Enactment of Product Liability Law and Measures Taken for It by the Japanese Pharmaceutical Industry

摘要

Many large product liability (PL) cases in Japan have been related to adverse drug reactions. The main cases are as mentioned in Table 1 and have been resolved by amicable settlements. The Japanese pharmaceutical industry has therefore taken various measures for assuring the safety of medicine and preventing adverse drug reactions for the last several decades. Compared with other consumer products, medicine has the following special features. We must take into account these special features when we consider the liability for adverse drug reaction.