This article discusses how genomics and individualized genetic testing could transform the evaluation of causation in toxic tort litigation. Currently, experts rely on population-level epidemiological studies that have limitations and do not prove specific causation for an individual plaintiff. Emerging technologies allow analysis of an individual's entire genome and biomarkers to identify predispositions, mutations, and evidence of exposure. This could eliminate reliance on statistical studies and establish causation through direct genetic evidence. However, using genetic testing also raises ethical, legal and privacy issues that courts will have to address. As costs go down, genomic analysis is predicted to become routine in proving or disproving causation in toxic tort cases.
ACMG guidelines 2015: How to interpret DNA variants? [Today's paper]HeonjongHan
Today's paper is a summary of each scientific article that I've read.
Today I covered "Standards and Guidelines for the Interpretation of Sequence Variants: A Joint Consensus Recommendation of the American College of Medical Genetics and Genomics and the Association for Molecular Pathology." published in 2015, Genetics in medicine.
Thanks for watching!
DOI: 10.1038/gim.2015.30
ACMG guidelines 2015: How to interpret DNA variants? [Today's paper]HeonjongHan
Today's paper is a summary of each scientific article that I've read.
Today I covered "Standards and Guidelines for the Interpretation of Sequence Variants: A Joint Consensus Recommendation of the American College of Medical Genetics and Genomics and the Association for Molecular Pathology." published in 2015, Genetics in medicine.
Thanks for watching!
DOI: 10.1038/gim.2015.30
Prostate cancer is the most prevalent and second cause of death from cancer in
men worldwide. Immunotherapy is a new method for the treatment of several cancers
that fights cancer cells by strengthening the immune system through some medications.
While immunotherapy is a useful method for cancer treatment; its’ side effects still are
not totally clarified. Numbers of prostate cancer patients which take immunotherapy are
experiencing prostate inflammation and prostatitis after treatment period.
Enterococcus faecalis is Gram-positive and catalase-negative cocci that are common
in the intestines of humans and other animals and cause most enterococcal infections such as intestinal
infections, prostatitis, gastroenteritis and endocarditic. Present study aimed to evaluate the mRNA level of virulence genes which are involved in Enterococcus faecalis pathogenesis in prostate cancer patients that treated by immunotherapy. Expression level of gelatinase E (gelE) and Enterococcal surface protein (
esp genes were examined by Real time PCR in three groups of 68 male subjects. Group A normal subjects, group B prostate cancer patients before start treatment and group C prostate cancer patients after six months immunotherapy period.
Death prompts a review of gene therapy vectorLindsay Meyer
Case study and analysis of Targeted Genetics' adeno-associated virus, tgAAC94. Includes overview of clinical trial design, FDA action, NIH investigation, and outcomes surrounding the death of a patient enrolled in the investigational trial.
Data analytics to support exposome research course slidesChirag Patel
We present new publicly available tools to bootstrap your own data-driven investigations to correlate the environment with phenotype. Course materials here: http://www.chiragjpgroup.org/exposome-analytics-course/
NOYS' business slides gives you a brief introduction of what we do and can do. We have included some markets and industry slides, as well as market charts.
Prostate cancer is the most prevalent and second cause of death from cancer in
men worldwide. Immunotherapy is a new method for the treatment of several cancers
that fights cancer cells by strengthening the immune system through some medications.
While immunotherapy is a useful method for cancer treatment; its’ side effects still are
not totally clarified. Numbers of prostate cancer patients which take immunotherapy are
experiencing prostate inflammation and prostatitis after treatment period.
Enterococcus faecalis is Gram-positive and catalase-negative cocci that are common
in the intestines of humans and other animals and cause most enterococcal infections such as intestinal
infections, prostatitis, gastroenteritis and endocarditic. Present study aimed to evaluate the mRNA level of virulence genes which are involved in Enterococcus faecalis pathogenesis in prostate cancer patients that treated by immunotherapy. Expression level of gelatinase E (gelE) and Enterococcal surface protein (
esp genes were examined by Real time PCR in three groups of 68 male subjects. Group A normal subjects, group B prostate cancer patients before start treatment and group C prostate cancer patients after six months immunotherapy period.
Death prompts a review of gene therapy vectorLindsay Meyer
Case study and analysis of Targeted Genetics' adeno-associated virus, tgAAC94. Includes overview of clinical trial design, FDA action, NIH investigation, and outcomes surrounding the death of a patient enrolled in the investigational trial.
Data analytics to support exposome research course slidesChirag Patel
We present new publicly available tools to bootstrap your own data-driven investigations to correlate the environment with phenotype. Course materials here: http://www.chiragjpgroup.org/exposome-analytics-course/
NOYS' business slides gives you a brief introduction of what we do and can do. We have included some markets and industry slides, as well as market charts.
Challenges to the Admissibility of Evidence in the ‘Omics’ Era RonaldJLevine
Product Liability Law & Strategy: Challenges to the Admissibility of Evidence in the ‘Omics’ Era, Law Journal Newsletter’s Product Liability Law & Strategy
The word genome can refer specifically to the DNA in the nucleus of a cell, but it can also refer to the genome of organelles
that contain their own DNA. Additionally, the genome can include
non-chromosomal genetic elements - viruses, plasmids and transposons. When the genome of a sexually reproducing organism is
said to be sequenced, it is typically understood that one haploid set
of autosomes and one of each type of sex chromosome has been sequenced, which together describe the genomes of both sexes. The
term “genomic sequence” can include a mosaic of data collected
from the chromosomes of different individuals, so this sequence is
representative of the genetic material of a given species. The study
of the general properties of the genome, their evolution and the
connection with the phenotype is called genomics, and thus differs
from genetics, which in principle studies the properties of a single
gene or group of genes.
The Potential Impact of Preimplantation Genetic Diagnosis on Discrimination o...blaine_5
The argument that selection against specific genetic traits will lead to increased discrimination is both compelling and troubling. Indeed, it is reasonable to conclude that if a large number of people use PGD to select against traits they consider to be disabilities then the probability of increased discrimination and marginalization would be greatly increased. However, as this Note argues, most participants in the PGD disability debate overlook important limitations of both trait selection and large-scale PGD adoption that will likely mitigate the negative potentially negative impact of PGD technology.
General Psychology Interpret an instance of behavior (individual .docxlianaalbee2qly
General Psychology
: Interpret an instance of behavior (individual or collective) recently in the news from the point of view of any two of the three schools of thought that became popular when psychology emerged as a discipline. Your response should include specific details including the major theorists and goals of the two selected schools of psychological thought. Your response should be at least 200 words in length. You are required to use at least your textbook as source material for your response. All sources used, including the textbook, must be referenced; paraphrased and quoted material must have accompanying citations. Wade, C., Tavris, C., & Garry, M. (2014). Psychology (11th ed.). Upper Saddle River, NJ: Pearson Education. Must be done in APA format
ONE PAGE /275 WORDS ONE SOURCE BOOK REFERENCE
[1/29/16, 11:29 AM] josphat mungai (
[email protected]
):
Author: R.A. Noe
Employee training and development (6th ed.). New York, NY: McGraw-Hill
2:General Psychology
: A researcher hypothesizes that adults will respond differently to the same baby depending on how the child is dressed. Her colleague, on the other hand, hypothesizes that boys and girls are treated equally and that only temperamental differences lead to differences in their handling. Design a research study to test their hypotheses. Your response should be at least 200 words in length. You are required to use at least your textbook as source material for your response. All sources used, including the textbook, must be referenced; paraphrased and quoted material must have accompanying citations. Wade, C., Tavris, C., & Garry, M. (2014). Psychology (11th ed.). Upper Saddle River, NJ: Pearson Education. Must be done in APA format
ONE PAGE /275 WORDS ONE SOURCE BOOK REFERENCE
[1/29/16, 11:29 AM] josphat mungai (
[email protected]
):
Author: R.A. Noe
Employee training and development (6th ed.). New York, NY: McGraw-Hill
Put to the test: as genetic screening gets cheaper and easier, it's raising questions that health-care providers aren't prepared to answer
The American Prospect, November 2010
When my children were born in the mid-1990s, new parents could already see that prenatal genetic testing was altering the terrain of pregnancy and childbirth. Growing numbers of educated women were having children at older ages, with resulting difficulties and risks. More and more parents faced challenging, deeply personal decisions about whether to engage in genetic testing and what to do if they received unfavorable results.
I remember my own anxieties when my wife, Veronica, took a blood test that searched for elevated alpha-fetoproteins, which are associated with diverse ailments ranging from spina bifida to anencephaly. The mere prospect of these rare conditions--and even the choice to undergo the tests--was surprisingly painful. At least genetic counselors and other professionals were available to help guide us.
By that point, amniocentesis had been in wide use for more than t.
Put to the test as genetic screening gets cheaper and easier,.docxamrit47
Put to the test: as genetic screening gets cheaper and easier, it's raising questions that health-
care providers aren't prepared to answer
The American Prospect, November 2010
When my children were born in the mid-1990s, new parents could already see that prenatal genetic
testing was altering the terrain of pregnancy and childbirth. Growing numbers of educated women were
having children at older ages, with resulting difficulties and risks. More and more parents faced
challenging, deeply personal decisions about whether to engage in genetic testing and what to do if they
received unfavorable results.
I remember my own anxieties when my wife, Veronica, took a blood test that searched for elevated
alpha-fetoproteins, which are associated with diverse ailments ranging from spina bifida to
anencephaly. The mere prospect of these rare conditions--and even the choice to undergo the tests--
was surprisingly painful. At least genetic counselors and other professionals were available to help guide
us.
By that point, amniocentesis had been in wide use for more than two decades. As researchers identified
the genetic markers associated with a growing list of important conditions, educated, secular, and
affluent communities began to embrace genetic testing. A small but lucrative market in assisted
reproductive technologies quickly emerged, which provided parents with greater control over the
genetic characteristics of their offspring. In some parts of America, new diagnostic technologies
provoked unease regarding their eugenic potential.
In retrospect, these innovations were incredibly tame. Technological limits, cost, intrusiveness, and risk
constrained the scope of screening efforts. Roughly one in every 200 amniocenteses resulted in
miscarriage, which made the procedure too risky to justify screening the full population of pregnant
women. The human genome had yet to be sequenced. Newborn screening was routinely used to
identify a handful of important metabolic disorders, but it was a very expensive process. There was a
certain clarity, too. The most common use of amniocentesis was (and remains) to detect conditions
associated with very serious physical or intellectual disabilities. When such conditions were detected,
most parents chose to terminate the pregnancy.
Fast forward to 2010. Prospective parents can now be tested before pregnancy, and those found to be
carriers for serious conditions have the option of in-vitro fertilization, whereby embryos can be pre-
tested for genetic markers associated with Alzheimer's disease, hemophilia, muscular dystrophy, Tay-
Sachs disease, and more. Many of these same markers can also be detected by do-it-yourself genetic-
testing kits, which are beginning to appear on the Internet and on drugstore shelves. Walgreens may
soon sell a cheap home test that covers 37 genetic conditions. (Sales are postponed pending approval by
the Federal Drug Administration.) You will soon ...
Predictive Probes (Art. 1)by Jerry E. BishopSeveral years .docxChantellPantoja184
Predictive Probes (Art. 1)
by Jerry E. Bishop
Several years ago, Nancy Wexler’s mother died of Huntington’s disease, a hereditary and always-fatal affliction that strikes in midlife. Since then, Ms. Wexler, the 38-year-old president of the Hereditary Diseases Foundation in Santa Monica, Calif., has lived with the uncertainty of whether she, too, inherited the deadly gene.
That uncertainty may soon be resolved. A few months ago, scientists announced they were on the verge of completing a new test to detect the gene for Huntington’s disease (formerly called Huntington’s chorea). But deciding whether to submit herself to the test is an anguishing choice for Ms. Wexler. “If I came out lucky, taking the test would be terrific, of course,” she says. “But if I came out unlucky, well …”
Her dilemma is an extreme example of the kind thousands of Americans will face in the not-too-distant future as scientists learn how to pinpoint genes that cause or predispose a person to a future illness.
The test to detect the Huntington’s disease gene should be ready within one to two years. Researchers already have detected some of the genes that can lead to premature heart attacks and, in the near future, hope to spot those that could predispose a person to breast or colon cancer. Eventually, scientists believe they will be able to detect genes leading to diabetes, depression, schizophrenia and the premature senility called Alzheimer’s disease.
“This new technology has an extraordinary power to predict any disease where there is any kind of genetic influence,” Ms. Wexler says. “Instead of looking in a crystal ball to see your future, you’ll look in your genes.”
Doctors long have been able to crudely predict a person’s future illness. By studying disease patterns, for example, they can say that heavy cigarette smokers have 10 times the risk of developing lung cancer as nonsmokers and that middle-aged men with high blood cholesterol levels have higher-than-normal risk of heart attacks. Geneticists also look at family medical pedigrees to determine the chances of children inheriting any of the 3,000 known genetic disorders.
But such predictions are similar to casino odds. Doctors can’t predict which smokers will actually develop lung cancer, which individual will have a premature heart attack or which child actually inherited a defective gene.
Genetic probes, however, will change predictive medicine. The probes are synthetic versions of genes that cause disease. Tossed into a test tube with a small sample of a person’s own genetic material—his DNA—the probes cling to and identify their natural counterparts.
“Raft of Questions.”
Proponents of predictive medicine cite its potentially tremendous benefit in that it will allow, in some instances, people to take preventive measures to ward off certain illnesses. “But it also raises a raft of questions on almost every level—social, psychological, personal, legal and ethical,” says Ms. Wexler, a psychologist who h.
Preimplantation genetic screening (pgs) current ppt2
Genomics and Toxic Tort Causation
1. T h e O l d e s t L a w J o u r n a l i n t h e U n i t e d St a t e s 1 8 4 3 - 2 0 1 6
philadelphia, Tuesday, July 26, 2016
By Dean C. Seman
Special to the Legal
T
he current state of causa-
tion evidence in toxic tort
litigation has generated
grumbles of unreliability, under-
standable controversy and the
feeling of a jury crap shoot. Jurors
are often left weighing statistical
evidence containing large data
gaps and speculative extrapolations
versus sympathetic claims often
involving debilitating or fatal dis-
eases. However, the emerging
advances in genomics, the ever-
increasing compilation of genetic
data and the lower costs of indi-
vidualized testing has opened the
door for the use of individualized
genetic evidence to support and
defend toxic torts with a level of
unprecedented reliability.
Genomics is the study of human
genes, their interactions with other
genes and the impact of environ-
mental factors. DNA is the road
map guiding and directing all liv-
ing organisms. DNA regulates
protein production, which affects
body’s cell, tissue and organ forma-
tion and function. Humans, in
general, have tumor suppression
genes, DNA repair genes, genes
that control cell growth and genes
that affect the metabolism of toxic
substances in your body. When
“normal” genes are damaged
(mutated) through multifactorial
source(s), discussed below, your
ability to combat disease is com-
promised, potentially leading to
the development of cancer and
other illnesses. While more sim-
plistic DNA and genetic evidence
is commonplace in criminal cases,
paternity disputes and medical
malpractice litigation, the emerg-
ing genomic-based evidence will
predictably become a critical and
routine practice in toxic torts.
Toxic torts are a type of personal
injury suit whereby a plaintiff
claims that exposure to a substance
or chemical has caused a particular
injury or disease. The more com-
mon toxic tort claims arise from
cancers allegedly caused by expo-
sure to asbestos, tobacco, benzene,
pesticides, herbicides or more
recently talcum (baby powder).
For example, in February and May
2016, juries awarded verdicts of
$72 million and $55 million against
Johnson & Johnson (J&J), respec-
tively, to plaintiffs who claimed
their personal use of talcum pow-
der caused gene mutations in their
ovary tissue leading to cancer. The
overwhelming percentage of these
verdicts were for punitive damages
due to the jurors’ belief that J&J
failed to warn its consumers,
despite 40 years of statistical evi-
dence, of an increased risk (up to
33 percent) associated with femi-
nine genital use of talcum powder
and ovarian cancer. J&J argued
that available studies prove that
talc, which has been used for over
100 years, is safe. J&J also argued
that the plaintiffs’ statistical
Will Genomics Become Routine in Toxic
Torts Causation Evaluation?
E n e r g y a n d E n v i r o n m e n t a l L a w
DEAN C. SEMAN is a
partner at Weber
Gallagher in the envi-
ronmental/toxic tort
group and a former
environmental engi-
neer in the tri-state area. Seman defends
business owners and companies in envi-
ronmental matters, toxic torts and con-
struction defect and accident cases. He
may be reached at dseman@wglaw.com.
2. evidence was inaccurate, mislead-
ing and unreliable. There are
about 1,200 talcum powder cases
pending with a threat of large ver-
dicts despite no definitive under-
standing exactly how talc may
cause cancer. Perhaps genomics
and individual genetic data will
provide definitive answers to the
statistical causation evidence
debate in analogous future cases.
To prove the causal link in toxic
torts between exposure and injury,
a plaintiff must prove that, first, the
substance may cause the claimed
injury in the general population
(general causation); and that, sec-
ond, the exposure did, in fact, cause
the individual’s injury (specific cau-
sation). Experts typically rely on
epidemiological studies (trends of
exposure and disease in the general
population) to prove or refute gen-
eral causation. While there are an
ever-increasing number of epide-
miological studies, courts have
shown a reluctance to allow experts
to broadly rely on this data, as in
Burst v. Shell Oil, No. 15-30592,
2016 U.S. App. LEXIS 9386 (5th
Cir. May 23, 2016) (precluding the
plaintiff’s expert opinion relying
on “pure benzene” exposure stud-
ies in an attempt to link the plain-
tiff’s occupational gasoline fume
exposure to his acute myeloid leu-
kemia, rather than any “gasoline
containing benzene” exposure
studies). Even when respected
epidemiological studies substanti-
ate general causation—specific
causation often becomes an
insurmountable burden leading to
the preclusion of experts under
Frye or Daubert challenges or
admissibility challenges under
Federal Rule of Evidence 702 or
the states’ equivalent.
To support specific causation
arguments, the experts generally
evaluate “relative risk,” “differential
diagnoses” and dose-response data.
Most courts require a relative risk
of two or greater, which means that
an “exposed” group is at least twice
as likely (“more likely than not”) to
develop a disease than the general
“unexposed” population. The
specific causation arguments are
complex considering that diseases
alternatively originate from gene
mutations (improperly functioning
genes) caused by multi-factorial
sources including: inherited
(germline) mutations; acquired
(somatic) mutations that occur from
natural or unknown reasons during
cell division or DNA replication;
and/or through environmental fac-
tors such as nutrition, lifestyle and
exposure. For example, in Milward
v. Rust-Oleum, No. 13-2132, 2016
U.S. App. LEXIS 7470 (1st Cir.
Apr. 25, 2016), the plaintiff alleged
that his occupational exposure to
benzene caused acute promyelo-
cytic leukemia. The court preclud-
ed the plaintiff’s expert’s specific
causation testimony on unreliable
methodology grounds because she
failed to explain why she relied on
favorable studies to establish an
increased relative risk between an
individual’s exposure to benzene
and APL, while completely ignor-
ing contrasting studies. Emerging
genomics may eliminate the need
for the statistical approach to
causation evidence.
In 2003, an international
collaboration of scientists com-
pleted the revolutionary Human
Genome Project (HGP), which
Two key emerging areas
providing individualized
and reliable evidence are
biomarkers and predisposi-
tion or susceptibility genes.