Supreme blunder?

[Update: The WSJ has an opinion piece on this topic]

http://blogs.usatoday.com/oped/2009/03/opposing-view-t.html#more

An unfortunate error cost a woman her arm. She had been given a drug, administered in a manner that was strongly warned against in the drug's documentation, that caused gangrene. But now the Supreme Court has ruled that warning labels are simply not enough, even though the FDA strictly advises on how labels are written and what they must contain.

This drug has been approved and used since 1955 with very few unfavorable results "It had been used beneficially and with very rare incidents more than 200 million times since 1955 under FDA-approved labeling." One botched injection in violation of the warning on the label and poof, expect this mfr to lose lots of money. And the inevitable negative impact is that drug prices will increase to cover potential losses across the board--I mean even more so than already.

Of course USA Today's editorial board feels differently. And the initial jury found Wyeth liable for $7.4M.

USA Today and the Surpreme Court seem to think that a warning label written for medical professionals under federal guidelines is not enough. "The drug label's warnings had been approved by the U.S. Food and Drug Administration, but a Vermont jury found that Wyeth could have — and should have — made those warnings stronger." And according to one article I read "Wyeth has never been remiss in reporting incidents of gangrene from Phenergan via IV push, this is not the kind of Merck/Vioxx-type case in which a drug company deliberately withheld risks from the FDA."

I can tell you one way that Wyeth could have avoided "acting negligently". They could have decided that this exceedingly small risk (by my short googling research, about 50 incidents...math follows: 50 / 200e6 = 0.000025%) meant that they ought not to sell this drug.

Thirty seconds of googling show many journal articles discussion the danger, although they certainly can be related to this case. I'd love to cut&paste the actual warning as printed, but the PDF document does not allow text extraction. So follow this link and read along. On page 2, it says "Under no circumstances should PHENERGAN Injection be given by intra-arterial injection due to the likelihood of severe arteriospasm and the possibility of resultant gangrene (see WARNINGS-Injection Site Reactions)." [bold face and capitalization as in the document]. Now scroll down to middle of page 4 "Injection Site Reactions" and the two paragraphs describing the results of Inadvertent Intra-Arterial Injection. Gangrene and amputation are listed at least twice!

Does this look like a "mild warning" per this article?

The FDA has ostensibly known about the drug’s gangrene risks for many years, and despite the over 50 amputations that have resulted from the IV push method of administration, has continued to approve the drug for IV push use, including only a mild warning on the label to advise doctors of the risk.

I just can't see how anyone could rightly think Wyeth is at fault here.