All legal aspects surrounding product liability in Japanese Pharma. Prepared in association with Nishimura & Asahi, a leading law firm in Japan, this is an extract from The Pharma Legal Handbook: Japan, available to purchase here for USD 99.

1. What types of liability are recognized in your jurisdiction?

Liability under contract and liability under tort law are two basic civil liabilities. The liability under tort law, in principle, requires intention or negligence. However, there is a Product Liability Law, under which liability arises without negligence if a defect is found in a product.

2. How do these types of liabilities apply to the manufacturers of medicines and devices?

All of the above apply to the manufacturers of medicines and medical devices.

3. Does potential liability extend to the manufacturer only or could claims extend to corporate executives, employees, and representatives?

In principle, the product liability extends to the manufacturer. However, theoretically, a person who conducted themeslves willfully or under negligence may be liable under the tort law.

4. How can a liability claim be brought?

A liability claim shall be brought through courts that have jurisdiction.

5. What defenses are available?

The plaintiff owes the burden of proof in the lawsuit, and any defense under civil procedure is available for the defendant. Under the Product Liability Law, defense of development risks is applicable to the defendant, but practically, the standard of the defense of development risk is strict and not accepted at the court.