Medtronic Facing Hundreds of Infuse Bone Graft Lawsuits
Roughly 1,000 people have filed lawsuits against Medtronic over its bone morphogenetic protein-2 (BMP-2) device, Infuse, with many more lawsuits likely on the way.
About the Infuse Medical Device
Infuse was approved by the U.S. Food and Drug Administration in 2002, and was meant to revolutionize spinal surgery by reconstructing bone through the use of the protein ingredient rhBMP-2. However, within a few short years, the FDA had begun to warn doctors of that the device could result in life-threatening complications.
According to Medpage Today, first red flag came when a FDA advisory panel member, Stephen Li, PhD, brought up concerns that nine of the doctors who had conducted the BMP-2 research submitted to the FDA as part of the marketing application process were financially invested in Medtronic and the Infuse system.
Further, the data submitted by those nine researchers was drastically inconsistent with, and much more positive than, data presented by researchers who did not have a financial stake in the product; however, questions of the inconsistent findings were reportedly glossed over during a 2002 meeting and comments made by Li during the meeting were reportedly “laughed off.”
Post-Approval Finding Question Medtronic/FDA Integrity
Following Infuse’s approval, studies began to confirm that the device had been linked to numerous adverse event reports and was also being used for unapproved indications. A subsequent review by FDA advisers re-raised questions of financial conflict in addition to new questions about the integrity of the FDA approval process.
Later investigations would find that Medtronic had paid $210 million to a group of 13 doctors and two corporate entities in connection to Infuse, including more than $34 million to Thomas Zdeblick, the orthopedic surgeon who had co-authored a series of papers about the product.
By 2013, multiple reports had found that Infuse offered no significant benefits over conventional spine surgery and, in the face of adverse effects including cancer and sterility in men, conventional spine surgery was a better fit for the majority of patients.
1,000 People Sue Medtronic
In a series of lawsuits representing roughly 1,000 Infuse patients, plaintiffs are seeking financial compensation for damages including:
- Compression of the airways and neurological structures of the neck
- Emergency tracheotomies
- Inhospital Complications
- Pain linked to irritated nerve roots
- Ectopic bone formation
- Troubling bone formations in the spinal canal
- Implant removal
Experts are comparing the current lawsuits to those filed against Johnson and Johnson for the DePuy metal-on-metal hip implants as both were touted as medical breakthroughs prior to marketing and were later found to be extremely harmful to patients.