FDA Clears Remaining Recalled Boston Scientific DefibrillatorsMay 24, 2010 | Parker Waichman LLP
Boston Scientific has resumed sales of five defibrillators that had been the subject of a recall several months ago. In a regulatory filing, the company said the U.S. Food and Drug Administration (FDA) cleared changes to the Livian and Renewal cardiac resynchronization therapy defibrillators, or CRT-Ds, and Confient, Prizm, and Vitality implantable cardioverter defibrillators, or ICDs.
Boston Scientific’s failure to notify the FDA of manufacturing changes prompted it to halt sales and began retrieving field inventory of all of its ICDS and CRT-Ds on March 15. Companies are required to submit a notification of any change in manufacturing procedures or methods of manufacturing that affect the safety or effectiveness of the devices.
All of the devices in the recall were acquired by Boston Scientific in 2006 when it purchased medical device manufacturer Guidant Corp., of St. Paul, Minn., for $28.4 billion.
Boston Scientific had already resumed sales of Cognet and Telgen defibrillators in April. But sales of the five older devices remained suspended, following disclosure by the company that it found some other manufacturing changes that should have been cleared by the FDA.
The five older devices account for less than 10 percent of the division’s sales.
The sales halt caused Boston Scientific last month to cut its 2010 revenue forecast by about $500 million as first-quarter U.S. defibrillator sales fell 21% to $312 million missing the midpoint of the company’s projected range by $64 million.
Boston Scientific also faces other fallout from the March recall. Shareholders have filed suit against the company, accusing it 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.
The Wall Street Journal has also reported that in March, an internal memorandum circulated to company executives revealed that both the Department of Justice and the Securities and Exchange Commission (SEC) have opened probes. According to the memo, federal prosecutors have sent Boston Scientific a subpoena, and the SEC has begun an informal inquiry.
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 memorandum said the firm was cooperating with the two agencies.