Passing of the sentence 9. February 2004 about
Lariam
(translated by a non-lawyer)
The producer of Lariam must pay damages to a consumer who in
connection with a tourist travel to Thailand at year end 1998/99
took Lariam as prophylactics against malaria. By error the producer
had not seen to/made sure that there were information sheets in
the boxes with Lariam with information about side effects.
The pills with Lariam had been prescribed by the consumers own
doctor, but the court reasoned that nor he had given the consumer
guidance about the side effects.The consumer took two pills with
Lariam and experienced a number of psychiatric nuisances.
The court found it proven that the psychiatric nuisances were
side effects after taking Lariam. If the consumer had been familiar
with the possible side effects from Lariam it was likely that
he never would have taken the pills. The producer was thus made
responsible. The court gave judgement in favour of the producer
for a claim of damages to the consumers cohabitee and fellow traveller.
It was not proven. that the nuisances which the fellow traveller
had had, came from taking Lariam.
Extract from the verdict as of 9. February in case no. BS 678/1999:Flemming
Jay and Trine Lund against Roche A/S
The courts reasons and result
The court finds that malaria is a serious infection disease.
It exists in most tropical and subtropical areas of Africa,, Asia
and Latin America. Infection happens through pricks by mosquitoes.
The disease starts 1-2 weeks after infection, and there is often
constant high fever with noticeable anaemia and the risk of death
after just a few days.. The real risk of getting infected with
malaria varies strongly and depends among others upon where you
go and how you go. The risk of getting infected can be limited
also without taking medicine for example by using mosquito net
and mosquito balm.
There are several different medications against malaria but the
medicine Lariam is a most efficient one both for treatment and
as prophylactics. A part of the travellers who take lariam as
prophylactics experience side effects. Most side effects are easy
(light) such as nausea, light headache and diarrhoea, but known
are also less often but serious side effects among others visual
disturbances , anxiety, restlessness, depression, forgetfulness,
confusion, hallucinations and psychotic and paranoid and other
psychic reactions. Serious neurological side effects are only
seen with very few persons who are treated with Lariam as prophylactics.
In Denmark Lariam is mainly used as a prophylactic treatment when
persons travel to destinations with high risk of infection with
malaria and where it is estimated that other malaria medicines
- with fewer and/or less serious side effects than Lariam - are
not efficient enough. It is a very complicated weigh in each case
to determine if Lariam should be taken as prophylactics. By a
prophylactic treatment the medicine is given to a well person
with the purpose to seek to avoid that the person gets a very
serious disease. But there is a risk that the well person gets
side effects - including also serious side effects - from the
medicine. The risk of getting infected must thus be weighed against
the risk of side effects. It must be a part of the weighing how
effective a protection Lariam gives in the concrete situation
in relation to other less side effect heavy prophylactics. Especially
when it is about tourist travels there is furthermore a reason
to consider if the risk of infection should be minimised or eventually
excluded completely by choice of other mean of travel or different
travel destination.
In connection with a planned vacation to Thailand with a stay
in Bangkok, a travel about and a stay at the vacation island Koh
Samui, by consultation with own doctor on 2 December 1998 the
plaintiffs were prescribed Lariam as prophylactics against malaria.
At that time the Statens Serum Institute did not recommend Lariam
for travels to Thailand. This was the case no matter destination
in Thailand and means of travel. The Travelmedicine handbook recommended
Lariam but only for destinations and means of travel where there
were a maximum risk of infection which was travels with sleep
over in the farm districts away from the coast and outside the
tourist areas.
From the doctors record nothing is said about the basis for the
prescription and choice of Lariam as anti-malaria medicine. It
does neither say if the doctor during consultation informed about
the side effects attached to the use of Lariam.
On this background and by the plaintiffs concurrent explanations
about the course of the consultation held together with the nature
of the travel which the plaintiffs had bought ( a group tour with
Larsen Travel) which travel not even after recommendations in
Travelmedicine Handbook should give cause for prophylactic treatment
with Lariam it is reasoned that the plaintiffs did not get proper
guidance about side effects in connection with the consultation
by own doctor.
It emerges from the rules in §§ 28 and 29 in departmental
order no. 314 from 18 May 1993 about marking of and information
sheets for medicine that the defendant were obliged to at latest
from 14 February 1996 to supply all packages with Lariam with
an information sheet. The purpose of an information sheet is among
others to inform medicine users about eventual risks for side
effects from the medicine. Already since the end of the 1980'ies
the defendant has been familiar with the risk of side effects
from taking Lariam, but nevertheless packages with Lariam were
still not supplied with an information sheet on 7. December 1998
when the plaintiffs bought the preparation.
The defendant has during trial acknowledged that the missing information
sheet was due to error from the defendant. Thus the plaintiffs
did not get any information about or warning against side effects.
The product therefore had a defect according to §5, 1 paragraph.
in Law about product responsibility, since the defendant as producer
did not give the consumer information about one by defendant known
risk why the product did not present the security which rightful
could be expected by a consumer of a prophylactic medicine.
It does not change anything that Lariam was an approved medicine,
that the defendant had given adequate information about all Lariams
side effects to the relevant authorities, that the side effects
long had been commonly known in doctoral circles and that Lariam
only can be had on basis of a doctor ordination..When medicine
is given to completely well persons solely to prevent disease
it is difficult to accept side effects of any kind. Especially
when questions are risen about eventual consumption of prophylactic
medicine in connection with tourist travels some consumers will
raise even very high standards to the medicine's security. Much
higher than in the case where the medicine must betaken to cure
a disease. Furthermore the need to take the prophylactics medicine
fairly easy can be changed just by changing the way of travel
or travel destination. Therefore there is a special need to give
information about the side effects by a product like Lariam. The
probability that the information will have an influence on weather
the consumer chooses to take the medicine is much higher regarding
a product like Lariam than the corresponding probability is by
medicine with the purpose of curing a disease.
If the packages with Lariam had had information sheets it is likely
that the plaintiffs would have been aware of the side effects
attached to Lariam. When at the same time it cannot be assumed
that the plaintiffs had received information about side effect
during consultation by own doctor it is possible that the plaintiffs
would have chosen not to take the preparation. Since it is due
to an error by defendant that the packages - contrary to the regulations
in departmental order about marking of and information sheets
for medicines - did not have information sheets it must during
these circumstances be the responsibility of the defendant to
prove that the missing information sheet has had no importance
in regards to the plaintiffs taking the medicine. This burden
of proof has not been lifted. Therefore there is a cause connection
between the lacking information sheet and the plaintiffs taking
Lariam.
The plaintiffs took the first pill 26. December 1998 and the
second pill 3. January 1999. Flemming Jay has in court given a
coherent and detailed explanation about his course of illness.
He has among others told how the first symptoms in the form of
headache, fatigue, and problems to speak occurred already on 28.
December. Before departure on 4. January he contacted Euro-Alarm,
doctor Ralph Kempinski who advised the plaintiffs to immediately
stop taking Lariam. In Thailand his symptoms became worse. Most
of the time he was in bed, crying and curling up like a dog. He
was not capable of making decisions about even the simplest of
things. He was afraid and periodically aggressive. He slept 12-14
hours per day. When he slept he had violent nightmares where he
saw snakes and monkeys in the room.
On 10. January his cohabit and co-traveller Trine Lund contacted
Euro-Alarm, special medical consultant in psychiatry Thomas Brinck.
There were hereafter daily telephone contacts between Flemming
Jay and Thomas Brinck. After the return on 19. January 1999 Flemming
Jay was reported sick until 12. February 1999 and again from 2.
March till 26. March 1999.
After argumentation the court finds that Flemming Jay's description
of symptoms corresponds with possible known side effects by Lariam.
Under these circumstances and by the timewise tight connection
between taking Lariam, the occurrence of the symptoms, the plaintiffs
address to the doctor Ralf Kempinski plus the information about
the following very often and close contact to special medical
consultant in psychiatry Thomas Brinck combines (held together
with) the letters of 4. February and 4 March 1999 from Euro-Alarm
with quotation from special medical consultant in psychiatry Thomas
Brinck and a statement from 26 April 1999 from medical officer
of health Per Vagn-Hansen in which it says "that there after
the informed is no reason to doubt that the signs of sickness
which Flemming Jay has experienced after starting the prophylactic
malaria treatment is caused by it", the court finds it proven
that there is connected reason between Flemming Jay's taking of
Lariam and his course of disease as described above.
The court does not find that without medical information about
the background for the second sick report from 2. March till 26
March 1999 with full sufficient certainty can be reasoned that
also this sick report was caused by side effects from Lariam.
After the production of evidence it has not sufficient enough
been proven that there is a connected reason between Trine Lunds'
taking Lariam and the course of sickness which she has told to
the court. This regardless that the court reasons that the course
of sickness corresponds with known side effects from Lariam.
As the case has been presented the plaintiffs loss because of
Flemming Jays' sickness can be listed as follows:
expenses to Flemming Jays' trip 8,098.00
Travel insurance 932.00
Lariam 204.70
Sting and pain for the time 04.01.99 - 12.02.99 (40 days each
80 Kroner) 3,200.00.
All together : 12,434.70
The expenses to Trine Lund's trip must be added because considering
the nature of Flemming Jays' sickness it is an expected and adequate
consequence that the trip also for Trine Lund has been worthless.
Expenses to Trine Lunds' trip 8,098.00
travel insurance 932.00
All together : 21,464.70
Total loss is 21,464.70 before interest and before considering
the agreement with own doctor. The defendant must thus pay 50%
of 21,464.70 Kroner or total 10,732.35 to the plaintiffs. Out
of the 10,732.35 the sting and pain damage is 50% of 3,200.00
or in total 1,600.00 Kroner. The amount for sting and damage,
1,600.00 Kroner must be paid interest on from the time of damages
according to law about liability to pay compensation § 16.
The rest of the amount, total 9,132.35 must be paid interest on
from the day legal action was taken.
The court rules:
Within 14 days the defendant Roche A/S must pay 10,732.35 to
the plaintiffs Flemming Jay and Trine Lund supplemented with procesinterest
( bank rate plus 5%) of 1,600.00 kroner from 4. January 1999 and
of 9,132.35 from 12. August 1999 till day of payment.
Within the same deadline the defendant Roche A/S must pay the
costs for the case to the plaintiffs Flemming Jay and Trine Lund
with 20,000.00 kroner.
Britt Falster Klitgaard
Senior deputy judge
5. February 2004:
uphold of the decision of the lower court.
22.January,
2004: The verdict has been postponed due to an appeal to a higher
court about recording and transmitting pictures and sound from
the ruling. No new date so far.
Sorry:
No verdict on January 23rd at One o'clock p.m.
The
final hearing on 8. January 2004 began with an orientation that
on the night before a settlement had been reached with
the accused doctor who has paid the plaintifs DKK
35,000 . The doctor has already received a final indictment from
the Patient's complaints board.
Thus
the final hearing was solely about the trial against Swiss medicineproducer
Roche, who was representet by lawyer Frank Bøggild.
The
plaintifs were represented by lawyer Christiane Schaumburg.
Here
some of the statements from Thursday.:
Lariam
was registrered in Danmark in 1989.
According to a law from 1992 there must be information
sheets in all medicine packets.
On 14. Feb. 1995 The National Health Service of Denmark
informs Roche that the up-to-date product resumé (for lariam)
must be opdated on the information sheet.
Same info from the authorities to Roche (regarding lariam product
resumé and information sheets) in the summer of 1998.
In the early summer of 1999 TV2East reports, that there
is (still) no information sheets in the lariam packages.Roche
is told immediately to provide information sheets or else their
special license will be withdrawn.
The
Canadian information sheet contains a warning that "is not
advisable to drink alcohol while taking lariam".
The
plaintifs told that what should have been the dream journey of
their lives instead became the nightmare of their lives. Both
became depressive before the trip, found it difficult to pack
the suitcases, to go away and afterwards were very sick during
the entire stay in Thailand. European Travel Insurance's Ralph
Kempinsky said on the phone (they called him from Thailand) about
lariam: "Don't you take that. Throw it out of the window".
Flemming
Jay, who was the worst sufferer from the prophylaxis was scanned
at a hospital in Thailand to find out if he had a brain tumor.
He didn't.
Chief
of Marketing Hanne Kappel, Roche A/S said among others.:
"In
2002 Roche had a worldwide turnover of 140 billion kroner, of
which 280 mio. kroner in Denmark. Lariam is sold all over the
world, 90% of the sale is prophylaxis and10% treatment. In Denmark
the sale is 0,1% of turnover, against 1,9% of turnover i 1998.
The sale has declined since malerone came on the market."
"We
don't make any money on it (lariam), but we keep it up - we call
it a service product."
Hanne Kappel also said undocumented to the court, that "there
are 38 cases out of one million users who has got a depression."
(Comment from Lariam-Victims: We have far more members
with depression from lariam than the mentioned number. From 1994
till Feb. 1999 34.576 people have taken lariam according to the
Danish Medical Board and since the sale of lariam has declined
considerably afterwards we estimate that approx. 60-70.000 Danes
till now have taken lariam, we must question this undocumentet
information from Roche.)
Hanne
Kappel furthermore informed:
-that there can be differences in the information sheets from
country to country,
-that she herself has not tried lariam,
-that there should have been information sheets in the packages,
and
-that
it was a matter of a human error.
Also
the former Chief of Marketing with Roche, Torben Jung Laursen,
now C.E.O. of Alpharma called it a human error and a sloppiness
that there were no information sheets in the packages. He said
that it is the Roche register department which is responsible
for the information sheets. He informed furthermore that he himself
deliberately has avoided taking lariam.
On
Friday there was procedure with replications and rejoinders from
both lawyers speaking for acquittal and conviction.
The
trial was taken to court on 11. August 1999.
By
New Year 2003-2004 it has been five years since the plaintifs
each took two lariam tablets.
