Too Bad Its Unpublished

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A reader recently recommended that we take a look at Rounds v. Genzyme Corp., ___ Fed. Appx. ___, 2011 WL 3925353, slip op. (11th Cir. Sept. 8, 2011) (applying Florida law), even though it’s unpublished. We’d blogged about this case when the district court first dismissed it, but we confess we’ve missed the affirmance because our online check of Eleventh Circuit opinions only brings up opinions that are intended to be published. So we took a look, and we have to say we wish this opinion had been published. It addresses some interesting issues.

For one thing Rounds involves a biologic product, not a drug or medical device. That shouldn’t make a legal difference, but plaintiffs (such as Ms. Rounds) occasionally argue that it does. In a footnote the court observed that, for purposes of the learned intermediary rule, drug/device/whatever makes no difference. As long as it's a prescription-only product, the learned intermediary rule applies, whether it’s a drug, a device, or anything else:

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