The PIP scandal could provide a landmark case for medical tourism


In December 2011, news broke that breast implantssupplied by the French manufacturer, Poly Implant Prosthèse (PIP) and used in Europe since 2001 contain sub-standard non-medical grade silicone. The rupture rate in PIP breast implants was confirmed as being much higher than other types of silicone. So, concerns were raised that when they do rupture, they release non-medical-grade silicone into the body, and this may have harmful effects. Disgruntled patients are fighting for compensation and the removal and replacement of these implants.

Could medical tourism agencies be held liable?

Medical negligence law within Europe mostly assumes that the hospital/clinic is liable for any negligent act, although in some cases the doctor/ surgeon can also be personally liable.

But the law has not caught up with the world of medical tourism where the customer arranges treatment via a medical tourism agent; and there are many unanswered questions on whether the agent is an agent of the customer or of the hospital or both.

Agencies have assumed that, as most claims are in tort (a civil case for negligence), that they cannot be guilty of anything, as they have no control over the medical procedures. But it appears likely that class actions on PIP implants will be under contract law, which makes the person the customer dealt with the primary culprit. This could be deemed to be the agent or facilitator.

Planned class/group actions from 50 law firms on behalf of 40,000 UK women who had PIP implants may, or may not, produce guidance. The claims could be made both under standard negligence (tort) and also under contract law. Under contract law, the argument is whether or not the contract is with the hospital or with the agent or the surgeon, or some combination. In any group action it would be normal for lawyers to jointly sue the agency and the clinic to ensure no wriggle room and leave the defendants to argue who pays what share of any damages and costs.

The need for professional indemnity insurance

This case could be a benchmark for medical tourism as if the agency is also or even solely legally responsible under contract and/ or tort it would make it vital for all such agencies to buy professional indemnity insurance. Few buy this at present but there are special covers around for medical tourism. Many small agencies do not buy it as it is not cheap and they feel that they are not legally liable. If a claim succeeds against an agency with no insurance, then it could bankrupt the company. If the agency is not a company but run as a sole trader, the claim would be against the owner’s personal assets. This may be a good argument for all agencies to trade as a limited company, not as a sole trader or partnership.

Taking UK patients as an example, whether they had treatment in the UK or Europe, if they dealt direct with the clinic then the clinic is the one to sue. But if they dealt via an agent, they may sue the agent, not the clinic. Bearing in mind the number of people who could sue, and the number of lawyers involved, the defence costs, even if the clinics and agencies are proved totally innocent, could be huge.

40,000 women in Britain have undergone breast surgery or breast enlargement using PIP implants,.  Private clinics / hospitals performed 95% of the related operations; the remainder were carried out by the NHS. The implants contain industrial rather than medical grade silicone. Following the recall of the implants by the French medical regulatory authority, PIP went into liquidation.

Who pays?

The issue, for patients and their legal advisers is what is to be done and who is to pay.  For patients treated privately who, if anyone, is legally responsible for the predicament in which they now find themselves? Breast augmentation surgery is a works and materials contract and is governed by The Supply of Goods and Services Act 1982 (SGSA), which requires goods supplied under such contracts to be of satisfactory quality (SGSA section 2). The normal defence of the costs of rectifying the damage being too high in relation to the problem is unlikely to work here. So the women can sue for the costs of having the product removed and/or replaced. The remedies are exercisable against the person with whom the patient had entered into the contract for the supply of goods and services.

Usually this will be with the clinic.  In some cases the claim may be made against the surgeon who performed the surgery. In some cases where the patient had an exclusive contract with a third party who then sub-contracted to purchase theatre facilities and nursing care from a hospital or clinic and surgical skills from a surgeon it is likely that only the third party contractor could be claimed against since in such circumstances the patient is unlikely to have had a contract with the sub-contractors.

A negligence claim can be an alternative, as it is not necessary for there to be a contractual link between the parties to the action:  one need only show that the defendant owed the claimant a duty of care, and such duty has been breached.   This breach of duty could apply equally to the surgeon, the clinic and the agent.

Ian Adamson of Bircham Dyson Bell comments, “With action against the manufacturer futile, the most likely means of redress for an affected patient is a claim against the person with whom she had the contract for her treatment.  Who this is will vary from case to case, and will not necessarily be the hospital where the procedure was carried out or the surgeon who performed it.”

If a medical tourism agency is operating without professional negligence cover, is it putting its business at risk?


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