Lawyers representing victims of Medtronic’s Infuse Bone Graft device are trying a new strategy to circumvent the 2008 Supreme Court ruling protecting medical device companies from personal injury lawsuits. Riegel v. Medtronic, the case in question, barred most state law claims against any medical device which received approval from the FDA after successful completion of the extensive safety review process.
Plaintiff’s attorneys are now alleging that the Bone Graft device was illegally promoted for uses not previously approved by the FDA. Such “off label promotion” is a parallel claim and thus not barred by federal law.
Personal injury cases surrounding medical device companies have relied on parallel claims since the Riegel decision, and have allowed attorneys to pursue the medical device companies for damages directly.
Plaintiffs argue that the collagen sponge soaked in genetically engineered protein, used by the device to promote bone growth in the lower spine, is a rare procedure, and thus was marketed to physicians for uses other than frontal spine surgeries.
Victims are coming forward throughout the nation, contending that their rear spine surgeries performed with the Bone Graft device, a procedure not directly approved by the FDA, have caused severe complications including unwanted bone growth, nerve compression, and the necessity for additional surgeries.
As more individuals speak out against the medical device company, more suits will follow. Off label promotion litigation is still very much in its infancy, and as more serious cases mount, the courts will have some tough decisions on their hands.