Fertility drug cause of birth defects?

TORRANCE, Calif. (M) - On
June 19 Mark Breimhorst will
be four. His parents, Ingrid and
Heinz, call him "the most fan-
tastic little boy that ever was."
"We love him as if he was
normal," says Ingrid Breim-
horst. But the legal fight over
Mark's birth could continue past
many more birthdays.
THE BLOND youngster, born
without hands, with facial para-
lysis, impaired eyes, knock
knees and deformed feet, is
the subject of the nation's first
major court judgment against a
fertility drug manufacturer. The
drug company says it will ap-
peal the ruling.
A superior Court jury of seven
men and five women, which
heard a month of testimony in
this Los Angeles suburb, recent-
ly awarded $530,000 in damages,
ruling that the fertility drug
Clomid, widely used throughout
the world, caused Mark's de-
formities.
The verdict was unanimous,
although under civil court law
only nine out of 12 votes would.
have been required.
THE PRODUCERS of Clomid,
Richardson-Merrill Inc. of Cin-
cinnati, Ohio, maintained
throughout the trial that Mark's
defects were not unusual and
could be blamed on the simple
chance incidence of such de-
fects in the general population.
The company does not plan to
withdraw Clomid which treats
women who have irregular ovu-
lation. By regulating ovulation,
the drug supposedly allows con-
ception to take place.
"Such a deformity is a great
human tragedy," a company
spokesman said of Mark's case
. . But this particular deform-
ity has -been known for more
than 100 years, and we believe
the drug is in no way respon-
sible for it."

THE BREIMHORST'S lawyers
took a different view. Such
extreme abnormalities, t h e y
felt, could not be credited to
chance. They began an investi-
gation which lasted three years,
and upon its completion they
would credit only one thing to
chance - that the lawsuit was
ever launched.
Two young attorneys, Roslyn
Chasan and Terrence Mix, met
Ingrid Breimhorst in 1970 after
she had been involved in a mi-
nor auto accident. While consult-
ing with Mrs. Chasan about the
legal details, she mentioned she
was three months pregnant..
"I decided to wait to settle
the auto case until after the
baby was born," said Chasan,
"to make sure nothing w as
wrong." Six months later Breim-
horst gave birth.
"I RESEARCHED this, talked
to her obstetrician and pedia-
trdician, and they were unani-
mous in stating that Mark's
condition could not be the result
of the auto accident," said the
attorney.
Fascinated by the case, Chas-
an began asking Breimhorst
about her family history.
During one of the conversa-
tions, Breimhorst mentioned
that she had taken a fertility
drug.
"WE HAD been married for
two years," Breimhorst recall-
ed, "and we decided we wanted
to have children. I stopped the
birth control pill and I thought
'Bingo, I'm going to get preg-
nant.!' But it didn't work that
way."
She consulted several doctors,
underwent tests and was told
she was "oligo-ovulatory," that
she ovulated during some
monthly cycles, but. not during
others. A doctor recommended
Clomid.
After taking the drug twice
she became pregnant. She re-
members the pregnancy as

normal and trouble-free.
."THE FIRST minute that I
knew anything was wrong was
when the baby was born."
Chasan asked Mix to join her
on the case. "After eliminating
all the possibilities we were left
with only one thing - t h i s
drug. We decided that this was
the agent that caused Mark
Breimhorst to be born with these
overwhelming abnormalities."
PROVING THEIR beliefs was
more difficult. Chasan and Mix
found that all scientific data on
the drug was in possession of
the drug company they were
suing. Court orders were requir-
ed.
The evidence they ultimately
presented to the jury was bas-
ed on facts obtained from Rich-
ardson-Merrill.
Facts which were not disputed
were that Clomid was synthesiz-
ed in 1957 under the geneic
name clomiphene citrate. It was
tested in clinical situations from
1960 to 1967 on volunteer women
and from 1962 to 1967 on rats
and rabbits.
THE CHIEF disputes between
plaintiff and defense in the suit
were whether there was enough
testing, whether reporting of
malformations in the Clomid
babies was complete and whe-
ther the incidence of birth de-
fects during the pregnancies -
about three per cent - would

have warranted stronger warn-
ings than were contained in lit-
erature given to doctors with
the drug.
The Breimhorsts' also sug-
gested that the drug should have
been tested on monkeys "be-
cause their reproductive sys-
tems are very similar to those
of human beings."
Numerous experts testified for
both sides. Mark Braimhorst,
who attends a special school for
the orthopedically handicapped,
did not appear at the trial. But
jurors were shown a 30-minute
black and while film, "A Day
in the Life of Mark Breimhorst"
which showed him at school
struggling with his handicaps.
THE JURY which heard t h e
evidence deliberated nearly two
days before reaching its ver-
dict. In addition to the award

to Mark, which is to compen-
sate for a lifetime of unemploy-
ability, the parents were award-
ed $40,000 in damages for medi-
cal expenses.
The money will not be given
to Mark or his parents unless
all future appeals uphold t h e
verdict.
"It is obvious that if I had
known of the possibility of birth
defects I would not have taken
the drug," said Breimhorst.
"But Mark is our son. We love
him as if he was normal.
"WE HAVE decided," she
adds, "not to have any other
children. It would be unfair to
Mark and unfair to the baby.
"Raising Mark takes an enor-
mous amount of time and en-
ergy. But we think he is the
most fantastic little boy that
ever was."

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I