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.
Waxman points out that Wyeth did seek a stronger warning label, which the FDA declined to adopt. Eureka. It's the FDA's fault! And that's why the FDA should be given exclusive authority to determine the content of all warning labels for all time.
Deputy Solicitor Edwin Kneedler has 10 minutes to argue on behalf of the Bush administration, which came into this case on Wyeth's side. Justice Ruth Bader Ginsburg demands that Kneedler clarify whether this is a dramatic departure from former FDA policy, which until very recently took the position, as she says, that "tort suits were a helpful adjunct to the FDA's own efforts to protect consumers." The subtext here is whether this kamikaze pre-emption blitz is part of some Dr. Evil-style effort by the Bush administration to block lots and lots of product-safety suits, a conspiracy theory shored up somewhat last week with the release of internal documents showing that career officials at the FDA objected to using federal pre-emption doctrine to Bigfoot state lawsuits. One such official wrote that reliance upon the pre-emption shield "is not, as it purports to be, consistent with the agency's role in protecting the public health."
Ginsburg is also a little worried about the FDA's ability to effectively monitor the "11,000 drugs that have its approval. Is the FDA really monitoring every one of those to see if there is some new information that should change the label?" Kneedler waxes enthusiastic about all sorts of 2007 reforms that will now give the FDA new authority to do just that kind of monitoring. "Enforcement tools," "clinical studies," "430 new employees"!! Justice Stephen Breyer notes politely that this all happened a little late to help Ms. Levine.
This launches the court onto a new tangent about whether the new information about the harms of the drug must be "old" or "new" or "borrowed" or "blue" in order to justify a label change. David Frederick has 30 minutes to represent Levine, and he starts by trying to explain what triggers a label revision but quickly runs into the Tasmanian Scalia, who will detain him for the bulk of his argument. Justice Scalia wants to know whether "opening up stuff that's already been considered by the FDA would make a mush out of it." Justice Scalia wants to know why, if Levine thinks the FDA acted irresponsibly, she isn't suing the FDA. Justice Scalia wants to know why the physician wasn't responsible for failing to follow the FDA warning. When Frederick responds that the amount of Phenergan administered "had no bearing" on the case, it was hitting the artery that did the damage, Justice Scalia wants to know, "Are you serious?"
Chief Justice John Roberts, for his part, wants to boil the whole case down to this: "So, your case depends upon us determining that the risk presented here was a new risk that the FDA did not consider?" Round and round they go over whether the duty to warn arises with new, newish, or old information and whether the misbranding begins when the old information becomes brand-new or when the new information becomes newly dangerous. Frederick contends that Wyeth knew, or should have known since at least the 1970s, that the dangers of an IV push of Phernergan warranted stronger warnings. He says Pfizer, by contrast, stopped allowing an IV push for its own anti-nausea drug after just two amputations.
Poor Diane Levine. She has lost most of her arm, her livelihood, and now her whole story to the doctrine factory that is the Supreme Court. She told Tony Mauro this week, "I thought this case had to do with me." No, ma'am. This case is so deep in the pre-emption weeds, the word guitar was never even whispered. On the one hand, draining cases of their heated emotional component is what courts do best. On the other hand, why do the court's conservatives turn so purple when they are trying to sound most dispassionate? And on the other hand, well, shouldn't the other hand matter just a little?