The claim concerned the stem of a hip replacement implant which had fractured three years after implantation. It was manufactured as the producer had intended, but the claimant argued that the design made the stem susceptible to failure, that the producer should have eliminated this risk by adopting a different design, and that the product was defective under the Consumer Protection Act 1987 (CPA). However, the claimant failed to establish defect.
The Court noted from the text of Annex I of the Medical Devices Directive (93/42/EC) that “acceptable risks” were to be balanced against “the benefits to the patient”, and noted from chapter 5 of the textbook “Clinical Negligence” (5th edition, Powers QC and Barton) that licenses for pharmaceutical products were only to be granted where there is “deemed to be a positive balance of risks and benefits”, or the product is, in the regulator’s words, “acceptably safe”.
The fact that a ‘risk-benefit’ analysis is conducted before a pharmaceutical product or medical device is allowed onto the market clearly underpinned the Court’s approach in this case.