I INTRODUCTION TO THE PRODUCT LIABILITY FRAMEWORK

Product liability in Germany is understood as civil liability for all direct and collateral damages resulting from the use or application of a specific product.2 Civil liability may be based on contractual3 or legal provisions.4 Relevant and primary sources of law are the Law of Torts as set forth in Section 823 et seq. of the German Civil Code (BGB)5 as well as the German Product Liability Act (ProdHaftG),6 the latter coming into effect on the basis of a transposition of Council Directive 85/374/EEC into national law.7 Contrary to the liability provisions of the BGB, in case of damage to an item of property the ProdHaftG shall only apply if the damage was caused to an item of property other than the defective product and this other item of property is of a type ordinarily intended for private use or consumption and was used by the injured person mainly for his or her own private use or consumption.8 Furthermore, the liability for personal damages under the ProdHaftG is limited to a maximum amount of €85 million.9 Finally, any damage to an item of property is subject to an accidental damage excess of €500.10

In addition to the aforesaid the regulatory product safety laws comprising a wealth of provisions have to be observed. These provisions, in particular the German Product Safety Act (ProdSG)11 as the core piece of legislation, transpose the European New Legislative Framework (NLF) into national law. Directives (EC) No. 764/200812 and No. 765/200813 are in immediate and final effect in all EU Member States throughout Europe and binding in their entirety.14 Decision No. 768/2008/EG15 forming an integral part of the NLF was adopted into German law as an integral component of the provisions of the ProdSG. In addition to these a number of other European rules and regulations regarding product safety16 were transposed into German law.17

Finally, product liability is also considered in criminal law in Germany. In addition to the core provisions of the German Criminal Code (StGB)18 special provisions regarding criminal product liability have been established.19 These provisions are applicable upon breach of product-specific obligations,20 in particular,21 but not limited to provisions relating to general food law,22 medicinal products law23 and medical devices law.24,25

II REGULATORY OVERSIGHT

Market surveillance in Germany is exercised by the respective competent authorities in the 16 German federal states,26 and responsibility for the enforcement of the ProdSG therefore lies with the 16 German federal states.27 Notwithstanding the foregoing, the German federal administration is also partially competent for market surveillance, for example:

  • a the German Federal Institute for Drugs and Medical Devices28 takes part in the supervision of medicinal products and medical devices;29
  • b the Federal Motor Transport Authority30 is the competent authority for market supervision regarding motor vehicles and trailers operated on public roads;
  • c the Federal Network Agency for Electricity, Gas, Telecommunications, Post and Railway31 is the competent federal authority for the implementation of the Act on Electromagnetic Compatibility of Equipment and the Act regarding Radio and Terminal Equipment; and
  • d the Federal Institute for Occupational Safety and Health32 provides support on market surveillance to other authorities.33

Any potential criminal product responsibility is investigated by each of the 16 German federal states’ district attorney’s offices as well as the police departments fully independent from other authorities’ activities.

Market surveillance in Germany for the most part is aimed at consumer protection with the express aim of minimising risks as far as possible.

III CAUSES OF ACTION

Civil liability claims come into existence upon unlawful and either wilful or negligent causation of damages, in particular a person’s death, injury to his or her body or damage to his or her health, his or her personal liberty, damage to an item of property or to any other right.34 Contrary to the liability claims based on the BGB, liability on the basis of the ProdHaftG is limited insofar as a defective product has to have caused a person’s death, injury to their body or damage to their health, or damage to an item of property.35

Infringements of regulatory product safety laws may lead to market surveillance authorities taking the adequate measures. The authorities will take action if they suspect the respective product not to meet the necessary statutory requirements and are expressly authorised and empowered to place a ban on the sale of products of this kind.36

Criminal product responsibility may be considered upon breach of product-specific obligations.37 The principles of criminal product responsibility are applicable in case of the manufacturer’s use of a mark that could be confused with a GS or CE mark as far as a person’s life or his or her health or items of property of significant value are endangered.38

IV LITIGATION

i Forum

Ordinary contentious jurisdiction in Germany comprises civil as well as criminal courts. Administrative courts are part of the ‘special courts’. The 16 German federal states and the federal administration operate ordinary as well as special courts, the former with several instances. As a general rule and, in particular, depending on the amount in dispute three instances are available to the persons seeking justice. The first two instances are (regional) courts of the respective federal state; however, the court of last resort is a federal court.

Instances of the ordinary contentious jurisdiction are the district (or local) courts, the regional courts either as courts of the first instance or, if courts of the second instance, as appellate courts, the courts of appeals and the Federal Court of Justice. The administrative court system also provides three instances: the administrative courts, the higher administrative courts and the Federal Administrative Court.

A constitutional complaint to a constitutional court39 offers the opportunity to enforce all civil rights and liberties granted by the Constitution against the Federal Union and the 16 German federal states. The constitutional complaint is not meant to provide an extension of the appeal stages but a prerogative writ limited to the investigation of a potential breach of specific provisions of constitutional law.40

The European Court of Justice, inter alia, rules on the interpretation of the treaties entered into among the 28 Member States of the European Union by way of preliminary rulings as well as the validity and interpretation of a measure (in particular a regulation, directive or decision) adopted by an institution, body, office or agency of the European Union. The national courts may, and sometimes must, refer to the European Court of Justice and ask it to clarify a point concerning the interpretation of EU law, so that they may ascertain, for example, whether their national legislation complies with that law. If the need for a preliminary ruling is related to an imprisoned person the European Court of Justice will rule without undue delay.41

As a general rule civil product liability claims will be tried, heard and ruled at the civil courts composed of professional judges. Jury trials are not provided for under the German Code of Civil Procedure (ZPO); the same applies for (US-style) class actions. Civil claims resulting from criminal offences may be pursued in a separate civil law proceeding (‘adhesive procedure’) forming an integral part of the criminal proceedings.42

Disputes pertaining to regulatory product safety laws are tried and heard before the administrative courts. These courts, with the exception of the Federal Administrative Court, are composed of both professional and lay judges with a professional judge presiding.

Criminal product responsibility is tried at the criminal courts with at least one professional judge presiding. Lay judges may be involved in proceedings both at the district and regional court level.43

ii Burden of proof

As a threshold matter, there are no generally accepted rules regarding the onus of proof applicable to both civil and administrative proceedings.44 Therefore, at least in most cases, the general rule as to the onus of proof will be applied. On the basis of this general rule a fact remaining uncertain is deemed to be non-existent and non-proven. As a result of the foregoing, the claimant has to establish full proof of the facts his or her claim is based on and the opposing party is obliged to establish proof for the subsequent loss of the claimant’s right or its estoppel.45

The ZPO lays down certain exceptions treating constitutive facts as equal to being void and in doing so shifts the onus of proof to the respective opposing party.46 In the case of claims based on the Law of Torts, wide-reaching rules have been established with respect to the reversal of the onus of proof regarding breaches of duty and, in particular cases, with regard to defects that caused the damage not existing at the time when the producer put the product into circulation. The reversal of the onus of proof is particularly established by taking into consideration the injured claimant’s lack of evidence regarding knowledge of the producer’s internal processes and the related inability to establish and prove a defect and the producer’s breach of duty.47 The injured party, therefore, has to establish and prove all facts within the own reach of responsibilities which may be proven by the accepted means of evidence (e.g., the state of scientific and technical knowledge at the time when the producer put the product into circulation)48 or any facts obligating the producer to warn or instruct.49 The injured person bears the onus of proof and has to establish the defect, the damage and the causal relationship between defect and damage.50 The principles of the reversal of the onus of proof applicable for claims under the Law of Torts remain unaffected by concurrent contractual claims.51

Based on Section 1(4) ProdHaftG the injured person bears the burden of proving the defect, the damage and the causal relationship between defect and damage. If it is disputed whether the obligation to pay compensation is excluded pursuant to Section 1(2) or (3) ProdHaftG, the producer bears the burden of proof. According to Section 3(1) ProdHaftG, a product has a defect when it does not provide the safety that one is entitled to expect, taking all circumstances into account, in particular its presentation, the use to which it could reasonably be expected that it would be put, and the time when it was put into circulation. A product is not defective, however, for the sole reason that a better product is subsequently put into circulation.52

In all cases regarding regulatory product safety law the onus of proof is also affected by the respective relief sought by the claimant. In actions for annulment of an administrative deed involving a burden the onus of proof lies with the agency with regard to all facts substantiating and justifying the deed.53 The same basically applies if the agency denies the applicant a permit in cases of a preventive ban with reservation on the granting of such permit.54

The following applies in criminal proceedings: in order to establish the truth, the court shall, proprio motu, extend the taking of evidence to all facts and means of proof relevant to the decision.55 The court shall decide on the result of the evidence taken according to its free conviction gained from the hearing as a whole.56 Deviations from this principle are based on either exclusion of evidence including improperly obtained evidence or rules of evidence binding a criminal court with regard to certain third-party findings.57

iii Defences

Civil claims under the Law of Torts, Section 823 BGB et seq., become time-barred after three years (Section 195 BGB). The standard limitation period commences at the end of the year in which the claim arose and the obligee obtains knowledge of the circumstances giving rise to the claim and of the identity of the obligor, or would have obtained such knowledge if he or she had not shown gross negligence (Section 199(1) BGB). Limitation of action with regard to claims against the company does not necessarily coincide with the limitation of claims against the company’s management.58

Contrary to the foregoing, claims under the ProdHaftG become time-barred three years from the date the claim arose and the obligee obtains knowledge of the circumstances giving rise to the claim and of the identity of the obligor, or would have obtained such knowledge if he or she had not shown gross negligence.59

With regard to the regulatory product safety law it has to be stated that claims of public agencies, both proprietary and non-pecuniary, may become time-barred.60

The statute of limitation also applies to criminal product responsibility and the related criminal and administrative offences; after limitation occurs the related punishment is precluded. The respective limitation periods relate to the respective threat of punishment.61

In addition to the foregoing both claims under civil and public law may be forfeited, in particular, but not limited to cases of venire contra factum proprium, meaning that a right or claim may no longer be enforced when the opportunity to enforce the right or claim has not been exercised for a long period of time and the belated exercise of a right constitutes a breach of good faith. This is the case if the obligor based on a certain behaviour of the obligee relied on the non-action of the right or claim and made arrangements in this regard so that any belated exercise of the rights and claims would be likely to cause unreasonable damage to the obligee.62 In any case, all legal prerequisites for forfeiture have to be reviewed and verified individually.

Under the ProdHaftG the producer’s liability obligation may be excluded by proving that:

  • a he or she did not put the product into circulation;
  • b under 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;
  • c the product was neither manufactured by him or her for sale or any other form of distribution for economic purpose nor manufactured or distributed by him or her in the course of his or her business;
  • d the defect is due to compliance of the product with mandatory regulations at the time when the producer put the product into circulation; or
  • e 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 defect to be discovered.63

The obligation to pay damages of the producer of a component part is also excluded if the defect is attributable to the design of the product in which the component has been fitted or to the instructions given by the manufacturer of the product. The first sentence shall apply to the producer of a raw material mutatis mutandis.64

Where fault on the part of the injured person contributes to the occurrence of the damage, Section 254 BGB shall apply; in case of damage to property, the fault of the person who exercises actual control over the item of property is deemed to be equal to the fault of the injured person. The liability of the producer shall not be reduced when the damage is caused both by a defect in the product and by the act or omission of a third party.65

In accordance with Section 15(1) ProdHaftG the provisions of the Act shall not apply to medicinal products if damage was caused as a result of the administration of a medicinal product intended for human use, which was distributed to the consumer within the purview of the Drug Law (AMG). Liability claims may only be brought based on Section 84 et seq. AMG – strict liability – or under the Law of Torts, Section 823 BGB et seq.66

iv Personal jurisdiction

The conflict of laws in the field of product liability was harmonised by the Regulation (EC) No. 864/2007 of the European Parliament and of the Council of 11 July 2007 on the law applicable to non-contractual obligations (the Rome II Regulation). The application of the Rome II Regulation is not limited to conflicting legislation of two or more Member States of the EU but also in conflicts with legislation of a non-Member State.67 If damage occurs in Germany caused by a product imported from Canada in accordance with Article 3 of the Rome II Regulation the applicable law has to be determined in accordance with Article 5 of the Regulation. However, one needs to consider that subject to Article 14 of the Regulation the parties to a dispute are free to agree on the applicable law both by an agreement entered into after the event giving rise to the damage occurred or where all the parties are pursuing a commercial activity, also by an agreement freely negotiated before the event giving rise to the damage occurred.

Agreements regarding the choice of law with at least one party being a consumer are only valid after the event giving rise to the damage occurred.

The following has to be checked with regard to the applicable law on the basis of the Rome II Regulation:68

  • a choice of law: Article 14(1);
  • b habitual residence in the same country: Articles 4(2) and 5(1)1;
  • c habitual residence if product was marketed in that country: Article 5(1)1 lit. a, and foreseeability for the producer: Article 5(1)2;
  • d country in which the product was acquired if the product was marketed in that country: Article 5(1)1 lit. b, and foreseeability for the producer: Article 5(1)2;
  • e country in which the damage occurred, if the product was marketed in that country: Article 5(1)1 lit. c, and foreseeability for the producer: Article 5(1)2;
  • f habitual residence of the producer if the product was not marketed in the country the damage occurred and the producer did not foresee the marketing: Article 5(1)2; and
  • g delegated jurisdiction: Article 5(1), excluding choice of law, on the basis of a manifestly closer connection with another country: Article 5(2).

From a procedural perspective and due to the qualification of product liability forming a part of the Law of Torts the place of jurisdiction is established in accordance with Section 32 ZPO.69 For civil proceedings based on the Law of Torts, Regulation (EU) No. 1215/2012 of the European Parliament and of the Council of 12 December 2012 on jurisdiction and the recognition and enforcement of judgments in civil and commercial matters (EuGVVO) offers a choice of several venues within the EU, both at the place of habitual residence of the defendant (Article 4(1) EuGVVO) and the place the damage and the direct consequences have occurred (Article 7 No. 2 EuGVVO), taking potential conflict of laws at the competent venue into consideration.70 The injured party is offered a choice between several venues unless specific connections limit the injured party’s choice to either the country the product was marketed in or the direct consequences have occurred.71

The ProdHaftG and the United Nations Convention on Contracts for the International Sale of Goods are applicable concurrently.72

v Expert witnesses

An expert witness is one of several means of evidence made available to the parties to a court procedure under the ZPO and other rules of procedure. It is the expert witness’s task to assist the court deemed ill-informed in a certain field with regard to special knowledge in such field. In brief, the expert witness passes on his or her expertise to the court.

vi Discovery

Neither German law in general nor the ZPO in particular provide for US-style discovery. Orders and requests to produce documents or data forming part of a discovery may not be enforced against a German company under the Convention of 18 March 1970 on the Taking of Evidence Abroad in Civil or Commercial Matters as Germany, in accordance with its Article 23,73 has declared not to execute letters of request issued for the purpose of obtaining pretrial discovery of documents as known in common law countries. If a party to a court proceeding violates his or her obligation related to a pretrial discovery this violation may both be sanctioned by the foreign court and may also serve as a basis for a negative ruling by this court.

Deviating from the foregoing a legal right to obtain information is established under Section 84 et seq. AMG for medicinal products. This right to information may be enforced against both the pharmaceutical manufacturer and the competent agency in case of any damages potentially caused by a medicinal product. The legal right to information is limited if the requested information has to remain confidential owing to legal provisions or the non-disclosure is based on either the manufacturer’s or any third party’s interest worth being protected.74

Further, in German civil cases a secondary onus of proof may be established to the disadvantage of the party not bearing the (primary) onus of proof. This applies in all matters where a party is obliged to produce information due to the fact that the other party primarily bearing the onus of proof has no detailed knowledge of the determining factors and the other party may be expected to produce the information requested with reasonable effort.75

Where, according to the allegation made by the party tendering evidence, the record or document is in the hands of a public agency or of a civil servant in the narrower sense of the term, evidence shall be offered by filing the petition with the court that the public agency or the civil servant be requested to provide the record or document.76

In administrative disputes regarding regulatory product safety matters, obligations to provide information may exist and be in effect.77

In criminal procedures relating to criminal product liability all criminal investigations are conducted by applying the accepted ways and means to obtain evidence including but not limited to securing and seizing objects and searching the body, the property or the private and other premises of a person.78

vii Apportionment

Obligors under the ProdHaftG are both all persons controlling and supervising the production process who have produced the final product, a raw material or a component part and also anyone who imports or takes into the area of application of the Agreement on the European Economic Area a product for sale, hire, leasing or any form of distribution with an economic purpose in the course of his or her business. The protection of an injured person under the ProdHaftG is much more pronounced compared to the Law of Torts under Section 823 BGB et seq. This is owed to the fact that all obligations of producers as well as distributors are based on the potential obligor’s respective activities and are, therefore, de facto limited. The ProdHaftG does not differentiate between persons having produced the final product, suppliers and raw material producers and who is in breach of his or her respective duty of care. The resulting ‘accumulation’ of obligors adds to the protection of the injured person and is meant to facilitate the enforcement of claims by avoiding the difficult need for the obligor to identify the real obligee within the network of interacting producers of the final product, component part producers and distributors.79 Where the producer of the product cannot be identified, each supplier of the product shall be deemed to be its producer unless he or she informs the injured person within a month of his or her receipt of a demand to this effect of the identity of the producer or of the person who supplied him or her with the product.80

If two or more producers are liable to pay damages for the same damage, they shall be liable jointly and severally. In the relationship of the parties liable to pay damages, liability in damages as well as the extent of compensation to be paid depends, unless otherwise specified, on the circumstances, in particular to what extent the damage is caused mainly by one or the other party.81

viii Mass tort actions

German law does not provide for mass tort and class actions in the field of product liability. However, proceedings may be filed against multiple persons (co-parties) if the respective obligation is based on the same legal and factual grounds82 or if claims or potential obligations are brought to court on similar, or for the most part similar, legal and factual grounds.83 Identity of legal grounds is also assumed, in particular, if various claimants claim for damage compensation under the Law of Torts resulting from the same offence but with varying amounts in dispute.84 Notwithstanding the foregoing, ‘connected’ proceedings of co-parties described above are rarely to be found in Germany owing to the lack of a legal obligation to act uniformly as co-parties and the resulting fact that most co-parties tend to act independently in the proceedings.

ix Damages

On the basis of Section 823(1) BGB, the liable party has to compensate the injured person for all damages illegitimately and culpably caused. The party liable for damages must restore the position that would have existed had the circumstance obliging him or her to pay damages not occurred. Where damages are payable for injury to a person or damage to a thing, the obligee may demand the required monetary amount in lieu of restoration. Liability to compensate for damage resulting from a tort directed against the injured person extends to the disadvantages the tort produces for the livelihood or advancement of the injured person. The party liable for damages is also responsible for compensation of any indirect damages85 and intangible damages, in particular, but not limited to damages for pain and suffering.

Liability under the ProdHaftG is limited where personal injuries have been caused by a product or by identical products with the same defect; in this scenario the party liable to pay damages shall be liable only up to a maximum amount of €85 million. Should the combined indemnification to be paid to several injured parties exceed the maximum amount specified above, then the individual compensation shall be reduced pro rata to the maximum total given.86 In addition, in the case of damage to property, the injured party shall pay for damages up to an amount of €500 himself or herself.87

V YEAR IN REVIEW

The European Commission strives to improve product safety and better market surveillance for products in the European Single Market. With these aims, the Commission introduced a bill for a ‘Product Safety and Market Surveillance Package’.88 Sessions regarding enacting of the Package took place; however, the efforts of the European Commission to bring the package into effect as of 1 January 2015 failed for undisclosed reasons. It remains open, therefore, whether the Product Safety and Market Surveillance Package will come into effect at all and how the Commission intends to deal with the results of the deliberations so far.


Footnotes

1 Christoph Wagner is a partner at Heuking Kühn Lüer Wojtek.

2 Tobias Lenz in Tobias Lenz, Produkthaftung, 2014, Section 3 Rn. 1.

3 E.g., material damages liability under an asset purchase agreement.

4 Liability under the Law of torts and liability regardless of culpability (‘Strict Liability’).

5 Section 823 – Liability in damages –, Book 2 – Law of Obligations –, Division 8 – Particular types of obligations –, Title 27 – Torts –, German Civil Code in the version promulgated on 2 January 2002 (Federal Law Gazette [Bundesgesetzblatt] I, p. 42, 2909; 2003 I, p. 738), last amended by Article 4 paragraph 5 of the Act of 1 October 2013 (Federal Law Gazette I, p. 3719); www.gesetze-im-internet.de/englisch_bgb/index.html; liability under the Law of Torts; see also Sections 826 and 831 BGB.

6 Act on Liability for Defective Products – Product Liability Act – of 15 December 1989 (Federal Law Gazette I, p. 2198), last amended by Article 9(3) of the Act of 19 July 2002 (Federal Law Gazette I, p. 2674); www.gesetze-im-internet.de/englisch_prodhaftg/index.html; liability regardless of culpability (‘Strict Liability’).

7 Council Directive 85/374/EEC of 25 July 1985 on the approximation of the laws, regulations and administrative provisions of the Member States concerning liability for defective products; Directive 1999/34/EC of the European Parliament and of the Council of 10 May 1999 amending Council Directive 85/374/EEC on the approximation of the laws, regulations and administrative provisions of the Member States concerning liability for defective products.

8 Section 1(1)2 ProdHaftG.

9 Section 10(1) ProdHaftG: In such case as personal injuries have been caused by a product or by identical products with the same defect, the party liable to pay damages shall be liable only up to a maximum amount of €85 million.

10 Section 11 ProdHaftG: In the case of damage to property, the injured party shall pay for damages up to an amount of €500 himself or herself.

11 Act on making products available on the market (Product Safety Act – ProdSG) of 8 November 2011 (Federal Law Gazette I, p. 2178; 2012 I, p. 131), www.gesetze-im-internet.de/englisch_prodsg/index.html.

12 Regulation (EC) No. 764/2008 of the European Parliament and of the Council of 9 July 2008 laying down procedures relating to the application of certain national technical rules to products lawfully marketed in another Member State and repealing Decision No. 3052/95/EC.

13 Regulation (EC) No. 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No. 339/93.

14 Article 288(2) of the Treaty on European Union and the Treaty on the Functioning of the European Union.

15 Decision No. 768/2008/EC – a common framework for the marketing of products in the EU.

16 Regulation (EC) No. 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No. 339/93; Regulation (EC) No. 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No. 339/93; Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to Medicinal Products for human use; Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by Law, Regulation or Administrative Action relating to proprietary Medicinal Products; Council Directive 93/42/EEC of 14 June 1993 concerning medical devices; Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices; Council Directive 96/98/EC of 20 December 1996 on marine equipment; Regulation (EU) No. 305/2011 of the European Parliament and of the Council of 9 March 2011 laying down harmonised conditions for the marketing of construction products and repealing Council Directive 89/106/EEC; Directive 2006/95/EC of the European Parliament and of the Council of 12 December 2006 on the harmonisation of the laws of Member States relating to electrical equipment designed for use within certain voltage limits; Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009 on the safety of toys; Directive 2009/105/EC of the European Parliament and of the Council of 16 September 2009 relating to simple pressure vessels; Council Directive 90/396/EEC of 29 June 1990 on the approximation of the laws of the Member States relating to appliances burning gaseous fuels; Council Directive 89/686/EEC of 21 December 1989 on the approximation of the laws of the Member States relating to personal protective equipment; Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery, and amending Directive 95/16/EC; Directive 2013/53/EU of the European Parliament and of the Council of 20 November 2013 on recreational craft and personal watercraft and repealing Directive 94/25/EC; Directive 2014/34/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to equipment and protective systems intended for use in potentially explosive atmospheres; European Parliament and Council Directive 95/16/EC of 29 June 1995 on the approximation of the laws of the Member States relating to lifts; Council Directive 75/324/EEC of 20 May 1975 on the approximation of the laws of the Member States relating to aerosol dispensers; Directive 97/23/EC of the European Parliament and of the Council of 29 May 1997 on the approximation of the laws of the Member States concerning pressure equipment.

17 Act implementing Regulation (EU) No. 305/2011 of the European Parliament and of the Council of 9 March 2011 laying down harmonised conditions for the marketing of construction products and with regard to the implementation and application of other legislative acts of the European Union regarding construction products (Act on Construction Products – BauPG); Medicinal Products Act (the Drug Law – AMG), www.gesetze-im-internet.de/englisch_amg/index.html; Act regarding the Use of Nuclear Energy for Peaceful Purposes and the Protection against its dangers (the Atomic Energy Act); Act on Genetic Engineering (GenTG); Medical Devices Act (MPG); Decree on Ship Safety (SchSV); First Decree to the ProdSG (Decree regarding the Provision of Electrical Equipment for the Use within Defined Voltage Limits – 1. ProdSV); Second Decree to the ProdSG (Decree regarding Toy Safety – 2. ProdSV); Sixth Decree to the ProdSG (Decree regarding the Provision of Simple Pressure Vessels – 6. ProdSV); Seventh Decree to the ProdSG (Decree regarding Consumer Installations – 7. ProdSV); Eighth Decree to the ProdSG (Decree regarding the Provision of Personal Protective Gear – 8. ProdSV); Ninth Decree to the ProdSG (Decree regarding Machinery – 9. ProdSV); Tenth Decree to the ProdSG (Decree regarding the Provision of Pleasure Craft and Related Traffic – 10. ProdSV); Eleventh Decree to the ProdSG (Decree regarding Explosives – 11. ProdSV); Twelfth Decree to the ProdSG (Decree regarding Elevators – 12. ProdSV); Thirteenth Decree to the ProdSG (Decree regarding Aerosol Packaging – 13. ProdSV); Fourteenth Decree to the ProdSG (Decree regarding Pressure Equipment – 14. ProdSV).

18 German Criminal Code in the version promulgated on 13 November 1998, Federal Law Gazette I, p. 3322, last amended by Article 1 of the Law of 24 September 2013, Federal Law Gazette I, p. 3671 and with the text of Article 6(18) of the Law of 10 October 2013, Federal Law Gazette I, p. 3799; www.gesetze-im-internet.de/englisch_stgb/index.html.

19 Tobias Lenz in Tobias Lenz, Produkthaftung, 2014, Section 2 Rn. 1 and 59 et seq.; Kühne, Strafrechtliche Produkthaftung in Deutschland, NJW 1997, 1951.

20 Tobias Lenz in Tobias Lenz, Produkthaftung, 2014, Section 2 Rn. 59.

21 Sections 39 and 40 of the Act on making products available on the market (Product Safety Act – ProdSG) of 8 November 2011 (Federal Law Gazette I, p. 2178; 2012 I, p. 131), www.gesetze-im-internet.de/englisch_prodsg/index.html.

22 Section 58 et seq. of the Foodstuffs and Consumer Goods Law (LFGB); Section 38 et seq. of the GenTG; Section 48 et seq. of the Wine Act (WeinG).

23 Section 95 et seq. AMG.

24 Section 40 et seq. MPG.

25 Tobias Lenz in Tobias Lenz, Produkthaftung, 2014, Section 2 Rn. 59; Kühne, Strafrechtliche Produkthaftung in Deutschland, NJW 1997, 1951.

26 The Working Committee Market Surveillance (LASI) coordinates supervisory activities and publishes a user’s manual called Handlungsanleitung für die Ausführung der Marktüberwachung in Deutschland: http://lasi-info.com/uploads/media/LV_36_2014.pdf.

27 See Article 24(1)1 ProdSG and Decree of the Baden-Württemberg Department of the Environment on jurisdiction in the field of Product Safety (ProdSZuVO) issued 13 February 2012, GBl. BW Nr. 2, S. 62.

28 Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM), www.bfarm.de/EN/BfArM/_node.html.

29 Section 32(1) MPG; Section 64(2) AMG.

30 Kraftfahrt-Bundesamt (KBA), www.kba.de/EN/Home/home_node.html.

31 Bundesnetzagentur, www.bundesnetzagentur.de/cln_1432/EN/Home/home_node.html.

32 Bundesanstalt für Arbeitsschutz und Arbeitsmedizin (BAuA), www.baua.de/en/Homepage.html.

33 Article 32(2) and (4) ProdSG.

34 Section 823(1) BGB.

35 Section 1(1) ProdHaftG.

36 Article 26(2) Nr. 6 ProdSG.

37 Tobias Lenz in Tobias Lenz, Produkthaftung, 2014, Section 2 Rn. 59.

38 Articles 40, 39(1) Nr. 9, 22(4) ProdSG.

39 The Federal Constitutional Court or constitutional courts of the 16 German federal states.

40 Basic Law for the Federal Republic of Germany, www.gesetze-im-internet.de/englisch_gg/index.html, and Contitutions of the 16 German federal states.

41 Article 267 of the Treaty on European Union and the Treaty on the Functioning of the European Union.

42 Section 403 et seq. of the Code of Criminal Procedure (StPO) in the version published on 7 April 1987 (Federal Law Gazette Part I, p. 1074, 1319), as most recently amended by Article 3 of the Act of 23 April 2014 (Federal Law Gazette Part I, p. 410), www.gesetze-im-internet.de/englisch_stpo/englisch_stpo.html.

43 District court: court of lay assessors; regional court: criminal and second criminal division, second criminal division as assize court.

44 BVerwG, Decision dated 31 August 1961 – II C 117.58, BVerwGE 13, 36.

45 Dawin in Schoch/Schneider/Bier, Verwaltungsgerichtsordnung, 31. EL Oktober 2016, Section 108 Rn. 96.

46 Foerste in Musielak/Voit, ZPO, 13. Auflage 2016, Section 286 Rn. 35 f.

47 BeckOK BGB Section 823 Rn. 552, also see: BGH, Decision dated 26 November 1968 – VI ZR 212/66, NJW 1969, 269.

48 BeckOK BGB Section 823 Rn. 552; also see: OLG Düsseldorf, Decision dated 31 May 1996 – 22 U 13/96, NJW-RR 1997, 1344.

49 BeckOK BGB Section 823 Rn. 552; also see: BGH, Decision dated 17 March 1981 – VI ZR 191/79, NJW 1981, 1603.

50 BeckOK BGB Section 823 Rn. 552, also see: BGH, Decision dated 8 December 1992 – VI ZR 24/92, NJW 1993, 528.

51 BeckOK BGB Section 823 Rn. 552, BGH, Decision dated 19 November 1991 – VI ZR 171/91, NJW 1992, 1039.

52 Section 3(2) ProdHaftG.

53 Dawin in Schoch/Schneider/Bier, Verwaltungsgerichtsordnung, 31. EL Oktober 2016, Section 108 Rn. 102.

54 Dawin in Schoch/Schneider/Bier, Verwaltungsgerichtsordnung, 31. EL Oktober 2016, Section 108 Rn. 102; a law reservation of authorisation can be found in Section 20(1)1 MPG.

55 Section 244(2) StPO.

56 Section 261 StPO.

57 Ott in Karlsruher Kommentar zur Strafprozessordnung, 7. Auflage 2013, Section 261 Rn. 34.

58 Vgl. BGH, Decision dated 12 December 2000 – VI ZR 345/99, NJW 2001, 964.

59 Section 12(1) ProdHaftG.

60 Section 53 of the Administrative Procedure Act (VwVfG); vgl. Bader/Gerstner-Heck in Bader/Ronellenfitsch Beck’scher Online-Kommentar VwVfG, 30. Edition, Stand: 1 January 2016, Section 53 Rn. 6 et seq.; Ossenbühl: Verzicht, Verwirkung und Verjährung als Korrektive einer polizeilichen Ewigkeitshaftung, NVwZ 1995, 54.

61 Section 78(3) StGB – from three to 30 years.

62 Ossenbühl: Verzicht, Verwirkung und Verjährung als Korrektive einer polizeilichen Ewigkeitshaftung, NVwZ 1995, 54; Bundesverwaltungsgericht, Decision dated 20 January 1977 – V C 18/76, VerwRspr 1978, 243.

63 Section 1(2) ProdHaftG.

64 Section 1(3) ProdHaftG.

65 Section 6 ProdHaftG.

66 Section 91 AMG.

67 Article 3 of the Rome II Regulation.

68 Tobias Lenz in Tobias Lenz, Produkthaftung, 2014, Section 6 Rn. 74; Wagner in Münchener Kommentar zum BGB, 6. Auflage 2013, ProdHaftG Einleitung Rn. 23 f.

69 ‘For complaints arising from tort, the court in the jurisdiction of which the tortious act was committed shall have jurisdiction.’

70 Junker in Münchener Kommentar zum BGB, 6. Auflage 2015, Preliminary remarks to Article 1 Rome II Regulation Rn. 26.

71 Wagner in Münchener Kommentar zum BGB, 6. Auflage 2013, ProdHaftG Einleitung Rn. 26.

72 Tobias Lenz in Tobias Lenz, Produkthaftung, 2014, Section 6 Rn. 53 et seq.; BGH, Decision dated 28 November 1994 – VIII ZR 44/94, IPRax 1996, 124.

73 ‘The Federal Republic of Germany declares in pursuance of Article 23 of the Convention that it will not, in its territory, execute Letters of Request issued for the purpose of obtaining pre-trial discovery of documents as known in common law countries.’

74 Section 84a AMG.

75 Bacher in Vorwerk/Wolf, Beck’scher Online-Kommentar ZPO, 23. Edition, Stand: 1 December 2016, Section 284 Rn. 85.

76 Section 432 ZPO.

77 See also Section 26(3) No. 4, (5) MPG.

78 Section 94 et seq. StPO.

79 Wagner in Münchener Kommentar zum BGB, 6. Auflage 2013, Section 4 ProdHaftG Rn. 1.

80 Section 4(3) ProdHaftG.

81 Section 5 ProdHaftG.

82 Section 59 ZPO.

83 Section 60 ZPO.

84 See BayObLG, Decision dated 20 October 1998 – 1Z AR 75-98, NJW-RR 1999, 1010.

85 Sections 823, 249 et seq. and 842 et seq. BGB.

86 Section 10 ProdHaftG.

87 Section 11 ProdHaftG.

88 Communication from the Commission to the European Parliament, the Council and the European Economic and Social Committee, More Product Safety and better Market Surveillance in the Single Market for Products, 13 February 2013, COM(2013) 74 final; Communication from the Commission to the European Parliament, the Council and the European Economic and Social Committee, 20 actions for safer and compliant products for Europe: a multi-annual action plan for the surveillance of products in the EU, 13 February 2013, COM(2013) 76 final; Report from the Commission to the European Parliament, the Council and the European Economic and Social Committee on the implementation of Regulation (EC) No. 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No. 339/93, COM (2013) 77 final; also see Klindt in Klindt, Produktsicherheitsgesetz, 2. Auflage 2015, Einführung Rn. 34 et seq.