August means vacation time in the law business. Still, vacation does not mean (to some of us, anyway) forgetting about drugs and devices altogether. With that in mind, here are a couple of items of interest for summer reading − one’s fairly long; the other fairly short.
The long one that we recommend reading is
While we’re still sitting around waiting for the Second Circuit to decide Caronia, we though we’d pass along a new article on the First Amendment and the FDA’s restrictions on off-label use. It’s by Kyle Thompson, a law student at BU, and it’s titled “The Changing Landscape of the Commercial Speech Doctrine and FDA
While we’re all waiting for the Second Circuit to decide the Caronia case – and, we hope, hold that the FDA’s prohibiting the truthful promotion of off-label use violates the First Amendment – we’d like to pass along some light reading. The current issue of Health Matrix, published by the Case Western Reserve Law
A lot of people think that Ronald Reagan won the presidency in 1980 in his first debate when he replied jokingly “there you go again” to then-President Carter’s attempt to portray him as some sort of rightwing nut intent upon destroying accepted government programs like Medicare.
Whether one believes that President Reagan’s election was a good thing or a bad thing, there’s no denying that his disarming line was effective in dispelling his opponent’s attempt to sow fear of his then unknown policies.
We’ve confronted similar situations ourselves as, periodically, some law review article or another decides to tilt at the windmill of FDA regulatory informed consent claims in off-label use cases. Bexis dealt with that topic in a law review article he wrote long before he wised up and started blogging. Beck & Azari, “FDA, Off-Label Use, and Informed Consent: Debunking Myths and Misconceptions,” 53 Food & Drug L.J. 71 (1998) (available here).
Here on the blog, we addressed this topic back in 2007, critiquing an article that advocated informed consent suits against doctors for not discussing the non-FDA-approved status of off-label use, essentially as a means of indirectly punishing drug companies for allegedly promoting such uses too effectively.Continue Reading There They Go Again
A recent law review note, Kristie Lasalle, “A Prescription for Change: Citizens United‘s Implications for Regulation of Off-Label Promotion of Prescription Pharmaceuticals, 19 J. L. & Pol’y 867 (2011), copy here, puts an interesting twist on the First Amendment arguments against the FDA’s ban against truthful promotion of off-label use. It analogizes between
Catherine Sharkey, one of the leading academic commentators on preemption in the administrative context, has released a new article on the subject, entitled “Inside Agency Preemption.” The Sharkey article has a broad scope, and includes a proposal for a state notification procedure for preemption similar to that process outlined for AG notification in the Class
We’ve found something quite rare – a balanced law review article on TwIqbal. It’s called Iqbal “Plausibility in Pharmaceutical and Medical Device Litigation,” 71 La. L.R. 541 (Winter 2011), and it’s by Prof. William Janssen (we don’t think there’s any connection to Janssen Pharmaceuticals of Oxycontin fame, but we don’t know for sure one
Everybody knows the excuses that courts use to justify imposing – and expanding – product liability: (1) It induces the manufacture of safer products; (2) it causes the prices of products to reflect their “true” cost by internalizing risk; (3) victims will be compensated for their losses. Courts say these things all the time, but
The New England Journal of Medicine bills itself as “the world’s most influential medical journal,” and it unquestionably publishes groundbreaking articles about medicine. But all too often in recent years the NEJM has strayed from what it knows — medicine – into what it doesn’t – law and public policy, particularly tort policy. No longer
Richard Nagareda, law professor at Vanderbilt, is a really smart guy. Bexis got to know him while Professor Nagareda was one of the Reporters for ALI’s Aggregate Litigation Principles Project and Bexis was a defense-oriented gadfly on the Members’ Consultative Group for that project.
Anyway, they kept in touch, and he’s given us a sneak