Government Subpoenas Medtronic, Boston Scientific Over Heart Devices

The federal government is investigating the cardiac rhythm management divisions at Medtronic and Boston Scientific, according to both companies’ most recent filing with the Securities and Exchange Commission (SEC).

A subpoena from the U.S. Department of Health and Human Services-Office of Inspector General in California requests documents about both firms’ heart rhythm products. The devices, which include pacemakers and defibrillators, are the most profitable products at both companies: Medtronic reported $4.96 billion in cardiac rhythm disease management sales in 2008, while Boston Scientific amassed $2.43 billion in CRM sales that year.

In its quarterly filing with the SEC, Medtronic said it received the subpoena on Sept. 16. The government requested various types of documents, including those relating to 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 SEC filing read.

Medtronic said it would comply with the terms of the subpoena.

Medtronic’s disclosure of the subpoena shortly before Christmas comes one month after Boston Scientific revealed it had received a legal order from the same government agency on Sept. 25. Boston Scientific’s subpoena requested information about contributions the company’s CRM group made to charities with ties to doctors or their families.

The government’s investigation of Medtronic’s CRM division is the third in two years for the Minneapolis, Minn.-based medical device behemoth. In November 2008, the firm was subpoenaed by the U.S. Department of Justice over off-label use of its Infuse Bone Graft product. Infuse is specifically approved for use in the lower back but has been used in other areas. In July 2008, the U.S. Food and Drug Administration warned doctors that Infuse could lead to problems swallowing, breathing and speaking if used in neck surgery.

In June, the government subpoenaed Medtronic again over Infuse, seeking information about Dr. Timothy Kuklo, a former military surgeon who allegedly fabricated results for an Infuse Bone Graft study.