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Home » Medtronic the subject of 15 probes

Medtronic the subject of 15 probes

December 9, 2010 By MassDevice staff

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Medtronic Inc. (NYSE:MDT) reported receiving 15 requests for documents and evidence from state and federal authorities since 2005, according to a filing with the federal Securities & Exchange Commission (Medtronic said it is cooperating with all of the investigations that aren’t yet in the courts):

  1. Oct. 14, 2010: Subpoena issued from the U.S. attorney for the western New York “relating to the Company’s sales, marketing, and reimbursement support practices regarding certain neurostimulation devices. The Company is fully cooperating with this investigation.”
  2. March 12, 2010: Civil investigative demand from the U.S. Dept. of Justice “seeking information regarding the company’s knowledge about claims to Medicare for the implantation of ICDs, including reimbursement advice given by the Company, payments to persons or entities involved in decisions about implantation of ICDs, and the national coverage determination relating to ICDs.”
  3. Feb. 22, 2010: Civil investigative demand from the U.S. attorney for Massachusetts “seeking documents relating to the CoreValve clinical trial and Medtronic’s interactions with hospitals, other medical institutions, and physicians.”
  4. Spet. 16, 2009: Subpoena from the Dept. of Health & Human Services inspector general in 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.”
  5. June 16, 2009: Administrative subpoena from the New Jersey attorney general “requesting production of documents relating to the company’s clinical studies, its financial arrangements with certain physicians and healthcare providers, and clinical research done by certain physicians and healthcare providers.”
  6. May 21, 2009: Subpoena from the U.S. attorney for Massachusetts “seeking documents related to a study published in the British volume of the Journal of Bone & Joint Surgery, and contracts, research grants, speaking and education programs, and payments for certain named physicians.”
  7. April 13, 2009: Administrative healthcare subpoena from the U.S. attorney for northern Indiana “requesting documents relating to the Company’s relationship with customers, as well as documents relating to certain employees.”
  8. Feb. 9, 2009: Letter notice that the U.S. Dept. of Justice in southern Texas is investigating marketing practices, reimbursement advice of the company, and appropriateness of therapy delivery relating to the company’s cardiac surgical ablation devices. On July 2, 2009, the U.S. District Court for the Southern District of Texas ordered the unsealing of a qui tam complaint related to the same matter that was filed against Medtronic on November 17, 2008. On August 21, 2009, the Dept. of Justice decided not to intervene at that time but reserved the right to intervene in the future. The qui tam complaint was served on October 1, 2009. On December 16, 2009, Medtronic filed a motion to dismiss the complaint. On October 1, 2010, the motion was granted without prejudice with leave to amend.”
  9. Oct. 6, 2008: Subpoena from the U.S. attorney for Massachusetts “requesting production of documents relating to Medtronic’s INFUSE Bone Graft product. On September 14, 2010, the Company received a supplemental subpoena requesting information regarding a Humanitarian Device Exemption (HDE) relating to INFUSE and MasterGraft.”
  10. Dec. 18, 2008: Civil investigative demand from the Massachusetts attorney general requesting production of documents related to Medtronic’s INFUSE Bone Graft product.”
  11. June 2008: Subpoena from the U.S. attorney for Massachusetts “relating to the company’s marketing of biliary stents. The company is fully cooperating with this inquiry. On February 19, 2010, a complaint captioned U.S. of America ex rel Tricia Nowak and Enda Dodd v. Medtronic, filed in the U.S. District Court for the District of Massachusetts and relating to similar issues was unsealed. On April 23, 2010, Medtronic filed a motion to dismiss the complaint.”
  12. October 2007: Letter from the U.S. attorneyfor eastern Pennsylvania “requesting documents relating to the company’s relationship with one of its customers and any payments or things of value provided by the company to physicians, physician groups, hospitals, medical practices, or other entities relating to the purchase of the company’s cardiac resynchronization therapy devices and cardiac stents.”
  13. Sept. 25, 2007; Nov. 16, 2007: Letters from the Securities & Exchange Commission and U.S. Dept. of Justice “requesting information relating to any potential violations of the U.S. Foreign Corrupt Practices Act in connection with the sale of medical devices in several non-U.S. countries. A number of competitors have publicly disclosed receiving similar letters. Subsequently, the SEC and Dept. of Justice have made additional requests for information from the company.”
  14. Starting Sept. 2007: Letter requests from Sen. Charles Grassley (R-Iowa) “requesting information on a variety of subjects, including financial ties between the medical device industry and physicians; the company’s decision to suspend distribution of its Fidelis family of defibrillation leads; financial ties between the company and physicians who use INFUSE Bone Graft; the Cardiac Research Foundation and Columbia University; certain communications regarding INFUSE Bone Graft; and the company’s clinical research projects with the U.S. military and compensation paid to physicians working for the U.S. military.”
  15. Oct. 24, 2005: Subpoena from the U.S. attorney for Massachusetts “requesting documents the company may have, if any, relating to pacemakers and defibrillators and related components; monitoring equipment and services; a provision of benefits, if any, to persons in a position to recommend purchases of such devices; and the company’s training and compliance materials relating to the fraud and abuse and federal Anti-Kickback statutes. In September 2008, the U.S. Attorney’s office for the District of Massachusetts informed Medtronic that it is no longer pursuing its investigation of Medtronic, related to the October 24, 2005 subpoena. On September 5, 2008, Medtronic received a subpoena from the Office of Inspector General for the Dept. of Health and Human Services in the District of Minnesota, requesting production of substantially the same materials covered in the 2005 Massachusetts subpoena.

Filed Under: Business/Financial News, Legal News

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