Last Updated on May 29, 2021 by LawEuro
Medicinal Products Act (Laws / Regulations of Germany)
CHAPTER SIXTEEN
Liability for damages caused by medicinal products
Section 84
Absolute liability
(1) If, as a result of the administration of a medicinal product intended for human use, which was distributed to the consumer within the purview of this Act and which is subject to compulsory marketing authorisation or is exempted by ordinance from the need for a marketing authorisation, a person is killed, or the body or the health of a person is substantially damaged, the pharmaceutical entrepreneur who placed the medicinal product on the market within the purview of this Act shall be obliged to compensate the injured party for the damage caused. The liability to compensate shall only exist 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.
(2) If the medicinal product administered is capable of causing the damage, in the circumstances pertaining to the individual case, the damage will be presumed to have been caused by the medicinal product in question. The capability in the individual case will be 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. The presumption shall not apply if, in the light of the circumstances pertaining to the individual case, another fact 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 be considered as another fact unless, owing to the administration of these medicinal products, claims for reasons other than the lack of causality for the damage, do not exist under this provision.
(3) The pharmaceutical entrepreneur shall be exempted from liability to pay damages pursuant to sub-section 1 sentence 2 number 1, if the facts indicate that the damaging effect of the medicinal product is not attributable to its development and manufacturing process.
Section 84a
Right to disclosure
(1) Where facts exist to justify the assumption that a medicinal product has caused the damage, the injured party can request information from the pharmaceutical entrepreneur unless such information is not necessary to verify a right to compensation pursuant to Section 84. The right refers to effects, adverse reactions and interactions known to the pharmaceutical entrepreneur as well as suspected adverse reactions and interactions brought to his/her attention and all further knowledge which could be of significance in assessing the justifiability of harmful effects. Sections 259 to 261 of the Civil Code shall be applied mutatis mutandis. A right to disclosure shall not exist where statutory provisions require that the data remain secret or when non-disclosure is justified by an overriding interest of the pharmaceutical entrepreneur or a third party.
(2) A right to disclosure also exists, under the conditions laid down in sub-section 1 vis-à-vis the authorities responsible for the authorisation and supervision of medicinal products. The authority is not obliged to disclose the information where provisions require that the data remain secret or when non-disclosure is justified by an overriding interest of the pharmaceutical entrepreneur or a third party. This shall be without prejudice to claims under the Freedom of Information Act.
Section 85
Contributory negligence
If negligence on the part of the injured party has helped to cause the injury, Section 254 of the Civil Code shall apply.
Section 86
Extent of liability for damages in the case of death
(1) In the case of death, compensation shall be made by reimbursing the costs of an attempted cure as well as the costs incurred by the pecuniary prejudice sustained by the deceased party as a result of the suspension or reduction of his/her earning capacity or the resultant increase in his/her needs for the duration of the disease. The party liable for damages shall furthermore reimburse the funeral costs to the party who is responsible for defraying these expenses.
(2) If at the time of injury, the deceased party maintained a relationship with a third party by virtue of which he/she was or was liable to come under the legal obligation to support this third party and if the third party was deprived of the right to maintenance as a result of the death, the party liable for damages shall indemnify the third party, guaranteeing maintenance to the extent to which the deceased party would have been liable for the length of lifespan he/she would probably have had. Liability for damages shall also be enforced if, at the time of injury, the third party had been conceived but not yet born.
(3) The party liable for damages shall pay the surviving dependent, who had a special personal intimate relationship with the deceased at the time of injury, an appropriate monetary compensation for the metal suffering inflicted on said surviving dependent.A special personal intimate relationship is assumed if the surviving dependent was a spouse, life partner, parent or child of the deceased party.
Section 87
Extent of liability for damages in the case of bodily injury
In the case of injury to a person’s body or damage to his/her health, compensation shall be given by reimbursing the costs of the treatment as well as the costs incurred by the pecuniary prejudice sustained by the injured party as a result of the temporary or permanent suspension or reduction of his/her earning capacity or the resultant increase in his/her needs. In this case, reasonable financial compensation can also be claimed when the damage is not of a pecuniary nature.
Section 88
Maximum amounts
The party liable for damages shall bear liability:
1. in the case of the death of or injury to a person, only up to a capital amount of 600,000 euros or an annuity of up to 36,000 euros per year,
2. in the case of the death of or injury to several persons by the same medicinal product, notwithstanding the limits stipulated in number 1, up to a capital amount of 120 million euros or an annuity of up to 7.2 million euros per year.
Should, in the case of sentence 1 number 2, the combined indemnification to be paid to several injured parties exceed the maximum amounts specified therein, then the individual compensation shall be reduced pro-rata to the maximum total given.
Section 89
Compensation in the form of annuities
(1) Compensation on account of the suspension or reduction of earning capacity and on account of increased need on the part of the injured party, as well as the compensation to be afforded a third party pursuant to Section 86 sub-section 2, shall be paid in the future by means of an annuity.
(2) The provisions of Section 843 sub-sections 2 to 4 of the Civil Code and of Section 708 number 8 of the Code of Civil Procedure shall apply mutatis mutandis.
(3) If a security bond was not awarded when the party liable was sentenced to pay the annuity, the entitled party may, nevertheless, demand a security bond if the pecuniary circumstances of the liable party have deteriorated considerably; under the same circumstances, he/she may demand an increase in the security bond specified in the verdict.
Section 90
Statute of limitations
(repealed)
Section 91
Extended liability
This shall be without prejudice to legal provisions according to which the party liable for damages under Section 84 shall be liable to a greater extent than stipulated by the provisions in this chapter, or according to which another party is responsible for the damage incurred.
Section 92
Mandatory provision
The liability for damages pursuant to this chapter may neither be excluded nor restricted beforehand. All agreements to the contrary shall be void.
Section 93
Several parties liable for damages
If several parties are liable for damages, they shall be jointly and severally liable. With regard to the relationship of the liable parties to each other, the obligation to pay compensation as well as the extent of the compensation to be paid shall depend on the extent to which the damage has been predominantly caused by one or the other party.
Section 94
Coverage provision
(1) The pharmaceutical entrepreneur shall ensure that he/she is able to meet his/her legal commitments in respect of compensation for the damage incurred as a result of the administration of a medicinal product intended for human use, placed by him/her on the market, and subject to a compulsory marketing authorisation or exempted by ordinance from a marketing authorisation (provision for coverage). The provision for coverage must be made available in the amounts specified in Section 88 sentence 1. It can only be made available by means of:
1. a third party insurance taken out with an independent insurance company authorised to conduct business within the purview of this Act, for which, in the event of a reinsurance, a reinsurance contract exists only with a reinsurance company that is established within the purview of this Act, in another Member State of the European Union, in another State Party to the Agreement on the European Economic Area or in another state recognised by the European Commission as equivalent according to Article 172 of Directive 2009/138/EC of the European Parliament and of the Council of 25 November 2009 on the taking-up and pursuit of the business of Insurance and Reinsurance (Solvency II) (OJ L 335 of 17.12.2009, p. 1), or
2. an exemption or warranty obligation issued by a domestic credit institution, or a credit institution of one of the other Member States of the European Union or another State Party to the Agreement on the European Economic Area.
(2) If the provision for coverage is afforded by a third party insurance, Section 113 sub-section 3 and Sections 114 to 124 of the Law on Insurance Contracts shall apply mutatis mutandis.
(3) Provision for coverage may only be made available using exemption or warranty obligations issued by a credit institution if it is guaranteed that the credit institution will be in a position to meet its commitments within the framework of the provision for coverage for such time as it can be expected to be called upon to do so. Section 113 sub-section 3 and Sections 114 to 124 of the Law on Insurance Contracts shall apply mutatis mutandis with respect to exemption or warranty obligations.
(4) The competent office within the meaning of Section 117 sub-section 2 of the Law on Insurance Contracts shall be the authority competent for carrying out supervision pursuant to Section 64.
(5) The Federal Republic of Germany and the federal Laender are not obliged to provide coverage in compliance with sub-section 1.
Section 94a
Local jurisdiction
(1) In the case of legal actions initiated on the basis of Section 84, the court in whose district the plaintiff has his/her domicile or, failing this, has his/her usual place of abode at the time of filing the action shall have jurisdiction.
(2) No account shall be taken of sub-section 1 when determining the international jurisdiction of the courts of a foreign nation pursuant to Section 328 sub-section 1 number 1 of the Code of Civil Procedure.
Leave a Reply