TORTINI

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

Washington Legal Foundation’s Paper on Statistical Significance in Rule 702 Proceedings

March 13th, 2017

The Washington Legal Foundation has released a Working Paper, No. 201, by Kirby Griffis, entitledThe Role of Statistical Significance in Daubert / Rule 702 Hearings,” in its Critical Legal Issues Working Paper Series, (Mar. 2017) [cited below as Griffis]. I am a fan of many of the Foundation’s Working Papers (having written one some years ago), but this one gives me pause.

Griffis’s paper manages to avoid many of the common errors of lawyers writing about this topic, but adds little to the statistics chapter in the Reference Manual on Scientific Evidence (3d ed. 2011), and he propagates some new, unfortunate misunderstandings. On the positive side, Griffis studiously avoids the transposition fallacy in defining significance probability, and he notes that multiplicity from subgroups and multiple comparisons often undermines claims of statistical significance. Griffis gets both points right. These are woefully common errors, and they deserve the emphasis Griffis gives to them in this working paper.

On the negative side, however, Griffis falls into error on several points. Griffis helpfully narrates the Supreme Court’s evolution in Daubert and then in Joiner, but he fails to address the serious mischief and devolution introduced by the Court’s opinion in Matrixx Initiatives, Inc. v. Siracusano, 563 U.S. 27, 131 S.Ct. 1309 (2011). See Schachtman, “The Matrixx – A Comedy of Errors” (April 6, 2011)”; David Kaye, “Trapped in the Matrixx: The U.S. Supreme Court and the Need for Statistical Significance,” BNA Product Safety & Liability Reporter 1007 (Sept. 12, 2011). With respect to statistical practice, this Working Paper is at times wide of the mark.

Non-Significance

Although avoiding the transposition fallacy, Griffis falls into another mistake in interpreting tests of significance; he states that a non-significant result tells us that an hypothesis is “perfectly consistent with mere chance”! Griffis at 9. This is, of course, wrong, or at least seriously misleading. A failure to reject the null hypothesis does not prove the null such that we can say that the “null results” in one study were perfectly consistent with chance. The test may have lacked power to detect an “effect size” of interest. Furthermore, tests of significance cannot rule out systematic bias or confounding, and that limitation alone ensures that Griffis’s interpretation is mistaken. A null result may have resulted from bias or confounding that obscured a measurable association.

Griffis states that p-values are expressed as percentages “usually 95% or 99%, corresponding to 0.05 or 0.01,” but this states things backwards. The p-value that is pre-specified to be “significant” is a probability or percentage that is low; it is the coefficient of confidence used to construct a confidence interval that is the complement of the significance probability. Griffis at 10. An alpha, or pre-specified statistical significance level, of 5% thus corresponds to a coefficient of confidence of 95% (or 1.0 – 0.05).

The Mid-p Controversy

In discussing the emerging case law, Griffis rightly points to cases that chastise Dr. Nicholas Jewell for the many liberties he has taken in various litigations as an expert witness for the lawsuit industry. One instance cited by Griffis is the Lipitor diabetes litigation, where the MDL court suggested that Jewell switched improperly from a Fisher’s exact test to a mid-test. Griffis at 18-19. Griffis seems to agree, but as I have explained elsewhere, Fisher’s exact test generates a one-tailed measure of significance probability, and the analyst is left to one of several ways of calculating a two-tailed test. SeeLipitor Diabetes MDL’s Inexact Analysis of Fisher’s Exact Test” (April 21, 2016). The mid-p is one legitimate approach for asymmetric distributions, and is more favorable to the defense than passing off the one-tailed measure as the result of the test. The mere fact that a statistical software package does not automatically specify the mid-p for a Fisher’s exact analysis does not make invoking this measure into p-hacking or other misconduct. Doubling the attained significance probability of a particular Fisher’s exact test result is generally considered less accurate than a mid-p calculation, even though some software packages using doubling attained significance probability as a default. As much as we might dislike bailing Jewell out of Daubert limbo, on this one, limited point, he deserved a better hearing.

Mis-Definitions

On recounting the Bendectin litigation, Griffis refers to the epidemiologic studies of birth defects and Bendectin as “experiments,” Griffis at 7, and then describes such studies as comparing “populations,” when he clearly meant “samples.” Griffis at 8.

Griffis conflates personal bias with bias as a scientific concept of systematic error in research, a confusion usually perpetuated by plaintiffs’ counsel. See Griffis at 9 (“Coins are not the only things that can be biased: scientists can be, too, as can their experimental subjects, their hypotheses, and their manipulations of the data.”) Of course, the term has multiple connotations, but too often an accusation of personal bias, such as conflict of interest, is used to avoid engaging with the merits of a study.

Relative Risks

Griffis correctly describes the measure known as “relative risk” as a determination of the “the strength of a particular association.” Griffis at 10. The discussion then lapses into using a given relative risk as a measure of the likelihood that an individual with the exposure studied develop the disease. Sometimes this general-to-specific inference is warranted, but without further analysis, it is impossible to tell whether Griffis lapsed from general to specific, deliberately or inadvertently, in describing the interpretation of relative risk.

Conclusion

Griffis is right in his chief contention that the proper planning, conduct and interpretation statistical tests is hugely important to judicial gatekeeping of some expert witness opinion testimony under Federal Rule of Evidence 702 (and under Rule 703, too). Judicial and lawyer aptitude in this area is low, and needs to be bolstered.

New York Rejects the Asbestos Substantial Factor Ruse (Juni Case)

March 2nd, 2017

I recall encountering Dr. Joseph Sokolowski in one of my first asbestos personal injury cases, 32 years ago. Dr. Sokolowki was a pulmonary specialist in Cherry Hill, New Jersey, and he showed up for plaintiffs in cases in south Jersey as well as in Philadelphia. Plaintiffs’ counsel sought him out for his calm and unflappable demeanor, stentorious voice, and propensity for over-interpreting chest radiographs. (Dr. Sokolowski failed the NIOSH B-Reader examination.)

At the end of his direct examination, the plaintiff’s lawyer asked Dr. Sokolowski the derigueur “substantial factor” question, which in 1985 had already become a customary feature of such testimonies. And Dr. Sokolowski delivered his well-rehearsed answer: “Each and every exposure to asbestos was a substantial factor in causing the plaintiff’s disease.”

My cross-examination picked at the cliché. Some asbestos inhaled was then exhaled. Yes. Some asbestos inhaled was brought up and swallowed. Yes. Asbestos that was inhaled and retained near the hilum did not participate in causing disease at the periphery of the lung. Yes. And so on, and so forth. I finished with my rhetorical question, always a dangerous move, “So you have no way to say that each and every exposure to asbestos actually participated in causing the plaintiff’s disease?” Dr. Sokolowski was imperceptibly thrown off his game, but he confessed error by claiming the necessity to cover up the gap in the evidence. “Well, we have no way to distinguish among the exposures so we have to say all were involved.”

Huh? What did he say? Move to strike the witness’s testimony as irrational, and incoherent. How can a litigant affirmatively support a claim by asserting his ignorance of the necessary foundational facts? The trial judge overruled my motion with alacrity, and the parties continued with the passion play called asbestos litigation. The judge was perhaps simply eager to get on with his docket of thousands of asbestos cases, but at least Dr. Sokolowski and I recognized that the “substantial factor” testimony was empty rhetoric, with no scientific or medical basis.

Sadly, the “substantial factor” falsehood was already well ensconced in 1985, in Pennsylvania law, as well as the law of most other states. Now, 32 years later, with ever increasingly more peripheral defendants, each involving less significant, if any, asbestos exposure, the “substantial factor” ruse is beginning to unravel.1

Juni v. A.O. Smith Water Products Co.

Arthur Juni was a truck and car car mechanic, who worked on the clutches, brakes, and manifold gaskets of Ford trucks. Juni claimed to have sustained asbestos exposure in this work, as well as in other aspects of his work career. In 2012, Juni was diagnosed with mesothelioma; he died in 2014. Juni v. A.O. Smith Water Products Co., at *1,No. 190315/12 2458 2457, 2017 N.Y. Slip Op. 01523 (N.Y. App. Div. 1st Dep’t, Feb. 28, 2017).

Juni sued multiple defendants in New York Supreme Court, for New York County. Most of the defendants settled, but Ford Corporation tried the case against the plaintiff’s widow. Both sides called multiple expert witnesses, whose testimony disputed whether the chrysotile asbestos in Ford’s brakes and clutches could cause mesothelioma. The jury returned a verdict in favor of the plaintiff, but the trial court granted judgment nothwithstanding the verdict, on the ground that the evidence failed to support the causation verdict. Id. At *1; see Juni v. A. 0. Smith Water Prod., 48 Misc. 3d 460, 11 N.Y.S.3d 415 (N.Y. Sup. Ct. 2015).

Earlier this week, the first department of the New York Appellate Division affirmed the judgment for Ford. 2017 N.Y. Slip Op. 01523. The Appellate Division refused to approve plaintiffs’ theory of cumulative exposure to show causation. The plaintiffs’ expert witnesses, Drs. Jacqueline Moline and Stephen Markowitz, both asserted that even a single asbestos exposure was a “substantial contributing” cause. The New York appellate court, like the trial court before, saw through the ruse, and declared that both expert witnesses had failed to support their assertions.

The “Asbestos Exception” Rejected

Although New York has never enacted a codified set of evidence rules, and has never expressly adopted the rule of Daubert v. Merrill Richardson, the New York Court of Appeals has held that there are limits to the admissibility of expert witness opinion testimony. Parker v. Mobil Oil Corp., 7 N.Y.3d 434 (2006), and Cornell v. 360 W. 51st St. Realty, LLC, 22 NY3d 762 (2014); Sean Reeps. v BMW of North Am., LLC, 26 N.Y.3d 801 (2016). In Juni, the Appellate Division, First Department, firmly rejected any suggestion that plaintiffs’ expert witnesses in asbestos cases are privileged against challenge over admissibility or sufficiency because the challenges occur in an asbestos case. The plaintiff’s special pleading that asbestos causation of mesothelioma is too difficult was invalidated by the success of other plaintiffs, in other cases, in showing that a specific occupational exposure was sufficient to cause mesothelioma.

The Appellate Division also rejected the plaintiff’s claim, echoed in the dissenting opinion of one lone judge, that there exists a “consensus from the medical and scientific communities that even low doses of asbestos exposure, above that in the ambient environment, are sufficient to cause mesothelioma.” The Court held that this supposed consensus is not material to the claims of a particular plaintiff against a particular defendant, especially when the particular exposure circumstance is not associated with mesothelioma in most of the relevant studies. In Juni, the defense had presented many studies that failed to show any association between occupational brake work and mesothelioma. The court might also have added that a characterization of low exposure is extremely amiguous, depending upon the implicit comparison that is being made with other exposures. It is impossible to fit a particular plaintiff’s exposure into the scale of low, medium, and high without some further context.

Single Exposure Sufficiency Rejected

The evidence that chrysotile itself causes mesothelioma remains weak, but the outcome of Juni turned not on the broad general causation question, but on the question whether even suggestive evidence of chrysotile causation had been established for the exposure circumstances of an automobile mechanic, such as Mr. Juni. Plaintiffs’ expert witnesses maintained that Juni’s cumulative asbestos exposures caused his mesothelioma, but they had no meaningful quantification or even reasonable estimate of his exposure.

Citing the Court of Appeals decision in Reeps, the Appellate Division held that plaintiff’s expert witnesses’ causation opinions must be supported by reasonable quantification of the plaintiff’s exposure, or some some scientific method, such as mathematical modeling based upon actual work history, or by comparison of plaintiff’s claimed exposure with the exposure of workers in reported studies that establish a relevant risk from those workers’ exposure. In the Juni case, however, there were no exposure measurements or scientific models, and the comparison with workers doing similar tasks failed to show a causal relationship between the asbestos exposure in those tasks and mesothelioma.

Expert Witness Admissibility and Sufficiency Requires Evaluation of Both Direct and Cross-examination Testimony and Relied Upon Studies

The Juni decision teaches another important lesson for challenging expert witness testimony in New York: glib generalizations delivered on direct examination must be considered in the light of admissions and concessions made on cross-examination, and the entire record. In Juni, the plaintiffs’ expert witnesses, Jacqueline Moline and Stephen Markowitz, asserted that asbestos in Ford’s friction products was a cause of plaintiff’s mesothelioma. Cross-examination, however, revealed that these assertions were lacking in factual support.

Cumulative Exposure

On cross-examination, the plaintiffs’ expert witnesses’ statements about exposure levels proved meaningless. Moline attempted to equate visible dust with sufficient asbestos exposure to cause disease, but she conceded on cross-examination that studies had shown that 99% of brake lining debris was not asbestos. Most of the dust observed from brake drums is composed of resins used to manufacture brake linings and pads. The heat and pressure of the brake drum causes much of the remaining chrysotile to transform into a non-fibrous mineral, fosterite.

Similarly, Markowitz had to acknowledge that chrysotile has a “serpentine” structure, with individual fibers curling in a way that makes deeper penetration into the lungs more difficult. Furthermore, chrysotile, a hydrated magnesium silicate, melts in the lungs, not in the hands. The human lung can clear particulates, and so there is no certainty that remaining chrysotile fibers from brake lining exposures ever reach the periphery of the lung, where they could interact with the pleura, the tissue in which mesothelioma arises.

Increased Risk, “Linking,” and Association Are Not Causation – Exculpatory Epidemiologic Studies

When pressed, plaintiffs’ expert witnesses lapsed into characterizing the epidemiologic studies of brake and automobile mechanics as showing increased risk or association, not causation. Causation, not association, however, was the issue. Witnesses’ invocation of weasel words, such as “increased risk,” “linkage,” and “association” are insufficient in themselves to show the requisite causation in long-latency toxic exposure cases. For automobile mechanics, even the claimed association was weak at best, with plaintiffs’ expert witnesses having to acknowledge that 21 of 22 epidemiologic studies failed to show an association between automobile mechanics’ asbestos exposure and risk of mesothelioma.

The Juni case was readily distinguishable from other cases in which the Markowitz was able to identify epidemiologic studies that showed that visible dust from a specific product contained sufficient respirable asbestos to cause mesothelioma. Id. (citing Caruolo v John Crane, Inc., 226 F.3d 46 (2d Cir. 2000). As the Appellate Division put the matter, there was no “no valid line of reasoning or permissible inference which could have led the jury to reach its result.” Asbestos plaintiffs must satisfy the standards set out in the New York Court of Appeals decisions, Parker v. Mobil Oil Corp., 7 NY3d 434 2006), and Cornell v. 360 W. 51st St. Realty, LLC, 22 N.Y.3d 762 (2014), for exposure evidence and causal inferences, as well.

New York now joins other discerning courts in rejecting regulatory rationales of “no safe exposure,” and default “linear no threshold” exposure-response models as substitutes for inferring specific causation.2 A foolish consistency may be the hobgoblin of little minds, but in jurisprudence, consistency is often the bedrock for the rule of law.


1 The ruse of passing off “no known safe exposure” as evidence that even the lowest exposure was unsafe has been going on for a long time, but not all judges are snookered by this rhetorical sleight of hand. See, e.g., Bostic v. Georgia-Pacific Corp., 439 S.W.3d 332, 358 (Tex. 2014) (“the failure of science to isolate a safe level of exposure does not prove specific causation”).

2 See, e.g. Bostic v. Georgia-Pacific Corp., 439 S.W.3d 332, 358 (Tex. 2014) (failing to identify safe levels of exposure does not suffice to show specific causation); Henricksen v. ConocoPhillips Co., 605 F. Supp. 2d 1142, 1165-66 (E.D. Wash. 2009) (rejecting a “no threshold” model of exposure-response as unfalsifiable and unvalidated, and immaterial to the causation claims); Pluck v. BP Oil Pipeline Co., 640 F.3d 671, 679 (6th Cir. 2011) (rejecting claim that plaintiff’s exposure to benzene “above background level,” but below EPA’s maximum permissible contaminant level, caused her cancer); Newkirk v. ConAgra Foods, Inc., 727 F. Supp. 2d 10006, 1015 (E.D. Wash. 2010) (rejecting Dr. David Egilman’s proffered testimony on specific causation based upon his assertion that there was no known safe level of diacetyl exposure).

Social Media, Rhetoric, and Science – Antivaxxers

February 24th, 2017

In a recent news conference, Donald Trump (née Drumpf) proclaimed that that he had won the presidency by the largest electoral college margin since Ronald Reagan. When an earnest (but obviously “dishonest”) reporter challenged him and pointed out that William Jefferson Clinton and Barack Obama had larger majorities in the electoral college, Trump, the fabulist-in-chief, did not lose a beat. Like the old Grinch, Trump was “so smart and so slick, he thought up a lie, and he thought it up quick!”

From his whopper, Trump retreated to the assertion that he was talking only about Republican presidents. But the earnest young reporter was relentless and pressed the challenge. And when pressed, Trump lamely offered1:

I was given that information. I don’t know. I was just given it. We had a very, very big margin.”

Oh my. As John Adams, observed, before he became President:2

Facts are stubborn things; and whatever may be our wishes, our inclinations, or the dictates of our passion, they cannot alter the state of facts and evidence.”

For a President who regularly embraces alternative facts, who has such a tenuous relationship with reality, and who says whatever was last whispered in his ear, we would expect science to be challenging. Some observers might note that Trump’s behavior mirrors how some lawyers treat scientific evidence and issues in litigation. Rhetoric has its place in science, but scientific disputes cannot be advanced simply because someone gave you “some information.” And yet, people try all the time.

If you search out the The World Mercury Project, you will be treated to a video of Robert F. Kennedy, Jr., who had made a career for the lawsuit industry of pursuing dubious scientific claims.3

The video, also available on YouTube, is vintage Kennedy, self-aggrandizing, and holding forth with accusations against pharmaceutical companies and vaccine manufacturers of “child abuse,” and “even worse.” The epistemic arrogance continues with assertions that Kennedy knows how to fight them, the greedy, murderous bullies.

The Trump presidency, with its alternative facts and its bullying, has emboldened conspiracy theorists of all stripes.

Last week, Robert F. Kennedy, Jr., along with Robert De Niro, convened a news conference on Wednesday at the National Press Club to announce their latest stunt, a $100,000 cash reward to the first person who comes forward with a “peer-reviewed scientific study demonstrating that the mercury in vaccines is safe.” National Press Club Conference (Feb. 15, 2017) [Expurgated Version].

A stunt, of course, because no one study would “demonstrate” safety, although the mass of epidemiologic evidence does. Furthermore, even in face of the overwhelming evidence that thimerosal in vaccines is not associated with autism, we could always hypothesize that there is one child who has some unique susceptibility.

The anti-vaxxers are quick to jump on the individual susceptibility argument. At their (fake) news conference, Kennedy and De Nira exhumed Bernadine Healy, who died in 2011, for a replay of a 2008 interview, in which Healy speculated that the then available science had not ruled out the existence of susceptible subgroups of children, who might be at risk from some one or multiple vaccines. Healy is best known as the first woman physician to serve as Director of the National Institutes of Health, from 1991 to 1993. For her acknowledgement that there might be vulnerable subgroups, and that this issue of idiosyncratic reaction should be studied, Healy was named 2008 “Person of the Year” by the anti-vaccine group, the Age of Autism.

Not surprisingly, anti-vaxxers Kennedy and De Niro, and their followers, missed the obvious. Healy’s suggestion that there might be a vulnerable subgroup of children is not evidence that thimerosal or any vaccine or vaccine regimen is unsafe.

Also not surprisingly, President Trump, with his affection for alternative facts and speculative conspiracy theories, is in the same epistemic muddle as Kennedy and De Niro. While still a candidate, Trump met with Andrew Wakefield and other dubious characters from the anti-vaxxer movement. With his propensity to repeat whatever was last said to him, Trump tweets about “doctor-inflicted autism,” and other claims.

And to make matters worse, toady American Republican party cannot seem to distance themselves from whatever nonsense Alt-President Trump dishes out. Pratik Chougule, an executive editor at The American Conservative recently wrote a disturbingly uncritical essay in support of Trump’s twittering approach to scientific policy. Pratik Chougule, “Why the Kennedy-De Niro Vaccine Challenge MattersA presidential commission led by Robert Kennedy Jr. could raise uncomfortable questions about the incentives driving vaccination recommendations,The American Conservative (Feb. 15, 2017) (noting that Trump has said that he couldn’t care less’ about the shills of conventional medical wisdom, the pharmaceutical companies, and their ‘fudged up reports’. In typical fashion, he declares that ‘the doctors lied’ and that he is ‘being proven right about massive vaccinations’.”)

Sad. Fake news. Fake science. Where is Daubert when you need it?


Talc Litigation in Missouri – Show Me the Law and the Evidence

February 22nd, 2017

In New Jersey, where the courts are particularly plaintiff friendly but not beyond the persuasive force of evidence, lawsuit industry claims that talc causes ovarian cancer have not fared well. Last year, Judge Johnson, of Atlantic County, New Jersey, held that the plaintiffs’ causal claims failed to meet even the minimal New Jersey legal threshold of scientific validity.1 Meanwhile, in Missouri, juries have been returning large verdicts for plaintiffs on their claims that their use of talc products caused their ovarian cancers.2

What gives? Why is the outcome of similar litigation so different in New Jersey from that in Missouri? One might mistakenly think that courts in Missouri would be skeptical of scientifically dubious claims. After all, Missouri is the “Show Me” state; right? Many people understand the state’s nickname to mean that Missourians are not gullible.3

The reality of the origins of the Missouri nickname may well be different. The most cited account reports that a congressman from Missouri, Willard Duncan Vandiver, used the phrase in an 1899 speech:

I come from a state that raises corn and cotton and cockleburs and Democrats, and frothy eloquence neither convinces nor satisfies me. I am from Missouri. You have got to show me.”

Basically, according to Vandiver, Missourians are “show me” simple folks because they do not read or understand eloquent language. Vandiver might have thought that scientific language was beyond his neighbors’ ken as well. Of course, things have changed since 1899. Missouri is no longer a state populated by Democrats. In the 2016 general election, Donald Drumpf received 56.8% of the Missouri votes cast. Hilary Clinton received 38.1%.4  Inquiring minds will want to know whether “Show Me” connotes incredulity or illiteracy.

One relevant difference between Missouri and many other states, and all the federal courts, is that some courts in Missouri engage in a particularly edentulous form of judicial gatekeeping of expert witness opinion testimony. The talc claims that resulted in large verdicts in Missouri never got off the dime (or got a dime) in New Jersey because plaintiffs’ expert witnesses’ opinions were excluded from courtrooms in the Garden State.

The resulting trials in Missouri have showcased some curious, doubtful rhetoric from legal counsel for the lawsuit industry. In his closing argument in Giannecchini v. Johnson & Johnson, the plaintiff’s lawyer accused Johnson & Johnson of having “rigged” regulatory agencies to ignore the dangers of talc.5 The argument was apparently effective and it has been repeated in another Missouri trial, in Swann v. Johnson & Johnson6, now underway. The plaintiffs’ opening “statement” in Swann was marked by overwrought, hyperbolic rhetoric.7

And the first trial days in Swann were dedicated by plaintiff’s counsel to showing, not that talc actually causes ovarian cancer, but to showing that the defendants engaged in lobbying with respect to the carcinogenic classification of talc by regulatory agencies.8 According to the coverage in legal news media, the first testimony offered was offered to show that after the National Toxicology Program (NTP) nominated talc for inclusion in its list of potential carcinogens, industry trade groups, such as the Cosmetic, Toiletry and Fragrance Association, “shut down serious regulator concerns through intensive lobbying efforts.”9

This is a remarkable digression from the truth finding function of an American jury trial for several reasons. First, the “shutting down” of regulator concern was not, in the media reports, associated with any fraudulent misrepresentations of the scientific record. By casting the lobbying in an unflattering light, the plaintiff was able to undermine the truth value of agencies’ refusal to characterize talc as an ovarian carcinogen. The media coverage did not suggest that the lobbying involved the presentation of sham evidence or arguments that might have misled agencies about the correctness of their position.

Second, if the industry lobbying had badly misled the National Toxicology Program, or other government body, then there would no doubt be a conclusive case for causation today. The fact of the matter, however, is that there is no conclusive case for the claim that talc causes ovarian cancer. Late last year, the “Sister Study,” which explored whether there was any association between perineal talc use and ovarian cancer, was published in Epidemiology.10 The Sister Study (2003–2009) followed a cohort of 50,884 women whose sisters had been diagnosed with breast cancer. Talc use was ascertained at baseline, before diagnosis of subsequent disease and before any chance for selective recall. The cohort was followed for a median of 6.6 years, in which time there were 154 cases of ovarian cancer, available for analysis using Cox’s proportional hazards model. Perineal talc use at baseline was not associated with later ovarian cancer. The authors reported a hazard ratio of 0.73, less than expected, with a 95% confidence interval of 0.44, 1.2. Such a powerful study, showing the absence of any large or even modest association, would hardly be feasible if the science were so clear in the year 2000 that no reasonable scientist would have advocated against the NTP’s proposed classification.

Third, the lawsuit industry’s focus on lobbying activities in the Giannecchini and the Swann cases raises serious issues of infringing upon the defendants’ first amendment rights. The defendants’ advocacy for non-sham, non-fraudulent scientific positions is protected by the federal constitution, under what has come to be known as the Noerr-Pennington doctrine.

The Noerr-Pennington Doctrine of Immunity

One of the first agenda items for the first United States Congress was the drafting of a “Bill of Rights” to be submitted to the individual States for ratification. The First amendment (originally the third until the first two were dropped) sets forth a basic “right of the people to peaceably assemble, and to petition the government for a redress of grievances.”11 In the context of lobbying legislatures and regulatory agencies, the Supreme Court has long regarded lobbying and advocacy for and against legislation and regulation as core political speech that is protected by the right to petition the government.12

Part of this constitutional guarantee is a freedom to associate with others to lobby for redress.13 The constitutional protection is not lost by an economic or self-interested motivation in the lobbying or advocacy.14  This constitutional protection of advocacy positions results in an immunity from civil liability for speech, association, and conduct undertaken to advance advocacy positions before legislatures, agencies, and courts.15 This immunity, over half a century old, has come to be known as the Noerr-Pennington doctrine.

Although the original Noerr-Pennington doctrine cases specifically addressed claims of antitrust liability, later cases have held that the immunity applies with equal force in tort cases. State courts, regardless of their state constitutions, are of course obliged to grant and protect the federal Noerr-Pennington immunity.16

The unconstitutional infringement of defendants’ first amendment rights is hardly an innovation in Giannecchini and Swann cases. For decades, the lawsuit industry, which jealously guards its own first amendment rights, has overzealously pressed conspiracy and tort claims against manufacturing industry for trying to influence legislation and regulation. In Senart v. Mobay Chem. Corp., 597 F. Supp. 502 (D. Minn. 1984), plaintiffs alleged that they were harmed by exposure to toluene diisocyanate (TDI), a feedstock chemical used in making polyurethane foam. The plaintiffs sued TDI manufacturers, on conspiracy claims that the manufacturers had jointly influenced the Occupational and Safety Health Administration (OSHA) to reject a recommendation from the National Institute for Occupational Safety and Health (NIOSH) for lower permissible exposure standards for TDI. Senart, 597 F. Supp. at 504. The plaintiffs’ conspiracy complaint was based upon allegations that the manufacturing defendants knew of a body of scientific evidence which suggested that workers could suffer harm at exposure levels below the prevailing … standard,” and and that they “conspired to ‘obfuscate and confuse’ scientific findings which supported a more stringent standard.” Id. Plaintiffs also alleged that the TDI manufacturers knew that a more stringent TDI exposure standard would harm their businesses. Id.

The trial court dismissed the conspiracy count in Senart. “[E]ven accepting plaintiffs’ allegations as true, defendants concerted action sought only permissible ends and acted through permissible means.” Id. at 505-6 (footnote omitted). The defendants work in concert through their trade association to persuade OSHA to reject the NIOSH proposal was clearly protected by the first amendment. Id. at 506 (internal citations omitted).

Following Senart, federal courts in later products cases have applied he Noerr-Pennington doctrine to bar tort claims. In a 1996 class action, a district court held that the immunity barred a class action filed by relatives of gunshot victims against gun manufacturers. Hamilton v. ACCU-TEK 935 F. Supp. 1307 (E.D.N.Y. 1996). The court, in Hamilton, found the plaintiffs’ negligence and product liability claims untenable:

Defendants’ efforts to affect federal firearm policies through lobbying activities are prime examples of the types of activity the First Amendment, through its rights of free speech and petition, sought to protect… . A core principle of the Noerr-Pennington doctrine is that lobbying alone cannot form the basis of liability… .”

Id. at 1321. The court in Hamilton dismissed the product liability claims. See also Tuosto v. Philip Morris USA Inc., No. 05 Civ. 9384 (PKL), 2007 WL 2398507, at *5 (S.D.N.Y. Aug. 21, 2007) (noting that the immunity “applied to bar liability in state common law tort claims, including negligence and products liability claims, for statements made in the course of petitioning the government”).

The lawsuit industry is one of the largest rent-seeking groups in the United States. Our courts need to apply constitutional standards in a symmetrical fashion, with an understanding that what is spoken in the halls of legislatures and agencies is protected at least as much as speech in the courtroom, and that the constitutional rights of manufacturing industry should not be subordinated to the rights of the lawsuit industry. Maybe lawyers need to figure out how to “show” the constitution in pictograms, without all the 18th century eloquence.


1 Carl v. Johnson & Johnson, No. ATL-L-6546-14, 2016 WL 4580145 (N.J. Super. Ct. Law Div., Atl. Cty., Sept. 2, 2016).See New Jersey Kemps Ovarian Cancer – Talc Cases” (Sept. 16, 2016).

2Talc Litigation – Stop the Madness” (Nov. 10, 2016) (describing large verdict for plaintiff in Giannecchini v. Johnson & Johnson); see also Myron Levin, “Johnson & Johnson Hammered Again in Talc-Ovarian Cancer Verdict of $70 Million,” Law360 (Oct. 27, 2016); Brandon Lowrey, “J & J, Talc Co. Hit With $70M Baby Powder Cancer Verdict,” Law360 (Oct. 2016).

3 SeeThe Show-Me State,” last visited Feb. 21, 2017.

4 SeeState of Missouri – 2016 General Election – November 8, 2016,” last visited Feb. 21, 2017. I leave it to the reader to assess whether the state nickname describes incredulity or illiteracy.

5 Myron Levin, “Johnson & Johnson Hammered Again in Talc-Ovarian Cancer Verdict of $70 Million,” Law360 (Oct. 27, 2016); Brandon Lowrey, “J & J, Talc Co. Hit With $70M Baby Powder Cancer Verdict,” Law360 (Oct. 2016).

6 Swann v. Johnson & Johnson, case number 1422-CC09326-01, in the 22nd Judicial Circuit of Missouri.

7 Cara Salvatore, “J&J Hid Talc Risk For ‘Love Of Money’, Jury Hears,” Law360 (Feb. 9, 2017).

8 Cara Salvatore, “Talc Lobbyists Stymied Carcinogen Classification, Jury Hears,” Law360 (Feb. 10, 2017).

9 Id.

10 Nicole L. Gonzalez, Katie M. O’Brien, Aimee A. D’Aloisio, Dale P. Sandler, and Clarice R. Weinberg, “Douching, Talc Use, and Risk of Ovarian Cancer,” 27 Epidemiology 797 (2016).

11 U.S. Const. amend. I.

12 California Motor Transp. Co. v. Trucking Unlimited, 404 U.S. 508, 510 (1972) (disallowing a cause of action “predicated upon mere attempts to influence the Legislative branch for the passage of laws or the Executive branch for their enforcement.”); United Mine Workers of Am. v. Ill. State Bar Ass’n, 389 U.S. 217, 222 (1967) (characterizing the right to petition as “among the most precious of the liberties safeguarded by the Bill of Rights”). United Mine Workers of Am. v. Pennington, 381 U.S. 657, 669-70 (1965); Doe v. McMillan, 566 F.2d 713, 718 (D.C.Cir. 1977), cert. denied, 435 U.S. 969 (1978) (holding that the first amendment constitutional right to petition the legislature “extends to administrative agencies and the courts”).

13 N.A.A.C.P. v. Button, 371 U.S. 415, 430 (1963) (protecting the right “to engage in association for the advancement of beliefs and ideas”); N.A.A.C.P. v. Alabama ex rel. Patterson, 357 U.S. 449, 460 (1958) (“[e]ffective advocacy of both public and private points of view, particularly controversial ones, is undeniably enhanced by group association … .”). The right of association to further lobbying activities has been described as having a “preferred place” along with other first amendment freedoms, such that the Court will not tolerate “dubious intrusions.” Thomas v. Collins, 323 U.S. 516, 530 (1945).

14 Virginia State Bd. of Pharmacy v. Virginia Citizens Consumer Council, 425 U.S. 748, 762 (1976); Sawyer v. Sandstrom, 615 F.2d 311, 316 (5th Cir. 1980) (“The right to freely associate is not limited to those associations which are ‘political in the customary sense’, but includes those which ‘pertain to the social, legal, and economic benefit of the members’.”) (citing Griswold v. Connecticut, 381 U.S. 479, 483 (1965)); International Union v. National Right to Work Legal Defense & Education Foundation, Inc., 590 F.2d 1139, 1148 (D.C. Cir. 1978) (“Even economically motivated expression or association is not disqualified from protection under the first amendment.”); Greminger v. Seaborne, 584 F.2d 275, 278 (8th Cir. 1978) (observing that the constitutionally protected [f]reedom of association includes membership in unions or other organizations concerned with ‘business and economic causes’.”); Senart v. Mobay Chem. Corp., 597 F. Supp. 502, 506 (D.Minn. 1984) (“Selfish motivations do not lessen one’s right to present views to the government.”).

15 Eastern Railroad Presidents Conference v. Noerr Motor Freight, Inc., 365 U.S. 127 (1961); United Mine Workers v. Pennington, 381 U.S. 657 (1965).

16 Fraser v. Bovino, 317 N.J. Super 23, 37 (App. Div. 1998) (recognizing “the fundamental values that undergird a citizen’s right to communicate on issues of public import”); Village Supermarket, Inc. v. Mayfair, 269 N.J. Super. 224, 229-32 (Law Div. 1995) (refusing to interpret New Jersey tort law to permit claims based on lobbying activity protected by the First Amendment); ARTS4ALL Ltd. v. Hancock, 810 N.Y.S.2d 15, 16 (App. Div. 2006) (denying employee’s motion for summary judgment on claim for breach of no-disparagement clause in severance agreement, holding that employer’s statements to government officials were protected by Noerr-Pennington doctrine); Concourse Nursing Home v. Engelstein, 692 N.Y.S. 2d 888, 891 (Sup. Ct. 1999) (holding law firm was immune from business tort claims for successful lobbying efforts); I.G. Second Generation Partners v. Reade, 793 N.Y.S.2d 379, 381 (App. Div. 2005) (holding that NoerrPennington immunity barred claim for tortious interference); Diaz v. Southwest Wheel, 736 S.W.2d 770, 771 (Tx. Ct. App. 1987) (holding that Noerr-Pennington immunity barred conspiracy claims against tire manufacturer, which as a member of a trade association, opposed the recall on defective tire rims and restrictions on multi-piece wheels).