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Lariam is an anti-malaria medicine which can make you very sick

 

The sentence was appealed on 9. Feb. by Roche's lawyer. Since then Roche's lawyer has demanded respite twice - so far until 11. October 2004.

LATEST NEWS: More than eight months after the verdict Roche's lawyer has demanded to ask four more questions to the medico-legal council.

This has been rejected by the plaintiff as being unnecessary.

Now both parties await the court's decision on this matter.

Final hearing in the trial against Hoffmann-La Roche - 4,5 years after the trial was taken to court. Before that it has been through the Patients' complaints board.

 

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.

 

 

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