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Who Jumped the Shark in United States v. Harkonen

April 28th, 2013

My friend Chris Guzelian thinks that I have jumped the shark in joining with Professors Makuch and Lash in filing an amicus brief in United States v. Harkonen.  Or maybe just a big-mouthed bass. No one has taken a longer, harder, more sustained look at false scientific speech than Professor Guzelian, and for the most part I agree with his assessment that scientific speech can be so false or misleading as to be the subject of prohibition. See, e.g., Christopher Guzelian & Philip Guzelian, “Editorial:  Prevention of false scientific speech: a new role for an evidence-based approach,” 27 Human & Experimental Toxicol. 733 (2008).

Professors Guzelian (Chris’s father is an esteemed medical toxicologist) note, with approval, several instances in which scientific speech is curtailed or even penalized.  Advertising claims for dietary supplements are subject to a salutary requirement of “Significant Scientific Agreement” (SSA), made out to the FDA’s satisfaction.  In order to make out SSA, sellers must show that the totality of sound, relevant evidence supports the health claim in a systematic review. FDA, Guidance for industry evidence-based review system for the scientific evaluation of health claims (2007).

Study quality and methodology must be pre-specified, with the hierarchical nature of various study designed honored. Making health claims on labels of homeopathic remedies is a bit like crying “fire!” in a crowded theater.  Most purchasers do not have the time or ability to evaluate the accuracy of the claim; and they react rather than deliberate, often to their detriment.

These and other examples provided by the Professors Guzelian are illustrative and revealing.  Context for the scientific speech to be proscribed is important.  Thus, when Ninth Circuit Judge Alex Kozinski expresses the libertarian position, he is no doubt thinking of what is published in scientific journals and texts:

“[T]here are many varieties of noncommercial speech that are just as objective as paradigmatic commercial speech and yet receive full first amendment protection. Scientific speech is the most obvious; much scientific expression can easily be labeled true or false, but we would be shocked at the suggestion that it is therefore entitled to a lesser degree of protection. If you want, you can proclaim that the sun revolves around the earth, that the earth is flat, that there is no such thing as nitrogen, that flounder smoke cigars, that you have fused atomic nuclei in your bathtub — you can spout any nonsense you want, and the government can’t stop you.”

Alex Kozinski & Stuart Banner, “Who’s Afraid of Commercial Speech?” 76 Va. L. Rev. 627, 635 (1990), cited and quoted in Christopher Guzelian, “Scientific Speech,” 93 Iowa L. Rev. 882, 910 (2008).

In other contexts, the government can and should intervene to avoid palpable harm from misleading scientific speech.  Surely, the judiciary can stop expert witnesses from opining that flounder smoke cigars, and many other unsubstantiated, speculative, unreliable opinions.  Federal Rule of Evidence 702.  The presentation of unreliable “expert” witness opinion testimony in court, to lay jurors, is also like shouting “fire!” in a crowded theater.  Someone will get hurt.  The courtroom is not a free speech zone although many zealous political scientists have sought to turn it into an “anything goes” forum.  As one district judge described the problem in a case with epidemiologic evidence:

“According to plaintiffs, the rate of PD [Parkinson’s disease] mortality is so poor a proxy for measuring the rate of overall PD incidence, that the Coggon study proves nothing. In the next breath, however, plaintiffs set forth an unpublished statistical analysis (by Dr. Wells) of PD mortality data collected by the National Center for Health Statistics, arguing it proves that welders, as a group, suffer earlier onset of PD than the general population.77 Of course, the devil is in the details, discussion of which is beyond the scope of this opinion (and perhaps beyond the scope of understanding of the average juror),78 but this example shows how hard it is to tease out whether the limitations of a given study make it unreliable under Daubert.”

In re Welding Fume Prods. Liab. Litig., No. 1:03-CV-17000, MDL 1535, 2006 WL 4507859, *33 (N.D. Ohio 2006).  In footnote 78, the district judge elaborated about what she meant by stating that the issues were beyond the scope of the average juror’s understanding:

“The Court does not at all mean to impugn the intelligence of the average juror; however, even the smartest and most attentive juror will be challenged by the parties’ assertions of observation bias, selection bias, information bias, sampling error, confounding, low statistical power, insufficient odds ratio, excessive confidence intervals, miscalculation, design flaws, and other alleged shortcomings of all of the epidemiological studies.”

Id. at *33 n.78.  The danger of harm in subversion of the fact-finding process requires that district judges intervene and make threshold decisions under Rules 702 and 703.  As one Supreme Court Justice expressed the matter:

“[A] trial judge, acting as ‘gatekeeper’, must ‘ensure that any and all scientific testimony or evidence admitted is not only relevant, but reliable’.  This requirement will sometimes ask judges to make subtle and sophisticated determinations about scientific methodology and its relation to the conclusions an expert witness seeks to offer— particularly when a case arises in an area where the science itself is tentative or uncertain, or where testimony about general risk levels in human beings or animals is offered to prove individual causation. ***

Of course, neither the difficulty of the task nor any comparative lack of expertise can excuse the judge from exercising the ‘gatekeeper’ duties that the Federal Rules impose — determining, for example, whether particular expert testimony is reliable and ‘will assist the trier of fact’, Fed. Rule Evid. 702, or whether the ‘probative value’ of testimony is substantially outweighed by risks of prejudice, confusion or waste of time. Fed. Rule Evid. 403. To the contrary, when law and science intersect, those duties often must be exercised with special care.”

General Elec. Co. v. Joiner, 522 U.S. 136, 147–49 (1997) (Breyer, J., concurring) (citations omitted).

Jurors are especially vulnerable to the misleading speech of expert witnesses.  They are selected for their ignorance of the underlying scientific principles, and in many jurisdictions, no one on the jury will have any significant training or experience in scientific or statistical principles. By the nature of their engagement, jurors are further prohibited from seeking outside assistance or making their own independent inquiries.  Explicit time limitations on witness examinations, or implicit limitations that result from jurors’ lack of aptitude or attention to scientific methodology result in extreme abridgments of scientific evidence in American civil and criminal trials.  This situation calls out for tight control over scientific evidence and speech in the courtroom.

Press releases are a very different context in which scientific evidence is presented and described. For many years, press releases have been used by commercial and academic scientists to announce study results.  None of the imminent, irremediable harms from arguably misleading courtroom scientific speech are at issue in the context of press releases.  Scientists and physicians do not need to make a decision on the basis of claims in a press release, and they are trained to demand more careful presentation of data and analysis.  Even law students recognize that press releases are different:

“When submitting studies for peer review, scientists choose significance levels so as to minimize the chance of Type I error and maximize the potential for advancing scientific knowledge.134 When submitting press releases, however, scientists tend to report positive aspects of study results with less caution than they would in a scientific journal.135”

“Developments in the Law: Confronting the New Challenges of Scientific Evidence,” 108 Harv. Law. Rev. 1481, 1553 & n.135 (1995) (citing Lawrence K. Altman, MD, “The Doctor’s World; Promises of Miracles:  News Releases Go Where Journals Fear to Tread,” New York Times (Jan. 10, 1995) (“When speaking to the public, some scientists, in conjunction with their institution’s press office, are willing to make much bolder claims for their work. *** Many come from a news release or news conference, when public relations officials get carried away with enthusiasm. Sometimes scientists become willing partners with institution officials and say things in releases that they would never dream of saying in a scientific paper, where evidence is demanded to support a claim.”)

A press release that accurately reports data, but draws a conclusion that is more enthusiastic than the government thinks to be appropriate is hardly criminal fraud.  Here context is important, especially when the press release announces that more detailed presentation of data and analyses will be forthcoming within a week or so.  Surely, given the fulsome reports of retractions and investigations of false and fabricated data in published articles, the government must have better things to do than to police press releases.

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Wake Forest Publishes the Litigation Industry’s Views on Milward

April 20th, 2013

This week, The Wake Forest Journal of Law & Policy published six articles from its 2012 Spring Symposium, on “Toxic Tort Litigation After Milward v. Acuity Products.”  The Symposium was a joint production of The Center for Progressive Reform and the Wake Forest University School of Law.  The articles are now available online:

Steve C. Gold, “A Fitting Vision of Science for the Courtroom” PDF

Michael D. Green, “Pessimism About Milward” PDF

Thomas O. McGarity & Sidney A. Shapiro, “Regulator Science in Rulemaking and Tort: Unifying the Weight of the Evidence Approach,” PDF

Carl F. Cranor, “Milward v. Acuity Specialty Products: Advances in General Causation Testimony in Toxic Tort Litigation,” PDF

Joseph Sanders , “Milward v. Acuity Specialty Products Group: Constructing and Deconstructing Sciences and Law in Judicial Opinion,” PDF

Steve Baughman Jensen, “Sometimes Doubt Doesn’t Sell: A Plaintiffs’ Lawyer’s Perspective on Milward v. Acuity Products” PDF

As I noted previously, this symposium was a decidedly lopsided affair, as one might expect from its sponsorship by The Center for Progressive Reform (CPR), which speaks for the litigation industry in the United States. See “Milward Symposium Organized By Plaintiffs’ Counsel and Witnesses” (Feb. 16th, 2013).

Consistent with its sponsorship, the articles are largely cheerleading for the Milward decision.  The Milward plaintiffs’ partisan expert, Carl Cranor, has a paper here, as does a plaintiffs’ lawyer prominent in ATLA/AAJ.  The defense expert witnesses from Milward were not represented at the symposium in the symposium proceedings; nor were there any papers from defense counsel presented or published.  Of the six published papers, only Professor Sanders adopts a somewhat neutral stance towards Milward and the First Circuit’s embrace of Weight of the Evidence in analyzing Rule 702 issues. Cf. Elizabeth Laposata, Richard Barnes, & Stanton Glantz, “Tobacco Industry Influence on the American Law Institute’s Restatements of Torts and Implications for Its Conflict of Interest Policies,” 98 Iowa L. Rev. 1 (2012) (arguing that tobacco lawyers influenced the American Law Institute’s Restatement process).

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David Bernstein on the Daubert Counterrevolution

April 19th, 2013

David Bernstein has posted a draft of an important new article on the law of expert witnesses, in which he documents the widespread resistance to judicial gatekeeping of expert witness opinion testimony among federal judges.  Bernstein, “The Daubert Counterrevolution” (Mar. 11, 2013).  Professor Bernstein has posted his draft article, set to be published in the Notre Dame Law Review, both on the Social Science Research Network, and on his law school’s website.

Professor Bernstein correctly notes that the Daubert case, and the subsequent revision to Federal Rule of Evidence 702, marked important changes in the law of expert witnesses.  These changes constituted important reforms, which in my view were as much evolutionary, as revolutionary.  Even before the Daubert case, the law was working to find ways to improve expert witness testimony, and to downplay “authoritative” opining in favor of well-documented ways of knowing.  After all, Rule 702, with its emphasis on “knowledge,” was part of the Federal Rules of Evidence, as adopted in 1975.  Pub. L. 93–595, § 1, Jan. 2, 1975, 88 Stat. 1926 (effective July 1, 1975).  Since their first adoption, Rule 702 required that expert witnesses’ knowledge be helpful to the trier of fact.  By implication, the rule has always suggested that hunches, speculation, and flights of fancy did not belong in the court room.

Professor Bernstein certainly acknowledges that Daubert did not spring out of a vacuum.  Critics of judicial decisions on expert witnesses had agitated for decades to limit expert witness conduct by standards and guidances that operate in the scientific community itself.  The Supreme Court’s serial opinions on Rule 702 (Daubert, Joiner, Kumho Tire, and Weisgram) reflect the need for top-down enforcement of a rule, on the books since 1975, while many lower courts were allowing “anything goes.”

What is perhaps surprising, but well documented by Professor Bernstein, is that after four opinions from the Supreme Court, and a revision in the operative statute itself (Rule 702), some lower federal courts have engaged in a rearguard action against expert witness gatekeeping.  Professor Bernstein rightfully settles on the First Circuit’s decision in Milward as exemplifying a trend to disregard the statutory language and mandate for gatekeeping.  For Bernstein, Milward represents the most recent high-water mark of counterrevolution, with its embrace of errors and fallacies in the name of liberal, if not libertine, admissibility.

I suppose that I would go a step further than Professor Bernstein and label the trend he identifies as “reactionary.”  What is clear is that many courts have been willing to flout the statutory language of Rule 702, in favor of old case law, and evasive reasoning on expert witness admissibility.  Indeed, the Supreme Court itself joined the trend in Matrixx Initiatives, Inc. v. Siracusano, 131 S. Ct. 1309 (2011), when it unanimously affirmed the reversal of a trial court’s Rule 12(b)(6) dismissal of a securities fraud class action.  The corporate defendant objected that the plaintiffs failed to plead statistical significance in alleging causation between Zicam and the loss of the sense of smell.  The Supreme Court, however, made clear that causation was not required to make out a claim of securities fraud.  It was, and would be, sufficient for the company’s product to have raised sufficient regulatory concerns, which in turn would bring regulatory scrutiny and action that would affect the product’s marketability.

Not content to resolve a relatively simple issue of materiality, for which causation and statistical significance were irrelevant, the Supreme Court waxed on, in obiter dicta, about causation and statistical significance, perhaps unwittingly planting seeds for those who would eviscerate Rule 702.  See Matrixx Unloaded (Mar. 29, 2011).  Although the Supreme Court disclaimed any intention to address expert witness admissibility in a case that was solely about the sufficiency of pleading allegations, it cited three cases for the proposition that statistical significance was not necessary for assessing biological causation:

“We note that courts frequently permit expert testimony on causation based on evidence other than statistical significance. See, e.g., Best v. Lowe’s Home Centers, Inc., 563 F. 3d 171, 178 (6th Cir 2009); Westberry v. Gislaved Gummi AB, 178 F. 3d 257, 263–264 (4th Cir. 1999) (citing cases); Wells v. Ortho Pharmaceutical Corp., 788 F. 2d 741, 744–745 (11th Cir. 1986). We need not consider whether the expert testimony was properly admitted in those cases, and we do not attempt to define here what constitutes reliable evidence of causation.”

Id. at 1319.

Remarkably, two of the three cases were about specific causation, arrived at using so-called “differential etiology,” which presupposed the establishment of general causation.  These cases never involved general causation or statistical reasoning, but rather simply the process of elimination (iterative disjunctive syllogism).  The citation to the third case, Wells, was a notorious pre-Daubert, pre-Rule 702 revision case, revealed disappointing scholarship.  Wells involved at least one study that purported to find a statistically significant association.  What was problematic about Wells was its failure to consider the complete evidentiary picture, and to evaluate study validity, bias, and confounding, as well as significance probability.  See Wells v. Ortho Pharmaceutical Corp. Reconsidered – Part 1 (Nov. 12, 2012).

Wells was an important precursor to Daubert in that it brought notoriety and disrepute to how federal courts (and state courts as well) were handling expert witness evidence.  Significantly, Wells was a bench trial, where the trial judge opined that plaintiffs’ expert witnesses seemed more credible based upon atmospherics rather than on their engagement with the actual evidence. See Marc S. Klein, “After Daubert:  Going Forward with Lessons from the Past,” 15 Cardozo L. Rev. 2219, 2225-26 (1994) (quoting trial testimony of trial testimony of Dr. Bruce Buehler: “I am sorry sir, I am not a statistician . . . I don’t understand confidence levels. I never use them. I have to use the author’s conclusions.” Transcript of Jan. 9, 1985, at 358, Wells v. Ortho Pharm. Corp., 615 F. Supp. 262 (N.D. Ga. 1985).

Given the Supreme Court’s opinion in Matrixx, the reactionary movement among lower courts is unsurprising.  Lower courts have now cited and follow the Matrixx dicta on statistical significance in expert witness gatekeeping, despite the Supreme Court’s clear pronouncement that it did not intend to address Rule 702.  See In re Chantix (Varenicline) Prods. Liab. Litig., 2012 U.S. Dist. LEXIS 130144, at *22 (N.D. Ala. 2012); Cheek v. Wyeth Pharm. Inc., 2012 U.S. Dist. LEXIS 123485 (E.D. Pa. Aug. 30, 2012).

Professor Bernstein’s article goes a long way towards documenting the disregard for law and science in this movement.  The examples of reactionary decisions could easily be multiplied. Take for instance, the recent Rule 702 gatekeeping decision in litigation over Celexa and Lexapro, two antidepressant medications.  Judge Rodney W. Sippel denied the defense motions to exclude plaintiffs’ principal expert witness, Dr. David Healy.  In re Celexa & Lexapro Prods. Liab. Litig.,  ___ F.3d ___, 2013 WL 791780 (E.D. Mo. 2013).  In attempting to support its decision, the court announced that:

1. Cherry picking of studies, and data within studies, is acceptable for expert witnesses.  Id. at *5, *7, *8.

2. Outdated law applies, regardless of being superseded by later Supreme Court decisions, and the statutory revision in Rule 702.  Id. at *2 (citing pre-Joiner case:   “The exclusion of an expert’s opinion is proper only if it is so fundamentally unsupported that it can offer no assistance to the jury.” Wood v. Minn. Mining & Mfg. Co., 112 F.3d 306, 309 (8th Cir.1997) (internal quotation marks and citation omitted).”

3.  The Bradford Hill factors can be disregarded.  Id. at *6 (citing In re Neurontin Mktg., Sales Practices, and Prod. Liab. Litig., 612 F. Supp. 2d 116, 133 (D. Mass. 2009) (MDL 1629), and In re Viagra, 572 F.2d 1071 (D. Minn. 2008)).

These features of the Celexa decision are hardly novel.  As Professor Bernstein shows in his draft article, disregard of Rule 702’s actual language, and of the post-Daubert Supreme Court decisions, is prevalent.  See, e.g., In re Avandia Marketing, Sales Practices & Prod. Liab. Litig., 2011 WL 13576 (E.D. Pa. 2011)(announcing that MDL district judge was bound to apply a “Third Circuit” approach to expert witness gatekeeping, which focused on the challenged expert witnesses’ methodology, not their conclusions, in contravention of Joiner, and of Rule 702 itself).

The Celexa decision pushes the envelope on Bradford Hill.  The two decisions cited downplayed Bradford Hill’s considerations, but did not dismiss them.  In re Neurontin Mktg., Sales Practices, and Prod. Liab. Litig., 612 F. Supp. 2d 116, 133 (D. Mass. 2009) (MDL 1629)(“Although courts have not embraced the Bradford Hill criteria as a litmus test of general causation, both parties repeatedly refer to the criteria, seemingly agreeing that it is a useful launching point and guide. Accordingly, this Court will begin its inquiry by evaluating Plaintiffs’ evidence of an association between Neurontin and suicide-related events, the starting point for an investigation under the criteria.”);  In re Viagra Prods. Liab. Litig., 572 F.Supp.2d at 1081 (“The Court agrees that the Bradford Hill criteria are helpful for determining reliability but rejects Pfizer’s suggestion that any failure to satisfy those criteria provides independent grounds for granting its Daubert Motion.”).

Of course, Sir Austin’s considerations were merely those that he identified in a speech to a medical society.  They were not put forward in a scholarly article; nor are his considerations the last word on the subject.  Austin Bradford Hill, “The Environment and Disease: Association or Causation?” 58 Proc. Royal Soc’y Med. 295 (1965).

Even as a précis, given almost 50 years ago, Hill’s factors warrant some consideration rather than waving them off as not a litmus test (whatever that means), followed by complete disregard for any of the important considerations in evaluating the causality of an association.

There was brief bright spot in this fairly dim judicial decision.  The district judge refused to exclude Dr. Healy on grounds that his opinion about particular studies differed from the authors’ own interpretations.  In re Celexa & Lexapro Prods. Liab. Litig.,  ___ F.3d ___, 2013 WL 791780, at *5 (E.D. Mo. 2013) (Sippel, J.).

That is the correct approach, even though there is language in Joiner that suggests that the authors’ views are dominant.  See Follow the Data Not the Discussion.  But the refusal to discount Healy’s opinions on this ground was done without any real inquiry whether Healy had offered a valid, competing interpretation of the data in the published studies.

At the core of the reactionary movement identified by Professor Bernstein is an unwillingness, or an inability, to engage with the scientific evidence that is at issue in various Rule 702 challenges.  Let’s hope that Bernstein’s article induces closer attention to the law and the science in future judicial gatekeeping.

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Conspiracy Theories: Historians, In and Out of Court

April 17th, 2013

“The United States has long been a breeding ground for conspiracy theorists… .”  It did not take long for conspiracy theories surrounding the tragedy in Newtown, Connecticut, to circulate.  Lee-Anne Goodman, “Latest American conspiracy theory claims Newtown mass shooting a hoax” (Jan. 15, 2013) (Associated Press) (“Sandy Hook Truthers, as they’ve been dubbed, believe last month’s mass shooting in Newtown, Conn., was a hoax”).  And the tragedy of the Boston marathon bombing gave rise to conspiracy theories within hours of the horror.  Meghan Keneally, “Conspiracy theorists claim Boston was ‘false flag’ attack arranged by the government” (April 17, 2013) (“false flag” staged attack); Amanda Marcotte, “The Boston Marathon Bombing Could Become a Conspiracy Theory Hotbed” (April 16, 2013).

Conspiracy theories are not confined in the United States to the lunatic fringe; nor are they the creatures of internet fantasies.  Conspiracy theories inundate our courts, and occasionally make for a rattling good yarn from academic writers. A couple of years ago, I wrote about historians of occupational health and safety as particularly susceptible to the lure of conspiracy theories.

Professors Rosner and Markowitz, historians of silicosis, certainly come to mind:

“In the postwar era, professionals, industry, government, and a conservative labor movement tried to bury silicosis as an issue.”

David Rosner & Gerald Markowitz, Deadly Dust:  Silicosis and the Politics of Occupational Disease in the Twentieth Century America 213 (Princeton 1991).  This is a remarkable group libel of scientists, physicians, industrialists, and labor union leaders. Perhaps readers may infer that the unions branded “conservative” are the ones not committed to Marxist-Leninist principles, such as the Western Federation of Miners, later known as International Union of Mine, Mill, and Smelter Workers.  In their book, Rosner and Markowitz singled this union out for its for heroic resistance to the putative conspiracy of government, academics, scientists, industry, and the non-Communist-influenced labor movement.

Reality is often much less glorious than speculative conspiracy theories.  Professor Beth J. Rosenberg, an Assistant Professor, in the Department of Public Health & Community Medicine, in Tufts University School of Medicine, Boston, Massachusetts, is an unabashed activist.   She has championed workers’ safety and rights.  She has tried, but failed, to organize workers and unions in Massachusetts over the real hazards of abrasive sandblasting, only to find that their concerns lay elsewhere.  Beth Rosenberg, “Second Thoughts About Silicosis,” 13 New Solutions 223 (2003).

“The main point here is that the men I’ve interviewed are not terribly concerned about silica dust. They care about being treated decently and respectfully by their bosses. They’re concerned about being encouraged to work too fast to work safely. They care about lead dust, particularly bringing it home to their families, so they get really angry when the foreman wants to lock up the yard at five o’clock and doesn’t leave them enough time to shower and change their clothes. They feel that they are expendable. And although most are fully aware of silica’s dangers, silica is not a top priority for them. The silica agenda was set by some physicians and health professionals who are outraged that anybody is still dying of this 100 percent preventable disease. This is understandable, and I am one of those people, but I’m not sure this is the best way to be of service. I see that there are other, more pressing issues than silica.

Id. at 229 (emphasis added).  See also  CDC, “Ten Great Public Health Achievements – United States, 1900 – 1999,” 48(12) CDC Morbidity and Mortality Weekly Report 241 (April 02, 1999)(“Work-related health problems, such as coal workers’ pneumoconiosis (black lung), and silicosis — common at the beginning of the century — have come under better control.”).

Is there any substance to the claim that everyone, after the Great Depression, other than a few radical labor leaders, tried to bury the issue of silicosis?  As I have noted, we can find some objective indication of continued interest in silicosis from the number of publications in the National Library of Medicine’s database (PubMed) on silicosis.  A simply search on “silicosis,” with limits to each decade after the 1930s reveals a pattern that silicosis had not been buried at all:

Date Range                    Number of Articles from Keyword Search

1940 – 1949                      113

1950 – 1959                    1,421

1960 – 1969                    1,867

1970 – 1979                    1,178

1980 – 1989                       940

1990 – 1999                       882

2000 – 2009                      843

To be sure, the low count in the 1940s likely results from the lack of coverage of publications in the database, as well as the growth in the number of biomedical journals after the 1940s.  The Post-War era certainly presented distractions in the form of other issues, including the development of antibiotics, chemotherapies for tuberculosis, the spread of poliomyelitis and the development of vaccines for this and other viral diseases, radiation exposure and illnesses, tobacco-related cancers, and other chronic diseases.  Given the exponential expansion in scope of public health, the continued interest in silicosis after World War II, documented in the PubMed statistics, is remarkable.

Recently, in my own blog reading, I came across a post by David Oliver on the use of Google’s database of digitized books to create charts of word hits in this digital library.  See David Oliver, Fun With Google Books’ Ngram Viewer (Dec. 17, 2010).  Oliver hypothesizes that the number of times that a word appears in the database of over 5 million books is a reasonable proxy for identifying the active interests and concerns of society.  Google labs offers the opportunity to run this search as a function of year, and to produce a chart that reflects the prevalence of the keyword over time.

With David Oliver’s permission, here charts he prepared, using Google labs, for two very different diseases, mesothelioma and silicosis, with their very different levels of interest and concern among various writers:

* * * * * * * * * * *

 

 * * * * * * * * * * *

 

* * * * * * * * * * *

This Google tool may be incomplete and imperfect, but it shows, along with the PubMed database, that it may well be time to look for more objective bases for historical opinions, both in court and in academia.

 

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Washington Supreme Court Illustrates the Difference Between Frye and Rule 702

April 15th, 2013

Last month, the Washington Supreme Court decided a public and private nuisance case against a local utility for fear of future illnesses from exposure to electro-magnetic frequency radiation (EMF).  Lakey v. Puget Sound Energy, Inc., ___ Wn. 2d ___ , 2013 WL 865468 (Mar. 6, 2013).

The defendant utility and local municipality had moved for the exclusion of plaintiffs’ expert witnesses, under Frye v. United States, 54 App. D.C. 46, 293 F. 1013 (1923), and the Washington state version of Rule 702.  The plaintiff homeowners submitted declarations from two expert witnesses, Dr. De Kun Li and and Dr. David Carpenter.

Dr. Carpenter was the Director of the Institute for Health and the Environment at the University at Albany and a Professor of Environmental Health Sciences within the School of Public Health. He also has held the position of Dean of the School of Public Health at the University of Albany and the Director of the Wadsworth Center for Laboratories and Research of the New York State Department of Health.  Dr. Carpenter apparently has been active in testifying about EMF health issues.  See, e.g., Amended Declaration of David Carpenter (2011).

The trial court conducted a three-day Frye hearing, at which both sides offered expert witness testimony.  Plaintiffs called Carpenter, and the defendants called Dr. Nancy Lee, an epidemiologist, and Dr. Mark Israel, a professor at Dartmouth’s Geisel School of Medicine, and a specialist in the molecular and cellular biology of brain tumors.

At the hearing, Dr. Lee testified that Carpenter had failed to follow generally accepted epidemiologic methodology of considering all pertinent data.  Carpenter had “cherry picked”; his opinion selectively ignored studies that contradicted his conclusions.  Even among the studies that Carpenter had relied upon, he ignored data that undermined or contradicted his conclusion.  Slip op. at 6.  Furthermore, Carpenter ignored the toxicologic data and studies available. Id.  Among the studies ignored by Carpenter were the most recent, and most carefully conducted, studies. Id.  The trial court excluded Li and Carpenter, and the plaintiffs appealed.

Affirming the exclusion, the Supreme Court of Washington engaged in a curious two step.  The Court reversed the trial court’s exclusion on Frye grounds.  In Supreme Court’s view, the plaintiffs’ witnesses sufficiently deployed a generally accepted method when they waded into the field of epidemiology because epidemiology is generally accepted.  The Frye doctrine does not require that expert witnesses apply the established methodology well, reliably, or soundly.  The expert witnesses are immunized from exclusion by relying upon studies from a generally accepted discipline, no matter how poorly or selectively they have analyzed and interpreted these studies.  An expert witness’s errors in engaging with a particular scientific discipline that is in general considered generally accepted “go to the weight, not the admissibility, of the evidence unless the error renders the evidence unreliable.” Slip op. at 11.

Carpenter’s cherry-picking approach to data and studies, however, was properly excluded under Rule 702.  Carpenter’s approach vitiated the reliability of his opinion with the consequence of :

“seriously tainting his conclusions because epidemiology is an iterative science relying on later studies to refine earlier studies in order to reach better and more accurate conclusions. Carpenter refused to account for the data from the toxicological studies, which epidemiological methodology requires unless the evidence for the link between exposure and disease is unequivocal and strong, which is not the case here. Carpenter also selectively sampled data within one of the studies he used, taking data indicating an EMF-illness link and ignoring the larger pool of data within the study that showed no such link, Carpenter’s treatment of this data created an improper false impression about what the study actually showed.”

Slip op. at 12.

So that’s the difference between Frye and Rule 702!

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Further Musings on U.S. v. Harkonen

April 15th, 2013

Epistemic Crimes

In U.S. v. Harkonen, the government prosecuted a physician, company CEO, for issuing a press release that stated a clinical trial “demonstrated” benefit when the government believed that the clinical trial was inconclusive.  No doubt the government was intent upon punishing what it thought was off-label promotion in the same press release, but the jury acquitted on the charge of misbranding, and convicted on the wire fraud count.  The trial court denied post-trial motions, and recently, the United States Court of Appeals, for the Ninth Circuit, affirmed, in an unpublished per curiam opinion.  United States v. Harkonen, No. 11-10209, No. 11-10242, 2013 WL 782354, 2013 U.S. App. LEXIS 4472 (9th Cir. March 4, 2013).

A Gedanken Experiment

An expert witness writes a report that X, a drug therapy, causes Y, a benefit in survival, for a disease, Z.

The expert witness sent his report by email, and regular mail, to counsel, who then served it upon his adversary.  The report set out some of the support for the opinion, as follows.

The expert witness relied upon a randomized clinical trial, conducted with one primary and nine secondary endpoints.  The multiple endpoints were chosen because of uncertainty of how the anticipated benefit would manifest.  Mortality (survival), although obviously a very important endpoint, was not made primary endpoint because the scientists who conducted the trial did not anticipate sufficient deaths over the course of the trials to see a statistically significant benefit.

This clinical trial had surprising results. Although the trial did not show a difference on the primary endpoint, a composite defined in terms of various pulmonary functional changes or death, the trial did “demonstrate,” according to the witness, a survival benefit.  Indeed, the survival benefit was clinically significant.  Patients randomized to therapy experienced a 40% decrease in mortality, compared to those randomized to placebo. (p = 0.084).  The expert witness pointed out, in his report, that the survival benefit was even stronger in a subgroup of the clinical trial, which consisted of the patients who had mild- to moderate-disease at the time of randomization.  For this subgroup, the decrease in mortality was even more dramatic, 70%, p = 0.004.  The witness’s report did not clearly label this subgroup as “post-hoc,” although a discerning reader might well have assessed it as such.

The expert witness was not relying upon only one clinical trial.  His report identified an earlier trial, published in a leading clinical medical journal, which reported benefit from the drug, p < 0.001.  This trial was extended, with continuing strong evidence of differential survival.  In terms of survival at five years, the earlier trial showed survival in the therapy group at 77.8%, compared to 16.7% in the control groups, p = 0.009.

The expert witness’s report did not explicitly reference clinical experience, or the in vitro and in vivo mechanistic evidence that the therapy, X, plays a role in inhibiting processes that are clearly involved in producing the disease, Z.  The expert witness could have written a stronger expert witness report with these references, but did not expect that this level of completeness was required.  The expert witness did note that he would marshal the data in more detail at a later time. The expert witness further relied upon the assessment of the principal investigator of the later clinical, who had written that the benefit against mortality of X was “compelling,” and that the finding was “a major breakthrough.”  The principal investigator of the trial noted that X was “the first treatment ever to show any meaningful clinical impact in this disease in rigorous clinical trials, and these results would indicate that [X] should be used early in the course of this disease in order to realize the most favorable long-term survival benefit.”  The report went on to note, accurately, that there are no FDA-approved therapies for Z.

Adversary counsel, receiving this report, moved pursuant to Federal Rules of Evidence 702 and 703, to exclude the expert witness’s report and his opinions.  The motion to exclude was made in advance of the deposition, and without a preliminary motion for more detail about the supporting data.  In particular, the motion to exclude claimed that the expert witness was unjustified in concluding that a benefit had been “demonstrated,” as opposed to being merely suggested.

What would be the challenger’s chances of success on the Rule 702 motion?  The outcome, Y, was not “statistically significant” at the conventional two-tail 5% (but would have been on a one-tail test).  The subgroup that sported a p-value of 0.004 was not clearly marked as a post-hoc subgroup, although the challenger could discern that it was likely exploratory, and challenged it as uncorrected for multiple testing.  The challenger, however, did not attempt to offer a modified p-value that took into account of multiple testing.  The essence of this challenge was that the expert witness’s statement that a benefit had been “demonstrated” was not supported by sufficient evidence, and that the low p-value of 0.004 was not truly “significant” because the result emerged from an analysis that was not pre-planned.

My hunch, based upon published judicial opinions on both state and federal Rule 702 motions, is that many judges would allow the challenged expert witness to testify.  There would be the usual judicial hand waving about the challenge’s going to the weight not the admissibility of the expert witness’s opinion.  Perhaps an occasional judge might order additional discovery.  I believe that most judges would not find that this expert witness had engaged in pathologically bad science such that the party proponent should be denied its expert witness.

Transmuting Disputed Causal Inferences Into Criminal Fraud

Instead of moving to exclude the expert witness’s opinion, why not turn the report over to the U.S. Attorney’s office to prosecute for wire or mail fraud?  Even if a trial court were to brand the opinion “inadmissible,” that outcome would hardly suggest that the opinion was the kind of speech that could qualify as fraudulent under federal wire or mail fraud statutes. Branding a scientist as a fraudfeasor, however, was exactly the result reached in U.S. v. Harkonen, where the Ninth Circuit upheld a wire fraud conviction of a physician whose written statements would likely have been admissible in most federal courtrooms, under Federal Rule 702.  As much as I would like to see more stringent gatekeeping of expert witness opinions, there is something unseemly about the government’s efforts here to criminalize scientific opinions with which it disagrees.

Dr. Harkonen has petitioned the Ninth Circuit for reconsideration, in a brief filed by attorneys, Mark Haddad and colleagues, of Sidley Austin.  Petition for Rehearing En Banc (filed 29, 2013).  The case raises important First Amendment and due process issues, which were addressed by the party and amici briefs before the Panel.

The case also raises the specter of prosecutions of scientists for speech in various contexts, including grant applications and reports, under the False Claims Act, for witness perjury for testimony in judicial, administrative, or legislative proceedings, or for wire or mail fraud for manuscript submissions to journals. On April 8th, Professor Robert Makuch, of Yale University, Professor Timothy Lash, of Emory University, and I filed an amicus brief, which addresses the government’s controversial branding statements “false as a matter of statistics.” The government has gone from one extreme of painting, broad brush, that statistical significance is not important or necessary (in Matrixx Initiatives Inc. v. Siracusano), to the other extreme that statistical significance is so important that a scientist who his opinion on causality on evidence the government believes is not statistically significant has committed fraud (in Harkonen).  Both extreme positions are untenable.

Posted in Causation, Rule 702, statistical evidence | Comments Off on Further Musings on U.S. v. Harkonen

Gatekeeping in Allen v. Martin Surfacing — Postscript

April 11th, 2013

Back in November 2012, I wrote a review and analysis of a district court’s handling of Rule 702 challenges to expert witness opinions, in a case involving a tragic ALS death, Allen v. Martin Surfacing, 263 F.R.D. 47 (D. Mass. 2009).  See Bad Gatekeeping or Missed Opportunity – Allen v. Martin Surfacing (Nov. 30, 2012).

I received correspondence from one of the plaintiffs’ expert witnesses, Dr. Marcia Ratner, who was not entirely happy with my discussion of the Allen case.  Suffice it to say, on the medico-legal issues, we do not have much common ground for agreement.  Dr. Ratner, however, asked me to update my post by noting two facts:

1.  First, plaintiffs’ counsel had asked her to testify that solvent fumes, including toluene, had caused Mr. Allen’s ALS, and she refused.  She was unwilling to acquiesce in their request, and she testified only about acceleration of onset.

2.  Second, Dr. Ratner objected to my including the colorful comments about her brush with the law.  My report was factual and documented, but I am sympathetic.  Dr. Ratner would have me note that she is a registered Republican and a staunch defender of Second Amendment rights; her arrest result when she “inadvertently stepped into a liberal trap when [she] came down [to Massachusetts] from Vermont.”

As a lawyer, I am indeed sympathetic to anyone who has truly stepped into a trap.  As for the Allen case, the matter settled, and so there never was a chance to see how a jury would react to the various theories in the case.  More important, there never was appellate judicial review of the gatekeeping efforts.

Posted in Expert Witnesses, Rule 702 | Comments Off on Gatekeeping in Allen v. Martin Surfacing — Postscript