Science in the Tort Law • An injured party typically must show two causal claims that must be supported by evidence and testimony: a) Defendant’s product can cause the kind of harm plaintiff suffered, and b) Defendant’s product did cause plaintiff’s harm.
Moral Issues with Tort Law Procedures • Similar ideas hampered redress of diseases. • Commentators and a few courts demanded “ideal” science—multiple lines of the “best” evidence— which bars redress for most injured parties. (Black & Lilienfeld, 1984; Wade-Greaux, 1994 ) • Many courts required human statistical data—“the only [ones] having [a] bearing on causation.” (Judge Weinstein, Agent Orange , 1985)
Common Moral Issues in Administrative Laws and Torts • Stringent scientific norms dominated legal values. • Public Health under-protection of citizens; tort law possibly excluding deserving plaintiffs. • Were administrators gripped by a too-rigid scientific paradigm? • Regulating Toxic Substances “ recognizes and integrates the values of two complex and disparate institutions.” (Cecil, FJC, 2014)
A Tort Law Sea Change: The Daubert Trilogy 1993-1999 • The U.S. Supreme Court transformed litigation: • Daubert v. Merrell-Dow Pharmaceutical, Inc. (1993) • General Electric v. Joiner (1997) • Kumho Tire v. Carmichael (1999) • These decisions improved science, led to mistakes, hampered access to the law and reduced success of Cambridge University injured parties in court. Press, 2006, 2008
Diagnosing Daubert v. Merrell-Dow Pharmaceuticals, Inc. : One Janus Face • The Federal Rules of Evidence (FRE) “relaxed the traditional barriers to 'opinion' testimony.” ( Daubert, at 589) • Testimony could be challenged with • “Vigorous cross-examination … • Contrary evidence, and • Instruction on the burden of proof” ( Daubert, at 596)
Daubert v. Merrell-Dow’s Other Mien • Justice Blackmun conflated scientific studies with expert testimony and how to review them . • This misled lower courts, which excluded reliable testimony that did not satisfy standards for studies.
Daubert v. Merrell-Dow’s Other Mien • A number of courts demanded human statistical (epidemiological) evidence. • Tensions: demands for “excellent scientific evidence” can make “bad law.” (Cranor, 1993,1996, 1998, 2006; Cranor & Eastmond, 2001)
General Electric v. Joiner (1997) • Issue: Could and did PCBs contribute to plaintiff’s lung cancer? • The Court: upheld a trial judge’s “atomistic” evaluation of each “piece” of evidence for whether it supported plaintiff’s ultimate causal conclusion. Cambridge, 2006, 2008)
Diagnosing General Electric v. Joiner • The Federal Judicial Center: The ‘atomistic approach’ … • “[is contrary to] scientific inferences that require consideration of numerous [lines] of evidence” to support conclusions. (Berger, Ref. Man. on Scientific Evidence 3d , 2011; [Cranor, 1996, 1998, 2001, 2006])
If Judges Err on the Science and Bar Experts, No Jury Trial P files D answers Discovery Judicial P presents D Judge Jury Post trial Appeals Complaint hearing case-in–chief presents issues verdict motions on admissibility then rests c-i-c, jury JNOV? of experts & rests. instrns scientific Parties foundation. propose Judge rules on adm . jury Case goes and sufficiency of instrns to jury evidence P may face motion to dismiss D motion to Dismiss? __x_______x_______x________ X __________________x_________ x_______x_______ x_______x________x__ Approximate abstract time line of events of a civil action
Diagnosis: Consequences of New Decisions? 1. Requiring ideal evidence became the enemy of the good. (Wade-Greaux, (1994); Zoloft Products Liability Litigation , WL 3943916 (E.D.Pa, 2014); Cranor, Toxic Torts: Science, Law and the Possibility of Justice, 2006, 2016 )
Diagnosis: Tort Law Deficiencies 2. Early on many courts required human epidemiological studies to show harm. ( Agent Orange ( 1985); Lynch v. Fisher (1987) ; Brock v. Merrell-Dow (1993); Richardson v. Richardson-Merrell (1989); Renaud v. Martin Marietta (1990); Chambers v. Exxon (2000). Later, courts did not require such studies. (Federal Judicial Center & Restatement of Torts) , 2011)) But they didn’t always practice what they preached. (Compare: Milward v. Acuity Specialty Products (2010) with 1 st Circuit decision (2011)).
Diagnosis: Tort Law Deficiencies 3. Some courts precluded other studies that help could reveal human harm—e.g., animal or mechanistic data—barring some plaintiffs. ( Brock v. Merrell-Dow (1993); In re Breast Implant Litigation, 2000), Chambers v. Exxon (2000); Bernstein, 1994, Harvard Law Review, 1995; Black & Lilienfeld, 1984))
Diagnosis: Tort Law Deficiencies • Naïve judicial choices about science can produce mistaken law and prevent just redress.
International and National Scientific Committees • Many lines of evidence can reveal toxicity to people and improve the possibility of just redress: • Human epidemiological studies, • Animal data, • Mechanistic data, and • Human case reports, inter alia .
Example: Scientists Use All the Relevant Scientific Evidence • MOCA, a curing agent, is a known human carcinogen: no human statistical evidence. • Excellent animal data for carcinogenicity. • Three humans with asymptomatic bladder tumors & MOCA exposure (2 men < 30yrs). • Identical MOCA-DNA adducts in animals & in one man. • MOCA is “comprehensively genotoxic. ” (IARC, 2010)
Daubert and Joiner had Consequences • A review of 4 million cases found • Defendants sought Daubert jurisdictions; plaintiffs tried to avoid them. (Jurs & DeVito, “The Stricter Standard,” (2013); “ Et Tu , Plaintiffs?” (2013)) • Injured parties may be precluded by lawyers and experts as well as judges: • "If they're not a quadriplegic, a paraplegic or losing some part of their body, there's no way I'm going to take that case. ” (Craig Hilborn, NYT, 1/30/00) (Cambridge University Press, 2016)
Kumho Tire v. Carmichael (1999): Invited Wider Science • Experts must exhibit “the same level of intellectual rigor” in court as in their professional fields. ( Kumho Tire ) • Heuristic: Testimony should be in “the range where experts might reasonably differ and where the jury must decide among the conflicting views of different experts, even though the evidence is ‘shaky.’” ( Kumho Tire, citing Daubert ) • This recognizes respectable disagreement permitting testimony not based on the most certain evidence.
Improving Torts: Milward v. Acuity Specialty Products “ One of the most significant toxic tort cases in recent memory.” � (Green, 2011) Brian Milward with his granddaughter while he was receiving chemotherapy treatment for benzene-induced leukemia. Courtesy of Brian Milward and the Center for Public Integrity .
Milward v. Acuity Specialty Products: At the District Court (2009) • Brian Milward, 47, contracted acute promyelocytic leukemia (APL) (2004), claiming benzene in 22 products caused it. • The district judge dismissed the case because of “unreliable” testimony. • He objected to • A widely accepted view about mechanisms of leukemia. • UCB toxicologist Martyn Smith’s scientific presentation. • Smith’s weight-of-the-evidence argument. • The absence of “statistically significant” human studies.
Milward v. Acuity Specialty Products At the First Circuit Court of Appeals The Appellate Court Ruled • Trial judge “abused his discretion:” Judges assess the “reliability of scientific testimony;” juries must assess its correctness. • Human statistical evidence is not needed; various lines of evidence can point to adverse effects.
Milward at the First Circuit • The court rejected the trial court’s “atomistic analysis of evidence” • “No serious argument can be made that [inferences to the best explanation] are inherently unreliable.” Admissibility rests on how experts apply it. (Milward, 18-19)
Milward at the First Circuit • “Dr. Cranor [explained] … inference to the best explanation … [involves] six general steps, some of which may be implicit … ” (Milward at 17) • The total body of relevant lines of evidence must be integrated to assess what it shows. • Moral Assessment: Wider, more sensitive evidence can foster better science in the law and the chances for just redress.
Milward after the First Circuit • Defendants appealed the First Circuit decision to the Supreme court; it was not accepted. • 21 of 22 companies settled with Mr. Milward or showed no benzene exposure. • A new trial judge: one defendant did not contribute to Mr. Milward’s APL.
Some Moral Consequences of Milward “ One of the most significant toxic tort cases in recent memory. ” � (Green, 2011) • Permits wider evidence and arguments that may • Increase redress of harms. • Increase deterrence. • Increase authoritative determinations about toxicants. • Reduce some toxic ignorance. • Foster a safer world.
Brian Milward Is Alive! • He has not succumbed to APL. • Chemotherapy, diabetes and a rare bowel disorder produced “‘absolutely ridiculous’ fatigue.” Trying to work, “he [napped] to endure an eight- hour shift. [Given] … office duty, … he fell asleep at his desk.” • He can’t repair race cars, work in his yard, play with his grandchildren. “It just sucks when you get a cancer like this.” (Lombardi, Center for Public Integrity, 2014) • Companies and preventive administrative law failed him; the tort law redressed his harm as best it could. • His life opportunities have been unjustly curtailed.
Return to Preventive Administrative Law Harvard University Press, 2011, 2013
New Science—The “Developmental Origins of Disease”—Reveals Worse Shortcomings of Postmarket Laws (2007) • Children are among the most vulnerable humans that are exposed to toxicants. • How well do our laws protect them? (Cranor, 2008, 2008; Cranor, 2011) Harvard University Press, 2011, 2013
What Is the Developmental Basis of Disease? • Some chronic diseases originate from environmental insults during development—from embryos to fetuses to infants, and teenagers. (Cao, 2016) • Major mechanisms are epigenetic phenomena that turn genes on or off or alter protein regulation, but do not change DNA sequences. (Heindel, 2008)
Developing Children Are Especially Vulnerable to Toxicants • Have greater exposures per body weight. • Are more susceptible to toxicants. • Have lesser defenses. • Have a longer lifespan for diseases to develop. • Some adverse effects are irreversible.
Three Major Catastrophes Presaged These Findings • In utero e xposures to • Methylmercury • Thalidomide • Diethylstilbestrol
In utero Exposure to Methylmercury (1950s) Methylmercury exposure in utero at Minimata Bay, Japan, induced cerebral palsy as well as • mental retardation • limb deformities • constricted visual field • sensory disturbance • ataxia (poor muscle control) • auditory disturbance • disturbance of gait • death. • Cats having eaten contaminated fish “ danced ” strangely, jumped into the sea; birds fell from the sky. (Harada, 1995) • 2,265 “official victims;” Sandra Bullock signs an autograph for Lisa Patrick, who suffers from Cerebral Palsy, and 10,000 compensated greets fans while at a red carpet premiere of her latest film, "The Blind Side," in New Orleans, Thursday, Nov. 19, 2009. AP Photo
First Trimester Ingestion of the Sedative Thalidomide (1960s) Extra appendage on left foot Thalidomide induced • shortened limbs (affected 5k-7k children worldwide) • no ears, deafness [subsequent retardation] • no or small eyeballs • spinal malformations • congenital heart disease Malformed right limb • kidney abnormalities • obstetrical problems (e.g., double vaginas) • central nervous system problems, but often normal mentality • autism (30 x higher) • epilepsy, learning disorders • death. • 7k-8k were stillborn. National Cancer Institute, 1962
In utero Exposure to a Synthetic Estrogen Diethylstilbestrol (DES) in utero induced cervical/vaginal cancer in daughters at age 20; 20 years later they were at increased risk of breast cancer. DES mothers were also at increased risk of breast cancer. Cancerous growth Cedars Sinai Hospital, http://www.righthealth.com/Health/ Photos%20Of%20Cervical%20Cancer-s?lid=goog-ads-sb-8536643334
Fetal Alcohol Syndrome Alcohol: At the same dose fetal alcohol effects § are worse than for adults. ( Lemoine, 1968; Grandjean, et. al., 2007) Can also affect vision hearing memory attention span abilities to learn and communicate Bioportfolio, http://www.bioportfolio.com/ search/fetal_alcohol_syndrome_pictures.html
Contamination • 304+ manmade toxicants contaminate citizens. (CDC, 2017; Woodruff, et. al., 2011) • Pregnant women can harbor 43+ toxicants shared with developing children in utero . (ACOG, 2013) Newborns have toxicants in their bodies. (Fimrite, 2009) •
Sources of Contamination Courtesy Tracey Woodruff, Obstetrics, UCSF
Routes of Contamination • Ingestion • Inhalation • Absorption through the skin
Recent Science Shows the Urgency to Change Legal Approaches • The developmental basis of disease and our permeability to toxicants • Reveals the Inadequacy of legal protections. • We cannot prevent permeability or developmental vulnerability. • Preventive laws could reduce toxic contamination and clean up toxicants in the environment.
Women ’ s Chemical Burden is Shared with Developing Fetuses and Newborns • “[T]he vast majority of chemicals given a pregnant animal (or woman) reach the fetus in significant concentrations soon after administration. ” (Schardein, 2002) • Plastic nanoparticles cross the placenta. (Wick, et al., 2010; 29 March 2010, EHN.org)
Development is a genetic Development is an open program system (developmental plasticity, ECO-DEVO) 1960s: Perceived as comparatively impermeable (Needleman light food And Bellinger, 1995) hormones toxicants Mother is the fetal Mother is the fetal environment incubator Courtesy Ana Soto
Developing Children Have Greater Exposures • They often have larger toxic doses per body weight than the mother, via cord blood and breast milk. (Faroe ’ s Statement, 2007) Methylmercury: 5 times higher in fetal brain than in mother ’ s § blood. (Honda, et. al., 2006) Lipophilic substances: concentrate in cord blood and breast § milk. (Heinzow, et. al., 2007) • Lead: transferred from mother’s bones to developing child via the “ calcium stream. ” (Bellinger & Needleman, 1994)
Developing Children Have Greater Exposures Once born children have • Higher metabolism, breathing, absorption, circulation rates. (Miller, et. al.) • Higher fluid and food intake rates per body weight. (Miller, et. al.) • They play close to ground/floor, “ mouth ” everything, ingest more dust.
Exquisite Sensitivity: Tiny Doses Can Pose Problems • Mutagenic carcinogens—no threshold for toxicity. (David Eastmond, UCR Environmental Toxicology) • Lead—no identified threshold for toxicity. (Lanphear, 2000, Canfield,2003; Bellinger & Needleman 2003, Goyer & Clarkson, 2006; Weaver & Silbergeld, 2007)
Tiny Doses Can Pose Problems A single Thalidomide pill caused § malformations in at least one child. (Claudio, et. al., 2000) A single dose of valproic acid (anti-epileptic § drug) in animal studies can cause autism- like behavior. (Dufour-Rainfray, et. al., 2011).
Tiny Doses Can Pose Problems • Sometimes low doses cause greater harm than larger doses. • High doses of tamoxifen inhibit breast cancer cell growth, lower concentrations stimulate breast cancer cells, and highest doses are acutely toxic. (Vandenrberg, 2012)
Developing Children Are More Susceptible Than Adults to Toxicants • Toxicants can disrupt differentiating cells and forming tissues altering physiological functions. (Hood, 2006; Barouki, 2012) • Children have lesser defenses—less developed immune system, blood brain barrier, liver, detoxifying enzymes. (Grandjean & Landrigan, 2006; Dietert & Piepenbrink, 2006; Dietert, et. al., 2010)
Developing Children Are More Susceptible • E.g., the developing brain and immune system are “ uniquely susceptible. ” • Brains grow from a single cell into billions and must follow “ precise pathways ” in the “ correct sequence ” to function properly. (Grandjean & Landrigan, 2006; Grandjean, 2013) • For both systems there is “ one chance to get it right.” (Dietert & Zelikoff, 2010) • Developing reproductive systems in animals: once harmed, there is little chance to “make it right.” (Mike Skinner’s lab)
Genetic Variation Increases Children’s Vulnerability • Susceptibility genes for • polycyclic aromatic hydrocarbons (by- products of combustion) . (Perera, et. al.) • organophosphate pesticides. (Eskenazi, et. al., 2008) • methylmercury. (Julvez, et. al., 2013)
Numerous Chronic Diseases Arise from In Utero, Early Childhood or Teenage Toxic Exposures
Neurodevelopmental Diseases or Morbidities
Neurodevelopmental Diseases or Dysfunctions and Annual Costs Landrigan, et. al., EH P 2002
Lead and Neurodevelopmental Diseases • Lead—Causes lower IQs, motor skill problems, attention disorders [ADHD], violent behavior , and cardiovascular disease. (Cecil, et. al.,4/18/ 11; Chen & Wessler, 2011; Silbergeld and Rothenberg, 2007)
Lead-Caused Diseases or Dysfunctions and Annual Costs § Landrigan, et. al., EH P 2002
Parkinson’s: Human Data Human data: • MPTP-contaminated heroin produced 5 young “ frozen addicts ” (26-42 years old). (Langston, et. al., 1983; NOVA 1986) • Paraquat and rotenone contribute to Parkinson’s at consumer exposures. (Tanner, et. al , 2011) • Solvents increase risks of PD: TCE (6x), perchloroethylene (10.5x), and carbon tetrachloride (2.3x). (Goldman, et. al., 2012) • 1997 Annual Costs ($12-25 billion). (Landrigan, et al., 2005)
Immune System Dysfunctions/Diseases • Immune system dysfunctions affect many different organ systems, e.g., respiratory, neurological, cardiovascular, dermal, and gastrointestinal. (Dietert, Luebke, 2012) • Chemicals, drugs, microbes, and psychological factors can cause immune dysfunctions. (Dietert, Luebke, 2012)
Annual Costs of Asthma Landrigan, et. al., EH P 2002
Immune System Dysfunctions/Diseases • Exposed infants have greater dose-sensitivity, severity of effects, and persistence than adults. (Dietert, Piepenbrink, 2006) DES and lead create invisible immunotoxic • alterations until the system is stressed with a second “hit.” (Dietert, Piepenbrink, 2006)
Immune System Dysfunctions/Diseases Many human immunotoxicants: • lead, DES, dioxin and mercury, • benzo[a]pyrene, chlordane, cyclosporin A, • dexamethasone, diaszepam • 7/12 dimethybenz[a]ahthracene, ethanol, Genistein, • methoxychlor, nonylphenol, paracetamol, T-2 toxin, tributyltins. (Dietert, Piepenbrink, 2006)
Early Immune Dysfunctions Can Signal Life-long Morbidities Inflammation-related Infection-related (Dietert, Zellikoff, 2010)
Early Immune System Dysfunctions Can Signal Life-long Morbidities Allergy-related Autoimmune-related (Dietert, Zellikoff, 2010)
Childhood Cancers
Childhood Cancers • Most childhood cancers, begin in the womb, e.g., acute lymphoblastic (ALL) and acute myeloid childhood leukemias (AML) (Greaves & Wiemels, 2003; Smith, 2009;) • Pesticide e xposures are associated with ALL (11x) and AML (14x). (Ross, et. al. , 1994) • Numerous paternal and maternal exposures elevate risks. (Ross, et. al. , 1994)
Childhood Cancers Childhood cancers typically take 2 hits: • characteristic chromosomal translocations plus • major immunological stress. (Greaves & Wiemels, 2003; Smith, 2009) •
Childhood Cancers Bring Additional Chronic Conditions • “[S]erious, disabling, and life-threatening chronic health conditions … [cause] functional impairment and activity limitations.” (NCI, https://www.cancer.gov/types/childhood-cancers/late-effects-hp-pdq) • The original disease and additional morbidities all curtail opportunities.
Treatment of Childhood Cancers Adds to Adverse Effects • Neurological problems, e.g., ADHD, reading, math difficulties, sometimes strokes. • Secondary cancers/other diseases e.g., breast cancer, heart disorders, cognitive problems, diabetes, and infertility. • Failure to “thrive.” • Earlier mortality; accelerating the aging process. (McGinley, 2016) • The disease and treatment-morbidities hamper opportunities.
Annual Costs of Childhood Cancer Landrigan, et. al., EH P 2002
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