Sunday, March 02, 2008

Counting Noses (Predicting Kent)

People who try to predict the results of Supreme Court cases invariably make complete and utter fools of themselves.

We're just the guys for the job!

Although our crystal ball is cloudy, we're calling Warner-Lambert v. Kent five to three for the good guys. (Coming from our mouths, the "good guys" is the drug industry, in case you're either a first-time visitor to this blog or don't have much of an eye for bias.)

Here's a link to the transcript of the oral argument. Remember that Chief Justice Roberts recused himself, so we're counting only to eight here, instead of the usual nine. Here's how we count the noses:

1. We lost Ginsburg in Riegel. We ain't gettin' her here. (And she confused "drug manufacturers" with "drug dealers" during oral argument. (Tr. at 8-9.) Call us crazy, but we don't take that as a good sign.)

0 to 1.

2. Breyer poses this question: "[W]ho would you rather have make this decision as to whether this drug is, on balance, going to save people or, on balance, going to hurt people? An expert agency, on the one hand, or 12 people pulled randomly for a jury role who see before them only the people whom the drug hurt and don't see those who need the drug to cure them? Now, that it seems to me is Congress's fundamental choice, and Congress has opted for the agency." (Tr. at 30-31.)

We couldn't have said it better ourselves!

1 to 1.

Our crystal ball gets cloudier here.

3. When Breyer is asking the question we just quoted, "Scalia smiles." (That's from the report from our intrepid correspondent who attended the argument and provided a guest post. But we're reading tea leaves here, so we'll take whatever clues we can get.) Scalia also later tells plaintiffs' counsel that you can "trust the FDA to do the job" of policing fraud on the agency. (Tr. at 41.) Scalia goes our way.

2 to 1.

4. Stevens pushes pretty hard on whether claims of fraud on the FDA have in fact burdened the agency. (Tr. at 22.) And it "seems to" Stevens that "we've got a bunch of theoretical litigation out here without much actual experience with any of these cases." (Tr. at 27.) We don't like the sound of that.

2 to 2.

5. Kennedy seems more accepting than Stevens of the idea that private litigation over whether the FDA had been defrauded would burden the agency. ("[T]he discovery is exhaustive and quite burdensome. . . . [Y]ou have to have federal regulators go back through all of this stuff again." (Tr. at 29.)) And Kennedy seems offended that private plaintiffs will "tell [a] jury that the drug should not have been on the market." (Tr. at 34.)

3 to 2 for us.

6. Alito asks this beauty: "[W]ouldn't [having a jury decide whether the FDA would have approved the drug] very seriously interfere with what the FDA is doing?" (Tr. at 36.)

Looking good at 4 to 2.

7. Souter is very concerned about what Kent means for the "regulatory compliance" defense.

In many jurisdictions, a defendant can offer evidence that it complied with applicable regulations. This is considered to be some -- but not conclusive -- evidence that the defendant acted properly. Michigan law is now different. Under the Michigan statute, FDA approval is conclusive -- it is a complete defense to the plaintiff's claims (unless the plaintiff proves fraud on the FDA, and that exception may be preempted).

This is the tricky piece of Kent. Most of the justices seem offended to have a jury second-guess whether the FDA would have approved a drug (or withdrawn a marketed drug) if the FDA had known additional information. The FDA is a big agency; it can take care of itself.

But, if the Court holds that private plaintiffs can't second-guess the FDA's decisions to approve or withdraw drugs, how far does that logic extend? Can private plaintiffs second-guess other regulatory decisions made by the FDA? Suppose the FDA has inspected a manufacturer's facility and found no violations of Good Manufacturing Processes regulations. Can a private plaintiff nonetheless contend that the manufacturer violated those regulations?

This slope is a slippery one, and it's hard to tell where the Court will draw the line. Indeed, an expansive decision in Kent could easily portend a favorable result for industry in Wyeth v. Levine next Term.

Souter could go either way.

8. Finally, Thomas, who didn't speak a word during argument. He often sides with Scalia and Kennedy. We're optimists by nature. We won Riegel 7 to 1 and Buckman 9 to 0, so we have a pretty good margin for error here.

We're picking up either Souter or Thomas, and we win: 5 to 3.

You heard it here first.

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