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Recrudescence of Traumatic Cancer Claims

June 4th, 2014

In 1991, Peter Huber, discussing traumatic cancer claims, wrote:

“After years of floundering in the junk science morass of traumatic cancer, judges slowly abandoned sequence-of-events logic, turned away from the sympathetic speculations of family doctors, and struggled on to the higher and firmer ground of epidemiology and medical science.  Eventually, the change of heart among appellate judges was communicated back down to trial judges and worker’s compensation boards, and traumatic cancer went into almost complete remission.”

Peter W. Huber, Galileo’s Revenge: Junk Science in the Courtroom 55-56 (1991).

With the advent of Daubert and meaningful gatekeeping of expert witness opinion testimony, the traumatic cancer claims did recede. For a while. Plaintiffs’ counsel, and stalwart opponent of epistemic standards for scientific claims in court, Kenneth Chesebro attacked Huber’s précis of the traumatic cancer law and science. Kenneth J. Chesebro, “Galileo’s Retort: Peter Huber’s Junk Scholarship,” 42 Am. Univ. L. Rev. 1637 (1993). Defenses of the dubious science continue to appear, although mostly in non-peer-reviewed publications.[1]

One of the more disturbing implications of the West Virginia Supreme Court’s decision in Harris v. CSX Transportation, Inc., 232 W.Va. 617, 753 S.E.2d 275 (2013), was the Court’s reliance upon its own, recent approval of traumatic cancer claims.  The Harris Court cited, with approval, a 2002 traumatic cancer case, State ex rel. Wiseman v. Henning, 212 W.Va. 128, 569 S.E.2d 204 (2002).  The Wiseman case involved a specious claim that a traumatic rib injury caused multiple myeloma, a claim at odds with scientific method and observation.  The West Virginia Supreme Court blinked at the challenge to the physician expert witness who advanced the causal claim in Wiseman; and in Harris, the Court made clear that blinking is what trial courts should do when confronted with methodological challenges to far-fetched causal opinions.

A couple of years ago, the New York Times ran an article about traumatic cancer. C. Claiborne Ray, “Injury and Insult” (Nov. 5, 2012), responding to the question “Is it possible for cancer to develop as a result of an injury?” Here is how Times science reporter responded:

A. “It’s a common myth that injuries can cause cancer,” the American Cancer Society says on its Web site. Until the 1920s, some doctors believed trauma did cause cancer, “despite the failure of injury to cause cancer in experimental animals.” But most medical authorities, including the cancer society and the National Cancer Institute, see no such link. The more likely explanation, the society suggests, is that a visit to the doctor for an injury could lead to finding an existing cancer.

Other possibilities are that scar tissue from an old trauma could look like a cancerous lesion and that an injured breast or limb would be more closely watched for cancer to develop.

Ms. Ray went on to note a published study, in which would-be myth-busters presented observational data purportedly showing a relationship between physical injury and subsequent breast cancer.  The paper cited by Ms. Ray was a report on a small case-control study done by investigators at the Department of Geography, Lancaster University. See Jan Rigby, et al., “Can physical trauma cause breast cancer?” 11 Eur. J. Cancer. Prev. 307 (2002). The study consisted of 67 breast cancer cases and 134 controls, matched on age, family history, age of menarche, parity, age at first birth, and menopausal status.

Not surprisingly, considering its small size, the Rigby study reported no statistically significant differences for several factors known to be associated with breast cancer: social class, education, residence, smoking and alcohol consumption.  Although lacking power to detect differences of known risk factors, this study turned up a large, statistically significant association between physical trauma and breast cancer:

“Women with breast carcinoma were more likely to report physical trauma to the breast in the previous 5 years than were the controls (odds ratio (OR) 3.3, 95% confidence interval (CI) 1.3-10.8, P < 0.0001).”

* * * * *

“More likely to [self-]report” hardly implies causation, but the authors jumped not only to a causal explanation but to a causal conclusion:

* * * * *

“In conclusion, recall bias is an unlikely explanation for these results in view of the nature and severity of physical trauma. Models of epithelial cell generation indicate that a causal link between physical trauma and cancer is plausible. A latent interval between cancer onset and presentation of under 5 years is also plausible. The most likely explanation of the findings is that physical trauma can cause breast cancer.”

Rigby at 307.

The Rigby study is a valuable demonstration of how malleable researchers can be in discovering plausible explanations for their data.  The authors fail to discuss the natural history of breast carcinoma, such as tumor doubling time, which would make their five-year window decidedly implausible.  The Rigby paper also demonstrates how strident researchers can be in claiming that they have produced a study that has eliminated bias in observational research, when they have barely scratched the surface of bias or confounding. Magical thinking is not the exclusive domain of lawyers.

Until reading the Harris and Wiseman cases, I had thought that the legal system had graduated from the “mythology” of traumatic cancer cases.[2]  To be sure, in the past, any number of physicians have supported traumatic cancer claims, in print and in the courtroom.[3] Some authors attempted to put some rational limits on the extent of the traumatic cancer claims.[4] By 1947, at least, the trauma theory was criticized in leading texts.[5]  In 1974, the Mayo Clinic published a review that emphasized the lack of experimental evidence to support the claim that uncomplicated trauma causes cancer.[6] The law review literature attempted to make sense of the compensation-frenzied courts, without much success.[7]

Many cases from most jurisdictions have approved traumatic cancer claims.  Some are set out below. Some courts heroically resisted the pro-compensation Zeitgeist, usually on case-specific evidentiary issues.[8]

In New York, judges seem to be well aware that post hoc ergo propter hoc is a fallacy.  Cassano v. Hagstrom, 5 N.Y.2d 643, 159 N.E.2d 348, 187 N.Y.S.2d 1 (1959) (affirming dismissal of case based because of plaintiffs’ attempt to use fallacious reasoning in the form of  “post hoc ergo propter hoc”); Holzberg v. Flower & Fifth Ave. Hosps., 39 AD 2d 526 (N.Y. 1st Dep’t 1972). Still, the New York courts struggled with traumatic cancer claims, and appeared to oscillate wildly without clear guidance on whether or to what extent the courts could reject specious claiming supported by speculative or unreliable expert witness opinion testimony.[9] Given the current hostility to gatekeeping of expert witness opinion, a recrudescence of traumatic cancer claims is likely.

Opinions Approving Causation in Traumatic Cancer Cases

California

Santa Ana Sugar Co. v. Industrial Accid. Comm’n, 170 P. 630, 630 (Cal. Dist. Ct. App. 1917)

Colorado

Canon Reliance Coal Co. v. Indus. Comm’n, 72 Colo. 477, 211 P. 868, 869-70 (1922) (cancer caused by being hit on cheek with a lump of coal)

Georgia

National Dairy Prods. Corp. v. Durham, 154 S.E.2d 752, 753-54 (Ga. Ct. App. 1967)

Kentucky

Louisville Ry v. Steubing’s Adm’r, 136 S.W. 634, 634 (Ky. Ct. App. 1911)

Louisiana

Reed v. Mullin Wood Co., 274 So. 2d 845, 846-47 (La. Ct. App. 1972), cert. denied, 275 So. 2d 729, 791 (La. 1973);

Thompson v. New Orleans Ry. & Light Co., 83 So. 19, 20 (La. 1919)

Michigan

Wilson v. Doehler-Jarvis Div. of Nat’l Lead Co., 353 Mich. 363, 91 N.W.2d 538, 539-40 (1958) (blow to lip caused cancer)

Mooney v. Copper Range RR, 27 N.W.2d 603, 604 (Mich. 1947)

Minnesota

Daly v. Bergstedt, 267 Minn. 244, 126 N.W.2d 242, 247–48 (1964) (affirming jury finding of causation between traumatic leg fracture and breast cancer; six physicians testified against causation; one stated cancer “could” result from trauma; imagining that scientific and legal standards of causation differ)

Pittman v. Pillsbury Flour Mills, Inc., 48 N.W.2d 735, 736 (Minn. 1951)

Hertz v. Watab Pulp & Paper Co., 237 N.W. 610, 611 (Minn. 1931)

Austin v. Red Wing Sewer Pipe Co., 163 Minn. 397, 204 N.W. 323, 323-24 (Minn. 1925) (cancer developed one year after worker was hit in the face with coal)

Gaetz v. City of Melrose, 193 N.W. 691, 692 (Minn. 1923)

Missouri

Vitale v. Duerbeck, 338 Mo. 536, 92 S.W.2d 691, 695 (1936)

New Hampshire

Jewell v. Grand Trunk Ry, 55 N.H. 84 (1874) (reversing traumatic cancer verdict on other grounds)

New Mexico

White v. Valley Land Co., P.2d 707, 708-10 (N.M. 1957)

Ohio

Hanna v. Aetna Ins., 24 Ohio Misc. 27, 52 Ohio Op. 2d 316, 259 N.E.2d 177, 177-79 (Ohio Mun. Ct. Dayton 1970)(breast lump found three months after car accident)

Glenn v. National Supply, 129 N.E.2d 189, 190-91 (Ohio Ct. App. 1954)

Oregon

Devine v. Southern Pacific Co., 207 Or. 261, 295 P.2d 201 (1956) (holding that physician’s testimony as to “probable” causation between shoulder fracture and lung cancer was sufficient; jury verdict for plaintiff reversed on other grounds).

Pennsylvania

Baker v. DeRosa, 413 Pa. 164, 196 A.2d 387, 389–90 (Pa. 1964)

Menarde v. Philadelphia Transp. Co., 376 Pa. 497, 103 A.2d 681, 684(1954) (the fact that breast cancer was found in the same place as the injury-caused bruise helped establish causation);

Southern S.S. Co. v. Norton, 41 F. Supp. 103 (E.D. Pa. 1940) (trauma to skull and lower back held to have caused lung cancer)

Tennessee

Koehring-Southern & Am. Mut. Ins. Co. v. Burnette, 464 S.W.2d 820, 821 (Tenn. 1970)

Boyd v. Young, 193 Tenn. 272, 246 S.W.2d 10, 10 (Tenn. 1951)

Rhode Island

Valente v. Bourne Mills, 77 R.I. 274, 278-79, 75 A.2d 191, 193-94 (1950) (adopting house of cards position in which any rational inference suffices even if not supported by expert medical opinion)

Emma v. A.D. Julliard & Co., 75 R.I. 94, 63 A.2d 786, 787-89 (R.I. 1949)(plaintiff had malignant tumor removed from her breast seven weeks after being hit with a can of juice)

Texas

Traders & General Insur. Co. v. Turner, 149 S.W.2d 593, 597-98 (Tex. Civ. App. 1941) (testicular cancer)

Virginia

Ellis v. Commonwealth Dep’t of Highways, 28 S.E.2d 730, 731-32, 735 (Va. 1944) (accepting post-hoc reasoning “[f]acts prevail over possibilities or probabilities”)

Winchester Milling Corp. v. Sencindiver, 138 S.E. 479, 480-81 (Va. 1927)

[1] See, e.g., Melvin A. Shiffman, Can Trauma Cause or Accelerate the Growth of Cancer? Forensic Examiner 6 (Fall 2004).

[2] See Manasco v. Insurance Co. of State of Pennsylvania, 89 S.W.3d 239 (Tex. App. Texarkana 2002) (affirming denial of benefits to worker who claimed head injury caused brain tumor; citing to epidemiological studies that failed to show an association between trauma and brain tumors).

[3] See, e.g., George R. Parsons, “Sufficiency of Proof in Traumatic Cancer Cases,” 2 Tort & Med. Year Book 335 (1962); Stoll & Crissey, “Epithelioma from Single Trauma,” 62 N.Y. St. J. Med. 496 (Feb. 15, 1962); Wilhelm C. Hueper, Trauma and Cancer (1959); Arden R. Hedge, “Can a Single Injury Cause Cancer?” 90 Calif. Med. 55 (1959); R. Crane, “The Relationship of a Single Act of Trauma to Subsequent Malignancy,” in Alan R. Moritz & David S. Helberg, eds., Trauma and Disease 147 (1959); Shields Warren, M.D., “Minimal criteria required to prove causation of traumatic or occupational neoplasms,” Ann. Surgery 585 (1943); Bishop, “Cancer, Trauma, and Compensation,” 32 So. Med. J. 302 (1939); Knox, “Trauma and Malignant Tumors, 26 Am. J. Surg. 66, 69-70 (1934); William B. Coley & Norman L. Higinbotham, “Injury as a causative factor in the development of malignant tumors,” 98 Ann. Surg. 991 (1933); Wainwright, “Single Trauma, Carcinoma and Workman’s Compensation,” 5 Am. J. Surg. 433 (1928); Alson R. Kilgore & Curtis E. Smith, “Industrial liability for cancer,” 25 Calif. & Western Med. 70 (1926); Charles Phelps, “The relation of trauma to cancer formation,” 51 Ann. Surgery 609 (1910).

[4] James Ewing, “Modern Attitudes Toward Traumatic Cancer,” 19 Arch. Path. 690, 692 (1935); James Ewing, “The Relation of Trauma to Malignant Tumors,” Am. J. Surg. 30, 31-34 (Feb. 1926).

[5] See, e.g., James A. Tobey, Public Health Law 321 (3ed 1947) (“Although there is little, if any, scientific evidence to prove conclusively that malignant growths such as carcinoma, sarcoma, and other forms of cancer are ever caused by single blows, wounds, injuries, or other forms of trauma, the courts have awarded damages in a number of instances to persons who have developed cancers following single injuries.”) (internal citations omitted).

[6] George R. Monkman, Gregg Orwoll & John C. Ivins, “Trauma and Oncogenesis,” 49 Mayo Clinic Proc. 157 (1974).

[7] The trauma theory of carcinogenesis was discussed and questioned in several law review articles.  See, e.g., Orrin E. Tilevitz, “Judicial Attitudes Towards Legal and Scientific Proof of Cancer Causation,” 3 Colum. J. Envt’l L. 344 (1977); Donald J. Ladanyi, “Impact Trauma As ‘Legal Cause’ of Cancer,” 20 Cleveland State L. Rev. 409 (1971); Theodore Dyke, “Traumatic Cancer?” 15 Clev.-Marshall L. Rev. 472 (1966); Jerry G. Elliott, “Traumatic cancer and ‘an old misunderstanding between doctors and lawyers’,” 13 U. Kan. L. Rev. 79 (1964); Comment, Sufficiency of Proof in Traumatic Cancer: A Medico-Legal Quandary, 16 Ark. L. Rev. 243 (1962); Comment, “Sufficiency of Proof in Traumatic Cancer Cases,” 46 Cornell L.Q. 581 (1961); Adelson, Injury and Cancer, 5 Western Res. L. Rev. 150 (1954).

[8] State Compensation Ins. Fund v. Kindig, 445 P.2d 72 (Colo. 1968) (head injury held not to have caused leukemia 68 days later); Slack v. C.L. Percival Co., 198 Iowa 54, 199 N.W. 323, 326 (1924) (anticipating Daubert by rejecting expert witness opinion that was “wholly in the realm of conjecture, speculation, and surmise”); Ortner v. Zenith Carburetor Co., 207 Mich. 610, 175 N .W. 122 (1919) (holding that 30 months was too long for a claim that accident that crushed worker’s fingers caused blood poisoning and penile cancer); Stordahl v. Rush Implement Co., 417 P.2d 95 (Mont. 1966) (rejecting traumatic causation of malignant tumor); Tonkovich v. Dep’t of Lab. & Indus., 31 Wash. 2d 220, 195 P.2d 638 (1948) (injury to foot held not to have caused abdominal cancer)

[9] See Dennison v. Wing, 279 App. Div. 494, 110 N.Y.S.2d 811, 813 (1952) (rejecting cancer claim when latency was two months on grounds that cancer took longer to develop); Sikora v. Apex Beverage Corp., 282 App. Div. 193, 196-97 (1953) (reversing judgment for plaintiff based upon jury’s finding that slip and fall accelerated breast cancer based upon lack of evidentiary support), aff’d, 306 N.Y. 917, 119 N.E.2d 601 (1954); Frankenheim v. B. Altman & Co., 13 Misc. 2d 1079, 1080-81, 177 N.Y.S.2d 2 (Bronx Cty. S.Ct. 1958) (granting motion to set aside verdict for plaintiff based upon traumatic cancer claim on grounds of insufficient evidence), app. dism’d, 8 App. Div. 2d 809 (First Dep’t 1959). But see McGrath v. Irving, 24 App. Div. 2d 236, 265 N.Y.S.2d 376 (1965) (affirming jury verdict based upon claim that plaintiff’s swallowing glass in car accident caused or accelerated development of laryngeal cancer); Mattfield v. Ward Baking Co., 14 App. Div. 2d 942, 221 N.Y.S.2d 224, 224 (1st Dep’t 1961) (affirming award for traumatic cancer based upon the “usual” conflicting expert witness testimony) Mattfield v. Ward Baking Co., 14 App. Div. 2d 942, 942 (1961) (affirming workman’s compensation award for “aggravation” of cancer, which resulted after “the usual conflict of medical opinion”); Pezzolanti v. Green Bus Lines, 114 App. Div. 2d 553, 553-54, 494 N.Y.S.2d 168, 169 (1985) (affirming workman’s compensation award for disability to wrist, which resulted from “trauma” of hitting pothole, which in turn injured asymptomatic wrist destabilized by pre-existing cancer).

Posted in Causation, Expert Witnesses, Rule 702, Scientific Evidence | Comments Off on Recrudescence of Traumatic Cancer Claims

Intellectual Due Process in West Virginia and Beyond

June 1st, 2014

Harris v. CSX Transportation

I have borrowed and modified the phrase “Intellectual Due Process” from earlier writers because of its obvious implications for the presentation, interpretation, synthesis, and evaluation of scientific evidence in court. See Scott Brewer, “Scientific Expert Testimony and Intellectual Due Process,” 107 Yale L. J. 1535 (1998). The major reason courts write opinions is to explain and justify their decisions to litigants, present and future, and to a wider audience of lawyers, scholars, and the general public. Judicial opinions involving scientific evidence, whether in legislation, regulation, or litigation must satisfy the societal need to explain and justify the acceptance and rejection of scientific claims. Despite a great deal of hand waving that law and science are somehow different, in the end, when courts describe their acceptance or rejection of scientific claims, they are addressing the same epistemic warrant that scientists themselves employ. Even a cursory review of the judicial output reveals an unsatisfactory state of affairs in which many courts mangle scientific and statistical evidence and inference.  There is much that is needed to correct the problem.

One proposal would be to require that the parties file proposed findings of facts in connection with Rule 702 gatekeeping challenges.  Courts should file detailed findings of facts that underlie their decisions to admit or to exclude expert witness opinion testimony.  Another proposal would require courts to cite properly the scientific studies that they discuss in reaching a legal conclusion about sufficiency or admissibility.  These are small steps, but ones that would help reduce the gross inaccuracies and the glib generalizations, while increasing the opportunity for public scrutiny and criticism.

We do not think anything is amiss with special courts for tax, patent, family law, national security, equity, or commercial matters.  There is an even greater need for scientific skill, knowledge, and aptitude in a specialized science court.  The time has come for special courts to hear cases involving scientific claims in health effects and other litigation.

*   *   *   *   *   *   *

A decision of the West Virginia Supreme Court, late last year, illustrates the need for substantial reform of how claiming based upon “scientific evidence” is permitted and evaluated in court.  Mrs. Harris sued the railroad for the wrongful death of her husband, who died of multiple myeloma. Mr. Harris had been exposed, in his railroad workplace, to diesel exhaust, which Mrs. Harris claimed caused his cancer. See Harris v. CSX Transportation, Inc., 232 W.Va. 617, 753 S.E.2d 275 (2013). The trial court excluded Mrs. Harris’s expert witnesses. Harris v. CSX Transportation, Inc., No. 12-1135, 2012 WL 8899119 (Cir. Ct. Marshall Cty., W.Va. Aug. 21, 2012).

1. The West Virginia Supreme Court reversed the trial court’s exclusion of witnesses on the basis of an asymmetrical standard of review, which would allow de novo review of trial court decisions to exclude expert witness opinions, but which would privilege trial court decisions to admit opinions by limiting appellate review to abuse of discretion. This asymmetry was, of course, the same dodge that the Third and Eleventh Circuits had used to keep the “gates open,” regardless of validity or reliability concerns, and the same dodge that the Supreme Court shut down in General Electric v. Joiner. A single judge dissented in Harris, Justice Loughry, who took the majority to task for twisting facts and law to get to a desired result.

2. The Harris Court cited a federal court case for dicta that “Rule 702 reflects an attempt to liberalize the rules governing the admissibility of expert testimony.” See Harris, 753 S.E.2d at 279 (citing and quoting from Weisgram v. Marley Co., 169 F.3d 514, 523 (8th Cir.1999). Remarkably, the Harris Court omitted reference to the United States Supreme Court’s unanimous affirmance of Weisgram, which saw Justice Ginsburg write that “[s]ince Daubert, moreover, parties relying on expert evidence have had notice of the exacting standards of reliability such evidence must meet.” Weisgram v. Marley Co., 528 U.S. 440, 442 (2000).  The Harris Court’s lack of scholarship is telling.

3. Meta-analysis appeared to play a role in the case, but the judicial decisions in Harris fail to describe the proffered evidence. The majority in Harris noted that one of plaintiff’s expert witnesses, Dr. Infante, relied upon a meta-analysis referred to as “Sonoda 2001.” Harris, 753 S.E.2d at 309. Neither the Court nor the dissent cited the published meta-analysis in a way that would help an interested reader in finding the paper.  One could imagine the hue and cry if courts cited judicial cases or statutes by short-hand names without providing enough information to access the relied upon source.  In this case, a PubMed search reveals the source so perhaps the error is harmless. Tomoko Sonoda, Yoshie Nagata, Mitsuru Mori, Tadao Ishida & Kohzoh Imai, “Meta-analysis of multiple myeloma and benzene exposure,” 11. J. Epidemiol. 249 (2001).  Still, the time has come for courts to describe and report the scientific evidence with the same care and detail that they would use in a car collision case.

4. A quick read shows that the Sonoda meta-analysis supports the dissent’s assessment:

“‘Dr. Infante testified on direct examination that Sonoda 2001 considered 8 case-control studies specific to engine exhaust and stated it concluded that diesel and non-diesel engine exhaust causes multiple myeloma.’ Yet, as the trial court found, ‘[o]n cross examination Dr. Infante acknowledged that none of the 8 papers included in the Sonoda meta-analysis mention diesel exhaust’.”

Harris, 753 S.E.2d at 309.  The dissent would have been considerably more powerful had it actually adverted to the language of Sonoda 2001:

“These results suggested that benzene exposure itself was not likely to be a risk factor of MM [multiple myeloma]. It is thought that several harmful chemical agents in engine exhaust, other than benzene, could be etiologically related to the risk of MM. Further case-control studies on MM are needed to obtain more information about detailed occupational exposure to toxic substances.”

Sonoda at 249 (2001) (emphasis added).  Contrary to Infante’s asseveration, Sonoda and colleagues never concluded that diesel exhaust causes multiple myeloma.  The state of scholarship and “intellectual due process” makes it impossible to tell whether or not Dr. Infante was telling the truth or the Harris Court badly misunderstood the record. Either way, something must give.

The dissent went on to note that Dr. Infante conducted his own meta-analysis, which included studies that did not mention diesel exhaust. Harris, 753 S.E.2d at 309.  The railroad complained that some of the studies were small and had limited power, but that is exactly why a meta-analysis would be appropriate.  The more disturbing complaints were that the meta-analysis left out important studies, and that it included irrelevant studies of benzene exposure and myeloma, which raised insuperable problems of external validity.

5. A half empty glass that is always full.  According to the Harris Court, the West Virginia shadow of Rule 702 is a rule of “admissibility rather than exclusion.” Harris, 753 S.E.2d at 279 (citing and quoting from In re Flood Litig. Coal River Watershed, 222 W.Va. 574, 581, 668 S.E.2d 203, 210 (2008), which in turn quoted a federal case, Arcoren v. United States, 929 F.2d 1235, 1239 (8th Cir. 1991), decided before the Supreme Court decided Daubert.)  This is just silly hand waving and blatant partisanship.  A rule that sets out criteria or bases for admissibility also demarcates the inadmissible.

6. Cherry Picking. Dr. Infante was permitted by the Harris Court to aggregate data from studies that did not observe diesel exposure, while he failed to include, or he deliberately excluded data from, a large, powerful, exonerative study conducted by scientists from the National Cancer Institute, the International Agency for Research on Cancer (IARC), and the Karolinska Institute. See Paolo Boffetta, Mustafa Dosemeci, Gloria Gridley, Heather Bath, Tahere Moradi and Debra Silverman, “Occupational exposure to diesel engine emissions and risk of cancer in Swedish men and women,” 12 Cancer Causes Control 365 (2001). Dr. Infante inexplicably excluded this study, which found a risk ratio for men exposed to diesel exhaust that was below one, 0.98, with a very narrow 95% confidence interval, 0.92-1.05. Boffetta at 368, Table 2.

7. The West Virginia articulated an incohorent definition of “reliable,” designed to give itself the ability to reject gatekeeping completely. Citing its earlier decision in Flood, the Court offered its own ipse dixit:

“The assessment of whether scientifically-based expert testimony is “reliable,” as that term is used in [Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993), and Wilt v. Buracker, 191 W.Va. 39, 443 S.E.2d 196 (1993)], does not mean an assessment of whether the testimony is persuasive, convincing, or well-founded. Rather, assessing ‘reliability’ is a shorthand term of art for assessing whether the testimony is to a reasonable degree based on the use of knowledge and procedures that have been arrived at using the methods of science — rather than being based on irrational and intuitive feelings, guesses, or speculation. If the former is the case, then the jury may (or may not, in its sole discretion) ‘rely upon’ the testimony. In re Flood Litig., 222 W.Va. at 582 n. 5, 668 S.E.2d at 211 n. 5.”

Harris, 753 S.E.2d at 279-80. Surely, this is circular or vacuous or both. Opinions not “well-founded” will be ones that are based upon guesses or speculation.  Opinions arrived at by the “methods of science” will be ones that have an epistemic warrant that will survive a claim that they are not “well-founded.”

8. The Harris Court evidenced its hostility to scientific evidence by dredging up one of its own decisions involving a multiple myeloma causation claim, State ex rel. Wiseman v. Henning, 212 W.Va. 128, 569 S.E.2d 204 (2002).  Wiseman involved a specious claim that a traumatic rib injury caused multiple myeloma, a claim at odds with scientific method and observation:

“Some research has suggested that people in some jobs may have an increased risk of developing multiple myeloma because they are exposed to certain chemicals. But the International Agency for Research on Cancer (IARC) states that the evidence is limited overall. It has been suggested that people may have an increased risk if they work in the petrol or oil industry, farming, wood working, the leather industry, painting and decorating, hairdressing, rubber manufacturing or fire fighting. But there is no evidence to prove that any of these occupations carry an increased risk of myeloma.”

Cancer Research UK, “Myeloma risks and causes” (last visited May 28, 2014). Even the most non-progressive jurisdictions have generally eradicated specious claiming for trauma-induced cancers, but West Virginia has carved out a place second to none in its race to the bottom.

9. WOE.  Not surprisingly, the Harris Court relied heavily on the First Circuit’s “weight of the evidence” end-run around the notion of epistemic warrant for scientific claims, citing Milward v. Acuity Specialty Products Group, Inc., 639 F.3d 11 (1st Cir.2011), cert. denied sub nom., U.S. Steel Corp. v. Milward, ___ U.S. ___, 2012 WL 33303 (2012). The Harris Court went on to conflate and confuse WOE with Bradford Hill, and cited a recent New York case that confidently saw through WOE hand waving, while ignoring its devasting critique of expert witnesses’ attempts to pass off WOE for scientific, epistemic warrant.  Reeps ex rel. Reeps v. BMW of N. Am., LLC, No. 100725/08,

2013 WL 2362566, at *3, 2012 N.Y. Misc. LEXIS 5788; 2012 NY Slip Op 33030U  (N.Y. Sup. Ct. May 10, 2013).

10.  Link.  Dr. Infante links a lot, even when his sources do not:

“Dr. Infante testified that the International Agency for Research on Cancer issued Technical Publication Number 42 in 2009, and that the publication stated that diesel exhaust exposures have been linked to multiple myeloma and leukemia.”

Harris, 753 S.E.2d at 294. The Harris Court neglected to give the title of the publication, which tells a different story.  Identification of research needs to resolve the carcinogenicity of high-priority IARC carcinogens. The dissent was willing to go behind the conclusory and false characterization that Dr. Infante and plaintiff gave to this publication.  Harris, 753 S.E.2d at 309. The trial court’s finding (and the dissent’s assertion) that the IARC Technical Publication 42 intended to express a research agenda, not to make a causation statement, seems unassailable.  Furthermore, it appears to be precisely the sort of specious claim that a court should keep from a jury.  The cited IARC source actually notes that the then current IARC classification of diesel exhaust was of inadequate evidence for human carcinogenicity, with a focus on lung cancer, and barely a mention of multiple myeloma.

11.  The Benzene Connection. Plaintiffs’ expert witnesses, including Dr. Infante, argued that benzene was a component of diesel exhaust, and benzene caused multiple myeloma.  This move ignored not only the lack of evidence to implicate benzene in the causation of multiple myeloma, but it also ignored the large quantitative differences between the benzene occupational exposure studies and the very small amounts of benzene in diesel exhaust.  The Harris Court held that the trial court acted improperly by inquiring into and finding the following facts, which were “exclusively” for the jury:

  • “There is substantially more benzene in cigarette smoke than diesel exhaust.
  • Benzene is present only in trivial doses in diesel exhaust.
  • The hypothesis that diesel exhaust causes multiple myeloma is confounded by the fact that cigarette smoking does not.”

The Harris majority further chastised the trial court for adverting to the ten or so studies that failed to find a statistically significant association between benzene exposure and multiple myeloma.  Harris, 753 S.E.2d at 305-06.  This inquiry directly calls into question, however, Dr. Infante’s methodology.

If these facts, found by the trial court, were reasonably established, then Dr. Infante’s argument was less than bogus, and a major underpinning for inclusion of benzene studies in his meta-analysis was refuted.  These are precisely the sort of foundational facts that must be part of an inquiry into the methodological grounds of an expert witness’s opinion.

12.  The Harris Court confused “proving causation” with “showing a methodology that provides an epistemic warrant for concluding.” Harris, 753 S.E.2d at 300. The Harris Court asserted that the trial court exceeded its gatekeeping function by inquiring into whether Mrs. Harris’s expert witnesses “proved” causation. Harris, 753 S.E.2d at 300. Speaking of “proof of” or “proving” causation is an affectation of lawyers, who refer to their evidence as their “proofs.”  Epidemiologic articles and meta-analyses do not end with quod erat demonstrandum. Beyond the curious diction, there is a further issue in the majority’s suggestion that the trial court set the bar too high in declaring that the plaintiff failed to “prove” causation.  Even if we were to accept the continuous nature of strength of evidence for a causal conclusion, Dr. Infante and the other plaintiff’s witnesses, would be fairly low on the curve, and their lowly position must of necessity speak to the merits of the defense motion to exclude under Rule 702.

13. Purely Matters for Jury. The Harris Court criticized the trial court for conducting a “mini-trial,” which set out to “resolve issues that were purely matters for jury consideration.” Harris, 753 S.E.2d at 305. In holding that the matters addressed in the pre-trial hearing were “exclusively grist for the jury and which had no relevancy to the limited role the trial court had under the facts of this case,” the Harris Court displayed a profound disregard for what facts would be relevant for a challenge to the plaintiff’s expert witnesses’ methodology. Many of the facts found by the trial court were directly relevant to “general acceptance,” validity (internal and external) of studies relied upon, and reliability of reasoning and inferences drawn. Aside from the lack of general acceptance and peer review of the plaintiff’s claimed causal relationship, the proffered testimony was filled with gaps and lacunae, which are very much at issue in methodological challenges to an opinion of causality.

*   *   *   *   *   *   *

The Harris case has taken its place next to Milward in the litigation industry’s arsenal of arguments for abandoning meaningful judicial supervision and gatekeeping of expert witness opinion testimony.  See Andrew S. Lipton, “Proving Toxic Harm: Getting Past Slice and Dice Tactics,” 45 McGeorge L. Rev. 707, 731 (2014) (plaintiffs’ bar cheerleading for the Harris decision as “a lengthy and thoughtful analysis”, and for the Milward case as roadmap to evade meaningful judicial oversight).  Not all was perfect with the trial court’s opinion.  The defense seemed to have misled the court by asserting that “a difference between a case group and control group is not statistically significant then there is no difference at all.”  See Respondent’s Brief at 5, Harris v. CSX Transportation, Inc., 2013 WL 4747999 (filed (Feb. 4, 2013) (citing  App. 169, 228-230 (Shields) as having explained that the p-values greater than 0.05 do not support a causal association).

This is hardly true, and indeed, the lack of statistical significance does not lead to a claim that the null hypothesis of no association between exposure and outcome is correct.  The defense, however, did not have a burden of showing the null to be correct; only that there was no reliable method deployed to reject the null in favor an alternative that the risk ratio for myeloma was raised among workers exposed to diesel exhaust.

Still, the trial court did seem to understand the importance of replication, in studies free of bias and confounding. Courts generally will have to do better at delineating what are “positive” and “negative” studies, with citations to the data and the papers, so that judicial opinions provide a satisfactory statement of reasons for judicial decisions.

Posted in Causation, Expert Witnesses, Meta-analysis, Rule 702, Scientific Evidence | Comments Off on Intellectual Due Process in West Virginia and Beyond

Biostatistics and FDA Regulation: The Convergence of Science and Law

May 29th, 2014

On May 20, 2014, the Food and Drug Law Institute (FDLI), the Drug Information Association (DIA), and the Harvard Law School’s Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics, in collaboration with the Harvard School of Public Health Department of Biostatistics and Harvard Catalyst | The Harvard Clinical and Translational Science Center, presented a symposium on“Biostatistics and FDA Regulation: The Convergence of Science and Law.”

The symposium might just as well have been described as the collision of science and law.

The Symposium agenda addressed several cutting-edge issues on statistical evidence in the law, criminal, civil, and regulatory. Names of presenters are hyperlinked to presentations slides that are available.

I. Coleen Klasmeier, of Sidley Austin LLP, introduced and moderated the first section, “Introduction to Statistics and Regulatory Law,” which focused on current biostatistical issues in regulation of drugs, devices, and foods by the Food and Drug Administration (FDA). Qi Jiang, Executive Director of Amgen, Robert T. O’Neill, retired from the FDA, and now Statistical Advisor in CDER, and Jerald S. Schindler, of Merck Research Laboratories, presented.

II. Qi Jiang moderated and introduced the second section on safety issues, and the difficulties presented by meta-analysis and other statistical assessments of safety outcomes in clinical trials and in marketing of drugs and devices. Lee-Jen Wei, of the Harvard School of Public Health, Geoffrey M. Levitt, an Associate General Counsel of Pfizer, Inc., and Janet Wittes, of the Statistics Collaborative, presented.

III. Aaron Katz, of Ropes & Gray LLP, introduced the third section, on “Statistical Disputes in Life Sciences Litigation,” which addressed recent developments in expert witness gatekeeping, the Avandia litigation, and the role of statistics in two recent cases, Matrixx, Inc. v. Siracusano, and United States v. Harkonen.  Anand Agneshwar, of Arnold & Porter LLP, Lee-Jen Wei, Christina L. Diaz, Assistant General Counsel of GlaxoSmithKline, and Nathan A. Schachtman presented.

IV. Christopher Robertson, a law professor now visiting at Harvard Law School, moderated a talk by Robert O’Neill on “Emerging Issues,” at the FDA.

V. Dr. Wittes moderated a roundtable discussion on “Can We Handle the Truth,” which explored developments in First Amendment and media issues involved in regulation and litigation. Anand Agneshwar, and Freddy A. Jimenez, Assistant General Counsel, Johnson & Johnson, presented.

Posted in Meta-analysis, Rule 702, statistical evidence | Comments Off on Biostatistics and FDA Regulation: The Convergence of Science and Law

The Outer Limits (and Beyond?) of Ex Parte Advocacy of Federal Judges

May 23rd, 2014

As every trial lawyer knows, people sometimes reveal important facts in curious ways, incorporated in their own biased narrative of events.  Recently, I heard a recorded lecture about expert witnesses, by a plaintiffs’ lawyer, who revealed a damning fact about a judge.  The lawyer clearly thought that this fact was commendatory, but in fact revealed another effort of scientific advocates and zealots to subvert the neutrality of federal judges.  See In re School Asbestos Litigation, 977 F.2d 764 (3d Cir. 1992) (describing effort by plaintiffs’ lawyers and the late Dr. Irving Selikoff to corrupt state and federal judges with one-sided ex parte presentations of their views at the so-called Third-Wave Conference).

Anthony Z. Roisman is the Managing Partner of the National Legal Scholars Law Firm.  This firm has a roster of affiliated law professors who serve as consultants for plaintiffs in environmental and tort cases. (Some other participants in this law firm include Jay M. Feinman, Lucinda M. Finley, Neil Vidmar, and Richard W. Wright.) Roisman has been active in various plaintiff organizations, including serving as the head of the ATLA Section on Toxic, Environmental & Pharmaceutical Torts (STEP). 

Roisman lectures frequently for the American Law Institute on expert witness issues. Recently, I was listening to an mp3 recording of one of Roisman’s lectures on expert witnesses in environmental litigation.  Given Roisman’s practice and politics, I was not surprised to hear him praise Judge Rothstein’s opinion that refused to exclude plaintiffs’ expert witnesses’ causation opinions in the PPA litigation.  See In re Phenylpropanolamine Prod. Liab. Litig., 289 F. 2d 1230 (2003).  What stunned me, however, was his statement that Judge Rothstein issued her opinion “fresh from a seminar at the Tellus Institute,” which he described as “organization set up by scientist trying to bring common sense to interpretation of science.”

Post hoc; ergo propter hoc?

Judge Rothstein’s PPA decision stands as a landmark of judicial gullibility.  Judge Rothstein conducted hearings and entertaining extensive briefings on the reliability of plaintiffs’ expert witnesses’ opinions, which were based largely upon one epidemiologic study, known as the “Yale Hemorrhagic Stroke Project (HSP).”  In the end, publication in a prestigious peer-reviewed journal proved to be a proxy for independent review: “The prestigious NEJM published the HSP results, further substantiating that the research bears the indicia of good science.” Id. at 1239 (citing Daubert II for the proposition that peer review shows the research meets the minimal criteria for good science). The admissibility challenges were refused.

Ultimately, the HSP study received much more careful analysis before juries, which uniformly returned verdicts for the defense. After one of the early defense verdicts, plaintiffs’ counsel challenged the defendant’s reliance upon underlying data in the HSP, which went behind the peer-reviewed publication, and which showed that the peer review failed to prevent serious errors.  The trial court rejected the plaintiffs’ request for a new trial, and spoke to the significance of challenging the superficial significance of peer review of the key study relied upon by plaintiffs in the PPA litigation:

“I mean, you could almost say that there was some unethical activity with that Yale Study.  It’s real close.  I mean, I — I am very, very concerned at the integrity of those researchers.”

“Yale gets — Yale gets a big black eye on this.”

O’Neill v. Novartis AG, California Superior Court, Los Angeles Cty., Transcript of Oral Argument on Post-Trial Motions, at 46 -47 (March 18, 2004) (Hon. Anthony J. Mohr)

Roisman’s endorsement of the PPA decision may have been purely result-oriented jurisprudence, but what of his enthusiasm for the “learning” that Judge Rothstein received at the Tellus Institute.  Tell us, what is this Tellus Institute?

In 2003, roughly contemporaneously with Judge Rothstein’s PPA decision, SKAPP published a jeremiad against the Daubert decision, with support from none other than the Tellus Group. See Daubert: The Most Influential Supreme Court Ruling You’ve Never Heard Of;  A Publication of the Project on Scientific Knowledge and Public Policy, coordinated by the Tellus Institute (2003). The Tellus Institute website tells us very little specific detail about the Institute’s projects, other than stating some vague and pious goals.  The alignment, however, of the Tellus Institute with David Michael’s SKAPP, which was created with plaintiffs’ lawyers’ funding, certainly seems like a dubious indicator of neutrality and scientific commitment.  See “Skapp a Lot” (April 30, 2010).

We might get a better idea of the organization from the Tellus membership.

Richard Clapp and David Ozonoff are both regular testifiers for plaintiffs in so-called toxic tort and environmental litigation. In an article published about the time of the PPA decision, Clapp and Ozonoff acknowledged having benefited from discussions with colleagues at the Tellus Institute.  See Richard W. Clapp & David Ozonoff, “Environment and Health: Vital Intersection or Contested Territory?” 30 Am. J. L. & Med. 189, 189 (2004) (“This Article also benefited from discussions with colleagues in the project on Scientific Knowledge and Public Policy at Tellus Institute, in Boston, Massachusetts.”).

In the infamous case of Selikoff and Motley and their effort to subvert the neutrality of Judge James M. Kelly in the school district asbestos litigation, the conspiracy was detected in time for a successful recusal effort. In re School Asbestos Litigation, 977 F.2d 764 (3d Cir. 1992).  Unfortunately, in the PPA litigation, there was no disclosure of the efforts by the advocacy group, Tellus Institute, to undermine the neutrality of a federal judge. 

Outside observers will draw their own inferences about whether Tellus was an “honest broker” of scientific advice to Judge Rothstein. One piece of evidence may be SKAPP’s website, which contains a page about Richard Clapp’s courtroom advocacy in the PPA litigation. Additional evidence comes from Clapp’s leadership role in Physicians for Social Responsibility, and his own characterization of himself as a healthcare professional advocate. Clapp, a member of Tellus, was an expert witness for plaintiffs in PPA cases.

Was Clapp present at the Tellus Institute meeting attended by Judge Rothstein? History will judge whether the Tellus Institute participated in corrupting the administration of justice.

Posted in Conflicts of Interest, Expert Witnesses, Rule 702 | Comments Off on The Outer Limits (and Beyond?) of Ex Parte Advocacy of Federal Judges

The Fallacy of Cherry Picking As Seen in American Courtrooms

May 3rd, 2014

After a long winter, the cherry trees are finally managing to blossom.  Before we know it, it will be cherry-picking time.

Cherry picking is a good thing; right?  Cherry picking yields cherries, and cherries are good.  Selective cherry picking yields the best, ripest, sweetest, tastiest cherries. Cherry picking data no doubt yields the best, unbiased, unconfounded, most probative data to be had.  Well, maybe not.

What could be wrong with picking cherries?  At the end of the process you have cherries, and if you do it right, you have all ripe, and no rotten, cherries.  Your collection of ripe cherries, however, will be unrepresentative of the universe of cherries, but at least we understand how and why your cherries were selected.

Elite colleges cherry pick the best high school students; leading law schools cherry pick the top college students; and top law firms and federal judges cherry pick the best graduates from the best law schools.  Lawyers are all-too-comfortable with “cherry picking.”  Of course, the cherry-picking process here has at least some objective criteria, which can be stated in advance of the selection.

In litigation, each side is expected to “cherry pick” the favorable evidence, and ignore or flyblow the contrary evidence.  Perhaps this aspect of the adversarial system induces complacency in judges about selectivity in the presentation of evidence by parties and their witnesses.  In science, this kind of adversarial selectivity is a sure way to inject bias and subjectivity into claims of knowledge.  And even in law, there are limits to this adversarial system. Undue selectivity in citing precedent can land a lawyer in a heap of trouble. See Thul v. OneWest Bank, FSB, No. 12 C 6380, 2013 WL 212926 (N.D. Ill. Jan. 18, 2013) (failure to cite relevant judicial precedent constitutes an ethical offense)

In science, the development of the systematic review, in large measure, has been supported by the widespread recognition that studies cannot be evaluated with post hoc, subjective evaluative criteria. See generally Matthias Egger, George Davey Smith, and Douglas Altman, Systematic Reviews in Health Care: Meta-Analysis in Context (2001).

Farmers pick the cherries they want to go to market, to make money and satisfy customers. The harvesters’ virtue lies in knowing what to pick to obtain the best crop.  The scientist’s virtue lies in the disinterested acquisition of data pursuant to a plan, and the evaluation of the data pursuant to pre-specified criteria.

The scientist’s virtue is threatened by motivations that are all-too human, and all-too common. The vice in science is wanting data that yields marketable publications, grants, promotions, awards, prizes, and perhaps a touch of fame. Picking data based upon a desired outcome is at the very least scientific fallacy if not scientific fraud. Cherry picking does not necessarily imply scienter, but in science, it is a strict liability offense.

The metaphor of cherry picking, mixed as it may be, thus gives us a label for fallacy and error.  Cherry picking incorporates sampling bias, selection bias,  confirmation bias, hasty generalization, and perhaps others as well. As explained recently, in Nature:

“Data can be dredged or cherry picked. Evidence can be arranged to support one point of view. * * * The question to ask is: ‘What am I not being told?’”

William J. Sutherland, David Spiegelhalter & Mark Burgman, “Policy: Twenty tips for interpreting scientific claims,” 503 Nature 335, 337 (2013).

Cherry picking in the orchard may be a good thing, but in the scientific world, it refers to the selection of studies or data within studies to yield results desired results, however misleading or counterfactual.  See Ben Goldacre, Bad Science 97-99 (2008). The selective use of evidence is not a fallacy unique to science. Cherry picking is widely acknowledged to seriously undermine the quality of public debate See Gary Klass, “Just Plain Data Analysis: Common Statistical Fallacies in Analyses of Social Indicator Data” (2008).  See generally Bradley Dowden, “Fallacies,” in James Fieser & Bradley Dowden, eds., Internet Encyclopedia of Philosophy.

The International Encyclopedia of Philosophy describes “cherry picking” as a fallacy, “a kind of error in reasoning.”  Cherry-picking the evidence, also known as “suppressed evidence,” is:

“[i]ntentionally failing to use information suspected of being relevant and significant is committing the fallacy of suppressed evidence. This fallacy usually occurs when the information counts against one’s own conclusion. * * * If the relevant information is not intentionally suppressed but rather inadvertently overlooked, the fallacy of suppressed evidence also is said to occur, although the fallacy’s name is misleading in this case.”

Bradley Dowden, “Suppressed Evidence,” International Encyclopedia of Philosophy (Last updated: December 31, 2010). See also “Cherry picking (fallacy),” Wikipedia (describing cherry picking as the pointing to data that appears to confirm one’s opinion, while ignoring contradictory data).

In 1965, in his landmark paper, Sir Austin Bradford Hill described some important factors to consider in determining whether a clear-cut association, beyond that which we would attribute to chance, was a causal association. Hill, Austin Bradford Hill, “The Environment and Disease: Association or Causation?” 58 Proc. Royal Soc’y Med. 295, 295 (1965).

One of the key Hill factors is, of course, consistent, replicated results.  Surely, an expert witness should not be permitted to manufacture a faux consistency by conducting a partial review.  In birth defects litigation, the problem of  “cherry picking” is so severe that one of the leading professional societies concerned with birth defects has issued a position paper to remind its members, other scientists, and the public that “[c]ausation determinations are made using all the scientific evidence”:

“Causation determinations are made using all the scientific evidence. This evidence is derived from correctly interpreted papers that have been published in the peer-reviewed literature. Unpublished data may be useful if available in sufficient detail for an evaluation and if derived from a source that is known to use reliable internal or external review standards. A National Toxicology program report would be an example of an unpublished source that is typically reliable. All available papers are considered in a scientific deliberation; selective consideration of the literature is not a scientific procedure.”

The Public Affairs Committee of the Teratology Society, “Teratology Society Public Affairs Committee Position Paper Causation in Teratology-Related Litigation,” 73 Birth Defects Research (Part A) 421, 422 (2005) (emphasis added).

* * * * * *

Cherry picking is a main rhetorical device for the litigator. Given the pejorative connotations of “cherry picking,” no one should be very surprised that lawyers and judges couch their Rule 702 arguments and opinions in terms of whether expert witnesses engaged in this fulsome fruitful behavior.

The judicial approach to cherry picking is a just a little schizophrenic. Generally, in the context of exercising its gatekeeping function for expert witnesses, the elimination of cherry picking is an important goal. Lust v. Merrell Dow Pharmaceuticals, Inc., 89 F.3d 594, 596-98 (9th Cir. 1996) (affirming exclusion of Dr. Done in a Chlomid birth defects case; district court found that “Dr. Done has seen fit to ‘pick and chose’ [sic] from the scientific landscape and present the Court with what he believes the final picture looks like. This is hardly scientific.”) (internal citation omitted); Barber v. United Airlines, Inc., 17 Fed. Appx. 433, 437 (7th Cir. 2001) (holding that a “selective use of facts fails to satisfy the scientific method and Daubert”). See also Crawford v. Indiana Harbor Belt Railroad Co., 461 F.3d 844 (7th Cir. 2006) (affirming summary judgment in disparate treatment discharge case, and noting judicial tendency to require “comparability” between plaintiffs and comparison group as a “natural response to cherry-picking by plaintiffs”); Miller v. Pfizer, Inc., 196 F. Supp. 2d 1062, (D. Kan. 2002) (excluding, with aid of independent, court-appointed expert witnesses, a party expert witness, David Healy, who failed to reconcile the fact that other research is contrary to his conclusion), aff’d, 356 F.3d 1326 (10th Cir.), cert denied, 125 S. Ct. 40 (2004).

In Ellis v. Barnhart, the Eighth Circuit affirmed a district court’s reversal of an Administrative Law Judge for “cherry picking” the record in a disability case.  392 F.3d 988 (8th Cir. 2005).  Clearly cherry picking was a bad thing for a judicial officer to do when charged with the administration of justice. Several years later, however, the Eighth Circuit held that a trial court erred in excluding an expert witness for having offered an opinion that ignored the witness’s own prior, contrary opinions, a key National Institutes of Health clinical trial, and multiple other studies.  The adversary’s charges of  “cherry picking” were to no avail. Kuhn v. Wyeth, Inc., 686 F.3d 618, 633 (8th Cir. 2012) (“There may be several studies supporting Wyeth’s contrary position, but it is not the province of the court to choose between the competing theories when both are supported by reliable scientific evidence.”), rev’g Beylin v. Wyeth, 738 F.Supp. 2d 887, 892 (E.D.Ark. 2010) (MDL court) (Wilson, J. & Montgomery, J.) (excluding proffered testimony of Dr. Jasenka Demirovic who appeared to have “selected study data that best supported her opinion, while downplaying contrary findings or conclusions.”).

But wait, the court in Kuhn did not cite its own published opinion on cherry picking in Ellis.  Some might say that the Circuit cherry picked its own precedents to get to a desired result. Anthony Niblett, “Do Judges Cherry Pick Precedents to Justify Extralegal Decisions?: A Statistical Examination,” 70 Maryland L. Rev. 234 (2010) (reviewing charges of cherry picking, and examining data [cherry picked?] from California).

The situation in the federal trial courts is chaotic. Most of the caselaw recognizes the fallacy of an expert witness’s engaging in ad hoc selection of studies upon which to rely.  Federal courts, clear on their gatekeeping responsibilities and aware of the selection fallacy, have condemned cherry-picking expert witnesses. Judge Lewis Kaplan, in the Southern District of New York, expressed the proper judicial antipathy to cherry picking:

“[A]ny theory that fails to explain information that otherwise would tend to cast doubt on that theory is inherently suspect,” and “courts have excluded expert testimony ‘where the expert selectively chose his support from the scientific landscape.’”

In re Rezulin Prod. Liab. Litig., 369 F. Supp. 2d 398, 425 & n.164 (S.D.N.Y. 2005) (citation omitted).

Judge Breyer, of the Northern District of California, expressed similar sentiments in ruling on Rule 702 motions in the Celebrex personal injury litigation:

“these experts ignore the great weight of the observational studies that contradict their conclusion and rely on the handful that appear to support their litigation-created opinion.”

In re Bextra & Celebrex Mktg. Sales Pracs. & Prods. Liab. Litig., 524 F. Supp. 2d 1166, 1181 (N.D. Cal. 2007).  The “cherry-picking” of favorable data “does not reflect scientific knowledge, is not derived by the scientific method, and is not ‘good science.’” Id. at 1176.

Other illustrative federal cases include:

In re Bausch & Lomb, Inc., 2009 WL 2750462 at *13-14 (D.S.C. 2009) (“Dr. Cohen did not address [four contradictory] studies in her expert reports or affidavit, and did not include them on her literature reviewed list [. . .] This failure to address this contrary data renders plaintiffs’ theory inherently unreliable.”)

Rimbert v. Eli Lilly & Co., No. 06-0874, 2009 WL 2208570, *19 (D.N.M. July 21, 2009) )(“Even more damaging . . . is her failure to grapple with any of the myriad epidemiological studies that refute her conclusion.”), aff’d, 647 F.3d 1247 (10th Cir. 2011) (affirming exclusion but remanding to permit plaintiff to find a new expert witness)

LeClercq v. The Lockformer Co., No. 00C7164, 2005 WL 1162979, at *4, 2005 U.S. Dist. LEXIS 7602, at *15 (N.D. Ill. Apr. 28, 2005) (“failure to discuss the import of, or even mention … material facts in [expert] reports amounts to ‘cherry-pick[ing]’ … and such selective use of facts fail[s] to satisfy the scientific method and Daubert.”) (internal citations and quotations omitted)

Contractors Ass’n of E. Pa. Inc. v. City of Philadelphia, 893 F. Supp. 419, 436 (E.D. Pa., 1995) (holding that expert witness opinion was unreliable when witness’s conclusions rested on incomplete factual data)

Galaxy Computer Servs. Inc. v. Baker, 325 B.R. 544 (E.D. Va. 2005) (excluding expert witness when witness relied upon incomplete data in reaching a valuation assessment).

Dwyer v. Sec’y of Health & Human Servs., No. 03-1202V, 2010 WL 892250, at *14 (Fed. Cl. Spec. Mstr. Mar. 12, 2010)(recommending rejection of thimerosal autism claim)(“In general, respondent’s experts provided more responsive answers to such questions.  Respondent’s experts were generally more careful and nuanced in their expert reports and testimony. In contrast, petitioners’ experts were more likely to offer opinions that exceeded their areas of expertise, to “cherry-pick” data from articles that were otherwise unsupportive of their position, or to draw conclusions unsupported by the data cited… .”)

Holden Metal & Aluminum Works, Ltd. v. Wismarq Corp., No. 00C0191, 2003 WL 1797844, at *2 (N.D. Ill. Apr. 3, 2003) (“Essentially, the expert ‘cherrypicked’ the facts he considered to render his opinion, and such selective use of facts failed to satisfy the scientific method and Daubert.”) (internal citation omitted).

Flue-Cured Tobacco Cooperative Stabilization Corp. v. EPA, 4 F. Supp. 2d 435, 459 – 60  (M.D.N.C. 1998) (finding that  EPA’s selection of studies for inclusion in a meta-analysis to be “disturbing,” and that agency’s selective, incomplete inclusion of studies violated its own guidelines for conducting risk assessments), rev’d on other grounds, 313 F.3d 852, 862 (4th Cir. 2002) (Widener, J.) (holding that the issuance of the report was not “final agency action”)

Fail-Safe, LLC v. AO Smith Corp., 744 F. Supp. 2d 870, 889 (E.D. Wis. 2010) (“the court also finds the witness’s methodology unreliable because of how Dr. Keegan uniformly treated all evidence that undermined his underlying conclusion: unwarranted dismissal of the evidence or outright blindness to contrary evidence. … In fact, it is readily apparent that Dr. Keegan all but ‘cherry picked’ the data he wanted to use, providing the court with another strong reason to conclude that the witness utilized an unreliable methodology. * * * Dr. Keegan’s two reports are rich with examples of his ‘cherry picking’ of the evidence.”)

As noted, however, there are federal trial courts that are all too willing to suspend judgment and kick the case to the jury.  Here is a sampler of cases that found cherry picking to be an acceptable methodology, or at least a methodology sufficient to require that the case be submitted to the finder of fact.

In Berg v. Johnson & Johnson, the district court noted the defendants’ argument that proffered testimony is unreliable because witness “cherry-picked” data in order to form an opinion solely for purposes of litigation. 940 F.Supp. 2d 983, 991-92 (D.S.D. 2013). The trial judge, however, was not willing to look particularly closely at what was excluded or why:

“The only difference between his past and present research seems to exist in how he categorized his data. Defendants label this ‘cherry-picking’. The court views it as simply looking at the existing data from a different perspective.”

Id.  Of course, expert witnesses on opposite sides look at the case from different perspectives, but the question begged was whether the challenged expert witness had categorized data in an unprincipled way. Other cases of this ilk include:

United States v. Paracha, 2006 WL 12768, at *20 (S.D. N.Y. Jan. 3, 2006) (rejecting challenge to terrorism expert witness on grounds that he cherry picked evidence in conspiracy prosecution involving al Queda)

In re Chantix (Varenicline) Products Liab. Litig., 889 F. Supp. 2d 1272, 1288 (N.D. Ala. 2012) (“Why Dr. Kramer chose to include or exclude data from specific clinical trials is a matter for cross-examination, not exclusion under Daubert.“)

Bouchard v. Am. Home Prods. Corp., 2002 WL 32597992 at *7 (N.D. Ohio May 24, 2002) (“If Bouchard believes that [the expert]… ignored evidence that would have required him to substantially change his opinion, that is a fit subject for cross-examination, not a grounds for wholesale rejection of an expert opinion.”)

In re Celexa & Lexapro Prods. Liab. Litig., 927 F. Supp. 2d 758, 2013 WL 791780, at *5, *7, *8 (E.D. Mo. 2013) (Sippel, J.) (rejecting challenge to David Healy in antidepressant suicide case)

Allen v. Takeda Pharms., MDL No. 6:11-md-2299, No. 12-cv-00064, 2013 WL 6825953, at *11 (W.D. La. Dec. 20, 2013) (challenged expert witness in Actos litigation sufficiently explained his choices to be exonerated from charges of cherry picking)

In re NuvaRing Prods. Liab. Litig., No. 4:08–MD–1964 RWS, 2013 WL 791787 (E.D. Mo. Mar. 4, 2013) (“As to cherry picking data, the Eighth Circuit has recently made clear that such allegations should be left for crossexamination.”)

McClellan v. I-Flow Corp., 710 F. Supp. 2d 1092, 1114 (D. Ore. 2010) (“Defendants are correct that plaintiffs’ experts must elucidate how the relevant evidence lends support to their opinions by explaining…..”) (rejecting cherry picking but denying Rule 702 challenge based in part upon alleged cherry picking)

Rich v. Taser Internat’l, Inc., No. 2:09–cv–02450–ECR–RJJ, 2012 WL 1080281, at *6 (D. Nev. March 30, 2012) (noting the objection to cherry picking but holding that it was an issue for cross-examination)

In re Urethane Antitrust Litig., No. 04-1313-JWL, MDL No. 1616, 2012 WL 6681783, at *3 (D. Kan. Dec. 21, 2012) (allowing expert testimony that “certain events are consistent with collusion”; “the extent to which [an expert] considered the entirety of the evidence in the case is a matter for cross-examination.”)

In re Titanium Dioxide Antitrust Litig., No. RDB-10-0318, 2013 WL 1855980, 2013 U.S. Dist. LEXIS 62394 (D. Md. May 1, 2013) (rejecting Rule 702 cherry-picking challenge to an expert who cherry picked; witness’s selection of documents upon which to rely from a record that exceeded 14 million pages was not unreliable. “ If important portions of the record were overlooked, then the Defendants may address that issue at trial.”)

STATE COURTS

The situation in state courts is similarly chaotic and fragmented.

In Lakey v. Puget Sound Energy, Inc., the Washington Supreme Court resoundingly rejected “cherry picking” by expert witnesses in a public and private nuisance case against a local utility for fear of future illnesses from exposure to electro-magnetic frequency radiation (EMF).  Lakey v. Puget Sound Energy, Inc., 176 Wn.2d 909 (2013). The court held that the plaintiffs’ expert witnesses’ cherry-picking approach to data and studies was properly excluded under Rule 702. Their selective approach vitiated the reliability of his opinion with the consequence of :

“seriously tainting his conclusions because epidemiology is an iterative science relying on later studies to refine earlier studies in order to reach better and more accurate conclusions. Carpenter refused to account for the data from the toxicological studies, which epidemiological methodology requires unless the evidence for the link between exposure and disease is unequivocal and strong, which is not the case here. Carpenter also selectively sampled data within one of the studies he used, taking data indicating an EMF-illness link and ignoring the larger pool of data within the study that showed no such link, Carpenter’s treatment of this data created an improper false impression about what the study actually showed.”

Id.; see also “Washington Supreme Court Illustrates the Difference Between Frye and Rule 702” (April 15, 2013).

Other state Supreme Courts have recognized and rejected the gerrymandering of scientific evidence.  Betz v. Pneumo Abex LLC, 2012 WL 1860853, *16 (May 23, 2012 Pa. S. Ct.)(“According to Appellants, moreover, the pathologist’s self-admitted selectivity in his approach to the literature is decidedly inconsistent with the scientific method. Accord Brief for Amici Scientists at 17 n.2 (“‘Cherry picking’ the literature is also a departure from ‘accepted procedure’.”)); George v. Vermont League of Cities and Towns, 2010 Vt. 1, 993 A.2d 367, 398 (Vt. 2010)(expressing concern about how and why plaintiff’s expert witnesses selected some studies to include in their “weight of evidence” methodology.  Without an adequate explanation of selection and weighting criteria, the choices seemed “arbitrary” “cherry picking.”); Bowen v. E.I. DuPont de Nemours & Co., 906 A.2d 787, 797 (Del. 2006) (noting that expert witnesses cannot ignore studies contrary to their opinions).

Lower state courts have also quashed the cherry-picking harvest. Scaife v. AstraZeneca LP, 2009 WL 1610575, at *8 (Del. Super. June 9, 2009) (“Simply stated, the expert cannot accept some but reject other data from the medical literature without explaining the bases for her acceptance or rejection.”); see also In re Bextra & Celebrex Prod. Liab. Litig., No. 762000/2006, 2008 N.Y. Misc. LEXIS 720, at *47 (Sup. Ct. N.Y. Co. Jan 7, 2008) (stating that plaintiffs must show that their experts “do not ignore contrary data”).

The Nebraska Supreme Court appears to recognize the validity of considering the existence of cherry-picking in expert witness gatekeeping.  In practice, however, that Court has shown an unwillingness to tolerate close scrutiny into what was included and excluded from the expert witness’s consideration.  King v. Burlington No. Santa Fe Ry, ___N.W.2d___, 277 Neb. Reports 203, 234 (2009)(noting that the law does “not preclude a trial court from considering as part of its reliability inquiry whether an expert has cherry-picked a couple of supporting studies from an overwhelming contrary body of literature,” but ignoring the force of the fallacious expert witness testimony by noting that the questionable expert witness (Frank) had some studies that showed associations between exposure to diesel exhaust or benzene and multiple myeloma).

“Of all the offspring of time, Error is the most ancient, and is so old and familiar an acquaintance, that Truth, when discovered, comes upon most of us like an intruder, and meets the intruder’s welcome.”

Charles MacKay, Extraordinary Popular Delusions and the Madness of Crowds (1841)

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On The Quaint Notion That Gatekeeping Rules Do Not Apply to Judges

April 27th, 2014

In In re Zurn Pex Plumbing Prods. Liab. Litig., 644 F.3d 604 (8th Cir. 2011), the United States Court of Appeals for the Eighth Circuit rejected the defendant’s argument that a “full and conclusive” Rule 702 gatekeeping procedure was required before a trial court could certify a class action under the Federal Rules. The Circuit remarked that “[t]he main purpose of Daubert exclusion is to protect juries from being swayed by dubious scientific testimony,” an interest “not implicated at the class certification stage where the judge is the decision maker.”  Id. at 613.

Surely, one important purpose of Rule 702 is to protect juries against dubious scientific testimony, but judges are not universally less susceptible to dubious testimony.  There are many examples of judges being misled by fallacious scientific evidence, especially when tendentiously presented by advocates in court.  No jury need be present for dubious science testimony + “zealous” advocacy to combine to create major errors and injustice.  See, e.g., Wells v. Ortho Pharmaceutical Corp., 615 F. Supp. 262 (N.D. Ga. 1985)(rendering verdict for plaintiffs after bench trial), aff’d and rev’d in part on other grounds, 788 F.2d 741 (11th Cir.), cert. denied, 479 U.S.950 (1986); Hans Zeisel & David Kaye, Prove It With Figures: Empirical Methods in Law and Litigation § 6.5 n.3, at 271 (1997) (characterizing Wells as “notorious,” and noting that the case became a “lightning rod for the legal system’s ability to handle expert evidence.”).  Clearly Rule 702 does not exist only to protect juries.

Nemo iudex in causa sua! Perhaps others should judge the competence of judges’ efforts at evaluating scientific evidence.  At the very least, within the institutional framework of our rules of civil procedure and evidence, Rule 702 creates a requirement of structured inquiry into expert opinion testimony before the court.  That gatekeeping inquiry, and its requirement of a finding, subject to later appellate review and to public and professional scrutiny, are crucial to the rendering of intellectual due process in cases that involve scientific and technical issues.  The Eighth Circuit was unduly narrow in its statement of the policy bases for Rule 702, and their applicability to class certification.

The case of Obrey v. Johnson, 400 F.3d 691 (9th Cir. 2005) provides another cautionary tale about the inadequacies of judges in the evaluation of scientific and statistical evidence.  The plaintiff, Mr. Obrey, sued the Navy on a claim of race discrimination in promoting managers at the Pearl Harbor Naval Shipyard.  The district court refused plaintiff’s motion to admit the testimony of a statistician, Mr. James Dannemiller, President of the SMS Research & Marketing Services, Inc. The district court also excluded much of plaintiff’s anecdotal evidence, and entered summary judgment.  Id. at 691 – 93.

On appeal, Obrey claimed that Dannemiller’s report showed “a correlation between race and promotion.” Id. at 693. This vague claim seemed good enough for the Ninth Circuit, which reversed the district court’s grant of summary judgment and remanded for trial.

The Ninth Circuit’s opinion does not tell us what sort of correlation was supposedly shown by Mr. Dannemiller. Was it Pearson’s r?  Or Jaspen’s multi-serial coefficient? Spearman’s ρ?  Perhaps Kendall’s τ? Maybe the appellate court was using correlation loosely, and Mr. Dannemiller had conducted some other sort of statistical analysis. The district court’s opinion is not published and is not available on Westlaw.  It is all a mystery. More process is due the litigants and the public.

Even more distressing than the uncertainty as to the nature of the correlation is that the Ninth Circuit does not tell us what the correlation “effect size” was, or whether the correlation was statistically significant.  If the Circuit did not follow strict hypothesis testing, perhaps it might have told us the extent of random error in the so-called correlation.  The Circuit did not provide any information about the extent or the precision of the claim of a “correlation”; nor did the Circuit assess the potential for bias or confounding in Mr. Dannemiller’s analysis.

Indeed, the Ninth Circuit seemed to suggest that Mr. Dannemiller never even showed a correlation; rather the court described Mr. Dannemiller as having opined that there was “no statistical evidence in these data that the selection process for GS-13 through GS-15 positions between 1999 and 2002 was unbiased with respect to race.” Id. at 694. Reading between the lines, it seems that the statistical evidence was simply inconclusive, and Mr. Dannemiller surreptitiously shifted the burden of proof and offered an opinion that the Navy had not ruled out bias. The burden, of course, was on Mr. Obrey to establish a prima facie case, but the appellate court glossed over this fatal gap in plaintiff’s evidence.

On appeal, the Navy pressed its objections to the relevance and reliability of Mr. Dannemiller’s opinions. Brief of the Navy, 2004 WL 1080083, at *1 (April 7, 2004).  There seemed to be no dispute that Mr. Dannemiller’s “study” was based entirely upon “statistical disparities,” which failed to take into account education, experience, and training.  Mr. Dannemiller appeared to have simplistically compared race make up of the promoted workers, ignoring the Navy’s showing of the relevancy of education, experience, and training.  Id. at *13, 18.

The Ninth Circuit not only ignored the facts of the case, it ignored its own precedents.  See Obrey v. Johnson, 400 F.3d at 696 (citing and quoting from Coleman v. Quaker Oats Co., 232 F.3d 1271, 1283 (9th Cir. 2000) (“Because [the statistics] failed to account for many factors pertinent to [the plaintiff], we conclude that the statistics are not enough to take this case to trial.”). The court, in Obrey, made no effort to distinguish its treatment of the parties in Coleman, or to justify its decision as to why the unspecified, unquantified, mysterious statistical analysis of Mr. Dannemiller sufficed under Rule 702. The Circuit cryptically announced that “Obrey’s evidence was not rendered irrelevant under Rule 402 simply because it failed to account for the relative qualifications of the applicant pool.”  Obrey, 400 F.3d at 695.  Citing pre-Daubert decisions for the most part (such as Bazemore), the Ninth Circuit persuaded itself that Rule 702 requires nothing more than simple relevancy. Had the Circuit taken even a cursory look at Bazemore, it would have seen that the case involved a much more involved multiple regression than whatever statistical analysis Mr. Dannemiller propounded.  And the Ninth Circuit would have seen that even the Bazemore decision acknowledged that there may be

“some regressions so incomplete as to be inadmissible as irrelevant… .”

478 U.S. 385, 400 n.10 (1986). It is difficult to imagine a discrimination claim analysis more incomplete than one that did not address education, training, and experience.

Sadly, neither the Navy’s nor Mr. Obrey’s brief, 2004 WL 545873 (Feb. 4, 2004) provided any discussion of the nature, quality, findings, or limits of Mr. Dannemiller’s statistical analysis.  The Navy’s brief referred to Mr. Dannemiller as a “purported” expert.  His resume, available online, shows that Mr. Dannemiller studied history as an undergraduate, and has a master’s degree in sociology. He is the president of SMS Research, a consulting company.

The taxpayers deserved better advocacy from the Department of Justice, and greater attention to statistical methodology from its appellate judges.  See ATA Airlines, Inc. v. Federal Exp. Corp., 665 F.3d 882, 888-96 (2011) (Posner, J.) (calling for lawyers and judges to do better in understanding and explaining, in plain English, the statistical analyses that are essential to their cases). Judges at level need to pay greater attention to the precepts of Rule 702, even when there is no jury around to be snuckered.

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Duty of Objectivity for Expert Witnesses – Up North and Abroad

April 19th, 2014

In the United States, we talk of the requirements for admissibility of expert witness opinion testimony; proffered testimony must be relevant and reliable.  If the requirements go unsatisfied, the legal consequence is usually limited to the preclusion of the expert witness’s challenged opinion.  If the opinion is necessary to support the sponsoring party’s claim or defense, the further legal consequence may be the entry of judgment adverse to the retaining party.

A few states have permitted a party to sue its own expert witness for “expert malpractice,” committed in the scope of the witness’s engagement as an expert witness. See, e.g., LLMD of Michigan Inc. v. Jackson-Cross Co., 740 A.2d 186 (Pa. 1991). Fewer states permit the adverse party to sue its adversary’s expert witness. Davis v. Wallace, 565 S.E.2d 386 (W. Va. 2002).

In the United Kingdom and Canada, courts impose duties directly upon expert witnesses themselves.  The following enumeration is frequently cited as setting forth the independent duties, owed to the court, by expert witnesses:

“1. Expert evidence presented to the Court should be, and should be seen to be, the independent product of the expert uninfluenced as to form or content by the exigencies of litigation.

2. An expert witness should provide independent assistance to the Court by way of objective unbiased opinion in relation to matters within his expertise. An expert witness in the High Court should never assume the role of an advocate.)

3.  An expert witness should state the facts or assumption upon which his opinion is based. He should not omit to consider material facts which could detract from his concluded opinion.

4.  An expert witness should make it clear when a particular question or issue falls outside his expertise.

5.  If an expert’s opinion is not properly researched because he considers that insufficient data is available, then this must be stated with an indication that the opinion is no more than a provisional one.  In cases where an expert witness who has prepared a report could not assert that the report contained the truth, the whole truth and nothing but the truth without some qualification, that qualification should be stated in the report.

6.  If, after exchange of reports, an expert witness changes his view on a material matter having read the other side’s expert’s report or for any other reason, such change of view should be communicated (through legal representatives) to the other side without delay and when appropriate to the Court.

7.   Where expert evidence refers to photographs, plans, calculations, analyses, measurements, survey reports or other similar documents, these must be provided to the opposite party at the same time as the exchange of reports.”

National Justice Compania Naviera S.A. v. Prudential Assurance Co. Ltd., (“The Ikarian Reefer”), [1993] 2 Lloyd’s Rep. 68 at 81-82 (Q.B.D.), rev’d on other grounds [1995] 1 Lloyd’s Rep. 455 at 496 (C.A.)(embracing the enumeration of duties).

It is unclear, however, what the consequences of breach of these duties are.  Often the sponsoring party may be complicit in the breach, and the harm will be to the court and the adverse party. 

In the United States, perhaps the heavy lifting of judicial gatekeeping, required by Federal Rule of Evidence 702, might be assisted in recognizing these independent duties of expert witnesses.

The duties of expert witnesses, set out in the The Ikarian Reefer, have been generally accepted by courts in Ontario and throughout Canada. See, e.g., Frazer v. Haukioja, 2008 CanLII 42207, at ¶141 (O.S.C.) (Moore, J.) (quoting from Ikarian Reefer).  The Ontario court system decided not to leave compliance with these duties to chance or instructions from counsel. Starting in 2010, Ontario’s New Rule 4.1 of its Rules of Civil Procedure went into effect to define explicitly the duties of an expert witness:

RULE 4.1 DUTY OF EXPERT

4.1.01 (1)

It is the duty of every expert engaged by or on behalf of a party to provide evidence in relation to a proceeding under these rules,

(a) to provide opinion evidence that is fair, objective and non-partisan;

(b) to provide opinion evidence that is related only to matters that are within the expert’s area of expertise; and

(c) to provide such additional assistance as the court may reasonably require to determine a matter in issue.

Duty Prevails

The duty stated in the Ontario Rule 4.1 trumps any contractual or positional obligations expert witnesses may owe to the parties that engaged them. Remarkably, the Ontario courts do not leave to chance whether expert witnesses will understand and act upon their mandated obligations.  Ontario Rule 53,  subrule 53.03(2.1), requires expert witnesses to submit signed acknowledgment forms (Form 53, below), which recite their understand of their duties.

FORM 53

 Courts of Justice Act

 ACKNOWLEDGMENT OF EXPERT’S DUTY

 1. My name is _______________________________ (name). I live at

___________________ (address), in the __________________ (name of city) of _________________________ (name of province/state).

2. I have been engaged by or on behalf of ___________________ (name of party/parties) to provide evidence in relation to the above-noted court proceeding.

3. I acknowledge that it is my duty to provide evidence in relation to this proceeding as follows:

a. To provide opinion evidence that is fair, objective and non-partisan;

b. To provide opinion evidence that is related only to matters that are within my area of expertise; and

c. To provide such additional assistance as the court may reasonably require, to determine a matter in issue.

4. I acknowledge that the duty referred to above prevails over any obligation which I may owe to any party by whom or on whose behalf I am engaged.

 

Date: ___________________  ___________________________                                                                                             (signature)

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Relative Risk of Two in Medical Malpractice Cases

April 14th, 2014

Counsel for plaintiffs and defendants in toxic tort cases are well aware of the need to show a sufficiently large relative risk, greater than two, to have sufficient evidence to satisfy the burden of proof on proximate causation between a known causal exposure and a specific plaintiff’s injury.  As Judge Jack Weinstein wrote 30 years ago, “[a] government administrative agency may regulate or prohibit the use of toxic substances through rulemaking, despite a very low probability of any causal relationship.  A court, in contrast, must observe the tort law requirement that a plaintiff establish a probability of more than 50% that the defendant’s action injured him. … This means that at least a two-fold increase in incidence of the disease attributable to Agent Orange exposure is required to permit recovery if epidemiological studies alone are relied upon.” In re Agent Orange Product Liab. Litig., 597 F. Supp. 740, 785, 836 (E.D.N.Y. 1984), aff’d 818 F.2d 145, 150-51 (2d Cir. 1987)(approving district court’s analysis), cert. denied sub nom. Pinkney v. Dow Chemical Co., 487 U.S. 1234 (1988).

In toxic tort cases, the risk ratio at issue allegedly results from a higher incidence of the disease in exposed persons compared to the incidence in unexposed persons.  A similar risk ratio issue occurs in medical malpractice cases when a healthcare provider negligently fails to administer a therapy, or fails to administer a therapy in a timely fashion, to the detriment of the plaintiff.  In instances in which the therapy is almost always efficacious, the risk ratio of a bad patient outcome will be very high, and the corresponding probability that the bad outcome would have been avoided by proper or timely therapy will be close to 100 percent.  On the other hand, for some therapies, even timely administration is efficacious in a limited number of cases, less often than the 50-plus percent of cases that would support a proximate cause opinion between the allegedly negligent failure to administer therapy and the patient’s bad health outcome.

Unfortunately, the relative risk issue goes unlitigated in many cases, in New York and elsewhere. One recurring malpractice claim involves the alleged failure to administer clot-busting drugs to ischemic stroke patients.  One such drug, tissue plasminogen activator (t-PA), which was approved by the Food and Drug Administration in 1996, can substantially reduce brain damage if administered within three hours of stroke onset.  Even if administered within the crucial therapeutic time window, however, t-PA will benefit only about 30 percent of patients, and there is no medical “fingerprint”that identifies who has benefitted from the t-PA. In Samaan v. St. Joseph Hospital, 670 F.3d 21 (1st Cir. 2012), the First Circuit acted on its gatekeeping responsibilities to perscrutate the risk evidence and found that it fell short of what is required by Federal Rule of Evidence 702, and the “more likely than not” standard for civil cases. See also Smith v. Bubak, 643 F.3d 1137, 1141–42 (8th Cir.2011) (rejecting relative benefit testimony and suggesting in dictum that absolute benefit “is the measure of a drug’s overall effectiveness”); Young v. Mem’l Hermann Hosp. Sys., 573 F.3d 233, 236 (5th Cir.2009) (holding that Texas law requires a doubling of the relative risk of an adverse outcome to prove causation), cert. denied, ___ U.S. ___, 130 S.Ct. 1512 (2010).

Samaan and the cases cited by the First Circuit are hardly unique; the size of the relative risk issue has helped the defense prevail in other t-PA and similar malpractice cases around the country. Kava v. Peters, 450 Fed.Appx. 470, 478-79 (6th Cir. 2011) (affirming summary judgment for defendants when plaintiffs expert witnesses failed to provide clear testimony that plaintiff specific condition would have been improved by timely administration of therapy); Bonesmo v. The Nemours Foundation, 253 F.Supp. 2d 801, 809 (D.Del. 2003); Joshi v. Providence Health System of Oregon Corp., 342 Or. 152, 156, 149 P. 3d 1164, 1166 (2006) (affirming directed verdict for defendants when expert witness testified that he could not state, to a reasonable degree of medical probability, beyond 30%, that administering t-PA, or other anti-coagulant would have changed the outcome and prevented death); Ensink v. Mecosta County Gen. Hosp., 262 Mich.App. 518, 687 N.W.2d 143 (Mich.App. 2004) (affirming summary judgment for hospital and physicians when patient could not greater than 50% probability of obtaining a better result had emergency physician administered t-PA within three hours of stroke symptoms); Merriam v. Wanger, 757 A.2d 778, 2000 Me. 159 (2000) (reversing judgment on jury verdict for plaintiff on grounds that plaintiff failed to show that defendant failure to act were, more likely than not, a cause of harm). In Michigan, the holding of the t-PA and similar medical malpractice cases has been codified by statute:

“In an action alleging medical malpractice, the plaintiff has the burden of proving that he or she suffered an injury that more probably than not was proximately caused by the negligence of the defendant or defendants. In an action alleging medical malpractice, the plaintiff cannot recover for loss of an opportunity to survive or an opportunity to achieve a better result unless the opportunity was greater than 50%.”

Mich. Comp. Laws § 600.2912a(2) (2009).  But see O’Neal v. St. John Hosp. & Med. Ctr., 487 Mich. 485, 791 N.W.2d 853 (Mich. 2010) (affirming denial of summary judgment when failure to administer therapy (not t-PA) in a timely fashion more than doubled the risk of stroke). In one unpublished Kentucky case, involving t-PA, the court seemed to acknowledge the general principle, but became confused as to whether 30 percent, was a reasonable probability. Lake Cumberland, LLC v. Dishman, 2007 WL 1229432, *5 (Ky. Ct. App. 2007) (unpublished) (citing without critical discussion an apparently innumerate opinion of expert witness Dr. Lawson Bernstein).

Despite the success of medical malpratice defense counsel in litigating dispositive motions in t-PA cases, the issue seems to go unnoticed in New York cases. For instance, in Gyani v. Great Neck Medical Group, a stroke victim sued on various allegations of medical malpractice, including failure to administer t-PA.   N.Y. S.Ct. for Nassau Cty, 2011 WL 1430037 (April 4, 2011). The trial court denied summary judgment on proximate cause grounds, and noted that

“[t]he plaintiffs’ expert ultimately opines that the failure to administer t-PA allowed Gyani’s stroke to go untreated and progress to the point of her being locked-in permanently which would not have happened had t-PA been administered.”

From the court’s opinion, it would appear that defense counsel never pressed beyond this conclusory opinion, devoid of quantified relative risk. Behind the curtain of “ultimate” opinion is an expert without a meaningful basis for his opinion.  It is time to pull the curtain.

Posted in Causation, Expert Witnesses, Risk and Risk Factor, Rule 702 | Comments Off on Relative Risk of Two in Medical Malpractice Cases

“Dummkopf! You’re Fired” – Judge Posner on Expert Witness Gatekeeping

February 15th, 2014

“Equity is a roguish thing, for law we have a measure, know what to trust to. equity is according to the conscience of him that is chancellor, and as that is larger or narrower so is equity. ’Tis all one as if they should make the standard for the measure we call a foot, a chancellor’s foot. What an uncertain measure would this be. One chancellor has a long foot, another a short foot, a third an indifferent foot; ’tis the same thing in the chancellor’s conscience.”

John Selden, The Table Talk of John Selden (1689), at 61 (Samuel Harvey Reynolds, ed., Oxford 1892).

*  *  *  *  *  *  *  *

As Equity in days of old varied with the size of the Chancelor’s foot, today the quality of judicial gatekeeping of expert witness opinion testimony varies with the acumen of the trial judge in the area of the challenged witness’s expertise.  In Apple Inc. v. Motorola, Inc., 2012 WL 1959560 (N.D. Ill. 2012), the parties challenged each other’s damages expert witnesses under Federal Rule 702, only to find that the trial judge was considerably more astute than their expert witnesses. When it came to assessing the validity and reliability of the damages opinions, the trial judge was a veritable “big foot,” kicking the courthouse door closed to some dodgy damage calculations.

The Hon. Richard Posner is a judge of the United States Court of Appeals, for the Seventh Circuit.  Judge Posner is also an economist and a stalwart of law-and-economics jurisprudence. In Apple v. Motorola, Judge Posner sat by designation as a trial judge.   Instead of judging whether a trial judge had abused his or her discretion in admitting or excluding expert witness testimony, Judge Posner had to put his own discretion on the line. 

Judge Posner identified the biggest challenge in gatekeeping as:

“distinguish[ing] between disabling problems with the proposed testimony, which are a ground for excluding it, and weaknesses in the testimony, which are properly resolved at the trial itself on the basis of evidence and crossexamination.”

Apple Inc. v. Motorola, Inc., 2012 WL 1959560, *1. Posner cites old caselaw, arguably superseded by the current Rule 702, for the chestnut that:

“the judge should not exclude evidence simply because he or she thinks that there is a flaw in the expert’s investigative process which renders the expert’s conclusions incorrect. The judge should only exclude the evidence if the flaw is large enough that the expert lacks ‘good grounds’ for his or her conclusions.”

Id. (quoting In re Paoli R.R. Yard PCB Litigation, 35 F.3d 717, 746 (3d Cir.1994)). Of course, flawed reasoning or methodology is the essence of what deprives anyone from making an claim to knowledge; this little chestnut is not very nourishing.

Judge Posner does better in “operationalizing” Kumho Tire for making the distinction between flaws that weaken, and those that vitiate, the epistemic bases for opinions.  Whether an expert witness “employs in the courtroom the same level of intellectual rigor that characterizes the practice of an expert in the relevant field” is a key test for determining on which side of the distinction a challenged opinion falls. Id. at *2 (quoting Kumho Tire Co. v. Carmichael, 526 U.S. 137, 152 (1999)).

“The Kumho principle implies that an expert witness must provide reasons for rejecting alternative hypotheses ‘using scientific methods and procedure’ and the elimination of those hypotheses must be founded on more than ‘subjective beliefs or unsupported speculation, … .’ ”

Id. at *8 (internal citations omitted).

Posner tempers, and dilutes, Kumho by qualifying the Kumho principle to require a testifying expert to use the same approach as used in the relevant field “if it is feasible for him to do so.” Id. at *3. It is always feasible, but rarely seen, for an expert witness to profess insufficient knowledge, facts, or data to give an opinion. Posner goes further and rewrites the statute, Rule 702, which was designed to keep uncertainty from being masqueraded as certainty:

“when the plaintiff has done his best to prove damages his inability to dispel uncertainty concerning the accuracy of his claim is not fatal. But if an expert witness fails to conduct a responsible inquiry that would have been feasible to conduct, his failure cannot be excused by reference to the principle that speculation is permitted in the calculation of damages; that permission presupposes the exhaustion of feasible means of dispelling uncertainty. Uncertainty is a bad; it is tolerated only when the cost of eliminating it would exceed the benefit.”

Id. at *5.  Sometimes the best efforts to eliminate uncertainty will leave us uncertain.  And the issue of acceptable uncertainty is not necessarily tied to the cost of eliminating it.

Nevertheless, Posner goes on to identify multiple unreasonable assumptions, alternative inferences, missing data, and flawed methods that vitiated most of the opinions before him in Apple v. Motorola.

Judge Posner applies the Kumho principle in the context of damages with a series of counterfactual Gedanken experiments.  He asks what if the plaintiff’s expert witness were working for the defendant (and vice versa), and charged with ascertaining the lowest cost to avoid infringing the plaintiff’s patent.  If the expert submitted the most expensive approach, or an extremely speculative, answer, the defendant would indeed fire the expert: “Dummkopf! You’re fired.” Id. at *9. And if the expert offered unverified evidence that came from an interested, adverse party, the expert’s opinion would again be worthy of no consideration.

Judge Posner is at home in the world of assessing economic damages, and as a “Chancellor,” he proved to have a very big foot indeed. The parties’ expert witnesses came up short on almost every damages opinion examined.

Not all evidentiary issues can be resolved by Judge Posner’s economic reductionism as neatly as the damages issues in this patent infringement case.  Posner’s approach is less satisfying in the context of health effects litigation, where expert witnesses will often have the option of proclaiming inadequate knowledge or method to ascertain general or specific causation.  Still Posner’s Gedanken experiments are contagious.  Suppose we were confronted with a birth defect case in which plaintiffs claimed that the mother’s use of a medication in early pregnancy caused the child’s birth defect.  It is generally conceded that most such birth defects have no known cause, but the plaintiffs’ expert witnesses contend that they have conducted a differential etiology and ascribed causation of the baby’s defect to the mother’s use of the defendant’s   medication.  Suppose there was a serious economic (or life-and-death) consequence to the expert’s opinion.  If the defect were drug-induced, there was no surgical or other correction, but if the defect were “idiopathic,” it could be readily repaired surgically.  Would the expert witness, acting as a treating physician, withhold the treatment because he was “reasonably medically certain” that the defect was caused by the drug?  I don’t think so.  Dr. Dummkopf, you’re fired!

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The Capture of the Public Health Community by the Litigation Industry

February 10th, 2014

The American Public Health Association (APHA) is a significant organization ostensibly committed to the improvement of public health. Among its many activities, the APHA publishes a journal, the American Journal of Public Health.  Here is how the APHA describes itself and its activities to advance public health:

“The American Public Health Association champions the health of all people and all communities. We strengthen the profession of public health, share the latest research and information, promote best practices and advocate for public health issues and policies grounded in research. We are the only organization that combines a 140-plus year perspective, a broad-based member community and the ability to influence federal policy to improve the public’s health.”

How could anyone be against the APHA?

A dubious development in the APHA’s history was its evolution as a tool of the litigation industry.  In 2004, after several years of lobbying, agents of the litigation industry managed to push a policy statement past the Association’s leadership, to condemn the requirement of evidence-based reasoning in federal courts in the United States.

The litigation industry’s victory is memorialized in the “Final Minutes of Meetings of the APHA Governing Council, ” held in November 2004, when the industry’s attack on evidence-based science and data transparency, known as “Policy Number: 2004-11 Threats to Public Health Science,” was adopted as an APHA policy statement.

“2004-11” was published in the American Journal of Public Health and is still available on the APHA website, as Policy Number: 2004-11 Threats to Public Health Science.  I have excerpted contentions and recommendations from the APHA policy, in the left column of the chart, below.  My comments are on the right.

 

APHA Policy

Comment
“Acknowledging that within science, absolute proof and perfect information are rare;” Notice the false dichotomy between absolute proof and perfect information and the entire remaining spectrum of scientific information.  This dichotomization has been part of the litigation strategy of passing off hypotheses, preliminary conclusions, unreplicated findings, etc., as though they were acceptable bases for causal conclusions.
“Recognizing that special interests have exploited the nature of science, specifically scientific uncertainty, to delay protective legal and/or regulatory action;” Notice the asymmetry of the accusations; the APHA apparently has no concern for “special interests” that exploit the nature of science by passing off hypotheses as conclusions, and seek to accelerate protective legal and regulatory action by manufacturing faux scientific conclusions.
“Acknowledging that some public health decisions must be made in the absence of perfect scientific information;” “Le mieux est l’ennemi du bien.” But isn’t the good also the enemy of the shabby, dodgy, and fraudulent? Notice again the false dichotomy between “perfect” information and everything else, as though our failing to achieve the perfect opens the door to the worst. True, of course, that sometimes action is needed on incomplete records, but such action is rarely needed for compensation claims.
“Recognizing that special interests, under the guise of a call for “sound science” have sponsored and promoted changes in public policy that have weakened and continue to threaten public health protections;” If the call for sound science cannot be sustained, then this rhetorical gambit will blowback hard on those “special interests.”  Why are these putative scientists, at APHA, so afraid of sound science?
“Recognizing that special interests have challenged highly regarded public health research and researchers, and inappropriately characterized established scientific methods as ‘junk science’;” Mon Dieu!  How cheeky of those special interests.  See the discussion of Dr. Barry S. Levy, below.
“Recognizing that the Daubert decision has propagated misinterpretations and misapplications of scientific principles relied upon throughout the public health sciences, such as insisting that any epidemiologic study that is relied on to support causation demonstrate a twofold increase in risk as well as a reliance on significance testing to determine which scientific findings are to be allowed as evidence;” This contention misunderstands the basic nature of evidence law. Studies, whether they have statistically significant results, or not, are rarely admissible in evidence.  What is admissible, or not, are opinions of duly qualified expert witnesses, who explain and justify the epistemic warrant for their opinions.  With respect to general causation opinions, expert witnesses will often have to show that they have properly ruled out chance, bias, and confounding to arrive at a causal conclusions.  Significance testing can be abused, in both directions, but the APHA ignores the need for having some quantitative approach to assess random variability. As for relative risks greater than two, the APHA is correct that general causation may often be found with small relative risks, but the attribution of causation in an individual claimant often can be made only on probabilistic inferences that will require relative risks greater than two, or even larger.
“Recognizing that special interests are engaged in a campaign to extend Daubert’s reach to those states that have not embraced prescriptive definitions of scientific reliability.” So the APHA makes common cause with those “special interests,” which would abolish all limits on the admissibility of expert witness opinions, and all normative assessments of scientific research.  This position ignores the prescriptive aspect of methodology, and the nature of epistemic warrant in a methodology.

 

What follows from these contentions? 

“Therefore, APHA:”

“Opposes legislation or administrative policies that attempt to define the characteristics of valid public health science, or dictate prescriptive scientific methodologies; and” Admittedly, defining good science is very difficult, but the law often works like science as defining health as the absence of disease.  There are obviously some well-known pathologies of scientific method, and it hardly seems extravagant to urge courts to avoid flaws, fallacies, and fraud.  
“Supports the efforts of other scientific organizations to promote the government’s ability to utilize the best available science to protect the public’s health; and” Of course, sometimes the “best” available science is rather shabby. 
“Urges friend of the court briefs that address the problem inherent in the adoption of Daubert and Daubert-like court rulings, the application of Daubert in regulatory proceedings, and when judges misinterpret scientific evidence in their implementation of the Daubert ruling.” We do not see many APHA-types deploring jury verdicts that offend scientific sensibilities; and so the APHA’s urging here seems again rather one-sided and partisan.  The fact, however, that judges’ misinterpretations of scientific evidence can be criticized publicly is one of the key differences that separates judicial gatekeeping from the black box of jury determinations.

In 2005, the APHA published, in its journal, APJH, a special supplement, “Scientific Evidence and Public Policy,” with

“academic analysis of the conflicts arising in the use of science in regulatory, civil and criminal proceedings. This special issue examines how recent developments in the legal and regulatory arenas have emboldened corporations involved in civil litigation and regulatory proceedings to accuse adversaries of practicing ‘junk science’.”

Apparently, the APHA was not, and is not, concerned with the emboldening the  litigation industry and its efforts to subvert the truth-finding function of civil litigation. 

David Michaels served as the guest editor for the APJH supplement.  Michaels repeated many of the contentions of the 2004 Policy Statement, above, and he added some new ones of his own:

  • Judges are no better than juries in assessing scientific evidence.
  • Scientists evaluate all the evidence by applying a “weight-of-the-evidence” approach.
  • Uncertainty in science is normal and does not mean the underlying science flawed.

David Michaels, “Editorial: Scientific Evidence and Public Policy,” 95 (Supp. 1) Am. J. Pub. Health S5 (2005). These are all serious half truths.  Many judges are quite astute when evaluating scientific evidence, but even the lowest aptitude judges must give articulated reasons for their decisions, which opens up a public process of comment, correction, and criticism.  Juries vote in secret, without having to explain or justify their verdicts.  Scientists, metaphorically speaking, weigh evidence, as do non-scientists, but this opaque metaphor hardly explicates the process of how scientists arrive at conclusions about causal relationships.  And uncertainty is a condition of many scientific fields, but the error lies in trying to pass off tentative, uncertain, preliminary observations and findings as knowledge.

Michaels sees the development of judicial gatekeeping as favoring “the powerful,” and hurting “the weak and vulnerable.” Id. Michaels did not seem to mind if his editorial recommendations favored the litigation industry and hurt the truth.  He now heads up the Occupational Health & Safety Administration.

Here is how Michaels and the APHA described the funding for the AJPH supplement:

“Support for the supplement was provided through unrestricted funding to the Project on Scientific Knowledge and Public Policy (SKAPP) from the Common Benefit Litigation Trust, a fund established by court order in the Silicone Gel Breast Implant Products Liability Litigation. SKAPP is an initiative of scholars that examines the application of scientific evidence in the legal and regulatory arenas. SKAPP is based at the George Washington University School of Public Health and Health Services; more information is available at www.DefendingScience.org.”

See APHA website <http://www.apha.org/about/news/pressreleases/2005/05arenas.htm>, last visited on February 10, 2014.

This pseudo-disclosure is perhaps the most fraudulent aspect of the entire APHA enterprise.  The Common Benefit Trust was a fund that was held back from settlement monies paid by defendants in the silicone gel breast implant litigation.  The Trust was nothing more than the Plaintiffs’ Steering Committee’s war chest, from which it could advance litigation goals within MDL 926 (silicone breast implant cases).  Ironically, the appointment of neutral, court-appointed expert witnesses led to the triumph of “sound science,” and the collapse of the plaintiffs’ counsel house of cards.  Rather than returning their litigation expense fund to the claimants, the plaintiffs’ counsel found a more worthwhile recipient — SKAPP — to advance their litigation goals, if not for MDL 926, then for the next MDL, and the next, and the next….  See SKAPP A LOT; and Conflicted Public Interest Groups.

* * * * * * *

The same year that the APHA published the SKAPP-inspired and funded challenges to Federal Rules of Evidence 702, the APHA awarded its most prestigious award, the Sedgwick Medal, to a physician whose opinions had routinely been found to be unreliable and irrelevant in various litigation industry efforts. “Barry Levy Wins APHA’s Oldest and Most Prestigious Award, the Sedgwick Medal.” (December 11, 2005).

Perhaps the APHA had Levy in mind when it complained that “special interests have challenged highly regarded public health … researchers….”  Dr. Levy seems to have less favorable accolades from trial and appellate judges.  For instance, one federal judge found Levy engaged in a dubious enterprise to manufacture silicosis claims in Mississippi.  In re Silica Products Liability Litigation, 398 F. Supp. 2d 563, 611-16, 622 & n.100 (S.D. Texas 2005) (expressing particular disappointment with Dr. Barry Levy, who although not the worst offender of a bad lot of physicians, betrayed his “sterling credentials” in a questionable enterprise to manufacture diagnoses of silicosis for litigation).[1] Interestingly, Judge Jack’s opinion was not mentioned in the APHA press release for Dr. Levy’s award ceremony.


[1] See Schachtman, Silica Litigation: Screening, Scheming & Suing; Washington Legal Foundation Critical Legal Issues Working Paper Series No. 135 (Dec. 2005) (exploring the ethical and legal implications of the entrepreneurial litigation in which Levy and others were involved). See also Lofgren v. Motorola, Inc., 1998 WL 299925, No. CV 93-05521 (Ariz. Super. Ct., Maricopa Cty. June 1, 1998); Harman v. Lipari, N.J. L. Div. GLO-L-1375-95, Order of Nov. 3, 2000 (Tomasello, J.) (barring the use of Barry Levy in class action for medical monitoring damages); Castellow v. Chevron USA, 97 F.Supp. 2d 780, 793-95 (S.D. Tex. 2000); Knight v. Kirby Inland Marine Inc., 482 F.3d 347 (5th Cir. 2007); Watts v. Radiator Specialty Co., 990 So. 2d 143 (Miss. 2008); Aurand v. Norfolk So. Ry., 802 F.Supp.2d 950 (2011); Mallozzi v. Ecosmart Technologies, Inc., 2013 WL 2415677, No. 11-CV-2884 (SJF)(ARL) (E.D.N.Y. May 31, 2013).

Posted in Conflicts of Interest, Expert Witnesses, Rule 702 | Comments Off on The Capture of the Public Health Community by the Litigation Industry

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