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.
We of course like Prof. Janssen’s conclusions. The first of which is that there is no valid basis for imposing any common-law duty to supply on a pharmaceutical company:
This foraging through the law has demonstrated that recognized and settled legal principles are unlikely to provide a source for a “duty” imposed on medicine manufacturers to avoid interruptions in the supply of their products. Indeed, one might fairly conclude that this tale of this journey has confirmed much the contrary, that manufacturers have no legal duty to continue selling medicines.
40 Am. J.L. & Med. at 384.
His second conclusion is that it would be a lousy idea for courts to try to create such a duty to supply out of whole cloth:
Here, though, the sprawling prevalence of federal pharmaceutical laws, the innumerable competing forces bearing on these products as articles circulating in a highly-competitive market economy, the irreducible importance of a safe, reliable, and accessible medicine supply, the very real human suffering inaccessible medicines can cause, the need for a vibrant incenting of medical product innovation and invention, and the tremendous practical risks accompanying missteps in setting the proper legal balance on the compelled-access question, all counsel otherwise.
Id. at 388.
Instead, of the blunt instruments of civil litigation, Prof. Janssen proposes a legislative fix through market incentives. We’re litigators here. We’ll leave that to the business types to evaluate.
If this topic interests you, so should Prof. Janssen’s article. Full disclosure, Bexis peer-reviewed the article.