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Saturday, November 28, 2009

Guest Blogger Ben Zipursky’s Reply to Drug and Device Law Blog

I am delighted to have had responses from several thoughtful commentators, including well known voices in products liability law – Restatement Reporter Michael Green, Mark Herrmann and Jim Beck of the Drug and Device Law Blog, and my own colleague, George Conk, who has long been a leading commentator from the plaintiffs’ side in drug-and-device law. 

I briefly responded to Mike Green and George Conk in a prior comment; their principal point was that Riegel was not really justifiable; Mike strikingly pointed out that the FDA is not even required to opine on device safety, making the device preemption argument even weaker, in some ways.    I agree that Riegel was wrongly decided, in part for the reasons they put forward, but most notably because I do not think it is really justifiable as an express preemption case, because I do not think a verdict in a products liability action counts as state law that is a requirement, and I do not think any of the Court’s precedents necessitated this otherwise unjustifiable analysis.  

A different question, of course, is whether the Court’s precedents prior to Riegel permitted it to reach this result on express preemption, without any implausible stretches in the precedent.   The answer is yes; Cipollone and Geier actually paved the way for Justices who wanted to reach this conclusion.   That does not mean that I believe the conclusion was correct as a matter of statutory interpretation or mandated by those precedents.   I do not.   Indeed, although I happen to be quite fond of Justice Scalia’s textualism in a number of settings, I do not think a textualist reading justified where he took the case, except when parts of the text were twisted by precedents there was no compulsion to follow.

The larger challenge is from Jim Beck and Mark Herrmann, on the Drug and Device Law Blog (“DD”, for short).   The exceptionally informative response on the blog corrected my off-the-cuff statement that most device cases are design defect; my gratitude for that.  As DD suspected, my main point was that design defect does not play a big role any longer in drug cases, but – if Riegel was in any way representative – continues to do so in device cases.

DD’s larger points were these:
1.   There might have been perfectly good reasons to think that the Medical Devices Amendments should be read as preempting state tort liability, quite apart from reasons for thinking there should be preemption for drugs too (which DD also believes).   One is historical (states were regulating more in the 70s, when the devices amendments came through); a second is that the generally smaller nature of device companies counts in favor of thinking they need greater protection; a third is that the shorter active life of a device type (relative to a particular prescription drug) also means that such companies will need greater protection.

2.   The “warning defect v. design defect” distinction does not work to explain the distinction between Levine and Riegel, and in any event there is no reason to speculate on why the cases were decided differently given that the Court actually provided its reasons, and there is no reason to take what the Court said at face value (unless one is an academic who has too much time to spend on rank speculation).

As to DD’s first point, I find the historical background quite illuminating.   Of course, this is just the kind of speculation about legislative thinking that Justice Scalia bridles at, and it is unsurprising that we see little of this.  In any event, it all goes to the question of why they might have wanted preemption of state requirements, and my whole point is that a verdict in a case involving the product, where a jury has decided this is hardly a requirement.  It is true that I closed my blog post by asking why Congress might have drawn a distinction on preemption of requirements, and I am grateful for the historical analysis.   But this does not take us anywhere on the issue of preemption of tort liability.

As to the second point, I think it is fair enough to ask what my problem was, and criticize me for, in effect, fabricating a problem.   There is no question that Riegel’s holding is not about design defect theories, and that it sweeps in failure-to-warn.   And there is no question that the Court did not purport to distinguish Levine in anything like the way my analysis suggested.   Moreover, I could not agree with DD more that lawyers and law professors alike should listen to what courts actually say, rather than making things up and speculating.   And I agree that the plaintiff in Levine had virtually nothing useful to say on what the warning should have been, and why that would have made a difference (although I think Levine was correctly decided by the United States Supreme Court on preemption, I think it was wrongly decided by the Vermont trial judge who denied Wyeth’s motions for judgment as a matter of law; these were not before the U.S. Supreme Court, of course).

Finally, even if I were interested in the speculation about judicial psychology, the broad and squishy distinction between design and warning cases is not where I would go. Although I, as a torts professor who worries a lot about causation, perceived the fact pattern of Diana Levine’s case as one that was really strong for Wyeth, I think I am quite peculiar.   Some of the Justices probably felt a lot like the jurors and the majority of the Vermont Supreme Court; they felt bad for a healthy, appealing Vermont guitarist whose migraine led to gangrene because of Wyeth’s drug (on a fairly easy to present version of “because of”).    There was a major publicity campaign for Levine.   Plus, several of the Justices were in an anti-Bush mood, and the FDA Preamble argument bit back, evidently enraging some of the Justices.   Riegel was easy to explain because it fit nicely into the trend of cases the Court had been deciding, where the presence of a statutory preemption clause provided a skeleton onto which they could place a tort preemption argument that they believed was sound as a matter of policy.   Levine was the odd case, from a predictive point of view, but the powerful facts and the anti-Bush sentiment seemed to play a significant role.  In any event, that would be my speculation.   And it is sort of interesting, but it is not the issue I tried to raise.

The issue I was trying to raise is not about speculation.   It is an effort to understand the legal scheme we now have.   I would have thought that practicing lawyers would have a better sense than I of just how odd this scheme might look to business people, consumers, and lower court judges.    I think it is good for law professors to step back and try to get a picture of what the system would look like to those who are not caught up in its details and the adventures of those who are trying to push it in one direction or another; perhaps there are certain domains where law professors might even have an edge in doing so (I kind of doubt it).  

When one stands back and looks, there is a pretty dramatic difference right now between devices and drugs.  Clearly, the way to explain it historically is by looking at the different statutes.   DD’s background on why the device statute might have turned out more protective (at least expressly) is helpful.   But I think a rationalizing instinct is often a good one try to exercise, and that is what I was trying to do. 

My current thinking on that front is that my suggestion of “design defect versus warning defect” is inadequate to rationalize the distinction.    However, I continue to believe one part of what I was saying was along the right track.   No doubt, having common law causes of action around for products that also need FDA approval is socially a very expensive thing to do (not just in money, but in reduced availability of new products, etcetera).   Of the many reasons for doing it, one is the idea that the tort system might provide findings of dangerousness and corporate conduct that present substantial threats to individuals and the public, where regulators perceive the same fact pattern quite differently, and that on some of these occasions, the regulators are in the wrong and the jury is onto something important.

I continue to think that the Justices – and many parts of our legal system – have a certain picture in their mind of what this “the jury gets it right and saves millions of future lives in the long run” picture is about.   It is a case with a drug that is widely used notwithstanding the manufacturer’s knowledge of hazards, which  have never been properly disclosed.   My suggestion would be that the conviction that juries might be onto something in some cases like this traces in part to the idea that juries can be quite good at saying when
information was really something doctors and patients should have been told – at judgments about informational wrongdoing.

Our system is evidently not willing to give up on this part of our tort  law.   Relative to this commitment, a case like Riegel does not seem too threatening, but a case like Levine (rightly or wrongly) does seem
very threatening.

- Ben Zipursky
Fordham University School of Law

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