A more detailed analysis of the impact of the work at the CJEU is featured in Clinica Medtech Intelligence.

Liability Spotlight now on the Notified Bodies

Background and Context

The so-called PIP-Breast-implant scandal now reaches the Court of Justice of the European Union (CJEU). As last week a German court referred a liability case to the CJEU, it is now upon the CJEU to provide further clarity on the responsibilities and liability scheme for medical devices in the EU. The key questions relate to the responsibility of the Notified Bodies which are in charge of granting the CE mark which again is required to place medical devices on the EU market. The CJEU’s answer will have an impact on the work of Notified Bodies and will be relevant for the liability of medical device manufacturers in the EU.

In the current case, the plaintiff has sued the German Notified Body TÜV Rheinland for damages as she had been implanted a PIP breast implant. PIP stands for the company name Poly Implant Prothèse which, for years, was illegally selling breast implants containing industrial silicone instead of the medical silicone for which they had received the CE mark. The founder of PIP and several former executives and managers were convicted of fraud and sentenced to jail by a court in France.

TÜV Rheinland was the Notified Body for PIP and in charge of conducting the conformity assessment pursuant to Article 11 of the Medical Devices Directive 93/42/EEC. In her claim, the plaintiff alleged that TÜV Rheinland did not comply with the said obligations. She further argued that if TÜV Rheinland had adequately reviewed PIP’s business records and conducted unannounced audits and product tests, PIP’s misconduct could have been detected and further placing on the market of these products prevented.

Notified Body Liability so far: “Yes” in France – “No” in Germany

In France, patients have also sued TÜV Rheinland as Notified Body and have so far been successful before French Courts. In 2013, the French Commercial Court in Toulon found TÜV Rheinland liable towards (French) victims of PIP irrespective of whether the Notified Body itself had been systematically deceived by PIP or not. For further information on the French Court’s ruling, please see our blog at: http://www.insidemedicaldevices.com/2014/01/13/french-court-finds-notified-body-liable-in-breast-implants-scandal/.

In contrast to the French litigation, German courts so far held that TÜV Rheinland is not liable for damages resulting from the PIP breast implants. However, one of these cases has now eventually reached the German Federal Court of Justice (BGH) and the BGH seems to be open to accept a liability of the Notified Body but first asks the CJEU for clarification of the underlying EU rules that govern the Notified Body’s obligations.

Therefore, on 9 April 2015, the BGH has referred the case to the CJEU and is seeking clarity on the interpretation of Directive 93/42/EEC. In particular, BGH asks whether the work of a Notified Body is supposed to have a protective effect towards patients so that patients are entitled to claim damages directly from the Notified Body. The lower German courts had dismissed the plaintiff’s claims held that the legal purpose of the Notified Body’s activities did not aim to protect potential patients. The BGH does not seem to be fully convinced by this general position.

Therefore, BGH has asked CJEU to provide clarity on following questions:

  1. Is it the objective and intention of the Medical Devices Directive 93/42/EEC that in case of Class III medical devices, Notified Bodies are also acting with the purpose of protecting potential patients so that the Notified Body can be liable towards patients when they negligently violate their obligations?
  2. Does Annex II of Directive 93/42/EEC require that that in case of Class III medical devices, Notified Bodies also have the – general or for-cause – obligation to test the respective product?
  3. Does Annex II of Directive 93/42/EEC require that in case of Class III medical devices, Notified Bodies also have the – general or for-cause – obligation to review the business records of the device manufacturer and/or carry out unannounced audits?

Perspectives and Potential Impact

The outcome of this case will, obviously, significantly impact the scope of legal responsibilities and the liability risks of Notified Bodies in the EU. If the CJEU should confirm that the work of the Notified Body aims to ensure safety of medical devices and, in so doing, should also increase the safety of the patients that may be treated with these devices, it is likely that the Notified Body will be held liable towards patients when negligently violating these obligations.

For the liability of Notified Bodies much will depend on the clear delineation of the scope of their legal obligations. These are subject to the second and third question of the BGH above. It will also be interesting to see to which extent the CJEU will consider the recent EU Commission Recommendation 2013/473/EU of 24 September 2013 on the audits and assessments performed by notified bodies in the field of medical devices.

The outcome of this case will also impact the relationship between medical device manufacturers and their Notified Bodies.

If this case should confirm a liability of the Notified Body, a subsequent question will be what this means for the product liability of the medical devices manufacturers. This could even reduce the liability risks of medical devices manufacturers.

In any event, the decision of the CJEU should provide useful clarity on the scope of responsibilities of Notified Bodies in the EU so that divergent decisions in different EU Member States on the same issue can be avoided.

Even though the referral by the BGH only addresses the liability situation regarding Class III devices, the CJEU’s response may also apply to Class IIa, IIb and even certain Class I medical devices.

Medical devices manufacturers should closely monitor this legal development. They generally need to be more cautious with respect to their product liability risks and medical devices vigilance obligations in the EU. This is also recommended in the light of the recent CJEU decision in which the court substantially increased the product liability risks for medical devices manufacturers in the EU (Judgment of the CJEU of 5 March 2015 in joined cases: C-503/13 and C-504/13).

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Photo of Dr. Dr. Adem Koyuncu Dr. Dr. Adem Koyuncu

Adem Koyuncu is double qualified as a lawyer and medical doctor and a partner in our Brussels and Frankfurt office. He is a chair of the firm’s “Food, Drug & Device” practice group and also a member of our Compliance practice. Adem is…

Adem Koyuncu is double qualified as a lawyer and medical doctor and a partner in our Brussels and Frankfurt office. He is a chair of the firm’s “Food, Drug & Device” practice group and also a member of our Compliance practice. Adem is recognized as a “leading lawyer for pharma and medical devices law” (JUVE 2021).

Adem helps clients on a wide range of EU and German law issues, including regulatory, compliance, privacy and liability matters. He also provides strategic advice. He knows the life sciences sector also from his earlier work in the pharmaceutical industry and as a medical doctor. He represents clients before courts and authorities and assists them in contract negotiations, investigations and transactions. For years, Adem is listed in various lawyer rankings.

See some Accolades from Clients and Surveys:

  • “He is one of the most detail-oriented and client-focused partners I have ever encountered.” (Client, Chambers 2021)
  • „Great professional and human competence, good team player.“ (Client/Adverse Party, JUVE 2022)
  • “I find him to be one of the most pragmatic regulatory lawyers. He was a doctor before a lawyer, has been in-house, worked on lots of stuff that I have to handle in-house, which helps when getting advice. He is really good at saying it’s a complex situation and your best option is to do this.” (Chambers 2022)
  • “He always comes through with extremely helpful advice. He brings a unique understanding and experience to his practice as both a lawyer and medical doctor.” (Chambers 2021)
  • “Adem Koyuncu is not only a lawyer but also a doctor and has worked in industry. He knows the perspectives that also move in-house lawyers.” (Legal 500 2022)
  • “He is very sharp and quick, while at the same time having a good sense of humor and nerves of steel. Very pleasant to work with.” (Legal 500 2022)
  • He is described as “versatile competent, reliable and high quality” (JUVE 2021) and “incredibly fast.” (JUVE 2018)
  • Provides advice at “an outstanding level.” (Legal 500 2015)
  • “Very strong negotiation skills.” (JUVE 2011)
  • Clients appreciate his “very broad knowledge and long-standing expertise” (JUVE 2021/22) and that “he is approachable, knowledgeable and really easy to talk to over the various issues. He is calm and has seen most problems before.” (Chambers 2020)
  • Peer lawyers described him as “highly competent” and a “very good and pleasant lawyer” (JUVE 2014) and as “the off-label-guru, substantively very good, creative.“ (JUVE 2022)

Adem is the author of numerous publications (e.g., in leading books on pharma law, product liability and clinical trials) and frequent speaker at different events. As such, he will soon speak at following events:

  • “Medical Device Liability and Risk Transfer 2.0 | A liability issue for the Management?!,” BVMed, Webinar (3/24/2023)
  • “Data Protection Requirements and Open Issues in the Pharma Sector – Status quo,” Speech at conference, 26. Marburger Gespräche zum Pharmarecht, Marburg (3/16/2023)
  • “Vendor Oversight & Vendor (Quality) Management in the Pharma Industry,” FORUM-Institut, Online Seminar (4/19/2023)