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PIPANEWS

PIP BREAST IMPLANTS European Court of Justice acknowledges lack of patient protection

The European Court of Justice today dismissed the claim of German patients with PIP breast implants who considered that the implementation of the PIP company’s insurance to French patients only was discriminatory.

Allianz, PIP’s insurer, had initially requested the cancellation of its liability insurance policy. Following the intervention of the French lawyer Olivier Aumaître before the Commercial Court of Toulon, the French courts had confirmed the validity of the insurance contract. However, it had restricted its benefit to patients operated on in France, as one of the clauses provided for. This principle had been validated in 2015 by the Court of Cassation.

The overall amount was also capped at 3 million euros. Allianz was able to manage the compensation of French patients alone and in total opacity.

The ECJ’s decision acknowledges one of the main shortcomings of European regulations concerning medical devices. No European directive requires manufacturers to take out insurance. They are therefore subject only to national laws, which vary widely.

This legal vacuum is a flagrant paradox. While the CE mark (European conformity) allows pacemakers, breast implants or hip prostheses to be freely marketed throughout the European Union and beyond, obtaining it does not oblige the manufacturer to take out insurance. Thus, 90% of PIP patients located outside France are not covered by PIP’s liability insurance.

For Olivier Aumaître, lawyer for PIP victims united within PIPA, “the regulation favours international exchanges of products, which is a good thing, but consumer protection stops at the border”.

More than 10 years after the revelation of the scandal, the European authorities have still not deemed it necessary to remedy this major deficiency.

Moreover, the regulations have changed very little. A new European directive voted in 2017 had its application delayed. In any case, it only marginally strengthens the regulations. As demonstrated by the implant files global survey, the health protection of consumers of CE products is still not a priority.

The European Union has refused any support, even though PIP implants carry its mark, a supposed guarantee of the seriousness of European products. When questioned, the Commission’s services have constantly downplayed the scale of the affair.

A new health scandal is therefore likely to occur at any time. The victims could then benefit from the PIP case law by turning against the certifier as the PIP patients did against TUV RHEINLAND and its insurers, of which ALLIANZ is also a member,

For Olivier Aumaître, “the decision of the CJE confirms that the system of protection for breast implant patients relies essentially on the certifier and its insurers, who are responsible and solvent”.

The path opened in 2010 by the lawyer against TUV Rheinland thus represents the only viable recourse for the 300,000 PIP patients worldwide.

Four court rulings have already ordered TÜV Rheinland in France to compensate PIP patients to the tune of approximately 65 million euros, i.e. barely 10% of the expected final compensation. The legal actions are still ongoing, while medical expertises have been ordered to assess the damages, which will take several more years before a final decision is taken.

In several decisions dated October 10, 2018, the French Supreme Court also ruled in favor of the victims represented by Olivier Aumaître, ruling that the TUV certifier was bound by an “obligation of vigilance” and that in the presence of indications of non-compliance, he had to carry out in-depth controls of raw materials and finished products and in particular unannounced visits. TÜV had not complied with any of these obligations, according to the decisions.

In a decision of 27 February 2020, the highest German court (BGH – Bundesgerichthof) ruled that the guarantee of individual health protection for patients with PIP implants is not only the responsibility of the manufacturer (PIP) “but also of the notified body” certifying these implants. The German Supreme Court also held that it is “necessary for the notified body to be exposed to the risk of criminal prosecution by third parties in the event of negligent checks”.

The German and French Supreme Courts also reminded that TÜV Rheinland had to maintain its independence from PIP. However, this independence was undermined by the commercial relationship between TÜV – via its French entity to which it had subcontracted the audits – and the implant manufacturer (TÜV Rheinland charged for training services and helped PIP to penetrate the Asian market, among other things).

In addition to the procedures that have already resulted in the first compensation payments for more than 20,000 victims, new actions have been initiated.

Women with PIP implants can still join ongoing procedures.

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