Schachtman Law

TORTINI

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

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.

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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.

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Good’s Expert Witness Opinion Not Good Enough in Tenth Circuit

September 8th, 2012

Last month, the Tenth Circuit reversed a significant judgment against Ford Motor Company in a rollover accident. Hoffman v. Ford Motor Co., No. 10-1137, 2012 WL 3518997, 2012 U.S. App. LEXIS 17215 (10th Cir. Aug. 16, 2012) (unpublished), rev’g 690 F. Supp. 2d 1179 (D. Colo. 2010). The plaintiff, Erica Hoffman, sustained severe injuries, with resulting quadriplegia, when she was thrown out of the passenger seat, and out of her parents’ 1999 Mercury Cougar, during the rollover.

Hoffman sued Ford Motor Company on the claim that the seatbelt, which she claims to have been wearing, released during the accident. Hoffman’s expert witness, Dr. Craig Good opined that Hoffman’s seatbelt “most probably” unlatched during the accident due to a design defect that permitted unlatching under various inertial forces. Dr. Good supported his opinion by testing that sought to show the threshold of inertial forces under which unlatching occurred. Good, however, lacked rollover crash data, and he thus used data from crash tests conducted only in the horizontal plane, rather than the more complex forces at work in a rollover situation. From the “planar” data, Good concluded that Hoffman’s accident presented sufficient force to cause the inertial unlatching of her seatbelt during the accident. The jury found Ford liable; the verdict, molded for comparative negligence, amounted to 4.5 million dollars.

Ford had objected, under Rule 702, to Good’s testimony, and to his extrapolation of his test data from a horizontal test scenario to the three-dimensional array of forces involved in the actual rollover accident. The gravamen of Ford’s complaint was that Good had failed to show the levels of acceleration needed to induce inertial unlatching in the laboratory in the real-world setting of Hoffman’s accident.

The panel of the Tenth Circuit, divided 2 to 1, agreed with Ford that the trial judge had not been:

“a sufficiently exacting gatekeeper; Daubert requires more precision. Good failed to present a scientific connection between the accelerations he found necessary to inertially unlatch buckles tested in the laboratory and accelerations that occurred could have occurred on Erica’s buckle during the rollover. As a result, his opinion (that Erica’s buckle was defective because it inertially unlatched during the accident) should not have been admitted at trial.”

Hoffman, 2012 U.S. App. LEXIS 17215, *4-5. Because Good’s opinion was necessary to support plaintiff’s recovery, and because there was no other evidence to support the claim of design defect, the Circuit reversed and remanded with instructions that judgment be entered in favor of Ford.

The Hoffman decision does not really broach new ground in the law of expert witnesses. The law requires that testing data bear on the situation in which the product supposedly malfunctioned. The opinion, however, has already had the salutary effect of causing the newly assigned trial judge to Watson v. Dillon Companies, to reconsider the previous Rule 702 rulings in this diacetyl consumer case.

Chief Judge Wiley Daniel took over the case for trial, when Senior Judge Miller assumed inactive senior status. Plaintiff Watson claims lung injuries from diacetyl inhaled in the course of consuming upwards of 7,000 bags of popcorn, over seven years. Judge Miller heard, and largely denied, defendants’ 702 motions. Watson v. Dillon Companies, Inc., 797 F. Supp. 2d 1138 (D.Colo. 2012). Chief Judge Daniel found the Hoffman precedent sufficiently on point to the challenged diacetyl exposure assessment, that he invited renewed argument on the challenges to plaintiffs’ expert witnesses. Order of Aug. 29, 2012.

In Chief Judge Daniel’s words:

“After reviewing the Tenth Circuit’s recent pronouncement on Daubert challenges and the admissibility of expert testimony at trial, I reexamined pertinent documents in this matter. Specifically, I reread Judge Miller’s June 22, 2011 order denying the motions to exclude expert testimony of Plaintiffs’ expert witnesses along with the opinion issued by the United States District Court for the Eastern District of Washington in Newkirk v. ConAgra Foods, Inc., 727 F. Supp. 2d 1006 (E.D.Wash. 2010). I also revisited the material submitted by Defendants surrounding the issue of the reliability of Dr. Martyny’s testing of diacetyl levels at Plaintiffs’ home, as Plaintiffs’ expert witnesses based some of their opinions on these test results.

I find that the Hoffman opinion may impact previous expert witness rulings including, but not limited to, Dr. David Egilman’s opinions. Accordingly, on Tuesday, September 4, 2012, prior to the commencement of jury selection in this matter, the parties shall be prepared to discuss these issues and how they may impact the trial.”

Along with the encouragement provided by the Hoffman case, the Chief Judge may have been moved to revisit the 702 issues by a defense filing that challenged the plaintiffs’ exposure level evidence. The defendant filed a motion in limine to preclude 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, but also precluded mention of the testing in front of the jury until the evidentiary matter is resolved. Order of June 22, 2012.

It appears that the plaintiffs may have withdrawn the challenged evidence, which if true, will have significance beyond this case, given the media and regulatory fora sought out by Dr. Egilman and his colleagues.

Let us hope that the Hoffman opinion inspires the court to be the sufficiently exacting gatekeeper required by law.

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The Supreme Court’s Unsteady Gatekeeping Pre-Daubert

September 8th, 2012

Some writers assert that the United States Supreme Court did not wade into the troubled waters of medical causation and expert witness testimony until it decided Daubert v. Merrell Dow Pharmaceuticals, 509 U.S. 579 (1993). Actually, the Court swam in these stormy waters in admiralty and FELA cases, at least up through the 1950’s.

In 1953, Mr. Sentilles, a marine engineer, was thrown to the deck of his ship, and washed off deck, by a wave. He became ill with tuberculosis, and he brought a person injury action (for “maintenance and cure”) against vessel owner. Inter-Caribbean Shipping Corp. v. Sentilles, 256 F.2d 156 (5th Cir. 1958). The vessel owner defended on the theory that the plaintiff’s diabetes pre-disposed him to TB, and that the plaintiffs’ expert witnesses were equivocal in their conclusions of causality or aggravation. The jury nonetheless found for the plaintiff.

The judgment entered on a jury verdict for the seaman was reversed by the Fifth Circuit, which found the plaintiffs’ expert witnesses’ testimony inadequate to support submission of the case to the jury:

“The rule as to the medical testimony respecting causation which is required to take a case to a jury has been thus stated:

It appears to be well settled that medical testimony as to the possibility of a causal relation between a given accident or injury and the subsequent death or impaired physical or mental condition of the person injured is not sufficient, standing alone, to establish such relation. By testimony as to possibility is meant testimony in which the witness asserts that the accident or injury `might have’, `may have’, or `could have’ caused, or `possibly did’ cause the subsequent physical condition or death or that a given physical condition (or death) `might have,’ `may have,’ or `could have’ resulted or `possibly did’ result from a previous accident or injury — testimony, that is, which is confined to words indicating the possibility or chance of the existence of the causal relation in question and does not include words indicating the probability or likelihood of its existence.”

Id. (internal citations omitted).

The Supreme Court granted a writ of certiorari, heard argument, and reversed the Court of Appeals. Sentilles v. Inter-Caribbean Shipping Corp., 361 U.S. 107 (1959). In announcing the Court’s opinion, Justice Brennan voiced the remarkable doctrine that the jury could find reasonable probability when the expert witnesses could not:

“The jury’s power to draw the inference that the aggravation of petitioner’s tubercular condition, evident so shortly after the accident, was in fact caused by that accident, was not impaired by the failure of any medical witness to testify that it was in fact the cause. Neither can it be impaired by the lack of medical unanimity as to the respective likelihood of the potential causes of the aggravation, or by the fact that other potential causes of the aggravation existed and were not conclusively negated by the proofs. The matter does not turn on the use a of particular form of words by the physicians in giving their testimony. The members of the jury, not the medical witnesses, were sworn to make a legal determination of the question of causation. They were entitled to take all the circumstances, including the medical testimony into consideration. Though this case involves a medical issue, it is no exception to the admonition that, ‘It is not the function of a court to search the record for conflicting circumstantial evidence in order to take the case away from the jury on a theory that the proof gives equal support to inconsistent and uncertain inferences. The focal point of judicial review is the reasonableness of the particular inference or conclusion drawn by the jury. * * * The very essence of its function is to select from conflicting inferences and conclusions that which it considers most reasonable. * * * Courts are not free to reweigh the evidence and set aside the jury verdict merely because the jury could have drawn different inferences or conclusions or because judges feel that other results are more reasonable.’”

Id. at 109-10. Justice Brennan thus ignored equally venerable precedent that juries are not free to speculate, and he failed to consider how the jury in this case could reach a determination in the face of conflicting evidence, and without ruling out alternative causes.

Sentilles was decided before the enactment of the Federal Rules of Evidence, and there was no challenge to the plaintiff’s expert witnesses’ testimony under the Frye doctrine. Another crucial difference, of course, is that Sentilles was an isolated case, not likely to recur frequently in the federal courts. With the rise of product liability law, and the emergence of epidemiology as a basis for inferring causality, the federal courts would soon see mass exposure situations resulting in mass torts. Dubious expert witness testimony resulting in dubious judgments of causation would attain much greater notoriety, for the expert witnesses, for the trial bar, and for the courts that tolerated the results.

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David Egilman’s Methodology for Divining Causation

September 6th, 2012

If the Method Yields An Erroneous Conclusion, then the Method is Wrong

David Stephen Egilman wanted very much to testify in a diacetyl case. One judge, however, did not think that this was such a good idea, and excluded Dr. Egilman’s testimony. Newkirk v. Conagra Foods, Inc. 727 F.Supp. 2d 1006 (E.D. Wash. 2010).

Egilman was so distraught by being excluded that he sought to file a personal appeal to the United States Court of Appeal. See “Declaration of David Egilman, M.D., M.P.H., in Support of Opposition to Motion for Order to Show Cause Why Appeal Should Not Be Dismissed for Lack of Standing.” (Attached: Egilman Motion Appeal Diacetyl Exclusion 2011 and Egilman Declaration Newkirk Diacetyl Appeal 2011.)

Egilman improvidently, if not scurrulously, attacked the district judge for having excluded Egilman’s proffered testimony. If Egilman’s attack on the trial judge were not sufficiently odd, Egilman also claimed a right to intervene in the appeal by advancing the claim that the Rule 702 exclusion hurt his livelihood. Here is how Egilman put the matter:

“The Daubert ruling eliminates my ability to testify in this case and in others. I will lose the opportunity to bill for services in this case and in others (although I generally donate most fees related to courtroom testimony to charitable organizations, the lack of opportunity to do so is an injury to me). Based on my experience, it is virtually certain that some lawyers will choose not to attempt to retain me as a result of this ruling. Some lawyers will be dissuaded from retaining my services because the ruling is replete with unsubstantiated pejorative attacks on my qualifications as a scientist and expert. The judge’s rejection of my opinion is primarily an ad hominem attack and not based on an actual analysis of what I said – in an effort to deflect the ad hominem nature of the attack the judge creates ‘straw man’ arguments and then knocks the straw men down, without ever addressing the substance of my positions.”

Egilman Declaration at ¶ 11.

The Ninth Circuit, unmoved by the prospect of an impoverished Dr. Egilman, denied his personal appeal, and affirmed the district court’s exclusion. Newkirk v. Conagra Foods, Inc., 438 Fed. Appx. 607 (9th Cir. 2011).

In his appellate papers, Egilman did not stop at simply citing his pecuniary interest. With no sense of false shame or modesty, Egilman recited what a wonderful expert witness he has been. Egilman suggested that courts have been duly impressed by his views on the scientific assessment of causation:

“My views on the scientific standards for the determination of cause-effect relationships (medical epistemology) have been cited by the Massachusetts Supreme Court (Vassallo v. Baxter Healthcare Corporation, 428 Mass. 1 (1998)):

‘Although there was conflicting testimony at the Oregon hearing as to the necessity of epidemiological data to establish causation of a disease, the judge appears to have accepted the testimony of an expert epidemiologist that, in the absence of epidemiology, it is “sound science…. to rely on case reports, clinical studies, in vivo tests and animal tests.” The judge may also have relied on the affidavit of the plaintiff’s epidemiological expert, Dr. David S. Egilman, who identified several examples in which disease causation has been established based on animal and clinical case studies alone to demonstrate that “doctors utilize epidemiological data as one tool among many”.’”

Egilman Declaration at p.5-6.

We may excuse Dr. Egilman, a non-lawyer, for incorrectly referring to a non-existent court. Massachusetts does not have a “Supreme Court,” but the quoted language did indeed come from the Supreme Judicial Court of Massachusetts, in Vassallo v. Baxter Healthcare Corporation, 428 Mass. 1, 12, 696 N.E.2d 909, 917 (1998).

The Massachusetts court’s suggestion that there was conflicting testimony at the “Oregon hearing,” about the need for epidemiologic evidence is itself rather bizarre. The Oregon hearing was the Rule 702 hearing before Judge Jones, of the District of Oregon. Judge Jones appointed four technical advisors to assist him in ruling on the defendants’ motions to exclude plaintiffs’ causation opinions. One of the appointed advisors was an epidemiologist. More important, the plaintiffs’ counsel presented the testimony of an epidemiologist, Dr. David Goldsmith. The Massachusetts court did not, and indeed, could not cite the Oregon District Court’s opinion, or the underlying record, for any suggestion that epidemiologic testimony was not needed to show a causal relationship between silicone breast implants and the development of autoimmune disease. See Hall v. Baxter Healthcare Corp., 947 F. Supp. 1387 (D. Or. 1996). Judge Jones made his views very clear: epidemiology was needed, but lacking, in the plaintiffs’ case. The argument that epidemiology was unnecessary came from Dr. Egilman’s report, and the plaintiffs’ counsel’s briefs.

There is more, however, to the disingenuousness of Dr. Egilman’s citation to the Vassallo case. The Newkirk court, in receiving his curious affidavit, would not likely know that Vassallo was a silicone gel breast implant case, and one may suspect that Dr. Egilman wanted to keep the Ninth Circuit uninformed of his role in the silicone litigation. If Dr. Egilman submitted an affidavit in connection with the so-called Oregon hearings, which took place during the summer of 1996, it was not a particularly important piece of evidence. Egilman is not mentioned by name in the Hall decision, even though the district court clearly rejected the plaintiffs’ witnesses and affiants, in their efforts to make a case for silicone as a cause of autoimmune disease.

A few months after the Oregon hearings, Judge Weinstein, in the fall of 1996, along with other federal and state judges, held a “Daubert” hearing on the admissibility of expert witness opinion testimony in breast implant cases, pending in New York state and federal courts. Plaintiffs’ counsel suggested that Egilman might testify, but ultimately he was a no show. After the New York hearings, Judge Weinstein granted, sua sponte, partial summary judgment against all plaintiffs’ claims of systemic immune-system injury. In re Breast Implant Cases, 942 F. Supp. 958 (E.&S.D.N.Y. 1996).

At the New York hearings, plaintiffs’ counsel again attempted to make an epidemiologic case, and once again called Dr. David Goldsmith. Marshaling the evidentiary display that Egilman would have presented had he shown up in New York, Dr. Goldsmith’s testimony did not go well. At one point, Judge Weinstein interrupted and offered his interim assessment of Dr. Goldsmith and the plaintiffs causation case:

THE COURT: Why are you presenting this witness, for epidemiological purposes?

MR. GORDON: That’s correct.

THE COURT: And I can tell you for epidemiological purposes, based on the only testimony I have seen, he doesn’t meet my standard of anybody who can be helpful to a jury, not because he isn’t a great epidemiologist, I’m sure he is, but because the data he is relying on admittedly is almost useless. I’m not going to go forward with a trial on this kind of haphazard abstract without any basic definition or explication.

Transcript at p.159:7-18, from Nyitray v. Baxter Healthcare Corp., CV 93-159 (E.D.N.Y. Oct. 9, 1996)(pre-trial hearing before Judge Jack Weinstein, Justice Lobis, and Magistrate Cheryl Pollak). In his semi-autobiographical writings, Judge Jack B. Weinstein elaborated upon his published breast-implant decision, with a bit more detail about how he viewed the plaintiffs’ expert witnesses. Judge Jack B. Weinstein, “Preliminary Reflections on Administration of Complex Litigation” 2009 Cardozo L. Rev. de novo 1, 14 (2009) (describing plaintiffs’ expert witnesses in silicone litigation as “charlatans”; “[t]he breast implant litigation was largely based on a litigation fraud. … Claims—supported by medical charlatans—that enormous damages to women’s systems resulted could not be supported.”)

When Judge Weinstein began to create a process for the selection of Rule 706 court-appointed expert witnesses, plaintiffs’ counsel rushed to have Judge Pointer take control over the process. Because Judge Pointer believed that there must be some germ of validity in the plaintiffs’ case, the plaintiffs were hoping that his courtroom, the center of MDL 926, would be a more favorable forum than Judge Weinstein’s withering skepticism. Ultimately, Judge Pointer, through a select nominating committee, appointed appointed expert witnesses, in the fields of toxicology, immunology, rheumology, and epidemiology. MDL 926 Order No. 31 (Appointment of Rule 706 Expert Witnesses).

Each of the four witnesses prepared, presented, and defended his or her own report, but all the reports soundly rejected plaintiffs’ causation theories. Laural L. Hooper, Joe S. Cecil, and Thomas E. Willging, Neutral Science Panels: Two Examples of Panels of Court-Appointed Experts in the Breast Implants Product Liability Litigation (Fed. Jud. Ctr. 2001).

In the United Kingdom, the British Minister of Health ordered an independent review of the breast implant controversy, which led to the formation of the Independent Review Group (IRG) to evaluate the causal claims that were being made by claimants and advocates. The IRG concluded that there was no demonstrable risk of connective tissue disease from silicone breast implants. Independent Review Group, Silicone Breast Implants: The Report of the Independent Review Group 8, 22-23 (July 1998).

In 1999, The Institute of Medicine delivered its assessment of the safety of silicone breast implants. Again, the plaintiffs’ theories were rejected. Stuart Bondurant, Virginia Ernster, and Roger Herdman, eds., Safety of Silicone Breast Implants (1999).

Still, Egilman persisted. As late as 2000, Egilman was posting his breast-implant litigation report at his Brown University website. His conclusion, however awkwardly worded, was clear enough:

“Although a prospective, large epidemiological study investigating atypical symptoms and disease would clearly contribute to underestimating of the strength of association between silicone breast implants and disease, the available epidemiologic evidence is suggestive of a causal association for silicone breast implants and atypical connective tissue diseases and scleroderma.”

David S. Egilman, “Breast Implants and Disease” (2000) (“For purposes of this report SBI induced disease is considered an iatrogenic environmental disease.”) (<http://209.67.232.40/brown/implants/sbi.html> lasted visited on Mar. 28, 2000).

Sometime after 2000, Egilman developed a sensitivity to being associated with the plaintiffs’ side of the silicone litigation. In 2009, Dr. Laurence Hirsch, published an article critical of Egilman’s disclosures of conflicts of interest, in some of his published articles. Hirsch struck a sensitive nerve in mentioning Egilman’s involvement in the breast implant litigation:

“Egilman reports having testified for plaintiffs in legal cases involving asbestosis, occupational lung disease, beryllium poisoning, silicone breast implants and connective tissue disease (characterized as the epitome of junk science91), selective serotonin reuptake inhibitor and suicide risk, atypical antipsychotics and metabolic changes, and selective COX-2 inhibitors and cardiovascular disease, an amazing breadth of medical expertise.”

Laurence J. Hirsch, “Conflicts of Interest, Authorship, and Disclosures in Industry-Related Scientific Publications: The Tort Bar and Editorial Oversight of Medical Journals,” 84 Mayo Clin. Proc. 811, 815 (2009).

Egilman apparently besieged Dr. Hirsch and the Mayo Clinic Proceedings with his protests, and it seems that he was able to induce the author or the journal into a “correction”:

“Dr Egilman has not testified in court in breast implant and connective tissue disease, or in antidepressant or antipsychotic drug cases.”

Laurence J. Hirsch, “Corrections,” 85 Mayo Clin. Proc. 99 (2010). But this correction is itself incorrect because Dr. Egilman testified over the course of three days, in court, in the same Vassallo v. Baxter Healthcare case he holds up as having embraced his causal “principles.” The Vassallo case involved allegations that silicone had caused systemic autoimmune disease, an allegation that was ultimately shown to be meritless by the MDL court’s neutral expert witnesses, as well as the Institute of Medicine.

Perhaps this history helps explain Dr. Egilman’s coyness in what he told the Newkirk appellate court about his involvement in the Vassallo case. More likely is that Dr. Egilman understands, all too well, the logical implications of his being wrong in the breast implant litigation. If his vaunted method leads to an erroneous conclusion, then the method must be wrong. It is a simple matter of modus tollens.

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