More than one year after the first lockdown, Germany is still struggling with the COVID-19 pandemic. Vaccinations represent a ray of hope. Most of the public is in favour of vaccinations and the supply of vaccines to vaccination centres in federal states is becoming increasingly efficient.
However, in recent months there have been several incident reports regarding vaccinations. These primarily concern cerebral venous thrombosis, which in some cases has caused serious health damage to patients or even death.
Against this background, the question arises as to how the law responds to damage to patients caused by vaccinations. In this regard, the different relationships must be separated – namely:
- patients versus physicians;
- patients versus pharmaceutical companies; and
- patients versus the authorities.
Any damage is likely to be caused by the vaccines themselves rather than by physicians. However, physicians' liability could arise under the Civil Code (BGB) in the context of patients' informed consent. Under Section 630e of the BGB, physicians must inform patients about all of the relevant circumstances of the vaccination. This information represents the basis for informed consent.
Since the available vaccines are new, not all of the relevant circumstances are known. Therefore, physicians must pay special attention to the situation, such as by asking questions (eg, regarding pre-existing conditions) and providing particularly detailed information. Failure to do so might result in inadequate patient information. Informed consent based thereon would be deemed invalid, leading to unlawful treatment.
Patients versus pharmaceutical companies
Section 84 of the Pharmaceuticals Act (AMG) provides for strict liability for damages caused by pharmaceuticals (ie, no default is required).
Section 84 of the AMG states as follows:
If, as a result of the administration of a pharmaceutical intended for human use, which was distributed to the consumer within the purview of the AMG 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 company who placed the medicinal product on the market within the purview of the AMG shall be obliged to compensate the injured party for the damage caused.
Besides these prerequisites, liability requires that:
- pharmaceuticals are used within their intended purpose and damage occurs which exceeds the limits considered tolerable in light of current medical knowledge; or
- damage has occurred as a result of labelling, expert information or instructions for use which do not comply with current medical knowledge.
Therefore, a pharmaceutical company's liability for damage caused by vaccinations under Section 84 of the AMG requires that:
- the pharmaceutical is intended for human use;
- the pharmaceutical is within the purview of the AMG;
- the pharmaceutical is subject to market authorisation (or is exempt therefrom);
- the pharmaceutical is applied within its intended use;
- the damage exceeds the limits considered tolerable or results from the labelling, expert information or instructions for use; and
- causality between the application of the pharmaceutical and damage exists.
While the first four requirements are likely to be given in the context of the vaccines currently available in Germany, the fifth and sixth requirements could cause difficulties. The patient must prove not only that damage has occurred but also that the damage exceeds the limits considered tolerable. In this regard, it must be considered whether the adverse effects, if they were known at the time of making the pharmaceutical available on the market, could have been accepted in the medical situation at that time. As a rule, to answer this question, both medical and legal experts must be involved.
Regarding causality between application and damage, the burden of proof lies with the patient. While causality can be assumed under certain circumstances, pharmaceutical companies can rebut this assumption by outlining that alternative causes for the damage exist. In practice, pharmaceutical companies must assess the patient's medical files in depth.
Besides Section 84 of the AMG, liability could also arise under Section 823 of the BGB. This section does not provide for strict liability (ie, a default by the pharmaceutical company is necessary and must be proved by the patient). Liability under the Product Liability Act (ProdHaftG) may be considered only in specific cases – for example, if the vaccine does not fall under the approval requirement or is exempted from a respective requirement or handed over outside the purview of the AMG (Section 15 of the ProdHaftG).
Section 60 of the Infection Protection Act (IfSG) specifically provides for care in cases of vaccination damage. It states as follows:
Whoever, by means of a protective vaccination or by means of another measure of specific prophylaxis has suffered an injury to health, shall, after vaccination, receive care in accordance with the provisions of the Federal Pensions Act on account of the damage caused by vaccination within the meaning of § 2 No. 11 IfSG or in its corresponding application in the case of another measure on account of the health and economic consequences of the injury, unless the IfSG provides otherwise.
Under the IfSG, 'vaccination damage' is defined as any health or economic consequence of damage to health, caused by a vaccination, which exceeds the usual extent of a vaccination reaction. This includes cases in which a patient is vaccinated with pathogens capable of reproduction and someone other than the vaccinated person is harmed.
Apart from vaccination damage, an entitlement for care under the IfSG requires that the vaccination:
- has been publicly recommended by a competent state authority and is undertaken in its area;
- was ordered based on the IfSG;
- was required by law; or
- was carried out based on the regulations for the implementation of the International Health Regulations.
Therefore, an entitlement for care under Sections 60 and 2 of the IfSG requires:
- the application of the (approved) vaccine;
- vaccination damage;
- a competent state authority's public recommendation of the vaccination; and
- causality between the application of the vaccine and the damage.
It appears that the requirements of the IfSG are easier to meet in cases of vaccinations than the requirements under Section 84 of AMG, although this will depend on the facts of the case. In general, the damaged person must prove all of the requirements. The first three requirements can be proven easily; the standing vaccine commission at the Robert-Koch-Institut has recommended vaccination against COVID-19 and the government has implemented a national strategy which includes vaccinations. The legislature recognised that the fourth requirement could cause difficulties, since proof would require medical and legal experts. Therefore, the legislature introduced Section 61 of the IfSG, which provides for a lower burden of proof – namely, that a probability of causality is sufficient. In specific cases, the vaccination damage can even be declared given (by the competent authority) without further proof.
The law provides for different kinds of relief in cases of vaccination damage. This relief is structured as:
- physicians' liability under the BGB;
- pharmaceutical companies' strict liability under Section 84 of the AMG and the BGB; and
- an entitlement for care under Sections 60 and 2 of the IfSG.
Generally, the party that is claiming for damages regarding an entitlement for care must prove that all of the conditions are met. However, the legislature has introduced provisions which lower the burden of proof.
Regarding relationships between patients and pharmaceutical companies concerning competent authorities, in cases where claims under Section 84 of the AMG and the BGB and Sections 60 and 2 of the IfSG exist, the latter prevails. Therefore, claims under Section 84 of the AMG and the BGB must be transferred to the competent authority, which deals with claims for entitlement for care to the extent provided for by the IfSG. Consequently, the damaged party may claim damages under Section 84 of the AMG and the BGB only where such damages do not fall under Sections 60 and 2 of the IfSG.
