Country:

UK (England)

Case Name:

Foster v Biosil (2000) 59 BMLR 178

Court:

Central London County Court, 19 April 2000

Topics/Issues:

Defect

Product Liability

Burden of Proof

Causation

Breast Implants

Legislation referred:

Consumer Protection Act 1987 s. 3, s. 4

Product Liability Directive 85/374/EEC Art. 4

Cases Referred:

Richardson v LRC Products Ltd (2000) 59 BMLR 185

Facts:

The claimant, Mrs Foster, claimed damages under the Consumer Protection Act 1987 (CPA) in relation to two silicone breast implants inserted on 11 August 1994. She alleged that the breast implants, manufactured by the defendant, were defective in that the left implant ruptured prematurely and the right implant leaked silicone. Consequently, the left implant had to be removed on 19 January 1995 and the right breast was removed on 14 March 1995. There was no allegation of negligence against the surgeon who inserted the implants. The Claimant submitted that she only had to prove that the products failed in a way which was unsafe and contrary to what persons generally were entitled to expect. However, the defendant manufacturers contended that the Claimant not only had the burden of proving that a defect existed, but also that the cause of the defect was attributable to the implants being defective within the meaning of s 3 CPA 1987.

Legal Questions:

(1) Whether it was the Claimant who had to prove the fact of the defect in the product.

(2) Whether the Claimant carried the burden of proof to show the cause of the defect was attributable to the implants being defective.

Decisions:

(1) Whether the Claimant has the burden of proving the fact of the defect

The court held that it was the Claimant who had to prove the fact of the defect in relation to the implants. It further stated that the Claimant on the balance of probabilities must first establish that there was a defect in the product and not merely that the product failed in circumstances which were unsafe and contrary to what persons might generally expect.

(2) Whether the Claimant had to prove the cause of the defect was attributable to the defective product

The court held the burden of proof as to causation of the defective implants was that of the Claimant. The judge stated that although the Product Liability Directive (85/374) aimed to approximate the laws of the Member States in relation to product liability whilst overturning the law on negligence by imposing strict liability, it did not reverse the burden of proof of causation.

On the evidence presented, the court held that the Claimant had failed to establish the existence of a defect in respect of either the left or the right breast implant. The right implant was found to have been intact at the time of the removal and the clear liquid in the capsular space was likely to be exudate and not silicone from the implant. The judge concluded that on the contrary, the facts tended to suggest the implants had been incorrectly weighed by the Claimant's expert. The ruptured left implant had not been available for examination by the experts of either party. In light of the fact that an implant from the same batch had successfully been inserted into the claimant as a replacement, and that statistically ruptures were a rare occurrence, the judge found that on the balance of probabilities the Claimant had failed to establish the rupture was due to a defect in the implant.

Comments:

This case confirms that the burden of proof is on the claimant to show defect and causation: there is no reversal of the burden merely because liability is strict. Following Richardson v LRC Products, the fact that a product is unsafe and contrary to consumer expectations does not necessarily mean that there is a product defect.

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