HOME / supreme court dispatches: Oral argument from the court.

Label ConsciousThe Supreme Court gets positively passionate about pre-emption.

By Dahlia LithwickPosted Monday, Nov. 3, 2008, at 7:57 PM ET

(Continued from page 1)

RSS

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?

BONUS reader contest: Anyone wanna place a bet on which justice will cuss first in tomorrow's FCC case and what word he or she will say? Send mail to .