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?
	At the end of 2002, CPSC had reports of 5,239 ATV related deaths Deaths and injuries associated with all-terrain vehicles (ATVs) have shown an increasing trend in the last several years. This was an increase of 698 deaths from 2001. These additional reported deaths occurred during the years 1999 to 2002. Of these reported fatalities, about one-third were children under 16 years old. Fourteen percent were under 12.