TORTINI

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

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. SeeRFK, 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. Seehttps://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).

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.

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 86th 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 86th Street, amid great fanfare and cheering. When the subway reached 72nd 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 96th, 86th, 72nd, and 63rd 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 86th, 72nd, and 63rd 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.

More Ancient Document Epistemic Nihilism

December 30th, 2016

Man-Bats and Woman-Bats have populated the moon. It’s a fact.

Man- and Woman-bats playing at a lunar resort in 1835

As Daniel Capra has pointed out, newspapers can qualify for ancient documents and an exception to the rule against hearsay. 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). Newspaper articles older than 20 years, found in a place where you would expect them, such as the library or an on-line archive, are admissible for their truth. Ammons v. Dade City, Florida, 594 F. Supp. 1274, 1280 & n.8 (M.D. Fla. 1984) (citing pre-Federal Rules of Evidence case, Dallas County v. Commercial Union Insurance Co.,286 F.2d 388 (5th Cir.1961) (upholding admissibility of 58 year old newspaper articles to illustrate the scope of the ancient doctrine exception), and post-Rule cases, Bell v. Combined Registry Co.,397 F. Supp. 1241, 1246, 1247 (N.D.Ill. 1975) aff’d 536 F.2d 164 (7th Cir. 1976) (admitting newspaper articles into evidence under Federal Rule of Evidence 803(16)).

In August 1835, The New York Sun ran a series of six articles that announced and described the discovery of interesting life forms on the moon, including unicorns, two-legged beavers, and most important man-bats. Also women-bats; all frolicking among giant crystals, flowing rivers, and lush vegetation. See Andrew Grant, “Great Astronomical Discoveries Lately Made by Sir John Herschel, L.L.D, F.R.S, &c. at The Cape of Good Hope. [From Supplement to the Edinburgh Journal of Science] New York Sun (August 1835). 

Dr. Grant was described as a colleague of the then famous astronomer Sir John Herschel, but alas, the author noted by the Sun never existed. And the Edinburgh Journal of Science had long been defunct well before 1835, when the articles ran in the Sun. The articles are often attributed to a Cambridge-educated journalist, Richard Adams Locke. Locke supposedly was satirizing a popular religious writer, Reverend [sic] Thomas Dick, whose books described extraterrestrial life, including billions of inhabitants on the moon. Of course, clerics are used to making things up or accepting ancient documents as Gospel truth.

Today the incident is known as the Great Moon Hoax, which shows that fake news has been with us for a long time, perhaps forever. Matthew Goodman, The Sun and the Moon: The Remarkable True Account of Hoaxers, Showmen, Dueling Journalists, and Lunar Man-Bats in Nineteenth-Century (2008)

You may wonder whether the newspaper articles, found in places where you would expect them, could count as evidence in a courtroom today for man-bats. And woman-bats. The Sun has never retracted its series on Man-Bats, and the paper is now defunct.  There is no one alive today who had the opportunity to observe the lunar surface through a high-power telescope in the 1830s. Perhaps the opponent of this evidence could call an expert witness on hoaxes to offer an opinion that the series of articles were, in his opinion, a fabrication. Of course, many hoaxes persist. Maybe we should do away with a federal rule that would give life to these fantastic creatures.

Man-bat with lunar volcano in background circa 1835

The opinions, statements, and asseverations expressed on Tortini are my own, or those of invited guests, and these writings do not necessarily represent the views of clients, friends, or family, even when supported by good and sufficient reason.