Adverse effects of drugs and vaccines in Switzerland

1. Drug adverse effects: kinds of responsibility

1.1 Which are the main kinds of responsibility (contractual, in tort, criminal) of the following subjects with respect to adverse drugs reactions?

A. Manufacturers

Manufacturers may be liable based on the Product Liability Act ("PLA") for damage caused by defective products. The PLA provides for a strict (i.e. no fault) liability regime.

In addition, manufacturers may be liable based on general (fault-based) tort law according to Art. 41 of the Swiss Code of Obligations ("CO").

Criminal liability may arise under general criminal law (e.g. assault or homicide). Note that a company may be liable if an act or omission is not attributable to a specific natural person due to inadequate organisation of the company. 

In the context of ADR, manufacturer liability may arise in particular if the manufacturer omits to take suitable actions to prevent or minimize damage after placing the medicinal product on the market. Typical omissions include failure to comply with (regulatory) monitoring duties, such as (i) maintaining a product monitoring system on ADR, (ii) reporting newly discovered ADR to relevant bodies/ HCPs/the public (pharmacovigilance), (iii) updating product information in case of new findings and (iv) recalling products from the market. 

B. Healthcare professionals 

Liability of a healthcare professional ("HCP") depends on the legal nature of the relationship to the patient. Whereas the relationship of a privately operating HCP with a patient is usually based on a treatment contract (which falls under the category of a "simple agency contract" according to Art. 394 et seq. CO), liability of HCPs working in public hospitals is regulated by cantonal public law. Cantonal laws usually provide for full state liability with a right of recourse of the state against the employee who caused a damage while on duty.

Fault-based national tort law may apply in absence of a treatment contract with the patient, for example in medical emergencies.

In addition, a HCP may face criminal liability under the Swiss Criminal Code (for assault or homicide).

A HCP is typically liable for medical interventions or omissions, if they breached their duty to treat the patient in accordance with state of the art medical sciences. For example, Art. 26(1) of the Swiss Therapeutic Products Act ("TPA") provides that an HCP must respect the recognised rules of pharmaceutical and medical sciences when prescribing, dispensing and using a medicinal product. A HCP may therefore also face criminal liability under the TPA in case of breach of these duties (see Art. 86(1)(a) TPA).

In the context of ADR, liability may also arise when a HCP fails to inform the patient correctly and fully on the inherent risks to a medicinal product.

C. State

As mentioned above, state liability may arise in relation to HCPs working for a public health institution.

In connection with ADR, state liability may also arise (i) based on a misconduct of the national authorisation and supervisory authority for drugs and medical devices "Swissmedic" (Art. 80 TPA), or (ii) for ADR related to vaccines declared mandatory or recommended by the state, (e.g.  Covid-19 vaccines), based on Art. 64 of the Epidemics Act. For more information on state liability for vaccines, please consult the Swiss chapter of our CMS Expert Guide to Vaccine Compensation Regimes, available on our webpage.

2. Claiming compensation for damages caused by adverse drugs reactions

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.  

3. Compassionate use programmes

3.1 How would the answers above change if adverse drugs reactions occur within a compassionate use program?

The TPA distinguishes between two types of compassionate use: (i) the general use of non-authorized medicinal products against life-threatening or debilitating diseases on an unspecified number of patients (Art. 9a TPA); and (ii) the use of medicinal products (tested in ongoing clinical trials) on specific patients outside clinical trials (Art. 9b(1) TPA). The latter compassionate use in not limited to treatments of life-threatening or debilitating diseases, because an individual benefit/risk assessment for every patient is carried out first. 

For both types of compassionate use, Swissmedic may grant a temporary authorisation.

There is no specific legislation enacted in relation to liability in the context of compassionate use. However, liability regulation in the context of clinical trials provides useful guidance: According to Art. 10 of the Clinical Trials Ordinance, liability is exempted upon proof that the extent of the damage is not greater than would be expected in the current state of scientific knowledge and (i) comparable damage could also have occurred if the injured party had undergone standard therapy; or (ii) in the case of acutely life-threatening diseases for which no standard therapy exists. 

Based on that, the case can be made that lack of alternative treatment options as well as the severity of the disease may have liability-reducing effects in the context of compassionate use.   

4. Off-label use

4.1 How would the answers above change if the adverse drugs reactions occur as part of an off-label use?

There is no specific legislation enacted in relation to liability in the context of off-label use.

Under the TPA, liability of a manufacturer depends on whether the general safety expectations of the product are met (see Section 2.1 above). The circumstance that a medicinal product is used off-label must be considered as lowering safety expectations, since the manufacturer did not apply for the respective use of the product. 

However, if the manufacturer is aware of the off-label use, and the use is medically and scientifically recognised, his monitoring obligations in principle extend also to that use. In such cases, the manufacturer may be liable for off-label use that he did not oppose to. Likewise, a manufacturer may be held liable if he engaged in advertising for the off-label use. 

As for HCPs, off-label use is not per se against state of the art but occurs under the responsibility of the HCP. Special attention is required with regard to the HCPs' information duties as they must ensure that the patient has given their informed consent to the off-label use. 

5. Vaccines

5.1 How would the answers above change if the adverse drugs reactions concern a vaccine?

There is no specific legislation enacted in relation to liability in the context of vaccines, apart from Art. 64 of the Epidemics Act (please refer to Section 2.1 above and to the Swiss chapter of our CMS Expert Guide to Vaccine Compensation Regimes, available on our webpage).

5.2 Is any public indemnity/compensation provided in the case of both compulsory and not compulsory vaccination?

Yes (please refer to Section 2.1 above and to the Swiss chapter of our CMS Expert Guide to Vaccine Compensation Regimes, available on our webpage).

6. Insurance issues

6.1 Which liabilities can be insured? Is there any compulsory insurance?

Liability for personal injury based on the PLA, contract law and general tort law may be insured through a commercial or professional third-party liability insurance. 

For HCPs, third-party liability insurance is a professional obligation (see Art. 40(h) of the Medical Profession Act). 
From a patient's perspective, health and accident insurance is compulsory in Switzerland. 

7. Procedural issues (litigation)

7.1 Are there particular procedural issues to be highlighted in relation to ADR claims?

In compensation claims based on personal injury, issues may arise in connection with proving the extent of the damage and the causal link between an act/omission and the damage. Apart from that, we are not aware of any particular procedural issues in relation to ADR claims.

Portrait ofPatrick Sommer
Dr Patrick Sommer, H.E.E.
Partner
Zurich
Portrait ofHadi Mirzai
Hadi Mirzai
Senior Associate
Zurich