Law Review Articles

Subscribe to Law Review Articles via RSS
Photo of Bexis

Maybe our motto here at DDLaw should be “we read law review articles so you don’t have to.”  Here are a couple of recent ones that looked interesting to us.

Tort Liability and Medical Innovation

The first one is Anna B. Laakmann, “When Should Physicians Be Liable For Innovation?,” 36 Cardozo L. Rev. 913 (Feb. 2015).  The title caught our eye because of our interest in off-label use, which is sometimes (when not yet the recognized standard of care) considered medical “innovation.”  Since Bexis’ 1998 law review article popularized the now-overwhelmingly adopted position that informed consent includes medical risks, not regulatory matters such as off-label use, we are particularly interested in patrolling that boundary.  If a treatment is so new that its risks and benefits cannot accurately be assessed, then a warning about its experimental nature is appropriate, but that kind of warning is a small subset of “off-label use” as an FDA regulatory status.

Here is the article’s thesis:

This Article proposes a fiduciary framework to regulate physician innovation under conditions of endogenous [we think that means “inherent” in this context] uncertainty.  The proposed approach could be described as a “libertarian paternalism” model of medical decisionmaking.  It mandates close scrutiny of the decisionmaking process but deference to the substance of medical decisions.  Under this framework, the physician should be held liable for failing to act in the patient’s best interests, taking into account the patient’s unique clinical condition and value preferences.  Within these constraints, however, patients should have the freedom to choose − and assume the associated risks and uncertainties − from among a range of clinically acceptable alternatives.  Properly applied, fiduciary principles can strike a desirable balance that respects patient autonomy, deters unreasonable risks, and encourages beneficial innovation.

Id. at 914.  Okay, let’s see what this is all about.Continue Reading Law Review Articles That Caught Our Eye

Photo of John Sullivan

Friction between the First Amendment and the FDA’s  attempts to regulate off-label drug promotion has existed for decades.  It has sparked an ever growing body of case law that often finds the FDA overreaching.  One of the more recent examples is the Second Circuit’s decision in Caronia, which vacated a criminal conviction that had…

Photo of Bexis

Ever since we rejected the concept of a constitutional “life interest” creating a right to use investigational, or even experimental, drugs in connection with the Abigail Alliance litigation back in 2007, we’ve been interested in what can be called “duty to supply” cases.  Our beef with the postulated constitutional right was that, if such a right were recognized, the next lawsuit would be against a pharmaceutical company to “enforce” that right.

Well, even without a right, precisely such a “duty to supply” claim was made in a case called Gunvalson, which because it was in our back yard, we covered extensively.  Our ex-colleague and co-founder, Mark Herrmann, even filed an amicus brief in Gunvalson, successfully urging the Third Circuit to reverse an order that would have required a manufacturer to supply an investigational drug outside of its investigation.

There have been a few more such suits, all thankfully unsuccessful.  In this post, we want to let any of our readers who share our eclectic interest in this topic know that the best law review article that we’ve ever seen on this topic has recently been published.  Here’s a link.  See William M. Janssen, “A ‘Duty’ to Continue Selling Medicines,” 40 Am. J.L. & Med. 330 (2014).  Free copies can also be obtained at the SSRN site here.  The article is comprehensive, indeed “comprehensive” doesn’t do it justice.  We’ve looked through it, and it discusses every major case on this topic.  It definitely goes far beyond the
usual function of law review articles of filling much needed gaps in the literature.Continue Reading New Law Review Article About Duty To Supply Issues

Photo of Bexis

Anybody who has ever had the pleasure of listening (as we have) to Dean Erwin Chemerinsky  expound upon the Supreme Court’s constitutional decisions knows that the man is drop-dead brilliant.  If you haven’t caught one of his lectures, you should – and can, here and here.  He can go on for an hour, without notes, and rattle off not just the important holdings of dozens of Supreme Court decisions, but even how each justice voted on each case.

Dean Chemerinsky has undoubtedly forgotten more constitutional law than we know – and he doesn’t forget much.  Thus it is with some trepidation that we find ourselves in the position of offering a rejoinder to his recent piece in the online ABA Journal on preemption and prescription drugs. But in this limited area, preemption and prescription medical products, we’ve done a great deal of thinking and writing about both prescription drugs and medical devices.  So we’ve decided to take the plunge.

We don’t have much quarrel with Dean Chemerinsky’s initial observation that the existing regime for preemption and prescription drug product liability litigation, fashioned by the trilogy of Wyeth v. Levine, 555 U.S. 555 (2009), PLIVA v. Mensing, 131 S. Ct. 2567 (2011), and Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466 (2013), in his words, “makes no sense”:
Continue Reading Preemption – A Counter To Dean Chemerinsky’s Proposal

Photo of Bexis

What follows is a “guest post” by Melissa Wojtylak of Reed Smith.  We place the term in quotes because Melissa has expressed an interest in becoming a member of our crew of merry blogsters.  We’re inclined to say yes (anything that reduces our own workloads is great), so expect to reading more of her work.

We (or at least Bexis) also has to say that Melissa, in addition to her other accomplishments, is also a very nice person.  We (or at least Bexis) were inclined to be quite a bit more sarcastic about the subject of this article.
As always, Melissa deserves all the credit and assumes all the blame for what follows.
*********************
In our line of work, when you read anything that starts with the statement “[p]harmaceutical adverse effects are a leading cause of death and injury in America,” you know you’re at an away game.  This is precisely how a recent Comment in the George Mason Law Review begins.  As we noted in yesterday’s post, in the Comment, which is titled Picking Up the Tab for Your Competitors: Innovator Liability After Pliva, Inc. v. Mensing, the author waves the now-tattered banner of Conte v. Wyeth, Inc., 85 Cal. Rptr. 3d (Cal. App. 2009), and sets out his argument for why, in a post-Mensing world, brand-name manufacturers should be held liable for failure-to-warn claims brought by users of generic drugs – in essence, the holding in Conte – a holding that’s been rejected more times than a telemarketer calling during an American Idol finale.
Regular readers of this blog know how we feel about Conte.  It’s safe to say that the George Mason Law Review Comment has not changed our minds, although it has made us wonder what they’re teaching these days in torts classes at the George Mason Law School.  In any event, from our perspective, the Comment offers no compelling argument – much less legal justification – that supports a rejection of decades of established law, well-supported by practical considerations such as linking liability with responsibility, which holds that manufacturers cannot be liable for injuries to users of products that they did not sell.
Continue Reading Innovator Liability for Generic Drugs: The Answer Is Still No
Photo of Bexis

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…

Photo of Bexis

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…

Photo of Bexis

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…

Photo of Bexis

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

Photo of Bexis

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…

Drug & Device Resources

Bexis’ Book

FDA-regulated products now account for an estimated one-fifth of overall economic activity in the U.S. They have also been the focus of a litigation explosion. This timely guide covers all aspects of litigation involving drugs, medical devices, vaccines and other FDA-regulated prescription products.
Learn more about this book