Fordham Law

"The Differential Treatment of Medical Devices and Drugs in Preemption Doctrine: A Justified Distinction?"

Professor Benjamin C. Zipursky in Torts Prof Blog, November 23, 2009

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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