Legal Liability for Adverse Drug Reactions
Adverse drug reactions refer to harmful reactions that occur under normal usage and dosage of qualified drugs that are unrelated to the intended use of the drug or unexpected. Every medicine is three parts toxic, and adverse reactions to drugs have been accompanying them since their inception. The National Adverse Drug Reaction Monitoring Center recently released the "National Adverse Drug Reaction Monitoring Annual Report", which shows that in 2023, the National Adverse Drug Reaction Monitoring Network received a total of 2.419 million copies of the "Drug Adverse Reaction/Event Report Form". From 1999 to 2023, the National Adverse Drug Reaction Monitoring Network received a total of 23.275 million copies of the "Drug Adverse Reaction/Event Report Form". China has a sound system for reporting and monitoring adverse drug reactions, but currently there is no compensation/relief system for adverse drug reactions. In judicial practice, pharmaceutical companies, medical institutions, and other profit-making entities involved in cases need to bear responsibility for adverse drug reactions in the following situations:
1. For adverse reactions listed in drug instructions, the court considers them to be serious adverse reactions, and drug manufacturers, medical institutions, and other profit-making entities involved in the case need to jointly bear no fault liability
Article 1186 of the Civil Code stipulates that in the absence of a fault party, all parties shall fairly share the losses. In the civil judgment of Ezhou Intermediate People's Court in Hubei Province (2018) E07MinZai No. 8, the court held that the adverse reactions listed in the drug instructions were not defects of the drug or the fault of the manufacturer; In the case of serious adverse reactions to drugs, even if there is no fault, based on the principle of fairness, all profit-making entities (drug manufacturers, drug sellers, and medical institutions) should bear equal liability for damages compensation.
2. For adverse reactions that have not been notified in advance, drug manufacturers and medical institutions may need to bear fault liability based on the actual situation of the case
In the civil judgment (2018) Jin 01 Min Zhong 1007 issued by the Intermediate People's Court of Taiyuan City, Shanxi Province, the court held that after the occurrence of adverse reactions not listed in the drug instructions, the drug manufacturer did not report to the drug regulatory bureau in accordance with the law, and before the occurrence of adverse reactions not listed in the drug instructions, there were relevant literature and research discussions on related adverse reaction cases. As a professional pharmaceutical enterprise, one should be aware of the importance of the adverse reaction reporting system for drug production, revision of drug instructions, and drug use, and should fulfill strict reporting obligations. Drug manufacturers who conceal or fail to report their behavior have obvious faults, and medical institutions should bear corresponding compensation responsibilities for the losses caused to the victims based on their respective degrees of fault.
In addition to the aforementioned two situations, for adverse reactions that are unknown to all parties involved in the case, if the court considers them to be serious adverse reactions, drug manufacturers, medical institutions, and other profit-making entities involved in the case may also need to bear no fault liability in accordance with Article 1186 of the Civil Code.
