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SAD STORY OF THE HAPPY PILLS

The Guardian
April 5, 1994
by Clare Dyer

Six years and 30 million later, the legal system has shown it cannot cope with a group compensation claim for tranquilliser addiction. So what is the alternative?

They were dubbed the 'happy pills' and hailed as a safer and less addictive alternative to barbiturates when they were launched from the early 1960s. Valium, Librium, Mogadon, Ativan and the other tranquillisers and sleeping pills known as benzodiazepines quickly became household names as doctors rushed to prescribe them, making them the most commercially successful drugs of all time.

By the mid-seventies, at the height of their popularity, they were clocking up worldwide sales of $1,000 million. In 1980 nearly 40 million prescriptions were written by British GPs - 10 per cent of all drugs prescribed - at a cost of 30 million. By the early 1980s, 1.5 per cent of adults in Britain were taking drugs like Valium on a long-term basis. But doubts had begun to surface. In 1978 Professor Malcolm Lader, a psychopharmacologist and leading authority on tranquillisers, issued a warning about addiction in an article entitled Benzodiazepines - The Opium of the Masses.

In 1984, the British National Formulary, the prescriber's bible, warned that treatment should be limited to short periods because of addiction dangers and withdrawal problems. Two years later, the advice had become 'treatment by the lowest possible dose for the shortest possible time'. By 1988 it was advising gradual withdrawal for long-term users, warning that abrupt withdrawal could produce confusion, toxic psychosis, convulsions or a condition resembling delirium tremens. By then, more than 400,000 Britons were thought to be dependent on benzodiazepines. The tale of the 'happy pills' had turned into a horror story.

In January 1988 the Government's drug watchdog, the Committee on Safety of Medicines, warned doctors to limit prescriptions to a total of four weeks. John Wyeth and Brother, makers of Ativan, amended the drug's data sheet to warn that it should only be used for short periods in the more severe cases and halved the recommended dose.

In March 1988, lawyers launched a campaign for compensation for the tranquilliser addicts. They announced plans to sue the multinational companies which had developed and marketed the drugs, and the doctors who prescribed them, for failing to warn of the danger of addiction. They predicted that 10,000 people would join the action, making it the biggest personal injury claim ever brought in the British courts. The prediction proved right.

More than 17,000 people came forward, and more than 13,000 were granted legal aid. Over 2,000 firms of solicitors, 40 barristers and dozens of psychiatrists were involved. But six years and many preliminary hearings later, the case has collapsed. A year ago, legal aid was abruptly withdrawn for claims against Roche Products, makers of Valium, Mogadon and Librium, on advice from the plaintiffs' own legal team. Barristers reviewing the cases on the orders of the judge concluded that only a few hundred were winnable, and the board felt the potential damages would not justify the huge costs of continuing.

Last week, facing a bill for 25 to 30 million for the work so far, the board finally pulled the plug on 1,200 claims over Ativan, although each case has been vetted and approved by two barristers. With a trial - expected to last up to 12 months - still years away, the board concluded that the final costs would dwarf any damages awarded.

Plaintiffs' lawyers are bitter that aid was withdrawn before Wyeth had produced a defence and relevant documents - the point at which the strength of a case becomes clear - when funding had been granted specifically to include this stage. They will almost certainly seek a judicial review of the board's decision, and some claimants are making brave noises about fighting on without lawyers or trying to raise private funds. But the chances are that a few hundred claims over the banned sleeping drug Halcion will be all that remains of the largest personal injury claim in British legal history.

What went wrong and how did the costs escalate so alarmingly? In America, drug companies - including the makers of benzodiazepines - have paid out billions of dollars in damages to patients who claim to have been injured by their products. In Britain, no court has yet found a pharmaceutical company liable for injuries by a product, and no group action has even reached trial. The few cases in which patients have won damages have been settled out of court.

Paul Balen, spokesman for the plaintiffs' solicitors steering group, says the board's decision calls into question whether the English legal system is capable of resolving group claims over drug side effects. Given the low levels of compensation awarded in Britain and the high cost of resolving cases through the cumbersome litigation process, will aid ever be justified on a cost/benefit basis?

Colin Stutt, legal adviser to the Legal Aid Board, argues: 'The fundamental problems lie not within the legal aid system but more within the court system and the way the courts deal with these claims. The courts do not recognise group actions and treat them as a collection of individual claims. This can lead to open-ended escalation of costs.' In the next month, the board will deliver a report to the Lord Chancellor, Lord Mackay, on the lessons to be learned from the collapse of the benzodiazepine litigation. Both the board and plaintiffs' lawyers want new rules brought in as soon as possible to prevent similar debacles in future. The present rules leave it up to the judge to decide how group actions should be dealt with. Mr Justice lan Kennedy ruled that each of the individual cases had to be investigated first. According to the board, each of the 8,000 cases ruled out at an early stage cost a few hundred pounds, but the 5,000 which got as far as issuing proceedings cost 2,000 each to investigate - a total of 10 million.

In theory, sharing the costs with thousands of other plaintiffs should have made it possible for a complex case to be brought which would have been uneconomic for one or two. In the benzodiazepine case, the cost of investigating the unwinnable cases made it impossible for strong cases to go ahead. The work on multi-party cases is split into 'generic' issues - those common to all the cases, such as whether the manufacturer should have warned of a side effect - and 'specific' issues - those relating to the individual cases. In the benzodiazepine case, the generic issues at the heart of the case had still not been properly tackled six years into the litigation. Paul Balen says: 'There must be rules and those rules must allow access to justice.' He wants a sample of 'lead' cases to be chosen highlighting the generic issues. Those cases would be investigated and documents disclosed at an early stage 'so informed advice on liability can be given'. Meanwhile other cases would simply be registered on payment of a small fee, and the three-year time limit for suing would be suspended. Colin Stutt also suggests a register of claimants, with detailed analysis of a statistical sample of, say, 500 claims out of 10,000, and early concentration on the generic issues. Drug company lawyers insist, however, that generic issues are impossible to deal with in a vacuum, separate from individual cases.

Ultimately, says Mr Stutt, there is the more fundamental question of whether the present court system is the best way of resolving such cases. 'If you've got a claim about a certain drug, could you devise some sort of investigative tribunal? We're saying there ought to be consideration given to alternatives to the courts.'


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