Do You Have a Defective Product Complaint Against Medtronic?
The INFUSE™ bone graft was first used in clinical trials in 1999. In 2002, it was approved by the FDA for specific use in anterior-approach lumbar fusion surgery (through the abdomen). This is the only type of spinal surgery for which it is approved. It was never approved for use in upper back surgery of any kind.
Over the years, Medtronic has reaped hundreds of millions of dollars in profits from the sale of INFUSE bone graft products, much of it for uses for which the product was never approved. Now patients are suffering serious side effects, including severe pain, nerve damage, overgrowth of bone or loss of bone, loss of mobility, even cancer and infertility.
Walkup, Melodia, Kelly & Schoenberger has filed one of the first lawsuits against Medtronic for its INFUSE bone graft medical device. Our client, a vascular surgeon, was experiencing back problems. Like so many patients, she underwent a type of back surgery for which INFUSE was never approved. She is now in constant pain and can no longer work.
The promotion of off-label, unapproved usage of medical devices is known as misbranding. Lawsuits coming forward against Medtronic charge that the company engaged in illegal sales practices in promoting its product for off-label uses. Furthermore, Medtronic failed to warn doctors and patients of all known risks of the product, and fraudulently concealed risks as they became known.
You May Have a Case Against Medtronic
- Between 2002 and 2011, did you receive a lateral-approach lumbar interbody fusion surgery, a posterior-approach lumbar interbody fusion surgery or cervical spinal fusion surgery?
- Have you experienced difficulties breathing or swallowing, uncontrolled bone growth, nerve damage, incontinence, impaired mobility, inflammatory cyst formation, cancer or infertility (in men)?
- Have you experienced INFUSE bone graft problems that are impairing your ability to work or do daily tasks?
How to Bring a Defective Product Claim
Contact an INFUSE bone graft defect lawyer at the California law firm of Walkup, Melodia, Kelly & Schoenberger for a FREE CONSULTATION. Call toll free (415) 981-7210.
A San Francisco product liability claim attorney will discuss your injuries. If it seems you have a case, we will engage a medical expert to review your medical records. You will not be charged any fees for the legal or medical review, so there is no financial risk to you when getting a professional opinion about whether you have a case.