Allergan Biocell textured breast implants update
Where does the recent Paris Appeals Court Decision in PIP leave women adversely affected by Allergan Biocell textured implants?
On Thursday 20 May, the Paris Appeals Court found that German firm, TUV Rheinland, was negligent in certifying that Poly Implant Prosthese (PIP) breast implants were safe for use by women across the EU.
The decision is seminal in that it holds the Notified Body responsible for certifying the safety of the implants responsible for compensating women affected, rather than the manufacturer or producer of the product, as would conventionally be the case under longstanding product liability legislation operative across the EU.
The PIP problem
The brand of implants produced by French company PIP were pulled from the market worldwide in 2010. This decision followed an investigation which found that a proportion of the 300,000 women who had received PIP implants had been implanted with products composed of non-medical grade silicone which had not been cleared for human use. This resulted in many women with PIP implants suffering implant rupture and other adverse health effects.
In the first instance, women across the EU sought to use conventional product liability legislation to hold the manufacturer and/or distributors to account in their respective jurisdictions.
The founder of PIP, Jean-Claude Mas, was subsequently arrested in France, fined, and sentenced to prison for fraud. Consequently, the company went into liquidation, leaving an insurance policy that would only answer to claims for women implanted in France – leaving large numbers of women implanted outside France without no obvious route to compensation. In the UK some Claimants tried to use contract law routes to hold the private surgeons and cosmetic clinics responsible for the harms suffered, with mixed success. For women who could not pursue a contract law route - because the implanting clinic had gone into liquidation, or because they were implanted through the NHS - there appeared to be no realistic chance of recovering compensation.
A ground-breaking legal solution
A team of French lawyers decided to take action against TUV Rheinland, the entity they maintained had ultimate responsibility for certifying the product as safe for market, and which had ongoing responsibilities to certify product safety under the Medical Device Directive (MDD) post first marketing.
Proceedings were initially issued against TUV Rheinland, in France in 2010. The outcome of proceedings over the next 10 years has been something of a roller coaster with French courts of different tiers deciding first in favour of the Claimants, then the Defendants, and now with this latest decision the Court of Appeal of Paris confirming that responsibility for release of the defective PIP implants lies with TUV.
Subject to an appeal by TUV, the level of compensation to be awarded to each Claimant will be determined in a judgment expected in September 2021.
The impact of this decision for other women affected by defective breast implants in the UK and beyond
This ground-breaking action, anchored in France, involved claimants from multiple EU jurisdictions and beyond - with claimants from South America being joined in proceedings.
With the MDD retained in the UK under the Withdrawal Agreement, this decision by the French Courts indicates that under existing European law there may be a valid alternate route of action for claimants who suffer harm because of defective products against the Notified Body that cleared the product as safe, in lieu of the manufacturer.
For women adversely affected by other breast implants, including Allergan Biocell, that have been associated with a form of non-Hodgkin’s lymphoma known as BIA-ALCL, this latest decision may well provide a potential route to compensation – particularly where more traditional routes, through contract law, and under the Consumer Protection Act 1987, have proven difficult for Claimants to use in the UK.
With thanks to Emilio Miranda-Graham for his assistance.
Hausfeld are investigating potential routes to compensation for those affected by Allergan Biocell textured breast implants. If you would like to know more about our investigations, please register your interest by emailing AllerganGroup@hausfeld.com.