Headcount II: The Learned Intermediary Rule And Medical Devices

Our post last month about Breen v. Synthes-Stratec, Inc., 947 A.2d 383 (Conn. App. 2008), got us thinking (always dangerous) about medical devices and the learned intermediary rule. Is there any valid reason why the learned intermediary rule shouldn’t apply to medical devices where it also applies to prescription drugs?Well, we thought about that question for a while – maybe all of fifteen minutes – and we couldn’t think of any generally valid distinction. Perhaps a peculiar statute, but nothing grounded in the rationale of the rule came to mind. After all, as we discussed in our long post about the learned intermediary rule, there are really only two prerequisites for its application: (1) the product must be available only by a physician’s prescription, and (2) it must actually have been prescribed in the context of a... [read full story]