Cosmetic implants scandal, where will liability fall?

A PIP implant

A growing scandal is erupting within the world of cosmetic surgery with continuing revelations over the safety of breast implants manufactured and supplied by the French company Poly Implant Prothèse (PIP). These implants have been alleged to have a potential rupture failure rate of 7% and to have been manufactured (for cost cutting reasons) using industrial as opposed to medical grade silicone, and ‘Fuel’ additives specifically ‘Baysilone’ more often used in textiles and as a mattress filler, allegations which PIP’s legal team refute. Some cosmetic surgery patients have claimed that they have suffered medical problems as a result, including one potential related death in France, and leading Surgeons have recommended their removal.

Many patients are therefore naturally and justifiably worried regarding the health implications that may or may not now occur, and are looking to have the implants removed with no additional cost implications. The specific problem that is arising however is who will ultimately accept the cost liability for such remedial surgery? Under the current law in the UK, and under such situations costs would usually be sought either under Contractual liability against the party who conducted the surgery, or common law negligence against the manufacturer of the implants. A number of problems however arise under either strand.

Under contract, the defendant in this case would be the cosmetic practitioner who undertook the surgery on each victim, supplying the implants during the course of such surgery. The problem however arises where for many, implant removal would be pre-emptive surgery based on a concern of failure as opposed to an actual failure. While there may be a 7% chance of failure, there is a correspondingly high 93% non failure rate. While it is legally correct to say that persons should expect to receive products that are reasonably fit for purpose and durable in what would likely be considered a supply of goods and services contract, the question arises as to whether a 7% potential for failure would take the products within the realm of being unfit for purpose and thereby raise contractual liability.

However due to the fact of the implants have been manufactured using inappropriate materials regarding the silicone filling, there is room to argue that they were unfit for purpose from the outset, a point emphasised by Freeth Cartright LLP on their own website, and thereby the nature of the implants could bring them within s.4 of the supply of Goods and Services Act 1982 as being not of a standard that a reasonable person would consider as satisfactory, and also possibly due to their containing incorrect materials, not of the correct description. The only issue that may hamper establishing such a claim involves statements of the Governments Chief Medical officer as reported in the Mail Online that

‘Women with PIP implants should not be unduly worried. We have no evidence of a link to cancer or an increased risk of rupture.’

This stance could however change as more information on the risk becomes available, and there have been conflicting statements from other Government officials including Tim Goodacre, a leading Surgeon currently investigating the affair, and in recent days assessments of risk have fluctuated wildly low and high.

It is likely as appears clear from reports that many practitioners will argue against any such liability given that many are apparently charging up to £3000.00 for removal. They argue that they should not be liable on the basis that they purchased the implants ‘in good faith’ (of which there is no evidence to suggest otherwise), that they could face substantial financial difficulties if forced to undertake the surgery free of charge, and that any liability should rest with the manufacturer, although if a cause of claim under contract can be found, this last argument would fail as such claim would lie against the other contracting party, not the manufacturer who was not privy to the contract between patient and surgeon / practitioner.

There is therefore potential scope for potential claims of breach of contract against the cosmetic surgery practitioners with whom individual patients undertook surgery which could yield damages claims for the cost of removal, and any associated suffering or injury that the patient suffers. They could also be liable for contractual affirmation should the patient so request in which case replacement and satisfactory implants could be claimed.

What of the manufacturer however?

Given that the manufacturer is not liable to victims in contract, the only potential remedy would lie in common law negligence. This however brings a number of problems including the fact that the manufacturer PIP is both outside the UK in France and they are currently in liquidation following revelations and investigations regarding the quality and composition of their products.

The company founder and owner Jean-Claude Mas is also now the subject of a manhunt having fled Costa Rica to avoid criminal charges for drink driving. Further revelations have also surfaced regarding his background with allegations that he has been amongst many things a butcher and delicatessen proprietor, and that he may face manslaughter charges in France following the death of one patient with PIP implants.

The fact is however that with the extra jurisdictional location of PIP and its current status of being in liquidation the probability of recovering damages through a negligence claim is virtually nil, particularly where PIP’s insurance brokers have stated that they will not indemnify foreign claimants. Mas himself may also not be worth suing if such personal liability could be established due to the high numbers of potential claimants not just from the UK (which numbers in the tens of thousands), but worldwide given that PIP implants have been exported to many countries worldwide. This leaves any liability he may face being solely under the potential manslaughter charges as stated, or under other elements of French law due to his operations.

One final option being mooted is that the cost of remedial surgery could be borne by the state in return for treatment on the NHS. Ordinarily the NHS do not offer cosmetic procedures for vanity purposes, and would likely do so only if the implants posed a significant health risk, though they would probably offer removal only, not replacement.

There are reports that the French and Venezuelan governments are going to pay for removal surgery for all victims with cost projections in France being up to £60 million. It is however questionable whether it is appropriate to expect the tax payer to foot the bill to remedy problems with surgery undertaken privately and often for reasons other than medical necessity. This may be particularly so where there may be appropriate claims in contract against practitioners who should have insurance to help alleviate any associated cost, though what other implications to the cosmetic surgery industry may result is unknown.

However this issue is resolved, it looks to be one that will continue for some time.

Mike Farrell 07/01/2012