Healthcare & Life Sciences
Minister for Social Affairs and Health Marisol Touraine recently suggested that class actions in the health sector are imminent. This announcement is concomitant with examination by Parliament of the Consumer Bill, which introduces class actions to the Consumer Code – except in the health and environmental sectors. Thus, this proclamation is perhaps somewhat premature.
Product Regulation & Liability
The Cour de Cassation recently ruled on the notions of defect and the causal relationship between defect and damage in a case where there is still no scientific proof that the product in question can cause such damage. Although this decision concerned a vaccine, it is part of a new trend which may have direct consequences for product liability law, especially in the life sciences sector.
Several eagerly awaited judgments have recently been handed down by the French civil courts in product liability cases involving the vaccine for the hepatitis B virus. These were the first decisions on the issue since the Court of Cassation altered its case law on May 22 2008 with respect to the demonstration of a causal relationship between the vaccine and neurological disorders such as multiple sclerosis.
Until recently, the Court of Cassation had consistently rejected product liability claims from hepatitis B vaccination patients who have subsequently suffered neurological disorders. However, the court has now altered its position, opening the doors for compensation in these cases.
The Supreme Court recently considered whether the development risk defence is applicable to products released during the 10-year period in which implementation of the EU Product Liability Directive was delayed. Its decision confirms previous case law: producers are not entitled to rely on the defence for defective products that were put into circulation before the directive was implemented.
During the past few years, there has been much debate about whether children should be able to claim damages from doctors for acts causing disability at birth. On January 24 2006 the Civil Supreme Court followed two European Court of Human Rights decisions of October 2005 and restricted the temporal application of the Kouchner Law to cases initiated after its entry into force.
The matter of compensation for victims of asbestos exposure and penalties for those responsible has received considerable attention. The Senate's Investigative Group on Asbestos published a report in October 2005 which blamed the state and the asbestos industry for the asbestos problem. The report almost coincided with a judgment handed down by the Supreme Court in relation to a criminal investigation.
In the 1990s patients developed Creutzfeldt-Jacob disease after being treated with human growth hormones. Eight individuals were indicted on grounds of deceit. The Supreme Court recently affirmed the indictment, finding that deceit was a 'clandestine misdemeanour' and the action was thus not time-barred.
France recently modified its improper implementation of the Product Liability Directive, and has also implemented the Consumer Guarantees Directive and the revised General Product Safety Directive. New guarantees for consumers, which complement the rights already available in France, will assist potential claimants and encourage manufacturers to meet higher safety standards.
The introduction of the precautionary principle in the French Constitution - expected to be debated in Parliament in early 2005 - will not immediately result in fundamental changes for producers, as it will be limited to environmental issues and directed only at public authorities. However, it is a clear manifestation of what seems to be a strong and durable trend.
A preliminary criminal investigation was recently launched by the public prosecutor's office in Lille in relation to the extent of information provided to pregnant women by alcohol manufacturers and distributors. The investigation is a response to a complaint filed by an association of parents whose children suffer from foetal alcohol syndrome.
Under French law, pharmaceutical products are governed by the legal regime applicable to products generally. However, some believe that a specific regime should be implemented to lighten the burden of proof borne by claimants, taking into account the technical features of these products, and the disparity between the knowledge and resources of the manufacturers and the claimants.
Two recent court judgments have rejected indemnification claims issued by smokers against cigarette manufacturers. The decisions signal the refusal of the French judiciary to break away from traditional liability principles and indicate that US-style tobacco litigation is unlikely to flourish in France.
The French Supreme Court has held that in the case of a dispute over the imputability of a hepatitis C infection, the claimant must present sufficient elements to allow the presumption that the infection was caused by a blood transfusion or an injection of blood products. The burden of proof then shifts to the defendant to prove otherwise.
The Montpellier Court of First Instance recently found a manufacturer liable for breaching its safety duty with regard to growth hormones. The court considered that certain elements of the plaintiff's claim were made out and shifted the burden of proof onto the defendant. Further, the development risk defence was not available to the defendant.
A French tribunal recently found a pharmaceuticals manufacturer liable for a defective product which was given to the plaintiff's mother during pregnancy. The court found that there was a sufficient causal link between the product and the plaintiff's cancer. The development risks defence was not available to the defendant.
A recent ruling from the European Court of Justice (ECJ) condemns France for failing to implement the 1985 Product Liability Directive correctly. In particular the ECJ ruled that an EU member state cannot offer consumers more protection than is laid out in the directive.
The European Court of Justice has recently ruled that France had no excuse to ban British beef after the European Commission lifted the prohibition on export from the United Kingdom.