[Direct answer]In the Beijing area, the burden of proof for harm caused by defective medical products is, in principle, borne by the patient (the infringed party), who must provide initial proof, while the producer bears the liability for tort without fault. According to Article 1202 of the Civil Code of the People's Republic of China, if a product defect causes harm to others, the producer shall bear tort liability; Article 1203 grants the infringed party the right to choose to claim compensation from the producer or seller. The patient needs to prove that he/she has used the medical product, suffered harm, and that there is a causal relationship between the defect and the harm. If the producer claims exemption from liability, he/she must provide evidence of the statutory grounds for exemption from liability. It is recommended to seal the medical records and product packaging, keep the purchase receipts, and, if necessary, apply for product quality appraisal and medical harm appraisal. For more details, please refer to the following link:Legal services for personal injury and medical disputes.

1. Problem background and typical scenarios

Medical product defects often cause harm during clinical use, with typical scenarios including: patients developing infections, rejection reactions, or fractures after implanting medical devices, suspecting product quality issues; experiencing serious adverse reactions after using defective drugs; harm caused by transfusion or use of unqualified medical devices; and personal injury caused by using unqualified products in cosmetic surgery. Many patients mistakenly believe that "whoever suffers the harm is in the right", but they are not aware that they need to prove the existence of product defects and causality, which leads to obstacles in protecting their rights. Such disputes are often intertwined with medical treatment behaviors, and distinguishing whether it is a product defect or medical negligence directly affects the determination of the defendant and the principle of liability. For cases involving personal injury identification, it can be combined with other evidence to determine the cause of the injury.Personal injury and medical dispute servicesCoordinated assessment.

II. Key points of contention

The focus of disputes in such cases centers on four points. Firstly, the determination of defects: whether the product meets national or industry standards, or whether there are unreasonable dangers that endanger personal safety. Secondly, the causality: whether the damage is caused by product defects or due to individual physical conditions or medical treatment. This is a difficult point to prove. Thirdly, the attribution of liability and exemption from liability: the producer bears no-fault liability, but can defend against legal grounds such as not putting the product into circulation, the defect not existing at the time of circulation, or the technological level at that time not being able to detect the defect. Fourthly, the choice of compensation subject: the infringed party may request compensation from either the producer or the seller, or claim joint and several liability from both parties. In the case of subsequent recourse, it can be connected to the next step.Creditor-debtor relations and enforcement case services.

III. Professional analysis by Hengluo Lawyers

Based on practical observations in handling medical product liability cases, the key to winning or losing such disputes lies in "evidence and appraisal". According to Articles 1202 and 1203 of the Civil Code, producers and sellers bear no-fault liability, and patients do not need to prove the producer's fault, but they still need to provide preliminary evidence of the use facts, damage consequences, and causality. In practice, the proof of causality highly depends on product quality appraisal and medical damage appraisal. If the application for appraisal is not timely or the evidence is lost, it will directly lead to a loss of the case. Hengluo Lawyers usually suggest: Firstly, immediately seal the medical records, product packaging, and original items, fix the purchase receipts, and apply for appraisal in the litigation according to the Civil Procedure Law of the People's Republic of China to transform the abstract causality into a credible conclusion. For cases involving enterprise product compliance, it can be followed up accordingly.Intellectual property protection and corporate legal services.

IV. Practical suggestions and legal basis

The legal basis is Article 1202 of the Civil Code (effective January 1, 2021) (liability of producers without fault), Article 1203 (the right of the infringed person to request compensation from the producer or seller at his discretion), Article 1204 (recourse) and Article 1205 (grounds for exemption from liability of producers); the supporting "Interpretation of the Supreme People's Court on Several Issues Concerning the Application of Law in the Trials of Medical Damage Liability Disputes" (promulgated on December 13, 2017 and amended on December 23, 2020) regarding the rules of evidence for medical product liability, as well as the "Drug Administration Law of the People's Republic of China" (effective December 1, 2019) and the "Regulations on the Supervision and Management of Medical Devices". Practical suggestions: Seal the medical records and the actual products after the incident, and keep the purchase receipts; clarify the types of defects and the causality of the damage; apply for product quality and medical damage appraisals in a timely manner; select the defendants and claim compensation. For cross-regional rights protection, it can be combined with other legal provisions.Special services and other case servicesAdvance.

5. Hengluo Law Firm's Advice

When seeking legal redress for defective medical products, it is crucial not to "sue and settle the matter once and for all". First, it is necessary to clarify whether the defect lies in the product or in the medical negligence, as this determines the defendant and the liability apportionment. Regarding evidence, it is important to seal the medical records, the original product, and the purchase receipts to prevent the loss of evidence. The causality must be proven through expert appraisal, rather than relying on unsubstantiated claims. At the same time, attention should be paid to the statute of limitations—for claims for compensation arising from bodily harm, the statute of limitations is three years, calculated from the date when the claimant knows or should have known that their rights have been infringed and the identity of the obligee. It is recommended to consult a professional lawyer as soon as possible to secure evidence and choose the appropriate legal path to avoid losing the case due to insufficient evidence. For cases involving contracts and product quality, relevant provisions can be referred to for guidance.Business and contract dispute services for enterprises.

VI. Frequently Asked Questions

Q1: In cases of defective medical products, is there a high probability of patients winning the lawsuit?

The success of the lawsuit does not depend on a promise of the outcome, but on whether the evidence is in place. According to Articles 1202 and 1203 of the Civil Code, producers and sellers bear no-fault liability, so patients do not need to prove the producers' fault, which is more advantageous than general infringement cases. However, patients still need to provide preliminary evidence of the use of the product, the harm caused, and the causal relationship. In practice, the key to winning the lawsuit lies in appraisal: product quality appraisal to confirm the defects, and medical damage appraisal to confirm the causality. If both are available, the probability of winning compensation will be significantly increased. If the product does not have defects or the harm is caused by the patient's own disease or medical treatment, it will be difficult to gain support. It is recommended to first preserve the evidence and then evaluate it, and never believe in unrealistic promises of winning the lawsuit.

Q2: When suing for defects in medical products, what evidence do I need to prepare?

The core evidence includes: medical records and treatment records (to prove that the damage occurred after using the product), the actual product or packaging labels (to prove the product's source and the characteristics of the defect), purchase receipts or invoices (to prove the sales relationship), records of the use process and adverse reaction materials, as well as opinions on product quality assessment and medical damage assessment. The organization of evidence should focus on the three points of "using the product - occurrence of damage - causality between the defect and the damage". The evidence must be sealed as soon as possible to avoid being consumed or lost. If the materials are insufficient, the court can be requested to retrieve them or an appraisal can be commissioned. It is not advisable to give up the claim just because the evidence is weak.

Q3: What are the approximate legal fees and litigation costs for this type of lawsuit?

The litigation fees shall be paid in accordance with the "Measures for the Payment of Litigation Costs", with the amount of the litigation request as the base for cumulative payment in stages. The losing party shall bear the fees, and in cases where the plaintiff partially wins and partially loses, the fees shall be shared proportionally. Lawyer's fees are related to the complexity of the case, the amount of the subject matter, and the lawyer's qualifications. They can be charged on a per-case, hourly, or percentage-of-the-subject-matter basis, subject to the terms of the retainer agreement. There is no unified government pricing for these fees. Medical product defect cases often involve appraisal fees, which must be included in the cost calculation. It is recommended to clarify the fee charging method and upper limit with the law firm before entrusting the case, and to start the litigation after weighing the benefits and costs to avoid making small-amount disputes uneconomical due to high costs.

Q4: How long does it usually take to litigate a lawsuit over defects in medical products?

The timeframe depends on the pace of the proceedings and the appraisal process. In ordinary first-instance proceedings, the case is typically concluded within six months, and in summary proceedings, it is concluded within three months; however, such cases often require two appraisals - product quality and medical damage - and the appraisal period may last several months, prolonging the overall process. If the defendant appeals, the second-instance proceedings typically take three months. After the judgment takes effect, if the other party refuses to perform its obligations, it is necessary to apply for enforcement. Overall, simple cases may take more than half a year from filing to collecting the payment, and complex cases may take even longer. It is recommended to apply for evidence preservation and property preservation simultaneously during the litigation to prevent the loss of evidence or the transfer of assets by the liable party.

Q5: If I find a suspected product defect, what should I do first?

It is recommended to proceed in four steps: First, immediately stop using the suspected defective products, seal the original products, packaging, instructions, and remaining parts, and take photos and videos to fix the status; Second, copy and seal all medical records and treatment records, and have them stamped and confirmed by the medical institution; Third, keep the purchase receipts, invoices, and communication records, and identify the information of the sellers and producers; Fourth, consult professional lawyers as soon as possible to assess whether there are defects and causal clues, and apply for appraisal and file a lawsuit within the statute of limitations. Throughout the process, keep all communication records and do not discard the product inspection materials without authorization, so as not to lose key evidence bases.

The above answer is based on the judicial practice in Beijing. The adjudicative opinions in other provinces and cities may vary. For specific cases, please refer to the local rules and evidence situations.

If you are facing similar problems, it is recommended that you consult a professional lawyer as soon as possible with the relevant evidence materials, so as to avoid missing the statutory time limit.Personal injury legal services·Beijing Hengluo Law Firm

Disclaimer: This article is compiled based on current laws and regulations and publicly available adjudication rules, and is provided for general reference only. It does not constitute formal legal advice for specific cases. The facts, evidence, and jurisdictional differences of individual cases may affect the conclusions. In the event of a dispute, please consult a practicing lawyer promptly.