- Pharma and MedTech manufacturers and importers managing product-liability exposure
- Companies coordinating recalls or field-safety corrective actions (FSCAs)
- Defendants in product-liability claims
Product liability
GAWEL Legal advises pharma and MedTech companies on product-liability exposure under the PrHG and the OR and defends claims brought against them. The work covers liability allocation across the supply chain, recall and field-safety-corrective-action coordination, and claims defense, which runs on a capped retainer across related claims; advice is billed by time and litigation is priced per matter.
- Manufacturer
- Product-liability exposure
- Importer and supplier
- Recourse and indemnity terms
- Claims and recalls
- Legal coordination and defense
Advice on liability under the PrHG and OR
Who this is for
Scope
- Liability risk assessment:mapping the exposure that follows from producer liability for defective products (Art. 1 PrHG) together with the contractual and tort rules of the OR that run alongside it
- EU product liability:exposure under the national laws transposing the revised Product Liability Directive, which apply to products placed on the market or put into service after 9 December 2026 (Art. 2(1) and Art. 22(1) of Directive (EU) 2024/2853)
- Supply-chain allocation:structuring who bears which risk between manufacturer, importer and supplier, the persons the PrHG treats as producer (Art. 2 PrHG), through recourse and indemnity clauses in the supply and distribution contracts
- Statutory defenses:positioning the documentation and evidence for the exceptions from liability (Art. 5 PrHG), including the development-risk defense that the defect could not have been recognized by the state of science and technology when the product was placed on the market
- Recall and FSCA coordination:the legal side of recalls and field-safety corrective actions (communications, documentation and liability posture), run alongside the client's regulatory and quality teams
- Claims defense:defending product-liability claims on a capped retainer across related claims, with litigation priced per matter
- Prevention:using findings from claims and near-misses to review contracts, instructions and warnings
How the work proceeds
- Risk review The assessment covers product-liability exposure across the supply chain and contracts.
- Allocation Liability is allocated between manufacturer, importer and distributors in the contractual arrangements.
- Recall / FSCA The legal side of recalls and field-safety corrective actions is coordinated.
- Defense The defense of a claim runs on a capped retainer; litigation is priced per matter.
- Prevention The findings inform a review of contracts and documentation.
Fees
Advice by time; capped defense retainer
Advice is billed by time; the defense of a claim runs on a capped retainer across related claims; litigation is priced per matter.
Questions
- What law governs product liability in Switzerland?
- Swiss product liability rests principally on the PrHG, which establishes liability for damage caused by defective products (Art. 1 PrHG), alongside the general contractual and tort rules of the OR. GAWEL Legal works from both.
- Who is liable along the supply chain?
- Liability can attach to manufacturers, importers and, in defined circumstances, suppliers (Art. 2 PrHG). How it is allocated between them depends on the PrHG framework and on the contracts in place, which is why liability allocation and contract drafting are part of the advisory work, not just claims defense.
- How does GAWEL Legal support a recall or FSCA?
- A recall or field-safety corrective action has both a regulatory and a liability dimension. GAWEL Legal coordinates the legal side (communications, documentation and liability posture) alongside the client's regulatory and quality teams so the response is consistent.
- Can product liability be excluded or capped by contract?
- Not toward the injured person: agreements that limit or exclude liability under the PrHG vis-à-vis the injured party are void (Art. 8 PrHG). What can be shaped by contract is the allocation between the commercial parties in the supply chain, through recourse and indemnity clauses between manufacturer, importer and distributors.
Related articles
- The EU Product Liability Directive Lands on US Pharma Supply Chains: Strict Liability, Presumed Defects, and a 25-Year Tail
- Pharma Supply Chain Liability: When Contracts Meet Reality
- Three Regimes, One Supply Chain: Life Sciences Due Diligence Under the CSDDD, the LkSG and the Draft Swiss NUFG
- NIS2 for Connected Medical Devices: Cybersecurity Requirements and Implications
- Software as a Medical Device (SaMD): Classification Pitfalls in Switzerland and the EU
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