In Lumpenepidemiology, I detailed how one federal judge, the Hon. Helen Berrigan, was willing to “just say no” to bad epidemiology and bad science, and to shut an expert witness’s attempt to distort and subvert scientific methodology. Judge Berrigan closely examined the plaintiffs’ claim that a mother’s ingestion of Paxil caused a child’s heart defect, and found the proffered expert witness testimony to fail legal and scientific standards. Frischhertz v. SmithKline Beecham Corp., 2012 U.S. Dist. LEXIS 181507 (E.D.La. 2012). The plaintiffs’ key expert witness, Dr. Shira Kramer, attempted to provide plaintiffs with a necessary association by “lumping” all birth defects together in her analysis of epidemiologic data of birth defects among children of women who had ingested Paxil (or other SSRIs). Given the clear evidence that different birth defects arise at different times, based upon interference with different embryological processes, the trial court discerned this “lumping” of end points to be methodologically inappropriate. Id. at *13 (citing Chamber v. Exxon Corp., 81 F. Supp. 2d 661 (M.D. La. 2000), aff’d, 247 F.3d 240 (5th Cir. 2001).
Frischhertz was decided in December 2012, the same month that another trial judge, right here in New York City, caught Dr. Shira Kramer in the commission of similar lumpenepidemiology, in Reeps v. BMW of North America, LLC, New York S.Ct., Index No. 100725/08 (New York Cty. Dec. 21, 2012) (York, J.). See William Ruskin, “Frye Decision in BMW Case Results in Exclusion of Plaintiff’s Experts” (Jan. 17, 2013). Reeps was also a birth defects case. Debra Reeps claimed that during the first trimester of her pregnancy, she was exposed to gasoline fumes from a fuel-line leak in her BMS 525i. She also claimed that her son’s adverse birth outcomes (which included severe mental retardation, severe cerebral palsy, and a congenital heart defect) were caused by her inhalation of gasoline fumes. Heading the plaintiffs’ team of expert witnesses in support of these claims, Epidemiologist Shira Kramer opined that all of the boy’s problems were caused by the mother’s exposure to unleaded gasoline fumes.
Kramer’s opinions read like the Berenstain Bears’ guide to epidemiology. She asserted that gasoline vapors and its constituents (toluene, benzene, solvents, etc.), individually or collectively, cause “birth defects” generally, and Sean Reeps’ defects specifically. Kramer also asserted that she used a “weight-of-evidence assessment,” which included a consideration of Bradford Hill’s criteria for judging causality. BMW moved to exclude plaintiffs’ witnesses, including Kramer, on grounds that the witnesses’ evidence and methods were “novel, unorthodox, unreliable and not generally accepted in the relevant scientific communities.” Reeps slip op. at 5. The number of ways that Kramer’s opinions ran afoul of New York law of expert witness opinions is remarkable.
Animal Studies
The animal studies found no relevant adverse birth effects, even at high gasoline fume exposure levels. Kramer and her posse nonetheless cited animal studies involving cancer, miscarriage, and anemia for the general claim that gasoline fumes causes birth defects, as though such defects could all be lumped together.
Case Reports
Kramer relied upon two published papers of case reports in which women were exposed to leaded gasoline and then gave birth to children with malformations. Given that the exposures reported were to leaded gasoline, the case reports were dubious in the first instance. Furthermore, the reported defects were not even the same as those experienced by Sean Reeps. Although the court seemed willing to engage in a discussion of what these case reports might offer towards a synthesis of all evidence, it ultimately recognized that, pace Raymond Wolfinger, plural of anecdote is not data. “Courts have recognized that … case reports are not generally accepted in the scientific community on questions of causation.” Slip op. at 17 (quoting from Heckstall v. Pincus, 19 A.D.3d 203, 205, 797 N.Y.S.2d 445 (1st Dept. 2005)).
Exposure Assessment
The chemical components in gasoline, blamed by Kramer, make up no more than two percent of gasoline vapor. Reeps, slip at 6. One of plaintiffs’ expert witnesses asserted, without measurements, that Debra Reeps experienced atmospheric concentrations of gasoline at least 1,000 p.p.m. Plaintiffs claimed that this level of exposure was tantamount to recreational solvent abuse, in an attempt to rely upon studies of solvent exposure at very high levels. BMW showed that the witnesses’ speculation was unfounded and implausible. The fuel-line leak would have to leak about a gallon per mile driven to generate 1,000 p.p.m. in the passenger compartment. Id. at 8.
Teratology Principles
Because certain structures, organs, and tissues in a developing embryo or fetus form at predictable stages of pregnancy, the science of teratology plays close attention to when the exposure to the putative teratogen occurred in the time course of a pregnancy. Late exposures to known teratogens cannot very well explain harms that can result only from exposure early in pregnancy. Similarly, early exposures cannot explain harms that arise only out of teratogenic exposures. Debra Reeps’ claimed gasoline exposure occurred in her first trimester. Despite Dr. Shira Kramer’s efforts, the neurological deficits and injuries in Sean Reeps thus cannot be explained by his mother’s early term exposures, even if gasoline fumes had the claimed teratogenic properties.
Ipse Dixit
Debra Reeps had a history of herpes simplex infection, which could explain her son’s cerebral palsy. Slip op. at 7. Dr. Kramer asserted that there were no alternative causes.
Epidemiology
Apparently no analytical epidemiologic study (either cohort or case-control) found an association between gasoline fume exposure in pregnancy and Sean Reeps’ birth defects. Kramer attempted to claim that the “[f]ailure to detect a statistical association does not establish that there is no association between an exposure and an outcome.” Slip op. at 15. Absence of evidence may not show evidence of absence, but it also does not show evidence of harm.
In one episode of Seinfeld, Jerry Seinfeld chides a rental car clerk for not honoring a reservation. “You know how to take the reservation; you just don’t know how to hold the reservation. And that’s really the most important part.” Scientific methodology is similar to making reservations. Anyone can claim to be following Sir Austin Bradford Hill’s causal criteria, but actually applying the criteria faithfully is really what the “methodology” is all about. The abridged form favored by Dr. Kramer is indeed unorthodox, novel, unreliable, invalid, and unacceptable, scientifically and legally, as Justice York found in Reeps. In essence, the plaintiffs argued that all their expert witnesses need show is that they are aware of proper methodologies, not that they actually used the methodologies properly. Shira Kramer, and the other plaintiffs’ expert witnesses, offered a pastiche of a method, in the hopes that this would be sufficient. Absent was a systematic review, and a proper analysis of the evidence. The Reeps case rejoined: the law requires the real thing.
New York’s adherence to a Frye standard creates a potential roadblock to meaningful gatekeeping. If an expert witness could evade gatekeeping by simply claiming to be following epidemiologic methods, regardless of how badly, that witness could undermine the interests of the justice system in weeding out speculative, unreliable, or invalid opinions. The New York Court of Appeals demonstrated its unwillingness to tolerate such evasions. See, e.g., Parker v. Mobil Oil Corp., 7 N.Y.3d 434, 857 N.E.2d 1114, 824 N.Y.S.2d 584 (2006) (excluding testimony of Dr. Bernard Goldstein, and dismissing leukemia (AML) claim based upon claimed low-level benzene exposure from gasoline) , aff’g 16 A.D.3d 648 (App. Div. 2d Dep’t 2005).
In Reeps, Justice York makes clear that it is the “plaintiff’s burden to prove the methodology applied to reach the conclusions will not be rejected by specialists in the field.” Slip op. at 11. The trial court recognized that a Frye hearing in New York must determine whether plaintiffs’ expert witnesses are faithfully applying a methodology, such as the Bradford Hill criteria, or whether they are they are “pay[ing] lip service to them while pursuing a completely different enterprise.” Id. To be sure, litigants might not welcome this level of scrutiny for their expert witnesses. Justice York’s recognition that the court must examine a proffered opinion to determine whether it “properly relates existing data, studies or literature to the plaintiff’s situation, or whether, instead, it is connected to existing data only by the ipse dixit of the expert,” carries with it, an acknowledgment that New York law, like federal Rule 702, requires an assessment of the validity and sufficiency of the evidence and inferences that make up an expert witness’s opinions. Id. (internal quotations omitted).
