Friday, August 22, 2008

"The Case For Field Preemption of State Laws In Drug Cases"

We can't figure out how to italicize the title of a post, so we'll repeat that title here, with our emphasis added:

"The Case for Field Preemption of State Laws in Drug Cases."

That's the provocative title of Richard Epstein's piece posted yesterday at Northwestern University Law Review's Colloquy site. Here's a link.

Everyone argues for conflict preemption in drug cases, but one rarely sees an argument for field preemption.

Epstein has made this argument before. See Richard A. Epstein, "Why the FDA Must Preempt Tort Litigation: A Critique of Chevron Deference and a Response to Richard Nagareda," 1 J. Tort. L. art. 5 (2006), available at http://www.bepress.com/jtl/vol1/iss1/art5/ (link).

It's nice to see him make it again, particularly with Wyeth v. Levine pending in the Supreme Court.

In a nutshell, Epstein criticizes the Kessler/Vladeck argument against preemption on two grounds: That argument ignores both (1) the incentives that cause the FDA to delay (or refuse) approval of beneficial drugs, which can cause more harm than premature (or incorrect) approval, and (2) the reasons why the tort system is ill-equipped to decide complex pharmaceutical product liability cases.

Epstein also criticizes Catherine Sharkey's "agency reference" model for preemption. See Catherine M. Sharkey, "What Riegel Portends for FDA Preemption of State Law Products Liability Claims," 102 Nw. U. L. Rev. Colloquy 415 (2008), available at http://www.law.northwestern.edu/lawreview/colloquy/2008/24/LRColl2008n24Sharkey.pdf (link).

In Epstein's words, the burdens of analyzing an agency's decision-making record in a typical situation "are trivial compared to wading through the normal complex FDA record. In addition, this onerous task would have to be done in thousands of separate cases. The sheer weight of litigation would open up the possibility of third-party depositions of present and past FDA employees, and extensive discovery of FDA doctrines."

Additionally, "Sharkey’s proposal does not correct the deficient error-cost analysis in the Kessler-Vladeck plan. Nor does it take into account the substantive weaknesses of the current duty to warn law in most states, with the high risks of false positives on liability. The proposal’s ex ante effects are also likely to deter new drug innovation by adding private law sanctions to the impressive administrative obstacles that now impede new drug development. Finally, its helter-skelter results undermine the uniformity that grounds the public acceptance of the law."

We have two reactions to this.

First, we're always pleased to see a public debate on issues of importance (and particularly pleased when really smart people jump in on our side).

Second, Northwestern's Colloquy site may well represent the future of a certain type of legal scholarship. There will probably always be room in the law reviews for timeless articles about "law and poetry" and the "law of pre-Columbian civilizations." But, for people who are trying to engage in discourse on a hot topic of the day, the Colloquy format is better. It's great to see Sharkey post an intelligent (if not quite law review length) article on July 21 and to see Epstein's intelligent (if not quite law review length) response posted a month later. For subjects such as these, the debate should not be drawn out by a year-long editing process at the law reviews.

Kudos to the participants, and kudos to Northwestern.

2 comments:

hg said...

You write:

"First, we're always pleased to see a public debate on issues of importance...."

Here, I could not agree with you more. I have several times tried to engage _serious_ people in favor of preemption (as I certainly see both of you) in open, public debate. But I have never gotten a response.

This has led me to the cynical conclusion that those in favor of preemption would prefer it _not_ be subject to public debate.

I would love to be proven wrong in this regard. I am a teacher most of all. There are many civics lessons in all of this, and critical questions about policy and how to think about it.

I understand you have allegiances to your clients first and foremost. But would you be willing to help me create public fora (not involving either you or me) in which this issue could be discussed in a thorough and public way? To this point, the discussion has been mainly (in my view) self-indulgent rage, talking points, and partisan trivia that has served no one.

Anonymous said...

Given the wordy responses to all the comments, aren't plaintiffs going to say any new study or reanalysis that shows any increase calls for immediate changes in the labeling? Rather than deny preemption, won't a hostile judge just find that the new data constitutes reasonable notice of risks that should have been immediately inserted under the CBE provisions?