Are juries too stupid to judge the highly complicated technical issues involved in drug safety and regulation in cases like Wyeth v. Levine, where a middle-aged musician given an antinausea drug intravenously immediately developed gangrene and lost her arm? That was the argument advanced yesterday by Yale law professor Peter H. Schuck on the New Republic's Treatment blog.

Juries have great virtues in many kinds of cases, but making these medical cost-benefit tradeoffs is not one of them. They sit in only one case, and the plaintiff's lawyer makes sure that the severely injured, extremely sympathetic plaintiff whom they see is not representative of the much larger group of those who reap the drug's benefits when it is properly administered. The trial lawyers intentionally seek jurors who know nothing about the subject at hand. The jury's verdict is completely opaque and unexplained. It is accountable to no one.

His solution? Echoing the Wall Street Journal editorial page, he asked Congress to step in and explicitly allow the Food and Drug Administration's regulatory decisions to preempt state tort laws that require manufacturers warn consumers about the potential hazards of their products.

The FDA, he argued, has the technical expertise to make these decisions, not juries:

The FDA had actually considered a stronger warning as recently as 1998, but did not require it. It may have reasoned that IV-push is more beneficial than the alternative (IV-drip) in situations like Levine's when speed is essential, and that IV-push is safe when the clinician heeds the clear warnings. . . . Balancing these kinds of tradeoffs is precisely the kind of technical judgment calls that FDA was established to make.

It's too bad Professor Schuck didn't read the decision more closely, because the majority of justices directly addressed the issue of FDA competency in its reasoning for maintaining the state law backstop for failures of federal oversight. "The FDA has limited resources to monitor the 11,000 drugs on the market, and manufacturers have superior access to information about their drugs, especially in the postmarketing phase as new risks emerge," they wrote.

The footnote for that part of the decision noted the historical context. In the very same year that Wyeth's drug Phenergan was approved (1955!), an FDA advisory committee warned that "the budget and staff of the FDA are inadequate to permit the discharge of its existing responsibilities for the protection of the American public." Three very recent reports noted by the decision suggest things have only gotten worse. The FDA's own Science Board in its 2007 report concluded the agency "suffers from serious scientific deficiencies and is not positioned to meet current or emerging regulatory responsibilities."

A 2007 Institute of Medicine report cited in the footnote noted that "there is widespread agreement that resources for postmarketing drug safety work are especially inadequate." And a 2006 Government Accountability Office report specifically pointed out that the FDA Chief Counsel Dan Troy's 2006 assertion that the FDA regulations preempted state tort laws "was based on erroneous assertions about the ability of the drug approval process to ensure accurate and up-to-date drug labels."

The jury system may be an imperfect solution to this flawed regulatory system, but sometimes it is the only option. As the footnoted reports point out, the FDA over many decades has been denied the resources it needs to do its job properly. In the past decade, it has been run by political appointees like former drug industry counsel Dan Troy, who nakedly used public office to advance the interests of his former clients. When regulation fails, the states' civil justice system -- including the right to a jury trial -- remains a vital backstop. Juries may start out without much knowledge, but at least they get to hear both sides of the story.

It's inconceivable that the current Congress would follow Professor Schuck's advice. Indeed, legislation was introduced yesterday that would repeal the law that gave FDA decisions on medical devices preemptive power over state laws. I don't know if it will pass. But it should.