Patients in the US who suffered severe side-effects from revolutionary new drugs may be denied recourse to the courts under a new law being drawn up by President Bush's second administration.
The move would shield the world's major drug companies from waves of expensive litigation, in effect capping the costs associated with controversial drugs such as Vioxx, Merck's arthritis painkiller which the manufacturer withdrew after several users suffered heart attacks or strokes.
For years, the pharmaceutical industry's most vigorous opponents have been American class-action lawyers, who routinely sue companies on behalf of patients who have suffered side-effects.
Recent large payouts have included $1.3bn (£700m) to those harmed by the fen-phen diet drug made by Wyeth and more than $1bn to people harmed by Bayer's cholesterol lowering drug, Baycol. Both drugs were quickly pulled from the market when patients began litigation.
Aside from Merck, Pfizer is also bracing itself for lawsuits linked to its arthritis drug, Celebrex.
Lawyers are also circling the British-based AstraZeneca, amid debate over the safety of its cholesterol-lowering drug Crestor. Privately, drug company executives say the major firms each spend hundreds of millions of dollars a year on legal fees and costs.
A medical malpractice bill - expected to be introduced in the US - is thought to contain a clause that could prevent future lawsuits.
US media reports suggest that if the bill gets through Congress, drug manufacturers would be safe from punitive damages as long as the regulator - the food and drug administration - had approved the drug for sale. The initiative is being widely attributed to President Bush personally.
Yet the FDA has been severely criticised recently for being too friendly with drug companies and not taking patients' safety seriously enough.
Senator Harry Reid, the Democratic leader in the Senate, declared recently: "Congress should not be giving a free pass to big drug companies at a time when millions of Americans may have had their health put at risk by pharmaceutical giants."
Pharma industry campaigners have played up the sobering effect of litigation in the US health sector. Many have speculated, for example, that this is why Merck moved so quickly to withdraw Vioxx from the market when evidence of the risk of heart attacks emerged.
The Association of Trial Lawyers of America says that taking away the threat of legal action would lose the incentive to make the safest drugs possible and remove them from the market if necessary.
