Which are the conditions for claiming compensation (including the burden of proof)?
2.1 In order to be able to claim compensation under the Civil liability regime, the following conditions must be met:
Product Liability Act
Under the PLA, manufacturer liability may arise if the claimant can prove the following three core elements:
- a product defect
- a damage (death or personal injury)
- a causal link between these two
A product is deemed defective if it does not provide the safety that an average consumer is generally entitled to expect, taking into account all circumstances, including the product's presentation, its reasonably expected use and the time it was placed on the market (Art. 4(1) PLA).
In the context of ADR, a product may be defective if known ADR are not accurately disclosed. In its landmark decision of 2015 regarding the Yasmin pill (commonly referred to as the "Yasmin case"), the Federal Supreme Court ruled that the reasonably expected use of prescription drugs must be assessed from the prescribing HCP's perspective. This means that when assessing whether the safety expectations of a prescription drug are met, the warnings made in the specialist information intended for HCPs are decisive (not the package leaflet intended for patients). In the Yasmin case, only the specialist information mentioned an increased VTE risk of Yasmin compared to other contraceptive pills. Based on that, the Federal Supreme Court held that the manufacturer had sufficiently warned on ADR and denied liability under the PLA.
Besides cases in which known ADR are not accurately disclosed, liability under the PLA may also arise if ADR have – in breach of duty – remained unknown, i.e. should have been discovered by the manufacturer based on the available science and technology at the time of the market placement of the product.
Tort and contract law
In (fault-based) tort law and contract law the liability elements are the following:
- damage (death or personal injury)
- unlawfulness (tort) / breach of contract (contract law)
- a causal link between these two
- fault
The burden of proving the existence of the damage, the unlawful conduct / breach of contract and the causal link is on the claimant.
In claims for breach of contract, the law assumes fault of the HCP, but the HCP may exculpate himself. With regard to claims alleging insufficient patient information, the HCP has to prove correct and comprehensive information was given to the patient – also with regard to possible ADR (e.g. by showing the minutes of the information process or a signed information form). However, even if the HCP did not duly inform the patient on possible ADR, the HCP could still invoke hypothetical consent of the patient (patient would have consented even if fully informed).
By contrast, for claims based on tort law (Art. 41 CO), the claimant bears the burden of proving fault.
State liability for damage related to vaccination under the Epidemics Act
The state compensates damage from vaccination under the Epidemics Act subject to the following conditions:
- the vaccine has been officially declared mandatory or recommended;
- the vaccine has led to a severe and long term health impairment. Expectable short term effects like fever, fatigue, swellings, headache etc. are not eligible for compensation;
- causal link between the vaccine and the health impairment; and
- the damage is not (fully) covered under other regimes, i.e. by those primarily responsible (manufacturer, HCP, clinic) and/or by social or private insurance.
The Epidemics Act provides for a strict liability regime. The applicant requesting compensation has to provide full evidence of the damage. By contrast, the required causality between vaccine and health impairment is confirmed rather easily and even in case of rare health reactions.
2.2 Which are the grounds for exclusion of liability?
A. Manufacturers
Under the PLA, the main defence for the manufacturer is to prove that the defect (the ADR) was not discoverable based on the state of scientific and technical knowledge at the time the product was placed on the market (Art. 5(1)(e) PLA). As to known ADR, note that the Federal Supreme Court in the Yasmin case (see Section 2.1 above) denied liability for ADR that were accurately described in the specialist information addressed to HCPs.
B. Healthcare professionals
If the conditions for claiming compensation laid out above (see answer to question 2.1) are fulfilled, there are no grounds for exclusion of liability. In particular, any contractual exclusion of liability for unlawful intent or gross negligence is deemed void (Art. 100(1) CO). In addition, the vast majority of scholars argue that in the context of personal injury the exclusion of liability for slight negligence is equally void.
C. State
If the conditions for claiming compensation laid out above (see answer to question 2.1) are fulfilled, there are no grounds for exclusion of liability.
On a general note, exclusion of liability (or reduction of compensation) is possible in case of self-inflicted fault of the patient or contributory negligence of a third party.
2.3 Which are the time limits for submitting a claim for compensation?
Product Liability Act
Claims based on the PLA are time-barred after three years from the date the claimant has become aware of the damage, defect of the product and identity of the manufacturer (Art. 9 PLA). In addition, there is an absolute time limit of ten years after the manufacturer has placed the defective product on the market (Art. 10 PLA).
Tort and contract law
Tort and contract based claims arising from an injury or death are subject to a relative statute of limitations of three years from the date on which the person suffering damage became aware of the damage and the identity of the person liable for it. Awareness of the damage in this context means knowledge of its approximate extent. In other words, the claimant cannot wait until the exact extent of damage becomes clear, as the three-year period may already have expired by that point. The absolute statute of limitations is twenty years after the date on which the harmful conduct took place or ceased (Art. 60(1bis) and 128a CO).
State liability for damage related to vaccination under the Epidemics Act
Claims based on the Epidemics Act must be filed within five years of the vaccination taking place or before the date on which the damaged person reaches the age of 21.
2.4 Which damages can be compensated?
Swiss law does not generally restrict or exclude compensation of specific types of damage, with the exception of punitive damages, which are not available.
In the context of personal injury, typical recoverable damages are medical expenses (e.g. rescue and recovery costs, medical and hospital treatment, costs of household help), loss of income due to inability to work, and loss of future earnings. In severe cases, moral compensation for mental suffering may be awarded. In the event of homicide of a person who was (or would have become) the main provider of other (surviving) person(s), e.g. children, the spouse, the latter may claim compensation for their loss of support (Art. 45(3) CO).
Under the Epidemics Act, moral compensation is capped at CHF 70'000. In addition, compensation is excluded for minor post-vaccinal adverse reactions such as redness, swelling or mild fever.
2.5 Is it possible to claim compensation directly to the insurance company of the damaging party?
Under current insurance law, it is not possible to claim compensation directly to the insurance company of the damaging party. However, the new Art. 60(1bis) of the Federal Law on Insurance Contracts, which will enter into force on 1 January 2022, provides the possibility to directly claim compensation against the insurance company of the damaging party.
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