Faulty PIP Breast Implants: Act Soon For Possible Claims!

 The manufacturer Poly Implant Prothèse (PIP) had placed breast implants made of inferior industrial silicone on the market. The case is still in the courts, and TÜV Rheinland is also liable. Those affected should now take steps against the statute of limitations.

The essentials in brief:

• Statutory health insurance companies bear the costs for removing the faulty implants, but in the case of purely aesthetic operations, the insured can contribute to the costs of the treatment.
• Recent case law gives reason to hope that affected consumers can assert claims for damages against TÜV Rheinland.
• In order to prevent the risk of any claims becoming time-barred, the consumer advice centers recommend that you seek legal assistance as soon as possible.

Does health insurance pay for breast implant removal?

In 2012, the Federal Institute for Drugs and Medical Devices (BfArM) issued a recommendation to have the inferior implants removed as a precautionary measure. The Federation of German Consumer Organizations (vzbv) then demanded that the costs of removing the defective medical devices should be fully covered by statutory health insurance.

However, social courts subsequently decided that statutory health insurance companies basically have to bear the costs for the removal of the inferior breast implants. However, you can share the costs with the insured in the case of purely aesthetic interventions. According to case law, the costs for the insertion of new implants (for aesthetic reasons) are to be borne in full by those affected.

Can I assert claims against TÜV Rheinland?

The legal situation surrounding the liability of TÜV Rheinland, which was commissioned by PIP to carry out the so-called conformity assessment procedure for the implants, has not yet been finally clarified. Most recently, a verdict by a French court of appeal , which had affirmed that the German test center was jointly responsible, caused a stir.

In Germany, the legal situation for affected consumers is currently as follows:

After the European Court of Justice had clarified in its judgment of February 16, 2017 (Az. C-219/15) that the issue of TÜV Rheinland's liability should be based on national law, the Federal Court of Justice ruled in a judgment of June 22, 2017 ( Az. VII ZR 36/14) back the revision of an affected person. At the time, the court was unable to identify any violation of the obligations of the test center arising from the Medical Devices Directive.

Last year, the Federal Court of Justice changed course: In their judgment of February 27, 2020 (Az. VII ZR 151/18), the judges declared that there was no question of contractual liability, since the consumers concerned were not in the scope of protection of the testing and certification agreement between PIP and TÜV Rheinland are included. However, the court indicated that a so-called tortious liability of TÜV Rheinland according to § 823 paragraph 2 BGB in connection with the Medical Devices Act (MPG) is not excluded.

To clarify whether a legal obligation arising from the Medical Devices Act had been violated by TÜV Rheinland, the matter was referred back to the Nuremberg Higher Regional Court. The consumer advice center of North Rhine-Westphalia asked this court about the status of the proceedings: The proceedings are still ongoing; a negotiation and decision date has not yet been set. The legal dispute may be settled by a settlement between TÜV Rheinland and AOK Bayern.

Important : If your health insurance has already covered the costs for follow-up treatments, any claims for damages have passed to them. However, they are still considered

1. the assertion of a compensation for pain and suffering (§ 253 Para. 2 BGB) and
2. the determination of TÜV Rheinland's obligation to compensate for consequential damage that may occur in the future .

The amount of possible compensation for pain and suffering depends on the type and duration of the consequences that have occurred, in particular the pain suffered, the necessary follow-up treatments and the economic situation of the person concerned. In 2017, the Federal Court of Justice faced a claim for compensation for pain and suffering in the amount of 40,000 euros.

What do I have to do to ensure that any claims do not become time-barred?

Claims for damages and compensation for pain and suffering would become statute-barred within three years. The statute of limitations usually begins on December 31 of the year in which you became aware or could have become aware of the circumstances giving rise to a claim (§ 199 Para. 1 BGB). In this regard, it is recognized that an uncertain and dubious legal situation can delay the start of the limitation period. The more recent decision of the Federal Court of Justice in 2020 should have clarified the legal situation sufficiently. According to this, you would now have to become active in the three years to the end of 2023 at the latest .

In addition to a lawsuit, the chances of success of which are uncertain due to the not yet established case law, alternatively contacting TÜV Rheinland with the aim of waiving the statute of limitations until the final decision on the pending court proceedings can be considered. You should first seek legal advice for this.

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