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?
	2.2 million “SMC” brand oscillating floor fans can be dangerous Floor fans by SMC Marketing Corp. and Home Depot U.S.A., Inc. The recall includes 18-inch, pedestal floor fans with model number SR-18 or SP-18. The damage to the cord can result in a short circuit and possible ignition of the plastic case, posing a fire hazard. CPSC is aware of 31 incidents in which the cord on these fans was damaged, which resulted in smoke and fires. At least nine of these incidents resulted in substantial property damage.