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.”

Congress in The Medical Device Amendments of 1976 put into the statute (quoting from the Supreme Court ruling), "that a state shall not ‘establish or continue in effect with respect to a device intended for human use any requirement —. . . (1) which is different from, or in addition to, any requirement applicable under [federal law] to the device, and . . . (2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under.’"

It was pretty clear to the Supreme Court (8-1) that the law as written meant that a person who was injured from a Class III medical device was not entitled to get relief under state laws, and it worried that medical innovation would be stifled if every state could set up its own set of medical device risk standards. What's more, in the Court's opinion, "A jury, on the other hand, sees only the cost of a more dangerous design, and is not concerned with its benefits; the patients who reaped those benefits are not represented in court." Thus, the good of the many outweigh the costs to the few.

Unfortunately, patients injured by a Class III device seemingly can’t get any sort of relief under federal law either unless they can show that the FDA's premarket approval process was tainted in some way, and that isn’t going to be easy, if even practical. And even that claim may not hold up under judicial scrutiny.

With this ruling, it falls on the FDA to be even more diligent in its approval of Class III medical devices, and very aggressive in removing approval for devices that might be faulty. However, as the Washington Post notes, the FDA has been understaffed and underfunded, not a good thing as the “first and final arbitrator of safety.”

The Post also notes that maybe what is needed is a government-run compensation fund for patients harmed by Class III devices, like it does with government-approved vaccines. This is a sensible solution, and one that Class III medical device manufacturers and the FDA should rapidly embrace, given that one element of managing risk has been severely constrained by the Supreme Court’s ruling.

For now, a patient contemplating the use of Class III devices now has to decide whether to do a new risk-benefit analysis or trust the FDA's judgment on a medical device's safety. At the very least, patients need to realize that if something goes wrong, one usual course of action is not available, even if the device is later found to be faulty.

I would not be too surprised that a year or two from now, if Congress doesn't act, that some patients (even though they suffer from serious health problems) will have been found deciding that the benefits of certain Class III medical devices are not worth their risk, and will either postpone their use or forgo them altogether.