The New York Times reported today that the Supreme Court has ruled that the manufacturer of a federally approved medical device cannot be sued under state law if the device causes an injury. This ruling has huge implications for the health care-technology industry and their victi – oops, I mean customers.

The article, "Justices Make It Tougher to Sue Medical Device Makers," by David Stout, tells us the Supreme Court ruled 8-to-1 in favor of Medtronic, upholding a lower court's decision that plaintiff Charles R. Riegel, who was severely injured when a Medtronic balloon catheter burst while he was undergoing angioplasty, cannot sue the Minneapolis-based maker of cardiovascular devices. Riegel and his wife contend that the catheter had been designed, labeled and manufactured in a way that violated New York state law, with defects that caused severe and permanent injuries in Charles Riegel. But a federal district court and the United States Court of Appeals for the Second Circuit (in Manhattan), dismissed the Riegels’ suit on grounds that the catheter had been given pre-market approval by the Food and Drug Administration, thus protecting the manufacturer from liability under state law.

Justice Antonin Scalia, writing for the majority, said that the FDA spends an average of 1,200 hours reviewing each device application and grants pre-market approval only if it finds there is a “reasonable assurance” of its “safety and effectiveness.” “It may thus approve devices that present great risks if they nonetheless offer great benefits in light of available alternatives,” he wrote, noting that the FDA approved a ventricular assist device for children with failing hearts “even though the survival rate of children using the device was less than 50 percent.” Jurors would probably not be in a position to weigh the benefits and dangers of medical devices as well as agency experts, he concluded. A jury “sees only the cost of a more dangerous designed, and is not concerned with its benefits; the patient who reaped those benefits are not represented in court.”

This ruling is a remarkable statement of faith in the FDA – that it is doing its job the way it should, with a high degree of excellence and integrity, and immune to the pressures exerted by the millions of dollars the medical device industry regularly spends on lobbying. The fact is, the FDA has admitted it is in shambles, which is why it is even now under intense Congressional scrutiny and scrambling to clean itself up.

Truth be told, if I were the parent of a child with a failing heart who didn’t know so much about how regulatory agencies work, I would want all device options open to me and support this ruling, which encourages device makers in their MO to get their products to market as quickly as possible.

But if I were a woman thinking about getting cosmetic breast augmentation, I would be very very careful in deciding for myself whether or not breast implants are defective medical devices before going through with the procedure. If, later on, I experience severe complications, finding out way too late that breast implants are defective indeed, not only would I end up fighting a losing battle with insurance companies to get coverage for treatment, I would not even have legal recourse to some financial compensation from the maker to help cover my costs.

So Buyer Beware, Ladies, Buyer Beware. The Supreme Court has put its trust in our most dysfunctional government agency. This is Bush's last stand against women's health.