In today’s Washinton Post, prominent liberal columnist Michael Kinsely makes a pointed critique of the Supreme Court’s decision in Wyeth v. Levine and upbraids Congress for its flawed handling of federal drug regulation. From “Drug Regulators in the Jury Box“:
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.
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.
To fill in the one gap in Kinsley’s analysis, it’s worth noting that the medical clinic that improperly administered the anti-nausea drug reached a settlement with Ms. Levine. But it wasn’t enough for her and her lawyers, who turned a clear malpractice case into a multi-million-dollar lawsuit against the manufacturer of a very useful and proven drug.
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