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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 Matters – A 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?

1 German Lopez, “Trump keeps lying about his Electoral College victory: He made two false claims about his win at a news conference on Thursday,” (Feb. 16, 2017).

2 John Adams, “Argument in Defense of the Soldiers in the Boston Massacre Trials,” (Dec. 1770).

3 See Seth Mnookin, “How Robert F. Kennedy, Jr., Distorted Vaccine Science; His anti-vaccine credentials date back to 2005,” Scientific American (Jan. 11, 2017); “Quackers & Cheese – Trump Picks Kennedy to Study Vaccine Safety,” (Jan. 11th, 2017).

Posted in Rule 702, Scientific Evidence, Scientific Misconduct | Comments Off on Social Media, Rhetoric, and Science – Antivaxxers

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.¹⁴This 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 18^th 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).

2 “Talc 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 See “The Show-Me State,” last visited Feb. 21, 2017.

4 See “State 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 Noerr–Pennington 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).

Posted in Causation, Expert Witnesses, Rule 702, Scientific Evidence | Comments Off on Talc Litigation in Missouri – Show Me the Law and the Evidence

Quackers & Cheese – Trump Picks Kennedy to Study Vaccine Safety

January 11th, 2017

Science necessarily involves a willingness to follow evidence to whatever conclusions are warranted, if conclusions properly can be had. When it comes to vaccination conspiracies, Democrats have it in their political DNA to distrust pharmaceutical companies that research, develop, and manufacture vaccines. The current Republican party, which has been commandeered by theocrats and populists, see vaccination as federal government aggrandizement, and resist vaccination policy as contrary to God’s will. Science is often the loser in the cross-fire.

And so we now have the public spectacle of watching the left and the right join in similar scientific apostasies. Consider how both McCain and Obama both suggested that vaccines and autism were related in the 2008 election. (Although both candidates were to some extent slippery in their suggestions, which might have been appropriate given how little they knew about the controversies.) And consider Michelle Bachmann was converted to a similar view about the HPV vaccine on the basis of a woman’s anecdote about her child. And then on the far left, you have the uplifting story of Robert F. Kennedy Jr, and his brief on how thimerosal supposedly causes autism.

So it should be no surprise that Donald Trump, a Birther, a Mirther, a mid-night Twitterer, should embrace the anti-vaccination movement. Trump has made it clear that he rejects evidence-based policy, and so no one should expect him to embrace a scientific policy that is driven by high-quality scientific evidence. According to Kennedy, Trump wants Kennedy to head up a “commission on vaccine safety and scientific integrity.” Michael D. Shear, Maggie Haberman & Pam Belluckjan, “Anti-Vaccine Activist Says Trump Wants Him to Lead Panel on Immunization Safety,” N.Y. Times (Jan. 10, 2017); Domenico Montanaro, “Despite The Facts, Trump Once Again Embraces Vaccine Skeptics,” National Public Radio (Jan. 10, 2017).

Who needs the National Academy of Medicine when you can put a yutzball lawyer in charge of a “commission”?

Some of the media refer to Robert F. Kennedy Jr. as a vaccine skeptic, but their terminology is grossly inaccurate and misleading. Kennedy is a vaccine denier; he has engaged in a vitriolic campaign against the safety and efficacy of vaccines. He has aligned himself with the most extreme deniers of science, medicine, and public safety, including the likes of Andrew Wakefield and Jenny McCarthy. Kennedy has not merely engaged hyperbolic rhetoric against vaccines, he has used his radio show on the lawsuit industry’s Ring of Fire, to advance his campaign against public health as well as to shill for the lawsuit industry on other issues. See “RFK, Jr.: Science Shows That Autism — Mercury Link Exists – PT. ½,” Ring of Fire (Mar 8, 2011).

Kennedy should not be characterized as a skeptic, when he is a shrill ideologue, for whom science has no method that he is bound to respect. Back in July 2005, Kennedy published an article, “Deadly Immunity,” in both Rolling Stone and on Slate’s website. The article was a hateful screed against Big Pharma and government health agencies for an alleged conspiracy to hide the autism risks of thimerosal preservatives in vaccines. Several years later, on January 16, 2011, Salon retracted the article. See “https://en.wikipedia.org/wiki/Deadly_Immunity” entry in Wikipedia. See also Phil Plait, “Robert F. Kennedy Jr.: Anti-Vaxxer,” Slate (June 5 2013) (describing Kennedy as a full-blown anti-vaccination conspiracy theorist); Rahul K. Parikh, M.D., “Inside the vaccine-and-autism scare: A pediatrician traces the rise of the anti-vaccine movement that falsely linked thimerosal with autism and turned parents away from the most lifesaving medicine in history,” Salon (Sept. 22, 2008); Keith Kloor, “Is Robert F. Kennedy Jr. Anti-Science?” Discover Magazine (June 1, 2013); Steven Novella, “RFK Jr.s Autism Conspiracy Theory,” (Jun 20 2007).

Back in 2008, President Obama apparently considered Robert Kennedy for a cabinet-level position, but on sober reflection, thought better of it. See Steven Novella, “Politics and Science – The RFK Jr. Test,” (Nov. 07 2008). The Wall Street Journal, joined by many others, are now urging Trump to think harder and better about the issue, perhaps with some evidence as well. See Alex Berezow & Hank Campbell, “Ignore Anti-Vaccine Hysteria, Mr. Trump: Robert F. Kennedy Jr.’s conspiracy theories have no place in the White House,” Wall Street J. (Jan. 10, 2017).

Posted in Causation, Cognitive Biases, Conflicts of Interest, Evidence, Public Nuisances, Scientific Evidence, Scientific Misconduct | Comments Off on Quackers & Cheese – Trump Picks Kennedy to Study Vaccine Safety

Kiker v. Smithkline Beecham & the Pathology of Judicial Gatekeeping

January 4th, 2017

“There is no expedient to which a man will not go to avoid the labor of thinking.” Sir Joshua Reynolds

Medical students study pathology not only to understand the nature, course, and causation of disease, but also to understand better normal tissue and cellular function and structure. Similarly, lawyers can improve their understanding of judicial decision making, not only from studying well-reasoned judicial opinions, but from also studying pathological opinions, with clear, demonstrable errors that help illustrate both the pathogenesis of intellectual and judicial error, as well as the normal, proper function of judging.

At the end of each year, bloggers and pundits traditionally call attention to the best and the worst decisions, usually from a partisan perspective. One federal judicial decision on Rule 702, however, stands out for special treatment as a veritable Berenstain Bears’ manual on how not to adjudicate so-called Daubert motions. Kiker v. Smithkline Beecham Corp., 2:14-cv-02164-EAS-TPK, (S.D. Ohio, Dec. 15, 2016) (Sairgus, C.J.) [cited below as Kiker slip op.] The Kiker opinion is as worthy of dissection as a judicial opinion for lawyers, as is the dissection of a cadaver by medical students in their first-year course on clinical anatomy.

The Kiker plaintiffs claimed that maternal use of paroxetine (tradename Paxil) caused her child to develop a ventricular septal defect. The defendant, GlaxoSmithKline LLC (GSK), invoking Federal Rule of Evidence 702, moved to exclude opinion testimony of several of plaintiffs’ expert witnesses, including Laura M. Plunkett, Ph.D., Ra-id Abdulla, M.D. Kiker slip op. at 1. The gravaman of the plaintiffs’ case is that GSK did adequately warn physicians of the risk to offspring of women who took paroxetine in pregnancy until September 2005. At that time, GSK revised its labeling for Paxil to warn of the “increased risk for cardiovascular malformations.” Kiker slip op. at 3.

The plaintiffs threw in the kitchen sink with their allegations, which included specific averments that GSK should have informed the medical community about “significant” adverse event reporting and the meaning of claimed deaths among rat pups in high-dose maternal toxicity testing. Not content with a failure to warn case, plaintiffs ratcheted their allegations into a fraudulent misrepresentation case, as well. Kiker slip op. at 3-4. Laura Plunkett and Ra-id Abdulla were the principal expert witnesses relied upon by plaintiffs for their hyperbolic claims.

The Standard

Chief Judge Sargus started his description of the governing law by insisting that the standard for expert witness gatekeeping was “flexible”; that is, he would follow the “Gumby Rule,” which allows the trial judge maximal flexibility and stretch to admit dubious expert witness opinions. Chief Judge Sargus employed the usual reductionist criteria for assessing “reliability.” Citing Kumho Tire, he explained that the court’s role was to ascertain whether

“an expert . . . employs in the courtroom the same level of intellectual rigor that characterizes the practice of an expert in the relevant field.”

Kumho Tire Co. v. Carmichael, 526 U.S. 137, 152, (1999). He also acknowledged that Daubert had provided some indicia of reliability in factors such as

“testing, peer review, publication, error rates, the existence and maintenance of standards controlling the technique’s operation, and general acceptance in the relevant scientific community.”

Kiker slip op. at 7, quoting from United States v. Langan, 263 F.3d 613, 621 (6th Cir. 2001) (citing Daubert v. Merrell Dow Pharm, Inc., 509 US. 579, 593-94 (1993)).

Chief Judge Sargus was then quick to point out that the cited Daubert factors do not make up a definitive, dispositive test or checklist, which presumably gave him license to ignore these factors and their absence, all together. Nowhere later in his opinion on the contested reliability of plaintiffs’ expert witnesses’s causation opinions is there any discussion of the actual testing, its validity, its pre-publication and post-publication peer review, error rates, standards for assessing causation, or general acceptance of the claimed methodologies. And of course, the discretion permitted district judges in performing their gatekeeping function is not the discretion to abandon the gatekeeping function and to ignore relevant methodological criteria. See Kumho Tire, 526 U.S. 137, 158-59 (Scalia, J., concurring).

Semantic Legerdemain Substitutes for Demonstration of General Causation

Chief Judge Sargus acknowledged that there is a “specific methodology” used by scientists to assess a body of evidence for causation of birth defects, but then proceeded to ignore that methodology without bothering to describe or apply it. Kiker slip op. at 10. What gave the trial judge his argument for ignoring the “specific methodology” used by scientists, the Daubert factors, and indeed any and all factors for assessing the validity of a scientific claim and conclusion, was the language used by the Food and Drug Administration (FDA) and GSK, the NDA-holder, in various communications. Rather than engage in an intellectually challenging exploration and evaluation of the actual scientific evidence and analysis that underlay the plaintiffs’ expert witnesses’ causation opinions, Chief Judge Sargus pointed to the language used by the FDA in its original Public Health Advisory about the issue of congenital cardiac malformations in children of mothers who ingested paroxetine in their first trimester of pregnancy:

“[t]he FDA has determined that exposure to paroxetine in the first trimester of pregnancy may increase the risk for congenital malformations, particularly cardiac malformations. At the FDA’s request, the manufacturer has changed paroxetine’s pregnancy category from C to D and added new data and recommendations to the WARNINGS section of paroxetine’s prescribing information. FDA is awaiting the final results of recent studies and accruing additional data related to the use of paroxetine in pregnancy in order to better characterize the risk for congenital malformations associated with paroxetine.”

Kiker slip op. at 10, quoting from FDA Public Health Advisory (Dec. 8, 2005), available at <http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm051731.htm> (emphasis added).

Chief Judge Sargus apparently was oblivious to the difference between “X causes Y” and “X may increase the risk of Y.” As the trial judge, he also fixed on the FDA’s decision to change the pregnancy category labeling for paroxetine from Category C to Category D, with the latter category’s reflecting “positive evidence of human risk.” Kiker slip op. at 11. Again, the existence of evidence for risk is not, and never has been, the existence of evidence that would support a reasonable, reliable conclusion that paroxetine causes cardiac birth defects. Nothing can explain or justify this incredible reliance and misinterpretation of language, and Chief Judge Sargus makes no attempt to defend his linguistic contortions.

Chief Judge Sargus ends with an implied assertion that he, as trial judge, need not spend any time on assessing the quantity or quality of evidence for a conclusion of causality because GSK has admitted that paroxetine causes cardiac birth defects. The GSK Dear Healthcare Provider Letter, the FDA Safety Alert, along with the (preliminary) results of a single epidemiologic study

“combine in this instance to constitute an admission that Paxil can cause injury, and is sufficient to create an issue of fact regarding causation.”

Kiker slip op. at at 15.

Whence comes this incredible reliance upon the language of a package insert? Chief Judge Sargus points to Judge James Gwin’s decision in In re Meridia, and proceeds to provide two pages, single-spaced, of block quotation from the Meridia decision. Kiker slip op. at 13-15, quoting from In re Meridia Prods. Liab. Litig., 328 F. Supp. 2d 791, 800-01 (N.D. Ohio 2004).

Interspersed in the two pages of quotation from Meridia were citations to Ferebee and Wells, two of the most discredited, disreputable federal court decisions on biomedical causation, both of which were effectively overruled sub silentio by the Supreme Court in Daubert. Chief Judge Sargus argues that the Meridia decision held that “product inserts to both physicians and patients” constituted “admissions of Meridia’s potential to cause substantial increases in blood pressure in some patients. Meridia, 328 F. Supp. 2d at 810. Affirming the district court’s decision in Meridia, the Sixth Circuit specifically upheld the district court’s determination that the FDA warning label at issue in that case “constitutes an admission that Meridia can cause injury.” Meridia Prods. Liab. Litig. v. Abbott Labs, 447 F.3d 861, 866 (6th Cir. 2006).

This analytical shortcut has serious problems. First, as a first year law student might observe, the Meridia decision resulted in the exclusion of plaintiffs’ key expert witness and the grant of summary judgment to the defendant on adequacy of its warning, all of which the Sixth Circuit affirmed. Given that there was no liability, the comments about causation would seem to be dictum, not holding. Second, with respect to the issue of warnings as admissions, the Circuit agreed that the district court had construed the defendant’s package insert warning that the medication ‘‘substantially increases’’ blood pressure as an admission, but that such unequivocal language was quite different from warning language that states medication use ‘‘is associated with’’ an adverse event. 447 F.3d at 866. The FDA’s Public Health Advisory, the change to Category D, and GSK’s own sponsored study did not, individually or collectively, state a finding of anything more than an association, and that there “may be an increased risk.”

Of course, Chief Judge Sargus’s glib exercise eliminated all the difficult thought of evaluating actual scientific evidence. The indolent approach used in Kiker committed another blatant error. The approach not only relied incorrectly upon some language of the FDA and medication license holder, but it ignored all the contrary evidence, context, and analysis that kept the FDA from reaching a conclusion of causality in 2005, and most scientists to this very day. Furthermore, the Kiker approach conveniently ignored that over a decade of additional evidence, much of it exonerating paroxetine. Chief Judge Sargus has misidentified the weakest, incomplete, out-of-date, cherry-picked evidentiary display with reliable evidence that purports to support a causal conclusion.

Non-Specific Confusion on Specific Causation

Having announced that the court will not grant a hearing, or even an on-the-paper review of the actual evidence for plaintiffs’ causal claims, Chief Judge Sargus proceeded to make even shorter work of the issue of specific causation. The only support for specific causation in the case was in the proffered testimony of Dr. Ra-id Abdulla, a serial testifying expert witness in anti-depressant birth defects cases. Abdulla purported to conduct a differential diagnosis to discern the cause of the infant plaintiff’s birth defect, a ventricular septal defect. Kiker slip op. at 16.

The diagnosis of the infant Kiker’s birth defect, however, was never in doubt; rather it was the etiology of the septal defect, which was at issue. Abdulla claimed to have ruled out all other potential alternative causes. Kiker slip op. at 18. Even if Abdulla’s claim could be accepted for known causes of septal defects, he would still be faced with a situation in which there are baseline or background cases of septal defects, which occur in children with no known or even suspected risk factor. The court failed to explain how Abdulla ruled out such unknown, prevalent causes of septal defects in the Kiker plaintiff. To be sure, the court appeared to have fallen for the “treating physician” ruse, which suggests that treating a condition provides some magical insight into the cause of that condition. Kiker slip op. at 19-20.

No explanation was cited by the court for how Abdulla worked his magical clinical inference of specific causation. Sadly, there is no such magic, except in the form of the magic thinking evidenced here by Abdulla, and acquiesced in by Chief Judge Sargus. No biomarker of causal originst distinguishes the Kiker plaintiff’s septal defect from one caused by any other cause, whether or not established by current medical science. Moreover, Abdulla’s magical thinking cannot be swept under the Kumho Tire rug of appropriate level of rigor in the field. The Kiker court cited no evidence that pediatric cardiologists routinely and reliably make the specific causal attribution that Dr. Abdulla made in this case, as a paid, testifying expert witness. The court incredulously accepted Abdulla’s hand waving about the epistemic warrant of experience, education, training that has nothing to do with discerning individual causes.

GSK asked for oral argument, which may have been Chief Judge Sargus’s last clear chance to avoid these errors. Declaring that the record was fully developed, Judge Sargus denied the request for a hearing. Kiker slip op. at 1, 4. We are left with a profoundly flawed misunderstanding of scientific evidence and causal inference.

Posted in Causation, Rule 702, Scientific Evidence | Comments Off on Kiker v. Smithkline Beecham & the Pathology of Judicial Gatekeeping

In Queue for the Q

January 1st, 2017

All right, this has nothing to do with law, evidence, or statistics, but what a great day for New York and the Upper Eastside. Today, the “Second Avenue Line,” an extension of the Q subway line opened for business.

The local radio stations announced that the MTA would give away free subway day passes at 11 a.m., at the new 86^th street station. Even before the hour, a queue formed of locals eager for a free first ride on the Second Avenue line. At 11:15 a.m., Congresswoman Carolyn Mahoney arrived. She did not greet anyone in the queue; rather, she planted herself in front of TV cameras to which she made kissy faces and self-congratulatory noises. Of course, the MTA has little or nothing to do with the federal government, and the rationale for her presence was curiously absent. Mayor DeBlasio, who lives but four blocks away in Gracie Mansion, however could not be bothered to show up. No doubt he was still in bed, and nursing a hang over.

Not only did Mahoney did speak to anyone in the queue, going to the Q, her remarks for the TV and radio media were whispered into microphones. Standing about four feet away from her, I could barely hear a word she said. Surely no one behind me heard her, and she clearly did not care. Mahoney had greater audiences in mind, and no apparent interest in actually interacting with her constituents. Perhaps she was hung over from New Year’s Eve festivities.

With Congresswoman Mahoney were her minions, who started to hand out the coveted free passes, but not to the people who had peacefully assembled and patiently waited in line. Because the TV cameras set up around Mahoney, her minions had to hand out cards close to her and to the cameras so that the TV audiences would see the handouts as Mahoney’s largesse. There was a visually impaired woman at the front of the line, with her guide dog, Kudo, but they were ignored by Mahoney and her aides, as well as by the media. Finally, in a Bonfire of the Vanities moment, as Mahoney started to drift away, a boisterous woman pushed her way in front of the cameras, while exclaiming that she wasn’t being pushy, because, after all, she had bona fide press credentials. So the TV cameras shifted to her, and she, a media person, was then interviewed by the media. Where was Tom Wolfe to capture this wonderful New York moment?

Guide Dog Kudo Leads the Way as First Dog Rides the Second Avenue Line on New Year’s Day, 2017

Finally, at noon, the police tape was unceremoniously pulled away, and the Second Avenue line was opened to the hoi polloi. The subway cars were not new, but were appropriately clean for the occasion. The first downtown train today on the new Second Avenue line left from 86^th Street, amid great fanfare and cheering. When the subway reached 72^nd Street, the conductor held the train for almost 15 minutes due to traffic on the line. Huh? I suspect that the conductor wanted the passengers to have that real MTA experience.

The subway stations at 96^th, 86^th, 72^nd, and 63^rd streets all had that wonderful new subway station smell, almost as good as a new BMW. And each of these four stations has become a wonderful museum of public art, each worth an MTA card for the price of admission. See Muoio, “New York’s long-awaited Second Avenue subway features some incredible artwork” (Dec. 30, 2016). I will leave the exhibits for the art critics to describe, except to say that the 86^th, 72^nd, and 63^rd street stations have become outstanding artistic tributes to New York City and its residents. Thankfully, there was no sign of any likeness of Donald Trump.

A hundred years late, the Second Avenue subway has arrived. It does not go as far as it should, but perhaps Governor Cuomo will take a page out the Robert Moses playbook and use the stub as leverage to get the whole thing done. The Governor seems to have the right stuff to get infrastructure programs completed. If infrastructure were up to Mayor DeBlasio, we would still be waiting for the Second Avenue line along with the resurrection of Robert Moses himself.

Posted in Public Nuisances | Comments Off on In Queue for the Q

Epistemic Nihilism and Ancient Documents

December 28th, 2016

This year, the Judicial Conference Advisory Committee on Evidence Rules proposed abrogation of the current “ancient documents” exception to the rule against hearsay, Rule 803(16). The proposal would, if adopted, become effective on December 1, 2017. See James A. King & Kirsten Fraser, “Say Goodbye to the ‘Ancient Documents’ Rule,” A.B.A. Trial Evidence (Feb. 17, 2016).

Under the Federal Rules of Evidence, an old document, one over 20 years old, found in a place where one would expect to find it is treated as “authentic.” The finder of fact, judge or jury, may accept the document for what it purports to be simply because of its age and the manner of its discovery. Rule 901(b)(8). The Federal Rules, however, go further and permit the document, authenticated as a so-called “ancient document,” to be accepted for the truth of the statements it contains. Rule 803(16).

The rationale offered by the Deans of Evidence Law for this remarkable exception to the rule against hearsay is that old documents predate the legal controversies in which they might later be used in evidence, and that we might not have any other admissible evidence relevant to events in the distant past (greater than twenty years). “[A]ge affords assurance that the writing antedates the present controversy” wrote the Federal Rules of Evidence Advisory Committee. Fed. R. Evid. 803(16) advisory committee note.

Pithy and pathetic. The proffered rationale was not valid when Rule 803(16) was initially drafted or promulgated, and it is not valid today. Old does not suggest or equate with reliability, and the present controversy is not the only source of bias and error in past statements that happened to be put in writing.

First, contrary to the conjecture of the common law, many documents were and are created with a view to influence potential controversies decades later. Mergers, acquisitions, and divestitures of companies are often governed by documents that explicitly acknowledge controversies that could stretch into the distant future.

Second, sometimes the exact motivation to falsify, fabricate, or fudge is not exactly the same as later will exist in later litigation, but it is similar. So when a young patient misrepresents his smoking history to a physician, he may simply be trying to avoid a disapproving lecture from his healthcare provider. Years later when he has developed lung cancer, and he is trying to blame anything but smoking in a lawsuit, he will rely upon the distorted report of his tobacco consumption. Of course, in many other situations, the motive to create misleading documents will arise from the expectation of the possibility or probability of future litigation over intellectual or real property rights, insurance contracts, etc.

Professor Daniel J. Capra of Fordham Law School, for many years the Reporter to the Judicial Conference Advisory Committee on Evidence Rules, has not been shy about the slim to none justification for Rule 803(16). In a podcast interview with Professor Ed Cheng, Capra laid out the case against Rule 803(16), and its evanescent rationale. See Excited Utterance website, Daniel Capra, “Electronically Stored Information and the Ancient Documents Exception” (Aug. 22, 2016). Preliminary Draft of Proposed Amendments to the Federal Rules of Bankruptcy Procedure and the Federal Rules of Evidence (Aug. 2015). Capra had previously deconstructed Rule 803(16) in a law review article, with the usual scholarly apparatus of footnotes and review of historical sources. Daniel J. Capra, “Electronically Stored Information and the Ancient Documents Exception to the Hearsay Rule Exception to the Hearsay Rule: Fix It Before People Find Out About It,” 17 Yale J.L. & Tech. 1 (2015) [cited as Capra].

As Capra puts it, the justification for Rule 803(16) was “never very convincing in the first place,” Capra at 1, 5, and “a radical and irrational hearsay exception – an error of the common law,” Capra at 11. The equating of a document’s authenticity with the trustworthiness of assertions contained within the document is “curious.” Capra at 9. Curiously, Capra balks at complete abrogation.

The law professor may have well said that the rule is capricious. Still, on gossamer grounds, Capra argues to retain the rule for hardcopy old evidence, but to abandon it for electronically stored information. Capra seems to buckle under the prospect of abrogating a rule, which leads him to “split the baby.” As trenchant as Capra’s critique is, most of his defense of retaining the Rule for hardcopy documents is as unsupported as the original Rule 803(16). Capra, for instance, suggests that “the likelihood of finding a hardcopy document that is twenty years old and also relevant to an existing litigation is quite small.” Capra at 5. Capra offers no empirical evidence for this startling assertion. Similarly, Capra claims that Rule 803(16) is rarely invoked, but he cites only to the paucity of cases that discuss this exception. Capra at 12. Capra thus claims negative evidence for the infrequent use, but the failure of judges to discuss this rule in published decisions may well be the result mechanical simplicity of the rule, which rarely leads to post-trial motions and appeals.

The original rational for Rule 803(16), and a rallying cry for its retention, is the supposed necessity to have some evidence to make out the events of times past. The objectors, however, generally fail to make out their case that the residual hearsay rule (Rule 807), as well as the business record and other exceptions, do not accomplish the twin goals of providing some evidence of past events while maintaining some semblance of reliability in fact finding.

The Rule Committee’s proposal has been met with an organized campaign from the lawsuit industry, both through the self-aggrandizingly named American Association for Justice (AAJ) and many of its members.. A rough count suggests that about 82 out of 218 comments came from asbestos plaintiffs’ lawyers. See, e.g., Comment from Robert Jacobs, American Association of Justice; Comment from Larry Tawwater, American Association for Justice (AAJ); Testimony of Marc P. Weingarten; Comment from Robert Paul, NA; Comment from Mark Gallagher, NA; Comment from Joseph Rice, NA.

The lawsuit industry lawyers argue that they will be deprived of the ability to show scienter or knowledge of a risk in latent disease litigation in which disease outcomes are lagged several decades after first exposure. Their argument, however, misses the point that many documents in company files, while not admissible for their truth, will be evidence of “notice” of a potential hazard, and the documents would be admissible for “state of mind,” and not the truth, in any event. Given the changes in epistemic standards for establishing causation, it is unlikely that really ancient documents will move the fact finder any closer to the truth of the actual fact of asserted causation. See “Time to Retire Ancient Documents As Hearsay Exception” (Aug. 23, 2015); “Ancient Truths” (May 5, 2016).

The asbestos plaintiffs’ lawyers thus argue that they would be deprived of important evidence such as the “Sumner Simpson” documents in asbestos cases. See Threadgill v. Armstrong World Indus., Inc., 928 F.2d 1366 (3d Cir. 1991). The plaintiffs’ argument rests upon an epistemic mistake. If knowledge is true, justified belief, then they do not need Rule 803(16) to show that the Sumner Simpson documents contain true statements; it is enough that they show that the authors believed what they said. In other words, the plaintiffs need only show that the documents reflect the declarants’ state of mind. Whether the statements are justified as true will require a complex mixture of current evidence about what health effects can be shown to be caused by the exposures of old, and what justifications were valid in today’s knowledge that were available and embraced by the declarants in the ancient documents.

Insurance coverage plaintiffs’ counsel have argued that they need Rule 803(16) to meet their burden of proof, and that insureds rely on both internal and external records. A policyholder’s internal records might include financial statements, annual reports, meeting minutes, check registers, contracts referencing insurance, insurance policies referencing other insurance policies, and/or accounting ledgers. Comment from Sherilyn Pastor, NA.

Most of the special pleading of these interest groups is wide of the mark. Old statements may be relevant and admissible for the speaker’s or reader’s statement of mind, and thus not hearsay. Old reliable documents can still be admitted under the residual exception, Rule 807, or under the business records exception, 803(6). Statements made in the making of contracts are operative facts of offer and acceptance, “speech acts,” and not offered for their truth.

The fact that a document is old may perhaps add to its authenticity, but in many technical, scientific, and medical contexts, the “ancient” provenance actually makes the content unlikely to be true. As such, the rule as now in effect is capable of much mischief and undermines accurate fact finding. The pace of change of technical and scientific opinion and understanding is too fast to indulge this exception that permits out-dated, false statements of doubtful validity to confuse the finder of fact. With respect to statements or claims to scientific knowledge, the Federal Rules of Evidence have evolved towards a system of evidence-based opinion, and away from naked opinion based upon the apparent authority or prestige of the speaker. Similarly, the age of the speaker or of the document provides no warrant for the truth of the document’s content. Of course, the statements in authenticated ancient documents remain relevant to the declarant’s state of mind, and nothing in the proposed amendment would affect this use of the document. As for the contested truth of the document’s content, there will usually be better, more recent, and sounder scientific evidence to support the ancient document’s statements if those statements are indeed correct. In the unlikely instance that more recent, more exacting evidence is unavailable, and the trustworthiness of the ancient document’s statements can be otherwise established, then the statements would probably be admissible pursuant to other exceptions to the rule against hearsay, as noted by the Committee. The proposed abrogation of this exception to the rule against hearsay should be welcomed; it is long overdue. And if it Capra is correct that ancient hardcopy rarely exists, and that the ancient document rule is rarely invoked, then abrogation cannot have the effect of defeating expectations and reliance upon this dubious mode of proof.

Of course, witnesses who are the declarants in the ancient documents may have died or moved away, but that is precisely why the law generally has statutes of limitations. When the law has generously created discovery rules, it should not then promulgate unreasonable, unreliable rules of evidence simply because it has extended the life on what otherwise would be stale claims.

Posted in Evidence | Comments Off on Epistemic Nihilism and Ancient Documents

Fake Science News

December 17th, 2016

Fakers to the left; fakers to the right. Everyone has his or her knickers in a knot over fake news these days. But who will speak out against fake science news?

Oberle Communications LLC [1] puts out a “Product Safety Letter,” with almost daily emails that link to published articles of interest to lawyers and others who are concerned with product safety. According to its self-description, Product Safety Daily is a “fair-use news-link service,” and its owner claims not to be responsible for the accuracy, or truthfulness, of linked articles.

Sounds like Facebook; no?

The Guardian is British newspaper, with affiliates in the United States and elsewhere, owned by the Guardian Media Group, which in turn is owned by The Scott Trust Limited. The Scott Trust declares that it exists to produce The Guardian, and “to safeguard the journalistic freedom and liberal values of The Guardian free from commercial or political interference.” Lofty goals, those are. Oberle Communications might feel secure in pointing to an article in The Guardian, on product safety. As far as newspapers are concerned, The Guardian enjoys a good reputation, and has won awards for its investigative journalism, most recently on unlawful government surveillance.

Recently, the Product Safety Letter linked to an article by an Assistant Editor of The Guardian on supposed health effects of plastics. Chukwuma Muanya, “How Plastics Cause Autism, Diabetes, Cancer, Birth Defects,” The Guardian (London, England) (Dec. 13, 2016).

The Mr. Muanya’s headline shouts about causation, but there is nothing in the text of the article to support, even remotely, anyone’s conclusion about causality. The text of the article states, without support, that “[r]ecent studies have associated the rise in autism, diabetes, cancer and birth defects to increase in the use of plastics in making everyday containers, toys and baby teethers or pacifiers.” One would think, hope, pray that The Guardian would know the difference between association and causation, but there is no evidence in this article to support an imputation of knowledge or understanding.

A photograph of baby bottles contains a caption that ramps up the Guardian’s rhetoric and propaganda:

“KILLER PLASTICS… The invisible chemical cause neurological and behavioral disorders like autism and attention deficit and hyperactivity disorder (ADHD). They also affect IQ. And they manipulate hormones in a way that can cause cancer, diabetes, male infertility, and endometriosis. PHOTO CREDIT: http://www.viewzone.com/plastic-header.jpg”

Wow. These plastics are bad-ass actors. They manipulate; they cause; they kill.

From causation, to association, the author moves to the most abused journalese term in science reportage: “link”:

“the presence of toxins commonly found in plastic that have been linked to increased risk of cancer, heart disease and obesity.”

Mr. Muanya references, without link, citation, or mention of authors, a study by the American Chemical Society, which apparently reported that infants’ pacifiers contained Bisphenol A (BPA), Bisphenol S (BPS) or Bisephenol F (BPF), and that many also contained parabens, and antimicrobials such as triclosan and triclocarban. But the Society’s paper was about chemical content, not about health consequences. Without any reference or citation to published or unpublished studies, Mr. Muanya labels BPA, BPS, and BPF as “so-called endocrine-disrupting chemicals,” and tells us these chemicals “manipulate hormones in a way that can cause cancer, diabetes, male infertility, and endometriosis,” and that these chemicals “cause neurological and behavioral disorders like autism and ADHD,” and that they “also affect IQ.”

Apropos of nothing having to do with endocrine disrupters, or human disease, Mr. Muanya inserts a discussion of a Japanese study, reportedly published at the PLoS (but without providing link or citation) about how older male mice have offspring that exhibited “hyperlocomotion.” Still, Mr. Muanya, who has been billed as “Head Insight Team, Science & Technology,” does show that journalists can provide, when it suits them, actual references at least to authors by name. Nothing in the mouse study, however, explains the hypocognition exhibited by the Guardian’s science editor, or the shoddy journalistic practices.

So here we have a respected newspaper publishing a news story that at best is internally inconsistent and un-sourced, and which grossly misinterprets or overinterprets the available scientific evidence. Behold fake science news.

[1] 4915 St Elmo Ave, #204, Bethesda, MD 20814; Phone: (301) 215-9236.

Posted in Scientific Evidence | Comments Off on Fake Science News

Statistical Analysis Requires an Expert Witness with Statistical Expertise

November 13th, 2016

Christina K. Connearne sued her employer, Main Line Hospitals, for age discrimination. Main Line charged Connearne with fabricating medical records, but Connearne replied that the charge was merely a pretext. Connearney v. Main Line Hospitals, Inc., Civ. Action No. 15-02730, 2016 WL 6569292 (E.D. Pa. Nov. 4, 2016) [cited as Connearney]. Connearne’s legal counsel engaged Christopher Wright, an expert witness on “human resources,” for a variety of opinions, most of which were not relevant to the action. Alas, for Ms. Connearne, the few relevant opinions proffered by Wright were unreliable. On a Rule 702 motion, Judge Pappert excluded Wright from testifying at trial.

Although not a statistician, Wright sought to offer his statistical analysis in support of the age discrimination claim. Connearney at *4. According to Judge Pappert’s opinion, Wright had taken just two classes in statistics, but perhaps His Honor meant two courses. (Wright Dep., at 10:3–4.) If the latter, then Wright had more statistical training than most physicians who are often permitted to give bogus statistical opinions in health effects litigation. In 2015, the Medical College Admission Test apparently started to include some very basic questions on statistical concepts. Some medical schools now require an undergraduate course in statistics. See Harvard Medical School Requirements for Admission (2016). Most medical schools, however, still do not require statistical training for their entering students. See Veritas Prep, “How to Select Undergraduate Premed Coursework” (Dec. 5, 2011); “Georgetown College Course Requirements for Medical School” (2016).

Regardless of formal training, or lack thereof, Christopher Wright demonstrated a profound ignorance of, and disregard for, statistical concepts. (Wright Dep., at 10:15–12:10; 28:6–14.) Wright was shown to be the wrong expert witness for the job by his inability to define statistical significance. When asked what he understood to be a “statistically significant sample,” Wright gave a meaningless, incoherent answer:

“I think it depends on the environment that you’re analyzing. If you look at things like political polls, you and I wouldn’t necessarily say that serving [sic] 1 percent of a population is a statistically significant sample, yet it is the methodology that’s used in the political polls. In the HR field, you tend to not limit yourself to statistical sampling because you then would miss outliers. So, most HR statistical work tends to be let’s look at the entire population of whatever it is we’re looking at and go from there.”

Connearney at *5 (Wright Dep., at 10:15–11:7). When questioned again, more specifically on the meaning of statistical significance, Wright demonstrated his complete ignorance of the subject:

“Q: And do you recall the testimony it’s generally around 85 to 90 employees at any given time, the ER [emergency room]?

A: I don’t recall that specific number, no.

Q: And four employees out of 85 or 90 is about what, 5 or 6 percent?

A: I’m agreeing with your math, yes.

Q: Is that a statistically significant sample?

A: In the HR [human resources] field it sure is, yes.

Q: Based on what?

A: Well, if one employee had been hit, physically struck, by their boss, that’s less than 5 percent. That’s statistically significant.”

Connearney at *5 n.5 (Wright Dep., at 28:6–14)

In support of his opinion about “disparate treatment,” Wright’s report contained nothing than a naked comparison of two raw percentages and a causal conclusion, without any statistical analysis. Even for this simplistic comparison of rates, Wright failed to explain how he obtained the percentages in a way that permitted the parties and the trial court to understand his computation and his comparisons. Without a statistical analysis, the trial court concluded that Wright had failed to show that the disparity in termination rates among younger and older employees was not likely consistent with random chance. See also Moultrie v. Martin, 690 F. 2d 1078 (4th Cir. 1982) (rejecting writ of habeas corpus when petitioner failed to support claim of grand jury race discrimination with anything other than the numbers of white and black grand jurors).

Although Wright gave the wrong definition of statistical significance, the trial court relied upon judges of the Third Circuit who also did not get the definition quite right. The trial court cited a 2010 case in the Circuit, which conflated substantive and statistical significance and then gave a questionable definition of statistical significance:

“The Supreme Court has not provided any definitive guidance about when statistical evidence is sufficiently substantial, but a leading treatise notes that ‘[t]he most widely used means of showing that an observed disparity in outcomes is sufficiently substantial to satisfy the plaintiff’s burden of proving adverse impact is to show that the disparity is sufficiently large that it is highly unlikely to have occurred at random.’ This is typically done by the use of tests of statistical significance, which determine the probability of the observed disparity obtaining by chance.”

See Connearney at *6 & n.7, citing and quoting from Stagi v. National RR Passenger Corp., 391 Fed. Appx. 133, 137 (3d Cir. 2010) (emphasis added) (internal citation omitted). Ultimately, however, this was all harmless error on the way to the right result.

Posted in Rule 702, statistical evidence | Comments Off on Statistical Analysis Requires an Expert Witness with Statistical Expertise

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