Medtronic Infuse Bone Graft Lawyer
Los Angeles Superior Court Judge Rules that Medtronic Infuse Lawsuit May Proceed
August 20, 2012 – Los Angeles Superior Court Judge Michael Linfield presented Plaintiffs with an important victory in the Medtronic Infuse litigation by denying Defendant Medtronic’s motion to throw out a lawsuit filed in state court on the basis of preemption.
Preemption is a rule of law based on a U.S. Supreme Court decision (Riegel v. Medtronic) which holds that the FDA’s pre-market approval of a medical device supersedes state law claims challenging safety, efficacy, or labeling. Medical device manufacturers have attempted to use the Riegel preemption ruling to have medical device cases based on state law claims summarily dismissed.
In her lawsuit, Plaintiff April Cabana claimed she suffered debilitating and permanent injuries to her spine caused by Medtronic’s Infuse Bone Graft and another device, which were used in a manner that was never approved by the FDA.
Judge Linfield ruled that preemption did not apply in Cabana’s case because she did not base her lawsuit solely on a violation of state law, but rather alleged and submitted supporting evidence that Medtronic violated federal law and FDA regulations by illegally promoting Infuse bone graft for various off-label (unapproved) procedures, and even using paid consultants to train physicians in using Infuse for such off-label uses.
In his ruling, Judge Linfield wrote that the Plaintiff’s "claim is not based on allegations that Medtronic’s device violated state tort law…plaintiff here is alleging that Medtronic promoted the use of its device in violation of federal requirements. Accordingly, Riegel is not authority that plaintiff’s claims against Medtronic are preempted here."
The Medtronic Infuse Bone Graft is an absorbable collagen sponge that contains a recombinant human bone morphogenetic protein (rhBMP), which is a genetically engineered version of a naturally occurring protein that initiates bone growth in targeted areas of the spine. The use of rhBMP provides surgeons with some control over where bone re-growth occurs. It is an alternative to the painful harvesting of bone graft from other parts of the body and the use of bone harvested from cadavers. The Medtronic Infuse Bone Graft has only been approved for the treatment of degenerative disc disease, open fractures in the tibia, sinus augmentation and localized alveolar ridge augmentation.
Although the Infuse Bone Graft was only approved for these very limited circumstances, Medtronic allegedly promoted and encouraged its use in other types of spinal surgery, including thoracic fusion, cervical fusion, posterior lumbar fusion and multi-level fusions. This “off-label” use of the Infuse Bone Graft generated more than $3 billion in sales for Medtronic. It has been reported that physicians who participated in the off-label use of the Infuse Bone Graft and/or wrote favorable reports about the product received payments from Medtronic. As a result, the U.S. Senate Finance Committee is investigating physicians who served as paid consultants for Medtronic and the U.S. Department of Justice is conducting a criminal investigation. At least one surgeon has been accused of using falsified information when reporting positive results for the Infuse Bone Graft.
The Infuse Bone Graft has been linked to hundreds of adverse event reports, and it has been estimated that almost 75% of people who have received Infuse Bone Grafts suffered from over-grown bones. The FDA has issued a Public Health Notification to warn of the life-threatening complications related to the use of the Infuse Bone Graft.
Improper usage of the Infuse Bone Graft has resulted in serious or life-threatening complications, including:
- swelling of the airways resulting in difficulty breathing, swallowing or speaking
- respiratory depression
- nerve damage
- male sterility
- formation of inflammatory cysts
- unwanted bone growth
According to the FDA, most of these complications occurred between two and fourteen days after the surgery. The complications often resulted in the need for insertion of feeding tubes, respiratory support, anti-inflammatory medications, tracheotomies and additional surgery. The majority of patients who suffered from the more severe side effects received the Infuse Bone Graft in the cervical spine area.
If you or a loved one received an Infuse bone graft and have experienced side effects or complications, please contact us for a free and confidential evaluation of your case.