Boston Scientific Defibrillator Recall Sparks DOJ, SEC Investigations

Boston Scientific is facing two federal investigations over its massive recall of <"">implantable defibrillators. According to The Wall Street Journal, both the Department of Justice and the Securities and Exchange Commission (SEC) have opened probes.

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.

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’ve reported previously, 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.

This is not the first time Boston Scientific’s Guidant acquisition has proved troublesome for the device maker. In November, the company agreed to plead guilty and pay $296 million to resolve federal charges that failed to fully disclose earlier problems with its implantable defibrillators to the FDA.

In December, it also agreed to pay $22 million to settle a federal investigation into allegations that Guidant paid doctors kickbacks to get them to use its heart devices.

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