In 1997, French company Poly Implant Prothèse (PIP) gained CE mark approval to produce breast implants using medical grade silicone. CE marking is intended to be a key indicator of a product's compliance with European legislation.
ln March 2010, the French government’s regulatory body for healthcare products - often abbreviated to AFSSAPS - conducted an inspection of PIP's manufacturing site and discovered the use of an unapproved, industrial grade silicone in the implants. In response, the MHRA issued a recall notice for all remaining stocks of PIP implants in the UK.
The UK Government commissioned an expert investigation group, under the chairmanship of Sir Bruce Keogh (NHS medical director). The report, published in June 2012, concluded that exhaustive testing of PIP implants did not indicate anything that could cause a long term health threat. However, it was noted that anxiety over possible health risks is a form of health risk in itself and the inferior strength of the implants led to them being considered a substandard product.
It is against this backdrop that approximately 1,200 women in the UK have joined a group legal action aimed at securing compensation allegedly due to them following the implantation of these breast implants.
The UK claims are primarily contractual in nature, concerning alleged breaches of implied conditions as to the quality and fitness for purpose of the PIP implants. These conditions are implied by virtue of the Sale of goods Act 1979 (SOGA) and the Sale of Goods and Services Act 1982 (SOGSA).
The parties alleged to have been most commonly involved in supplying PIP implants to patients were (i) PIP themselves (as manufacturers) (ii) PIP’s UK distributor (iii) the claimant’s chosen private clinic (for non-NHS patients) and (iv) the individual surgeons (who inserted the implants).
PIP are now insolvent, as are some private clinics. Many claims have been redirected to individual surgeons. Our clinical negligence team are advising in the defence of a number of these cases.
The group litigation
In order to deal with the large number of claims in an expeditious and proportionate manner, the High Court endorsed a Group Litigation Order (GLO) on 9 March 2012. Whilst many surgeons have been notified of potential claims against them, they have not been made individual parties to the GLO at this stage.
Any proposed applications for surgeons to become part of the GLO had to be issued by 11 October 2013, with such applications to be heard at the forthcoming Case Management Conference on 20 May 2014. The High Court has restricted claims against surgeons to those cases where the claimant has reached a “concluded view that the relevant surgeon contracted to supply them with PIP implants”.
It is, therefore, apparent that contractual documents for the supply of PIP implants (eg, dispatch notes, invoices and patient agreements) are pivotal in these cases. We have successfully extricated a number of surgeons from this litigation or threat of litigation. In doing so, we have relied upon contractual evidence, demonstrating that the chain of supply was only between (i) the claimant and (ii) PIP's UK distribution company and / or the relevant private clinic.
We have also encountered numerous claimants who have failed to overcome the necessary procedural hurdles in order to proceed with their claims. Such failures are likely to prove critical in a number of instances, particularly in the light of the Jackson reforms in force since April 2013, which impose stricter sanctions on parties and their legal advisers in terms of compliance with court deadlines.
PIP claims in France
In contrast to the UK, the French Government recommended (in December 2011) that all women with PIP implants should have them removed as a matter of precaution.
Following this announcement, a number of women brought legal proceedings in the French commercial courts. In November 2013, the French court of first instance ordered TÜV Rheinland (TÜV) - a private company and regulatory predecessor to AFSSAPS - to pay substantial compensation to both distributors of PIP implants and the individual claimants. This decision was based on European Legislation, specifically the Medical Devices Directive 93/42/EEC (MDD). The MDD requires manufacturers of medical devices within the European Union (eg, PIP) to engage a "notified body" (such as TÜV) to review their designs and quality management systems. The French courts held that TÜV failed in its duty to monitor the quality of PIP’s implants. It was held that more rigorous testing and inspection of PIP's manufacturing sites would have identified the fraudulent use of non-medical grade silicone.
While the exact level of compensation for each claim remains subject to expert assessment, the French Court of Appeal upheld this first instance decision on 1 January 2014. If the courts adopt a similar approach in this country, this may herald significant changes within the medical devices sector, with notified bodies potentially facing greater exposure to liability where products fall foul of industry standards. The decision of the French courts also confirms that fraudulent activities, such as those in which PIP were engaged, will not provide notified bodies with a defence in terms of discharging their regulatory duties. Based on the outcome of the French litigation, regulatory bodies will also be required to undertake more extensive certification procedures before permitting the sale of medical devices within the European market.
The European Commission has already introduced interim measures relating to medical devices (see Commission Implementing Regulation 920/2013, and non-binding Commission Recommendation 2013/473/EU). These measures establish common criteria against which EU member states can measure and oversee the performance of notified bodies with a view to avoiding future complacency.