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Medtronic Says California Seeking Info on Heart Rhythm Devices

Dec 10, 2009 | Parker Waichman LLP Medtronic Inc. is being investigated in California over its heart rhythm devices.  According to The Wall Street Journal, Medtronic recently disclosed that it had received a subpoena from the Department of Health and Human Services' Office of Inspector General in California.

Medtronic reported the subpoena in a quarterly filing with the Securities and Exchange Commission (SEC) it had made on Wednesday.  The disclosure read as follows:

  • "On September 16, 2009, the Company received a subpoena from the Office of Inspector General for the Department of Health and Human Services in the District of California requesting production of documents relating to the Company’s cardiac rhythm medical devices, including revenue, sales, marketing and promotional documents, documents relating to reimbursement communications to customers pertaining to the devices, documents relating to scientific studies and registries pertaining to the devices, and documents relating to payments or items of value provided to customers. The Company will comply as required with the terms of the subpoena."

According to The Wall Street Journal, Medtronic is the  biggest player in the $11 billion global market for these implantable heart rhythm devices, including pacemakers and defibrillators.

Medtronic has been the subject of governmental probes in the past.  Last November, the company was subpoenaed by the U.S. Department of Justice over off-label use of its Infuse Bone Graft product.  The product is specifically approved for use in the lower back but has commonly been used in other areas.  In July 2008, the Food & Drug Administration (FDA) warned doctors that use of Infuse for neck surgeries has led to problems swallowing, breathing and speaking, which in some cases required additional surgeries.

This past June, Medtronic was again subpoenaed over Infuse.  This time, the Department of Justice was seeking it information about  Dr. Timothy Kuklo, the former military surgeon accused of fabricating  results  for an Infuse Bone Graft study.

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