The U.S. Food and Drug Administration approved Medtronic’s INFUSE Bone Grafts for spinal fusions in 2002. The procedure has been used in over 100,000 spinal fusions virtually every year since its inception. It has also been approved to deal with tibial fractures and in some dental procedures that require sinus cavity repair.
INFUSE has not been approved for any other uses. However, Medtronic has been accused of encouraging and even bribing doctors to use their products for both approved and non-FDA-approved use. One of the most common “off-label” uses is for bone grafts in the neck or cervical spine procedures. There are even accusations that Medtronic has been intentionally hiding side effects to boost sales.
Medtronic’s deceptive marketing practices have been causing serious alarm. They are harming some INFUSE patients, particularly those who have been tricked into using INFUSE for a purpose that is not FDA approved. If you or a loved one has been negatively affected by INFUSE or another Medtronic bone graft product, you may have legal options. Hughes and Coleman Injury Lawyers can help you determine what your legal rights may be.
When used for off-label treatments of the cervical spine, INFUSE has been associated with serious side effects. These may include:
- Difficulty speaking or swallowing
- Difficulty breathing or shortness of breath
- Nerve damage or nerve pain
- Respiratory depression
- Swelling of the neck
- Irregular bone growth
- Increased risk of infection at the surgical site
- Swelling of the throat tissue
- Compression of the neurological structures of the neck
Off-label use of the INFUSE system can also lead to death in some circumstances. The incidence of developing cancer and pain is also higher in those who have used INFUSE bone graft compared to other types of bone grafts, even when INFUSE is used as approved by the FDA.
Symptoms that can result with even approved use of INFUSE include:
- Back and leg pain
- Inflammatory reactions
- Implant displacement
- Retrograde ejaculation (occurs when the sperm enters the bladder)
- Male sterility
- Degeneration of the bone tissue
Most side effects appear within two weeks after the surgery, but some side effects can appear as early as two days after surgery. Some of these side effects will require additional surgery to correct.
These serious side effects can change your life forever. Unfortunately, Medtronic may have known about many of these side effects before INFUSE even hit the market in 2002.
In 2011, Medtronic received some well-deserved scrutiny regarding testing and research for the protein component in the INFUSE system. Researchers found that those who did the studies relating to this protein failed to disclose some possible side effects regarding its use. Researchers also determined that those who conducted the study were paid between $1 million and $23 million per year in Medtronic-sponsored royalties and consulting fees. There are also reports of falsified and misleading test results.
Medtronic was also under fire for paying kickbacks to doctors who use the INFUSE system, including those who used it for off-label (non-FDA-approved) uses. Their kickback programs reportedly included fake consulting agreements and even payments by providing lavish trips for favored doctors. These kickbacks could have been the reason that an INFUSE procedure was recommended for you or your loved one in the first place.
Medtronic INFUSE Lawsuits
Many of the lawsuits already alleged against Medtronic focus on allegations of inadequate or biased research, hiding testing results, bribing doctors to increase sales, and encouraging off-label use of INFUSE. These are all serious allegations that have been supported by evidence provided in some cases.
Hundreds of lawsuits have been filed against Medtronic. Estimates predict that several thousand people have been negatively affected following an INFUSE surgery.
The most common side effect that victims in these lawsuits experience is pain. In fact, the pain is so severe for some individuals that they can no longer work or enjoy recreational activities that they were once able to do. Some have even had to go on disability because they will be unable to work for the rest of their lives.
Pain is a tricky side effect because it is difficult to pinpoint exactly why it is occurring or what is causing it. It is also difficult to prove to a judge and jury in some situations. However, because of the way that INFUSE has been shown to affect the nerves, pain is often one of the most debilitating side effects of Medtronic’s INFUSE.
Do not assume that because you are “only” experiencing pain, that you do not have a valid claim against Medtronic. If an INFUSE procedure caused any negative side effect, you might have a legal claim. There is no reason that you should have to suffer through these side effects without legal recourse. Call 800-800-4600 or use our online claim form for more information about your legal options with Hughes & Coleman.
Cases likely to be referred.
