Thursday, January 11, 2007

On the Idea of a "Research Scholar Privilege"

A post by Ted Frank at Point of Law directs us to another post, by Jim Beck and Mark Herrmann at Drug and Device Law, which adverts, in turn, to an article in the December 2006 issue of Neurology entitled "The impact of litigation on neurologic research." The article is authored by two faculty at the Washington University School of Medicine (Drs. Brad A. Racette and Joel S. Perlmutter) and two attorneys (Ann Bradley, internal university counsel, and Carrie A. Wrisberg, a partner in the St. Louis law firm Moser & Marsalek).

We sprang for the $20 that the American Academy of Neurology wanted, before it would let us download the article. Someone not wishing to spend the $20 might get the general flavor from Washington University’s press release. Like the Beck & Herrmann post, the Neurology piece posits that an undue burden is imposed on medical research (or can be) by litigants seeking discovery of the researchers' data. The authors float the idea of a federally legislated "research scholar privilege" to ameliorate this burden. Indeed, they call such legislation "essential to advancing medical science."

Before we get to defining the nature and dimensions of this problem, or assessing potential solutions, let’s start with the all-important task of assigning blame. Different observers, with different agendas, might see different parties or practices as blameworthy here. Some tort-repeal1 advocates, for example, might rest content to add “hampering neurological research” to their long list of the many alleged ills that could be cured altogether through the simple abolition of lawsuits. When it issued a press release entitled “Fast-multiplying lawsuits can stymie medical science, authors warn,” Washington University may have hoped to grab this now populous constituency’s attention. The lead sentence in the press release only ups the rhetorical ante from there: “Class-action lawsuits can significantly slow or halt science’s ability to establish links between neurological illness and environmental factors produced by industry, a team of scientists and lawyers warns in the journal Neurology.”2

To their credit, the article’s actual authors press no claims about “fast multiplying” litigation – let alone any claim about the supposed research-stymieing effects of “class-action lawsuits.” Nor, to their own credit, do Messrs. Beck, Herrmann, or Frank. All do make mention, however, of Daubert. It is correct, in fact, to perceive a direct connection between the prevailing federal standards for medico-scientific evidence and the emerging practice of subpoenaing the underlying data from published, peer-reviewed studies. Of this, more in the sequel.

Let’s turn, for now, to what the article does say. Three theses are first presented. Litigation, it is claimed, can: (1) “create investigator bias and conflicts of interest”; (2) “impair research activities”; and (3) “violate patient confidentiality and trust in research participation.” Several measures are then suggested to address these problems. Those measures range from the harmlessly benign to the highly controversial, but our focus here will be on the authors’ proposal for federal legislative adoption of a “research scholar privilege” that would presumably immunize researchers from discovery in state and federal litigation.

In support of their first thesis (litigation fosters “investigator bias” and conflicts of interest), the authors offer anecdotal support in the form of two parables. Parable #1 is the familiar saga of silicosis overdiagnosis. Parable #2 involves the lead industry’s spurious but reputation-damaging charges of academic fraud against a researcher whose findings linked childhood lead exposures with low IQ.

These two parables may be relevant to some elements of the authors’ programmatic agenda, but neither parable has any obvious bearing on the need for a “research scholar privilege.” No one contends, so far as we know, that the silicosis debacle has corrupted academic research. The “investigators” whose bias is at issue, in the case of the silicosis episode, would be the medical consultants employed by plaintiffs’ lawyers to screen clients. As despicable as the lead industry’s vendetta against a disfavored researcher may meanwhile have been, history shows that litigants do not require subpoena power, to launch smear campaigns against the authors of research perceived as dangerous to the litigants’ economic interests.

That said, it would be foolish to contest the fundamental truth of the authors’ first thesis. Modern litigation does exert a biasing effect on some published, peer-reviewed research. What is puzzling is that the authors of the Neurology piece completely ignore one prominent mechanism through which such bias occurs: attempts by repeat players in litigation to insinuate favorable material into the peer-reviewed scientific literature. That whole problem, of course, would scarcely militate in favor of a “research scholar privilege.” To the contrary, it would seemingly militate against insulating the researchers, or their data, from discovery.

In support of their second thesis (litigation “impairs research activities”), the authors offer more anecdotal evidence, consisting primarily of the burden and expense incurred by Washington University and its faculty in complying with third-party discovery seeking data (we gather) from a study on the prevalence of Parkinson’s among welders. This is a nontrivial concern, but some level of discovery into such research is probably an inevitable consequence of expert witness rules that make support in the peer-reviewed literature a key benchmark for admissibility. To bestow on researchers or peer reviewers a blanket immunity from discovery would be tantamount to asking that the unwashed litigious masses – parties, lawyers, judges, juries – take the scholarly literature on faith.

Mind you, this last proposal would probably strike many medico-scientific researchers as anything but absurd. Why should trust not be reposed in an elite cadre of well-educated professionals and scholars who have made it their life’s work to study the relevant issues? To this question there are many possible answers. One important answer, surely, is that the courts routinely demand, of persons possessing information relevant to litigants’ claims and defenses, that they disgorge that information for ultimate evaluation by others, despite some consequent inconvenience to the information-holders. Safeguards already exist that can protect respondents to third-party discovery, if the burdens of compliance become unduly oppressive. We should start by working from those, before we move to the more radical idea of exempting whole categories of information from legal process.3 Professor Childs has already done much to show the way here.

In support of their third thesis (discovery of research data might disincentivize participation by research subjects who felt their privacy at risk), the authors of the Neurology article focus largely on the HIPAA rights of study participants. This would be a rationale, at most, for some form of privilege in the case of medical studies. At the moment, however, it is not even that. As the authors concede, the posited disincentive is not empirical fact, but unempirical speculation. “Whether the potential release of de-identified research records to a court would impact research subject willingness to participate in clinical research,” they say, “remains unknown.”

Are we sympathetic to the plight of researchers who find themselves swarmed by vexatious litigants more interested in worldly gain (or the avoidance of worldly loss) than in the pursuit of knowledge on its own account? You bet we are. As a general rule, we believe the litigants should bear the costs associated with compliance. Courts regulating discovery should also be sensitive to the potential disruptive effects that such discovery can have on researchers and their institutions. In particular, courts should be alert to the potential for discovery abuses undertaken to chill scientific inquiry. And special protection is probably warranted for research-in-progress, as distinct from work already completed and published.

All in all, however, the Neurology article fails to make a convincing case that the state or progress of neurological or other medical research have suffered, or will suffer, at the hands of the litigation system. It certainly fails to make a credible case – logically or empirically – for a blanket “research scholar privilege.” Nevertheless, many of the concerns raised by the authors seem legitimate. It would surely be enlightening to have them exercise their imaginations in favor of approaches that didn’t give dispositive weight to researcher convenience in the overall balance of the competing interests.


1 We have previously suggested “anti-tort” as a more forthright description of the governing animus behind the soi-disant “tort reform” movement. Our suggestion, however, has yet to catch on, despite our normally hegemonic influence over the terms of legal discourse. That could be because “anti-tort” is an ambiguous expression; it might be interpreted as connoting simple opposition to tortious conduct. “Tort repeal” better captures the essence of the “reform” program, without suffering from any comparable ambiguity. It will therefore be our nomenclature of choice, henceforth, for purposes of counterspin.

2 Readers are asked to pause, take a breath, and read the lead sentence from the university’s press release aloud. Surely we will not be alone in suspecting that it arrived on earth aboard a spaceship of extra-galactic provenance.

3 A deeper answer, we suspect, is that much (most?) scientific research occurs – is funded, conducted, and published – because society has some practical interest in the findings. Society has a concomitant interest in subjecting those findings to rational scrutiny when their validity becomes an important concern, rather than simply accepting the findings based on arguments from authority. There is room, in that process, for some division of intellectual labor. But delegating to researchers a vital or even exclusive role in the process of intellectual discovery should not bestow on those researchers (or their peers) a monopoly on the apparatus of validation. It is central to a democratic culture that claims to knowledge be accessible to discursive testing and refutation, not just by licensed discussants but by an irritatingly skeptical polity. That accessibility is also a vital guarantor of scientific claims to epistemic legitimacy. It is in open and democratic cultures that science has most flourished. It is in closed and authoritarian cultures where science has met its most resounding defeats. Messy and frustrating though it may often be, a legal system founded on the adversary model is an integral part of our own democratic regime, and that legal system has often imposed sterner demands of rationality, on the evidence admitted there, than are usual in peer review. Far from hampering science, that works to benefit it. If it’s also an annoyance, that annoyance is to scientists, who are not to be equated with science itself (any more than lawyers are to be equated with the law).


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Fed. R. Evid. 702: If scientific, technical, or other specialized knowledge will assist the trier of fact to understand the evidence or to determine a fact in issue, a witness qualified as an expert by knowledge, skill, experience, training, or education, may testify thereto in the form of an opinion or otherwise, if (1) the testimony is based upon sufficient facts or data, (2) the testimony is the product of reliable principles and methods, and (3) the witness has applied the principles and methods reliably to the facts of the case.