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Two tracks (and why they collide)
- Medical damage / malpractice pathway — focus on standard of care, indication, surgical technique, informed consent for the procedure (patient-facing guides exist on this site).
- Product liability pathway — design defect, manufacturing defect, inadequate instructions/warnings, identification of producer/seller under Product Quality Law and Civil Code product rules.
- Strategy: early dual-track evidence plan so hospital records, device UDI/lot data, and explant chain-of-custody are not lost while parties point fingers.
Burden themes & defect theories
Claimants often emphasise producer responsibility and technical opacity of implants. Defence needs lot genealogy, design history files (or China registration dossier equivalents), complaint history, and IFU/warning evolution. “Burden inversion” rhetoric in Chinese practitioner search should be translated into concrete dossier readiness—not slogans.
Appraisal (鉴定) strategy
Judicial or medical damage appraisal can dominate outcomes. Fight the question presented: technique error vs product defect vs patient factor. Preserve the explant, packaging, and implant card; control unauthorised destructive testing; consider parallel technical expert work product under counsel direction.
Mass & batch events
Field actions and complaint clusters create multi-plaintiff risk and regulator attention. Coordinate: vigilance reporting, recall/field safety corrective action, media, and litigation holds. Do not let commercial “quiet replacements” create inconsistent admissions. Recall backbone: manufacturer recall guide.
Hospital claims after recall / returns
Hospitals and distributors may claim refund, replacement, inventory loss, or reputation damage. Contractual quality agreements and distribution terms decide more than tort theory—update them before the crisis (see distribution orientation).
Defence checklist for MAHs / importers
- UDI/lot traceability drill—can you identify implanted patients within days?
- IFU and training materials version control in Chinese.
- Complaint-to-vigilance decision tree with legal sign-off.
- Insurance notice (product liability and clinical trial if investigational).
- Counsel for both civil claims and administrative recall interfaces.
Related
Product liability law guide · Drug labeling & ADR · Product liability lawyers
FAQ · 高频检索问题
Chinese long-tail intents mapped to this guide (orientation only).
植入物断裂是医疗损害还是产品责任？
厂家举证责任倒置如何理解？
批量损害如何应对群体性纠纷？
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