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How the Fifty States View Electronic Data as a “Product”

Drug & Device Law

We have blogged several times about the somewhat esoteric issue of whether intangible items – chiefly computer software, website algorithms, and other electronic information – is treated as a “product” for purposes of imposing strict liability on their creators. So far, the would-be liability expanders haven’t done very well. 1145, 1165 n.135

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Criticizing FDA Reporting Systems Should Not Be Enough To Plead A Warnings Claim

Drug & Device Law

This is part of why rates, and particularly comparative rates, provide more useful information about devices and surgeries than do gross numbers. Even more authoritative sources than this Blog agree with us. Even more authoritative sources than this Blog agree with us.

FDA 59