Feds Investigating Boston Scientific Defibrillator RecallMar 30, 2010 | Parker Waichman LLP
Both the Justice Department and the Securities and Exchange Commission (SEC) are investigating Boston Scientific's recent recall of implantable defibrillators.
According to The Wall Street Journal, an internal company memorandum circulated last Friday said that federal prosecutors have sent Boston Scientific a subpoena, and the SEC has begun an informal inquiry. The SEC and Justice investigators are seeking company documents regarding the company’s 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.
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™. 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.
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. According to The Boston Globe, Boston Scientific’s lapse was related to documentation, the paperwork that companies are required to submit to federal regulators whenever they make material changes in their production processes.
The FDA is also investigating the recall. Boston Scientific is also waiting for the FDA to clear the manufacturing changes that led to it. However, the Pioneer Press reported today that the FDA has opted not to “expedite” its review of the Boston Scientific applications. That means the device maker won’t be able to resume sales of the defibrillators any time soon.