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Boston Scientific Shareholders File Suit

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Device maker Boston Scientific is facing more fallout over last month’s recall of of implantable cardiac defibrillator and implantable cardiac resynchronization therapy defibrillator devices. In addition to probes being conducted by the Department of Justice, and the Securities and Exchange Commission (SEC), the company was recently named in a shareholder lawsuit.

The shareholder lawsuit accuses Boston Scientific and certain of its officers and directors of violating the Securities Exchange Act of 1934 by issuing materially false and misleading statements regarding its business and prospects between April 20, 2009 and March 12, 2010.

As we reported previously, Boston Scientific halted sales and began retrieving field inventory of all its implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) on March 15. The recall impacted seven brands of Boston Scientific defibrillators: COGNIS®, CONFIENT™, LIVIAN™, PRIZM™, RENEWAL®, TELIGEN® and VITALITY™. The company said it initiated the recall because it did not get approval from the Food & Drug Administration (FDA) for changes to its manufacturing processes.

After the recall was announced, Boston Scientific shares dropped 12.6%, to close at $6.80.

The lawsuit was filed in United States District Court for the District of Massachusetts on behalf of anyone who purchased Boston Scientific Corporation common stock between April 20, 2009 and March 12, 2010.

The SEC and Justice investigators are seeking Boston Scientific documents regarding the its discovery that it hadn’t gotten FDA approval, as well as communications with regulators, physicians and stock analysts about the withdrawal. Investigators are also seeking any reports of injuries, the memorandum said. The company has said it is cooperating with the two agencies.

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