The fight that can't be won
The law courts are littered with the remains of failed litigation brought against the big pharmaceutical firms. Why, asks Jon Robins, are the odds stacked so heavily against the plaintiff in such cases?
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"Trying science in a court of law is doomed to failure," The Lancet concluded in a despairing editorial after the recent collapse of a legal action by nearly 100 women against the manufacturers of the oral contraceptive pill (OCP). For 4,000 people who claim to be hooked on new-wave antidepressants, the prospect of even getting into the courtroom seemed more remote after a decision by the Legal Services Commission to remove public funding at the end of last year.
According to Martyn Day, senior partner at Leigh Day & Co and the lawyer behind the Pill litigation, "The system just doesn't work." The OCP litigation fell apart after 44 days of legal argument and the contributions of 10 epidemiologists. It now joins an inauspicious roll call of failed product liability cases that includes Day's own attempts to bring the tobacco giants to trial.
"These are the cases that go to the very heart of the companies' existence and they are prepared to fight to within an inch of their lives," Day says.
The dubious relationship between the scientific research community and industry, often its paymaster, has been well documented. A blatant example of that is the brewing scandal in the world of science over "ghost-writing" in the peer-review press. This is the allegedly widespread practice of senior doctors signing themselves off as the "author" of papers written by researchers paid for by drug companies. It is alleged that the authors never see the raw data they are writing about.
No one knows the extent of the problem. But Dr David Healy, an academic who has given evidence in litigation against the pharmaceutical industry, reckons that around half of articles on new drugs are produced in this way. "These articles appear in the latest journals in the field," he says. "They get quoted more than any others, they're used to persuade health authorities and others to buy the drugs and they're used in the courts by companies as part of any legal defence."
Putting a case together against the pharmaceutical industry is always going to be a fight of David-and-Goliath proportions. "The first problem in any of these cases is even finding an expert who can help because they are nearly all receiving funding from the pharmaceutical industry," says Mark Harvey, a partner at Hugh James who is heading the antidepressant litigation and is planning to appeal the LSC's decision to pull the plug on the funding.
Harvey believes the problem is compounded because the licensing authority is "always made of individuals who have interests in the various drug companies". "What tends to happen is that the witness who is prepared to speak out against the system will lose their funding and end up being treated as a maverick and a pariah by the industry," he says.
The University of Toronto last year abruptly rescinded its offer of a lecturing post to Dr Healy after he delivered a speech claiming that Prozac and similar antidepressants might trigger suicide in patients. Such treatment prompted an angry letter of support from 27 scientists, including two Nobel laureates, claiming it had "besmirched" the university's name.
The furore about ghostwriting has sparked calls for tighter regulation of experts in courts. "There are some forensic scientists who should be banned from ever entering a court again except as a defendant," complains Barry Turner, a law lecturer in the department of biological science at Lincoln University who specialises in forensics. Turner favours court-appointed experts and a system of accreditation designed to keep out the rogue experts. "Scientifically naive judges and juries like to hear certainties as expressed by eminent scientists," Turner argues. "If the basis of these peoples' credentials is the published papers relied on by other researchers and they have neither researched nor written many of them, why should they be listened to in court?" In particular, the legal academic flags up a new system of accreditation by witness training companies and educational establishments that certify experts.
Certainly, both scientists and lawyers believe that court procedure should be overhauled to assimilate complex medical evidence. Following the OCP ruling, The Lancet called for a "binding arbitration of the facts based on expert international consensus". Martyn Day believes that judges should sit alongside one or two independent scientists. In that case, the claimants put forward four studies revealing a rough doubling of venous thromboembolisms associated with so-called third-generation pill use. The defendant drug companies funded a series of reports finding no risk, including one that used a controversial technique called Cox regression analysis that looked at the full lifetime use by women of various different kinds of contraceptive pills.
It was this report that Mr Justice Mackay decided was the "most compelling evidence" in the case. Martyn Day takes issue with not only the validity of the report but also the way in which the judge ruled on the case on the basis of one study. "I can accept the fact that we lost," the lawyer says. "But I felt that the way the judge dealt with the science of the case was poor."
Claimant lawyers fear the fate of other product liability cases. In particular, the MMR (measles, mumps and rubella) legal action, linking the vaccine with autism, where the families will have to not only take on the drugs companies but also challenge Government policy. "In cases like this you start with the science first and then the law will come right later," comments Richard Barr, a partner at Alexander Harris who is advising 800 families.
He reckons that it is a mistake to simply rely on "epidemiology" as was the case in the OCP action. "Our view is that where you can, you do direct testing and what we're doing is more like a research project than a law case anyway," he says. The law firm is presently running a testing programme with a nurse travelling the country taking blood and urine from allegedly MMR-damaged children.
A massive review of research on MMR, funded by the European Commission, last month revealed that out of 3,500 studies into the vaccine only 20 had any credibility. Dr Tom Jefferson, an independent researcher who works for the Cochrane Collaboration that prepares healthcare evidence, conducted the review. He believes that it is still possible for a UK court to get to the bottom of MMR by relying on systematic reviews. "You can't look at a single study any longer that is yesterday's science," he explains. "You have to assess a study within the whole body of evidence, and that is what the courts need to do."
None the less, Martyn Day believes that cutting-edge product liability law in this country has ground to a halt. Although the same balance-of-probabilities test is used on both sides of the Atlantic, the results of the two systems are very different. "The reality is that a jury lowers that hurdle to more like 33 per cent and a judge raises it to more like to 67 per cent," he says.
"There is now such a pattern of judicial decisions that are negative in these cases that I think that naturally conservative side of the judge worries about it being appealed and attacked by the industry and, again, it lifts the hurdles."