The Laws Contribution to a Lifetime Arc of Good Health Carl Cranor - - PowerPoint PPT Presentation

The Law’s Contribution to a Lifetime Arc of Good Health

Carl Cranor Distinguished Professor of Philosophy Faculty Member, Environmental Toxicology Graduate Program 65th Faculty Research Lecture

The Ancients’ Recognition of Good Health

• Health promotion had its roots in ancient Greece. (Tountas, 2009)
• Good health was urged as a virtue; physical training, inter alia,

was “necessary for improving one’s appearance, preparation for war, and good health at an old age.” (Plutarch, “Training of Children”)

• Plato:
• “[The soul and the body] … [should] be healthy and well balanced.
• [Intellectuals should] practice gymnastics;
• [Athletes] should practice music and all philosophy….” (Timaeus, 360 BCE)
• Juvenal: “[P]ray for a healthy mind in a healthy body.” ( 1st Century, CE)

Ravages of Infectious Diseases

Greek ideals for good health were deemphasized for centuries and, at the same time humans have been afflicted by infectious diseases, plagues, and pandemics.

In Developed Countries Public Health Actions Decreased Infectious Diseases

Chlorinated drinking water Introduced antibiotics Discovered vaccines We cleaned up a polluted environment

Decreases in Infectious Diseases

1936 New York street, www.mtfca.com

1926 New York Street,222. mtfca.com

Decreases in Infectious Diseases

A filthy New York City street in 1893; 2.5 million pounds/day

Decreases in Infectious Diseases

Sewage Entering the Delaware River, July 15, 1918.

Decreases in Infectious Diseases

Swimming in Delaware River sewage (July 1918) Department Historical Collection

Chronic Diseases

• Are now the leading causes of morbidity and mortality

in developed countries. (James F. Fries, 1980; Bruce Lanphear, 2005; Barouki, et al.,

2012; Dietert, Luebke, 2012)

• Examples: cancers, neurological disorders, immune

dysfunctions, lung disorders, diabetes, and cardiovascular diseases.

Chronic Diseases

• Persist for a long time.
• Are not “prevented by vaccines or cured by

medication.”

• Are “not communicable … and do not just

disappear.”(http://www.medicinenet.com/script/main/art.asp?articlekey=33490)

Chronic Diseases

• Can result from bad luck, unfortunate genes,

voluntary behavior, and the actions of others.

• Can cause greater or lesser interference with life-

long normal good health and flourishing.

• Neurological disorders
• Immune system disorders
• Cancers
• Lung diseases
• Some coronary-artery diseases
• Some Diabetes

Toxic Substances Also Cause Chronic Diseases

Moral Philosophers

• Study and write about actions, policies, or states
• f affairs that are, inter alia, right, wrong, just or

unjust and justifications for their rightness or wrongness.

• Legal philosophers study laws and institutions

and how they should function.

Visible Means of Inflicting Harm

• Bullets, knives, and blunt objects.

Invisible Molecular Agents Also Cause Harm

• Diagnosing and reducing their effects is more difficult

than for grosser forms of violence.

Diethylstilbestrol

• l

In utero exposure caused vaginal cancer at age 20, breast cancer later.

CH3 H3C OH HO

• How should we use the law and science to

reduce these harms?

A Justice Case for Preventing Chronic Diseases

• They can cause harm to a person, and
• arbitrarily interfere with having good health and

a flourishing normal life.

A Powerful Justice Principle-- Fair Equality of Opportunity— Identifies Important Features of Justice

• Fair equality of opportunity (FEOP) points to two

major institutions that can counteract disadvantages over which we have little or no control that frustrate opportunities.

• Good education helps counter disadvantages,

e.g., of poverty, ethnic background, family education, or place of birth. (Rawls, 1971; Daniels, 1981)

A Powerful Justice Principle-- Fair Equality of Opportunity— Identifies Important Justice Goals

• Good health-protection and health-care institutions

help counter diseases over which we largely lack control that frustrate life-long opportunities to:

• Pursue careers or change them. (Rawls, 1971, 1999)
• Develop life-plans, modify them, and pursue them

beyond working years. (Daniels, 1981; Cranor, 2011, 2016)

At 47 Leukemia Undermined Brian Milward’s Arc of Good Health and Opportunities

• His disease, chemotherapy, diabetes, and a rare bowel

disorder left him at age 57, “with ‘absolutely ridiculous’ fatigue.”

• His career and lifetime opportunities were greatly

diminished:

• He had to retire and take disability.
• He can’t do what he loves: 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)

(Cambridge, 2016)

Others Have An Arc of Good Health and Opportunities by Avoiding Serious Chronic Diseases

Oldest Woman to climb Kilimanjaro (86+) Oldest Man to Climb Kilimanjaro (85+) NY Times NY Times Oldest Man to Climb Mt. Everest (80) Oldest Woman to Climb Mt. Everest (73+)

Others have an Arc of Good Health and Opportunities by Avoiding Serious Chronic Diseases

Oldest male marathoner; retired at 102 Oldest female marathoner; retired (?) at 93

Others have an Arc of Good Health and Opportunities by Avoiding Serious Chronic Diseases

Retired professionally at 42 Diana Nyad, 64, completing 90 mile Cuba to Florida Swim

To Reduce Diseases that Curtail Fair Equality of Opportunity, Health Institutions Should

• Prevent diseases with preventive medicine and

environmental health protections.

• Treat diseases that undermine persons’ health; ensure

access to medical care.

• Maintain the chronically ill as close to normal

functioning as their ages and conditions allow; provide medical treatment and accommodations. (Daniels, 1981; Cranor,

2011, 2017)

The Law’s Contribution to Just Health-Protection and Health-Care

• Administrative health laws can prevent/reduce toxicity-

caused chronic diseases.

• Personal injury (or the tort) law can support treatment

and redress for diseases caused by others.

• How well have these institutions functioned?

Two Generic Strategies to Prevent Diseases from Chemical Creations

“Old” 1976 TSCA: Chemical creations enter commerce with no legally required routine testing or approval (~90- 80% of chemical creations). Authorize withdrawal after risks are shown.

Premarket laws

For drugs (1962) and pesticides (1968): Laws legally require routine toxicity testing & agency approval prior to commercialization(~10-20%

• f chemical creations).

Authorize withdrawal after risks are shown.

Postmarket laws

“Old” TSCA (1976)

• Grandfathered 62,000 general chemicals as safe.
• Permitted another 22,000 into commerce with little
• r no toxicity testing.

How Well Were Carcinogens Controlled in 1987?

• Reducing carcinogens was slow, science-

intensive, and post-harm.

• Federal agencies had “acted on” less than

½ of the substances within their purview.

U.S. Congress, Office of Technology Assessment, 1987

What Are Justice Aspects of the Science-Law Interaction in Administrative Agencies?

• Slow assessments leave toxicants in commerce.
• Rigid scientific norms frustrated legal and health

norms—e.g., low powered epidemiological studies (still an issue, 2017). (Cranor, et al., Amicus Brief, 4th Circuit Court of

Appeals (2017))

• Justice issue: With sufficient exposures sluggish

regulation leads to more cancers.

Oxford University Press, 1993, 1997

Injustice of Sluggish Protections: Hairdresser Sandy Guest’s Death

• She used Brazilian Blowout—“loaded with

formaldehyde”—and died of leukemia (55) .

(Morris, 2015)

• 1981-2011: 17 studies revealed formaldehyde

caused nasopharyngeal, sinonasal, and myeloid cancers; still no EPA protections.

• Industry resistance and slow EPA review likely

led to Guest’s death.

• A company and administrative law failed her.

Oxford University Press, 2017

Injustices from Exposures to C8 (PFOA) [Ingredient in Teflon, Gore-Tex]

• Carla Bartlett's kidney cancer (C8 in drinking water)—

$1.6 million. (2016)

• David Freeman’s testicular cancer (C8 in water)—$5.6

million with punitives. (2017)

• Kenneth Vigneron, Sr.’s, testicular cancer (C8 in water)—

$12.5 million with punitives. (2017)

• Wilbur Tennant’s dead cattle (C8 in creek).
• DuPont settled for $671 million to cover damages

affecting 3,550 plaintiffs and their communities. (2017)

• DuPont and administrative law failed them; the tort law

redressed some harms.

What Would Improve Postmarket Administrative Procedures?

• Policy considerations can address recalcitrant

uncertainties, e.g., low dose inferences, and speed up

• protections. (Cranor, “Eggshell Skulls and Loss of Hair from Fright,” 1997)

• Expedited risk assessments (under Proposition

65): Were accurate vs. science-intensive studies that would leave substances unassessed. (Hoover, et al., 1995) Would improve protections and lower the social costs of diseases. (Cranor, 1995)

These are modest improvements.

Improving Postmarket Administrative Procedures

At the Same Time How Well Did the Tort Law Use Science to Redress Harms?

• 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.

Science in the Tort Law

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
• nly [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 injured parties in court.

Cambridge University 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

• n admissibility then rests c-i-c,

jury JNOV?

• f 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 1st 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

• f 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

• f Disease”—Reveals Worse Shortcomings
• f 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 exposures to
• Methylmercury
• Thalidomide
• Diethylstilbestrol

In utero Exposure to Methylmercury (1950s)

Sandra Bullock signs an autograph for Lisa Patrick, who suffers from Cerebral Palsy, and greets fans while at a red carpet premiere of her latest film, "The Blind Side," in New Orleans, Thursday, Nov. 19, 2009. AP Photo

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;”

10,000 compensated

First Trimester Ingestion

• f the Sedative Thalidomide (1960s)

Malformed right limb Extra appendage on left foot National Cancer Institute, 1962

Thalidomide induced

• shortened limbs (affected 5k-7k children

worldwide)

• no ears, deafness [subsequent retardation]
• no or small eyeballs
• spinal malformations
• congenital heart disease
• 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.

In utero Exposure to a Synthetic Estrogen

Cedars Sinai Hospital, http://www.righthealth.com/Health/ Photos%20Of%20Cervical%20Cancer-s?lid=goog-ads-sb-8536643334

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

Fetal Alcohol Syndrome

§

Alcohol: At the same dose fetal alcohol effects are worse than for adults. (Lemoine, 1968; Grandjean, et. al., 2007)

Bioportfolio, http://www.bioportfolio.com/ search/fetal_alcohol_syndrome_pictures.html Can also affect vision hearing memory attention span abilities to learn and communicate

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)

light food hormones

Mother is the fetal incubator Mother is the fetal environment

Development is a genetic program Development is an open system (developmental plasticity, ECO-DEVO)

Courtesy Ana Soto

toxicants

1960s: Perceived as comparatively impermeable (Needleman

And Bellinger, 1995)

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., EHP 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., EHP 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
• rgan 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., EHP 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 exposures 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
• pportunities.

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., EHP 2002

Jarrett McElheney Had Childhood Cancer

• Early in life this adventurous boy loved water.
• After contracting “ALL (age 4) [from benzene] he was pale,

fatigued, had pain his knees and shoulders, screamed from spasms, and nearly died …”

• At 20 he had “feebleness, and fatigue—… lingering fears … [and is

at risk for] osteoporosis, cataracts, or even another cancer.” (Lombardi,

Center for Public Integrity, 2014)

Reproductive Disorders

Jill, Jarrett and Jeff McElheney stand in front of bulk-oil terminals. The McElheney's believe living near the terminal caused Jarrett's diagnosis with a form of childhood leukemia at 4 years old. (Phil Skinner, Center for Public Integrity, 2014)

Jarrett McElheney Had Childhood Cancer

• The McElheneys settled a tort case with British Petroleum, inter

alia, for contributing to Jarrett’s disease. Their lawyer earned $0.75 per hour on the case.

• Companies, the military, and administrative law failed Jarrett; the

tort law somewhat assisted him, but his lifetime opportunities have been unjustly limited.

Reproductive Disorders

Vaginal Cancer from in utero Exposure

Cedars Sinai Hospital, http://www.righthealth.com/Health/ Photos%20Of%20Cervical%20Cancer-s?lid=goog-ads-sb-8536643334

Diethylstilbestrol (DES) induced vaginal cancer in daughters about 20

years after exposure; 20 years later they were at increased risk of breast cancer. DES mothers were also at increased risk of breast cancer.

Cancerous growth

Some Consequences of Vaginal Cancer

• A woman with vaginal cancer
• May have multiple operations to burn out new cancers.
• May not have children.
• May not take birth control and some post-menopausal

drugs.

Breast Cancers: Worse Effects in Children v. Adults at Same Dose

• Breast cancer risks are higher for teenage (or

earlier) exposures than for adults to radiation (3-5X) and DDT (5x). (NAS 1990; Ronckers, 2004; Cohn, 2007).

Animal Data Show Transgenerational Reproductive Disorders

• Males: In utero toxic exposure causes transgenerational sperm

damage, sterility, cancers and immunological disorders in their

• ffspring. (Anway, et al., 2006; Skinner, et. al., 2007, 2009; Manikkam, et. al. 2012)
• Females: In utero toxic exposure causes transgenerational

polycystic ovarian disease (sex hormones out of balance) and primary ovarian insufficiency (fewer eggs). (Nilsson, et al., Skinner, 2012)

Obesity

Obesity

• A single dose of DES (or some other synthetic

estrogens) is sufficient to cause obesity in mice.

(Vom Saal, 2011)

• Not merely an energy imbalance

Obese Mouse; Normal Mouse

Same genes, same diet, same exercise, different in utero exposures to synthetic estrogens.

Pictures from Fred VomSaal

One gene methylated in utero at one location (8ppb)

Obese Mouse; Normal Mouse

http://t h eh eal th yskeptic.o rg/warn ing-d rinking-bottled-wat er-co uld-m ake-y ou-fat Effects of DES; simil ar effects fro m ph ytoestrogens, BPA , tributyltin and

Same genome, same diet, same exercise, different in utero exposure to one dose

• f a synthetic estrogen

A single gene methylated in utero at one location (8 ppb)

Obesity

• Chemical exposures disrupt hormonal pathways,

increasing susceptibility “to obesity in the face of … waistline-challenging lifestyles.” (Grens, 2015)

Obesity

• Examples:
• Organobromine flame retardants
• DDT
• PCBs
• rganophosphate insecticides
• BPA
• phthalates
• C8 (Teflon)
• cadmium, arsenic, tributyltin (TBT)

Obesity

• Michael Skinner’s lab identified transgenerational
• besity (and other) effects from DDT at consumer

exposures—in animal family lines (out to 4 generations).

(Skinner, Manikkam, et. al., 2013)

• His concern: DDT exposures 2 generations earlier may

predispose people to obesity.

“Contaminated Daddy” Factors

• Toxic contamination of males can produce miscarriages,

along with prenatal or neonatal problems:

• Paxil, anesthetic gases, morphine, lead, mercury, pesticides,

solvents, dyes, and paints. (Anthes, Miller-McCune, 2010; Schulavitz, NYT, 2013)

“Contaminated Parents:” Occupational and Developmental Issues

• Workers are “callously” unprotected. (Morris, 2015)
• “Yvette Flores’s body was a ‘toxic warehouse before

Mark was conceived.’”

• Mark was born with “extensive cognitive impairment,”

caused by in utero lead exposure. (Morris, 2015)

• Spectra-Physics (electronic industry) settled a tort case

for Mark’s injuries.

“Contaminated Parents:” Occupational and Developmental Issues

• Spectra-Physics and the Occupational

Safety and Health Administration failed Yvette and Mark.

• Mark (now 36) has no ordinary
• pportunities; he cannot conduct daily

living activities on his own.

• Justice requires more stringent
• ccupational protections for adults and

their children.

Brief Exposures Can Endure Biologically

• TINY, FLEETING EXPOSURES CAN BECOME BIOLOGICALLY

EMBEDDED IN INDIVIDUALS, IN THEIR CHILDREN, GRANDCHILDREN (MULTIGENERATIONAL), OR, WITH UNLUCKY TIMING IN GREAT GRANDCHILDREN AND BEYOND

(TRANSGENERATIONAL), CAUSING ADVERSE EFFECTS.

What Should Be Done?

Legal Failures

Congress chose “Old” TSCA to regulate 80-90%

• f chemical creations with postmarket laws:
• 84,000 are in commerce with little toxicity data.
• They remain there until a health agency carries a

difficult legal and scientific burden to reduce exposures.

Postmarket Laws Are Too Late to Protect Children

• Substances are already in commerce

exposing children and adults alike

Postmarket Laws Frustrate Better Health Protections

• EPA has the burden to reduce exposures.
• Companies pressure EPA to have “doubt free” data

before improving protections.

• Corporate phalanxes of “doubting experts” mire

health protections.

• “Doubt is our product… the best means of competing

with the ‘body of evidence that exits in the minds of the general public … [and] it also [establishes] a controversy.” (Brown and Williamson, 1969)

Postmarket Laws Frustrate Better Health Protections

• Health protection delays: TCE (20+ years), dioxin

(25+), perchloroethylene (18+), formaldehyde (19+), naphthalene (9+). (GAO, 2008; EPA 2010; EPA, 2014)).

• May, 2017—American Chemistry Council: reconsider

formaldehyde because of a new study; already long delayed.

Postmarket Laws

• Are unjust.
• Cannot prevent chronic

diseases and morbidity in children or adults.

• Undermine lifetime
• pportunities for some of us.

Legal Failures

• Premarket testing and approval laws can miss

adverse effects and need to test for developmental toxicants in drugs and pesticides.

• Most drugs are not tested for children, yet often
• prescribed. (FDA)

What Can Be Done about Toxicity-Induced Chronic Diseases?

• Vaccinations won’t prevent them; antibiotics won’t treat them.
• The law must “clean up” toxicants and prevent new contamination.
• We need legal changes and a political commitment to their

implementation.

Generic Legal Strategies for Public Health Protections

Postmarket laws

Substances enter commerce with no required testing or approval (90- 80% of industrial chemicals)

Premarket laws

Premarket testing and approval laws with routine toxicity testing & agency approval.

(Cranor & Eastmond, 2001; Cranor, 2006, 2011, 2016, 2017; Silbergeld, Cranor, Mandrioli, 2016)

Frank R. Lautenberg Chemical Safety for the 21st Century Act (2016)

• Congress enacted a “new” TSCA (June 2016) that
• Requires premarket review of new substances.
• Seeks to ensure “susceptible and highly exposed

populations—pregnant women, children, and workers”—are protected.

• Eases acquisition of needed data.
• Provides legal timetables to reduce old toxicants.
• The legacy of 84,000 untested substances is
• verwhelming—How many are “active” in commerce:

10,000, 20,000, 30,000 or more?

Some Conclusions

• Toxic contamination is unavoidable; no place to hide.
• Routine premarket testing under “new” TSCA will contribute

to an arc of good health.

• Removing existing toxicants will be slower than slothful;

they will linger for decades.

Some Conclusions

• The tort law can support the treatment of chronic diseases

caused by others and assist deterrence of other exposures.

• Kumho Tire and Milward will help, but the tort law is rarely

used.

• Both institutions will only serve justice goals if they are well-

and efficiently administered and officials use science appropriate to the legal tasks.

Thank you