Legal Principles and Key Points
- In the case of Wilkes v DePuy International Ltd  E.W.H.C. 3096, the manufacturer of an artificial metal hip, which fractured after surgery and caused metal debris to be shed around the patient’s hip joint, was not liable to the patient under the Consumer Protection Act 1987.
Facts of the Case
- In January 2007, C underwent surgery to insert an artificial left hip made of metal parts manufactured by D.
- One part was a steel femoral shaft called a ‘C-Stem.’
- In January 2010, the C-Stem fractured, requiring C to undergo surgery to replace it.
- When the C-Stem was replaced, there was metal debris shed around the joint.
- C claimed under the 1987 Act on the basis that the C-Stem was defective when D put it into circulation.
- Was the C-Stem defective under the 1987 Act?
Held by the Queen’s Bench Division
- Finding for D, that an ‘injured party’ did not have to prove negligence/fault, but still had to prove damage, a defect, and a causal relationship between them.
- Expected standards of safety could not be clearly defined because no medicinal product could be absolutely safe; the potential benefits and risks had to be balanced.
- There was no restriction on factors that the Court should consider in determining whether the safety of a product was acceptable.
- C failed to establish that the C-Stem was defective. It fell within the safety standard that persons were generally entitled to expect when it was put into circulation. It had been subject to greater pressures than it had been tested for, which was to a higher standard than the British standard.
- The fracture was a rare and unpredictable event, but it was a risk that had been expressly warned of in the instructions for use.
Mr Justice Hickinbottom
- Expert witnesses agree that the C-Stem complied with the standard for fatigue. The parameters of the test were clearly more demanding than those required by the British Standard. It is also uncontroversial that the material used for C-Stems also satisfied the relevant standard.
- Safety is inherently and necessarily a relative concept. No medicinal product, if effective, can be absolutely safe. Whilst I appreciate the debate between consumer expectations and risk-benefit, there cannot be a sensible expectation that any medicinal product is entirely risk-free. The potential benefits (including potential utility) of such a product have to be balanced against its risks.
- The potential benefits of a medicinal product for a particular patient are often substantial. Properly informed patients will often wish to accept risks posed by such a product, rather than continue to bear the symptoms and lack of functionality stemming from conditions for which the product is prescribed.
- “The fact that ‘expectation’ in this context is objective in that sense is vitally important; because ‘expectation’ can be (and, in common parlance, is often) used differently…A person undergoing spinal surgery with a 1% chance of being rendered paraplegic as a result of his operation due to a non-negligent complication, of which he is appropriately warned, if asked, would not say that he “expected” that complication to occur. It could be said that he does not expect it to occur. However, the patient is not entitled to expect that it will not do so, or that paraplegia will not happen to him, because there is a known (if very small) risk that it will, about which he was properly informed. The surgeon does not guarantee the aspired outcome.” .
- The loading to which C’s C-Stem was exposed was clearly greater than the C-Stem could withstand. However, that was the result of multiple factors, each variable, which came together in a manner leading to a fracture. That was rare, unpredicted and unpredictable; and it was a risk that was expressly warned.
- The failure of the C-Stem earlier than was predicted was unfortunate. However, D is only liable if the C-Stem had a defect when it was put onto the market. C has failed to satisfy me that the C-Stem suffered from such a defect, or that its safety was not such as persons generally were entitled to expect.