Interesting Circuit Court Ruling on Drugs

As I mentioned in a comment yesterday, the D.C. Circuit Court of Appeals has just issued an interesting ruling in a case called Abigail Alliance for Better Access to Developmental Drugs v. Eschenbach. The case involves the question of whether a terminally ill patient can be prescribed a drug that has not yet gotten FDA approval, but has passed Phase One clinical trials and been approved for expanded human testing. The 2-1 decision, including Chief Judge Douglas Ginsburg in the majority, was that said patients do have a right to access to such drugs under the Due Process Clause of the 14th amendment.

There are several fascinating things about the decision, the most obvious of which is that it involves the controversial concept of substantive due process. For a good basic discussion of substantive due process, see this post by Sandefur from a couple years ago. It's a fairly complex issue, but essentially the Supreme Court has co-opted the due process clause of the 14th amendment to provide the basis for doctrine that was intended to be based upon the priviliges and immunities clause instead. It's made for quite a mess.

But as Sandefur explains, there is nothing mystical about the notion of substantive due process, which is basically the idea that there are some exercises of power by government that are illegitimate regardless of whether the Constitution explicitly says so. This is basically the only way to make the 9th amendment mean anything genuine; without it, the 9th amendment is rendered essentially moot. We know that there are rights not enumerated in the Constitution that the government may not violate no matter how large a majority. And without the due process clause having some substantive, rather than merely procedural, meaning, the Bill of Rights would be reduced to saying, "The government may not violate individual rights....unless it chooses to do so and passes a law with the correct procedure." Clearly, that cannot be the case. As Sandefur put it:

Mere enactment cannot satisfy the due process clause, therefore, because the due process clause was intended to prevent special laws whereby unpopular minorities were subjected to unfair burdens simply due to their unpopularity: that is, it was written to require that deprivations of life, liberty and property were engaged in for legitimate public reasons, rather than as a mechanism of bullying behavior.

Substantive due process was rather popular in the courts until the 1930s and has been used relatively sparingly since, so it's notable that the Appeals Court invokes it explicitly in this case. The standard the courts have developed for substantive due process cases is that the right being asserted must "be implicit in the concept of ordered liberty" and must be "rooted in our Nation's history, legal traditions, and practices." And the court, in this case, found that the right to have access to possibly life saving medicines before they'd met with final FDA approval did meet that standard.

They found that it met that standard by referring to the Cruzan case, which involved a patient's right to terminate their life. They broadened this a bit, arguing that said right amounts to a "right to make the decision about her life free from government interference." This fits quite well with the reasoning of Lawrence, where Justice Kennedy asserted a general right to liberty - the right to live one's life as they see fit free from government interference unless there is a compelling state interest in denying them that right.

This, I have long argued, is the proper interpretation of the constitution, particularly when one reads the 9th amendment and the 14th amendment. Together, these provisions make clear that there should always be, to use Randy Barnett's phrase, a presumption of liberty. The presumption is with the individual's right to take a given action; the burden of proof should always be upon the government to justify asserting the power to interfere with a given action. So I'll be curious to see what the Supreme Court does with the case if they grant cert. Will they continue along the line that Justice Kennedy plotted in Lawrence? Or will they be more circumspect? This could be a very important fork in the road for the new Roberts court.

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I am glad you decided to post on this matter; I appreciate that on matters of law you describe complex concepts in layman's terms.

The very first article I read about this issue was entitled, "The Court Makes up a Right"

It did not seem to me that the court was making anything up at all.

By John Cercone (not verified) on 04 May 2006 #permalink

I think the court decision is good news. By the time patients become terminal they are often desparate to try anything and can fall prey to a lot of unscrupulous people lurking out there promising phoney cures. At least this way, for some, this gives them one more avenue they can try, though I suspect it will usually be a long shot.

I guess the downside is that it may prove difficult to conduct clinical trials for drugs being developed for treatment of diseases in their advanced stages. Before this ruling, the only way to get the medication was to enroll in the trial, which at least gave you a 50-50 change on getting on the drug. Now, if a drug company cannot deny a patient access to the medication then they may find it hard to find enough volunteers for the trial. Hmm.

Question: The ruling says that patients do have the right of access to these experimental drugs, but can't the government still legally ban drug companies from selling those drugs to those people? Does a ruling on one side of the transaction imply the same ruling on the other?