On a number of occasions – more during the first couple of years of the blog than recently – we opposed causes of action that would impose liability on drug/device manufacturers for investigational drugs that worked, and indeed worked well. By that we mean claims by research subjects demanding one form or another of continued
The Third Circuit just issued its opinion in Gunvalson v. PTC Therapeutics (link here), the case in which a trial court issued an injunction requiring a drug company, PTC Therapeutics, to provide an experimental drug to a patient outside of the context of a clinical trial. (One of our many earlier posts on
Gunvalson v. PTC Therapeutics is the case in which a federal trial court ordered a drug company to provide an experimental drug to a patient outside of the context of a clinical trial. We previously posted about Gunvalson here and here. (And Pathophilia commented on the case here and, before that, here.)
We
Everybody’s a critic.
We published a post last month analyzing Gunvalson v. PTC Therapeutics (here’s a link), in which a federal judge ordered a company to provide an experimental drug to a dying patient who did not qualify for a clinical trial. We wrote:
“Basically, a drug company would be crazy to open
A little over a year ago we caught considerable flak for our posts about Abigail Alliance for Better Access to Developmental Drugs v. von Eschenbach, 495 F.3d 695 (D.C. Cir. 2007) (en banc), the case that ruled against any constitutional right of patient access to unapproved, experimental, but potentially lifesaving drugs. We said then
We’re taking it on the chin in the “comments” over at the Volokh Conspiracy. Jonathan Adler linked to our post yesterday about the Abigail Alliance case, and the scholars are lining up to say that pharmaceutical companies are not “state actors” and so would never be compelled to provide experimental drugs to terminally ill patients.
Nobody who reads our blog can have any doubt that we’re four-square in favor of allowing drug and device manufacturers (our clients) to engage in the truthful promotion of off label uses. It’s not just that we think the restrictions are unconstitutional (although we do); it’s that we think that off-label use saves lives and