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August 16, 2004


Double Hurdles

Both an op-ed in the LA Times and Alex Tabarrok bemoan the lack of a safe harbor for industries that have to comply with extensive regulations before releasing a product; even getting expensive and time-consuming certification from the FDA that a drug is "safe and effective" won't protect a manufacturer from lawsuits claiming that the product is unreasonably dangerous on flimsy evidence. Such protection exists for medical devices (as opposed to drugs) under federal law, though some courts' narrow view of pre-emption law permit suits to go forward anyway. (Henry I. Miller, "There's a Cure for Frivolous Drug Lawsuits", LA Times, Aug. 16; Alex Tabarrok, Marginal Revolution blog, Jul. 27; Shannon P. Duffy, "FDA's Approval of Medical Device Bars Products Suit", Legal Intelligencer, Jul. 22; see also this site, Jul. 26 and Jul. 26; Overlawyered, Jul. 14 and links therein).

Posted by Ted Frank at 11:44 AM | TrackBack (1)



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