Schachtman Law

TORTINI

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

Union of Concerned Scientists on Criticism and Personal Attacks on Scientists

October 12th, 2012

The Union of Concerned Scientists (UCS) has produced a glossy pamphlet with a checklist of how scientists may respond to criticism and personal attacks. See UCS – Science in an Age of Scrutiny: How Scientists Can Respond to Criticism and Personal Attacks (2012).

The rationale for this publication is described at the UCS website. The UCS notes that scientists are under a great deal of scrutiny, and “attack,” especially when their research is at the center of contentious debate over public policy. According to the UCS, scientists are “sometimes attacked by individuals who do not like the research results. These attacks can take multiple forms—emails, newspaper op-eds, blogs, open-records requests, even subpoenas—but the goals are the same: to discredit the research by discrediting the researcher.

I am all for protecting scientists and researchers from personal attacks. The UCS account, however, seems a bit narcissistic. The UCS is making an ad hominem attack on the putative attackers for what they claim is an ad hominem attack on the researchers. What if the so-called attackers don’t care a bit about discrediting the researchers, but only the research?

The “even subpoenas” got my attention. Subpoenas have been propounded for good reason, and with good effect, on litigation-related research. See, e.g., In re Welding Fume Prods. Liab. Litig., MDL 1535, 2005 WL 5417815 (N.D. Ohio Aug. 8, 2005) (upholding defendants’ subpoena for documents and things from Dr. Racette author of study on welding and parkinsonism). The UCS has thus attacked motives of lawyers charged with protecting their clients from dubious scientific research; I suppose we could return the epithet and declare that the UCS goal is to discredit the process of compelling data sharing by discrediting the motives of the persons seeking data sharing.

Subpoenas served upon independent researchers, whose work bears on the issues in litigation, are a valid part of the litigation discovery process. Litigants, especially defendants who are involuntarily before a tribunal by compulsory process, are entitled to “every man’s evidence.”

The Union of Concerned Scientists seem either unduly sensitive or cavalier and careless in their generalization about the goals of lawyers who propound subpoenas. The goal is typically not to discredit the researcher. The personality, reputation, and position of the researcher are irrelevant; it’s about the data.

The Federal Judicial Center’s Manual for Complex Litigation describes subpoenas for researchers’ underlying data and materials at some length. See Fed. Jud. Center, Manual for Complex Litigation § 22.87 (4th ed. 2004). The Manual acknowledges that the federal courts have protected unpublished research from discovery, but that courts permit discovery of underlying data and materials from studies that have been published. Federal Rule of Civil Procedure 45(c)(3)(B)(ii) allows courts to enforce subpoenas against non-parties, on a showing of “substantial need for the testimony that cannot be otherwise met without undue hardship,” and on assurance that the subpoenaed third parties “will be reasonably compensated.” Manual at 444-45. The federal courts have recognized that litigants’ need to obtain, examine, and re-analyze data underlying research studies used to by their adversaries against them. Although the researchers have interests that should be protected in the discovery process, such as their claims “for protection of confidentiality, intellectual property rights, research privilege, and the integrity of the research,” these claims must be balanced against the necessity of the evidence in the litigation process. Id.

Of course, when the research is sponsored by litigants, whether by financial assistance or by assisting in recruiting study participants, and is completed, “courts generally require production of all data; for pending studies, courts often require disclosure of the written protocol, the statistical plan, sample data entry forms, and a specific description of the progress of the study until it is completed. Id.

Some have argued that the scientific enterprise should be immune from the rough and tumble of legal discovery because its essential collaborative nature is threatened by the adversarial interests at play in litigation. Professor George Olah, in accepting his Nobel Prize in Chemistry, rebutted this sentiment:

“Intensive, critical studies of a controversial topic always help to eliminate the possibility of any errors. One of my favorite quotation is that by George von Bekessy (Nobel Prize in Medicine, 1961).

‘[One] way of dealing with errors is to have friends who are willing to spend the time necessary to carry out a critical examination of the experimental design beforehand and the results after the experiments have been completed. An even better way is to have an enemy. An enemy is willing to devote a vast amount of time and brain power to ferreting out errors both large and small, and this without any compensation. The trouble is that really capable enemies are scarce; most of them are only ordinary. Another trouble with enemies is that they sometimes develop into friends and lose a good deal of their zeal. It was in this way the writer lost his three best enemies. Everyone, not just scientists, need a few good enemies!’”

George A. Olah, “My Search for Carbocations and Their Role in Chemistry,” Nobel Lecture (Dec. 8, 1994), quoting George von Békésy, Experiments in Hearing 8 (N.Y. 1960). The UCS should rejoice for its intellectual enemies. “Out of life’s school of war: What does not destroy me, makes me stronger.” Friedrich Nietzsche, The Twilight of the Idols Maxim 8 (1899).

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Summary Judgment in Gushue – Attempted Differential Diagnosis for Idiopathic Diseases Rebuffed

October 10th, 2012

Parkinson’s disease (PD) in young women is a rare disease. Exposure to manganese fumes from a pottery kiln is a rare disease. Plaintiff Kathleen Gushue, with the help of her expert witnesses, Drs. Paul Nausieda and Elan Louis, argued that the coincidence of both rare exposure and rare outcome must be probative of a causal relationship between the two. Supreme Court Justice Jeffrey K. Oing, realizing that one in million happens eight times a day here in New York City, excluded the proffered testimony of Drs. Nausieda and Louis, and granted defendants summary judgment. Gushue v. Estate of Norman Levy, et al., Supreme Court of New York, New York County, Index No.: 106645/05, Decision & Order (Sept. 28, 2012).

Manganese in very high doses can cause a parkinsonism, but Justice Oing avoided the semantic traps set for him by the plaintiff. Just because PD requires parkinsonism does not mean that manganese-induced parkinsonism can be equated with PD. A dog is a carnivorous mammal, with fur, four legs, and a tail. So is a cat, but a dog is not a cat. Similarly, PD and the specific features of manganese-induced parkinsonism are different. See Agency for Toxic Substances and Disease Registry, Draft Toxicological Profile for Manganese 16 (Draft 2008) (“While manganese neurotoxicity has clinical similarities to Parkinson’s disease, it can be clinically distinguished from Parkinson’s.”); id. at 66-67 (“Manganism and Parkinson’s disease also differ pathologically. * * * It is likely that the terms Parkinson-like-disease and manganese-induced-Parkinsonism will continue to be used by those less knowledgeable about the significant differences between the two.”).

Plaintiff and her expert witnesses also attempted the differential diagnosis ploy, but Justice Oing followed prior New York law that requires a claimant, who is alleging toxic cause, to “reliably rule out reasonable alternative causes of [the alleged harm) or idiopathic causes.” Id., citing Barbaro v Eastman Kodak Co., 26 Misc. 3d 1124 (A) (Sup. Ct., Nassau Cty. 2010) .

Logically and legally, plaintiff could not rule out idiopathic causes that are responsible for the great majority of PD cases. Parkinson’s disease has no known causes other than a few uncommon genetic variants. See John Hardy, “No Definitive Evidence for a Role for the Environment in the Etiology of Parkinson’s Disease,” 21 Movement Disorders 1790 (2006). See also J. Mortimer, A. Borenstein, and L. Nelson, “Associations of welding and manganese exposure with Parkinson disease: Review and meta-analysis,” 79 Neurology 1174 (2012) (reporting a statistically significant decreased risk of Parkinson’s disease among welding tradesmen).

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American Taliban and the Attack on Science

October 9th, 2012

Mostly I care about whether governmental policy is based upon facts, but discerning the facts requires intelligence. In some areas of human endeavor, it involves something we call science. Generally smart people are better at doing science than stupid people, but there may be the occasional idiot savant.

Political pundits focus on the dualism of America – rich and poor, but this is not the important divide. The crucial distinction is between the smart and the stupid.

Rick Santorum says that smart people have no place in the Republican party. Colleges and universities are the adversaries of the stupid. Stupid people are the base. See Kristen A. Lee, “Santorum complains to social conservatives about ‘smart people’” (Sept. 17, 2012). Santorum accuses President Obama of being a snob: “he wants everybody in America to go to college.” Santorum later backed away from his “What a snob,” remark, when he acknowledged that his comment was “probably not the smartest thing.” Of course, Santorum was really complimenting himself, and reaffirming his core values.

Shifting gears, just slightly.

Science flourished in the Islamic world until it didn’t. Most historians appear to accept that the rise of clerics and superstition killed a rich tradition of science in Islam, about the same time that the Reformation and other social changes in Europe allowed science to emerge from the shadows of the Church. The American Taliban would have us align ourselves with the current Islamic hostility to science.

Who are the American Taliban?

Meet Congressman Paul Broun. Broun serves on the House Science Committee. According to Wikipedia, the font of all knowledge, Broun has a bachelor’s degree in chemistry from the University of Georgia, and an M.D. degree from the Medical College of Georgia in Augusta. Broun calls himself a scientist.

Last month, at a church-sponsored event in Georgia, Broun declared that “all that stuff I was taught about evolution and embryology and the Big Bang theory” are “lies straight from the pit of hell.” And these lies are no casual fibs; according to Broun, the lies are part of a conspiracy to “to try to keep me and all the folks who were taught that from understanding that they need a savior.” And Broun really needs a savior.

Broun is also an accomplished geologist:

“You see, there are a lot of scientific data that I’ve found out as a scientist that actually show that this is really a young Earth. I don’t believe that the earth’s but about 9,000 years old. I believe it was created in six days as we know them. That’s what the Bible says.”

Broun made his comments to constituents at the Sportsman’s Banquet at Liberty Baptist Church in Hartwell, Georgia. In keeping with the Sportsman theme, members of the Bridge Project having been bird dogging Broun. Instead of shooting big game; they shot video of Broun’s speech, which they proudly distributed by YouTube, which of course is their right for now.

The House Science Committee apparently has become a safe haven for the American Taliban. Fellow scientist and Congressman, Todd Akin, also serves on the Committee. Akin gained fame for his definitive study, which showed that women who experience “legitimate rape” cannot become pregnant because their tubes shut down.

Not all bad science is practiced in the courts.

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Unraveling the “Master Historical Narrative” of Asbestos

October 6th, 2012

Sheila Scheuerman at the TortsProf Blog has posted a note about a forthcoming article by Rachel Maines, of the Cornell School of Electrical and Computer Engineering, entitled “The Asbestos Litigation Master Narrative: Building Codes, Engineering Standards, and ‘Retroactive Inculpation’.” The article was published “in press,” in August, and is slated to appear in an upcoming issue of Enterprise & Society.

Prof. Scheuerman has kindly provided a link to the in-press version of Professor Maines’ article: Download Maines Asbestos Litigation Master Narrative 2012. Several years ago, Professor Maines published a book that challenged the asbestos dogmas created in the occupational health community, and by plaintiffs’ counsel and their expert witnesses. R. Maines, Asbestos and Fire: Technological Trade-offs and the Body at Risk (Rutgers Univ. Press 2005). In her forthcoming article, Maines extends the thesis of her book, to explore how plaintiffs’ counsel conspired with their expert witnesses, such as Barry Castleman, to create what she calls “The Asbestos Litigation Master Narrative,” which involves the “retroactive inculpation” of industry for manufacturing asbestos-containing products. Her article explores how building codes, engineering standards, and federal regulations specified the use of asbestos in various products, for health and safety reasons. These codes, standards, and regulations represent a broad and deep consensus that asbestos could and should be used safely because of its important physical properties.

Maines notes that her search of LexisNexis revealed only two asbestos cases in which courts referenced building codes as standards that weighed against the plaintiffs’ constructed narrative of conspiracy tales and supposedly established historical knowledge of asbestos hazards. She seems to imply that defense counsel have not done enough to put the legal and regulatory insistence upon asbestos use before courts and juries, which must employ the retrospectoscope to assess past knowledge and exercise of due care.

While Maines presents a valuable and engaging counter-narrative, with careful historical scholarship, her implied criticism of the defense bar is unwarranted. In several key states (NJ and PA), where many asbestos cases have been tried, a combination of hyper-strict liability and trial bifurcation has kept juries from hearing the kind of evidence that Maines outlines. For many years, reverse bifurcation was mandated in Philadelphia County Court of Common Pleas. Causation and damages were litigated in the first phase of trial; liability in the second. Plaintiffs’ counsel sometimes played an ancient videotaped deposition of Dr. Katherine Sturgis, and the defense often did not respond, perhaps because Dr. Sturgis was so lackluster, and because most juries had a hard time in any event finding for the defense after they committed to a causation and damages verdict.

There were notable exceptions. One judge who took cases from the Mass Tort Program was the Hon. Levan Gordon, who resisted the MTP prescription for reverse bifurcation, and who tried cases “all issues.” In one case Tom Hanna and I tried against now Judge Sandy Byrd, back in May 1989, O’Donnell v. The Celotex Corp., Phila. Cty. Ct.C.P., July 1982 Term, Case. No. 1619, Judge Gordon followed his practice of trying cases all-issues, and I was thus able to put on a “state-of-the-art” defense, along with evidence of U.S. Navy military specifications for asbestos in insulation products. The plaintiffs’ product identification witness, Mr. George Rabuck, unexpectedly cooperated by offering a story of a shake-down cruise of a Navy vessel, in which the insulators had not covered a stretch of steam pipe with insulation. When a nearby oil valve broke, spraying oil onto the uninsulated pipe, a fire erupted, and two sailors died before it could be extinguish. I was able to have Mr. Rabuck agree that a fire on a ship was a terrible thing, and in my closing argument, I was able to paint the picture of the two dead sailors who taken off the ship in body bags because someone forgot to use asbestos. I felt that the risk-utility balance had been restored. Perhaps the jury did as well; they returned a general verdict for the defense.

I tell the war story, not only because it was one of my favorite trials, but also because the defense used evidence of governmental insistence upon procurement and use of asbestos-containing insulation. I am confident that many other defense lawyers have used similar mil-spec evidence as well, along with evidence of the U.S. government’s very deep knowledge of the potential hazards of asbestos.

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Sand in My Shoes

October 4th, 2012

Sharon L. Caffrey, Kenneth M. Argentieri and Julie S. Greenberg, of Duane Morris LLP, have written a piece for Law360, in which they suggest that the recent violations of the OSHA silica permissible exposure limit (PEL) by the fracking industry may lead to new silicosis claims. “Another Wave Of Silicosis Claims May Be On The Horizon” (Oct. 3, 2012)

Silicosis has been a preventable disorder for over half a century. There will, however, always be silicosis cases because there will always be people who do not follow basic industrial hygiene principles. Negligent employers will overexpose their workers. Negligent workers will ignore workplace safety rules.

But silicosis cases do not translate into valid claims. The essence of silicosis products liability claims is a failure to warn, and there is no basis in this millennium (and for the last few decades of the last millennium) for maintaining failure-to-warn claim against silica sand suppliers.

Caffrey and colleagues discuss the fraudulent claiming activity that resulted in Judge Jacks’ rebuke to the tort litigation industry in MDL 1553. In re Silica Products Liab. Lit., 398 F. Supp. 2d 563 (S.D. Tex. 2005). Judge Jack’s excellent gatekeeping and her opinion on litigation-sponsored medical screenings helped suppress an outbreak of silicosis litigation, but Her Honor actually worried that the bogus cases would obscure the real cases. There are, however, no real cases of failure to warn in the context of silicosis claims. In 1949, the U. S. Supreme Court, following the lead of the New York Court of Appeals, declared it to be a matter of common knowledge that breathing silica dust “is injurious to the lungs and dangerous to health,” a fact the plaintiff’s employer “was bound to know.” Urie v. Thomas, 337 U.S. 163, 180 (1949), citing Sadowski v. Long Island R.R., 292 N.Y. 448, 456 (1944). Selling sand no more requires a warning than selling a set of kitchen knives.

Today, warnings in connection with bulk sales of silica should be nothing more than regulatory and litigation eye candy – supererogatory acts intended to ward off plaintiffs’ lawyers. For the last two decades, the warnings have been frequent, intense, detailed, and lengthy. Material Safety Data Sheets are often 10 to 15 pages long. The silica exposures above PEL in the fracking industry, reported recent by NIOSH, took place at worksites managed by Halliburton, Schlumberger, Baker Hughes, and similar companies. These companies have the knowledge and resources to provide a safe workplace. They have had common law duties to control silica exposures for over a century. Most states introduced regulations that mandated limits in silica exposure by the 1950s. Government contractors had similar duties under the Walsh-Healey Act, and virtually all employers have been under a federal mandate to provide a safe workplace for the use of silica sand, since the effective date of the federal Occupational Health & Safety Act of 1970.

Caffrey and colleagues correctly note that OSHA has issued a Hazard Alert about exposures above the Permissible Exposure Limit in the fracking industry. OSHA Hazard Alert for Crystalline Silica Exposures from Shale Gas Fracturing (June 22, 2012). The lawyers’ discussion of the claim proliferation in MDL 1553 suggests that they were thinking of civil actions against suppliers. There may be claims in the future, but the only legitimate claims will be workman’s compensation claims. The recommendations made should help employers protect their employees from silicosis; better yet, the employers could just follow the law that has been in place for over 40 years.

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Hop on Pop Redux – Watson Case

October 3rd, 2012

Last month, Maxwell Kennerly of the Beasley Firm in Philadelphia posted about the Watson case in his blog. See Max Kennerly, “The Science And Law Behind The $7 Million Microwave Popcorn Lung Jury Verdict” (Sept. 20, 2012). This case has attracted a lot of attention, as it well should. See “It’s Alimentary, My Dear Watson” (Sept. 20, 2012); and “Good’s Expert Witness Opinion Not Good Enough in Tenth Circuit” (Sept. 8, 2012).

Kennerly is correct that we should not lump the Watson case with other frivolous cases, such as the infamous McDonald’s hot-coffee spill case. I suppose people can debate whether McDonald’s sold their coffee at too-high a temperature, but most civilized people can agree that McDonald’s makes bad coffee, and that everyone should be careful what they put between their legs, regardless of temperature.

Watson represents a paradigmatic tort case, involving exposure and diagnostic issues common to many toxic tort cases. Mr. Watson was a mega-consumer of microwavable popcorn, flavored with diacetyl. We can assume for discussion that diacetyl can cause bronchiolitis obliterans in factory workers who are exposed at relatively high levels. There are, however, other causes, as well as idiopathic cases. Two uncertainties overlapped in the Watson case: diagnosis and exposure assessment. A treating physician pondered a differential diagnosis between hypersensitivity pneumonitis (HP) and bronchiolitis obliterans (BO). As a carpet cleaner, Watson had occupational exposures that might well have caused HP. Indeed, in August 2006, an open lung biopsy requested by his treating physicians, by pathologists at University Hospital, at the University of Colorado, interpreted Watson’s lung pathology as HP. In 2010, Professor Eugene Mark, a well-known pulmonary pathologist at Harvard Medical School, interpreted the pathology as “in keeping with hypersensitivity pneumonitis.” Although Dr. Mark was consulting for the defense in this case, he is not a frequent testifier, and his few forays have been almost always for plaintiffs in asbestos cancer cases. To my understanding, none of the pathologists testified at the trial.

Despite the pathology report, Watson’s treating physician, Dr. Cecile Rose, advocated that the correct diagnosis was BO. She wrote a letter to NIOSH, and other federal agencies, in which advanced her diagnosis, although she did not mention the hospital pathology. Regulators and lawyers became involved. NIOSH measurements of diacetyl in Watson’s home were below the level of detection. Another set of diacetyl measurements taken by Watson’s legal team reported levels close to that of the industrial workers who sustained BO from workplace exposure to diacetyl. The plaintiffs’ expert witnesses relied upon these measurements suggesting high exposure. Just before trial, the defense renewed its Rule 702 motion, challenging the plaintiffs’ exposure level evidence. The defendant’s motion sought preclusion of the plaintiffs’ expert witnesses’ reliance upon data generated by an Innova Model 1312 Photoacoustic Multi-Gas Monitor. The court denied this motion, with leave to raise it at trial, and also precluded mention of the testing in front of the jury until the evidentiary matter is resolved. Order of June 22, 2012. I do not know how the court handled this important evidentiary issue at trial, and no analysis of the case is possible until this part of the story is told.

What can be said now, hypothetically, is that if the plaintiffs had no reliable evidence of high exposure, there was precious little in the exposure data to support Watson’s treating physician’s argument for BO, over HP. The treating clinician did not settle on the BO diagnosis until she had the dubious exposure data. The pathology reports consistently favored the HP diagnosis.

Watson is the third consumer diacetyl case litigated to date. The Newkirk case resulted in the 702 exclusion of plaintiffs’ expert witness, Dr. Egilman. Newkirk v. ConAgra Foods, Inc., 727 F. Supp. 2d 1006 (E.D.Wash. 2010), aff’d, 438 Fed.Appx. 607 (9th Cir. 2011). See also Egilman v. ConAgra Foods, Inc., No. 10-35667, U.S. Court of Appeals for the Ninth Circuit (Sept. 5, 2012; unpublished memorandum) (refusing personal appeal of expert witness who claimed defamation and “wrongful exclusion” by district court). A second case was tried to a jury verdict for the defense, and the appellate court upheld the judgment for the defense. Khoury v. Conagra Foods, Inc., 368 S.W.3d 189 (Mo. Ct. App. 2012).

Kennerly argues that Watson had proof! Referring to “evidence” as “proof” is a hyperbolic conceit of lawyers; I am sure have used the expression, as well. Outside the legal world, proofs and demonstrations are the work of geometers and mathematicians; factual propositions are usually more modestly shown or suggested by evidence. The “proof” that Kennerly cites is the testimony of Watson’s treating physician, Dr. Cecile Rose, MD, MPH, “a published expert and researcher of occupational pulmonary diseases,” who testified that the basis for her opinion:

“relates mainly to the fact that his lung disease has stabilized with the cessation of use of the product and exposure to the inhalants related with that product. The fact that there was no other causal explanation for his lung condition and the fact that the clinical findings in his lung disease were similar to those that occurred in workers who were exposed to butter flavoring also support that opinion.”

This is the same Dr. Rose who wrote to several federal regulatory agencies, to present a tendentiously abridged clinical case report of a patient with BO, who consumed thousands of bags of microwave diacetyl-flavored popcorn. Even with the serious omissions of information, and the problematic exposure measurements, Dr. Rose hedged in her attribution:

“It is difficult to make a causal connection based on a single case report. We cannot be sure that this patient’s exposure to butter flavored microwave popcorn from daily heavy preparation has caused his lung disease. However, we have no other plausible explanation. Given the public health implications of this possibility, we wanted to alert you to our concerns.”

To be sure, this is nothing like the McDonald’s coffee-spill case. This is a case of questioned and questionable science. Kennerly is correct; there is nothing frivolous about the Watson case. If the diagnosis were correct, and the exposure measurements were accurate, this case would raise very serious public concerns for consumer exposure to diacetyl. If the antecedents of the BO diagnosis are incorrect, then the judicial system has been snookered, again. The view from over 2,600 kilometers away suggests that the antecedent conditions were unlikely.

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Siracusano Dicta Infects Daubert Decisions

September 22nd, 2012

Gatekeeping is sometimes intellectually challenging, but the challenge does not excuse sloppy thinking. Understandably, judges will sometimes misunderstand the relevant science. The process, however, allows the public and the scientific community to see what is happening in court cases, rather than allowing the critical scientific reasoning to be hidden in the black box of jury determinations. This transparency can and should invite criticism, commentary, corrections, and consensus, when possible.

Bad legal reasoning is much harder to excuse. The Supreme Court, in Matrixx Initiatives, Inc. v. Siracusano, 131 S. Ct. 1309 (2011), unanimously affirmed the reversal of a trial court’s Rule 12(b)(6) dismissal of a securities fraud class action. The corporate defendant objected that the plaintiffs failed to plead statistical significance in alleging causation between Zicam and the loss of the sense of smell. The Supreme Court, however, made clear that causation was not required to make out a claim of securities fraud. It was, and would be, sufficient for the company’s product to have raised sufficient regulatory concerns, which in turn would bring regulatory scrutiny and action that would affect the product’s marketability.

The Supreme Court could have disposed of the essential issue in a two page per curiam opinion. Instead the Court issued an opinion signed by Justice Sotomayor, who waxed carelessly about causation and statistical significance, which discussion was not necessary to the holding. Not only was Justice Sotomayor’s discussion obiter dicta, but the dicta were demonstrably incorrect. Matrixx Unloaded (Mar. 29, 2011).

The errant dicta in Siracusano has already led one MDL court astray:

“While the defendant repeatedly harps on the importance of statistically significant data, the United States Supreme Court recently stated that ‘[a] lack of statistically significant data does not mean that medical experts have no reliable basis for inferring a causal link between a drug and adverse events …. medical experts rely on other evidence to establish an inference of causation.’ Matrixx Initiatives, Inc. v. Siracsano, 131 S.Ct. 1309, 1319 (2011).”

Memorandum Opinion and Order at 22, In re Chantix (Varenicline) Products Liability Litigation, MDL No. 2092, Case 2:09-cv-02039-IPJ Document 642 (N.D. Ala. Aug. 21, 2012)[hereafter cited as Chantix]. See Open Admissions for Expert Witnesses in Chantix Litigation.

It was only a matter of time before the Supreme Court’s dictum would be put to this predictably erroneous interpretation. See “The Matrixx Oversold” (April 4, 2011). Within two weeks, the error in Chantix propagated itself in another MDL case, with another trial court succumbing to the misleading dicta in Justice Sotomayor’s opinion. See Memorandum in Support of Separate Pretrial Order No. 8933, Cheek v. Wyeth Pharm. Inc. (E.D.Pa. Aug. 30, 2012)(Bartle, J.).

In Cheek, Judge Harvey Bartle rejected a Rule 702 challenge to plaintiffs’ expert witness’s opinion. I confess that I do not know enough about the expert witness’s opinion or the challenge to assess Judge Bartle’s conclusion. Judge Bartle, however, invoked the Matrixx decision for the dubious proposition that:

“Daubert does not require that an expert opinion regarding causation be based on statistical evidence in order to be reliable. Matrixx Initiatives, Inc. v. Siracusano, 131 S. Ct. 1309, 1319 (2011). In fact, many courts have recognized that medical professionals often base their opinions on data other than statistical evidence from controlled clinical trials or epidemiological studies. Id. at 1320.”

Cheek at 16. The Cheek decision is a welter of non-sequiturs. The fact that in some instances statistical evidence is not necessary is hardly a warrant to excuse the lack of statistical evidence in every case. The truly disturbing gaps in reasoning, however, are not scientific, but legal. Siracusano was not a “Daubert” opinion; and Siracusano does not, and cannot, support the refusal to inquire whether statistical evidence was necessary in a causation opinion, in main part because causation was not at issue in Siracusano.

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It’s Alimentary, My Dear Watson

September 20th, 2012

Mr. Watson, who claimed to have consumed thousands of bags of popcorn with diacetyl, sued for bronciolitis obliterans allegedly caused by the diacetyl.

Actually, with the help of frequent testifier David Egilman, Wayne Watson claimed his lung injury was inhalational.

The trial judges in Watson denied essentially the same challenges that were sustained in Newkirk v. ConAgra Foods, Inc., 727 F. Supp. 2d 1006 (E.D.Wash. 2010), aff’d, 438 Fed.Appx. 607 (9th Cir. 2011).

Yesterday, the jury returned a verdict for compensatory damages of $1.2 million, and punitive damages of $6 million, against the defendants, some of which had settled before trial.

For a predictably misleading, mainstream media account that fails to mention the interesting Daubert exclusions and defense verdicts in this litigation, see Colorado man Wayne Watson wins $7 million in “popcorn lung” lawsuit; and ‘Popcorn Lung’ Lawsuit Nets $7.2M Award (Sept. 20, 2012).

The supermarket defendant at trial should certainly appeal. It remains to be seen who gets the last pop in this case.

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Bipartisan Junk Science – Pork-Barrel Causation

September 19th, 2012

Despite the hand waving and finger pointing, junk science is embraced by both political parties in the United States, when it suits their purposes. Both parties want to have God and science on their sides.

Congress created September 11th Victim Compensation Fund, 49 USC § 40101, also known as the James Zadroga 9/11 Health and Compensation Act (P.L. 111-347) (signed into law in January 2011). The Act was a touching acknowledgement of the dedication and sacrifices of first responders to the World Trade Center and Pentagon victims of an Islamic jihad. Being a victim, however, implies that the harm to be compensated was caused by the attack and its consequences. The New York politicians soon learned that causality can be turned into a very malleable concept.

The law allocated over $4 billion for medical screening and treatment of fire fighters, policemen, emergency responders, and survivors. Most of the covered conditions were acute onset respiratory and mental disorders caused by gases, fumes, dusts, and stresses, to which the workers were exposed. The law also made the director of CDC’s National Institute for Occupational Safety and Health (NIOSH), the head of a World Trade Center Health Program, which could add new conditions to the list of compensable diseases, based upon a review of scientific evidence.

In September 2011, several New York congressmen and Senators petitioned the director, citing flimsy or non-existent scientific evidence, to add cancer to the list. Senators Kirsten Gillibrand (D-NY) and Charles Schumer (D-NY), and Representatives Carolyn Maloney (D-NY), Jerrold Nadler (D-NY), Peter King (R-NY), Charles Rangel (D-NY), Nita Velazquez (D-NY), Michael Grimm (R-NY), and Yvette Clark (D-NY), made their request, citing R. Zeig-Owens, M. Webber, C.B. Hall, et al., “Early assessment of cancer outcomes in New York City firefighters after the 9/11 attacks: an observational cohort study,” 378 Lancet 898 (2011).

This is pork barrel politics masquerading as sympathy for putative victims. The Zeig-Owens study reported a non-statistically significant standardized incidence ratio for all cancer, of either 1.10 (95% CI 0.98–1.25), with a comparison group of the generalized U.S. male population, or 1.19 (95% CI 0.96–1.47), with unexposed firefighters as a comparison group, and corrected for possible surveillance bias. Of course, given that there is no disease of cancer, the composite end point is not particularly meaningful.

Here are the authors’ (including Dr. Prezant’s) published interpretation of the data:

“We reported a modest excess of cancer cases in the WTC-exposed cohort. We remain cautious in our interpretation of this finding because the time since 9/11 is short for cancer outcomes, and the reported excess of cancers is not limited to specific organ types. As in any observational study, we cannot rule out the possibility that effects in the exposed group might be due to unidentified confounders.”

Zeig-Owens, at 898. The Zeig-Owens study did not support any conclusions of causality between the workers’ exposures in 2001, and any type of cancer. See NIOSH Report Sets Up Run on September 11th Victim Compensation Fund by Non-Victims.

The WTC Health Program director requested recommendations from the program’s Scientific – Technical Advisory Committee (STAC), whether to add cancer generally, or any particular kind of cancer, to the Zadroga Act’s list of compensable conditions. In April 2012, the STAC made its recommendations, essentially relying upon likely exposures, without any consideration of individual dose, duration, latency, and without any serious consideration of the available epidemiologic evidence.

The STAC claimed that the Lancet study reported statistically significant excesses of cancer; it did not. The Committee also failed to come to grips with the biological implausibility of excess rates of solid malignant tumors presenting within less than a decade since exposure:

“Given that cancer latencies for solid tumors average 20 years or more, it is noteworthy that the published FDNY study of fire fighters showed a statistically significant excess in all-site cancer with only 7 years of follow-up.”

In June 2012, NIOSH director, Dr. Howard, reported that he was inclined to accept the STAC’s recommendation, but held open a public comment period. See Anemona Hartocollis, “Sept. 11 Health Fund Given Clearance to Cover Cancer,” N.Y. Times (June 8, 2012). Not surprising, given the political pressure, the WTC Health Program director promulgated his final rule to include 50 types of cancer, including many that occurred less often than expected in the Zeig-Owens study.

This decision ignores appropriate scientific methodology for reaching causal conclusions. Worse than its intellectual shabbiness, the decision insults the true victims of the jihad terrorism.

The rule is effective October 12, 2012.

Posted in Causation, Scientific Evidence | Comments Off on Bipartisan Junk Science – Pork-Barrel Causation

Watson Popcorn Case Pops Along

September 8th, 2012

Earlier today, I discussed the pending motion that would have limited, or eliminated, Dr. Egilman’s testimony in the Watson diacetyl case. See Good’s Expert Witness Opinion Not Good Enough in Tenth Circuit. Apparently, Chief Judge Daniel denied the defendant’s renewed Rule 702 motion, and so “this trial must be tried.” Whether the gatekeeping was sufficiently exact, time will tell.

Details to follow.

Posted in Uncategorized | Comments Off on Watson Popcorn Case Pops Along

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