Country:

UK (England)

Case Name:

XYZ & others v Schering Health Care Ltd & others [2002] EWHC 1420

Court:

High Court (QBD), 29 July 2002

Topics/Issues:

Product Liability

Oral Contraceptives

Causation

Articles:

Consumer Protection Act 1987

Product Liability Directive 85/374/EEC

Cases Referred:

Facts:

X (the lead Claimant in a group action) suffered deep vein thrombosis (DVT) after taking a combined oral contraceptive (COC) named Femodene, manufactured by the Defendants. Also having taken the pills, the other Claimants had suffered a variety of cardio-vascular disorders, some of which were fatal. The Claimants claimed the contraceptives were defective for the purposes of the Consumer Protection Act 1987. It was alleged that the contraceptives carried more than twice the risk of venous thromboembolism than second generation COC's.

Legal Questions:

(1) Whether the 'third-generation' oral contraceptive pill produced by the defendants were defective within the meaning of the Consumer Protection Act 1987 (CPA)

(2) If so, whether the Defendants were entitled to the Developments Risks Defence under section 4 CPA, i.e. whether the "state of scientific and technical knowledge at the relevant time [was] such that a producer of products might be expected to have discovered the defect."

Decisions:

On the basis that Mackay J found that the Claimants had failed to establish that the risk of blood clots arising out of taking the third-generation pills was more than twice that of the second-generation pills (as they had alleged), the case was dismissed before the issue of whether the pills were defective was reached.

Comments:

The Claimants failed at the outset because they could not establish that the relative risk of VTE when using third generation COCs was twice the risk inherent in second generation COCs. Scientific evidence had shown that there was not, as a matter of probability, any increased relative risk. Although not explicitly an assessment of the causation stage (since the assessment of defect was not reached) this illustrates the difficulties in the application of the preponderance of the evidence standard of proof for causation to scientific evidence of relative risk.

For further commentary see:

"Strict liability for defective products: the ongoing debate", Dr. Paula Giliker, Bus. L.R. 2003, 24(4), 87-90.

"Women lose court action against new pill", Joshua Rosenberg, Telegraph, 30th July, 2002.

Original text:

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