Thailand Increases Liability for Drug and Device Manufacturers

In February 2009, Thailand’s “Liability for Damages Arising from Unsafe Products Act” came into effect. Drug and device manufacturers selling products in Thailand will need to be aware of the changes in the legal system. Liability of unsafe products will change drastically with this new law.

The Unsafe Products Act states that a consumer has only to demonstrate that they were harmed by the normal use or storage of a product to be able to collect damages. Also, anyone involved in the sale or import of the product is jointly liable for damages, including the manufacturer and distributor. If they are found guilty of gross negligence or marketing unsafe products while aware of their danger, responsible parties may be ordered to pay punitive damages in addition to compensation for physical and mental damage. A contract or waiver signed before damages occur does not limit the liability of the manufacturer or distributor.

In order to be found not guilty, the manufacturer and/or distributor must prove that: a) the product was not unsafe; b) the damaged party was aware that the product was unsafe, yet used it regardless; or c) the damage was a result of inappropriate product use or storage, clearly counter to the labeling or packaging instructions.

Contract manufacturers are not liable for damages if they can prove that the flaw was in the design and they were unaware of its danger. Similarly, the manufacturer of the product components is not liable if they can prove that the flaw was in the design or assembly, not in the manufacture of the components themselves.

Consumers have 3 years to sue after they learn of the damages and of the parties responsible, not exceeding 10 years after the product manufacture date.

In conjunction with the Consumer Case Procedure (CCP) enacted in August 2008, in Thailand’s new legal system, consumers have only to demonstrate that they suffered damages from the unsafe product. Consumers do not need to establish that the manufacturer or importer was at fault, so the burden of proof lies on the manufacturer to demonstrate that their product was not unsafe.