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Wyeth v. Levine -- When FDA Approval Isn't Good Enough

Diana Levine after her Supreme Court victory last week.
Diana Levine after her Supreme Court victory last week. (By Toby Talbot -- Associated Press)

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By Michael Kinsley
Friday, March 13, 2009

Diana Levine, a professional guitarist, "showed up at the hospital for the second time in one day complaining of 'intractable' migraines, 'terrible pain,' inability to 'bear light or sound,' sleeplessness, [and] hours-long spasms of 'retching' and 'vomiting.' " She was injected with an anti-nausea drug called Phenergan. The label on Phenergan says six times, in different ways, some of them in boldface capital letters, that if Phenergan gets into the arteries, the result can be disastrous. Nevertheless, a physician's assistant used the wrong method of injection, and Levine's arm turned gangrenous and ultimately had to be amputated.

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The drug company Wyeth has sold Phenergan, with Food and Drug Administration approval, since 1955. The official question in Wyeth v. Levine, decided last week by the Supreme Court (the quotes above are from Justice Samuel Alito's dissent), was whether that federal government approval "pre-empts" a Vermont jury ruling in favor of Levine. The court said no. A more interesting question is: How did we end up with such a crazy system for making important decisions?

Is there anyone who opposes drug regulation (I mean medical drugs) in principle? Very few, I suspect. We go through hindsight-based political cycles of first complaining that the government is too strict about approving new drugs and then charging that it is too lax. But the basic notion that government should screen what drugs we ingest isn't controversial. The trouble is the way we do it. On the one hand there is a federal agency, the FDA, charged with approving drugs. On the other hand there are courts where lawsuits attempt to draw the same line between safe and unsafe.

The flaws of litigation as a method of making important government decisions are well rehearsed. It is ungodly expensive: The lawyers typically cost more than even the most worthy plaintiff ever gets. It is arbitrary: The same issues get litigated again and again, usually with a different result each time. Most people who suffer never sue and get nothing. While the FDA has scientists, the courts have jurors, for whom ignorance of the subject at hand is not merely the norm but a virtual requirement. And because trials occur only when a risk has gone wrong, they inevitably overemphasize the risk and undervalue the benefit. Why did Levine return to the hospital for a second time the same day? After long spasms of retching and vomiting, she was desperate for a treatment like Phenergan.

To be sure, reading tossed-off phrases in Justice Stevens's ruling such as "the FDA approved Wyeth's 1981 application in 1998" gives one pause about the federal-agency method of regulation. So does an apparently serious discussion of whether it might have been illegal for Wyeth to put an even scarier warning on its label. But someone must decide whether Phenergan is safe and what warnings its label should carry, and one someone is preferable to two or more. In our system, everyone decides. Most of the court's ruling in Wyeth v. Levine is dedicated to a discussion, in excruciating detail, of what Congress may have intended to decide about whether decisions by the FDA take precedence over decisions by local courts and jurors. It took nine years from the time of Levine's tragedy for the Supreme Court to finally decide that one.

It would be typical -- wouldn't it? -- if Congress actually authorized a regulatory agency to protect us from dangerous drugs and actually intended to let that agency be overruled by anyone who happened to stroll by the courthouse with nothing better to do than attempt to decide these questions all over again. Even more typical would be if Congress intended nothing at all on this recherche topic except to pass the decision along like a hot potato, and is now having a good horse laugh watching the justices conduct an intellectual Easter egg hunt all over Capitol Hill trying to find its intent.

What happened to Diana Levine is a tragedy and a scandal. But what did Wyeth do wrong? Is there any way the company could have stayed out of trouble? It's unlikely. Phenergan has been legal for half a century. (If you Google the word "Phenergan," the results include pages containing an ad for Phenergan online.) So if you can't get them for the product itself, you nail them for a "failure to warn." The basic fiction at the heart of the whole system of regulation by lawsuits is that people read and act on warning labels. But the FDA approved Wyeth's original warning label and every change since. "Not good enough," said a Vermont jury, and, incredibly, a majority of the Supreme Court agreed.

kinsleym@washpost.com


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