More than one, two

The second case is another instance of shielding from public accountability, but this time the beneficiaries are corporations, not government spooks. On Wednesday, the Court said that

the manufacturer of a federally approved medical device cannot be sued under state law if the device causes an injury[, the New York Times reported].

The 8-to-1 ruling in favor of Medtronic, the Minneapolis-based maker of cardiovascular devices, made it much more difficult for patients and their families to sue makers of medical devices that have been granted federal approval.

In 1996, a man named Charles Riegel was undergoing a balloon angioplasty to open a blocked coronary artery when the balloon burst, causing him severe injury. He and his wife Donna

sued the company in federal court, contending that the catheter had been designed, labeled and manufactured in a way that violated New York state law, and that those defects had caused severe and permanent injuries to Mr. Riegel.

Lower courts ruled that Medtronic was immune from liability under state law because the catheter had been approved for the market by the FDA, arguing the Medical Device Amendments of 1976 barred such suits. On Wednesday, SCOTUS agreed.

Writing for the majority, Antonin Scalia - I really don't understand why he's supposed to be some great legal mind - made it clear that while liability was supposedly the issue, that wasn't the Court's, or at least his, real concern. He referred to how many hours, on average, the FDA spends reviewing a device application and noted that the FDA can approve devices with risks if the benefits appeared to outweigh them, mentioning specifically that

the F.D.A. 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,"

neither of which points seem relevant to the issue supposedly at hand, which is not whether or not an angioplasty has risks but whether or not the device at issue is unsafe and the manufacturer's liability.

But while they weren't relevant to the issue, they were relevant to Scalia's real point, which was that

jurors would probably not be in a position to weigh the benefits and dangers of medical devices as well as agency experts. A jury, he wrote, “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.”

In short, juries are too stupid to deal with such questions. And so, in fact, are state agencies.

I admit to a very personal bias in this case: My wife very nearly died when the balloon ruptured and tore a cardiac artery during an emergency angioplasty after a heart attack. "For about 30 seconds, we thought we were going to lose her," I was told in the hallway of the hospital as she was being taken for an emergency triple bypass. The doctor told me he thought the balloon was defective and offered to testify for us if we decided to sue. Ultimately we didn't because we were advised that even if we could show the device was defective, because she survived and survived the surgery, proving actual "harm" would be difficult.

So yeah, I feel this one particularly strongly.

Oh, by the way:

The majority was apparently persuaded by Theodore B. Olson, the lawyer for Medtronic....

Yes, that would be that Ted Olson, former US Solicitor General, counsel for Bush-Cheney in 2000's Bush v. Gore case, apple of George Bush's, Dick Cheney's, and John Ashcroft's eyes, the Ted Olson whose name was floated as a replacement for disgraced AttGen Earblot Slagzone only to be discarded as too partisan even for the Shrub gang to think they could get approved. That Ted Olson.

And here's an interesting coincidence:

In 1996, when there was a different lineup of justices, the Supreme Court ruled that medical devices approved by the F.D.A. under a different, more expedited process were not shielded from state liability. At the time, the federal government took that position. But in 2004, the Bush administration reversed the government’s position and began to take the side of manufacturers.

Olson was Solicitor General from June 2001 until July 2004.

Justice Ruth Bader Ginsburg was the lone dissenter on Wednesday, asserting that the majority had adopted an unnecessary “constriction of state authority.” Justice Ginsburg said she did not believe that Congress had intended to bring about “a radical curtailment of state common-law suits seeking compensation for injuries caused by defectively designed or labeled medical devices.”

Not only was she the only dissenter, she also was the only one actually understood Congressional intent:

“The Supreme Court’s decision strips consumers of the rights they’ve had for decades,” said Representative Henry A. Waxman.... “This isn’t what Congress intended and we’ll pass legislation as quickly as possible to fix this nonsensical situation.”

Senator Edward M. Kennedy of Massachusetts ... agreed, saying: “Congress never intended that F.D.A. approval would give blanket immunity to manufacturers from liability for injuries caused by faulty devices. Congress obviously needs to correct the court’s decision. Otherwise, F.D.A. approval will become a green light for shoddy practices by manufacturers.”

Now we just have to see if they'll walk the walk.