March 5, 2014 — Medtronic Inc. has reported in an SEC regulatory filing that approximately 1,000 people have filed 700 lawsuits involving Infuse Bone Graft side effects. Lawyers have told Medtronic that many additional cases will be filed in the coming months. Furthermore, several states are investigating sales and marketing practices.
Studies published in 2013 found that the Infuse Bone Graft is no better than traditional bone-grafting techniques, and it may have additional side effects like male sterility, infection, cancer, chronic pain in the back and legs, and more. In 2008, the FDA published a Safety Alert after receiving dozens of reports involving life-threatening swelling of the neck when Infuse was used “off-label” in the cervical spine (neck).
Medtronic marketed Infuse as superior than traditional bone grafts because it caused less pain and had a faster recovery time. Their marketing tactics worked — by 2011, Infuse was an $800 million-per-year product that was implanted in more than 1 million people undergoing spinal fusion surgery. Of these, 85% were “off-label” uses that were never evaluated or approved by the FDA.
When the U.S. Senate Finance Committee investigated, they found that Medtronic paid a group of doctors $210 million over 15 years, including $34 million to Dr. Thomas Zdeblick of the University of Wisconsin. In addition, the committee found that Medtronic secretly helped write and edited papers that were attributed to outside physicians. Not surprisingly, these papers promoted Infuse while downplaying the risk of side effects.