Implanting doubts
Date: 26 January 2012
Authors: David Hertzell, Colin Moore
Issue: Vol 162, Issue 7498
Categories: Opinion, Personal injury, Damages
The stand-off over Poly Implant Prothèse (PIP) implants between the government and private medical clinics, such as Harley Medical Group, is reminiscent of the defiant pronouncements of Ryanair boss Michael O’Leary during the disruption caused by the eruption of the Eyjafjallajokull volcano. Both companies aggressively marketed low cost products and were, without fault, suddenly left with thousands of claims for sums in excess of that originally paid. As history shows, Ryanair’s was a fruitless battle—is the same true of this dispute?
While it is arguable that PIP implants are defective within the meaning of the Consumer Protection Act 1987, a claim for breach of contract would be easier to prove and potentially offer more generous remedies than other types of claim.
Breast augmentation surgery is classified as a works and materials contract because the service (the surgeon’s skill and the operation) is so substantial that it is in effect the substance of the contract: the goods (the implants) are ancillary (Robinson v Graves [1935] 1 KB 579, [1935] All ER Rep 935). The Supply of Goods and Services Act 1982 (SGSA 1982) requires goods supplied under these contracts to be of satisfactory quality. Goods are of satisfactory quality if they meet “the standard that a reasonable person would regard as satisfactory, taking account of any description of the goods, the price (if relevant) and all the other relevant circumstances”.
Safety is a particular element of the definition of quality in SGSA 1982, but it is also highly relevant in this case to the wider concept of satisfactory quality. Breast implants fall within the Medical Devices Directive (93/42/EEC); as such, “particular attention” must be paid to the potential toxicity of materials used and to reducing “to a minimum” the risks posed by substances leaking from them. The question is whether PIP failed in these duties by filling its implants with industrial grade silicone. It is also reported that they omitted a protective coating designed to minimise the risk of rupture and prevent the escape of silicone. If true, it is arguable that the construction was inherently unsafe and therefore unlawful.
Unsatisfactory quality
Any claimant must show that the reasonable person would regard the implants as of unsatisfactory quality. In Niblett v Confectioners’ Materials [1921] 3 KB 387, [1921] All ER Rep 459, Atkin LJ said that if goods were in such a state that, “no one who knew the facts would buy them in that state” they were of unmerchantable quality. The question is would a reasonable person either buy, or regard as satisfactory, implants containing non-medical materials; would a rational person take a gamble with unknown and untested fillings? Price is not automatically relevant. In Godley v Perry [1960] 1 All ER 36, [1960] 1 WLR 9, a sixpence catapult made from plastic that was unsuitable for toys broke, blinding the claimant. The defendant was found liable for damages of £2,500. There are two further relevant factors when framing this test.
- First, that claimants will have placed reliance on the defendant’s skill and judgment in choosing which implants to offer.
- Second, the existence of a regulatory system which aims to deliver the highest possible levels of safety.
If goods are of unsatisfactory quality, the consumer is entitled, within a reasonable time, to a repair or replacement (s 11M, SGSA 1982), unless this would be disproportionate. This right stems from the 1999 Consumer Sales Directive (1999/44/EC) and the choice is the consumer’s. Here, claimants would be seeking the cost of replacement implants and surgery. It is irrelevant that the implants have not ruptured. If the goods are of unsatisfactory quality the consumer is entitled to a repair or replacement.
Proportionality?
An argument on proportionality may also be poorly received. The court in Weber v Wittmer [2011] 3 CMLR 27 emphasised that the Directive seeks to ensure a high level of consumer protection and that where only one of the remedies of repair or replacement is available, the seller may not refuse “the only remedy which allows the goods to be bought into conformity with the contract”. The court further held that, even where installation was not part of the original contract, consumers were entitled to all reasonable costs associated with the removal of the faulty goods and the installation of replacements. Claimants seeking the costs of a second operation and implants may find further support in the case of Hems v PIP [2007] CLY 1063 where the judge granted this remedy.
While this result may be unpalatable to some companies, it is worth remembering that the legislation provides them with a like claim against the company that supplied the defective goods to them—this may be unwelcome news for PIP’s UK distributor.
David Hertzell, law commissioner & Colin Moore, research assistant, Law Commission.
Website: www.justice.gov.uk/lawcommission
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