TORTINI

For your delectation and delight, desultory dicta on the law of delicts.

Carl Cranor’s Conflicted Jeremiad Against Daubert

September 23rd, 2018

Carl Cranor’s Conflicted Jeremiad Against Daubert

It seems that authors who have the most intense and refractory conflicts of interest (COI) often fail to see their own conflicts and are the most vociferous critics of others for failing to identify COIs. Consider the spectacle of having anti-tobacco activists and tobacco plaintiffs’ expert witnesses assert that the American Law Institute had an ethical problem because Institute members included some tobacco defense lawyers.1 Somehow these authors overlooked their own positional and financial conflicts, as well as the obvious fact that the Institute’s members included some tobacco plaintiffs’ lawyers as well. Still, the complaint was instructive because it typifies the abuse of ethical asymmetrical standards, as well as ethical blindspots.2

Recently, Raymond Richard Neutra, Carl F. Cranor, and David Gee published a paper on the litigation use of Sir Austin Bradford Hill’s considerations for evaluating whether an association is causal or not.3 See Raymond Richard Neutra, Carl F. Cranor, and David Gee, “The Use and Misuse of Bradford Hill in U.S. Tort Law,” 58 Jurimetrics 127 (2018) [cited here as Cranor]. Their paper provides a startling example of hypocritical and asymmetrical assertions of conflicts of interests.

Neutra is a self-styled public health advocate4 and the Chief of the Division of Environmental and Occupational Disease Control (DEODC) of the California Department of Health Services (CDHS). David Gee, not to be confused with the English artist or the Australian coin forger, is with the European Environment Agency, in Copenhagen, Denmark. He is perhaps best known for his precautionary principle advocacy and his work with trade unions.5

Carl Cranor is with the Center for Progressive Reform, and he teaches philosophy at one of the University of California campuses. Although he is neither a lawyer nor a scientist, he participates with some frequency as a consultant, and as an expert witness, in lawsuits, on behalf of claimants. Perhaps Cranor’s most notorious appearance as an expert witness resulted in the decision of Milward v. Acuity Specialty Products Group, Inc., 639 F.3d 11 (1st Cir. 2011), cert. denied sub nom., U.S. Steel Corp. v. Milward, 132 S. Ct. 1002 (2012). Probably less generally known is that Cranor was one of the founders of an organization, the Council for Education and Research on Toxics (CERT), which recently was the complaining party in a California case in which CERT sought money damages for Starbucks’ failure to label each cup of coffee sold as known to the State of California as causing cancer.6 Having a so-called not-for-profit corporation can also be pretty handy, especially when it holds itself out as a scientific organization and files amicus briefs in support of reversing Daubert exclusions of the founding members of the corporation, as CERT did on behalf of its founding member in the Milward case.7 The conflict of interest, in such an amicus brief, however, is no longer potential or subtle, and violates the duty of candor to the court.

In this recent article on Hill’s considerations for judging causality, Cranor followed CERT’s lead from Milward. Cranor failed to disclose that he has been a party expert witness for plaintiffs, in cases in which he was advocating many of the same positions put forward in the Jurimetrics article, including the Milward case, in which he was excluded from testifying by the trial court. Cranor’s lack of candor with the readers of the Jurimetrics article is all the more remarkable in that Cranor and his co-authors give conflicts of interest outsize importance in substantive interpretations of scholarship:

the desired reliability for evidence evaluation requires that biases that derive from the financial interests and ideological commitments of the investigators and editors that control the gateways to publication be considered in a way that Hill did not address.”

Cranor at 137 & n.59. Well, we could add that Cranor’s financial interests and ideological commitments might well be considered in evaluating the reliability of the opinions and positions advanced in this most recent work by Cranor and colleagues. If you believe that COIs disqualify a speaker from addressing important issues, then you have all the reason you need to avoid reading Cranor’s recent article.

Dubious Scholarship

The more serious problem with Cranor’s article is not his ethically strained pronouncements about financial interests, but the dubious scholarship he and his colleagues advance to thwart judicial gatekeeping of even more dubious expert witness opinion testimony. To begin with, the authors disparage the training and abilities of federal judges to assess the epistemic warrant and reliability of proffered causation opinions:

With their enhanced duties to review scientific and technical testimony federal judges, typically not well prepared by legal education for these tasks, have struggled to assess the scientific support for—and the reliability and relevance of—expert testimony.”

Cranor at 147. Their assessment is fair but hides the authors’ cynical agenda to remove gatekeeping and leave the assessment to lay juries, who are less well prepared for the task, and whose function ensures no institutional accountability, review, or public evaluation.

Similarly, the authors note the temporal context and limitations of Bradford Hill’s 1965 paper, which date and limit the advice provided over 50 years ago in a discipline that has changed dramatically with the advancement of biological, epidemiologic, and genetic science.8 Even at the time of its original publication in 1965, Bradford Hill’s paper, which was based upon an informal lecture, was not designed or intended to be a definitive treatment of causal inference. Cranor and his colleagues make no effort to review Bradford Hill’s many other publications, both before and after his 1965 dinner speech, for evidence of his views on the factors for causal inference, including the role of statistical testing and inference.

Nonetheless, Bradford Hill’s 1965 paper has become a landmark, even if dated, because of its author’s iconic status in the world of public health, earned for his showing that tobacco smoking causes lung cancer,9 and for advancing the role of double-blind randomized clinical trials.10 Cranor and his colleagues made no serious effort to engage with the large body of Bradford Hill’s writings, including his immensely important textbook, The Principles of Medical Statistics, which started as a series of articles in The Lancet, and went through 12 editions in print.11 Hill’s reputation will no doubt survive Cranor’s bowdlerized version of Sir Austin’s views.

Epidemiology is Dispensable When It Fails to Support Causal Claims

The egregious aspect of Cranor’s article is its bill of particulars against the federal judiciary for allegedly errant gatekeeping, which for these authors translates really into any gatekeeping at all. Cranor at 144-45. Indeed, the authors provide not a single example of what was a “proper” exclusion of an expert witness, who was contending for some doubtful causal claim. Perhaps they have never seen a proper exclusion, but doesn’t that speak volumes about their agenda and their biases?

High on the authors’ list of claimed gatekeeping errors is the requirement that a causal claim be supported with epidemiologic evidence. Although some causal claims may be supported by strong evidence of a biological process with mechanistic evidence, such claims are not common in United States tort litigation.

In support of the claim that epidemiology is dispensable, Cranor suggests that:

Some courts have recognized this, and distinguished scientific committees often do not require epidemiological studies to infer harm to humans. For example, the International Agency for Research on Cancer (IRAC) [sic], the National Toxicology Program, and California’s Proposition 65 Scientific Advisory Panel, among others, do not require epidemiological data to support findings that a substance is a probable or—in some cases—a known human carcinogen, but it is welcomed if available.”

Cranor at 149. California’s Proposition 65!??? Even IARC is hard to take seriously these days with its capture by consultants for the litigation industry, but if we were to accept IARC as an honest broker of causal inferences, what substance “known” to IARC to cause cancer in humans (Category I) was branded as a “known carcinogen” without the support of epidemiologic studies? Inquiring minds might want to know, but they will not learn the answer from Cranor and his co-authors.

When it comes to adverting to legal decisions that supposedly support the authors’ claim that epidemiology is unnecessary, their scholarship is equally wanting. The paper cites the notorious Wells case, which was so roundly condemned in scientific circles, that it probably helped ensure that a decision such as Daubert would ultimately be handed down by the Supreme Court. The authors seemingly cannot read, understand, and interpret even the most straightforward legal decisions. Here is how they cite Wells as support for their views:

Wells v. Ortho Pharm. Corp., 788 F.2d 741, 745 (11th Cir. 1986) (reviewing a district court’s decision deciding not to require the use of epidemiological evidence and instead allowing expert testimony).”

Cranor at 149-50 n.122. The trial judge in Wells never made such a decision; indeed, the case was tried by the bench, before the Supreme Court decided Daubert. There was no gatekeeping involved at all. More important, however, and contrary to Cranor’s explanatory parenthetical, both sides presented epidemiologic evidence in support of their positions.12

Cranor and his co-authors similarly misread and misrepresent the trial court’s decision in the litigation over maternal sertraline use and infant birth defects. Twice they cite the Multi-District Litigation trial court’s decision that excluded plaintiffs’ expert witnesses:

In re Zoloft (Sertraline Hydrochloride) Prods. Liab. Litig., 26 F. Supp. 3d 449, 455 (E.D. Pa. 2014) (expert may not rely on nonstatistically significant studies to which to apply the [Bradford Hill] factors).”

Cranor at 144 n.85; 158 n.179. The MDL judge, Judge Rufe, decidedly never held that an expert witness may not rely upon a statistically non-significant study in a “Bradford Hill” analysis, and the Third Circuit, which affirmed the exclusions of the plaintiffs’ expert witnesses’ testimony, was equally clear in avoiding the making of such a pronouncement.13

Who Needs Statistical Significance

Part of Cranor’s post-science agenda is to intimidate judges into believing that statistical significance is unnecessary and a wrong-headed criterion for judging the validity of relied upon research. In their article, Cranor and friends suggest that Hill agreed with their radical approach, but nothing could be further from the truth. Although these authors parse almost every word of Hill’s 1965 article, they conveniently omit Hill’s views about the necessary predicates for applying his nine considerations for causal inference:

Disregarding then any such problem in semantics we have this situation. Our observations reveal an association between two variables, perfectly clear-cut and beyond what we would care to attribute to the play of chance. What aspects of that association should we especially consider before deciding that the most likely interpretation of it is causation?”

Austin Bradford Hill, “The Environment and Disease: Association or Causation?” 58 Proc. Royal Soc’y Med. 295, 295 (1965). Cranor’s radicalism leaves no room for assessing whether a putative association is “beyond what we would care to attribute to the play of chance,” and his poor scholarship ignores Hill’s insistence that this statistical analysis be carried out.14

Hill’s work certainly acknowledged the limitations of statistical method, which could not compensate for poorly designed research:

It is a serious mistake to rely upon the statistical method to eliminate disturbing factors at the completion of the work.  No statistical method can compensate for a badly planned experiment.”

Austin Bradford Hill, Principles of Medical Statistics at 4 (4th ed. 1948). Hill was equally clear, however, that the limits on statistical methods did not imply that statistical methods are not needed to interpret a properly planned experiment or study. In the summary section of his textbook’s first chapter, Hill removed any doubt about his view of the importance, and the necessity, of statistical methods:

The statistical method is required in the interpretation of figures which are at the mercy of numerous influences, and its object is to determine whether individual influences can be isolated and their effects measured.”

Id. at 10 (emphasis added).

In his efforts to eliminate judicial gatekeeping of expert witness testimony, Cranor has struggled with understanding of statistical inference and testing.15 In an early writing, a 1993 book, Cranor suggests that we “can think of type I and II error rates as “standards of proof,” which begs the question whether they are appropriately used to assess significance or posterior probabilities.16 Indeed, Cranor goes further, in confusing significance and posterior probabilities, when he described the usual level of alpha (5%) as the “95%” rule, and claimed that regulatory agencies require something akin to proof “beyond a reasonable doubt,” when they require two “statistically significant” studies.17

Cranor has persisted in this fallacious analysis in his writings. In a 2006 book, he erroneously equated the 95% coefficient of statistical confidence with 95% certainty of knowledge.18 Later in this same text, Cranor again asserted his nonsense that agency regulations are written when supported by “beyond a reasonable doubt.”19 Given that Cranor has consistently confused significance and posterior probability, he really should not be giving advice to anyone about statistical or scientific inference. Cranor’s persistent misunderstandings of basic statistical concepts do, however, explain his motivation for advocating the elimination of statistical significance testing, even if these misunderstandings make his enterprise intellectually unacceptable.

Cranor and company fall into a similar muddle when they offer advice on post-hoc power calculations, which advice ignores standard statistical learning for interpreting completed studies.20 Another measure of the authors’ failed scholarship is their omission of any discussion of recent efforts by many in the scientific community to lower the threshold for statistical significance, based upon the belief that the customary 5% p-value is an order of magnitude too high.21

 

Relative Risks Greater Than Two

There are other tendentious arguments and treatments in Cranor’s brief against gatekeeping, but I will stop with one last example. The inference of specific causation from study risk ratios has provoked a torrent of verbiage from Sander Greenland (who is cited copiously by Cranor). Cranor, however, does not even scratch the surface of the issue and fails to cite the work of epidemiologists, such as Duncan C. Thomas, who have defended the use of probabilities of (specific) causation. More important, however, Cranor fails to speak out against the abuse of using any relative risk greater than 1.0 to support an inference of specific causation, when the nature of the causal relationship is neither necessary nor sufficient. In this context, Kenneth Rothman has reminded us that someone can be exposed to, or have, a risk, and then develop the related outcome, without there being any specific causation:

An elementary but essential principle to keep in mind is that a person may be exposed to an agent and then develop disease without there being any causal connection between the exposure and the disease. For this reason, we cannot consider the incidence proportion or the incidence rate among exposed people to measure a causal effect.”

Kenneth J. Rothman, Epidemiology: An Introduction at 57 (2d ed. 2012).

The danger in Cranor’s article in Jurimetrics is that some readers will not realize the extreme partisanship in its ipse dixit, and erroneous, pronouncements. Caveat lector


1 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).

2 The American Law Institute responded briefly. See Roberta Cooper Ramo & Lance Liebman, “The ALI’s Response to the Center for Tobacco Control Research & Education,” 98 Iowa L. Rev. Bull. 1 (2013), and the original authors’ self-serving last word. Elizabeth Laposata, Richard Barnes & Stanton Glantz, “The ALI Needs to Implement Modern Conflict of Interest Policies,” 98 Iowa L. Rev. Bull. 17 (2013).

3 Austin Bradford Hill, “The Environment and Disease: Association or Causation?” 58 Proc. Royal Soc’y Med. 295 (1965).

4 Raymond Richard Neutra, “Epidemiology Differs from Public Health Practice,” 7 Epidemiology 559 (1996).

7From Here to CERT-ainty” (June 28, 2018).

8 Kristen Fedak, Autumn Bernal, Zachary Capshaw, and Sherilyn A Gross, “Applying the Bradford Hill Criteria in the 21st Century: How Data Integration Has Changed Causal Inference in Molecular Epidemiology,” Emerging Themes in Epidemiol. 12:14 (2015); John P. A. Ioannides, “Exposure Wide Epidemiology, Revisiting Bradford Hill,” 35 Stats. Med. 1749 (2016).

9 Richard Doll & Austin Bradford Hill, “Smoking and Carcinoma of the Lung,” 2(4682) Brit. Med. J. (1950).

10 Geoffrey Marshall (chairman), “Streptomycin Treatment of Pulmonary Tuberculosis: A Medical Research Council Investigation,” 2 Brit. Med. J. 769, 769–71 (1948).

11 Vern Farewell & Anthony Johnson,The origins of Austin Bradford Hill’s classic textbook of medical statistics,” 105 J. Royal Soc’y Med. 483 (2012). See also Hilary E. Tillett, “Bradford Hill’s Principles of Medical Statistics,” 108 Epidemiol. Infect. 559 (1992).

13 In re Zoloft Prod. Liab. Litig., No. 16-2247 , __ F.3d __, 2017 WL 2385279, 2017 U.S. App. LEXIS 9832 (3d Cir. June 2, 2017) (affirming exclusion of biostatistician Nichols Jewell’s dodgy opinions, which involved multiple methodological flaws and failures to follow any methodology faithfully).

14 See Bradford Hill on Statistical Methods” (Sept. 24, 2013).

16 Carl F. Cranor, Regulating Toxic Substances: A Philosophy of Science and the Law at 33-34 (1993) (arguing incorrectly that one can think of α, β (the chances of type I and type II errors, respectively and 1- β as measures of the “risk of error” or “standards of proof.”); see also id. at 44, 47, 55, 72-76. At least one astute reviewer called Cranor on his statistical solecisms. Michael D. Green, “Science Is to Law as the Burden of Proof is to Significance Testing: Book Review of Cranor, Regulating Toxic Substances: A Philosophy of Science and the Law,” 37 Jurimetrics J. 205 (1997) (taking Cranor to task for confusing significance and posterior (burden of proof) probabilities).

17 Id. (squaring 0.05 to arrive at “the chances of two such rare events occurring” as 0.0025, which impermissibly assumes independence between the two studies).

18 Carl F. Cranor, Toxic Torts: Science, Law, and the Possibility of Justice 100 (2006) (incorrectly asserting that “[t]he practice of setting α =.05 I call the “95% rule,” for researchers want to be 95% certain that when knowledge is gained [a study shows new results] and the null hypothesis is rejected, it is correctly rejected.”).

19 Id. at 266.

21 See, e.g., John P. A. Ioannidis, “The Proposal to Lower P Value Thresholds to .005,” 319 J. Am. Med. Ass’n 1429 (2018); Daniel J. Benjamin, James O. Berger, Valen E. Johnson, et al., “Redefine statistical significance,” 2 Nature Human Behavior 6 (2018).

The Expert Witness Who Put God on His Reference List

August 28th, 2018

And you never ask questions
When God’s on your side”

                                Bob Dylan, “With God on Our Side” 1963.

Cases involving claims of personal injury have inspired some of the most dubious scientific studies in the so-called medical literature, but the flights of fancy in published papers are nothing compared with what is recorded in the annals of expert witness testimony. The weaker the medical claims, the more outlandish is the expert testimony proffered. Claims for personal injury supposedly resulting from mold exposure are no exception to the general rule. The expert witness opinion testimony in mold litigation has resulted in several commentaries1 and professional position papers,2 offered to curb the apparent excesses.

Ritchie Shoemaker, M.D., has been a regular expert witness for the mold lawsuit industry. Professional criticism has not deterred Shoemaker, although discerning courts have put the kibosh on some of Shoemaker’s testimonial adventures.3

Shoemaker cannot be everywhere, and so in conjunction with the mold lawsuit industry, Shoemaker has taken to certifying new expert witnesses. But how will Shoemaker and his protégées overcome the critical judicial reception?

Enter Divine Intervention

Make thee an ark of gopher wood; rooms shalt thou make in the ark, and shalt pitch it within and without with pitch.4

Some say the age of prophets, burning bushes, and the like is over, but perhaps not so. Maybe God speaks to expert witnesses to fill in the voids left by missing evidence. Consider the testimony of Dr. Scott W. McMahon, who recently testified that he was Shoemaker trained, and divinely inspired:

Q. Jumping around a little bit, Doctor, how did your interest in indoor environmental quality in general, and mold in particular, how did that come about?

A. I had — in 2009, I had been asked to give a talk at a medical society at the end of October and the people who were involved in it were harassing me almost on a weekly basis asking me what the title of my talk was going to be. I had spoken to the same society the previous four years. I had no idea what I was going to speak about. I am a man of faith, I’ve been a pastor and a missionary and other things, so I prayed about it and what I heard in my head verbatim was pediatric mold exposure colon the next great epidemic question mark. That’s what I heard in my head. And so because I try to live by faith, I typed that up as an email and said this is the name of my topic. And then I said, okay, God, you have ten weeks to teach me about this, and he did. Within three, four weeks maybe five, he had connected me to Dr. Shoemaker who was the leading person in the world at that time and the discoverer of this chronic inflammatory response.

*****

I am a man of faith, I’ve been a pastor and everything. And I realized that this was a real entity.

*****

Q. And do you attribute your decision or the decision for you to start Whole World Health Care also to be a divine intervention?

A. Well, that certainly started the process but I used my brain, too. Like I said, I went and I investigated Dr. Shoemaker, I wanted to make sure that his methods were real, that he wasn’t doing, you know, some sort of voodoo medicine and I saw that he wasn’t, that his scientific practice was standard. I mean, he changes one variable at a time in tests. He tested every step of the way. And I found that his conclusions were realistic. And then, you know, over the last few years, I’ve 1 gathered my own data and I see that they confirm almost every one of his conclusions.

Q. Doctor, was there anything in your past or anything dealing with your family in terms of exposure to mold or other indoor health issues?

A. No, it was totally off my radar.

Q. *** I’m not going to go into great detail with respect to Dr. Shoemaker, but are you Shoemaker certified?

A. I am.

Deposition transcript of Dr. Scott W. McMahon, at pp.46-49, in Courcelle v. C.W. Nola Properties LLC, Orleans Parish, Louisiana No. 15-3870, Sec. 7, Div. F. (May 18, 2018).

You may be surprised that the examining lawyer did not ask about the voice in which God spoke. The examining lawyer seems to have accepted without further question that the voice was that of an adult male voice. Still did the God entity speak in English, or in tongues? Was it a deep, resonant voice like Morgan Freeman’s in Bruce Almighty (2003)? Or was it a Yiddische voice like George Burns, in Oh God (1977)? Were there bushes burning when God spoke to McMahon? Or did the toast burn darker than expected?

Some might think that McMahon was impudent if not outright blasphemous for telling God that “He” had 10 weeks in which to instruct McMahon in the nuances of how mold causes human illness. Apparently, God was not bothered by this presumptuousness and complied with McMahon, which makes McMahon a special sort of prophet.

Of course, McMahon says he used his “brain,” in addition to following God’s instructions. But really why bother? Were there evidentiary or inferential gaps filled in by the Lord? The deposition does not address this issue.

In federal court, and in many state courts, an expert witness may base opinions on facts or data that are not admissible if, and only if, expert witnesses “in the particular field would reasonably rely on those kinds of facts or data in forming an opinion on the subject.5

Have other expert witnesses claimed divine inspiration for opinion testimony? A quick Pubmed search does not reveal any papers by God, or papers with God as someone’s Co-Author. It is only a matter of time, however, before a judge, some where, takes judicial notice of divinely inspired expert witness testimony.


1 See, e.g., Howard M. Weiner, Ronald E. Gots, and Robert P. Hein, “Medical Causation and Expert Testimony: Allergists at this Intersection of Medicine and Law,” 12 Curr. Allergy Asthma Rep. 590 (2012).

2 See, e.g., Bryan D. Hardin, Bruce J. Kelman, and Andrew Saxon, “ACOEM Evidence-Based Statement: Adverse Human Health Effects Associated with Molds in the Indoor Environment,” 45 J. Occup. & Envt’l Med. 470 (2003).

3 See, e.g., Chesson v. Montgomery Mutual Insur. Co., 434 Md. 346, 75 A.3d 932, 2013 WL 5311126 (2013) (“Dr. Shoemaker’s technique, which reflects a dearth of scientific methodology, as well as his causal theory, therefore, are not shown to be generally accepted in the relevant scientific community.”); Young v. Burton, 567 F. Supp. 2d 121, 130-31 (D.D.C. 2008) (excluding Dr. Shoemaker’s theories as lacking general acceptance and reliability; listing Virginia, Florida, and Alabama as states in which courts have rejected Shoemaker’s theory).

4 Genesis 6:14 (King James translation).

5 Federal Rule of Evidence. Bases of an Expert.

Coffee with Cream, Sugar & a Dash of Acrylamide

June 9th, 2018

Causal statements are made all the time without much thought of their epistemic warrant. On a day that the stock market indices fall, would-be economic pundits point to some putative cause, such as concern about wage inflation. When the stock market rises on the following day, the explanation is that investors were buoyed by corporate tax cuts, even though those tax cuts were supposedly designed to help companies increase wages. As philosophy professor Harry Frankfurt has explained:

Bullshit is unavoidable whenever circumstances require someone to talk without knowing what he is talking about. Thus the production of bullshit is stimulated whenever a person’s obligations or opportunities to speak about some topic exceed his knowledge of the facts that are relevant to that topic.”1

Of course, Frankfurt’s dictum aptly describes the situation with much of expert witness testimony in health effects litigation.

Nothing seems to stimulate speculative causal claiming as much as the potential rewards of rent-seeking litigation under Proposition 65. By popular referendum, the State of California has taken upon itself to make pronouncements about the causal effects of various foods, drugs, and exposures. The referendum became a California statute with the Safe Drinking Water and Toxic Enforcement Act of 1986. Proposition 65 and the subsequent Enforcement Act require the State of California to publish a list of chemicals it “knows” cause cancers or birth defects. California knows a lot. The list, updated annually, now includes about 800 chemicals.

When California knows that a chemical or an exposure causes cancer, the state does not necessarily know that the chemical or exposure causes cancer in human beings; nor does it necessarily know that the chemical or exposure causes cancer at the exposure level experienced by the citizens of the state. Furthermore, many exposures occur in the context of complex mixtures in which a hypothetical effect of one chemical might be offset or antagonized by another chemical in the mixture. But nonetheless, what California “knows” can hurt you if you are on the wrong side of a Prop 65 enforcement action.

What has California gotten for all its “knowledge”? Clearly, the Proposition 65 statute has created huge incentives for private citizens to sue for violations by creating private rights of action against businesses that supposedly violate the law by failing to warn about what California knows. The proof standards for “known to cause cancer” are so removed from scientific discourse that forcing monetary settlements out of California businesses has become at once a big business itself, and a twisted process that distorts the truth of health hazards and benefits. There have been occasional outcries about the abusive system created from what once was perhaps a well-intentioned reform,2 but for the most part, Prop 65 has become the abnormal normal in California.

Mostly California has gotten lawsuits and a glut of warnings with no difference in cancer or birth defect rates than those observed in states less knowledgeable on such matters.3 Some of California’s cancer rates may be a bit lower than the national rates but this outcome is largely the result of lower state rates for smoking and obesity. Some birth defect rates (neural tube defects) are actually higher in California than in the country as a whole.4

Last year, 681 Prop 65 settlements worth $25.6 million were reported to the California attorney general’s office. Attorneys’ and expert witness fees and other litigation costs made up more than 75% of the total.5 The rate of return has been steady over the years. In 2011, 74 percent of Proposition 65 awards went to attorneys’ fees and costs.6

Council for Education and Research on Toxics (CERT)

For all the hoopla over CERT’s lawsuit against Starbucks,7 there has been little coverage of the actual testimony from the trial. One journalist did report that Peter Infante, a frequent testifier for the lawsuit industry, testified on epidemiology for CERT’s lawyer, Raphael Metzger.8 Apparently, Infante described some studies as showing statistically significant correlations between coffee drinking and some kinds of cancer. Infante demurred on whether coffee caused these kinds of cancer, and admitted that one “would need a clinical trial to resolve the issue.” David Kessler, the former FDA commissioner who helped create the breast implant litigation fiasco and who now testifies frequently for the Lawsuit Industry, testified for Starbucks. Despite his substantial fear-mongering credentials, Dr Kessler emphasized that coffee is a “staple of the American diet,” and that drinking coffee has known health benefits. As everyone now knows, Starbucks failed to persuade the California trial judge that coffee, acrylamide and all, should come under the statute’s safe harbor provisions.

Almost five years ago, I first blogged about the CERT, in connection with the Milward case.9 When I first wrote back in 2013, and until the present, CERT, has not had a website, which is odd for an organization that professes to have an educational mission. In 2013, my research on CERT showed it to be a California corporation, EIN: 42-1571530, founded in 2003, with a business address at 401 E. Ocean Blvd., Ste. 800, Long Beach, California 90802-4967, and a telephone number:  1-877-TOX-TORT. CERT’s reported mission statement was furthering scientific understanding of toxins. Plaintiffs’ lawyer Ralph Metzger, a denizen of the Prop 65 world, was noted as the contact person for CERT, and indeed, the telephone number for CERT was the same as that for Metzger’s lawfirm, the Metzger Law Group.

As I started to watch the activities of CERT, I detected some curious patterns. I saw CERT file amicus briefs in legal cases, which is not the typical activity of a scientific research organization.10 Even more curious, and somewhat dubious, in two cases in which Ralphael Metzger of the Metzger Law Group represented the plaintiffs, another firm, Richard Alexander of the Alexander Law Group, represented CERT as an amicus in the same cases.11

Given the publicity created by CERT’s victory in its Proposition 65 citizen’s action against Starbucks, I recently revisited this research. See Alexander Nazaryan, “Will coffee in California come with a cancer warning?Los Angeles Times (Feb. 18, 2018). One group, “Deniers for Hire,” which describes itself as committed to “debunk anti-science propaganda and expose the activists who produce it,” identified CERT as:

a sham environmentalist nonprofit that sues food companies and collects settlements to fund additional lawsuits against other food companies. Founded in 2002 by toxicologist Martyn T. Smith, with backing from the shameless trial lawyers at Metzger Law Group, CERT uses junk science to target California businesses that can be sued under the state’s ill-conceived Proposition 65.”

The connection with Martyn T. Smith, was news to me, and interesting given how frequently Smith testifies for plaintiffs in cases involving even minimal benzene exposure. If correct, this website’s connecting Martyn Smith with CERT raises additional conflict-of-interest issues.

Funding of Research

Does CERT actually support research? Perhaps, after a fashion, but the money trail is as sketchy as is the ownership issue. Searching in Google Scholar turns up several publications that openly acknowledge funding from CERT. Perhaps only the young and naïve will be surprised that CERT money went to Martyn Smith, alleged founder of CERT and testifier for plaintiffs’ counsel, and to Smith’s students.12 In one instance, CERT support has been acknowledged by Martyn Smith and co-authors for the production of a meta-analysis, which can then be relied upon by Smith and other plaintiffs’ expert witnesses in benzene litigation. Although this meta-analysis credits funding from CERT, most readers of a professional journal will have little idea of the funding’s litigation provenance.13 The corresponding author of the CERT-funded meta-analysis was an official in the California state Office of Environmental Health Hazard Assessment, an office which is in a position to make decisions that help CERT in its California litigation goals.14

The funding of Martyn Smith and his students would certainly be questionable if Smith was a founder of or a participant in CERT. When Smith’s litigation opinions were challenged in one high-profile case, CERT rallied to his rescue with an amicus brief, which did not disclose any relationship between CERT and Martyn Smith, or CERT’s funding of Smith’s research. Milward v. Acuity Specialty Prods. Group, Inc., 639 F.3d 11 (1st Cir. 2011).

A current online listing at Guidestar gives Nancy Quam-Wickham as the “principal officer,” with the same EIN for CERT, as I saw five years ago. Quam-Wickham is a professor of history at California State University, in Long Beach. She seems an unlikely person to head up an organization given to research and education on “toxics.” The phone number for CERT is now 6101824891, but the mailing address is still Ralphael Metzger’s law office.

The Charity Navigator website does not rate CERT because its annual revenue is below $1 million. The website describes CERT as a 501(c)(3), with the same current address as Metzger’s lawfirm. According to Charity Navigator, CERT’s IRS 990 return listed assets of $21,880, and income of $137,354, for 2017.

So what are CERT’s educational activities? The sketchiness of CERT’s appearance as an “amicus” in Ralphael Metzger’s own lawsuits seems matched by the sketchiness of the organization’s professed educational mission. A deeper dive discovered that CERT has garnered some acknowledgements on the websites of other organizations. For instance, the Green Science Policy Institute, founded in 2008, for instance, acknowledges CERT for its “generous support” of the Institute’s work.

Some of CERT’s “educational” efforts have not fared particularly well. In the Chemtura Corporation bankruptcy, CERT attempted to intervene to assert a $9 billion claim to compensate “the public” for alleged injuries from the bankrupt’s allegedly toxic chemicals. In re Chemtura Corp., No. 09-11233, U.S. Bankruptcy Court (S.D.N.Y. 2010). Bankruptcy Judge Robert Gerber was not impressed with CERT’s educational efforts, and dismissed the entity as lacking the necessary standing to make a claim.15


1 Harry Frankfurt, On Bullshit 63 (2005).

2 See, e.g., Lisa L. Halko, “California’s Attorney General Acknowledges Prop 65 Abuse,” 22 no. 29 Wash. Leg. Fdtn. Legal Backgrounder (July 27, 2007); Pamela A. MacLean, “California Judge Blasts Firm in Toxic-Warnings Case,” Nat’l L.J. (April 13, 2006); Consumer Defense Group v. Rental Housing Industry Members40 Cal. Rptr. 3d 832 (Cal. Ct. App. 4th 2006) (“As the Attorney General pointed out in oral argument, it does not serve the public interest to have the almost the entirety of the state of California ‘swamped in a sea [of] generic warning signs’.”).

7 Council for Education and Research on Toxics v. Starbucks Corp., BC435759, California Superior Court, Los Angeles County.

8 Edvard Pettersson, “Toxic Java? California Law Carries Big Fines, Little Evidence,” Bloomberg (Oct. 25, 2017).

10 See, e.g., Parker v. Mobil Oil Corp., 7 N.Y.3d 434, 857 N.E.2d 1114, 824 N.Y.S.2d 584 (2006).

11 In Uriarte v. Scott Sales Co., 226 Cal. App. 4th 1396, 172 Cal. Rptr. 3d 886 (2014); Ramos v. Brenntag Specialties, Inc., 63 Cal.4th 500, 203 Cal. Rptr. 3d 273, 372 P.3d 200 (2016). In both of these cases, CERT was joined by a band of scientists proclaiming neutrality and failing to disclose their significant litigation activities and income: Dr. Jerrold Abraham, Dr. Richard W. Clapp, Dr. Ronald Crystal, Dr. David A. Eastmond, Dr. Arthur L. Frank, Dr. Robert J. Harrison, Dr. Ronald Melnick, Dr. Lee Newman, Dr. Stephen M. Rappaport, Dr. David Joseph Ross and Dr. Janet Weiss. SeeSand in My Shoe – CERTainly” (June 17, 2014). Of course, California appellate courts require that amici disclose financial interests. A motion for leave to file an amicus brief must include, among other things, the names of all persons or entities that contributed financially to the brief, and acknowledgments about whether any party of party’s lawyer helped fund the preparation or filing of the brief. Cal. Rules of Court, Rule 8.200(c)(3)(A)(ii), (B), 8.882(d)(3)(A)(ii) and (B).

12 See, e.g., Jimmy Phuong, Simon Kim, Reuben Thomas & Luoping Zhang, “Predicted Toxicity of the Biofuel Candidate 2,5-Dimethylfuran in Envt’l & Biological Systems,” 53 Envt’l & Molecular Mutagenesis 478 (2012); Michele Fromowitz, Joe Shuga, AntonioYip Wlassowsky, Zhiying Ji, Matthew North, Chris D. Vulpe, Martyn T. Smith, and Luoping Zhang, “Bone Marrow Genotoxicity of 2,5-Dimethylfuran, a Green Biofuel Candidate,” 53 Envt’l & Molecular Mutagenesis 488 (2012); Reuben Thomas, Jimmy Phuong, Cliona M. McHale and Luoping Zhang, “Using Bioinformatic Approaches to Identify Pathways Targeted by Human Leukemogens,” 9 Internat’l J. Envt’l. Research & Public Health 2479 (2012).

13 Frolayne M. Carlos-Wallace, Luoping Zhang, Martyn T. Smith, Gabriella Rader & Craig Steinmaus, “Parental, In Utero, and Early-Life Exposure to Benzene and the Risk of Childhood Leukemia: A Meta-Analysis,” 183 Am. J. Epidem. 1 (2016).

14 Dr. Craig Steinmaus, Office of Environmental Health Hazard Assessment, 1515 Clay Street, 16th Floor, Oakland, CA 94612.

15 Caroline Humer, “Judge rules against big Chemtura bankruptcy claim,” Reuters (April 8, 2010); John Parry, “Chemtura hits back at $9 billion claim over toxins,” Reuters (Mar. 24, 2010).

PubMed Refutes Courtroom Historians

February 11th, 2018

Professors Rosner and Markowitz, labor historians, or historians laboring in courtrooms, have made a second career out of testifying about other people’s motivations. Consider their pronouncement:

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); Gerald Markowitz & David Rosner, “Why Is Silicosis So Important?” Chap. 1, at 27, in Paul-André Rosental, ed., Silicosis: A World History (2017). Their accusation is remarkable for any number of reasons,1 but the most remarkable is that their claim is unverified, but readily falsified.2

Previously, I have pointed to searches in Google’s Ngram Book viewer as well as in the National Library of Medicine’s database (PubMed) on silicosis. The PubMed website has now started to provide a csv file, with articles counts by year, which can be opened in programs such as LibreOffice Calc, Excel, etc, and then used to generate charts of the publication counts over time. 

Here is a chart generated form a simple search on <silicosis> in PubMed, with years aggregated over roughly 11 year intervals:

The chart shows that the “professionals,” presumably physicians and scientists were most busy publishing on, not burying, the silicosis issue exactly when Rosner and Markowitz claimed them to be actively suppressing. Many of the included publications grew out of industry, labor, and government interests and concerns. In their book and in their courtroom performances,, Rosner and Markowitz provide mostly innuendo without evidence, but their claim is falsifiable and false.

To be sure, the low count in the 1940s may well result from the relatively fewer journals included in the PubMed 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 for its intensity, pace Rosner and Markowitz.


1Conspiracy Theories: Historians, In and Out of Court(April 17, 2013). Not the least of the reasons the group calumny is pertinent is the extent to which it keeps the authors gainfully employed as expert witnesses in litigation.

2 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.”).