Medtronic Discloses California Infuse InvestigationDec 8, 2011 | Parker Waichman LLP
Medtronic continues to be plagued by investigations into its controversial Infuse bone growth product. According to its most recent 10-Q filing with the Securities and Exchange Commission (SEC), the California Attorney General issued a subpoena to the company in October seeking information regarding Infuse.
According to the filing, the California Attorney General is just the latest state or federal official to express an interest in Infuse:
"On October 6, 2008, the Company received a subpoena from the United States Attorney’s Office for the District of Massachusetts pursuant to HIPAA requesting production of documents relating to Medtronic’s INFUSE Bone Graft product. The Company has since received supplemental subpoenas or document requests in connection with the INFUSE Bone Graft product, including a December 18, 2008 civil investigative demand from the Massachusetts Attorney General’s Office, an October 14, 2011 subpoena issued by the California Attorney General’s office, and several inquiries from the United States Senate Finance Committee. The Company is fully cooperating with these investigations."
Medtronic also revealed that Infuse sales fell 16 percent in the second quarter, something it blamed on the June 2011 publication of articles in The Spine Journal, which called the safety of Infuse into questions. According to the journal, Medtronic-paid surgeons had failed to report serious complications from Infuse, including cancer, sterility in men, infections, bone dissolution and worsened back and leg pain. The article said complications occurred in 10 to 50 percent of patients who got the product in 13 Medtronic-funded clinical trials between 2000 and 2010.