Opinion ID: 2777754
Heading Depth: 4
Heading Rank: 3

Heading: The Off-Label Marketing Allegedly Continues

Text: Plaintiffs allege that, even in the wake of the June 2011 Warning Letter, Abiomed continued to engage[] in pervasive off-label marketing of the Impella 2.5 beyond its FDA cleared indications. For example, during a February 2012 episode of the CNBC program Mad Money, Minogue suggested that the Impella 2.5 -11- could be used in patients experiencing heart attacks, and he held up an IABP and an Impella 2.5 side by side and stated that the latter was cost effective. Also, Abiomed made repeated claims in SEC filings and conference calls regarding the efficacy of the Impella 2.5 based on the results of the Protect II Study. Plaintiffs also allege that Abiomed trained its sales and clinical staff to compare the Impella 2.5 to the IABP and to prompt and steer physicians to ask about off-label uses of the Impella 2.5. CW1 and CW5, a clinical representative at Abiomed from February 2012 until February 2013, said they were provided with talking points about the Protect II Study and encouraged to discuss the superiority of the Impella 2.5 over the IABP. CW2 stated that Abiomed senior management knew Abiomed did not have the clinical studies to support the claims they were making. CW3, an account manager at Abiomed from September 2008 until the end of March 2011, relayed similar concerns to senior management and was blown off. CW7, a director of clinical operations for Abiomed . . . from February 2009 until November 2011, stated that Abiomed promoted the Impella 2.5 for use in procedures that take longer than six hours. CW4, a clinical representative in cardiology at Abiomed . . . from August 2007 until September 2010, -12- stated that Abiomed help[ed] doctors identify candidates to use the Impella 2.5 on, including high-risk PCI patients.4 On February 24, 2012, Abiomed and the FDA had a meeting, in part to discuss Abiomed's improper marketing practices. Plaintiffs allege that Abiomed never disclosed the true purpose of this meeting, instead stating in a later filing with the SEC that the meeting was held to present the final results of the Protect II Study and to discuss other unrelated matters.