Infuse Bone Graft Lawsuit Not Preempted. A judge has denied a motion filed by Stryker Corp. to issue a summary judgement in a lawsuit filed against it in which a woman claims the medical device company promoted its Infuse bone growth material for an off-label use to correct her previously botched back surgery.
In her lawsuit, April Cabana claims she received a Medtronic bone growth product in a surgery but when that resulted in painful complications, she was then implanted with the controversial Infuse product in a procedure to correct her initial surgery.
The use of Infuse promoted excessive bone growth and caused Cabana more pain than she was originally suffering from when she decided to have surgery.
According to a Law360.com report this week, Medtronic sought a summary judgement based on preemption. The company argued that a recent Supreme Court ruling “preempts state common-law claims targeting the performance of a medical device approved by the FDA before it hit the market.”
Judge Michael Linfield ruled that Cabana’s claim is not based on a violation of state law but on the federal law that prohibits medical device manufacturers from promoting one of its products for a use that’s not been approved by the Food and Drug Administration.
The costly pre-approval process that requires clinical data
A company is motivated to do so because they can avoid the costly pre-approval process that requires clinical data to back a claim that a new use of a previously-approved product is beneficial to patients.
Infuse has only been approved in certain types of back surgery but Medtronic has come under recent fire over its illegal promotion of the product, including its use in unapproved back and neck surgeries. The results have been devastating for many recipients of Infuse in these off-label indications.
Excessive bone growth causes severe and crippling pain in some cases and for other recipients, life-threatening conditions like a compressed airway, sterility in men, infections, and a wide array of cancers.
Cabana’s lawsuit names Medtronic, her surgeon, and the hospital where the surgeries were performed as Defendants in her lawsuit, which will now go forward and force the company to answer claims that it promoted off-label use of Infuse.
As the company continues to defend the product against a growing class of people who’ve received the product in an unapproved surgery, the company recently had another bone growth material’s approval denied by the FDA, Amplify.
The agency is skeptical of the risks posed by the bone growth protein rhBMP-2, which is found in Amplify. When Infuse is used in off-label indications, surgeons often must use higher doses of rhBMP-2 than they would if they had used Amplify.