The FDA Shield – The Medtronic Infuse Case and the Latest Tango of Preemption Versus Liability

The U.S. Supreme Court will shortly decide whether it will hear a case that will have a significant impact on the life sciences and medical device industry, specifically on the issue of whether approval by the Food and Drug Administration (FDA) of medical devices for “single limited use” shields and otherwise immunizes manufacturers from product liability suits results from non-FDA approved uses

What is the Medtronic Infuse Case About?

In 2010, Patricia Caplinger underwent spinal surgery in which as part of the procedure, a “Medtronic bioengineered bone graft device … was inserted through the back.”51 The surgery did not go well.

The Medtronic Infuse is described as “a device that stimulates bone growth to repair damaged or diseased vertebrae.”At the time of approval, the FDA required Medtronic include a warning label instructing that as part of the surgical approach, the Infuse should “be implanted via an anterior surgical approach.”53 The FDA warning label also set forth that the device’s “safety and effectiveness . . . in surgical techniques other than anterior open or anterior laparoscopic approaches have not been established” and that “[w]hen degenerative disc disease was treated by a posterior lumber [sic] interbody fusion procedure with cylindrical threaded cages, posterior bone formation was observed in some instances.”54 In other words, the device was only cleared to be inserted through the front of the body and not the back.