“In order to properly allege a design defect claim,” said US District Judge Carol E. Jackson in her ruling, “the plaintiff must plead ‘concrete allegations that the product sold by Medtronic was not the product-design approved in the [FDA’s] pre-market approval.’”
Judge Jackson did allow Arthur’s claims for fraudulent misrepresentation and breach of express warranty to move forward, but only if they are accompanied by more detailed pleadings. However, the judge ruled that Arthur’s assertions of defective design with regard to the Infuse Bone Graft, failure to warn and negligence could not move forward as they were preempted. In the judge’s view, such claims would place requirements that differ or add to those already observed by the US Food and Drug Administration (FDA).
In her Medtronic lawsuit, plaintiff Arthur claims that Medtronic bone graft is only approved for procedures involving the lower back. To that end, Arthur received the bone graft in her neck to treat issues with her cervical vertebrae. Her claim, beyond the design deficiencies she so alleges, is that in her case the Medtronic bone was used off-label.
A similar Medtronic off-label lawsuit was brought in Oklahoma federal court in 2012. In that case, plaintiff Patricia Caplinger alleged that the Infuse Bone Graft was inserted into her spine from the back, when it should have been inserted from the front. This, according to Caplinger, was a circumvention of FDA approval and therefore was an example of Medtronic off-label.
Both Caplinger and Arthur, in their respective lawsuits, allege that they suffered from Medtronic complications as the result of the off-label use of the product.
READ MORE MEDTRONIC INFUSE BONE GRAFT LEGAL NEWS
According to FDA guidelines, manufacturers are not allowed to promote any drug or medical device for off-label use. However, it is within the legal and ethical mandate of a prescribing doctor or surgeon to recommend a product for an off-label use based on the health care professional’s expert opinion. In this way, doctors and surgeons can circumvent the federal drug regulator.
The Arthur case is Kathleen A. Arthur v. Medtronic Inc., case number 4:14-cv-00052, in the US District Court for the Eastern District of Missouri.