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

Heading: The April 2012 Letter

Text: In April 2012, the FDA sent another letter to Abiomed asserting that its promotional materials were still improperly marketing the Impella 2.5. The FDA noted that the AbiomedImpella YouTube channel included several videos discussing unapproved uses of the Impella 2.5, and that the company's website contained a link to Patient Stories describing unapproved uses of the device. The agency also objected to Minogue's statements on the Mad Money episode. The letter stated that these examples represent[ed] a fraction of the objectionable claims regarding the Impella, and the agency threatened enforcement action absent prompt and effective corrections. 4 Plaintiffs include these allegations in the section of the complaint detailing Abiomed's allegedly improper marketing after the Warning Letter was issued, but they do not provide any indication of the specific time period to which the confidential witnesses' observations correspond. -13- Abiomed disclosed this FDA letter in its 2012 10-K, filed with the SEC on June 4, 2012. The company announced that it had received a follow up letter from the FDA stating that some of our promotional materials continued to market the Impella 2.5 in ways that are not compliant with FDA regulations and that it was cooperating with the FDA in addressing its concerns.