposed complaint does not allege that Axium was not FDA-approved. - 7 - sales force to keep quiet about defects in hopes of dodging FDA scrutiny.