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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

November 28, 2009 in Guest Blogger, Scholarship | Permalink | Comments (0) | TrackBack (0)

Thursday, November 26, 2009

Happy Thanksgiving 2009 from TortsProf Blog

We're grateful you read our blog!

--Bill, Sheila, and Chris

November 26, 2009 | Permalink | Comments (0) | TrackBack (0)

Wednesday, November 25, 2009

Monday's Guest Blogger: Jason Solomon

Solomon2 

Jason M. Solomon is Assistant Professor of Law at the University of Georgia School of Law.  His writing focuses on the theory and practice of civil justice, and his research interests also include regulatory theory and policy, the law of the workplace, and legal education. Since entering the legal academy, Solomon's scholarship has been published in the Northwestern, Vanderbilt and Texas law reviews.

Prior to joining the Georgia Law faculty, he was chief of staff and counselor to the president of Harvard University. He previously served as a judicial law clerk to Judge Chester J. Straub of the U.S. Court of Appeals for the 2nd Circuit and Judge John Gleeson of the U.S. District Court in Brooklyn. Before entering the law, he worked in the White House and the U.S. Treasury Department.

Solomon earned his bachelor's degree magna cum laude from Harvard University and his Juris Doctor from Columbia University, where he served as notes editor of the Columbia Law Review and was a James Kent Scholar.

--CJR

November 25, 2009 in Guest Blogger | Permalink | Comments (0) | TrackBack (0)

Tuesday, November 24, 2009

Products Liability Casebooks

It's that time of year - time for family, time for turkey, and time to select your casebook for your spring courses.   A reader wonders what case book to  use for a Products Liability course. 

Do you use -- Henderson & Twerski's Products Liability Problems and Process?  - Fisher, Green, Powers & Sanders's Cases and Materials on Products Liability?  - Phillips, Terry, Vandall & Wertheimer's Products Liability:  Cases, Materials, Problems?  - Owen, Montgomery & Davis's Products Liability and Safety, Cases and Materials?  - Another book?

Please share your input in the comments.

- SBS

November 24, 2009 in Teaching Torts | Permalink | Comments (0) | TrackBack (0)

Monday, November 23, 2009

Guest Blogger Ben Zipursky on "The Differential Treatment of Medical Devices and Drugs in Preemption Doctrine: A Justified Distinction?"

One year ago, many tort scholars and securities analysts believed that a major shift was about to occur in products liability law: our nation’s highest court was about to declare that claims against pharmaceutical manufacturers were preempted.   We all know that this did not occur, that in the much-awaited decision of Wyeth v. Levine, six members of the Court decided to leave state tort law for prescription drugs alone, at least for the moment.    Although I believe that the case was correctly decided, I am happy to admit that the decision came as something of a surprise.   Part of the reason for that surprise was the Court’s lopsided decision in favor of preemption just one year earlier, in Riegel v. Medtronic.   There, eight members of the Court voted in favor of a broad preemption doctrine in medical device cases.   Five of the Justices who voted for preemption in Riegel – Stevens, Kennedy, Thomas, Souter, and Breyer – voted against preemption in Wyeth.     

The combination of preemption in Riegel and no-preemption in Wyeth does not present any truly sharp inconsistencies or paradoxes, but it nevertheless merits exploration.   There is no actual contradiction between the cases for many reasons.   Most notably, the two cases presented questions of statutory interpretation, but did not involve the same statute. To get right to the point, Riegel applied a statute that actually contained an express preemption clause, while Wyeth applied a statute that lacked such a clause.   From this point of view, one could have known everything one needed to know about Wyeth by looking at Justice Stevens’ concurring opinion in Riegel, which essentially announced: “Make no mistake about it; I am voting for preemption here only because there is a preemption clause in the text of this statute.”  

Nevertheless, it is quite unsatisfying to explain away the distinction between these cases simply by reference to the textual difference.   To begin with, if we are candid we must admit that there was virtually no federal preemption in any cases involving FDA approved products a couple of decades ago; there has been a strong, industry-based push to create preemption doctrine, and it has been quite successful.   Where it matters most, however – the Supreme Court – there is a striking discrepancy.   There is a clear acceptance for (a large class of) medical devices and a clear rejection (so far) for drugs.  Yet the policy motivation is exactly the same – it makes sense to defer to federal agency expertise, and to forestall the costly state-by-state variations, especially given the relatively low probativeness of jury decisions on safety.   

Second, notwithstanding the eight votes for Medtronic in Riegel, the statutory interpretation argument in that case is far weaker than the Court admitted.   The Court has been fooling around with the concept of a “requirement” in express preemption clauses.   There is no evidence that Congress was conceiving of state tort liability as a form of legal requirement and, if there is any straightforward reading of the text, it does not cut in favor of preemption.    Obviously, there was already good precedent for Justice Scalia to build upon (Cippollone and Geier) to make this argument.   But those arguments were far from unassailable, both because each came with a fractured Court whose members wrote highly nuanced analyses, and because each of those products (cigarettes, airbags) was plainly unique in a way that mattered to the significance of agency decisionmaking.   More importantly, the precedents themselves reflected that many of the Justices were engaged by pro-preemption motivations.

The other side of the puzzle is that, while nothing in the text of the statute applicable in Wyeth permitted an easy, across-the-board express preemption argument there, plenty of opportunities to rule for Wyeth presented themselves.   Quite apart from the opportunities for deference to the FDA, which had taken a strong pro-preemption position, there were quite powerful implied preemption arguments made.   And the analogy to Geier, although imperfect, was quite strong.    Moreover, as Justice Alito’s quite fact-based and careful dissent illustrates, there was a fairly persuasive argument for Wyeth on the facts.   

And now, let’s admit that part of the point of preemption doctrine is that the Court gets to play the role of rationalizing the big picture scheme of the law.   If two aspects of the law – state and federal – are too badly out of whack with one another, then the Court will exercise its power to create a smoothing-out of the law.   It is odd, then, that the Court seems happily to countenance a stark difference in treatment between device law and drug law.  The discussion above is merely meant to remind us that there was nothing inevitable about this.   Finally, even if one were to take the view that statutory differences fully warranted the discrepancy, one would want to ask why medical device makers were given so much more protection against state tort liability.

This is all by way of a lengthy lead up to a tentative suggestion, one that is truly meant to invite discussion. Riegel – like most medical device cases (I believe … but would be happy to be corrected) – is a design defect case.   Wyeth – like most prescription drug cases – is a failure-to-warn case.    That means that, at a gestalt level (and, to some extent, at a practical level), the Court was deciding in Riegel whether juries would be allowed to displace FDA decisions on medical device design, while the Court in Wyeth was deciding whether juries would be allowed to displace FDA decisions on what information drug companies must convey to prescribing healthcare providers.   Is it possible that the difference between displacing design decisions and displacing informational decisions is part of what led us to where we are now?   If so, would this be a rational line to draw?   Does the difference between the two types of questions shed any light on why medical devices and drugs might be drawn differently?    (Is this distinction overdrawn?)   If so why?

When I put this question to myself, my mind tracked over to the somewhat analogous field of medical malpractice.   As torts professors and medical malpractice lawyers know, courts and legislatures do not look kindly on juries second-guessing experts on technical and scientific questions regarding the standard-of-care in medical malpractice cases.    It is black-letter law that juries cannot second-guess the standard-of-care accepted by experts in the field; T.J. Hooper does not apply to medical malpractice.   However, in a large number of jurisdictions today, informed consent cases work differently: jurors may second-guess what experts have decided is the right level of information disclosure.    That is, in part, because courts are willing to empower juries to second-guess experts on normative decisions about how much safety information should be disclosed.  This is the so-called “patient rule” rather than the “physician rule.”

The question raised is thus: does the Riegel/Wyeth dichotomy derive from a distinction similar to the medical malpractice/informed consent distinction?   Are the five justices who voted for Medtronic and against Wyeth preserving juror power to second-guess experts on informational decisions? If so, is this a justifiable position to take?

N.B. This contribution is written in the spirit of conversation, not scholarship.   Many of the suggestions thrown out are off the cuff – some, perhaps, are demonstrably  false.   Feel free to point this out, if so.

- Professor Benjamin C. Zipursky
Fordham University School of Law


November 23, 2009 in Guest Blogger | Permalink | Comments (5) | TrackBack (0)