• Login
    View Item 
    •   Home
    • Yale
    • Yale Journal of Health Policy, Law, and Ethics
    • View Item
    •   Home
    • Yale
    • Yale Journal of Health Policy, Law, and Ethics
    • View Item
    JavaScript is disabled for your browser. Some features of this site may not work without it.

    Browse

    All of openYLSCommunitiesPublication DateAuthorsTitlesSubjectsThis CollectionPublication DateAuthorsTitlesSubjects

    My Account

    LoginRegister

    Statistics

    Display statistics

    The FDA and the Tort System: Postmarketing Surveillance, Compensation, and the Role of Litigation

    • CSV
    • RefMan
    • EndNote
    • BibTex
    • RefWorks
    Thumbnail
    Name:
    27_5YaleJHealthPolyL_Ethics587 ...
    Size:
    5.255Mb
    Format:
    PDF
    Download
    Author
    Struve, Catherine
    
    Metadata
    Show full item record
    URI
    http://hdl.handle.net/20.500.13051/6059
    Abstract
    Both the tort system and the FDA seek to protect consumers of medical products. The tort system provides compensation when a consumer is harmed by a defective product and sets incentives for companies to design safer products. The FDA imposes an elaborate system of prior restraint: Pharmaceuticals and some medical devices must undergo extensive testing and stringent risk/benefit analysis before the FDA will approve them for marketing. Formerly, the FDA viewed its risk/benefit analysis as setting a floor but not a ceiling for product safety: FDA-approved products could be marketed, but the manufacturer might still incur liability if a court later decided that a product was defective or a warning was inadequate. This view has changed in recent years, however, as policymakers have stressed the need to bring innovative medical treatments to market. Some now argue that the FDA review process should set both a floor and a ceiling: FDA approval of a new product indicates not only that the product can be marketed, but that it should be; FDA rejection of a proposed product warning means not only that the warning is unnecessary, but that it could be counterproductive.
    Collections
    Yale Journal of Health Policy, Law, and Ethics

    entitlement

     
    DSpace software (copyright © 2002 - 2023)  DuraSpace
    Quick Guide | Contact Us
    Open Repository is a service operated by 
    Atmire NV
     

    Export search results

    The export option will allow you to export the current search results of the entered query to a file. Different formats are available for download. To export the items, click on the button corresponding with the preferred download format.

    By default, clicking on the export buttons will result in a download of the allowed maximum amount of items.

    To select a subset of the search results, click "Selective Export" button and make a selection of the items you want to export. The amount of items that can be exported at once is similarly restricted as the full export.

    After making a selection, click one of the export format buttons. The amount of items that will be exported is indicated in the bubble next to export format.