The Medtronic Infuse bone graft was approved in 2002. In many cases, it has been, used as an off-label device in surgical procedures for which it was never formally approved for by the FDA. In spite of the fact that this product was not approved (by the FDA) for certain surgeries Medtronic used doctor consultants to market the bone graft to be used on thousands of patients for surgeries including:
Off-Label Use Causing Severe Neck Injuries / Compression of the Airway
- Lumbar surgery through the back (posterior) or the side (lateral).
- Lumbar surgery outside L4-S1.
- Lumbar surgery at any other area of the spine.
- Cervical fusion surgery.
We believe tens of thousands of patients had implanted in them the Medtronic bone graft in this off-label manner.
The way these products are sold to the doctor is that Medtronic would hire doctors and pay them as consultants. These doctor consultants would then aggressively market to other doctors in their areas to use the products in such an off-label manner such as the types of surgeries listed above. Some statistics conclude that 85% of all Medtronic Infuse implantations occurred through the off-label use of the product.
Medtronic would pay royalty fees and consulting fees to doctors who then market the non-allowed uses to other doctors.
Nadrich & Cohen is reviewing side effect victim claims in all 50 states.
The side effects we are reviewing include the following:
- Successive uncontrolled bone growth
- Implant problems
- Bone resorption
- Urinary retention
- Back pain
- Leg pain
- Micro Fractures caused by the device
- The increasing restriction or tightening of tissue around the throat
The Medtronic Infuse Bone Graft for spinal surgery has caused serious side effects to victims because of its off-label use in cervical spine surgeries and lower back lumbar fusion procedures performed posteriorly.
There have been many side effects reported with this product such as uncontrolled bone growth, swelling of the neck and throat, radiating pain in the arms or legs, male sterility, retrograde ejaculation, compression of the airway and severe damage to the surrounding tissue of the neck creating problems including breathing, speaking and swallowing.
Medtronic, in March 2012, paid $85 million to settle a Shareholder lawsuit accusing it of misrepresenting the Infused/Bone Graft product by overstating its benefits and understating its risks. We believe Medtronic may have known of the risks for years. They have been aggressively promoting to the medical community unapproved uses of the Infuse devices.
Remember, we are a California law firm with 24 offices throughout California. We are handling bone graft side effects cases, throughout California and throughout all 50 states. We have successfully represented thousands of victims with legitimate claims against pharmaceutical and medical device companies.
We have settled other cases with Medtronic, the Infuse bone graft manufacturer. We would like to evaluate your potential claim.
We promise you we will invest the necessary resources, time and expertise in order to succeed in your case. If we take your case, we will do everything it takes to bring your case to trial and succeed on your behalf. We will leave no stone unturned. We understand the complications of the Infuse bone graft, what causes these side effects and how they affect the families.
Call us today at 1-800-718-4658 or complete the questionnaire, “Do I have a Case” on the right.