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Healthy Skepticism Library item: 4396

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

 

Publication type: news

Gibbs F.
Drug company offers £5,000 if victims of trial agree not to sue
Times Online 2006 Apr 19
http://www.timesonline.co.uk/printFriendly/0,,1-2-2140946-61,00.html


Notes:

Ralph Faggotter’s Comments:

It sounds like TeGenero’s lawyers are living in the same fantasy land as the rest of the company.


Full text:

Drug company offers £5,000 if victims of trial agree not to sue
By Frances Gibb, Legal Editor

SIX volunteers who suffered multiple organ failure during a trial of a new drug last month have been offered interim payments of £5,000 – but only if they agree not to sue.

Lawyers for four of the six say that TeGenero, the manufacturer of the drug, has accepted responsibility for paying the six men compensation.

But the terms of the compensation are that the victims agree to accept a “no-fault” procedure, under which the final sum would be determined by binding arbitration and without expert witnesses.

Three days ago it emerged that one of the men, Ryan Wilson, 20, who suffered the most severe effects, would lose some of his fingers and toes. He took part in the trials of the drug TGN1412 – for which the volunteers were paid £2,000 – to buy driving lessons and a holiday. He spent three weeks in a coma and is still in hospital. The other five, including Navneet Modi, 24, from Forest Gate, East London, and Egyptian-born Mohamed Abdelhady, 28, have been released.

The drug was developed to treat diseases such as rheumatoid arthritis. The long-term prognosis for all six is uncertain, but they may have suffered serious damage to their immune systems.

Martyn Day, the solicitor for four of them, said: “It seems to us an outrage that the drug company has put these men through all this and are now trying to force their hands. Clearly one has to weigh the expense of legal action against going down this route. But it is too early for our clients to be forced into a decision on this.”

He said that he had met lawyers for TeGenero, its insurers and Paraxel, who ran the trials. “Our clients have had to suffer a lot of losses, they cannot work, they have not been able to do anything where there are a significant number of members of the public – because they are weak and there is a real risk of infection.”

He had been told that they were being offered a £5,000 interim payment – on condition that they agree to the no-fault route. “They have instructed me to tell the drug companies that they do not intend giving in to this sort of manoeuvre,” he said.

The no-fault route is a procedure recommended by the Association of the British Pharmaceutical Industry. Its merits include the avoidance of expensive and lengthy court-based litigation. But there would be no expert witnesses for each side, just joint experts acting for both victims and insurers.

There would also be just a single lump sum award, and not provisional damages with later payments if needed. In a court action, damages would be awarded in line with the principles for personal injury, taking account of impact of the injuries suffered and long-term outlook. Another problem for the men is that the drugs company was insured only to a total of £2 million for the trials.

 

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...to influence multinational corporations effectively, the efforts of governments will have to be complemented by others, notably the many voluntary organisations that have shown they can effectively represent society’s public-health interests…
A small group known as Healthy Skepticism; formerly the Medical Lobby for Appropriate Marketing) has consistently and insistently drawn the attention of producers to promotional malpractice, calling for (and often securing) correction. These organisations [Healthy Skepticism, Médecins Sans Frontières and Health Action International] are small, but they are capable; they bear malice towards no one, and they are inscrutably honest. If industry is indeed persuaded to face up to its social responsibilities in the coming years it may well be because of these associations and others like them.
- Dukes MN. Accountability of the pharmaceutical industry. Lancet. 2002 Nov 23; 360(9346)1682-4.