In October 2012, damaging testimony in front of US Senate Investigators painted a dismal picture of the medical device industry and put Medtronic once again on the hot seat. It was alleged that Medtronic paid doctors millions of dollars in exchange for co-authoring papers on their Infuse products. These papers would intentionally downplay some of the serious and life-threatening risks associated with their Infuse bone graft products. Even worse, testimony given during the Senate hearing showed that the doctor who presented Infuse to an FDA advisory panel shortly before it was approved was actually paid by Medtronic as a consultant. According to the testimony, more than 13 doctors were paid over $210 million to craft papers in support of Infuse. These documents have been disclaimed as containing bias and marketing slants.
Promoting Medtronic’s Infuse for Off-Label Use
Originally, Medtronic’s Infuse was approved in 2002 for use in the lumbar spine only, but it is alleged that Medtronic actually promoted and encouraged the off-label use of Infuse in the cervical spinal as well. It is even alleged that Medtronic representatives were present during these off-label surgeries, encouraging doctors and surgeons to continue off-label use of Infuse bone grafts.
The Medtronic Infuse bone graft was used in more than 25% of the 432,000 spinal fusions that were performed in the United States. Many of those uses were unfortunately off-label and patients have suffered horrific injuries as a result. Patients who received a Medtronic Infuse bone graft in the cervical spine have reported numerous medical complications and life-threatening symptoms, including:
- Difficulty breathing
- Trouble swallowing
- Difficulty speaking
- Compression of the airway
- Respiratory depression
- Nerve damage
- Broken cervical bones
- Excessive bone growth in the neck
- Radiating pain
- Sterility, retrograde ejaculation, or other urogenital injuries
- Acute swelling
- Permanent nerve damage
One such patient from South Carolina received an off-label Infuse bone graft to repair three compressed discs in her cervical spine. After the surgery, everything started to go wrong. She began experiencing severe migraines every day, pain in her right arm, neck stiffness and pain, and back complications. She couldn’t even lift her arm anymore and when doctors took x-rays, it appeared that she had several broken bones in her neck from the Infuse bone graft and excessive bone growth. She now faces daily pain and additional surgeries to help repair the complications.
National Medtronic Lawsuit Attorneys
If you or someone you love has suffered a major complication because of a Medtronic medical device, it is important to know that you are not alone. To learn more about filing a Medtronic lawsuit call the experienced Medtronic lawsuit lawyers at Phillips Law Firm today. Call us at 1-800-708-6000. Our national Medtronic lawsuit attorneys are waiting to assist you 24/7, offering a free case evaluation.