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The test for determining whether a state law claim is impliedly preempted is whether or not the claim would exist in the absence of the FDCA.

Rarely do we drug and device law bloggers read such a pleasing sentence.  It’s lyrical.  It reads like romance language.  Well, at least to us it does.  The opening

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Here’s a preemption case that we’ll likely have an opportunity continue to follow.  A magistrate in North Carolina federal court recently issued a report recommending dismissal, on the basis of preemption, of product liability claims concerning the product Gelfoam.  Bradley v. Baxter Healthcare Corp., 2013 U.S. Dist. LEXIS 158935 (W.D.N.C. Oct. 18, 2013).  Gelfoam

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We talk a lot about the learned intermediary doctrine.  It’s rooted in the reality of the physician-patient relationship.  Patients gain access to prescription drugs only through doctors who have the expertise to understand and weigh the risks and benefits of the drugs.  The learned intermediary doctrine, accordingly, says that pharmaceutical companies’ duty is to warn

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When Bexis got back from hiking the Milford Track and doing all sorts of other ridiculously strenuous things in New Zealand, a friend of his from the Tar Heel State had sent along a new decision by a local appellate court rejecting medical monitoring where the plaintiff had no present injury. Our readers know we