TORTINI

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

The Slemp Case, Part I – Jury Verdict for Plaintiff – 10 Initial Observations

May 13th, 2017

While I greatly appreciate you informing me, on three separate occasions, that I am not under investigation, I nevertheless concur with the judgment of the Department of Justice that you are not able to effectively lead the Bureau.”

Letter from Donald Trump to James Comey (May 9, 2017) (emphasis added)

Just as a President’s poor diction does not define or guide good English grammar, a lay civil jury’s verdict on scientific issues does not resolve open scientific questions of causation between exogenous exposures and cancer or other chronic disease outcomes. Last week, a jury in St. Louis returned a substantial verdict for compensatory and punitive damages against Johnson & Johnson, and others, for supposedly causing Lois Slemp to develop ovarian cancer. From some of the media coverage, readers might infer that Ms. Slemp’s attorneys’ had presented a credible case of causation between perineal talc use and ovarian cancer. See, e.g., Daniel Siegal, “J&J Hit With $110M Verdict In Latest Mo. Talc Cancer Trial,” Law360 (May 4, 2017). The cause of this verdict requires close scrutiny of the scientific evidence, the jury and juries generally, the lawyering from both sides, and the judicial management of the trial. 

Hit.” Hit? When did comic-book language invade legal journalism? Why not “slammed,” “zapped,” or “kapow”?

The case, which has gained this recent notoriety is Lois Slemp v. Johnson & Johnson, case no. 1422-CC09326-01, 22nd Judicial Circuit Court of Missouri. The jury awarded Ms. Slemp $5.4 million in compensation, and $66 million against Johnson & Johnson, $39 million against Johnson & Johnson Consumer, and $50,000 against Imerys (the talc miner and supplier), in punitive damages. On the compensatory award, the jury ascribed 99 percent of fault to the two J & J companies, and 1 percent to Imerys. Id.

The truth is that the Slemp verdict, as is the case for most civil jury verdicts, does not represent a valid scientific judgment. Nonetheless, the verdict requires explanation. If talc does not cause ovarian cancer, we may well ask whether the case was poorly defended, whether the court system failed to serve as a gatekeeper, and whether the scientific case was beyond the comprehension of the lay jury.

The verdict of course also raises serious questions about our civil justice system. The law of products liability typically states that a manufacturer or seller is held to the level of an expert in knowing the harmful aspects of its products. If this knowledge is widely known about consumers, then the seller will generally have an obligation to warn about the latent harm. But what happens when there is no knowledge of a causal relationship? Or what happens when experts legitimately disagree? How can a manufacturer or seller be charged with outrageous misconduct, let alone negligence, when experts sincerely and legitimately disavow a causal relationship?

David H. Schwartz, Ph.D. of Innovative Science Solutions LLC, and I posted a preliminary, big-picture overview of the Slemp case at the Courtroom View Network’s website. See Schwartz & Schachtman, “10 Key Scientific Takeaways From Recent $110M Talc Powder Verdict,” Courtroom View Network Blog (May 12, 2017). Thanks to the generosity of Courtroom View, David and I were able to view the video of the Slemp trial, and to evaluate the legal process of presenting a complicated scientific case to a lay jury. There is much to be said about that process, what went right and what went wrong, but for now, I will simply repeat, below, what we said on CVN’s blog. I hope in subsequent posts to look more closely at specific issues, especially with respect to the presentation of statistical and epidemiologic evidence, by all parties.

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The following is a republication (with minor formatting changes) of the original post, by David H. Schwartz and Nathan Schachtman. 

Establishing a rigorous and reliable causal inference between an exposure and an adverse health outcome is one of the most difficult things to do in the health sciences. However, it is sometimes even more difficult to effectively and appropriately demonstrate that a causal relationship does not exist.

The difficulty of this task was illustrated in the most recent talcum powder trial in St. Louis, Missouri. As was widely reported, Johnson & Johnson and talc raw material producer Imerys received the third (and largest) plaintiff verdict in their four recent talc trials (3 plaintiff verdicts and one defense verdict). Having the enviable opportunity to watch the trial (in real time or on demand) on Courtroom View Network’s website provides an invaluable opportunity to review and learn from an important ongoing mass tort action.

At this trial, the defense put up a single expert witness, Dr. Huh, a clinician who defended the aggressive and wide-ranging scientific claims advanced by plaintiff’s expert witnesses in a number of scientific disciplines, including epidemiology, clinical medicine, and pathology. Dr. Huh, a skilled and experienced ObGyn and a clinical gynecological oncologist, attempted to neutralize plaintiff’s scientific allegations made by putting the clinical characteristics of the patient into context, while dismissing the many statistically significant epidemiological studies touted by plaintiffs as adequately establishing a causal inference for talcum powder and ovarian cancer.

In his cross examination, plaintiff counsel continuously barraged Dr. Huh with technical observations relating to the large body of epidemiologic studies that plaintiff expert witnesses claimed demonstrated that talc exposure caused ovarian cancer. From the perspective of a scientist who has consulted with many product manufacturers alleged to cause cancer and other chronic diseases, and a lawyer who has tried many science-based cases over the past 32 years, this most recent trial illustrates some important and emblematic issues that arise in pharmaceutical, medical device, and toxic tort cases. We provide 10 such observations below.

1. Provide overall context of Bradford Hill criteria

Unlike other legal cases where there is a paucity of epidemiologic data showing statistically significant associations between an exposure and a disease endpoint, in this case there are many epidemiologic studies – and even some meta-analyses – that invite plaintiffs to make the claim that the available scientific evidence meets the Bradford Hill criteria. Therefore, it is critical to provide the jury with a lucid understanding of why the Bradford Hill criteria are utilized and how they should appropriately be applied. Indeed, the Bradford Hill criteria were developed for a situation exactly like the talc litigation; that is, a relatively weak association is reported and scientists want to determine whether that association should validly and reliably be considered causal.

2. Build solid foundation for “correlation does not equal causation” argument

Multiple studies assert an association between talc and ovarian cancer. However, the defense position is that the studies used to make this assertion suffer from bias and confounding, making them unreliable. Relying upon multiple flawed or biased studies to demonstrate a relationship between two factors does not make the two factors causally related. For example, it does not matter how many times one shows that wearing work boots is associated with back injury, it does not make wearing work boots a cause of back injury. (The two factors are associated, but not causally so.) It is critical for the defense to make it crystal clear (as many times as he is questioned) that “correlation does not equal causation.”

3. Develop a genetic defense

Knowledge of the role of genetic data related to ovarian cancer is moving at breakneck speed. Indeed, a study was published in March identifying nine new susceptibility loci for different epithelial ovarian cancer histotypes. While these data may or may not have been relevant to the individual patient in the Slemp trial, there is no way to know unless the defense had a full genome sequence of the plaintiff’s germline. Such information could conceivably be aligned with newly published data to demonstrate that her genetic profile was consistent with the development of ovarian cancer.

4. Hone the lack of consistency argument

Not surprisingly, in his cross examination of Dr. Huh, plaintiff counsel repeatedly referred to the many case-control studies that reported statistically significant associations between talc and ovarian cancer to support the view that the Hill criterion of “consistency” was met. Dr. Huh repeatedly attempted to rebut this assertion, but failed to make a clear argument as to why these multiple studies failed to support the criterion of consistency. He did refer to the fact that the cohort studies disagreed with the case control studies, but failed to clearly articulate his interpretation of that discrepancy.

At the end of the day, it is not at all surprising that multiple confounded and biased studies all demonstrate the same association. To truly demonstrate the criterion of consistency, one must show that the same results are obtained when using different study methods. Indeed, when a different study design is utilized (cohort studies), the association vanishes. One can posit methodological flaws in the cohort studies (misclassification bias as was repeatedly stated by plaintiff counsel), but flaws can also be posited for the case control studies (recall bias and confounding). The point is that repeating the same poorly conceived study design over and over does not constitute consistency and that the criterion of consistency is therefore not met in this data set.

An example, such as the strong relationship between Vitamin A and cancer prevention might have helped. In observational studies, Vitamin A is clearly associated with a reduction of lung cancer rates based on multiple observational studies. When the claim was tested in randomized clinical trials, the claim failed miserably; indeed, Vitamin A might even increase the rate of lung malignancies in those who took supplements. Similarly, hormone replacement therapy (HRT) was once thought to decrease the risk of cardiovascular disease based on multiple observational studies. It was not until a large randomized controlled trial was conducted that the putative association between HRT and cardiovascular benefit was discredited.

5. Do not let conflict of interest arguments cloud the causal inference assessment

Alleged conflicts of interest were raised repeatedly in accusatory tones, suggesting that any research that J & J funded could not be trusted. Furthermore, suggestions were made that J & J controlled where funding was allocated through their contributions to the National Institutes of Health. These arguments must be addressed aggressively and should not be allowed to hang in the air without response.

6. Pathological evidence must be confronted by someone who studied the pathology slides

Plaintiff counsel confronted Dr. Huh with allegations by plaintiff’s pathologist about the type of cancer from which plaintiff suffered. Because Dr. Huh is not a pathologist and because he did not look at plaintiff’s pathology sides, he attempted to use his clinical impressions and medical records to counter the pathological evidence offered by the plaintiff’s expert witness in pathology. The defense seemed enamored of a “less is more” strategy, but forcing expert witnesses into testimony beyond their expertise requires fortitude and perhaps luck.

7. Put “authoritative”statements into appropriate context

Throughout his cross examination, plaintiff’s counsel confronted Dr. Huh with statements from web sites and textbooks suggesting that talc caused ovarian cancer or where talc is listed as a risk factor for ovarian cancer. Many times, such statements referred to a putative association as opposed to a causal relationship. It is critical to point out their inherent weaknesses, including the fact that they have been cherry picked and to counter with other authoritative sources where talc is not listed as a risk factor and/or the causal link has been questioned. It is also important to be ready with other risk factors that could be equally likely to be linked to ovarian cancer and to emphasize that focusing on talc is arbitrary. The plaintiff is this recent trial was morbidly obese, an undisputed risk factor for ovarian cancer.

As with the lack of consistency argument (#3, above), rebuttal of this contention would be effectively guided using specific examples. For instance, many textbooks and other authoritative sources stated that HRT had cardiovascular benefits based on multiple observational studies. The fact is that these statements were wrong.

8. Concede that cohort studies are not always better than case-control studies

The talc defense strongly asserted the view that cohort studies are necessarily better than case control studies. While this contention is generally true (all factors being equal), it is not always true and it leads to some effective cross examination (e.g., the general assertion that cohort studies may suffer, in some instances, from misclassification bias). As one of us (NAS) stated in a recent post related to the California Science Day hearings, there is no reason to make the blanket statement that cohort studies are always better than case control studies.

Rather, the general point can be made that each study type has its appropriate use and that in this case, the findings from studies using the two different methodologies do not agree with each other. Clearly, the role of differential recall is just as likely to bias a case control study as the role of misclassification is to bias a cohort study. This leaves the evidence at a draw at best.

9. Provide a multi-disciplinary defense

In a case involving so many complex disciplines, it does not seem tenable to address all of them with a single expert, even one as well qualified and experienced as Dr. Huh. Many defense lawyers firmly believe in the “less is more” strategy, but complex scientific data sets such as these necessitate a complete presentation of the exculpatory evidence. Although it is easy in hindsight to criticize trial strategy, forcing a clinical oncologist to address pathology, toxicology, and epidemiology places an unfair burden on the lone witness. Certainly, a jury may be more prone to view an expert witness, who is willing to testify outside his area of expertise, as a hired gun advocate.

10. Careful and consistent use of terminology

Because of the nuanced nature of the defense case (i.e., statistically significant associations demonstrated in observational studies may not be causal in nature), it is critical to use terms consistently and carefully. Terms such as “association,” “link,” “causal inference,” and “causation” must be carefully defined and utilized judiciously and with clear intent.

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Of course, looking at testimony in hind-sight is always 20/20. As stated at the outset of this piece defending the assertion that an exposure is not causally related to a clearly defined injury is one of the most difficult things to do in the courtroom, especially when this is attempted through a single expert witness and there are numerous studies purporting to make such a link. Nevertheless, some extremely critical lessons can be learned from this experience to guide future cases.

David Egilman and Friends Circle the Wagons at the International Journal of Occupational & Environmental Health

May 4th, 2017

Andrew Maier is an associate professor in the Department of Environmental Health, in the University of Cincinnati. Maier received his Ph.D. degree in toxicology, with a master’s degree in industrial health. He is a Certified Industrial Hygienest and has published widely on occupational health issues. Earlier this year, Maier was named the editor-in-chief of the International Journal of Occupational and Environmental Health (IJOEH). See Casey Allen, “Andy Maier Named Editor of Environmental Health Journal(Jan. 18, 2017).

Before Maier’s appointment, the IJOEH was, for the last several years, the vanity press for former editor-in-chief David Egilman and “The Lobby,” the expert witness brigade of the lawsuit industry. Egilman’s replacement with Andrew Maier apparently took place after the IJOEH was acquired by the scientific publishing company Taylor & Francis, from the former publisher, Maney.

The new owner, however, left the former IJOEH editorial board, largely a gaggle of Egilman friends and fellow travelers in place. Last week, the editorial board revoltingly wrote [contact information redacted] to Roger Horton, Chief Executive Officer of Taylor & Francis, to request that Egilman be restored to power, or that the current Editorial Board be empowered to choose Egilman’s successor. With Trump-like disdain for evidence, the Board characterized the new Editor as a “corporate consultant.” If Maier has consulted with corporations, his work appears to have rarely if ever landed him in a courtroom at the request of a corporate defendant. And with knickers tightly knotted, the Board also made several other demands for control over Board membership and journal content.

Andrew Watterson wrote to Horton on behalf of all current and former IJOEH Editorial Board members, a group heavily populated by plaintiffs’ litigation expert witnesses and “political” scientists, including among others:

Arthur Frank

Morris Greenberg

Barry S. Levy

David Madigan

Jock McCulloch

David Wegman

Barry Castleman

Peter Infante

Ron Melnick

Daniel Teitelbaum

None of the signatories apparently disclosed their affiliations as corporate consultants for the lawsuit industry.

Removing Egilman from control was bad enough, but the coup de grâce for the Lobby came earlier in April 2016, when Taylor & Francis notified Egilman that a paper that he had published in IJOEH was being withdrawn. According to the petitioners, the paper, “The production of corporate research to manufacture doubt about the health hazards of products: an overview of the Exponent Bakelite simulation study,” was removed without explanation. See Public health journal’s editorial board tells publisher they have ‘grave concerns’ over new editor,” Retraction Watch (April 27, 2017).

According to Taylor & Francis, the Egilman article was “published inadvertently, before the review process had been completed. On completing that review, it was decided the article was unsuitable for publication in the journal.” Id. Well, of course, Egilman’s article was unlikely to receive much analytical scrutiny at a journal where he was Editor-in-Chief, and where the Board was populated by his buddies. The same could be said for many articles published under Egilman’s tenure at the IJOEH. Taylor & Francis owes Egilman and the scientific and legal community a detailed statement of what was in the article, which was “unsuitable,” and why. Certainly, the law department at Taylor & Francis should make sure that it does not give Egilman and his former Board of Editors grounds for litigation. They are, after all, tight with the lawsuit industry. More important, Taylor & Francis owes Dr. Egilman, as well as the scientific and legal community, a full explanation of why the article in question was unsuitable for publication in the IJOEH.

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).

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).