Here is the human version of Wyeth v. Levine: Free-spirited Vermont singer/songwriter goes to clinic for a migraine. She is treated with an "IV push" of Phenergan, an anti-nausea drug. Her right arm—the "joyous" one, the guitar-strumming one —goes gangrene, requiring amputation. Wyeth, the maker of Phenergan, was aware of the danger of an "IV push" (increased likelihood of hitting an artery) yet failed to provide an adequate warning label. A jury awards her a $6.7 million judgment. She is still writing songs.
Here is the Vulcan version of Wyeth v. Levine:Levine's case is tragic, but accidents happen. The Food and Drug Administration approved Phenergan as safe and effective in 1955. After decades spent weighing the costs and benefits of the "IV push" method of administering the drug, the FDA crafted a warning label that—while not prohibiting it—indicated that the IV push was not "preferred." As a result of physician error, Levine's injection hit an artery. Wyeth is being punished because, although it complied with the FDA labeling standard, it failed to provide a second, stronger warning that would satisfy a hippie Vermont jury faced with an amputee guitarist. Drug companies should be required to meet a single, rational safety standard, not 50 standards set willy-nilly by juries in every state. The only solution to this dilemma: All state product-liability claims should from now on be pre-empted (read: obliterated) by federal law. The FDA is to have the first, last, and only word on prescription-drug labeling.
Wyeth is being called the most important business case of the year because, if the court finds that the FDA warning occupies the field of drug warnings, it will effectively immunize drug makers from many state tort suits. If it finds pre-emption here, the most business-friendly Supreme Court in decades can cancel the room with two queen-size beds and order a single king for itself and big pharma.
Argument this morning is Vulcan, in that the court's conservatives get most passionate and irrational about their own rationality. The transcript is here, and it offers more in the way of reason than rhyme. Former Solicitor General Seth Waxman represents Wyeth, and almost before he can get off an opening thought, Justice Anthony Kennedy assails him with the language of logic: "You argue that it's impossible for Wyeth to comply with the state law and at the same time the federal label. As a textual matter, as a logical matter, as a semantic matter, I don't agree."
Waxman points out that the FDA label already conveyed all the risks of Phenergan, with "four different references" to the dangers of an IV push. But Justice Samuel Alito wonders how the FDA could have possibly weighed the costs and benefits of Phenergan when, as he says, "on the benefit side of this you don't have a life-saving drug, you have a drug that relieves nausea. And on the risk side you have the risk of gangrene!"
Fie upon your logic, Justices! Waxman retorts: "This is labeling directed at medical professionals." Not only are juries too emotional and irrational to perform a cool cost-benefit analysis, evidently Supreme Court justices are as well.
One of the concerns about setting the FDA warning label as a "ceiling" beyond which states cannot deviate is that these labels become frozen in time, even as the drug companies continuously learn of new dangers posed by their drugs. We have come to rely on the state tort system to force drug companies to report new dangers, having found that hoping for the very best from them does not always work out. This prompts Justice David Souter to ask why Wyeth—based on new evidence the company had accumulated about Phenergan—didn't think the label ought to be changed. "Wyeth could have gone back to the FDA anytime, and it simply didn't do it," Souter says.