Edward G.
Ezrailson, Ph.D.
Science Consultan=
t
(979) 696-7879hon=
e =
§ (979) 696-7068 F=
ax
ezrailson@pharmtox.net OR edez1@prodigy.net
Science Expert
Chemistry, Biochemist=
ry,
Toxicology, Pharmacology, &Clinical Chemistry
Case Experiences: 1987-Present
– Plaintiff & Defense Issues
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TOXICOLOGY
Exposures to:
Chemicals-Solvents, Toxic Gases and Poisons
Assertions
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Challenges
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Evaluation – Chemicals, gases &
poisons – Industrial & Environmental
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Chemicals |
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Medical signs and
symptoms were profiled against the known toxic properties for the
substance(s) found in environmental samples (toxic torts), urinary
metabolites (workplace and environmental).
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Chemical properties examined – vapor
pressure, molecular weight, chemical reactivity with proteins and DNA. |
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Qualitative and quantitative chemical analyses
were requested and interpreted regarding levels of exposure. Multiple chemical interactions (=
e.g. immuno-suppression) were considered from these data,
chemical properties and environmental assessment. |
Sampling methods were evaluated and challenged
when appropriate. Alternati=
ve
exposures were considered (e.g. life style and hobbies) as a potential
cause. Previous employment
environment was advanced as the initial causation. |
|
Solvent and toluene diiso=
thiocyate
exposure in a closed, poorly ventilated building resulted in chronic heal=
th
problems in office workers in a newly constructed building. It was shown =
not
to be ready for occupancy. |
Molds on the plenum surface of ceiling tile we=
re
shown to be unrelated to allergies and memory problems for the
plaintiff. Methods used by =
the
treating physicians were found to have no scientific validity or basis. |
Toxic Gases |
|
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The toxicity of carbon monoxide, hydrogen cyan=
ide,
hydrogen sulfide (gas and solutions), oxides of sulfur and nitrogen, hydr=
ogen
chloride was presented relating compromised pulmonary function,
encephalopathy, peripheral neuropathy, and regional, selective brain dama=
ge. |
Exclusion of infectious agents must be made us=
ing
objective, scientifically validated clinical laboratory tests. Fluoro-deox=
yglucose
positron emission tomography (PET scan) data were absent in the developme=
nt
of abnormal brain function. |
Pesticides, Insecticides, & Herbicides |
|
|
The properties of organophosphates and other
reactive agents are considered as they relate to organ damage, e.g. neurotoxicity and muscular atrophy. Chronic and acute exposure model=
s are
evaluated with established symptoms.&nbs=
p;
Principle toxicologist – Ellis v Maritime. Ten million dollars awarded and =
upheld
three (3) times in the Texas Supreme Court. |
Failure to establish a route of exposure was
usually a strong test of scientific methodology. Estimation of dose levels was sh=
own to
be invalid. No cluster of t=
oxic
effects found and documented. |
Heavy Metals |
|
|
Lead dust was shown to cause typical symptoms =
in
children and adults exposed through an industrial exposure. A route was established through
chemical analyses. Cadmium
contamination of ground water has been related to toxic symptoms in a sma=
ll
community. |
Solubility products of various metals were
evaluated against known anions in the environment. Flaws in scientific methodology =
were
discovered. |
PHARMACOLOGY
Assertions
|
Challenges
|
|
Norplant© was demonstrat=
ed
to be similar to anabolic steroids under suspected barrier
(“plug”) failure.
Evaluation of the NDA data for variations in blood levels of levonorgestrel was associated with adverse physiolo=
gical
effects. Fruit modeling of =
drugs
has been presented. |
Good Manufacturing Procedures and quality cont=
rol
and assurance methods were presented in detail to demonstrate that several
products did not have extreme variations in formulation and / or stabilit=
y. |
|
Antibiotic and drug allergic reaction mechanism
were simplified for presentation to the jury. |
In vivo human adverse drug effects have multiple
metabolic pathways. Careful
extrapolation from animal data was shown not to have occurred. |
|
Selective serotonin re-uptake inhibitors (SSRI)
have adverse effects in a small group of patients taking these drugs. Genetic variations in their meta=
bolism
may account for this phenomenon. |
Patient non-compliance with a prescription drug
regimen lead to transplant rejection as the pr=
imary
reason for subsequent sequelæ. |
|
Poly-pharmacy – the administration of tw=
o or
more drugs that compete for metabolic sites in the liver resulted in toxi=
city
and death. |
Adequate warnings of interactions available to=
the
treating physician such that doses could be adjusted accordingly with
laboratory monitoring of the patient. |
|
Pseudo-ephedrine warnings were found to be
inadequate for a sixth-grade educated consumer. Issues regarding concerns about =
blood
pressure and monoamine oxidase inhibitors are
superficially approached. |
|
|
Illicit drugs use – Cocaine, marijuana, =
LSD,
amphetamines, PCP et cetera caused conditions that resulted in an =
accident
with injuries and death. |
Codeine use in prescription Tylenol ©=
;
had no relationship to the mishap at work at the docks. |
|
Ethanol
intoxication, ethanol and marijuana – with or without PCP were show=
n to
play a role in reckless driving, injury and death. |
The physiological effects of ethanol intoxicat=
ion
were related to the pharmacological and physiological underpinnings. The concept of “holding on=
es
liquor” was debunked from this presentation of these scientific
facts. Factors leading to
pedestrian accidents with motor vehicles were developed. |
|
Basic science issues regarding the safety of <=
span
class=3DSpellE>Baycol® were addressed relating to t=
he
inhibition lipoprotein synthesis in skeletal muscle. Electron microscopy was requeste=
d from
the defendant. Serum myoglobin levels were not
recommended in the direction insert to identify those patients showing si=
gns
of rhabdomyolysis. |
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CLINICAL LABORATORY PRACTICES - DRUG and ALCOHOL TESTING
Assertions
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Challenges
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|
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Forensic and legal use of blood alcohol data f=
rom
post-mortem specimens was evaluated for validity in terms of methods used
– chemistry and biochemistry. |
A false positive for a pregnancy test was foun=
d to
be a laboratory procedural error and was not a defect in the laboratory a=
ssay
kit or its manufacture.. |
|
|
Clinical
laboratory quality control policies were found to be inadequate and not
minimally meeting federal guidelines (CLIA ’88). |
Chain of custody issues lead results that were
found inadmissible. Cross
contamination factors also played a role |
|
|
Screening methods for athlete drug testing were
found to have no clinical relevance, since the positive specimen was simp=
ly a
“spiked” negative.
Positive specimens were not generated by using blood and urine
specimens collected from group of healthy volunteers. Negative specimens are from a
drug-group. |
Antibody mold assays conducted at a
physician’s office were found to be scientifically invalid. Sensitivity and specificity had =
not
been determined. No data we=
re
analyzed to establish a cut-off level for positivity=
. Poor documentation resulted in a=
Daubert challenge. |
|