1. Liability for a defective product
To establish product liability, it is required to show that an injury or damage has been caused by a defective product. A product is defective if it does not provide the safety which a person is entitled to expect taking all circumstances into account, in particular its presentation, the use to which it could reasonably be expected to be put and the time when it was put into circulation (section 3, Product Liability Act). It is not required to establish any wrongdoing.
2. Burden of proof
Under the Product Liability Act and in tort law, the claimant must prove beyond reasonable doubt that the product is defective and has caused damage. However, pre-trial discovery does not exist in Germany. Nevertheless, in practice, the defendant will have to demonstrate that it is not liable. For example, prima facie evidence can suffice if the damage is a typical result of the product defect. In many other cases, the burden of proof will be shifted to the defendant, if the claimant has not means to obtain the required evidence.
3. Defences to a product liability claim
A producer's liability under the Product Liability Act is excluded if the producer can prove that he did not put the product into circulation or manufactured it for sale or if in the circumstances it is probable that the defect which caused the damage did not exist at the time when the producer put the product into circulation. There will be also no liability if the defect is due to compliance with mandatory regulation at the time the product was put into circulation or if the state of scientific and technical knowledge at the time when the producer put the product into circulation was not such as to enable the existence of the defect to be discovered (development risk defence).
To avoid a tortious liability the producer must typically prove that he complied with his duty of care. A possible defence is that the producer's production processes, including quality control, complied with the state of the art at the relevant time. This may avoid liability for "outliners", that is, manufacturing defects which occur despite application of state of the art processes.
4. Product Recall
For a product recall it is sufficient that a product can cause injury, so proof of actual injury is not required. Further, it is not required that a specific product is actually defective, as long as a defect is possible in all products of a batch. Other "appropriate measures" can be public warnings or the withdrawal of the product.
5. Federal Drug Act
For medicinal products (pharmaceuticals), a special liability regime applies under the Federal Drug Act. In pharmaceutical product liability cases, a claim for information can be made under section 84a of the Federal Drug Act to obtain evidence from a party or a third party. A claimant can demand the disclosure of information by a pharmaceutical company, particularly in relation to adverse events.