Medtronic, Inc. has disclosed that the California Attorney General issued a subpoena to the company in October as part of an investigation into its Infuse bone graft product. In its latest 10-Q filing, Medtronic said it was fully cooperating with the California probe, as well as various other investigations involving Infuse.
Medtronic’s Infuse bone graft is made from a genetically engineered material called rhBMP-2 (recombinant human Bone Morphogenetic Protein-2), which stimulates bone growth. Infuse was approved by the U.S. Food and Drug Administration (FDA) for use in one type of spine surgery called anterior approach lumbar fusion. Later, it was approved for use in two types of dental surgeries.
Since its approval, Infuse has been at the center of several controversies. Not only has the device maker been accused of downplaying the serious side effects associated with Infuse, but most recently, a prominent researcher warned that Infuse may be associated with a higher risk of developing cancer. In 2008, the FDA warned that Infuse and similar bone growth products had caused serious problems when used in off-label in spinal procedures.
According to Medtronic’s latest 10-Q filing, it has received several subpoenas or document requests in connection:
“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 said in the filing that sales of Infuse declined 16 percent in the company’s second quarter. It attributed the sales drop to the June publication of two articles in The Spine Journal that raised questions about the safety and effectiveness of Infuse. As we’ve reported previously, those articles suggested that some clinical trials sponsored by Medtronic may have underreported complications and serious side effects associated with Infuse. One of the articles examined payment data from Medtronic to doctors who co-authored the Infuse studies, and found that, the median amount to the company paid to doctors was at least $12 million to $16 million per study (though it should be noted that none of the royalty payments related to Infuse.)
Because of the questions raised by the Spine Journal articles, Medtronic commissioned Yale University to oversee two independent, systematic reviews of all Infuse-related clinical data. According to the 10-Q statement, it expects results of the reviews to be concluded in the next fiscal year. Medtronic also said it will make all of the Infuse clinical data and results available to medical researchers.