The Risk is Now on You

Recently, the Supreme Court ruled that the balloon catheter manufacturer Medtronic whose catheter burst and injured a patient was immune from liability because its product, along with its warning labels about the product's risks, had received premarket approval from the Food and Drug Administration (FDA). The Supreme Court said that state laws allowing lawsuits against so-called Class III medical devices were not permissible.

Class III medical devices are, according to the FDA, “the most stringent regulatory category for devices. Class III devices are those for which insufficient information exists to assure safety and effectiveness solely through general or special controls.

“Class III devices are usually those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury.”