The Court Gives and the Court Takes Away

Kerry Howley | August 7, 2007

Last year, a three-judge panel for the U.S. Court of Appeals for the D.C. Circuit ruled that patients have a constitutional right to purchase potentially lifesaving developmental medicines prior to FDA approval, a huge (and hugely controversial) win for patient autonomy. The D.C. Circuit later granted en banc rehearing, and that opinion(pdf) was released this morning. The court now asserts that the Due Process Clause has nothing much to say about the right of the terminally ill to defend themselves against the onslaught of disease; it is the FDA's prerogative to deem a medicine too dangerous to ingest, even if the patient in question is about to die. Judges Ginsberg and Rogers, who together formed the majority in the original opinion, dissented.

Part of the Abigail Alliance's case hinged on the fact that the prohibition on trade in unapproved pharmaceuticals is a relatively new development; the court disputes this, and adds:

True, a lack of government interference throughout history
might be some evidence that a right is deeply rooted. But
standing alone, it cannot be enough. If it were, it would be easy
to employ such a premise to support sweeping claims of
fundamental rights. For example, one might argue that, because
Congress did not significantly regulate marijuana until 1937,
relatively late in the constitutional day, see Gonzales v. Raich,
545 U.S. 1, 11 (2005), there must be a tradition of protecting
marijuana use. Because Congress did not regulate narcotics
until 1866 when it heavily taxed opium, a drug created long
before our Nation’s founding, see United States v. Moore, 486
F.2d 1139, 1215-16, 1218 n.50 (D.C. Cir. 1973) (Wright, J.,
dissenting), it must be that individuals have a right to acquire
and use narcotics free from regulation...Indeed, creating
constitutional rights to be free from regulation based solely upon
a prior lack of regulation would undermine much of the modern
administrative state, which, like drug regulation, has increased
in scope as changing conditions have warranted.

The opinion cites Raich again elsewhere. The upshot: An opinion denying cancer patients access to a substance that would ease their pain (marijuana) is being used as precedent in an opinion that would deny cancer patients access to a substance that might... halt the spread of the cancer. 

My August/September feature on terminally ill patients, which includes reporting from the en banc rehearing, is here. Ron Bailey's take on the Abigail Alliance is here.

Comments

|8.7.07 @ 3:09PM|#

Boy, that is the money quote isn't it? If we follow the constitution on this issue, we would have to follow the constitution on every issue. And who wants that?

|8.7.07 @ 3:09PM|#

Actally, according to the government's own propaganda film Reefer Madness, the government HAD no federal power to regulated marijuana as it was grown in every individual state (there apparently being no interstate commerce in it).

Too bad the film had no basis in reality.

|8.7.07 @ 3:12PM|#

Indeed, creating
constitutional rights to be free from regulation based solely upon
a prior lack of regulation would undermine much of the modern
administrative state, which, like drug regulation, has increased
in scope as changing conditions have warranted.

And we don't dare do that!

::sobs::

|8.7.07 @ 3:14PM|#

...And euthanasia is illegal in most states. Thus, the law is clear: you have the right to choose between dying slowly and painfully without the medication of your choice, or the right to... nope, that's it! The land of the free! Yay!

D. Greene|8.7.07 @ 3:15PM|#

Truly, the idiots are running the asylum.

|8.7.07 @ 3:17PM|#

This sort of thing is why I am so glad that I am no longer working in the pharmaceutical industry. Whenever the FDA inspected our facilities we had to be nice to them. Every time I had to smile and shake one of those mass-murderers' hands it was harder than the time before.

Timothy|8.7.07 @ 3:18PM|#

Further evidence that the majority cares far more about controlling others than about tedious things like principles or the easing of human suffering.

|8.7.07 @ 3:20PM|#

When criticizing the decision, please keep in mind that the issue is whether there is a constitutional right to acquire experimental treatments, and not whether the regulations in question are a good or bad idea.

The point is, if you have a problem with the regulations, take it up with the other two branches.

crap-action-jackson|8.7.07 @ 3:23PM|#

... it would be easy to employ such a premise to support sweeping claims of
fundamental rights

as though that would be a bad thing...

|8.7.07 @ 3:23PM|#

"True, a lack of government interference throughout history might be some evidence that a right is deeply rooted. But standing alone, it cannot be enough."

And what, the fuck, might be "enough"?

SIV|8.7.07 @ 3:26PM|#

Once again(thanks to this ruling) you can Thank the progressive New Deal Congress and FDR for stealing away your rights.....in this case to treat an otherwise terminal disease.

|8.7.07 @ 3:38PM|#

Daniel,

Well, really the issue is whether the Constitution gives Congress the authority to deny patients access to these drugs, not whether they have a right to them. That's why they cited Gonzales vs Raich as precedent.


Jose O y G,

Amazingly, one of the reasons cited by Roe v Wade to justify the right to an abortion was the lack of laws against it in the early US. So doesn't this decision undermine Roe?

|8.7.07 @ 3:40PM|#

I am not a Constitutional scholar by any stretch of the imagination, but I have worked around the law enough to reach a simple conclusion. A judge quite often determines the result he or she wants and then finds (or makes) the law fit. As for the Supreme Court, I think they need a 45-minute lession on natural rights theory.

Christopher Monnier|8.7.07 @ 4:05PM|#

> Indeed, creating constitutional rights to be free from regulation based solely upon a prior lack of regulation would undermine much of the modern administrative state, which, like drug regulation, has increased in scope as changing conditions have warranted.

Really?

Amendment IX: The enumeration in the Constitution, of certain rights, shall not be construed to deny or disparage others retained by the people.

|8.7.07 @ 4:09PM|#

Christopher Monnier,

Ah, but Amendment IX was nullified by the emanation from the penumbra of the sentence constructed by taking the second letter of the odd-numbered words from each sentence in the 14th, and then -- Look over there, a dinosaur!

|8.7.07 @ 4:22PM|#

creating constitutional rights to be free from regulation based solely upon a prior lack of regulation would undermine much of the modern administrative state,

A long way of saying "We don't want to fuck with federal employees' livelihoods. People need jobs after all."

x,y|8.7.07 @ 4:26PM|#

creating constitutional rights to be free from regulation based solely upon a prior lack of regulation would undermine much of the modern administrative state

Or a long way of saying, "We reserve the right (though we won't tell you where this right comes from) to regulate your ass in the future ... and in ways we didn't think of before."

|8.7.07 @ 6:25PM|#

Damn! Now if only we could have government ban pain and disease, none of us would have to worry.

Harry Pelosi|8.7.07 @ 6:29PM|#

Damn! Now if only we could have government ban pain and disease, none of us would have to worry.

Well the only things stopping it are a Republican filibuster and Bush's Veto pen

Pirate|8.7.07 @ 7:54PM|#

It is time to ignore every Un-Constitutional law, every law that makes no sense at all.

Every person who needs drugs, just buy them. This will help the under ground pharmacists.

Screw them and their laws. If every person would stand up and tell the Gov & Police to fuck-off and mean it, then they would be so over whelmed, the written words of their bullshit laws would mean nothing. This could effectively pull their teeth, and power.

We need a weed/hash march on D.C.

Or organize a National Screw Da' Man day where everyone can take to the streets and proclaim "YES! I get HIGH! Yes I smoke weed, so fucking what!".

Goldthwait|8.7.07 @ 8:30PM|#

While it is certainly desirable to allow patients earlier access to drugs under development, it is certainly not a right, just as affordable housing and universal health care aren't rights. Every desirable outcome is not enshrined in the Constitution.

|8.7.07 @ 8:52PM|#

While it is certainly desirable to allow patients earlier access to drugs under development, it is certainly not a right, just as affordable housing and universal health care aren't rights. Every desirable outcome is not enshrined in the Constitution.

Right. This is essentially the same trade-off made between universal health care and market based health care. From the opinion:

The FDA noted that "[i]n the realm of reviewing
medical products to treat serious and life-threatening diseases,
there is inevitable tension between early availability of products
to patients, especially patients with refractory disease, and the
need to obtain sufficient data to provide a reasonable
expectation of benefit and lack of excessive harm."

...

The FDA concluded that accepting the Alliance's proposal
"would upset the appropriate balance that [it is] seeking to
maintain, by giving almost total weight to the goal of early
availability and giving little recognition to the importance of
marketing drugs with reasonable knowledge for patients and
physicians of their likely clinical benefit and their toxicity."

Obviously, lack of universal health care will result in some patients not receiving essential treatments, resulting in disability or death. The justification generally given for this is that a market-based health care system creates incentives to develop new treatments faster, ultimately saving more lives in the long run.

In short, the long-term benefits of market based health care justify denying relief to currently ill patients now.

For whatever reason, that same moral logic is being faulted when the FDA refuses to make drugs available to currently ill patients in an effort to preserve the integrity of the data collected in it's clinical trials. Suddenly the needs of the currently ill take precedence over collecting the data which will eventually result in the relief of even a greater number of people.

Go figure.

Yeah, yeah, I know... it's a government thing....

|8.7.07 @ 9:36PM|#

While it is certainly desirable to allow patients earlier access to drugs under development, it is certainly not a right, just as affordable housing and universal health care aren't rights.

Bullshit. All the govt has to do for people to have early access to drugs is to get the fuck out of the way. Again, the question should not be whether the Constitution grants a right to early access but whether it grants Congress the power to prohibit such access.

That's not the case with affordable housing and universal health care. Those require additional govt interference in the economy.

Bopo|8.7.07 @ 10:00PM|#

"Bullshit. All the govt has to do for people to have early access to drugs is to get the fuck out of the way. Again, the question should not be whether the Constitution grants a right to early access but whether it grants Congress the power to prohibit such access"

I think the Constitution pretty clearly does grant Congress the right to put regulatory apparatus in place. Furthermore, the quote you gave is not far off from very valid point. Libertarians are just as guilty as fabricating rights from whole cloth as the other political philosophies are.

George Mikan|8.7.07 @ 10:03PM|#

"That's not the case with affordable housing and universal health care. Those require additional govt interference in the economy."

So when individuals sue companies when they suffer from previously unknown side effects of untested drugs, it will not require some sort of government interference with the economy?

SIV|8.7.07 @ 10:20PM|#

So when individuals sue companies when they suffer from previously unknown side effects of untested drugs, it will not require some sort of government interference with the economy?

SIV|8.7.07 @ 10:23PM|#

So when individuals sue companies when they suffer from previously unknown side effects of untested drugs, it will not require some sort of government interference with the economy?.

Only to throw the case out as there would be a contractual waiver of liability for the drug manufacturer/vendor on "un-tested" drugs.

damn tags

BruceM|8.7.07 @ 10:47PM|#

What a horrible and sad decision. Bush told the court they had to "fix" the prior panel decision, so the court granted rehearing en banc and reversed course. How sad.

That there is a presumption of regulation and a presumption that liberty does not exist is simply pathetic.

|8.7.07 @ 11:34PM|#

First, John Locke's "Letter Conserning Tolerance" takes the right to make one's own medical decisions as a given. Second, can these judges explain why congress bothered passing the 18th ammendment if they had the power to ban drugs all along?

|8.7.07 @ 11:42PM|#

x,y | August 7, 2007, 4:26pm | #

creating constitutional rights to be free from regulation based solely upon a prior lack of regulation would undermine much of the modern administrative state

Or a long way of saying, "We reserve the right (though we won't tell you where this right comes from) to regulate your ass in the future ... and in ways we didn't think of before."

Lawrence v. Texas, 539 U.S. 558 (2003) actually gives individuals juristiction over that region. Roe v Wade enshrines our rights over reproductive decisions. Apparently all other organs belong to the state.

Robert|8.8.07 @ 12:25PM|#

> Indeed, creating constitutional rights to be free from regulation based solely upon a prior lack of regulation would undermine much of the modern administrative state, which, like drug regulation, has increased in scope as changing conditions have warranted.

Really?

Amendment IX: The enumeration in the Constitution, of certain rights, shall not be construed to deny or disparage others retained by the people.

Yes, really. The trouble with that amendment is the impossibility of nailing down which rights people had and which threfore are retained. What evidence can there be? There mere lack of a law against something at a certain time doesn't establish that it would've been illegal to have such a law, when it may be that gov't forebore for the time being legislating in an area that they had the right to legislate in, and that the people had no right to be free from. And if there was a law on the subject, how do we know the law wasn't illegal and a usurpation of a right the people were supposed to have had?

About all that could be done would be to plumb the assertions of legal scholars of or in the past, i.e. expert testimony.

Robert|8.9.07 @ 12:35AM|#

I'm surprised that nobody in the case brought up the fact that, except for controlled substances or drugs or devices under active patent, it's not against federal law or boilerplate state pharmacy law for persons to make their own unlicensed drugs or medical devices, or to hire other people to make them for them. So it could be argued that the marketing of drugs in interstate commerce is not a matter of necessity for patients to obtain them.