Caplinger v. Medtronic, Inc.

GORSUCH, Circuit Judge.

Some medical devices are so risky they can’t be sold without the federal government’s prior approval. While even relatively simple things like bandages face some degree of federal oversight, manufacturers of pacemakers, heart valves, and the like must prove the “safety and effectiveness” of their devices to the FDA’s satisfaction before offering them for sale. Batteries of tests must be performed and presented and the agency’s premarket approval process can take years. Beyond guarding the gate to the.market square, the FDA also acts as censor for those allowed to enter.…