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DuPont
Responsible for Birth Defects
A
US court has awarded damages to John Castillo, who
was born in June 1990 with no discernable eyes. The
chemical company DuPont, who markets the product,
was held responsible. Similar cases have occurred in
heavily sprayed areas in the UK. Alan Care
provides the background.
In
1993, the Observer, a UK national newspaper,
published the first in a series of articles on
children being born without eyes or with related
syndromes1. The largest group of nine
children was born over 12 years in a 40-mile radius
in North Lincolnshire, an intensively farmed area.
The
Observer suggested a possible link between
the exposure of mothers during pregnancy to the
pesticide Benlate (active ingredient benomyl)
manufactured by DuPont and the development of
microphthalmia and anophthalmia, conditions where
children are born either with poorly developed eyes
or without eyes. The Observer reported a 1991
Californian research study where pregnant rats given
benomyl gave birth to offspring with no eyes. The
eyes in the foetus develop during the early stages
of pregnancy, ‘the window of vulnerability’, unless
a toxic or other interruption takes place (known as
an ‘insult’)2.
In
January 1993, the Observer arranged a meeting
for parents of affected children which led to the
foundation of a charitable self-help group known as
the Micro and Anophthalmic Children’s Society (MACS)3.
DuPont responded to press coverage by stating that4:
‘Any substance, whether naturally occurring or
manufactured, can produce adverse effects in
laboratory animals if administered at high enough
rates. The British Medical Journal has stated that
experiments on animals have shown that X-rays,
anoxia and many chemicals can cause anophthalmia or
microphthalmia. Unlike many potentially harmful
substances to which we are all exposed everyday,
pesticides are subjected to detailed tests to
establish the dose at which such effects occur. This
enables the government registration authority to
evaluate possible risks from their use. Maximum use
levels can then be set to ensure a wide safety
margin. The safety level for benomyl could never be
reached through accidental exposure to the chemical,
spray mist or treated fruit and vegetables. The
Ministry of Agriculture have stated that, in the
light of the wide margin of safety that has been set
for benomyl, it is difficult to see how the defects
could be linked to benomyl exposure … DuPont will of
course provide any help we can to any independent
investigation into possible external links with this
tragic condition. However on the basis of over 20
years of research with the product we are confident
that benomyl is not involved.’
Benomyl concerns mount
Benomyl is a systemic fungicide which is used
pre-harvest and post-harvest as a dip or dust to
combat a wide range of fungal diseases in arable and
vegetable crops. Adverse effects such as eye birth
defects occur after exposing experimental animals to
high doses of pesticide. Two questions arise: is
there a safe level of exposure, and is the timing of
the exposure during pregnancy critical5.
In
1997, DuPont funded a scientific study by an
independent laboratory in Yorkshire. The internal
report, details of which emerged in 20026,
indicated that in rat studies a ‘high’ proportion of
benomyl was drawn to the eyes. The report showed
that after two hours, a third of the benomyl was
concentrated in the eyes, rising to two-thirds after
24 hours. After 10 days, 80% of the benomyl was
pooled around the eyes.
US
legal victory
On a hot day in 1989 Mrs Castillo was walking in
the country with her small daughter. She was
drenched by a cloud of spray drift from a passing
farm tractor. At the time she was unaware that she
was pregnant, or that the spray may be hazardous.
James Ferraro, a lawyer from Miami with experience
of claims for damages arising from chemical
exposure, investigated the case. Ferraro had taken
on the claims of the UK children, but legal aid
funding had been withdrawn by the Legal Aid Board
following written representations by DuPont’s London
based lawyers who stated there was no case to
answer.
In
June 1996, a jury in the Castillo case awarded
damages of $4 million against the defendants, DuPont
and Pine Island Farms. This verdict was subsequently
over-ruled by an Appeal Court. The original trial
verdict was reinstated and upheld by the final Court
of Appeal in Florida, the Supreme Court, in July
20037, after considering the case in
depth and handing down a 60-page judgment. DuPont
was found 99.5 percent responsible and Pine Island
Farms 0.5 percent responsible and the damages had to
be paid proportionately. It is understood that
DuPont has now paid the damages with substantial
interest.
Judgment links exposure
The evidence of University of Liverpool based
toxicologist Dr C V Howard was influential in
establishing that benomyl exposure during pregnancy
had caused John Castillo’s eye condition. The
Court’s judgment states:
The Castillos’ expert’s methodology for reaching
his opinion that benomyl is a human teratogen at
20 ppb, involved the following considerations:
1. animal studies, including DuPont’s own rat
studies, which showed that Benlate is
teratogenic and that it specifically causes
microphthalmia and anophthalmia
2. in vitro tests performed by DuPont, Dr. Van Velzen, and Dr. Howard, which showed the levels
at which Benlate can impair neurite growth and
functioning and induce cell death – either of
which could impair or prevent development of the
eyes
3. clinical epidemiological studies are not
available because Benlate is a toxic chemical
and thus not suitable for human experiment
4. geneticists had conducted every conceivable
genetic test and could find no known genetic
cause of John Castillo’s microphthalmia
5. there was no evidence of any other
environmental cause.
More cases pending
Claims for damages for
personal injuries have been filed in the United
States on behalf of a number of British families.
The first case to be heard at a preliminary hearing
in 2001 was that of Andrew Bourne in the US Court,
Southern District of West Virginia, Charleston,
before a single judge, Judge Copenhaver. The Judge
supported a DuPont motion to strike the expert
causation testimony of Drs Howard and Tackett, on
the grounds of lack of attention to epidemiology.
This case decision is now subject to an appeal. The
Bournes’ legal team, led by James Ferraro, believe
their case will be helped by the 1997 study carried
out for DuPont which reveals how the eyes act as a
powerful ‘magnet’ to attract benomyl and explains
how the chemical destroys the eyes of the foetus
(see above).
Further cases have been lodged with the Delaware
Court on behalf of other British parents and parents
of children from New Zealand. A decision in the
preliminary hearing will be handed down by the
Delaware Court shortly.
Benomyl withdrawn on ‘economic’
grounds
Although DuPont has been involved in litigation over
Benlate for several years, previous cases involved
claims that the fungicide caused damage to crops and
soil. In April 2001 DuPont announced it would
discontinue the manufacture of benomyl and phase out
sales globally after 33 years on the market. The
company has faced a vast number of claims for damage
to crops and soil, and announced that ‘it is no
longer willing to bear the high and continuing costs
of defending the product in the US legal system.’8
Conclusion
The decision of the Florida Supreme Court will be
highly influential and will have bearing upon any
other decisions in the US courts involving Benlate
and related exposure cases. The UK regulatory
authorities and particularly the Advisory Committee
on Pesticides (ACP) may well wish to revisit
benomyl. Of particular interest is the Court’s
ruling on the importance of the evidence of a
toxico-pathologist. The next US Delaware court
decisions affecting UK parent’s claims are awaited
with much interest.
1. Paduano M, McGhie J, Boulton A, ‘Mystery
of Babies with no eyes’, Observer, 17 January
1993.
2. Hoogenboom et al, Effects on the fetal rat
eye of maternal benomyl exposure and protein
malnutrition, Current Eye Research, 10.601-12,
1991.
3.
http://www.macs.org.uk/
4. DuPont press release, Alleged Benomyl Link
With Anophthalmia, 11 February 1993.
5. Benomyl fact sheet, Pesticides News 35, March
1997.
6. The unpublished study was seen by the
Guardian newspaper, who reported on the details:
Evans R, Hencke D, ‘Boost for parents’ court
fight over son born without eyes’, Guardian, 25
March 2002.
7. John Castillo v. EI DuPont De Nemours & co.
INC et al, No.SC00-490 p1-60, 10 July 2003
8. Borel JC, DuPont Crop Protection Products, 19
April 2001,
www.cps-scp.ca/benomyl.htm
Alan Care is a litigation executive with Thomson
Snell & Passmore, Tunbridge Wells representing UK
clients bringing claims in the US courts with
Ferraro & Associates of Miami. He specialises in
personal injury claims involving chemical poisoning
and is Co-ordinator of the APIL (Association of
Personal Injury Lawyers) Environment Special
Interest Group. | .gif)
