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law suits in France and elsewhere

Complaints by patients who have suffered adverse effects are investigated case by case in France, unlike in other countries where victims can bring class actions.

Dexfenfluramine and fenfluramine were withdrawn from the American market in 1997 for inducing heart valve disease in people taking them, either alone or in combination with phentermine. Around 60,000 people joined in class action proceedings after suffering cardiovascular effects associated with these drugs. One law firm estimated that the plaintiffs received $3.75 billion in compensation. In Quebec, a pharmaceutical company earmarked several million dollars to compensate people bringing a class action against it. In France, there is no such thing as a class action suit, and cases must be brought on an individual basis.

On 30 January 2006, a decision by the French Court of Appeal upheld the sentencing of the company Servier to compensate a patient who was a victim of dexfenfluramine in 1994. This outcome is encouraging: the Court took into account both the pharmacovigilance evidence and the insufficient information on the patient leaflet.

Judgments of this kind may incite companies and regulatory agencies to take pharmacovigilance more seriously and be more transparent when it comes to disclosing adverse effects. They also encourage patients not to give up, and remind us that it is a pity that in France victims have no possibility of launching a class action.

©Prescrire November 2008

Source: "Dexfenfluramine : process en France et ailleurs" Rev Prescrire 2008; 28 (300): 776-777.

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