Following a Food and Drug Administration (FDA) 515 Program Initiative Advisory Panel meeting and vote on retaining the Class III designation of Abiomed, Inc.’s (NASDAQ:ABMD) (“Abiomed”) Impella 2.5 system, Hagens Berman Sobol Shapiro, LLP, a securities class-action law firm, reminds investors of the Jan. 15, 2013, deadline to seek the position of lead plaintiff in a lawsuit filed on behalf of investors.
Investors with significant losses who purchased or otherwise acquired Abiomed stock between Aug. 5, 2011, and Oct. 31, 2012 (the “class period”), may contact Hagens Berman to discuss moving for lead plaintiff in the pending class-action lawsuit. Investors can contact Hagens Berman Partner Reed R. Kathrein, who is leading the firm’s investigation, by calling 510-725-3000 or by emailing ABMD@Hbsslaw.com.
On Nov. 1, 2012, Abiomed disclosed that it was being investigated by the U.S. Department of Justice regarding the marketing of its flagship product, the Impella 2.5 system, and had received a HIPAA subpoena. Following the disclosure, Abiomed stock fell more than 30 percent. The stock continues to trade below a class period high of nearly $23.00.
Yesterday, on Dec. 6, 2012, the Food and Drug Administration’s 515 Program Initiative Circulatory System Devices Panel met to discuss the issues surrounding Abiomed and Impella. At the conclusion of the meeting the Advisory voted to keep the Class III categorization of the Impella device. Accordingly, Abiomed will be required to conduct PMA-type trials.“The Advisory Panel’s vote shows that the FDA’s concern about Abiomed’s off-label marketing was material,” said Mr. Kathrein. “Our investigation continues to center on these marketing practices and the FDA’s communications with Abiomed concerning the Impella device.” Any member of the proposed class may move the court to serve as lead plaintiff through counsel of their choice, or may choose to do nothing and remain an absent class member. Class members need not seek to become a lead plaintiff in order to share in any possible recovery.