Medtronic Inc., the nation’s largest medical device manufacturer, is facing over 1,000 Infuse Bone Graft lawsuits with legal experts expecting the number to grow. Medtronic has been accused of deliberately concealing certain information from the healthcare community, which was vital to patient safety.

Plaintiff allegations vary but center around the claim that Medtronic marketed the Infuse Bone Graft System for off-label purposes not approved by the FDA and failed to adequately warn patients and physicians about potential complications. These Infuse Bone Graft complications include:

• cancer
• difficulty breathing and swallowing
• paralysis
• nerve damage
• difficulty talking
• chronic pain
• wrongful death

While it is not illegal for doctors to use medical products or drugs for off-label purposes, it is illegal for manufacturers to sell them for that reason. Infuse Bone Graft lawsuits accuse Medtronic of conducting this illegal marketing campaign across the country.

Personal injury lawyers advise potential plaintiffs to keep a strict account of their medical records and to keep all documentation of their Infuse Bone Graft injuries as advised by their physicians and attorneys.

Damages that may be awarded in an Infuse Bone Graft lawsuit could include compensation for past, current and future medical bills; lost wages; pain and suffering; loss of quality of life; loss of consortium (relations with your spouse), and other damages.

Infuse Bone Graft Overview

Every year, 100,000 patients undergo spinal fusion surgery using the Infuse Bone Graft System and it has been recently discovered that many of these surgeries could have been performed for off-label purposes. Instead of being used in the lower lumbar region of the back where the FDA approved the device, many patients used the Infuse Bone Graft to repair damage to their cervical spine. This are is not approved by the FDA, and has reportedly led to a variety of complications.

The Infuse Bone Graft was approved by the FDA in 2002 as a new treatment for spinal fusion surgery. Instead of harvesting bone marrow from different areas of the body, the bone protein from Infuse would be inserted into the damaged area of the spine and would allow for quick recovery time. Due to its non-invasive nature and shorter hospitalization time, Infuse quickly became one of the most popular medical devices in the United States.

Medtronic’s alleged illegal promotion of off-label marketing of Infuse landed the company in hot water with the U.S. Department of Justice in 2006. From this investigation, it was revealed in 2012 that Medtronic used false advertising and kickbacks to increase sales of the Infuse Bone Graft, including allegedly paying more than $200 million to study authors who spoke highly of Infuse.

This revelation has led to over 1,000 patients suing Medtronic, claiming the company failed to protect them from InfuseBone Graft complications.