A federal appeals court has upheld the dismissal of one woman’s Medtronic Infuse lawsuit, setting a precedent that could leave victims of defective medical products without legal recourse for their injuries.

Plaintiff Patricia C. is the recipient of a Medtronic Infuse Bone Graft, an implantable device used to treat degenerative disc disease. In spinal fusion surgery, the Infuse bone graft acts as an alternative to a traditional bone graft.

The FDA-required warning label states that the Infuse bone graft should be implanted using an anterior surgical approach. Patricia alleges, however, that Medtronic promoted use of the device through a posterior approach. She says that a Medtronic representative personally recommended using a posterior surgical approach to her doctor. The plaintiff further alleges that while her surgeon used this unapproved surgical technique, a Medtronic representative was present in the operating room.

In her Medtronic Infuse lawsuit, Patricia claims Medtronic knew about the dangers associated with posterior surgical placement of the Infuse bone graft, but purposely concealed that information from doctors and patients. Her infuse lawsuit raises claims for strict products liability, breach of warranty, negligent misrepresentation, and negligence. Unfortunately, all of these claims fall under state laws.

Infuse Claims Rejected Under Medical Device Amendments

In Patricia’s appeal, the Tenth Circuit determined that her state law claims were preempted by the language of the Medical Device Amendments to the Food, Drug, and Cosmetics Act. In the regulation of medical devices, these amendments expressly preempt any state requirements that are different from or more stringent than those under the federal act.

In Patricia’s case, the court determined her state law tort claims clearly exceeded the scope of the federal requirements. The court said her strict liability and breach of warranty claims failed because they had no analog in federal law.

As for her claims for failure to warn, negligence, and negligent misrepresentation, the court found these claims go far beyond the applicable federal requirements. These state claims address Medtronic’s advertising and oral representations, and therefore clearly cover more areas than the federal regulations, which address only the device’s labeling.

As for Patricia’s claim that was specific to the adequacy of the device’s labeling – the one remaining claim that could be construed to have a federal parallel – the court noted there is a federal regulation that generally protects medical device manufacturers from liability based on faulty labeling as long as the labeling meets FDA approval.

The court also rejected Patricia’s argument that her claims based on uses of the device other than those approved by the FDA – so-called “off-label” uses – were not subject to preemption. Looking at the plain language of the Medical Device Amendments, the court found a blanket grant of preemption that does not distinguish between approved and off-label uses.

Medtronic Infuse Bone Graft Lawsuits

Legal experts say there are no federal products liability laws. So between preemption of state claims and an absence of federal law to sue on, plaintiffs like Patricia may be left without recourse for the harm caused by a defective product.

Other plaintiffs have had better luck than Patricia. In May 2014, Medtronic Inc. settled 950 Infuse lawsuits for a total of $22 million and set aside as much as $140 million for another 3,800 pending claims.