Recalls / safety warnings

If a product problem comes to light, an adequate risk assessment is required as the first step with the objective of investigating the possible product risk. Based on our many years highly specialised professional practice, we have comprehensive experience of the preparation of risk assessments according to the RAPEX guidelines, both for consumer products and non-consumer products and/or technical work equipment. In addition, we are familiar with other practice-relevant methods of preparing risk assessments. If necessary, we work together with external experts in order to achieve the best possible result for our clients.

The preparation of the risk assessment requires cooperation between technology on the one hand and law on the other i.e. engineers and technicians from the client working together with us as specialised lawyers functions very well. As lawyers steeped in technology law, we understand the technical language of our clients and employ it in a legally reliable risk assessment. At the same time, our work on the risk assessment aims at a final work product (= the completed risk assessment) which is understood in detail by our client.
If the result of the (RAPEX) risk assessment is that the business is subject to a danger aversion obligation, frequently in practice a recall is set in motion.  Especially when consumer products are concerned, the preference is still for the “classic“ recall, free of charge to the consumer.  Recalls can also, of course, be considered in the case of non-consumer products or technical work equipment as a danger averting mechanism. The leading judgment of the Federal Court of Justice (BGH) of 2008 – the “Pflegebetten“ case – continues to be the decisive reference where German product liability law is concerned.

When it comes to supporting recalls, we are experts for the conception and the conduct of the complete (crisis) communication on the one hand and costs recovery (e.g. from suppliers) on the other hand. We work one-to-one through the strict requirements of the judgments of the highest courts. We thereby at the same time reduce or remove any legal risks under criminal law product responsibility for the responsible employees of the company.

If a recall has to be conducted in a number of sales territories – which is usually the case – we coordinate the necessary steps for our client with specialised law firms in each relevant country. That ensures compliance with national requirements in each case without exception. Finally, we ensure that the effectiveness of the recall (in stores as well as online) is well documented from start to finish. To that end, we focus particularly on the response quota and follow-up with affected end-consumers as the case may be. The legal success in all relevant sales regions is thereby reliably and legally securely ensured.
Safety warnings instead of “classic“ recalls dominate in practice especially in the case of non-consumer products or technical work equipment if the danger aversion obligation is triggered. Safety warnings may also be considered as a danger aversion method even for consumer products. We advise our clients comprehensively whether and if so under what conditions a safety warning is legally admissible or necessary in the specific case. The leading judgment of the Federal Court of Justice (BGH) of 2008 – the “Pflegebetten“ case – continues to be the decisive reference where German product liability law is concerned.

We are experts for the formulation and/or correction of warning notices in the course of the conduct of a safety warning since we are aware precisely of the legal pitfalls which arise in drafting such a notice.  We are therefore in a position to implement the requirements of the judgments of the highest courts on practical safety warnings and thereby reduce or remove any legal risks under criminal law product responsibility for the responsible employees of the company.

Finally, we ensure that the effectiveness of the safety warning (in stores as well as online) is well documented from start to finish. To that end, we focus particularly on the response quota and follow-up with affected end-consumers as the case may be. The legal success in all relevant sales regions is thereby reliably and legally securely ensured.
Even in advance of recalls and/or safety warnings, consideration should be given to these product law crisis subjects. Recall management is the term for such consideration. It means all precautions becoming relevant internally in the event of a future recall or safety warning. Important are personnel issues arising under the aspect of the composition of any recall or crisis teams (including questions of delegation), ad hoc measures to be taken e.g. sales stops or the documentation of possible costs. The establishment of recall management is therefore an indispensable element of functioning internal organisation. Efficient organisation in this context also always guards against organisational culpability in the business.

Overall, we advise comprehensively on all elements of such risk management. We rely in particular on our many years‘ experience of many recalls and/or safety warnings in which we have successfully acted for our clients in the past.
Typically, recalls and/or safety warnings are subject to notification. The business concerned (typically the manufacturer) is thereby obliged to notify the responsible market surveillance authority in the relevant sales region of the safety-relevant product problem. For some time now, the notification obligation has applied to both consumer and non-consumer products and technical work equipment.

Similar notification obligations exist worldwide so that identifying the specific notification recipients requires careful legal review. Within the European Union (EU) there is the newly established Product Safety Business Alert Gateway which serves the simple and efficient satisfaction of the notification obligation in the EU. With our many years‘ experience in dealing with recalls and safety warnings, we also know which channels of communication at which (European and/or German) market surveillance authorities provide prospects of success. It is to be particularly noted that many countries penalise the failure to observe these product safety legal obligations as administrative offences or even crimes. Every business should keep that in close focus during a product-related crisis situation.