The Justice Department and the SEC are investigating Boston Scientific's recent recall of implantable heart defibrillators, The Wall Street Journal reports, citing an internal company memo.
Although Boston Scientific declined to comment on the memo allegedly sent by General Counsel Timothy Pratt, the note reportedly tells certain employees that the SEC has begun an informal inquiry. An informal inquiry denotes an early-stage investigation--one that has begun but which hasn't been formalized by senior staff. The DOJ and SEC "are requesting information in connection with the recent" recall, the Journal quotes the memo as saying. "We are cooperating with these investigations."
The company voluntarily removed the ICDs and cardiac resynchronization therapy defibrillators from the market March 15. During a physician conference call held March 29, company officials emphasized that the current action isn't related to patient safety, but a submission process error. "There are no indications that these manufacturing changes pose any risk to patient safety, and we are not recommending device explants or any changes to normal follow-up procedure for patients implanted with our ICDs or CRT-Ds," Boston Scientific President and CEO Ray Elliott said during the call.
Last week, FDA officials reportedly said they won't expedite the review of manufacturing changes Boston Scientific needs to make to help it resume selling its implantable heart defibrillators.
This marks the just the latest brush the company has had with DOJ. Last December, the government reached a $22 million civil settlement with Boston Scientific to resolve allegations that its Guidant subsidiary used post-market studies as vehicles to pay kickbacks to induce physicians to implant its pacemakers and defibrillators.
Guidant also was charged last month in federal district court in Minnesota with concealing information regarding catastrophic failures in three models of implantable cardioverter defibrillators. The charges were filed following a four-year investigation into Guidant's handling of failures of the Ventak Prizm 2 DR (Model 1861) and the Contak Renewal (Models H135 and H155) ICDs.
- check out a transcript of the physician call
- see WSJ's coverage