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Rott, Peter --- "Compensation for vaccination damage under German social security law" [2019] OtaLawRw 11; (2019) 16 Otago LR 199

Last Updated: 20 November 2022

Compensation for Vaccination Damage under German Social Security Law


Compensation for Vaccination Damage under German Social Security Law

Peter Rott*

  1. Introduction
In Germany, it has proven to be nearly impossible to recover damage arising from, or in the aftermath of, vaccinations under the Arzneimittelgesetz (Pharmaceuticals Act), which represents a special product liability regime in the terms of Article 13 of the EU Product Liability Directive.1 Problems relate to the proof of the defectiveness of the vaccine as well as the causal link between the vaccination and the symptoms of the victim. Likewise, liability based on medical negligence of the doctor who has administered the vaccination can only relate to insufficient information on the potential side-effects of a vaccine and is rare because the medical profession bases their information on standardised comprehensive information sheets and makes patients sign that they have read and understood the information.2

In practice, vaccination damage claims are therefore usually brought under the Act on Protection against Infections (Infektionsschutzgesetz) of 2001; a no-fault compensation system that belongs to the sphere of social security law and which has developed entirely separately from product liability law.

This article presents the limitation that regular product liability law has shown in relation to vaccination damages as well as the reasons for the special regime of the Infektionsschutzgesetz, its scope of application and the alleviations that it offers to victims. The practical use as well as the limitations of the latter regime are illustrated with case law of the German social courts.

B Product Liability Law under the Pharmaceuticals Act

I Introduction3

The Arzneimittelgesetz (Pharmaceuticals Act; AMG) was first adopted in 1976 and recast in 2005.4 It is the encompassing legal regime

* Professor of Law, University of Oldenburg, Germany.

  1. Council Directive 85/374/EEC on the Approximation of the Laws, Regulations and Administrative Provisions of the Member States Concerning Liability for Defective Products [1985] OJL 210/29.
  2. For more details, see the author’s part of Eleonora Rajneri and others “Remedies for Damage Caused by Vaccines: A Comparative Study on Four European Legal Systems” (2018) 26 Euro Rev Priv L 57 at 77.
  3. The following discussion in this paper is partly based on the author’s part of Rajneri and others, above n 2, at 69-78.
  4. Bundesgesetzblatt (Federal Law Gazette; BGBl) 2005 I, 3394. An English translation of the Act is available at < englisch_amg/index.html>.

for pharmaceuticals, and vaccines are pharmaceuticals within the meaning of the AMG.5 Sections 84-94 of the AMG contain special strict liability rules that prevail over the general strict liability regime of the Produkthaftungsgesetz (Product Liability Act; ProdHaftG) of 1990, which implements the Product Liability Directive 85/374/EEC.6 The strict liability regime of the AMG predates the ProdHaftG, it had been introduced mainly as a reaction to the difficulties that victims of the Contergan (Thalidomide) scandal experienced when they tried to obtain compensation for the damage caused by that drug.7 The then existing rules of regular contract and tort law had proven to be insufficient for that effect, in particular for the requirements of negligence.8 The Act applies to pharmaceuticals that are intended for human use and that are subject to market authorisation or that would, in principle, be subject to market authorisation but have been exempted by special ordinance.

The main special features of liability under §§ 84-94 of the AMG are discussed below – in section II, a special definition of the grounds for liability, in section III a right of disclosure and in section IV special rules on causation. Moreover, as will be discussed, contrary to general product liability law, the so-called “development risk defence” of general product liability law does not apply, that is, the producer cannot avoid liability by showing that the state of scientific and technical knowledge at the time when he put the product into circulation was not such as to enable the existence of the defect to be discovered.9

  1. See § 4 para 4 of the AMG.
  2. See explicitly, § 15 ProdHaftG and the explanations of the German government, (31 al October 1989) 11/5520 Bundestags-Drucksache 17 (Printed Matters of the German Bundestag; BT-Drucks.). Some authors argue that the inapplicability of the Product Liability Act is in breach of art 13 of the Product Liability Directive. For an account of the debate, see Gerhard Wagner “§ 15 ProdHaftG” in Franz Jürgen Säcker and others (eds) Münchener Kommentar zum Bürgerlichen Gesetzbuch (translation: Munich Comment on the Civil Code) (7th ed, CH Beck, Munich, 2017) at para 8. The ProdHaftG only applies to pharmaceuticals outside the scope of application of the AMG, for example, to pharmaceuticals that the consumer has bought abroad and imported to Germany by himself, see § 73 para 3 AMG.
  3. See Peter Rott and Claudius Torp “Ereignishaftigkeit und Rechtsentwicklung in der Verbraucherpolitik seit den 1970er Jahren” (translation: Eventfulness and legal development in consumer policy since the 1970s) in Christian Bala and others (eds) Verbraucher in Geschichte und Gegenwart: Wandel und Konfliktfelder in der Verbraucherpolitik (translation: Consumers in History and Present: Change and Fields of Conflict in Consumer Policy) (Kompetenzzentrum Nordrhein-Westfalen, Düsseldorf, 2017) 189 at 191 and following, with further references.
  4. Criminal proceedings against the directors of Grünenthal, the producer of Contergan, ceased after the parents of the victims and Grünenthal settled their private law disputes, see LG Aachen, 18 December 1970, 4 KMs 1/68 (1971) Juristenzeitung 507.
  5. For general product liability law, see § 1 para 2 no 5 ProdHaftG, implementing art 7(e) Product Liability Directive 85/374/EEC.

II Grounds of liability

Under § 84 para 1 of the AMG, the producer is liable if 1) when used in accordance with its intended purpose, the medicinal product has harmful effects which exceed the limits considered tolerable in the light of current medical knowledge, or 2) the damage has occurred as a result of labelling, expert information or instructions for use which do not comply with current medical knowledge. With this definition, the provision expressly takes into account that many pharmaceuticals have side effects. Thus, the producer is held liable for design defects, manufacturing defects and warning defects.

Damage according to § 84 para 1 AMG means the death or significant personal injury or damage to health of the vaccinated person. Personal injury and damage to health are insignificant if there is no need of treatment and if it does not impact seriously on physical well-being.10 Since the reform of the law of damages of 2001,11 the victim can also claim damages for pain and suffering, which had previously been excluded under the strict liability regime of the AMG.

The risk / benefit balance follows the same rules as the assessment under the provision of § 25 para 2 no 5 AMG relating to grounds for the denial of admission of a pharmaceutical product.12 The risk / benefit balance is defined in § 4 no 28 AMG as an evaluation of the positive therapeutic effects of the medicinal product in relation to the risks. Those risks are defined in § 4 no 27 AMG in line with art 1 no 28 of Directive 2001/83/EC13 as any risk relating to the quality, safety or efficacy of the medicinal product as regards to patients’ health or public health. Thus, the balance requires three steps: the assessment of the positive therapeutic effects, the assessment of the risks, and the balancing between them.14 In practice, once a pharmaceutical has been admitted, it has been ascertained that its benefits outweigh any risks, therefore, it cannot normally have a design defect.

  1. Arno Kloesel and Walter Cyran Arzneimittelrecht (130th del, CH Beck, Munich, 2016) § 84 AMG at para 20.
  2. On which see Gerhard Wagner “Das Zweite Schadens-ersatz-rechts- änderungs-gesetz” (translation: The Second Amendment Act on Compensation Law) (2002) Neue Juristische Wochenschrift 2049.
  3. See also Oberlandesgericht (translation: Higher Regional Court; OLG) Hamm, 18 June 2003, 3 U 99/02 (2003) Neue Juristische Wochenschrift – Rechtsprechungsreport 1382.
  4. Directive 2001/83/EC on the Community Code relating to Medicinal Products for Human Use [2001] OJ L311/67.
  5. See Dieter Hart „Die Nutzen/Risikoabwägung im Arzneimittelrecht“ (translation: The Benefit/Risk Assessment in Pharmaceutical Law) (2005) 48(2) Bundesgesundheitsblatt – Gesundheitsforschung – Gesundheitsschutz 204.

Of primary importance for the benefit assessment is the therapeutic usefulness of the pharmaceutical product.15 The more serious the indication is, and the less available alternative treatment is, the more severe side effects must the consumer tolerate.16 The risks to be considered include the side effects but also the risk of insufficient quality and effectiveness of the pharmaceutical product. Usually, even serious side effects do not trigger the liability of the pharmaceutical company.

In an administrative procedure concerning the admission of a pharmaceutical product, the burden of proof for an unfavourable risk

/ benefit balance is, in principle, on the Authority, according to general principles of administrative law. It suffices, however, that the Authority can show scientific findings from which one can derive serious concerns that the pharmaceutical may be intolerably risky, rather than having to provide full proof. In such a case, it is for the producer to provide evidence of the absence of intolerable risk.17

Academic authors have discussed controversially whether tolerability is to be assessed under consideration of the state of the science at the time when the pharmaceutical was put into circulation,18 or at the time when the claim is brought.19 The latter opinion seems preferable with the view to the fact that § 84 AMG establishes a strict liability regime. As to warning defects in the terms of § 84 para 1 sent 2 no 2 of the AMG, the relevant question is whether the labelling and the instructions of use reflect the state of science and art.

The damage must arise despite the correct use of the pharmaceutical product, which is determined by the package insert that must be comprehensible not only for experts but also for laymen. The victim must provide full evidence for the fulfilment of the requirements of § 84 para 1 of the AMG. Thus, he or she does not only have to prove harmful effects

  1. Meike Hielscher „Zulassung von Phytopharmaka – Wirksamkeitsnachweis

– Risiko-Nutzen-Abschätzung“ (translation: Approval of Phytopharmaceuticals – Proof of Efficacy – Risk-benefit Assessment) (1984) Pharma Recht 1 at 4.

  1. Wolfgang A Rehmann Arzneimittelgesetz (translation: Pharmaceuticals Act) (4th ed, CH Beck, Munich, 2014) § 4, at para 30, with reference to Oberverwaltungsgericht (OVG) (translation: Higher Administrative Court) Berlin, 26 July 1983, 7 S 312.83.
  2. See Bundesverwaltungsgericht (translation: Federal Administrative Court), 26 April 2007, 3 C 36.06 (2007) Pharma Recht 423; OVG Nordrhein- Westfalen, 17 September 2009, 13 A 1428/08 (2010) Pharma Recht 85.
  3. Axel Sander Arzneimittelgesetz (translation: Pharmaceuticals Act) (1st ed, Kohlhammer, Stuttgart, 2015) § 84 at para 14; Peter von Czettritz and Tanja Strelow „Die Haftung für Impfschäden und die Verwirrung um die Schweinegrippe“ (translation: Liability for Vaccination Damage and the Confusion Surrounding Swine Influenza) (2010) 32 (4) Pharma Recht 163.
  4. Erwin Deutsch and Andreas Spickhoff Medizinrecht (translation: Medical Law) (7th ed, Springer, Berlin, 2014) at para 423.

but also that those harmful effects and their frequency are intolerable when compared to the benefits of the pharmaceutical.

III Right of disclosure

For the claimant who has no insights into the development and the manufacturing of the pharmaceutical product, it is very difficult to prove the existence of a design defect or a manufacturing defect in the terms of § 84 para 1 of the AMG.20 Therefore, a special right of disclosure was introduced in 2002, which aimed to improve the claimant’s procedural position21 and to re-establish equal terms between the parties.22 According to § 84a AMG, the victim can request information related to effects, side-effects and interaction of medical products that are known to the producer and to suspected effects, side-effects and interaction of medical products that were brought to the producer’s attention and all further knowledge which could be of significance in assessing the justifiability of harmful effects, provided that facts exist that justify the assumption that a medical product has caused the damage in question.

The full burden of proof relating to those facts is on the claimant,23 whereas the causation between the medical product and the damage must only be plausible.24

Section 84a para 2 AMG grants the same disclosure right as regards authorities that are responsible for the approval or supervision of the medical product. Exceptions apply on the grounds of secrecy laws and overriding secrecy interests of the producer and third parties.

Compliance of that disclosure right with the Product Liability Directive 83/374/EEC was debated in German academic literature, as that Directive aimed to fully harmonise product liability law and does not contain such a disclosure right. Most authors had, however, argued that § 84a AMG did not change the substantive liability rules in pharmaceutical liability cases but merely facilitates the procedural enforcement of the claim.25 On reference by the Bundesgerichtshof (Federal Supreme Court; BGH),26 the Court of Justice confirmed that view.27

  1. For an example, see Landgericht (Regional Court; LG) Traunstein, 29 September 1994, 1 O 1742/93 (1995) Medizinrecht 242.
  2. See BGH, 12 May 2015, VI ZR 328/11 (2015) Neue Juristische Wochenschrift 2502. On the procedural relationship between the disclosure claim and the claim for damages, see BGH, 29 March 2011, VI ZR 117/10 (2011) Neue Juristische Wochenschrift 1815.
  3. Andreas Spickhoff Medizinrecht (translation: Medical Law) (2nd ed, CH Beck, Munich, 2014) § 84a AMG para 1.
  4. See LG Berlin 18 October 2006, 22 O 75/06 (2007) Neue Juristische Wochenschrift 3584 (on Vioxx).
  5. For detailed analysis, see BGH, 12 May 2015, VI ZR 328/11, above n 21. See also OLG Köln, 26 January 2011, 5 U 81/10 (2011) Neue Juristische Wochenschrift - Rechtsprechungsreport 1319.
  6. See the references in BGH, 6 May 2013, VI ZR 328/11 (2013) Pharma Recht 459.
  7. Above n 25.
  8. Case C-310/13 Novo Nordisk Pharma GmbH v S ECLI:EU:C:2014:2385.

IV Causation

Under the 1976 version of § 84 para 1 of the AMG, the victim had to provide full evidence of the causal link between the defectiveness of the pharmaceutical and the damage.28

This heavy burden was alleviated with the above-mentioned 2002 amendment of the AMG. Under the then new § 84 para 2 of the AMG, the damage is presumed to have been caused by the medicinal product administered if that medicinal product is capable of causing the damage, in the circumstances pertaining to the individual case. The capability in the individual case is determined according to the composition and the dosage of the administered medicinal product, the manner and duration of its administration when used as intended, the temporal relationship to the occurrence of the damage, the damage symptoms and the person’s state of health at the time of the administration as well as all other circumstances which, in the individual case, speak for or against the causation of damage.

In contrast, the presumption of causation does not apply if, in the light of the circumstances pertaining to the individual case, another factor is capable of causing the damage. However, the administration of additional medicinal products which, in the circumstances pertaining to the individual case, are capable of causing the damage shall not normally be considered as another factor.

In essence, the victim must (only) prove the damage, the application of the actual pharmaceutical and the possibility of the pharmaceutical causing the damage,29 or, in the case of warning defects, that the damage was caused by the vaccination and the consequence of missing or incorrect instruction.30 In this regard, no full proof of causation is necessary, but the victim must prove that the medicinal product is capable of causing the damage. It is then for the producer to show that the damaging effects of the medical product do not have their cause in the areas of design and manufacturing.

V Various other rules

Under § 88 of the AMG, liability caps apply. Liability is limited to EUR 600,000 for the death of or injury to a person, or an annuity of EUR 36,000 per year. The total liability for the deaths or injuries of several persons arising from the same medical product is limited to EUR 120 million or annuities of EUR 7.2 million per year. If the sum of the individual damages exceeds that total liability, individual compensation is reduced pro rata.

  1. Ekkehart Reinelt “Zur Haftung des Arzneimittelherstellers für die Übertragung von Viren durch Blutprodukte”: (translation: The Manufacturers Liability for the Transmission of Viruses Through Blood) (1994) Zeitschrift für Rechtspolitik 333.
  2. Rehmann, above n 16, at § 84 para 9.
  3. Wagner, above n 11.

Several producers that have caused the same damage are jointly and severally liable, and as in general product liability law, a slight modification to the general rules on recourse of § 426 Bürgerliches Gesetzbuch (German Civil Code; BGB) applies, in that the apportionment is determined with a view to the particular circumstances of the individual case (rather than per capita) under § 93 AMG.

Under § 94 AMG, the producer has to provide financial coverage for potential damage, which can be arranged by way of insurance or a bank guarantee. That type of compulsory insurance is not present in general product liability law.

Finally, § 94a AMG has introduced special jurisdiction of the court where the victim has his or her domicile at the time of the filing of the action (rather than the place where the damage occurred).

VI Case law

The defectiveness of vaccinations in terms of § 84 para 1 of the AMG has only been discussed in very few court cases. In 2007, a claimant failed to show, to the satisfaction of the court, that a vaccination against tick-borne encephalitis was defective because she developed a Chronic Fatigue Syndrome.31 In the case of a child who turned blind after vaccination against hepatitis B, the court held that the risk / benefit balance clearly was in favour of the vaccine so that the vaccine was not defective. Moreover, no warning defect was present as the package insert mentioned the risk of damage to the visual nerve, and finally the court also rejected causation between the vaccination and the blindness, arguing that blindness could also have been caused by a bacterial or viral infection.32

VII Conclusion

Typically, vaccines cannot have a design defect once they have been admitted, as the test that is use for establishing defectiveness is the same test that is used in the admission procedure.33 What remains are defects relating to insufficient warnings about the potential side-effects, against which the producers shield themselves with lengthy package inserts. Thus, the special rules of the AMG that relax the proof of causation normally do not play any role in practice.

  1. See LG München, 12 January 2007, 6 O 23277/04 (2009) Zeitschrift für das gesamte Medizin- und Gesundheitsrecht 105.
  2. See OLG Hamm, 18 June 2003, 3 U 99/02, above n 12.
  3. See the explicit statement in Bundessozialgericht (Federal Social Court; BSG), 20 July 2005, B 9a/9 VJ 2/04 R (2005) 95 Entscheidungen des Bundessozialgerichts 66, at para 32. See also Dirk Liebold „Impfschäden

– aktuelle Entwicklungen“ (translation: Vaccination Damage: Current Developments) (2018) Zeitschrift für das gesamte Medizin und Gesundheitsrecht 284 at 287.

C The Act on Protection against Infections

  1. The Origin and Philosophy of the Rules on Vaccination Damages Section 60 of the Act on Protection against Infections (Infektionsschutzgesetz; IfSG) of 2001 provides for a special compensation regime under social
security law.

The origins and the philosophy of the rules of the Infektionsschutzgesetz (IfSG) on vaccination damages can be traced back to a judgment of the Bundesgerichtshof (Federal Supreme Court; BGH) of 1953.34 The case concerned a claimant that had been vaccinated at the age of one against small pox, on the basis of an Act of 1874 that provided for compulsory small pox vaccination. She claimed to have suffered severe health damage from that vaccination. The doctor who had administered the vaccination had not acted negligently. Thus, the claimant could only be successful under a no fault state liability scheme. At the time, no special vaccination damage regime was in place. Against an earlier decision of the Reichsgericht (Imperial Court; RG) of 1937,35 the BGH extended an old doctrine, according to which the State must compensate a citizen who is forced to sacrifice their rights for the benefit of the public, to the area of health damages. The decision was influenced by the new German constitution of 1949, the Grundgesetz (Basic Law; GG), that enshrined the fundamental right to personal integrity.36 The court argued that he or she who suffers health damage from a compulsory vaccination makes a sacrifice that goes beyond the sacrifice for the public good that everybody who is vaccinated has to bear. The basic idea is that vaccination is not only meant to protect the individual but also serves the public good of avoiding the spread of diseases.37 Thus, the individual who obtains the vaccination also acts in the public interest and shall not bear the risk of suffering damage from this. Instead, the damage shall be borne by the community.38

That case law was codified in §§ 51 and 52 of the Bundesseuchengesetz (Federal Epidemics Act; BSeuchG) of 1961.39 Section 51 of the BSeuchG covered the most immediate situation in which the vaccinated person suffered health damages beyond the normal consequences of a

  1. BGH, 19 February 1953, III ZR 208/51 (1953) Neue Juristische Wochenschrift 857; consenting Walter Jellinek „Anmerkung“ (translation: Annotation) (1953) Juristenzeitung 463. See also the earlier decision of Kammergericht (KG) Berlin-West, 8-9 June 1950, 4 U 3854/49 (1951) Neue Juristische Wochenschrift 78.
  2. RG, 16 November 1937, VII 200/36 (1937) 156 Entscheidungen des Reichsgerichts in Zivilsachen 305.
  3. Art 2 para 2 of the Grundgesetz (GG).
  4. Hans-Günther Ritz “Impfentschädigung” in Olaf Deinert and Felix Welti (eds) Stichwortkommentar Behindertenrecht (2nd ed, Nomos, Baden-Baden: 2014) at para 1.
  5. See BSG, 20 July 2005, B 9a/9 VJ 2/04 R, above n 33, at 66; von Czettritz and Strelow, above n 18, at 166.

39 BGBl 1961 I, 1012.

vaccination. The rules were amended several times (for details, see below), and the BSeuchG was recast in 1979.40 In 2001, the IfSG replaced the BSeuchG. The rules on vaccination damages are now established in

§§ 60 and 61 IfSG, without changes to the previous rules of §§ 51 and 52 of the BSeuchG.

If the requirements are met, the claimant can obtain, for example, medical treatment, sickness benefits, rehabilitation measures, a pension or compensation for the inability to exercise his or her profession further.41 The benefits have been improved over time. In particular, in 1971, the benefits were streamlined so as to remove differences that had become apparent in the compensation practice of the individual Länder (federal states), and new benefits were introduced.42 Of course, the exact determination of the compensation to be awarded is another source of disputes, including litigation,43 which shall however not be detailed in this article. What is of importance is that the benefits are vastly greater than under regular health insurance law in that they aim at securing a decent life. Unlike regular benefits for handicapped persons, they are independent from the financial resources of the victim.

The rules on vaccination damage belong to the broader category of “social compensation law”, which includes compensation of damage suffered in military service (in practice still mainly in World War II and subsequent war imprisonment),44 compensation of victims of war and of crime, compensation of political prisoners in the former German

40 BGBl 1979 I, 2262.

  1. Miriam Meßling “§ 60 IfSG Versorgung bei Impfschaden und bei Gesundheitsschäden durch andere Maßnahmen der spezifischen Prophylaxe” (translation: Section 60 IfSG Care for Vaccination Damage and Damage to Health through Other Specific Prophylaxis Measures) in Sabine Knickrehm (ed), Gesamtes Soziales Entschädigungsrecht (translation: Entire Social Compensation Law) (Nomos, Baden-Baden, 2012) at para 11.
  2. See Entwurf eines Dritten Gesetzes zur Änderung des Bundes- Seuchengesetzes (translation: Draft Third Act Amending the Federal Epidemics Act) BT-Drucks VI/1568, 6.
  3. See, for example, Landessozialgericht (State Social Court; LSG) Nordrhein- Westfalen 22 February 2007, L 7 V 5/05 (2007) Beck-Rechtsprechung 45251, on the question of how much the victim would have earned if she had not been disabled after the vaccination as a baby; the choice was between the income of her half-sister who had successfully studied law, and her otherwise non-academic background. The competent authority and the court opted for the latter. For critique, see Claudia Petri-Kramer “§ 34 Soziales Entschädigungsrecht” (translation: Social Compensation Law) in Hermann Plagemann (ed) Münchener Anwaltshandbuch Sozialrecht (translation: Munich Lawyers Social Law Manual) (5th ed, CH Beck, Munich, 2018) at para 72.
  4. The relevant Bundesversorgungsgesetz (Federal War Victims Relief Act; BVG) is the ‘leading’ legislation in the field of social compensation.

Democratic Republic and the like. The rules have been partly streamlined over time to make the system more coherent,45 and the social courts that are competent in vaccination damage cases46 have tried to increase the coherence further across the various areas of social compensation law.47

In December 2019, the legislator has passed the Gesetz zur Regelung des sozialen Entschädigungsrechts (Act Regulating Social Compensation Law),48 a major reform of the area of social compensation law, which results in a new act, the Sozialgesetzbuch XIV (Social Code XIV, SGB XIV), that will come into effect, for the parts that are relevant here, on 1 January 2024. The SGB XIV structures and streamlines even more of all these different areas, including vaccination damage, thereby making the system more comprehensible to victims and public authorities alike. The preconditions for the recognition of vaccination damage do not change, except from a moderate broadening of the vaccinations that are covered, in § 24 SGB XIV. The novelties rather relate to the benefits that victims of vaccination damage (and all the other areas) receive.49

II Personal scope of application

Quite obviously, the vaccination damage regime primarily aims at persons who have been vaccinated in Germany.

Two years after the adoption of the Act, in 1963, the personal scope of application was extended to include third persons who have been infected through the transmission of living pathogenic agents from

  1. See the explanations of the Federal Government concerning § 61 IfSG, Entwurf eines Gesetzes zur Neuordnung seuchenrechtlicher Vorschriften (Seuchenrechtsneuordnungsgesetz – SeuchRNeuG) (translation: Draft Law on the Reorganisation of Epidemic Law Provisions) (Epidemic Law Reorganisation Act – SeuchRNeuG) BT-Drucks. 14/2530, 88 (19 January 2001).
  2. See § 68 para 2 of the IfSG.
  3. See, for example, BSG, 19 March 1986, 9a RVi 2/84 (1984) 60 Entscheidungen des Bundessozialgerichts 58, aligning the standard of proof in vaccination damage cases to the standard of proof in war victim cases.

48 BGBl 2019 I, 2652.

49 One other issue is compensation for psychological damage; which appears less relevant in vaccination damage cases. On the reform, see Andreas Löbner „Die aktuelle Reform des Sozialen Entschädigungsrechtes“ (tranlsation: The Current Reform of Social Compensation Law) (2015) Sozialrecht aktuell 182; Steffen Schmidt and Bettina Süsskind „Abschied von der Kriegsopferversorgung – Aufbruch zum neuen Sozialen Entschädigungsrecht“ (translation: Farewell to the Care for War Victims – Departure for the New Social Compensation Law) (2017) Neue Zeitschrift für Sozialrecht 452.

persons who had been vaccinated against polio;50 a rule that was extended in 1971 to cover the transmission of all living pathogenic agents.51

Another amendment of 1971 related to German citizens who had not been administered the relevant vaccination in the Federal Republic of Germany but a comparable vaccination in the former German Democratic Republic or another country.52

Moreover, in 1971, the bereaved of a person who died from the vaccination, obtained their own distinct claim, provided the victim was already 18 years old. Otherwise, the bereaved only obtain compensation from the time when the victim would have been 18 years old.53 In 2007, this was extended to informal marriages in which the partner of the deceased victim has taken care of a common child and therefore has not worked. The claim is limited until the child is three years old.54 The latter amendment had retroactive effect, it also applied if the partner died after 1 November 1994.

III Vaccination damage

The claim under § 60 para 1 of the IfSG requires “vaccination damage”, which is defined by § 2 no 11 of the IfSG as the health-related and economic consequence of damage to health that exceeds the normal reaction to a vaccination. Since an amendment of 1979, damage arising from an accident on the way to or from the vaccination has been equated with vaccination damage.55

The assessment of a vaccination damage includes three steps that all need to be fully proven by the claimant: (1) the vaccination, (2) “primary damage”, which means the complication arising after the vaccination,

  1. Section 51 para. 4 BSeuchG as amended by the Gesetz zur Änderung des Bundesseuchengesetzes (translation: Act Amending the Federal Epidemics Act), BGBl 1963 I, 57. See also BGH, 7 July 1994, III ZR 52/93 (1994) Neue Juristische Wochenschrift 3012, on the transmission of living polio viruses after a polio vaccination. Here, the defendant Land was held liable due to negligence of the doctor who had administered the vaccination because the doctor had failed to inform the parents of the vaccinated baby of the transmission risk.
  2. Section 52 para 1 sent 2 BSeuchG as amended by the Zweites Gesetz zur Änderung des Bundesseuchengesetzes (translation: Second Act Amending the Federal Epidemics Act) BGBl 1971 I, 1401; now § 2 no 11 of the IfSG.
  3. Section 51 paras 2 and 3 BSeuchG as amended by the Zweites Gesetz zur Änderung des Bundesseuchengesetzes, above n 51.
  4. Section 51 para 4 BSeuchG as amended by the Zweites Gesetz zur Änderung des Bundesseuchengesetzes, above n 51.
  5. Section 60 para 4 IfSG as amended by art 5 Gesetz zur Änderung von Vorschriften des Sozialen Entschädigungsrechts und des Gesetzes über einen Ausgleich für Dienstbeschädigungen im Beitrittsgebiet (translation: Act Amending Provisions of Social Compensation Law and the Act on Compensation for Service Injuries in the Accession Area) BGBl 2006 I, 1305.
  6. Section 52 para 1 sent 3 of the BSeuchG (recast), above n 42; now § 60 para 5 of the IfSG.

and (3) the permanent health damage that has been caused by the primary damage.56

Section 60 of the IfSG (as its predecessor, § 51 para 1 of the BSeuchG 1961), however, only applies if the vaccination is mandatory or has been “publicly recommended” – that recommendation confirming the public interest in the vaccination. In the last 25 years, no vaccination was mandatory (the last mandatory vaccination having been against small pox until 1975), but with the Masernschutzgesetz (Measles Protection Act),57 vaccination against measles is made mandatory as of March 2020 for children in nursery and schools as well as for staff working there. “Publicly recommended” means, according to the case law of the Bundessozialgericht (Federal Social Court; BSG), that the competent public authority must have recommended the vaccination.58 In the German federal system, the competent authorities are the health authorities of the Länder. Their recommendations, however, are based on the recommendations of an independent advisory group, the Ständige Impfkommission (Standing Committee on Vaccination; STIKO),59 which was founded in 1972.60 Its recommendations, usually issued annually, are not only relevant for § 60 of the IfSG but also form the basis for what vaccinations the statutory health insurance pays for. Currently, recommendations relate to vaccinations against tetanus, diphtheria, pertussis, polio, hepatitis B, hib, pneumococcal disease, rotaviruses, meningococcal disease, measles, mumps, rubella, chicken pox, influenza and human papillomavirus (HPV).61

IV Causation

When state liability for vaccination damage was first regulated, normal causation rules applied. Thus, the claimant had to provide full proof of causation under the normal rules of German law,62 which are quite

  1. See BSG, 19 March 1986, 9a RVi 2/84, above n 47; LSG Bayern, 26 March 2019, L 15 VJ 9/16, BeckRS 2019, 5342.
  2. BGBl 2020 I. On concerns relating to the lawfulness of such a law, see Rüdiger Zuck “Gesetzlicher Masern-Impfzwang” (translation: Statutory Mandatory Measles Vaccination) (2017) 50(4) Zeitschrift für Rechtspolitik 118.
  3. For a case where a vaccine was used in clinical trials but had not yet been admitted to the market, and therefore the claim under § 60 IfSG failed, see BSG, 20 July 2005, B 9a/9 VJ 2/04 R, above n 33, at 66.
  4. See § 20 para 3 of the IfSG. See also Michael Pfleiderer and Ole Wichmann

„Von der Zulassung von Impfstoffen zur Empfehlung durch die Ständige Impfkommission in Deutschland“ (translation: From the Approval of Vaccines to the Recommendation of the Standing Vaccination Commission in Germany) (2015) 58 (3) Bundesgesundheitsblatt - Gesundheitsforschung

- Gesundheitsschutz 263.

  1. See now § 20 para 2 of the IfSG.
  2. See Standing Committee on Vaccination “Vaccination Recommendations by STIKO”, available at: < Vaccination/recommandations/recommendations_node.html>.
  3. See also Meßling, above n 41, at para 3.

burdensome, as explained above in the context of product liability law.

This changed with an amendment to the BSeuchG of 1971 that introduced a reduced burden of proof (discussed below at 1) as well as a hardship clause (discussed below at 2). Interestingly, the amendment had some kind of retroactive effect as it allowed persons whose applications had already been rejected due to lack of (proven) causation to reapply under the new rules.

1 Reasonable likelihood of causation

The claimant must prove that the vaccination caused an unusual reaction, and that that reaction caused the adverse consequences. Whereas the actual vaccination, the reaction and the adverse consequences must be fully proven, the claimant must only demonstrate reasonable likelihood of causation between them.63 According to the BSG, the causal link is present if, under consideration of the leading medical opinion, it is more likely than not that the vaccination was the cause of the permanent damage, whereas the mere possibility of causation is insufficient.64 Hereby, the court has to consider (and to explore by commissioning expert evidence) the state of scientific knowledge at the time of the court decision even if the vaccination had taken place many years ago.65 If there had been an equally likely alternative cause for the adverse reaction, causation will be rejected.66

What is crucial in practice is whether or not the primary damage is in line with the “typical” complications, and their time line, as described by the STIKO,67 as the insights of the STIKO are regarded to be the leading medical opinion.68 In that sense, it is most important to gather documentation of all events after the vaccination, including of course medical documentation, but also witness statements.

Where the origins of a particular disease are unclear that causal link cannot be established,69 but the hardship rule may come into play (see below).

  1. Section 61 sent 1 IfSG.
  2. See, for example, BSG, 19 March 1986, 9a RVi 2/84, above n 47.
  3. See BSG, 17 December 1997, 9 RVi 1/95 (1997) Beck-Rechtsprechung 30005378; LSG Sachsen, 30 January 2018, L 9 VE 25/14 (2018) Beck- Rechtsprechung 4180.
  4. See LSG Sachsen, 30 January 2018, L 9 VE 25/14, above n 65.
  5. The STIKO regularly publishes its insights in the journal „Epidemologisches Bulletin“ (translation: Epidemological Bulletin), available at <www.rki. de/DE/Content/Infekt/EpidBull/epid_bull_node.html>. See also Jana Schäfer-Kuczynski „Anmerkung“ (translation: Annotation) (2018) Fachdienst Sozialversicherungsrecht 405489.
  6. See Liebold, above n 33, at 285.
  7. See LSG Berlin-Brandenburg, 8 July 2016, L 13 VJ 16/12 (2016) Beck- Rechtsprechung 73023.

Examples of successful litigation include a claim relating to a pertussis vaccination, followed by encephalitis,70 and to a polio vaccination, also followed by encephalitis.71 In most cases, however, the claims failed because the courts saw no sufficient evidence of the causation between the vaccination and the damage.

This applies, in particular but not exclusively, to vaccinations with Infanrix Hexa. In 2015, the Landessozialgericht (State Social Court; LSG) Hamburg dealt with a case of autism. Here, the court decided that with regard to 750,000 vaccinations in Germany and several million vaccinations worldwide with the vaccine Infanrix Hexa, the few cases of brain damage that are claimed to have been caused by Infanrix Hexa could not be connected with that vaccine with sufficient probability. The mere theoretical possibility that the vaccination might have caused brain damage was not enough to trigger a claim under § 60 of the IfSG.72 Thus, the claim failed. Appeal against that decision was not allowed by the BSG.73

Courts have also denied sufficient likelihood of a causal link between vaccinations with Infanrix Hexa and diabetes mellutis type 1.74 A likely causal link between an Infanrix Hexa vaccination and a seizure disorder was denied in a case where such disorders had occurred in the wider family of the child so that a respective genetic disposition was at least as likely.75 In contrast, a child who developed a seizure disorder and had shown relevant symptoms on the day of the vaccination was successful in court.76

Beyond Infanrix Hexa, courts have rejected the likelihood of a causal link between an influenza vaccination and the development of a Chronic Fatigue Syndrome77 as well as between a vaccination against mumps, measles and rubella and severe brain damage.78

Time is of the essence: Where the problem does not become apparent within the usual time in which complications arise, the competent

  1. See LSG Berlin-Brandenburg, 29 January 2009, L 11 VJ 36/08 (2009) Beck- Rechtsprechung 55721.
  2. See LSG Berlin-Brandenburg, 16 March 2016, L 13 VJ 59/14 WA (2016) Beck-Rechtsprechung 69102.
  3. LSG Hamburg, 29 September 2015, L 3 VE 9 13 (2016) Beck-Rechtsprechung 70836.
  4. See BSG, 27 April 2016, B 9 V 73/15 B (2016) Beck-Rechtsprechung 69521.
  5. See LSG Berlin-Brandenburg, 8 July 2016, L 13 VJ 16/12 (2015) Beck- Rechtsprechung 112974.
  6. See LSG Sachsen-Anhalt, 19 February 2014, L 7 VI 21/07 (2014) Beck-

Rechtsprechung 68871.

  1. See Sozialgericht (Social Court; SG) München, 3 December 2015, S 9 VJ 2/06 (2016) Beck-Rechtsprechung 70604. See also LSG Bayern, 15 December 2015, L 15 VJ 4/12 (2016) Beck-Rechtsprechung 67978 (on Hexavac).
  2. LSG Nordrhein-Westfalen, 15 January 2016, L 13 VJ 27/13 (2016) Beck- Rechtsprechung 68405.
  3. LSG Baden-Württemberg, 21 April 2015, L 6 VJ 1460/13 (2015) Beck-

Rechtsprechung 69463.

authorities, and the courts as well, tend to reject the likelihood of a causal link.79 Successful litigation mostly relates to cases in which complications arose just outside the usual time frame.

2 Hardship clause

In 1971, the legislator introduced a special hardship clause for cases in which there is insufficient likelihood of causation only because of insufficient scientific knowledge about the causes of the medical condition. The legislator expressly referred to multiple sclerosis or facial nerve paresis.80 In such a case, the competent authority can still recognise vaccination damage in the individual case, with the consent of the competent state ministry; and after an amendment in 1979, there is also the possibility that the recognition is given for a whole category of cases. Despite its wording, the recognition of vaccination damage in such as case is not at the discretion of the competent authority but is mandatory.81

The legislation has concretised that this does not cover situations where in the individual case sufficient likelihood cannot be proven, or where alternative potential causes exist,82 but only to the situation of a general lack of scientific knowledge.83 Still, courts require at least a medical opinion that there can be a connection between the vaccination and the damage; or a “good possibility”, rather than simple suggestions by one or more doctors.84 Thus, although no leading opinion may have developed yet, there should be a minority opinion already held in circles of experts.85

In two recent cases, courts have confirmed claims concerning Guillain-Barré syndrome86 and narcolepsy87 following vaccinations (with the vaccine Pandemrix) against swine flu. The main reasons were the availability of statistical data, according to which after the mass vaccination against swine fever, there was an increase in the appearance

  1. See also BSG, 19 March 1986, 9a RVi 4/84 (1986) Beck-Rechtsprechung 05898; LSG Baden-Württemberg, 21 April 2015, L 6 VJ 1460/13, above n 78; LSG Bayern, 6 December 2018, L 20 VJ 3/17 (2018) Beck-Rechtsprechung 33421.
  2. BT-Drucks VI/1568, 9.
  3. See only LSG Nordrhein-Westfalen, 16 February 2008, L 6 (7) VJ 15/07 (2009) Beck-Rechtsprechung 50674.
  4. See LSG Bayern, 26 March 2019, L 15 VJ 9/16, above n 56.
  5. See part C no 4b of the ‘Versorgungsmedizinische Grundsätze’ (translation: Principles of medical care), published as Annex to the Versorgungsmedizin-Verordnung (translation: Pension Medical Ordinance) of 2009, Bundesgesetzblatt 2008 I, 2412.

84 See BSG, 12 December 1995, 9 RV 17/04; BSG, 17/7/2008, B 9/9a VS 5/06

R (2008) Neue Juristische Online-Zeitschrift 4665.

  1. See LSG Rheinland-Pfalz, 16 November 2011, L 4 VJ 2/10 (2012) Beck- Rechtsprechung 68261; LSG Sachsen-Anhalt, 25 September 2012, L 7 VJ 3/08 (2013) Beck-Rechtsprechung 72921; LSG Sachsen-Anhalt, 30 August 2017, L 7 VE 7/14 (2018) Pharma Recht 103.
  2. See LSG Sachsen-Anhalt, 30 August 2017, L 7 VE 7/14, above n 85.
  3. See SG Koblenz, 5 April 2018, S 4 VJ 4/15.

of Guillain-Barré syndrome, and a short time between the vaccination and the symptoms in the individual case. Likewise, there were studies in several European countries, according to which Pandemrix had increased the risk of narcolepsy. In contrast, in a case before the LSG Bayern, the court held that the time between the vaccination and the first symptoms was too long, and that it was therefore unlikely that the symptoms had been caused by the vaccination.88

In other cases, the courts could not even find a minority opinion that would support the claim, for example, in the case of West syndrome after a vaccination with Hexavac89 or in the case of autoimmune hepatitis after a vaccination against measles.90

Overall, however, the hardship clause seems to have been made increasing use of recently.91

3 The Sanofi Pasteur judgment of the Court of Justice

To avoid misunderstandings that may stem from reports in the general German press where authors have not clearly distinguished between liability under product liability law and liability under § 60 of the IfSG,92 it should be mentioned that the Sanofi Pasteur judgment of the Court of Justice93 is of no relevance for the latter. Indeed, there was already a first court decision that denied any relevance of Sanofi Pasteur on German law on vaccination damages.94 In Sanofi Pasteur, the Court of Justice had held that:94a

... a court ruling on the merits of an action involving the liability of the producer of a vaccine due to an alleged defect in that vaccine, in the exercise of its exclusive jurisdiction to appraise the facts, may consider that, notwithstanding the finding that medical research neither establishes nor rules out the existence of a link between the administering of the vaccine and the occurrence of the victim’s disease, certain factual evidence relied on by the applicant constitutes serious, specific and consistent evidence enabling it to conclude that there is a defect in the vaccine and that there is a causal link between that defect and that disease.

First of all, the Court of Justice only allowed that kind of alleviation of the burden of proof but did not require it from Member States. Secondly, and more importantly, the German vaccination damage regime is entirely

  1. LSG Bayern, 26 March 2019, L 15 VJ 9/16, above n 56.
  2. LSG Rheinland-Pfalz, 16 November 2011, L 4 VJ 2/10, above n 85.
  3. LSG Sachsen-Anhalt, 25 September 2012, L 7 VJ 3/08, above n 85.
  4. See Liebold, above n 33, at 286.
  5. See, for example, Sonja Kastilan „Obwohl Beweise fehlen?“ (translation: Although there is no Evidence?) Frankfurter Allgemeine Zeitung (3 July 2017) < impfschaeden-obwohl-beweise-fehlen-15086373.html>.
  6. Case C-621/15 NWand others v Sanofi Pasteur MSD SNC, ECLI:EU:C:2017:484.
  7. SG Regensburg, 4 July 2018, S 13 VJ 2/16 (2018) Beck-Rechtsprechung 25816.

94a Case C-621/15 NW and others v Sanofi Pasteur MSD SNC, above n 93, at

para 43.

unrelated to product liability law.95

V Statistics

In principle, doctors have to report vaccination complications to the municipal health authorities.96 Complications are of course not equivalent to vaccination damages. Information on vaccination damages or applications under § 60 of the IfSG is not systematically collected in a central database but only at the level of the Länder. The last available comprehensive analysis relates to the period of 2005-2009.

Statistics show that only a minority of damages that claimants allege to be caused by a vaccination is compensated under § 60 of the IfSG. Over time, the number of applications, as well as the number of recognised vaccination damages, have decreased.

From 1976 to 1990 4,569 applications were made to the competent authorities. In 1,139 cases, the applications were accepted. In the period from 1991 to 1999, only 389 out of 2,543 applications were successful. Thirty-eight per cent of the applications related to small pox vaccinations that were abandoned in 1982, accounting for 64.7 per cent of recognised vaccination damages.97

The figures for the period of 2005 to 2009 are even lower. Out of 1,036 applications, 169 were successful. The decrease of applications stems from the abolition of small pox vaccinations but also from the fact that certain vaccinations are not recommended anymore by the STIKO.98 Generally, official publications relate the low numbers of claims to the high level of safety of vaccinations.

The most problematic vaccinations in terms of recognised vaccination damage were vaccinations against tick-borne encephalitis and influenza; whereas the most controversial vaccinations are MMR and hexa infanrix that people suspect to cause all sorts of disabilities; which the leading scientific opinion rejects or regards as unlikely.99

  1. See also Johannes Friedrich and Matthias Friedrich „Kausalzusammenhang zwischen Impfungen und multipler Sklerose?“ (translation: Casual Link between Vaccinations and Multiple Sclerosis?) (2017) Zeitschrift für europäisches Sozial- und Arbeitsrecht 491 at 500; Liebold, above n 33, at 288.
  2. See § 96 of the IfSG.
  3. See Christiane Meyer and others “Anerkannte Impfschäden in der Bundesrepublik Deutschland 1990-1999” (translation: Recognised Vaccination Damage in the Federal Republic of Germany 1990-1999) (2002) 45(4) Bundesgesundheitsblatt – Gesundheitsforschung – Gesundheitsschutz 364, at 368.

98 At 369.

99 See also Karin Weißer, Immanuel Barth and Brigitte Keller-Stanislawski

„Sicherheit von Impfstoffen“ (translation: Vaccine Safety) (2009) 52(11) Bundesgesundheitsblatt – Gesundheitsforschung - Gesundheitsschutz 1, from 8; Doris Oberle and others „Impfkomplikationen und der Umgang mit Verdachtsfällen“ (translation: Vaccine Complications and Dealing with Suspected Cases) (2019) 62(4) Bundesgesundheitsblatt – Gesundheitsforschung – Gesundheitsschutz 450 at 455.

Cases under § 60 of the IfSG are more frequent than cases under product liability law but not largely more successful. The number of court cases in which compensation was awarded is very low, and the most likely reason is the high burden of proof.100

VI The efficiency of the system

What is efficient may depend on the aim of the system. If that aim is to merely recognise fairly clear-cut cases of vaccination damage, the system works very well. If in contrast, the system aimed to help persons who have suffered usually the most severe health damage in the aftermath of a vaccination, there is a lot to improve.

First, the possibility to obtain vaccination damage does not seem to be generally known by the public, although the vaccination cards contain a notice relating to the potential claims on the basis of §§ 60-64 IfSG and the competent authorities.101 The claim only arises with the relevant application with the competent authority. There have been instances where that application was only made 20 years after the vaccination and the appearance of complications; which also aggravates the burden of providing evidence, or convincing facts, about the exact timing of events in the aftermath of the vaccination.

One reason for the lack of general knowledge, or attention, may be that the medical treatment is covered by health insurance anyway; which is where one would turn to first when problems arise. In the case of disabilities, one can claim for support under social welfare law. The benefits under social compensation law, however, including in vaccination damage cases, are vastly greater and therefore vastly more expensive for the State. For example, in 2018 the Land Rheinland-Pfalz supported 157 vaccination victims (whereby only one case has been recognised since 2015 and 19 were rejected). According to the competent minister, payments and non-monetary benefits between 2015 and 2017 to those victims amounted to EUR 22 million.102

This may explain the resistance of the public authorities to recognise such claims. In fact, the Länder often do not even give in even after the first instance court and/or the appeal court has confirmed a claim but tend to appeal such decisions.

Overall, final decisions on a claim may take well over ten years if the case goes through three instances (social court, state social court and Federal Social Court), following the rejection of the claim by the

  1. See Liebold, above n 33, at 286.
  2. See § 22 para 3 IfSG.
  3. See SWR “157 Rentenbezieher wegen Impfschäden” (translation: 157 Pension Recipients for Vaccination Damage) available at <www.swr. de/swraktuell/rheinland-pfalz/Gesundheitsministerin-Baetzing- Lichtenthaeler-Gut-150-Rheinland-Pfaelzer-bekommen-Geld-wegen- Impfschaeden,impfschaeden-rlp-100.html>.

competent authority. The length of procedures appears to be a major source of distress on part of the (alleged) vaccination victims.103

D Conclusions

Whereas bringing a vaccination damage claim under the product liability law regime of the Arzneimittelgesetz is nearly hopeless, the social compensation law scheme of the Infektionsschutzgesetz (from 2024 on the Sozialgesetzbuch XIV) offers the major advantage that claims do not depend on the defectiveness of the vaccine. Still, showing causation between a vaccination and health damages has remained a great problem for claimants, although the standard of proof is much lower than in German law otherwise. Particular problems arise when it comes to diseases the origins of which are still unclear, such as multiple sclerosis. The situation is aggravated by complicated and lengthy procedures involving (expensive) expert evidence, which often goes beyond the strength of the victim and his relatives. The system is surely not meant to offer speedy help, which is provided mainly through the health insurance system. It rather aims to cover exceptional cases where the victim has (demonstrably and involuntarily) suffered a sacrifice for the general public.

  1. See Deutscher Sozialgerichtstag e.V., Entwurf eines Gesetzes zur Regelung des Sozialen Entschädigungsrechts (translation: Draft Act Regulating Social Compensation Law) (17 January 2019), available at <www.bmas. de/SharedDocs/Downloads/DE/PDF-Gesetze/Stellungnahmen/ gesetz-zur-regelung-des-sozialen-entschaedigungsrechts-deutscher- sozialgerichtstag.pdf? blob=publicationFile&v=2>.

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