Justice Dept. demands St. Jude Medical documents on ICDs

May 5, 2010 by MassDevice staff

The U.S. Justice Dept. issues a "civil investigative demand" for documents relating to St. Jude Medical Inc.'s implantable cardiac defibrillator business.

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The U.S. Dept. of Justice demanded documents from St. Jude Medical Inc. (NYSE:STJ) about its implantable cardiac defibrillator business, according to a regulatory filing.

The "civil investigative demand" from the Justice Dept. sought documents and "sets forth interrogatories" about "various indications for ICDs and a National Coverage Decision issued by Centers for Medicare and Medicaid Services," according to the filing.

Minneapolis-based St. Jude said it believes its major competitors were served with similar demands and is cooperating with the investigation.

The DOJ isn't the only federal agency taking a close look at the company. St. Jude disclosed in the same filing that the Food & Drug Administration sent a warning letter April 23 citing the company for "its promotion and marketing of the Epicor LP Cardiac Ablation System and the Epicor UltraCinch LP Ablation Device based on certain statements made in the Company’s marketing materials," according to the filing. The warning letter was based on an FDA inspection of St. Jude's Sunnyvale, Calif., plant in July 2009. St. Jude said it's "working diligently" to resolve the issue.

Even so, the company said, it expects increased scrutiny of the medical device industry and a raised compliance threshold from the watchdog agency.

Last month St. Jude reported an 11 percent increase for its cardiac rhythm management division, which includes ICDs and pacemakers, boosted by what the company called "The Boston Debacle," competitor Boston Scientific Corp.'s (NYSE:BSX) month-long hiatus on ICD shipments.