Wednesday, March 19, 2008

A Tea Leaf For Levine

Isn't it funny? The blogosphere has already beaten Riegel v. Medtronic to a pulp (we joined in the fun here, here, and here) and is moving on to other subjects, and the first law review article analyzing the case may not appear for months.

What does that say about the future of law reviews? (Then again, maybe the academics will distinguish themselves from us by saying something worthwhile.)

Anyway, we're moving on from Riegel, at least for today, and looking ahead to the blockbuster pharmaceutical preemption case that the Supreme Court will decide next Term, Wyeth v. Levine.

Many folks have been reading the tea leaves to try to decide what the decisions in Riegel and Warner-Lambert v. Kent mean for industry in Levine. As we've proved before, predicting the result of Supreme Court cases is notoriously tough -- especially before they've even been briefed.

But here's one thing to consider when you gaze into your crystal ball and speak the words Wyeth v. Levine. (The two of us were doing that just last night. Herrmann brought the crystal ball; Bexis brought the beer and chips.) (We told you we were fun guys.)

Anyway, here's the solitary tea leaf that we read. (Egad. Is this post a mishmash of mixed metaphors, or what?)

Since its decision in Cipollone v. Liggett Group, Inc., 505 U.S. 504 (1992), the Supreme Court has decided seven preemption cases in which it received amici curiae briefs giving the relevant federal agency's position on preemption.

In six of those seven cases, the Supreme Court has decided the preemption question in accord with the agency's view.

The outlier is Bates v. Dow Agrosciences, LLC, 544 U.S. 431 (2005), where the EPA favored preemption, and the Supreme Court recognized that some claims might be preempted, but held the particular claim before it was not.

Other than that, however, the Supreme Court has always ruled in favor of the position advocated by the agency.

Thus, in Geier v. American Honda Motor Co., 529 U.S. 861 (2000), the Department of Transportation thought that "no-airbag" claims should be preempted; the Supreme Court held that they were.

In Sprietsma v. Mercury Marine, 537 U.S. 51 (2002), the Coast Guard did not believe that claims relating to a propellor guard should be preempted; the Supreme Court held that they were not.

In Freightliner Corp. v. Myrick, 514 U.S. 280 (1995), the Department of Transportation opposed finding claims relating to anti-lock brakes on tractor-trailors to be preempted; the Supreme Court ruled consistently with the agency's position and found no preemption.

So, too, in the three drug or device cases the Court has heard.

In Medtronic v. Lohr, 518 U.S. 470 (1996), the FDA opposed preemption, and the Court found no preemption.

And in both Buckman v. Plaintiffs' Legal Committee, 531 U.S. 341 (2001), and Riegel v. Medtronic, __ U.S. __ (2008), the FDA favored preemption, and the Court found preemption.

This is not a very sophisticated analysis.

(Aw, c'mon. Given the source, what did you expect?)

No one has said that the relevant agency's views on preemption are always dispositive, and the Supreme Court has wrestled with the degree of deference owed to agencies' briefs and other statements. Moreover, arguments for or against preemption can be nuanced. The list that we compiled above may be giving more weight than is due to random chance -- the agency took one position out of two, and the Court took one out of two; sometimes, the positions line up.

On the other hand, the government did argue in favor of preemption in its briefing at the certiorari stage of Wyeth v. Levine, and that may well be a good sign for the pharmaceutical industry when the time comes to decide the merits.

If not, we're giving up on crystal balls.

Yo, Bexis: Do you own a Ouija Board?

3 comments:

Anonymous said...

A similar insight leads to my development of an "agency reference" model for preemption decisionmaking in a soon-to-be-published law review article, "Products Liability Preemption: An Institutional Approach," which can be downloaded at: http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1101448

Consistency of agency position may also be significant. In Bates, the Court remarked: “The notion that FIFRA contains a nonambiguous command to pre-empt the types of tort claims that parallel FIFRA’s misbranding requirements is particularly dubious given that just five years ago the United States advocated the interpretation that we adopt today.” And in Riegel: "If . . . we had found the statute ambiguous and had accorded the agency’s current position deference, the dissent is correct, that—inasmuch as mere Skidmore deference would seemingly be at issue—the degree of deference might be reduced by the fact that the agency’s earlier position was different."

FDA has of course changed its position from anti- to pro-preemption in the contexts of medical devices (Riegel) and drugs (Wyeth).

Catherine Sharkey

Anonymous said...

If your tiny crystal balls get shattered and you have no legal recourse, you'll have a different opinion of FDA preemption.

Henry Greenspan said...

This is a question that goes with Catherine Sharkey's good comment. Of course, we have all heard the arguments re: agencies being free to change their positions.

But the question is: Does that history impact the smoke in the ball or the lay of the tea leaves? (Glad you guys got at least two opinions.)