We’ve been corresponding recently with long-time friend-of-the blog, Dr. Frank Woodside over the unfortunate fact that junk science these days doesn’t only mean stuff (in the Jeb! sense) that isn’t published in what passes for scientific journals – and what can be done about it.  Dr. Frank has just written a law review article about this problem.  F. Woodside & M. Gray, “Researchers’ Privilege:  Full Disclosure,” 32 Cooley L.R 1 (2015), which is available online here.  Here’s the abstract:

An ever-growing chorus of academicians report that with the expanding number of academic journals there is a concomitant increase in the number of articles based on questionable methodology.  Many published studies contain improper statistical conclusions, flawed methodology, and results that cannot be replicated.  The recent controversy concerning the failure of parents to vaccinate their children because of the recommendations of flawed research exemplifies this crisis. This epidemic of faulty research has been exacerbated recently by the spread of low-quality academic journals and “pay-to-publish” journals, which will publish virtually anything for a fee.  This Article provides an analysis of a growing crisis of reliability in scientific research and how the so-called “researchers’ privilege” allows faulty research to go undetected.  This Article delineates the reasons why it is difficult, if not impossible, to evaluate published research findings without access to the underlying information that researchers have in their possession.  The Article then analyzes the state of the law regarding the ability of researchers to withhold records and data based on the so-called “researchers’ privilege.”  Finally, the Article explains why courts should favor the disclosure of research data and that confidentiality concerns should be addressed by a confidentiality order.

Id. at 1-2.  Here are the articles subheadings, which describe the material in it in more detail:

  • Misunderstanding and Misuse of Statistics and Research Methods
  • An Ever-Growing Number of Journals and “Pay to Play”
  • Fraud and Questionable Research Practices
  • Pre- and Post-Publication Peer Review Does Not Work

Continue Reading What To Do About Junk Science That’s Published?

The last couple of times we’ve commented on new law review articles, we haven’t liked what we’ve seen very much.  We’re gluttons for punishment, however, and this time we were rewarded.  We found a couple of recent law review articles that we think were actually worth the effort.

The first of these comes from our quest for enlightenment regarding 3D printing – which is already making an impact in the medical device market.  Aside from our own prior thoughts, we had not come across anything that we considered a serious analysis of the product liability possibilities when the user (or someone else farther along in the supply chain) also becomes the manufacturer of the product.  That changed with Heidi Nielson, “Manufacturing Consumer Protection for 3-D Printed Products, 57 Ariz.L. Rev. 609 (2015).  This article notes the various ways in which 3D printed products can reach the consumer:  (1) They could be manufactured and sold in the traditional way, with the consumer ordering a 3D printed product from a manufacturer or retailer; (2) a “hobbyist” (casual seller) sells a 3D printed product of his/her own design to a consumer (again, relatively traditional, but raising “deep pocket” concerns); (3) the consumer buys/downloads open source software and produces the product from the consumer’s own 3D printer; (4) the consumer, using acquired software, scans an existing product, creates his/her own printable file and then reprints the product from his/her own 3D printer (which could become typical for replacement parts).  Article, 57 Ariz. L. Rev. at 614-15.  This list already shows some serious thought.

The section on “Liability for Defective 3-D Printed Product” continues with the kind of discussion we’ve been hoping for.  In the first variant, it’s pretty traditional, except to the extent that a seller of 3D printed products claims to sell 3D printing “services” instead of products.  Such sellers “may attempt to contract out of liability for defects and instead hold CAD-file designers responsible.”  Id. at 616.  The article states that “independent designers of products are generally not held strictly liable for defects in their designs, but may be liable for negligence in their designs.”  Id. (citing law review article).  The casual seller problem is also noted.  Id. The bottom line (according to the article) is that small-scale sellers of 3D printed products would be subject to negligence, and larger-scale sellers subject to strict liability.  Id.

Continue Reading A Couple of Law Review Articles We Actually Like

We’ve blogged before about the interesting product liability issues created by 3D printing/additive manufacturing, in particular the novel separation that these techniques create (at least potentially) between “manufacturing” and “design” of products.  With respect to medical devices, if an implant is custom produced from equipment owned by, and located at, the hospital where the surgery is conducted, who’s the manufacturer for product liability purposes if, say, the implant fails in some way?  Our prior post provided some legal analogies that we thought might be useful.  We didn’t claim to be comprehensive or conclusive.

It’s a “wild, wild west” legal issue, so we were predictably intrigued when the law review article, Park, “For A New Heart, Just Click Print:  The Effect on Medical & Products Liability from 3-D Printed Organs,” 2015 U. Ill. J.L. Tech. & Pol’y 187 (Spring 2015), showed up on several of the half-dozen or so searches we run to stay current in our field.  Continuing with our “we read law review articles so our readers don’t have to” philosophy, we took a look.

We were disappointed, not particularly by its pro-plaintiff tone (we’re used to that from the academy), but by its superficiality.  Unfortunately, the article doesn’t seem to “get” the true legal complexities of 3D printing.  From beginning to end, it remains mired in the traditional paradigm – a prescription medical product produced by a “manufacturer” who provides warnings to the treating/implanting physician under the learned intermediary rule.  The paradigm shift that 3D printing promises, the devolution of the manufacturing function to on-site locations neither owned nor controlled by traditional Restatement of Torts “manufacturers,” goes totally unaddressed.

Maybe we were expecting too much.  It’s a student, rather than a professorial, article.  The best part of this article is its factual discussion of 3D printing in the field of medical devices.  “New Heart,” 2015 U. Ill. J.L. Tech. & Pol’y at 189-93.  These sections seem pretty current in the research and cite lots of interesting stuff, collecting it in one place.  Unfortunately, it’s largely downhill from there.  The article focuses in the most complex form of 3D printed medical device – artificial organs – and treats that in an utterly pedestrian manner.

We waded through a wholly unnecessary discussion of organ donation regulation, which is presented as some sort of alternative to the FDA.  We’ve been around long enough that it’s blindingly obvious to us that 3D printing of medical devices (and drugs, which the article does not consider at all) is and will be subject to extensive FDA oversight.  Thus, we think that the organ donation alternative discussed, and properly discarded, by the article (2015 U. Ill. J.L. Tech. & Pol’y at 193-95, 198-99) is a makeweight issue not worth the time spent on it.

Continue Reading Unfortunately Disappointing 3D Printing Law Review Article

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

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

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

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

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.

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