Product Liability News

Orphan drugs: the question of products liability

Orphan drugs, essential for the treatment of persons with rare diseases, generally are unprofitable for manufacturers to develop and market. While congressional and administrative efforts to promote the development of orphan drugs have met with modest success, application of products liability doctrine to orphan drug sponsors could subvert those efforts. This Note describes the provisions of the Orphan Drug Act and analyzes products liability law with respect to orphan drug litigation. It argues that the goals of tort law support the imposition of liability for design defect, failure to warn and negligence in testing. Finally, the Note acknowledges that liability costs create disincentives for orphan drug development and suggests mechanisms for reducing manufacturers' liability concerns.

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	Did You Know?
	In 2002, there were an estimated 212,400 toy-related injuries The individual body parts having the most injuries overall were faces (45,400), heads (27,100) and mouths (16,200). Lacerations, contusions, and abrasions were involved in over half of the total injuries (53%). CPSC has reports of 13 children who died in toy-related deaths in 2002.