We've been vigilant opponents of plaintiffs who would impose new duties upon drug and device companies with respect to products still in the development pipeline. If plaintiffs are granted access to experimental drugs and devices on the grounds that the risks of using unproven products become irrelevant when no other alternatives exist, we argued that the next step would see our clients being sued to force them to provide such products. Thus we were extremely skeptical of the attempt back in 2007 to create a "constitutional right" of access to experimental drugs for patients whose conditions were otherwise terminal. Fortunately, that effort failed. Abigail Alliance for Better Access to Developmental Drugs v. von Eschenbach, 495 F.3d 695 (D.C. Cir. 2007).
Even without a constitutional right of access at their backs, a "compassionate use" plaintiff still brought suit in Gunvalson v. PTC Therapeutics Inc., 303 Fed. Appx. 128 (3d Cir. 2008), and induced a sympathetic district judge to order a company to provide an investigational drug. Again, we were fortunate to get the Third Circuit to reverse, and find no duty in contract or tort that could be the basis of an injunction requiring a company to provide an investigational drug outside of a clinical trial.
Well it happened again. In Cacchillo v. Insmed, Inc., ___ F.3d ___, 2011 WL 1005427, slip op. (2d Cir. March 23, 2011), the Second Circuit reached essentially the same result as in Gunvalson. Not surprisingly, both cases involved muscular dystrophy patients. There remains no reliable treatment for this horrible disease. In Cacchillo, the plaintiff had at one point participated in a clinical trial for the drug, called Iplex. The defendant decided to terminate the trial and ceased producing the drug. All existing stock was committed to the treatment of patients with another incurable, progressive, wasting disease, amyotrophic lateral sclerosis. Slip op. at 3.
The plaintiff sued, demanding to be supplied with the drug even though the defendant had ceased production and committed what stocks it had left. Specifically, the plaintiff sought a "mandatory" injunction (one that compels affirmative action) requiring the defendant to provide an FDA "compassionate use" exemption form. Unlike Gunvalson, the District Court in Cacchillo denied the injunction. So the plaintiff was the appellant.
We'll spare you all the procedural stuff about standing and ripeness (which the Court of Appeals held existed) and take you straight to the bottom line. The defendant didn't enter into any agreement to supply the plaintiff with an experimental drug outside the boundaries of an FDA-regulated clinical trial:
"[Plaintiff’s] claims hinge on [defendant’s] alleged promise to support [plaintiff’s] compassionate care application. Yet, [plaintiff] has no evidence that such an agreement existed beyond her own vague recollection. [Plaintiff] has not described in any detail what exactly [defendant] allegedly promised her; [plaintiff] asserts only that (1) on its webpage, “[Defendant] stated that it supported clinical trial subjects’ compassionate use applications;” and (2) a clinical research coordinator not employed by [defendant] “told [plaintiff] that [defendant] would support [plaintiff’s] application.
Slip op. at 11. The website didn't contain those promises, and there was no basis on which the "coordinator" could be considered an "agent" capable of binding the defendant. Id. at 12.
As defense lawyers, we're used to being called heartless by the other side. It comes with the territory. But developing drugs is expensive. Creating legal obligations to continue supplying investigational drugs once a clinical trial is stopped - let alone after production has ceased as in Cacchillo - would create yet another level if disincentive to develop drugs, particularly where the disease is fatal like MD or ALS. These are sympathetic cases, but to permit them would only kill the goose that lays the golden eggs.