The product safety is of great importance in the life sciences industry, in particular for the pharmaceutical and medical device industry, the food industry and other health-related consumer goods. This topic is all about ensuring the highest quality of medical care and preventing health risiks respectively and thus to the great good of patient and consumer safety. Moreover, the subject plays a crucial role in creating public confidence in the quality, reliability and safety of the healthcare industry.
In the area of product safety, we advise our clients in particular in relation to the following:
- Cooperation with national and European authorities and bodies as well as Notified Bodies
- Legal risk assessment of product defects and development of notification approach
- Notification of competent authorities according to RAPID and RAPEX
- Market surveillance and the implementation of corrective actions (CAPA)
- In the area of drug safety (pharmacovigilance), we support the implementation of and compliance with national and European regulations by correct and functioning internal processes, structures and decision-making bodies
- Assist in the preparation and carrying out of official inspections, step plan procedure (Stufenplanverfahren) and third party audits (such as supplier audits)
- National and European procedures for risk control and revocation of product authorizations
Our advice covers the preventive counseling and if necessary also the legal enforcement of and defense against claims.
The case-law on manufacturer´s responsibility for its products has intensified significantly in recent years. One example is about the decision of the ECJ referred to potential product defects that has been issued in connection with recalls of pacemakers or ICDs (i.e. EuGH, 05.03.2015, C-503/13, C-504/13).
We have many years of experience in providing legal and strategic advice to the healthcare-, consumer- and chemicals industry in product liability cases and advise our clients in particular on the following topics:
- Planning and implementation of field safety actions and product recalls (including correspondence with regulatory bodies)
- Development and implementation of internal proceedings and decision-making processes in the context of field safety actions and product recalls
- Judicial and extrajudicial representation in the defense of product liability claims (in particular medical devices, medicinal products as well as consumer goods)
- Advise on information procedure according to Section 85a German Drug Act (AMG)
- Holistic legal and strategic advice in the treatment of serial damages (medical devices, medicinal products as well as consumer goods)
We are constantly monitoring the case law and adapt our legal advice accordingly to the new requirements. In regular publications, we contribute to the development of the law.