Photo of Bexis

We’re thinking about the recent Abigail Alliance case again. As readers of this blog know, the en banc D.C. Circuit held on August 7 that terminally ill patients do not have a constitutional right to take unapproved drugs in the hope of a cure.

We did a short post on that topic, which the Volokh Conspiracy picked up, which prompted our rejoinder, which led to yet more commentary at Volokh. (And all that in just two days. Is the web cool, or what?)

Here’s where we settled.

Our concern was that terminally ill patients who are permitted to take unapproved drugs must get the drugs from somewhere. The only place to get the drugs is from the people who have them – the pharmaceutical companies. Terminally ill patients will thus predictably turn handstands to try to force pharmaceutical companies to provide those drugs. And the emotional appeal of lawsuits filed to obtain access to those drugs will be truly compelling. Plaintiffs will be telling judges that they are terminally ill and have no hope for survival unless they are permitted to take an experimental drug. In that context, shouldn’t the drug manufacturer provide the drug, so the patient can have a chance to live?

The scholars at Volokh criticized our thinking in two ways. First, they insist that drug companies are not “state actors,” so no court would ever find that the fundamental constitutional right alleged in Abigail Alliance applies to them. As we said in our previous post, we’re far less sanguine about that than the academics are. The FDA regulates drug companies awfully closely, and judges will bend over backwards to find in favor of plaintiffs in the emotionally-charged situation we’ve just described. In that situation, we would not be surprised to find a judge (wrongly) ordering a company to provide an experimental drug.

But assume the scholars are right. If so, then drug companies are not state actors, and drug companies would never be subject to a constitutional obligation to provide drugs.

Here’s our question: If drug companies are not going to provide drugs to the patients, who the heck is?

The drug companies themselves would be crazy to provide these drugs. The companies would presumably have to provide the drugs free of charge. There’s no (economic) upside to providing the drugs. But there is a downside. The companies are forbidden to speak about the risks of unapproved drugs, so the companies could not protect themselves against “failure to warn” tort claims if they provided the drugs to patients.

Moreover, if terminally ill patients were permitted to ingest investigational drugs, the FDA would surely force manufacturers to track how those patients fared. The logistics and cost of that process would deter drug companies from providing drugs. And the results of those experiments – with most patients dying – might wrongly be used to delay approval of drugs or as purported ammunition for plaintiffs in later litigation.

One alternative would be for the drug companies not to produce the drugs themselves, but instead to license the drugs to other companies that could then sell them for experimental use.

But why? And to whom? Why would a licensee care to manufacture and sell drugs in a situation where it, too, would have no defense to resulting product liability lawsuits? And why would the licensee want to manufacture a drug either to give away free or sell for what would surely be no profit? There’s no incentive for licensees to act.

Moreover, the innovator drug company also has little incentive to grant the license. Just as plaintiffs sometimes join innovators in product liability lawsuits resulting from having ingested a generic version of a drug, a plaintiff who ingested an Abigail Alliance drug manufactured by a licensee might also choose to join the innovator as a defendant.

In the end, we just don’t get it. (No surprise there, right?) Assume the Abigail Alliance plaintiffs prevail and establish a constitutional right to ingest experimental drugs. Unless we’re missing something, almost no one would manufacture or sell those drugs, so the plaintiffs would have established the right to ingest drugs that will not be available anyway.

We have an awful lot of sympathy for the plaintiffs in Abigail Alliance and, as we’ve said before, we pass no judgment on the constitutional issues involved. But it does seem to us that, if you focus on the practicalities of the situation, the entire litigation is a tempest in a teapot. The plaintiffs may be fighting for a right that will ultimately have no practical effect at all.