The Supreme Court gets positively passionate about pre-emption.

Oral argument from the court.
Nov. 3 2008 7:57 PM

Label Conscious

The Supreme Court gets positively passionate about pre-emption.

Diana Levine. Click image to expand.
Diana Levine

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.

Dahlia Lithwick Dahlia Lithwick

Dahlia Lithwick writes about the courts and the law for Slate. Follow her on Twitter.

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.

Advertisement

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.

TODAY IN SLATE

Politics

Meet the New Bosses

How the Republicans would run the Senate.

The Government Is Giving Millions of Dollars in Electric-Car Subsidies to the Wrong Drivers

Scotland Is Just the Beginning. Expect More Political Earthquakes in Europe.

Cheez-Its. Ritz. Triscuits.

Why all cracker names sound alike.

Friends Was the Last Purely Pleasurable Sitcom

The Eye

This Whimsical Driverless Car Imagines Transportation in 2059

Medical Examiner

Did America Get Fat by Drinking Diet Soda?  

A high-profile study points the finger at artificial sweeteners.

The Afghan Town With a Legitimately Good Tourism Pitch

A Futurama Writer on How the Vietnam War Shaped the Series

  News & Politics
Photography
Sept. 21 2014 11:34 PM People’s Climate March in Photos Hundreds of thousands of marchers took to the streets of NYC in the largest climate rally in history.
  Business
Business Insider
Sept. 20 2014 6:30 AM The Man Making Bill Gates Richer
  Life
Quora
Sept. 20 2014 7:27 AM How Do Plants Grow Aboard the International Space Station?
  Double X
The XX Factor
Sept. 19 2014 4:58 PM Steubenville Gets the Lifetime Treatment (And a Cheerleader Erupts Into Flames)
  Slate Plus
Tv Club
Sept. 21 2014 1:15 PM The Slate Doctor Who Podcast: Episode 5  A spoiler-filled discussion of "Time Heist."
  Arts
Television
Sept. 21 2014 9:00 PM Attractive People Being Funny While Doing Amusing and Sometimes Romantic Things Don’t dismiss it. Friends was a truly great show.
  Technology
Future Tense
Sept. 21 2014 11:38 PM “Welcome to the War of Tomorrow” How Futurama’s writers depicted asymmetrical warfare.
  Health & Science
The Good Word
Sept. 21 2014 11:44 PM Does This Name Make Me Sound High-Fat? Why it just seems so right to call a cracker “Cheez-It.”
  Sports
Sports Nut
Sept. 18 2014 11:42 AM Grandmaster Clash One of the most amazing feats in chess history just happened, and no one noticed.