Wilkes v Depuy International Ltd [2016] EWHC 3096 (QB) (06 December 2016)

Wilkes v Depuy International Ltd [2016] EWHC 3096 (QB) (06 December 2016)

The C-Stem hip prosthesis was not defective under section 3 of the Consumer Protection Act 1987 at the time it was put into circulation. The product complied with all relevant regulatory standards, the risk of fracture was extremely low and within the range of risks persons are entitled to expect from such medical devices, and appropriate warnings were given. The occurrence of a very small number of fractures, including the Claimant's, did not render the product unsafe in the relevant legal sense. The Defendant is not liable to the Claimant under the Act for the fracture of the C-Stem.

Citation
[2016] EWHC 3096
Parties
Claimant: Anthony Frederick Wilkes; Defendant: DePuy International Limited
Jurisdiction
England and Wales
Judgment Date
06 December 2016
Procedural Posture
Product Liability Claim Under Consumer Protection Act 1987 / Trial of Preliminary Issue on Liability Under Section 3 of the Act
Outcome
Claim dismissed on the preliminary issue; Defendant not liable under section 3 of the Consumer Protection Act 1987 for the fracture of the C-Stem.
Legal Topics
Defect Under Consumer Protection Act 1987, Standard of Safety for Medical Devices, Risk Benefit Analysis in Product Safety, Objective Test for Defect, Role of Regulatory Compliance, Warnings and Instructions for Use
Product Liability Medical Devices Law Consumer Protection Defect Under Consumer Protection Act 1987 Standard of Safety for Medical Devices Risk Benefit Analysis in Product Safety Objective Test for Defect Role of Regulatory Compliance +1 more

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Parties

Anthony Frederick Wilkes

Claimant

DePuy International Limited

Defendant

Procedural Posture

Product Liability Claim Under Consumer Protection Act 1987 / Trial of Preliminary Issue on Liability Under Section 3 of the Act

Legal Issues

  1. 1 Whether the C-Stem hip prosthesis was defective under section 3 of the Consumer Protection Act 1987 at the time it was put into circulation
  2. 2 Whether the Defendant is liable to the Claimant for the fracture of the C-Stem by reason of defect under the Act, excluding negligence and metallosis

Ratio Decidendi

The C-Stem hip prosthesis was not defective under section 3 of the Consumer Protection Act 1987 at the time it was put into circulation. The product complied with all relevant regulatory standards, the risk of fracture was extremely low and within the range of risks persons are entitled to expect from such medical devices, and appropriate warnings were given. The occurrence of a very small number of fractures, including the Claimant's, did not render the product unsafe in the relevant legal sense. The Defendant is not liable to the Claimant under the Act for the fracture of the C-Stem.

Court Disposition

Claim dismissed on the preliminary issue; Defendant not liable under section 3 of the Consumer Protection Act 1987 for the fracture of the C-Stem.

Orders

  • Claim on the preliminary issue is dismissed.
  • No liability under section 3 of the Consumer Protection Act 1987 is established against the Defendant.