Multiple claimants v Sanifo-Synthelabo Ltd and another

Hearing dates: 23 & 24 July 2007

Approved Judgment

I direct that pursuant to CPR PD 39A para 6.1 no official shorthand note shall be taken of this Judgment and that copies of this version as handed down may be treated as authentic.

The claimants seek an order to the effect that there should be a trial of certain preliminary issues on the basis (or largely on the basis) of assumed facts. The purpose of their applications is “to substitute for the full trial of this multi-party action a trial of dispositive preliminary issues”. The defendants oppose the applications on the grounds that the court should not change the directions for the trial of these proceedings given by Master Leslie on 25 April 2006, and that the preliminary issues suggested by the claimants are impractical and inappropriate and the proposed trial of preliminary issues would be “futile”.

This litigation (sometimes called the “FAC litigation”) is subject to a group litigation order made with the approval of the Lord Chief Justice on 25 August 2006. It is complicated litigation giving rise to apparently difficult legal and scientific questions. It was observed during the hearing before me that it would assist to have a High Court Judge assigned to it. I agree, and it has now been arranged that the litigation be assigned to Mr. Justice Underhill. All future applications are to be heard by him unless otherwise ordered.

The claimants are all children of mothers who suffered from epilepsy and during their pregnancy, it is said, took an anti-epileptic drug (or anti-convulsant drug) called sodium valproate, which the defendants marketed under the name Epilim. The claimants say that Epilim is a known teratogen, which crosses the placenta during pregnancy and is recognised to cause various deformities, and that therefore it is unsafe for all pregnant women whose fetuses are exposed to it. However, some epileptic women of child-bearing age (and others suffering from epilepsy) need to take Epilim in order to prevent, or at least to reduce, seizures. There is no alternative safe drug for pregnant women with epilepsy, and for some forms of epilepsy Epilim remains an appropriate treatment during pregnancy.

Accordingly, the claimants say, a pregnant woman with epilepsy which can be managed by Epilim is placed in the impossible dilemma whether to take the drug in order to protect both herself and to her fetus from the risks associated with her epilepsy or to stop taking Epilim in order to avoid the risk to the fetus caused by its teratogenic properties. It is likely that the nature of the risk to the fetus depends upon genetic makeup, which cannot be known in advance. Epilim (or its metabolites) spreads through the placenta to the embryo and the fetus and so affects development and organogenesis, and causes damage to the fetus and therefore to the child when he or she is born. Although gross teratogenic damage caused by exposure to Epilim can be detected ante-natally, not all forms of teratogenic damage can be.

The claimants say that Epilim is a product in which there was a “defect” within the meaning of the Consumer Protection Act 1987. That Act was passed in order to give effect to the Product Liability Directive 85//374/EEC (“the Directive”) and is to be interpreted in light of the Directive. It provides that prima facie “there is a defect in a product… if the safety of the product is not such as persons generally are entitled to expect”: section 3(1). It also provides that in determining:

“what persons generally are entitled to expect in relation to a product all the circumstances shall be taken into account, including –(a) the manner in which, and purposes for which, the product has been marketed, its get-up, … and any instructions for or warnings with respect to, doing or refraining from doing anything with or in relation to product; ….”

Under the 1987 Act where any damage is caused wholly or partly by a defect in the product, among others a producer of the product shall be liable for the damage. There are statutory defences against liability including (at section 4(1)(e)) if the defendant shows:

“that the state of scientific and technical knowledge at the relevant time was not such that a producer of products of the same description as the product in question might be expected to have discovered the defect if it had existed in his products when they were under his control.”

The burden of proving this (and other statutory defences) is upon the defendant.

The claimants bring their action in reliance upon the Congenital Disabilities (Civil Liability) Act 1976 because their claims are for pre-natal injuries and such claims are now governed by the 1976 Act and not the common law. The Act provides that if a child is born disabled as a result of an “occurrence” before birth and a person other than the mother is answerable to the child in respect of the occurrence under the statute, the child's disabilities are to be regarded as damage resulting from the wrongful act of that person, and the child can claim damages. Section 1(2) provides as follows:

“An occurrence to which this section applies is one which—(a) affected either parent of the child in his or her ability to have a normal healthy child; or (b) affected the mother during her pregnancy or affected her or the child in the course of its birth so that the child is born with disabilities which would not otherwise have been present.”

The claimants say that in this case liability arises under section 1(2)(b). The 1976 Act provides at section 1(4) that “In the case of an occurrence preceding the time of conception, the defendant is not answerable to the child if at that time either or both of the parents know the risk of their child being born disabled (that is to say, the particular risk created by the occurrence)…”.

Section 1(5) of the 1976 Act that provides that “the defendant is not answerable to the child for anything he did or omitted to do when responsible in a professional capacity for treating or advising the parent, if he took reasonable care having due regard to then received professional opinion applicable to the particular class of case; but this does not mean that he is answerable only because he departed from received opinion”.

Section 6(3) of the 1987 Act deals with how the 1976 Act is to be given effect in relation to product liability. It provides, so far as is material, that section 1 of the 1976 Act shall have effect as if “a person were answerable to a child in respect to an occurrence caused wholly or partly by a defect in a product if he is or has been liable [under the 1987 Act] in respect of any effect of the occurrence on a parent of the child, or would be so liable if the occurrence caused a parent of the child to suffer damage”.

The claimants' pleaded case is that they were born disabled as a result of an occurrence within the meaning of section 1(2)(b) of the 1976 Act and section 6(3) of the 1987 Act, and that the “occurrence” was “the transplacental spread of Sodium Valproate or its metabolites to the embryo/fetus, which then affected the embryonic and fetal development and organogenesis…”.

The defendants respond to this pleading as follows:

i) First, it is said that there was no “occurrence” in the statutory sense because the regime that the claimants' mothers required to control their epilepsy was such that they were unable to have a “normal healthy child” (terminology derived from section 1(2)(a) of the 1976 Act).

ii) It is said that the only “occurrence” that affected the mothers' ability to have a normal healthy baby was their epilepsy that required treatment with anti-epilepsy drugs, including sodium valproate.

iii) Thirdly, it is denied that any transplacental spread of sodium valproate or its metabolites constituted an “occurrence”.

The defect that caused the occurrence is said by the claimants to be the teratogenic capacity of the sodium valproate. Their primary case is that information supplied with the drug to a user is not a relevant circumstance for the purpose of assessing the “legitimate expectation of safety of persons generally” for the purposes of the 1987 Act and the Directive. They also say that the information provided by the defendants was inadequate.

The defendants for their part say that all anti-epileptic drugs (“AED's”) have unwanted side effects and “The current state of scientific knowledge does not permit any of the AED's currently on the market to be deemed free of teratogenic potential”. They deny that “a pharmaceutical product such as Epilim is defective within the meaning of the Directive or the CPA where, by its very nature, its use carries a potential risk of adverse events and those potential risks are generally known to treating practitioners and/or specifically warned about by the marketing authorisation holder”, that is to say the person authorised to supply the product under domestic and European regulations. They plead “The Claimants' primary case on defect is bad in law. The Directive and the Act cannot properly be construed so as to require a Court to have no regard to the essential factual context of the guidance provided to treating practitioners and/or specific warnings provided by marketing authorisation holders as to adverse events or “harmful characteristics” inherent in the use of a pharmaceutical product”. Having...