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The U.S. Supreme Court’s landmark ruling in the case Daubert v. Merrell Dow Pharmaceuticals enunciated standards for the admissibility of scientific evidence in federal courts. The Daubert plaintiffs alleged that their children had been injured in utero by the anti-nausea drug Bendectin; their lawsuit exemplified an increasingly common variety of complex litigation involving presentation of scientific evidence and expert opinion to juries consisting primarily of non-scientists. The proliferation of such litigation necessitated the promulgation of official criteria for determining the reliability of scientific evidence, just as rules govern the introduction of other forms of evidence in judicial proceedings. Such criteria are necessary to ensure that evidence presented in court is relevant, authentic, nonprejudicial, and free of hearsay and speculation.
Given its immediate relevance to the work of the Vaccine Injury Compensation Program (VICP), which is exclusively devoted to the adjudication of medical causation claims, it was inevitable that the Daubert ruling would be promptly referenced in VICP decisions that followed its promulgation on June 28, 1993.
Haim v. HHS pertained to a child born in 1981 who developed a seizure disorder in infancy, and died the following year at the age of fourteen months. In 1990, the child’s mother, represented by vaccine-injury attorney Curtis Webb, filed a VICP claim in which she alleged that her daughter was fatally injured by a diphtheria-pertussis-tetanus (DPT) vaccination. A hearing was held in May 1993, with Special Master Laura Millman presiding. Obstretric geneticist Dr. Mark Geier and pediatric neurologist Dr. Gerald Slater offered expert testimony for the petitioner. Pediatric neurologist Dr. Arnold Gale testified for the U.S. Department of Health and Human Services (HHS).
The Special Master’s August 1993 opinion sets forth the heartbreaking facts of the child’s short and difficult history. She was chronically irritable from the second week of life, and sustained a head injury in an automobile accident when she was four weeks old. She was administered her first DPT vaccination at the age of two months. The shot was followed by some slight swelling at the injection site, irritability and sleepiness, all of which subsided within a day. Four days later, she experienced her first seizure. Over the following year, she experienced countless, uncontrolled seizures, and her liver began to shrink. The child’s treating doctors speculated that her deteriorating condition might be genetic in origin, induced by a viral disease of the central nervous system, or possibly brought about by the vaccine administered five days before onset. However, none of these doctors ever determined the cause of the illness that led to her death.
During the hearing, Dr. Gerald Slater expressed the opinion that the child’s seizures resulted from a DPT-induced encephalopathy, since no alternative etiologies could be found. In support of his opinion, he cited one document: the National Childhood Encephalopathy Study (NCES), which posited various possible effects of DPT vaccine.
Dr. Mark Geier discussed the mechanisms by which he believed DPT vaccine might cause neurological damage in certain children. Like Dr. Slater, he supported his opinions with the NCES, and to a lesser extent, with animal studies. During his testimony, he compared the varying standards of proof utilized by the courts, scientists and physicians, and discussed his professional application of such standards.
Dr. Geier distinguished three levels of “proof:” (a) more likely than not (50.1%); (b) statistically significant (95%); and (c) not proven until 100%. Many epidemiologists, scientists, and doctors rely on 95% statistical significance to prove their theories. As a physician, Dr. Geier does not base his opinions on 95% certainty. However, as a scientist, he forms opinions and publishes based on 95% certainty. To Dr. Geier, the most likely cause in this case cannot be determined scientifically. Therefore, Dr. Geier offers his opinion (that DPT caused N[…]‘s condition) as a physician, based on a more likely than not standard (50.1%). He testified that he is 75% to 90% certain N[…]‘s encephalopathy was caused by DPT vaccine.
Pediatric neurologist Dr. Arnold Gale characterized the child’s health problems as indicative of a progressive disorder rather than the consequence of an acute injury. Dr. Gale criticized the NCES, pointing out that the investigators failed to consider alternative causes for their subjects’ neurological problems. He called attention to the significance of the child’s early irritability, and a family history of seizures. He observed that the child’s clinical course resembled leukodystrophy, a genetic, metabolic nervous system disorder that emerges during the first few months of life, and is more common than post-DPT neurological damage, which generally manifests within seventy-two hours of vaccination.
After considering the evidence presented in the child’s medical records, and the testimony offered at the hearing, the Special Master determined that the only proven vaccine reaction experienced by the child was a local, transient injection-site reaction that abated within twenty-four hours. The records reflected that the mother had told the child’s doctors that she had long suspected that her daughter had some kind of underlying medical issue, and that these doctors could not pinpoint a cause for her problems once they emerged. Although the child’s doctors speculated that vaccines might have caused development of seizures, none had ever concluded that that was the case. Such a conclusion was reached only in retrospect, by experts retained by the mother years later, after the commencement of litigation — experts who proffered post-mortem diagnoses of “vaccine-induced encephalopathy” for which scarce contemporaneous medical evidence existed, and who relied on a single study of debatable power and applicability.
In her decision, the Special Master summarized the Supreme Court’s eight-week-old Daubert decision, relating it to administrative proceedings under the Vaccine Act in general, as well as to the Haim case in particular.
The recent United States Supreme Court decision in Daubert v. Merrell Dow Pharmaceuticals provides cogent guidelines regarding the validity of scientific evidence. Daubert concerned the admissibility of scientific evidence, whereas the present focus of this court is in weighing previously admitted evidence. The Federal Rules of Evidence do not bind this court because Congress intended to speed resolution of vaccine cases by creating a more informal forum. Nonetheless, the court finds the Supreme Court’s discussion on what criteria to use in determining the credibility of scientific evidence to be instructive and helpful.
According to Daubert, the first criterion for accepting scientific evidence is that the expert’s testimony pertaining to scientific knowledge is not only relevant, but reliable. Secondly, the “scientific” aspect of the testimony must be grounded in the methods and procedures of science. Thirdly, the “knowledge” aspect of the testimony must rely on more than subjective belief or unsupported speculation. The Supreme Court further stated:
“In order to qualify as “scientific knowledge,” an inference or assertion must be derived by the scientific method. Proposed testimony must be supported by appropriate validation — i.e., “good grounds,” based on what is known.”
Daubert focuses on evidentiary reliability. The Supreme Court states: “In a case involving scientific evidence, evidentiary reliability will be based upon scientific validity.” The expert’s opinion should have a “reliable basis in the knowledge and experience of his discipline.”
The Supreme Court instructs trial courts to assess preliminarily whether the reasoning or methodology underlying the expert’s testimony is scientifically valid as well as “whether that reasoning or methodology properly can be applied to the facts in issue.”
A key consideration in assessing the scientific reliability of testimony is whether the theory at issue can be or has been tested. Another consideration is whether the theory proffered has been accepted after peer review and in publications. Although not essential to establish reliability, peer review, i.e., the scrutiny of the scientific community, represents “good science” because it detects more likely substantive flaws in methodology.
Further, when a particular scientific technique is at issue, the court should ordinarily consider the known or potential rate of error and the standards controlling the technique’s operations. The Supreme Court states that a trial court may be properly skeptical about a known technique the scientific community only minimally supports. “The focus… [of the trial court] must be solely on principles and methodology, not on the conclusions that they generate.”
The Supreme Court, recognizing the difference between the quest for truth in the courtroom and the quest for truth in the laboratory, emphasizes that scientific inquiry advances “by broad and wide-ranging consideration of a multitude of hypotheses,” whereas the trial court is not intent on “the exhaustive search for cosmic understanding but for the particularized resolution of legal disputes.”
In conclusion, Daubert stands for the principle that a trial judge’s task is to ensure that an expert’s testimony both rests on a reliable foundation and is relevant to the issues of the case. “Pertinent evidence based on scientifically valid principles will satisfy those demands.”
The Special Master evaluated Dr. Geier’s testimony according to the criteria outlined in Daubert, and parsed the distinctions he had made between physicians, scientists and judges, and the levels of certainty upon which each might base their conclusions.
Dr. Geier’s testimony is based mainly on the NCES and secondarily on a theory of endotoxin “poisoning” of animals. The court holds that Dr. Geier’s testimony does not reach the level of evidentiary reliability that Daubert requires because it is not based upon scientific validity, valid methodology, peer review or testing, and more than minimal support within the scientific community.
Firstly, the court points out that Dr. Geier’s expertise as a doctor in the fields of genetics and obstetrics is of no relevance to the issues in the case. Therefore, when Dr. Geier testifies as a physician that he is 75% certain that more likely than not DPT caused N[…]‘s seizure five days later, his testimony is irrelevant to the court. The only relevancy Dr. Geier’s testimony has to the court is as a scientist who, according to Dr. Geier, is familiar with both epidemiology and animal testing. Dr. Geier testified that he does not hold opinions or publish as a scientist unless he is 95% certain. He further testified that he did not know to a scientific degree of certainty that more likely than not DPT caused N[…]‘s seizure. Dr. Geier testified that the most likely cause of N[…]‘s illness cannot be determined scientifically. The reason undoubtedly that he so testifies is that he cannot as a scientist give validity to the NCES and the toxin theory. Therefore, Dr. Geier offered his opinion that DPT caused N[…]‘s condition as a physician, not as a scientist.
This is legal legerdemain which in essence challenges the court to discern why Dr. Geier switches from physician to scientist for the purpose of discussing the basis of his opinion (the NCES and the toxin theory in animal testing), and then back from scientist to physician for the purpose of discussing his level of certainty regarding causation. Dr. Geier may be clever, but he is not credible. Unless the NCES and the toxin theory are based on principles and methodology that are scientifically valid, his conclusions are irrelevant to this court.
In a substantive footnote, the Special Master elaborated on the need to focus on the scientific validity of the process whereby experts reach their conclusions, and compared the case under consideration with a previous case cited by and involving both Dr. Geier and Mr. Webb.
Scientists refer to statistical significance, 95% certainty, in ascertaining whether to rely upon a study. This does not mean that the court requires an expert to testify that he is 95% certain in order to find his testimony credible. The standard is more likely than not. But, under Daubert, the foundation for the scientific expert’s testimony must be valid. If a scientist qua scientist would not base his conclusion upon a study because of its methodological flaws (including a broad confidence interval due to the small number of neurologically ill vaccinees), he does not have a valid basis upon which to testify in court. That the percentage of certainty drops from 95% in science to 50.1% in litigation does not obviate the need for the court to examine the basis for the expert’s testimony. Otherwise, experts become hired guns and expertise a sham. Compare the analysis in Estep v. Secretary of HHS, a four day-onset case, which is pre-Daubert. The court in Estep focused on the lower percentage of certainty (50.1%) in testifying compared to the percentage of certainty (95%) in science, but did not discuss the validity of the methodology and principles of the scientific analysis upon which the expert (also Dr. Geier) based his opinion. The Supreme Court in Daubert states that the court’s focus should not be conclusion-oriented (i.e., the expert is 50.1% sure), but should be methodology-oriented (i.e., is there scientific validity and thus evidentiary reliability underlying the expert’s opinion).
The Special Master discussed at length the one study upon which both Dr. Geier and Dr. Slater relied.
The NCES [National Childhood Encephalopathy Study] postulates DPT causation up to seven days after the vaccination, but the limit of seven days has no particular raison d’etre. The basis for the NCES conclusion rests upon merely seven cases. These children were presumed to be normal at the time of vaccination but no prevaccination neurological testing had been performed. Two of the seven children were not diagnosed with encephalopathy, but with seizures. The other five children were diagnosed with encephalopathy. Of these five, three had other conditions (factors unrelated): one had Reye’s syndrome; two had viral encephalitis. That leaves two cases of encephalopathy and two cases of seizures (which may or may not have resulted in neurologic impairment) out of 1,182 cases of serious acute neurologic illness in infants and children ages two to thirty-five months as the basis for the conclusion that DPT can cause neurologic damage up to seven days after vaccination. The NCES did not persuade the court in Ormechea v. Secretary of HHS. It does not persuade the court now.
The NCES itself issues cautionary advice to anyone relying upon its conclusions. For instance, it warns on pages 98-99 that two of its difficulties were its broad confidence limits (due to the small number of children studied) and the attributable risk it derived from the assumptions of the authors as well as from the broad confidence limits. The authors state these estimates of attributable risk “should be interpreted with considerable caution.”
Moreover, the authors included cases where there was evidence of possible etiologies other than DPT vaccine, expressly eschewing clinical judgment concerning probable cause in individual cases. The effect of including these cases (which in statutory terminology would be called factors unrelated) was to overestimate the risk from the vaccine.
The authors state that the NCES cannot by itself mean that any association between the vaccine and neurological illness is causal. The NCES results “suggest but do not prove” that DPT vaccine causes serious neurological disorders in a small number of children. Similar results were found in children who had received only DT vaccine (no pertussis) “which underlines the need for caution in attributing a cause in individual cases.”
The authors criticize their own design of the study, stating that it is not one that would normally allow for the calculation of attributable risk. They advise anyone relying on their estimates of attributable risk to interpret them with “great caution.” These estimates are only “indicators of the magnitude of risk after paying due attention both to the assumptions being made and to the confidence limits of the estimates. They are not precise measures of risk.”
The authors recognize that the NCES may be biased in the selective reporting of children with prior immunizations who had serious neurological injuries since the NCES’s concern to find neurologic illness post-DPT vaccine was known to clinicians:
“This would lead to the proportion of “vaccine associated” cases notified to the Study being greater than that of other cases, and the calculated risk of the onset of a serious neurological disorder being preceded by an immunization against pertussis would be greater than the actual risk. In these circumstances the Study results would show the vaccine to be more dangerous than it actually is.”
The authors agree that their “underlying assumptions are open to challenge.” They conclude that “it seems likely that permanent damage as a result of pertussis immunization is a very rare event and attribution of a cause in individual cases is precarious.”
The Special Master quoted extensively from an epidemiological update of the NCES, the proceedings of a symposium on pertussis, and another paper written by the NCES authors. In all of these sources, the researchers reiterated their concern that their study should not be overextended.
“[A]ttribution of a cause in individual cases is precarious.. The number of previously apparently normal children who had a vaccine-associated illness and whose clinical condition and development were assessed was very small and, therefore, particularly vulnerable to the effects of chance and to error or bias. Any conclusions based on such small numbers must be extremely cautious… It is essential not to place greater weight on the findings than the methods and operational weaknesses of the NCES will allow.” (emphasis in original)
The Special Master called attention to another element of the NCES that might contribute to inaccuracy:
The authors describe one of their criteria — time of onset — as the date when an acute, rather than a subacute, symptom occurred, thus having the effect of possibly lengthening the interval between vaccination and date of onset… That means that the seven-day NCES window of causal association upon which petitioner’s experts, particularly Dr. Geier, rely in basing their opinions may be too long an interval between vaccination and onset (keeping in mind that the NCES authors merely suggest the interval rather than posit causation). The NCES authors recorded the date of the first acute neurological symptom in their analysis of the few cases of neurologic injury scrutinized.
The Special Master compared the attitude taken by the NCES authors towards their own study with that taken by the petitioner’s experts.
N[…]‘s case is individual. Petitioner’s experts, Dr. Slater and Dr. Geier, seem not to have noted the caution with which the NCES’s authors approach the conclusions of their report particularly in the context of individual cases. Dr. Slater admitted that he bases his opinion solely on the NCES. Since this court, following the caution of the NCES’s authors, does not attach more weight to the NCES’s conclusions than the authors do themselves, the court rejects Dr. Slater’s and Dr. Geier’s testimony as to causation in fact based on the NCES.
(The court reiterates that it is not applying a higher standard than 50.1% to expert testimony. The focus is on methodology and principles, not conclusions. Considering the flaws in the NCES that both Drs. Geier and Slater recounted in their testimony as well as the deficiencies the NCES’s authors reveal about their study, it is inconceivable that any scientist could justifiably reach a conclusion on causation from the study. Actually, no scientist in the hearing did reach that conclusion. Dr. Slater did not testify as a scientist, but as a physician (expert in pediatric neurology). Dr. Geier proffered his opinion on causation not as a scientist, but as a physician (expert in genetics and obstetrics). That petitioner did not offer the testimony of a scientist qua scientist shows the theoretical nature of her case and the flimsiness of her proof.)
The Special Master addressed the relevance and applicability of data from animal studies to determination of disease causation in human beings.
Dr. Geier also relies on the results of animal studies to support his opinion. Presumably, use of endotoxins on animals has produced illness in the test subjects. Because Dr. Geier did not describe these animal studies with any specificity, the court cannot accept them as the basis for a valid opinion on causation in fact. Moreover, there are methodological deficiencies in animal testing which mar its acceptability as proof of causation.
Dr. Geier admitted that the amount of endotoxin varies depending on the lot of DPT vaccine. He did not know the amount of endotoxin in the lot of DPT vaccine administered to N[…]. Endotoxin itself, not DPT vaccine, is injected into laboratory animals for testing purposes. Dr. Geier did not reveal to the court the difference between the amount of endotoxin injected into the animals compared to the highest amount that could possibly be found in a particular lot of DPT vaccine. Comparison between N[…]‘s case and laboratory animals would, thus, be futile.
In addition, humans are considerably larger than the mice that scientists frequently inject with toxic substances. Dr. Geier did not explain to the court the difference in effect between an endotoxin injected numerous times (or in places unsuitable for humans, such as directly into the brain) into laboratory animals for the purpose of making them sick and DPT vaccine containing some amount of endotoxin injected once into a human being. There are too many variables here for the court to conclude DPT’s effect on humans is analagous to endotoxin’s effect on animals.
Dr. Geier has sloughed over fundamental scientific principles to offer as the second basis for his causation opinion the results of animal testing. The IOM [Institute of Medicine] categorically rejects any interpolation of animal studies in the context of attributing causation of neurologic illness to DPT vaccine:
“Superficial understanding of the effects on the human brain of various putative virulence factors and of pertussis vaccine makes it impossible to interpret previous results in animals with any certainty. Unless the basic nature of the postulated vaccine-induced encephalopathy in humans is understood, preferably at the molecular and cellular levels, it is not possible to determine whatever abnormalities produced in an animal represent a valid ‘model.”
The IOM states it is “almost impossible to extrapolate animal findings to humans with any certainty.” Curiously, routine testing of DPT vaccine lots includes the intracerebral (injection within the brain) mouse protection test which extends over two weeks. If the mice had developed serious encephalopathy, one would expect that the technicians and scientists would have discovered it during routine and continual testing of DPT vaccine. Dr. Geier’s reliance on animal testing as a basis of his opinion on causation in fact is less than candid and not persuasive to this court.
The Special Master then summarized her concerns and conclusions.
In both the epidemiologic and animal testing areas, Dr. Geier’s testimony fails the Daubert criteria. Dr. Geier has made a career of testifying in cases involving “long-onset” encephalopathy following DPT vaccine. In light of the clear language of Daubert, no other court should be without the tools with which to dissect Dr. Geier’s testimony and to recognize its frailty. Dr. Geier’s testimony is not reliable, or grounded in scientific methodology and procedure. His testimony is merely subjective belief and unsupported speculation.
The court sympathizes with the tragic loss of petitioner’s child, who not only became ill, but died. No treating doctor offered petitioner an etiology for N[…]‘s seizure disorder. Rather than accept an unknown cause, petitioner attributed the cause to DPT vaccine.
Although the petition was dismissed, compensation was paid from Program funds to the attorneys and experts who validated her attributions, and who developed and unsuccessfully prosecuted this largely speculative case.
Later VICP rulings would support Special Master Millman’s reference to Daubert as a guideline for assessment of scientific evidence and testimony in VICP proceedings. In the 1998 case Terran v. HHS, Special Master Richard Abell employed the Daubert criteria in discounting testimony offered by Dr. John Menkes, whose opinions — like those of Drs. Slater and Geier — also relied largely on the NCES and had little support in the broader scientific community. The claim was dismissed, and the petitioners requested judicial review of the decision, arguing in part that the Special Master had erred in his application of the standards of scientific reliability enunciated in Daubert. Judge Moody R. Tidwell III sustained the Special Master’s decision, observing that:
Although the Federal Rules of Evidence do not apply in vaccine cases, the court believes Daubert is useful in providing a framework for evaluating the reliability of scientific evidence. While the Supreme Court designed the test to determine whether evidence is relevant and reliable in the context of the Federal Rules of Evidence, it is equally capable of being used to determine whether information is relevant and reliable in the context of the Vaccine Act. It was not arbitrary and capricious for the Special Master to apply Daubert in this case to determine that Dr. Menkes’ theory was not reliable scientific evidence. His theory has never been published, it has not been tested on humans, the rate of error is completely unknown, and Dr. Menkes admits that only 20% of professionals in his field would support his theory…
The Special Master had the opportunity to observe the testimony, consider the comportment of the witnesses, and ask questions of each witness. The Special Master was uniquely able to make witness credibility determinations. The Special Master is not bound by the opinions of the expert witnesses and can reject the testimony for reasonable basis… The Special Master did not conclude that the Dr. Menkes’ theory was junk science nor that the theory was inadmissible. The Special Master applied Daubert to measure the reliability and credibility of Dr. Menkes’ theory compared to the theories offered by the respondent.
The Terran petitioners appealed. The United States Court of Appeals for the Federal Circuit ultimately ruled that:
[W]e do not read the Special Master’s decision as requiring that Terran’s proffered evidence meet all of the Daubert factors. Instead, we view the Special Master’s analysis as using Daubert’s questions as a tool or framework for conducting the inquiry into the reliability of the evidence.
The United States Supreme Court denied the plaintiffs’ request to review the Circuit Court’s decision.
Haim v. Secretary of HHS, Case 90-1031V, 1993 U.S. Claims LEXIS 145 (Aug. 27, 1993).
Ormechea v. Secretary of HHS, Case No. 90-1683V, 1992 U.S. Cl. Ct. LEXIS 274 (Jun. 10, 1992).
Estep v. Secretary of HHS, Case 90-1062V, 1992 U.S. Claims LEXIS 14 (Nov. 3, 1992), aff’d 1993 U.S. Claims LEXIS 89 (Jun. 25, 1993).
Daubert v. Merrell Dow Pharmaceuticals, 25 L. Ed. 2d 469, 113 S. Ct. 2786 (1993).
Terran v. Secretary of HHS, Case 95-451V, 1998 U.S. Claims LEXIS 321 (Jan. 23, 1998), aff’d, 41 Fed. Cl. 330, 1998 U.S. Claims LEXIS 151 (Jul. 10, 1998), aff’d, 195 F.3d 1302, 1316 (Oct. 27, 1999), cert. denied, 531 U.S. 812 (Oct. 2, 2000).
R. Alderslade, M.H. Bellman, N.S.B. Rawson, E.M. Ross, and D.L. Miller, The National Childhood Encephalopathy Study: A Report on 1000 Cases of Serious Neurological Disorders in Infants and Young Children from the NCES Research Team, in Whooping Cough: Reports from the Committee on Safety of Medicines and the Joint Committee on Safety of Medicines and the Joint Committee on Vaccines and Immunization 79-184 (Her Majesty’s Stationery Office 1981).
Institute of Medicine, Adverse Effects of Pertussis and Rubella Vaccines, (National Academy Press 1991).
D.L. Miller, E.M. Ross, R. Alderslade, M.H. Bellman, and
N.S.B. Rawson, Pertussis immunization and serious acute neurological illness in children, 282 Brit. Med. J. 1595-99 (1981).
K.R. Wentz, E.K. Marcuse, Diphtheria-Tetanus-Pertussis Vaccine and Serious Neurologic Illness: An Updated Review of the
Epidemiologic Evidence, 87 Pediatrics 287-97 (1991).
Fifth International Symposium on Pertussis, Severe Neurological Illness: Further Analyses of the British National Childhood Encephalopathy Study, 13 Tokai J. Exp. Clin. Med. 145-55 (Supp. 1988).
D.L. Miller, M.J.H. Wadsworth, and E.M. Ross, Pertussis vaccine and severe acute neurological illnesses. Response to a recent review by members of the NCES team, 7(6) Vaccine 487-89 (1989).
Previous: The New Testimonial Arena
Next: A Not-So-Hidden History
I think these might be my two favorite paragraphs… emphasis added.
“The court sympathizes with the tragic loss of petitioner’s child, who not only became ill, but died. No treating doctor offered petitioner an etiology for N[…]‘s seizure disorder. Rather than accept an unknown cause, petitioner attributed the cause to DPT vaccine.
"Although the petition was dismissed, compensation was paid from Program funds to the attorneys and experts who validated her attributions, and who developed and unsuccessfully prosecuted this largely speculative case."
— Ms. Clark Mar 6, 12:43 AM #out of all the children in my family. i am the only one who failed to develope a scare from the vaccines. but, i also, may have inherited a gene from my mothers side leaving me in a passive state of mind. so, was it the vaccines or the gene or perhaps both.
— rusty Mar 12, 02:32 PM #Unfortunately the pdf version at justia doesn’t display in my browser, can anyone point me to a text/html version?
— J.F Apr 6, 12:56 PM #Here you go.
— Kathleen Seidel Apr 6, 01:03 PM #