5 Plaintiffs File Infuse Bone Graft Lawsuit
Five plaintiffs have filed an Infuse bone graft lawsuit in California Superior Court, adding to the growing litigation against Infuse manufacturer Medtronic.
All five of these plaintiffs allege they received the Infuse device off-label and have since suffered serious complications due to bone overgrowth, neuropathy and other side effects.
Infuse bone graft lawsuit alleges off-label use led to injuries
The lawsuit was filed in Superior Court in Los Angeles County on December 6, 2013. Plaintiffs listed on the complaint include Dana Schuler of California, James Wadsworth of South Carolina, Lisa Smith of Indiana, Deanna Perkins of Wyoming, and Kim Hill of Kentucky. All five plaintiffs received the Infuse bone graft in spinal surgeries performed between 2006 and 2012.
The Infuse device was used off-label in these surgeries, as surgeons implanted the device into the cervical spine of the patients. Infuse has been approved by the FDA for use in specific surgeries of the lower spine and has not been approved for use in the cervical spine area. However, Medtronic has marketed the device for off-label uses, including use in cervical spine procedures.
Prior to the surgeries, neither the plaintiffs nor their surgeons were properly warned by Medtronic about the risks associated with the device, according to this Infuse bone graft lawsuit. However, previous reports had indicated severe Infuse bone graft complications linked to off-label use of the device, including bone overgrowth, male sterility, urinary complications and increased cancer risk. Plaintiffs in this complaint all experienced severe complications that have caused them persistent pain, emotional distress and the need for ongoing medical care.
Long history of use and complications
Infuse bone grafts have been available for some spinal surgeries since their approval by the FDA in 2002. Since that time, approval has been extended to treatment of some tibia injuries and specific dental procedures. The device works by filling in spaces where bone is missing and to assist in the bone healing process after surgery. However, preliminary study results and anecdotal evidence from Infuse patients suggest the device may not be as safe as first thought.
In this complaint, the plaintiffs have all suffered serious Infuse bone graft complications, including neuropath, bone overgrowth, muscle atrophy and nerve damage. Bone overgrowth is a relatively common complaint with the Infuse product. Early findings in clinical trials indicated significant rates of ectopic bone growth, which may lead to serious damage and compression within the spine. Patients diagnosed with this condition may experience persistent pain, paralysis and spasms associated with the damage.
Neuropathy refers to nerve damage of the peripheral nervous system. This damage may lead to tingling in the hands or feet, severe burning pain, sensitivity to touch and lack of coordination. All five plaintiffs in this Infuse bone graft lawsuit have suffered varying degrees of neuropathy, which have caused them pain, mental distress and ongoing medical expenses. In addition, lost wages due to an inability to work have also led to the financial stress these plaintiffs have faced.
As a result of their injuries, the plaintiffs in this complaint are seeking general, exemplary, punitive and consequential damages from Medtronic. They have included a number of counts in their lawsuit, including fraudulent misrepresentation, failure to warn, design defect and negligence.
This is not the first Infuse bone graft lawsuit to be filed in Los Angeles County Superior Court. In May, 2013, 38 plaintiffs filed a lawsuit in the same court, alleging similar complications from their Infuse devices. In addition, there are approximately 450 lawsuits filed against Medtronic involving their Infuse device nationwide.
- FDA, InFuse Bone Graft/LT-CAGE Lumbared Tapered Fusion Device, http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/recently-approveddevices/ucm083423.htm
- Bloomberg, Medtronic’s Infuse No Better than Bone Graft with Risk, http://www.bloomberg.com/news/2013-06-17/medtronic-s-infuse-benefits-equal-bone-graft-with-risk.html
- Medical News Today, What is Neuropathy? Neuropathy Causes and Treatments, http://www.medicalnewstoday.com/articles/147963.php
- Milwaukee Journal Sentinel, Infuse Cited in Patient’s Painful Bone Overgrowth,http://www.jsonline.com/watchdog/watchdogreports/124630959.html