To Joe or anyone, ? about Court of Appeals

[rosie]

There was a ruling in the US Court of Appeals on 5/2 ( the case was Abigail Alliance versus Eschenbach )that said that the FDA must allow terminal patients ( ie those with no other options and less than a year to live ) the same access to experimental drugs that have been proven safe as other patients. Not doing so will infringe on their right to choose and is a violation of part of the 5th amendment. This would be terrific for people who cannot enter anything but early phase 1 trials where they are looking at dose and toxicity not whether the drugs work because they are told they have had too much treatment.

I am told that the FDA has filed yet another appeal on this.

Does anyone know about this and have any ideas how to make use of it? I am told the ruling is tenuous pending the appeal.

[madubois63]

Don't have an answer, but thank you for posting. When I am up to it, I will research and see what I can find.

[LovingDaughter]

Do you know what circuit this came out of? If you can find any more information at all, I should be able to pull this opinion.

[LovingDaughter]

Nevermind. Here's the link to the opinion in case you would like to read it: http://pacer.cadc.uscourts.gov/docs/...5/04-5350a.pdf

[LovingDaughter]

In this case, the D.C. Circuit reversed the trial court's ruling that threw the plaintiffs' case out on a Rule 12(b)(6) motion to dismiss for failure to state a claim upon which relief could be granted. In direct contradiction to the trial court's ruling, the D.C. circuit concluded that the right asserted by the plaintiffs warrants protection as a fundamental right under the Fifth Amendment Due Process Clause (which applies to the federal government). Ultimately, the court held that the FDA's policy is only constitutional if it can meet the strict scrutiny standard--that is, the FDA must prove that its policy is narrowly tailored to serve a compelling interest--and remanded the case to the trial court for this determination. We won't know a whole lot about where this is going until the trial court makes this determination and until the case is appealed.

I can tell you this, however: Strict scrutiny is a very high standard to meet--in fact, in constitutional law terms, it is the highest standard applied. Rational basis is the lowest standard. If a court reviews a law under the rational basis standard, the plaintiff bears the burden of proof and the government must have a simple and basic basis for the law, and almost any rationale asserted will do. Intermediate scrutiny is a mid-level scrutiny--the court will look slightly more closely to the law to determine if the government is overstepping. Strict scrutiny applies when a fundamental right is involved. Apparently, the the D.C. Circuit has said that a fundamental right is involved in this case. Instead of the plaintiff having the burden of proof, the government bears the burden of proof. The government often loses cases in which strict scrutiny applies. If the US Supreme Court were to review this case and rule in favor of the FDA, it would likely do so by taking issue with the D.C. Circuit's conclusion that strict scrutiny applies, saying that the right involved is not a fundamental right and therefore applying only simple rational basis review.

Even if the lower court rules in favor of the FDA and determines that the FDA's policy is narrowly tailored to meet a compelling interest, the case will likely be appealed again in front of the D.C. Circuit and may eventually make its way before the U.S. Supreme Court.

Very, very interesting case. I wouldn't be surprised if this issue gains a substantial amount of national attention in the future.

Even though this case is still tied up in litigation and a final determination may not occur for quite some time (perhaps a few years), this case certainly opens the door to others who might want to bring suit. If more cases like this are filed, especially in other circuits that take a different approach, it definitely prompts the U.S. Supreme Court to review the issue.

The FDA has most certainly suffered a setback because it has been told by a U.S. court of appeals that its policy may in fact be unconstitutional, and that their rationale for having this policy in place may in fact have to give way to a person's fundamental right to life.

[rosie]

This is very interesting but I wonder how if at all this ruling can be used NOW to gain access to drugs? Any ideas?

[LovingDaughter]

You could file a similar suit. Basically, all that has happened in this case is that the trial court threw out the plaintiff's case and the appellate court reinstated the plaintiff's case because it said the plaintiff does in fact have a claim. However, there hasn't been a ruling declaring the FDA's policy unconstitutional yet.

Have you tried other avenues to get to these drugs? If you feel comfortable sharing more about your situation, I would be happy to help you brainstorm other ideas.