That is the intriguing title of the latest law review article written by the “Rabbi of Torts,” Prof. Aaron Twerski (we’re not making this up, Prof. Twerski’s Wikipedia page is the fifth result when we just Googled that phrase).  Prof. Twerski, one of the ALI’s reporters for the Restatement (Third) of Torts:  Products Liability, has probably spilled as much ink as anyone in making sense of Restatement (Second) of Torts §402A, comment k (1965), one of the more opaque parts of the venerable §402A.  Indeed, in a prior article, Prof. Twerski divined fully eight different interpretations of comment k, the Second Restatement’s discussion of, among other things, design defect claims involving prescription medical products (mostly drugs and vaccines, as medical devices were much less common back in 1965).  See James A. Henderson, Jr. & Aaron D. Twerski, “Drug Design Liability: Farewell to Comment K,” 67 Baylor L. Rev. 521, 542-44 (2015).

Then there’s the Third Restatement, which sought to replace comment k’s approach to design defect claims involving “unavoidably unsafe” products with:

§6 Liability of Commercial Seller or Distributor for Harm Caused by Defective Prescription Drugs and Medical Devices

*          *          *          *

(c) A prescription drug or medical device is not reasonably safe due to defective design if the foreseeable risks of harm posed by the drug or medical device are sufficiently great in relation to its foreseeable therapeutic benefits that reasonable health-care providers, knowing of such foreseeable risks and therapeutic benefits, would not prescribe the drug or medical device for any class of patients.

Restatement (Third) of Torts, Products Liability §6(c) (1998).

As we’ve chronicled on the blog, most courts still continue to grapple with comment k.  Conversely, §6(c) has received a mixed and tepid response from the courts.  Now Prof. Twerski has essentially concluded that further explication of the courts’ Talmudic approach to comment k and design defect claims in our sandbox is futile – such claims are all federally preempted.  That, of course, is something we’ve been saying on the Blog since the moment Mutual Pharmaceutical Co. v. Bartlett, 570 U.S. 472 (2013), was decided five years ago.  See, e.g., here, here, here, and here.  But we’re just bloggers; Prof. Twerski is an institution.  We’re flattered simply to be cited as authority on par with law reviews and other scholarly works.  See footnotes 6 & 19.

Here’s a link to Prof. Twerski’s latest article on SSRN.  Its formal citation is, 68(1) Am. Univ. L.R. 281-304 (2018).  The first thing we note about the article is that the title is limited to “drugs,” as opposed to medical devices.  Nothing in the article, however, expressly distinguishes medical devices, and Prof. Twerski concludes that the limited cause of action permitted by Restatement (Third) §6(c) – which treats prescription drugs and medical devices identically – is, indeed, preempted:

The Restatement test ultimately allows a common law design defect claim to prevail over the FDA’s approval of a drug.  The only thing that a defendant can do to escape liability is to stop selling the drug − a position that is in direct contravention of Bartlett.  Perhaps for a drug that is so egregiously dangerous, the Supreme Court might craft an exception to Bartlett.  But, otherwise, the Bartlett dissent is quite correct in predicting that the majority has rendered drug design defect immune from common law actions.

“Demise of Drug Design Litigation,” 68(1) Am. Univ. L.R. at 302 (footnotes omitted).

As we’ve pointed out on a number of occasions, most recently in our discussion of Gustavsen v. Alcon Laboratories, Inc., 903 F.3d 1 (1st Cir. 2018), the Mensing/Bartlett basis for impossibility preemption – that the FDA must pre-approve “major changes” to product designs, and therefore regulated manufacturers cannot act immediately and unilaterally to change “defective” designs, as state tort law requires − applies equally to design changes for both drugs and medical devices.

Interestingly, we also note that Prof. Twerski speculated that the Gustavsen preemption decision – then in the district court (the First Circuit decision was too recent to be in his article) – might be within “a small subset of design claims [that] may not be preempted.”  68(1) Am. Univ. L.R. at 303.  Prof. Twerski’s reasoning was “that the Supreme Court might take issue with the FDA characterization of a change in volume of the drops created by the bottle’s stopper as a ‘major change’ requiring FDA approval.”  Id.  Well, the First Circuit affirmed preemption of “major changes,” and it doesn’t seem like the plaintiffs in Gustavsen are as optimistic about their case as Prof. Twerski’s supposed they might be.  They did not bother appealing to the United States Supreme Court, and the deadline for doing so has expired.

Another interesting perspective offered by Prof. Twerski is that Bartlett was improperly decided – not on preemption, but as a matter of New Hampshire state law.  68(1) Am. Univ. L.R. at 284.  The Court in Bartlett held, as to New Hampshire product liability law:

But respondent’s argument conflates what we will call a “strict-liability” regime (in which liability does not depend on negligence, but still signals the breach of a duty) with what we will call an “absolute-liability” regime (in which liability does not reflect the breach of any duties at all, but merely serves to spread risk).  New Hampshire has adopted the former, not the latter.  Indeed, the New Hampshire Supreme Court has consistently held that the manufacturer of a product has a “duty to design his product reasonably safely for the uses which he can foresee.”

570 U.S. at 481 (string citation of New Hampshire cases omitted).  Prof. Twerski’s analysis, turning on a case Bartlett did not cite, Vautour v. Body Master Sport Industries, Inc., 784 A.2d 1178 (N.H. 2001), posits, instead, that in Vautour New Hampshire product liability became “absolute liability” based on pure risk/utility balancing, without any need for the plaintiff to assert an alternative design.

This is not the forum to rehash our strong objection to [absolute liability].  The point is that New Hampshire has embraced it.  Thus, liability was not regulatory in the sense that Justice Alito set forth in Bartlett.  New Hampshire did not impose a duty on [defendant] to develop a better warning nor did it require [defendant] to redesign [the drug].  It simply allowed a jury to find that the [drug], as designed with the warnings as given, was unreasonably dangerous.

68(1) Am. Univ. L.R. at 292-93 (footnotes omitted).

Pointing to the footnote in Bartlett (570 U.S. at 482 n.1) “sav[ing] for another day” the issue “whether a true absolute-liability state-law system could give rise to impossibility pre-emption,” Prof. Twerski suggests that Bartlett should have come to grips with the application of impossibility preemption to an absolute liability system of product liability.  68(1) Am. Univ. L.R. at 293-94.  We think that Bartlett actually did address absolute liability, perhaps back-handedly, in its discussion of the plaintiff’s claim that the defendant should never have sold its FDA-approved product.  What is that theory, if not absolute liability?  Liability, under a stop-selling theory seems pretty “absolute” to us, since the only way to avoid liability would be not to sell the product at all. Bartlett had no trouble holding that theory preempted:

The incoherence of the stop-selling theory becomes plain when viewed through the lens of our previous cases.  In every instance in which the Court has found impossibility pre-emption, the “direct conflict” between federal- and state-law duties could easily have been avoided if the regulated actor had simply ceased acting. . . .  Adopting the First Circuit’s stop-selling rationale would mean that not only [Mensing], but also the vast majority − if not all − of the cases in which the Court has found impossibility pre-emption, were wrongly decided.  Just as the prospect that a regulated actor could avoid liability under both state and federal law by simply leaving the market did not undermine the impossibility analysis in [Mensing], so it is irrelevant to our analysis here.

570 U.S. at 488-90 (detailed description of particular cases omitted).

So, did Bartlett mess up New Hampshire law?  Prof. Twerski makes a pretty convincing case as to what New Hampshire law actually is, but ultimately we don’t think it makes much difference.  First, we think that the majority in Bartlett was not interested in deciding the case based on New Hampshire having some sort of bats**t crazy tort regime, but rather wanted to emphasize preemption of more mainstream forms of product liability.  Second, nothing in Bartlett, and in particular in its affirmance of “stop-selling” preemption, indicates that absolute liability would escape the fate of other, more widely accepted, design defect liability theories.

Ultimately, Prof. Twerski concurs in that assessment.  Pure risk/utility balancing amounts to a definitively preempted stop-selling claim:

Can the state allow a common law remedy based on a finding of unreasonable danger, thus negating the FDA’s determination that the drug is reasonably safe so that it is approved for marketing? . . .  After running out of state common law duties to make the drug safer, the defendant was left with the sole option of not marketing a FDA approved drug to avoid tort liability.  This remaining option, however, is an option that Bartlett teaches flies in the teeth of preemption jurisprudence.

68(1) Am. Univ. L.R. at 300-01 (footnotes omitted).

Second, the most widely followed design defect rationale – risk/utility balancing of reasonable alternative designs (“RAD”) is precisely what Bartlett preempted:

[P]ost-Bartlett, it would seem quite clear that, for a drug that has received FDA approval, any argument that it can be modified by a RAD is federally preempted.  Justice Alito’s reasoning leaves little doubt when he said that “once a drug − whether generic or brand name- − is approved, the manufacturer is prohibited from making any major changes to the ‘qualitative or quantitative formulation of the drug.”’  If a court were to find a post-FDA approval drug to be a RAD, it would almost certainly be struck down on the same impossibility grounds set forth in Bartlett.

Id. at 295 (footnotes omitted).

Third, Prof. Twerski (like us) has only scorn for the “pre-approval design defect” theory that plaintiffs have turned to as an argument to avoid preemption.

How a court could censure a manufacturer for not developing a different drug without any assurance of its safety by the FDA is beyond comprehension.  As to preemption, the court in [Mensing] made short order of the argument that a plaintiff could challenge an FDA approved drug based on the supposition of what the FDA might do if asked to respond to a change. . . .  None of the cases opting for the “pre-approval theory” have adequately responded to either the common law or preemption arguments that negate this novel theory.

Id. at 296-97 (footnotes omitted).

Finally, as already discussed, the design defect theory enshrined in Restatement (Third) §6(c) also runs afoul of preemption.  Id. at 302 (footnote omitted).

Thus, Prof. Twerski concludes that design defect claims involving prescription drugs are preempted no matter how the plaintiffs package them.  In the end, however, Prof. Twerski sheds no tears over the demise of design defect litigation against FDA-approved drugs.  Design-based theories have never really amounted to very much:

The overwhelming majority of cases against pharmaceuticals have always been based on failure to warn. . . . Drug design, despite the fascination of scholars with this issue, has played only a minor role in drug litigation. The pillars of the republic will not fall if this questionable theory is laid to rest.

Id. at 304. That’s a sentiment with which we whole-heartedly agree.  We are always interested in reading more of Prof. Twerski’s views on design defect preemption – particularly with respect to prescription medical devices.

We recently read an interesting new empirical study that confirms what we’ve long suspected − that so-called “no-injury” class actions, those that allege that a product was “worth less” than it should have been due to some inchoate, unmanifested defect, are a litigation boondoggle, benefiting nobody but the lawyers who bring them.

The study is Joanna M. Shepherd, “An Empirical Survey of No-Injury Class Actions,” available through the Social Science Research Network, here. Ms. Shepherd, a professor at the Emory University School of Law, started with all class action settlements between 2005 and 2015 that could be located on Lexis or Westlaw – 2158 cases. She applied four criteria for identifying “no-injury” classes:

  1. the plaintiffs suffered no actual or imminent concrete harm giving rise to an injury in fact;
  2. the only harm alleged was a technical statutory violation (primarily of the Fair Debt Collection Practices Act, the Telephone Consumer Protection Act, the Fair Credit Reporting Act, and the Electronic Funds Transfer Act);
  3. if any out-of-pocket economic loss was negligible or infinitesimal; or
  4. the recovery sought was unrelated to compensating plaintiffs for economic or other harm.

Shepherd Empirical Study at 1. After applying those criteria, Professor Shepherd included only cases about which information existed on both attorneys’ fees and settlement funds. Id. This culling produced 432 class actions that could be studied.

Continue Reading Empirical Study Confirms That No-Injury Class Actions only Benefit Lawyers

When we examined Restatement (Second) of Torts §402A, comment k (1965), in our 2011 research post “Comment K, Some of the Way,” we remarked about how it said “a lot of things,” including: (1) that one can’t design away unavoidable risks, (2) that unavoidably unsafe products aren’t considered “unreasonably dangerous” for purposes of strict liability, and (3) that such products are “especially common” in the prescription medical product area. The first proposition suggests that design defect liability is incompatible with unavoidably unsafe product characteristics. The second indicates that unavoidably unsafe products shouldn’t be subject to strict liability. The third raises the issue of whether all prescription medical products should be considered unavoidably unsafe products – since their inherent risks are why they require a prescription in the first place.

We pointed out that some states, like California and Utah, prohibit design defect liability altogether, following that aspect of comment k. Others, like Pennsylvania, reject strict liability in the context of prescription medical products. Often, as is the case in Massachusetts, the status of negligent design liability is uncertain.

However, the most striking divide has always been between those states following a case-by case approach to determining whether a given product was “unreasonably dangerous” and those states that followed an “across-the-board” approach to comment k in the prescription medical product area. After adding everything up, we had to conclude in our blogpost that, despite its inherent inefficiency and tendency to second-guess the FDA, the case-by-case approach to comment k remained the majority rule.

Continue Reading Comment K Case by Case – Falling Out of Favor?

We have been riding the Philly subway for years, but only recently realized how much the ads on the car walls have changed. Not so long ago there were lots of ads for vocational schools, inducing today’s un- or underemployed to become tomorrow’s truck drivers and beauticians.  But nowadays at least three quarters of the ads are from plaintiff lawyers hawking their ability to wring cash out of slip-and-falls or the latest mass tort.  Mass transit advertising space that formerly advised riders to get skills is now dedicated to pleas to get paid.  The same is true for daytime television advertising.  Perhaps we are not alone in seeing this evolution as further proof, along with Keeping up with the Kardashians and the ascendancy of kale salad, that our culture is headed to Hell in a handbasket.

You won’t be surprised to hear defendants and their lawyers bemoan plaintiff lawyer advertising.  But we are not alone.  Recently, we heard a MDL judge express frustration about how plaintiff lawyer advertising was a blatant attempt to extend the tail of an over-mature mass tort.  Some plaintiff lawyer advertising is naked poaching of other plaintiff lawyer inventories – e.g., why pay a 40% contingency fee if you can pay only 20%?  But the most obvious aim and effect of such advertising is stirring up litigation.  What might not be so obvious is the extent to which plaintiff lawyer adverting causes adverse health outcomes.  A recent law review article looks into this issue and it is well worth reading. The article is by Elizabeth Tippett, a professor at the University of Oregon School of Law. The title is “Medical Advice from Lawyers: A Content Analysis of Advertising for Drug Injury Lawsuits,” 41 Am. J. L. & Med. 7 (2015).

Continue Reading The Risks of Plaintiff Lawyer DTC Advertising

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 been based on the FDA’s application of the Food Drug & Cosmetic Act’s misbranding provisions to off-label promotion.  In the decision, the court declined “the government’s invitation to construe the FDCA’s misbranding provisions to criminalize the simple promotion of a drug’s off label use by pharmaceutical manufacturers and their representatives.”  We’ve devoted a good number of our cyberpages to Caronia (here, here, here and no doubt elsewhere) and to First Amendment issues in general (here is a link to a number of posts), ultimately concluding that truthful, non-misleading commercial speech on scientific issues, whether by drug manufacturers or other participants in the scientific community, should not be curtailed.

But that notion needs practical application, a comprehensive regulatory model that sits well with both the Constitution and the FDA’s regulatory mandate.  That’s difficult to accomplish.  The authors of a recent Journal of Law and the Biosciences article, “Back to first principles: a new model for the regulation of drug promotion,” however, have taken up the task.  They have proposed a new regulatory model based on the reality that drug manufacturers engage in different types of communications, not solely commercial speech directed at the sale of drugs.  Some communications involve the free exchange of scientific communication amongst professionals and associations within the scientific community, some do in fact involve the sale of a drugs (e.g., approved labeling, sales aids and product websites), and some fall in between.  The authors propose different levels of FDA regulation for each type of communication, and at times no regulation at all.

We won’t go any further in describing it.  We’ll only muck it up.  Suffice it to say that it is a practical and thought-provoking proposal.  We recommend that you read the article.  Here’s a link.  Enjoy.

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