Case Description

In December 2022, Du was admitted to the hospital due to a broken internal fixation plate implanted after a fracture surgery. After discharge, Du sued the hospital and the manufacturer of internal fixation steel plates to the court, demanding that they bear the responsibility for medical product defects. Due to the inability of existing evidence to prove the defects of the internal fixation steel plate, Du originally intended to apply for judicial appraisal to determine whether the internal fixation steel plate had defects. However, considering that the judicial appraisal fees would need to be paid by the applicant, Du was not well-off and faced a dilemma.

Lawyer Analysis

Product defect liability is non fault liability. For general product defect liability, the plaintiff needs to prove that: ① the product has defects; ② There is personal injury and/or property loss; ③ There is a causal relationship between product defects and the consequences of damage.

For medical product defect liability, Article 1223 of the Civil Code stipulates that: If damage is caused to patients due to defects in drugs, disinfection products, medical devices, or the importation of substandard blood, patients may request compensation from drug marketing license holders, producers, or blood supply institutions, or from medical institutions. If patients request compensation from medical institutions, medical institutions have the right to recover compensation from responsible drug marketing license holders, producers, or blood supply institutions after compensation Article 7 of the Interpretation of the Supreme People's Court on Several Issues Concerning the Application of Law in the Trial of Medical Injury Liability Disputes (Revised in 2020) stipulates that: If a patient requests compensation in accordance with Article 1223 of the Civil Code, they shall submit evidence of the use of medical products or the importation of blood or the damage suffered. If a patient is unable to submit evidence of the causal relationship between the use of medical products or the importation of blood and the damage, and applies for appraisal in accordance with the law, the people's court shall allow it. Medical institutions, producers, sellers of medical products, holders of drug marketing licenses, or blood providers If the institution advocates not to bear responsibility, it shall bear the burden of proof for the defense reasons such as the absence of defects or qualified blood in the medical product From this, it can be seen that for liability for defects in medical products, the plaintiff only needs to prove: ① the use of medical products; ② There are consequences of damage; ③ There is a causal relationship between the use of medical products and the consequences of damage. The plaintiff does not need to prove that the medical product has defects, and the medical device manufacturer, seller, and hospital are responsible for proving that the medical product does not have defects.

In the Civil Judgment No. 2304 of the Intermediate People's Court of Jiangmen City, Guangdong Province (2018), as neither the plaintiff nor the defendant applied for judicial appraisal of whether the medical device product was defective, the court required the medical device manufacturer to bear the responsibility of failing to provide evidence to prove that the medical device product was defect free, presuming that the medical device product was defective, and thus requiring the medical device manufacturer to bear the responsibility for medical product defects.

Therefore, Du does not need to apply for judicial appraisal on whether the internal fixation plate has defects, only to prove: ① After the first fracture, the hospital implanted the internal fixation plate in his body; ② Second fracture; ③ After the first fracture, there is a causal relationship between the internal fixation plate implanted in the hospital and the second fracture. Medical device manufacturers have the obligation to prove that their internal fixation steel plates are free from defects, otherwise they will be responsible for medical product defects.