According to Judge Michael Linfield, Medtronic is not able to side step allegations that April Christine Cabana was injured by the Infuse Bone Graft on preemption because the plaintiff alleges the company violated federal laws by promoting the device for off-label uses.
According to the lawsuit, Stryker (also named as a defendant in the suit) pushed the use of two products used in Cabana’s back surgery even though the FDA had not approved them to be used in that way. The suit says that Cabana’s surgery resulted in excessive bone growth, forcing her to undergo a second surgery. The Medtronic Infuse Bone Graft was implanted, which made her pain and suffering worse, she said.
Medtronic, in seeking summary judgment, argued that in Riegel v. Medtronic, the U.S. Supreme Court decided that federal law “expressly preempts state common law claims targeting the performance of a medical device approved by the FDA” prior to it being released on the market, Law360 reports.
However, Judge Linfield said in a tentative ruling, “Plaintiff’s claim is not based on allegations that Medtronic’s device violated state tort law notwithstanding compliance with the relevant federal requirements…In contrast, plaintiff here is alleging that Medtronic promoted the use of its device in violation of federal requirements.”
Judge Linfield also dismissed Medtronic’s argument that Cabana’s claims are not protected by her focus on the company’s alleged off-label promotion.