A South Carolina couple filed a lawsuit against Medtronic over the Infuse Spinal Fusion System, a medical device. Their lawsuit alleges that the device caused serious complications.

The Infuse System/Device is designed to be implanted into the spine to repair degenerative disc disorder. Spinal discs are a type of connective tissue that separates the bones of the spine, adding shock absorption and support. However, spinal discs can degenerate. The standard treatment is to join adjacent backbones together. This sacrifices some mobility for greater strength, but it does relieve the pain associated with a degenerated disc. The Infuse Device consists of a metal cage and a gel created from a combination of the patient’s own tissue and bioengineered proteins. The metal cage holds vertebrae in place while the gel encourages the bone to grow together. Once the bones are fused, the cage remains in place to reinforce the joined bones. However, lawsuits like the one filed by plaintiffs Anne and Henry Guthrie allege the device is potentially more dangerous than the standard treatment.

According to the lawsuit, Anne Guthrie suffered injuries from having an Infuse device implanted in her spine in February 2010. After the surgery, she suffered from inflammation, weakness, numbness, and trouble controlling specific muscles. This ultimately required surgical revision — a second procedure to remove the Infuse Device and the accompanying bone overgrowth.

One issue that comes up in the Guthries’ lawsuit is off-label use of the implant. When the U.S. Food & Drug Administration (FDA) approves a medical device or drug, it is typically approved for one purpose at a time. A device like Infuse must be submitted for testing for each purpose it is approved for. Physicians may use a medical device for other purposes; this is not unusual. Sometimes new research suggests that a device may work for other purposes. Physicians are allowed to use medical devices for “off-label” uses, but companies are not legally allowed to promote their products for these unapproved purposes. Many of the lawsuits over the Infuse device have alleged that Medtronic promoted off-label use. Guthrie’s surgery was technically for an off-label surgery. This could have critical implications for the lawsuit.

The lawsuit could potentially join others in a group lawsuit. Multidistrict litigation (MDL) and class action lawsuits are two types of group lawsuits. Group lawsuits like MDLs and class action lawsuits involve dozens, hundreds, or even thousands, of individual plaintiffs seeking legal action against the same defendant over similar alleged-harm. This allows MDLs and class action lawsuits to streamline the legal process. MDLs are more common than class action lawsuit in cases with medical devices, since MDLs start out as individual lawsuits that are later coordinated into a single legal action.

The Infuse bone graft lawsuit is formally titled Anne Guthrie, et al. v. Medtronic Incorporated Inc., et al., Case No. 2:14-cv-01186-DCN, in the U.S. District Court for the District of South Carolina.