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

We recently took an ivory tower tour to see what academics were saying about Twombly/Iqbal. Not surprisingly, we found more disapproval than approval, and more complexity than clarity. One law review article, Effron, “The Plaintiff Neutrality Principle: Pleading Complex Litigation in the Era of Twombly and Iqbal,” 51 Wm & Mary L. Rev. 1997 (2010) (hereinafter “Effron“), quotes us on the applicability of Twombly/Iqbal to MDL master complaints.

First, thanks for noticing, Professor. We’re glad to see folks in the academy pay some attention to what actual practitioners think about the prominent legal issues of the day. Second, while we find parts of the article to be closely-reasoned and creative, we think the idea of narrowing Twombly/Iqbal to make the plausibility requirement more palatable is like saying half a loaf is better than none. Right now, we still think we’re entitled to the whole loaf.

Let’s start with the title of the article, focusing on that “Neutrality” word. Our business is advocacy. From where we stand, there isn’t much neutrality in sight. We argue for our client’s positions and cite to “neutral” principles when they are helpful and convenient. Plaintiff lawyers do likewise. Why? Courts necessarily say they like neutrality. When we were in law school in the Pleistocene era (well before the “Era of Twombly and Iqbal“), we were compelled to read a lecture by Columbia law professor Herbert Wechsler titled “Toward Neutral Principles of Constitutional Law.” It’s been a long time since we thought about that lecture.

Neutrality is a tool that takes one only so far. Kant and Rawls built entire philosophies around the concept of neutrality. What’s the categorical imperative but a mental exercise where you pretend you might be any random member of society before deciding how you’d like a certain set of arrangements? But it’s a strange, counterfactual mind-game, and it seems oblivious to huge chunks of human experience. Rawls’s Theory of Justice pretends people aren’t the passionate, risk-taking bundles of neurons they really are. The only time we’ve found the neutrality principle to work is when we’ve told our kids that one cuts the pie then the other chooses. We’ve found more wisdom in the philosophy of Thomas Hobbes, not just because “solitary, poor, nasty, brutish, and short” perfectly described our junior prom date, but because he said that “Reason scouts and spies for the passions.”

We’re not neutral when we litigate cases. Plaintiff lawyers aren’t neutral. Sad to say, but most judges don’t come across as neutral. If they don’t favor a side, they often seem to favor docket control, or passing frail cases along to juries so as to avoid tough decisions. Maybe gatekeeping should be neutral, but gatekeeping is hard work.

Continue Reading We’re Not Neutral on Twombly/Iqbal

The other day we put up a piece about a Twombly/Iqbal law review symposium that promised “diverse interpretations.”  From an academic perspective, it was an impressive collection of articles that attacked Twombly/Iqbal from no fewer than 12 different directions.  But from our perspective, it turned out to be something of a disappointment, since the promised “diversity” never materialized.  Instead it was the usual academic Greek chorus of criticism, with the only “diversity” being differing avenues of criticism.

Having smacked that one down, we’re feeling like Mickey Mouse as the Sorcerer’s Apprentice in Fantasia – smash one broom and two more rise up in its place.  Since that post, we’ve been deluged with additional articles….

Well, not exactly deluged, but our readers have sent us a couple.

The first of these, Edward A. Hartnett, “Responding to Twombly & Iqbal: Where Do We Go from Here?” generously views Twombly/Iqbal “as equivalent to the traditional insistence that a factual inference be reasonable.”  Id. at 1.

We think there’s quite a bit more to Twombly/Iqbal than that.  As we’ve said elsewhere, our view is that Twombly/Iqbal have taken the “a short and plain statement of the claim showing that the pleader is entitled to relief” language of Fed. R. Civ. P. 8(a)(2), and given it a different gloss – one that emphasizes the “showing that the pleader is entitled” language more, and the “short and plain” language less, than was the case under the now-discarded Conley v. Gibson, 355 U.S. 41 (1957), formulation.  From an institutional standpoint we thus view Twombly/Iqbal and Conley as equivalents, with the Court having as much authority to adopt one interpretation as the other.  But make no mistake about it, the interpretation itself has changed, and we think it’s the right one given the litigation explosion that Conley at minimum facilitated.

Continue Reading Once More Into The Breach