Wilkes v Depuy International Ltd [2016] EWHC 3096 (QB)

Facts

  • Mr. Wilkes received a Depuy Ultamet metal-on-metal hip implant during a total hip replacement in 2009.
  • The implant was intended to provide enhanced durability and reduce wear versus traditional components.
  • Mr. Wilkes suffered complications, including elevated metal ion levels and tissue damage, resulting in revision surgery in 2014.
  • He claimed the implant was defective under the Consumer Protection Act 1987, arguing it failed to meet the safety the public was entitled to expect.
  • Depuy International Ltd defended that the risks were known and accepted in the medical community at the time of supply, and that the device was rigorously tested and approved.
  • The complications were argued to be rare and unpredictable.

Issues

  1. Whether the hip implant was defective under section 3 of the Consumer Protection Act 1987, such that its safety was not as persons generally were entitled to expect.
  2. Whether assessment of defectiveness should consider the state of scientific and technical knowledge at the time of supply, rather than hindsight.
  3. Whether communication of risks to medical professionals and regulatory compliance adequately addressed public expectations of safety.

Decision

  • The High Court found that the implant met the statutory safety requirement, considering known risks and the state of knowledge at the time of supply.
  • The implant's design was founded on established scientific principles.
  • Regulatory approval and clear communication of risks to the medical community were found to meet the public's entitlement to safety.
  • Complications experienced were within the accepted risk profile; hence, the product was not defective under the Act.
  • The claim was dismissed.

Legal Principles

  • "Defect" under the Consumer Protection Act 1987 is based on whether the product's safety meets what persons generally are entitled to expect, assessed objectively.
  • Assessment of defectiveness is determined by the state of scientific and technical knowledge at the time the product was supplied—not by hindsight.
  • Compliance with regulatory standards and communication of risks are critical factors in evaluating defectiveness, especially for complex medical products.
  • The Act sets a standard of reasonable safety, not absolute safety, reflecting a balance between consumer protection and industrial innovation.

Conclusion

The High Court clarified the interpretation of "defect" under the Consumer Protection Act 1987, ruling that Depuy's hip implant was not defective given the knowledge and standards at the time of supply. The decision emphasizes objective safety expectations and the need to consider contemporary scientific knowledge, regulatory compliance, and risk communication in claims involving medical products.

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