| Summary: | 碩士 === 輔仁大學 === 財經法律學系碩士班 === 101 === Drugs possess the function of diagnosis, treatment, mitigation, prevention of disease, or affect the structure or any function of the body of humans according to the definition of drugs. Therefore the purpose of using drugs is to diagnose, cure, mitigate, or prevent disease and the subject is to alleviate the pain incurred by malady. If the use of drugs results in severe disability or death instead, it is absolutely not the outcome envisioned in the beginning. Once adverse drug events happen, victims and their families should find out who is liable besides the reasons and the solutions of the events. The liable one for the damage caused by drugs should compensate the drug users. As a result, to ascertain the liabilities of the obligors becomes very significant.
The drugs in this article are restricted to legal drugs which are rigorously approved by the Food and Drug Administration and sold in the market. But those drugs still have the potential dangers not discovered in clinical trials. Rigorous administrative management cannot eliminate the occurrence of adverse drug reaction. The reporting cases of adverse drug reaction increase annually according to the statistics by the National Reporting System of Adverse Drug Reactions in Taiwan. Consequently not all of the legal drugs are safe. Adverse drug reaction in this article is defined as “a response to a drug that is noxious and unintended and occurs at doses normally used in man for the prophylaxis, diagnosis or therapy of disease, or for modification of physiological function” according to the WHO’s definition. I discuss proper use of drugs which results in adverse drug reaction other than medication errors by the medical staff. Who should be liable for the consumers whom take medicine for treatment but induce unintended damage? The pharmaceutical entities on the chain of distribution, such as pharmaceuticals, pharmacies, and hospitals, are researched in this article.
Drugs are commodities manufactured by pharmaceuticals and sold in the market, and therefore the damage caused by those commodities could be applicable to the new developed type of torts –product liability. Pharmaceuticals could be sued for this liability frequently because of the status of producers. However, the function of drugs is treatment and prevention of disease, which is highly involved in livelihood of the public. On the other hand pharmacological mechanism incurs the side effect, making drugs unavoidably unsafe. Such features have drugs differ from other commodities, which let me think about what problem will occur if drugs are applicable of strict liability. How do the foreign regulations and precedents deal with drugs, and are the civil laws regarding product liability in our country enough for these special products like drugs? This article is intended to focus on product liability and compare with the laws of America, Germany, and Japan. Firstly I discuss the development of product liability which evolve with social change and decisions; secondly I explore the claims concerning contractual liability, tort liability, and product liability, and among them strict liability remains the most favorable to victims, which is alleged frequently in lawsuits. Finally I conclude the difference of drug product liability from ordinary product liability owing to the feature of drugs, review whether the regulations of our country are enough for drugs and what problem will have if the courts decide in accordance with the existing law, and recommend how to improve.
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