Terminally ill can now sue the FDA

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Terminally ill can now sue the FDA

Postby palmspringsbum » Fri May 12, 2006 11:41 am

The Irish Medical Times wrote:Terminally ill can now sue the FDA

By Emer Mullins
Irish Medical Times

A federal appeals court in Washington has given terminally ill patients seeking access to experimental, unapproved drugs a new chance at suing the Food and Drug Administration (FDA) by reinstating a lawsuit filed on behalf of the patients and returning the case to district court, according to the Associated Press (AP).

The case had initially been dismissed in district court in 2004. A year previously, the Abigail Alliance for Better Access to Developmental Drugs and the Washington Legal Foundation sued the FDA, seeking access to drugs for terminally ill people that had undergone preliminary safety testing, but had not been approved. The FDA does not usually approve drugs before they have been extensively tested on thousands of patients.

“Barring a terminally ill patient from the use of a potentially life-saving treatment impinges on this right of self-preservation,” Judge Judith W. Rogers wrote in the 2-1 opinion from the panel of the US Court of Appeals for the District of Columbia Circuit, according to the AP.

The ruling was described as a big defeat for the FDA by Paul Kamenar of the Washington Legal Foundation.

“The FDA has long prohibited life-saving medicines for terminally ill patients,” he said. “We think this is a tremendous victory for patient groups and those who are in need of these kinds of medicines.”

The FDA can now ask for the full appeals court to rehear the case. Otherwise, it returns to the lower court, the news agency reported.

Judge Thomas B. Griffith, in a dissenting opinion, said the cases raise “a number of vexing questions,” including whether patients could access any drug, including marijuana, that they and their doctors believe is potentially lifesaving. “Would the majority’s right guarantee access to federally funded stem cell research and treatment?” Griffith asked.

Frank Burroughs, president of the Abigail Alliance, was quoted as saying that providing access shouldn’t be solely an FDA decision.

“The decision is the patient’s decision, in consultation with their doctor, knowing at the time the known risks and benefits.”

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Postby palmspringsbum » Tue May 16, 2006 10:46 am

The American Thinker wrote:Preserving Self-Preservation

The American Thinker
May 16th, 2006

This month the D.C. Circuit Court of Appeals affirmed that there is a fundamental right of self-preservation protected by the U.S. Constitution. In Abigail Alliance v. Eschenbach (D.C. Cir. 2006), the D.C. Circuit faced a due process challenge to Food & Drug Administration (FDA) regulations for approval of new medical drugs.

Plaintiffs, represented by the Washington Legal Foundation, claimed persons should be free of government prohibition in obtaining pre-approval stage medications for life-preserving purposes. A 2-1 majority held the plaintiffs raised a valid constitutional claim and remanded the case for a trial. The onus is now on the FDA to prove a compelling governmental interest in prohibiting use of unapproved and potentially risky drugs until official approval is given.

The D.C. Circuit has given explicit recognition to the oft-forgotten right of self-preservation, though it arguably leaves open questions about the scope of government’s ability to regulate medical drugs.

The plaintiffs limited their claim to “mentally competent, terminally ill adult patients who have no alternative government-approved treatment options.” Specifically, they seek to prevent enforcement of FDA policy barring sales of new and potentially life-saving drugs that the FDA has not officially approved but nonetheless determined are sufficiently safe for expanded human testing.

In this case, sufficiently safe drugs are ones that have obtained Phase I approval. Under FDA regulations, Phase I involves new drug testing on 20 to 80 human subjects to determine side effects and obtain evidence of effectiveness. This takes approximately a year. Phase II involves targeted, controlled clinical studies of up to several hundred human subjects for evaluation of effectiveness and to determine common short-term side effects. Expanded trials of up to several thousand humans for the gathering of effectiveness and risk-benefit evaluations are conducted in Phase III.

In an opinion penned by Judge Judith W. Rogers (joined by Chief Judge Douglas Ginsburg), the panel’s majority concluded that liberty interests protected by the Due Process Clauses of the 5th and 14th Amendments extend to a right of self-preservation. Judge Rogers examined the right of self-preservation in light of the U.S. Supreme Court’s decision in Cruzan v. Director, Missouri Department of Health (1990).

Wrote Judge Rogers, Cruzan’s recognition of an individual’s right to make an informed decision refusing life-saving treatment to leads to the “logical corollary” than an individual must also be free to decide whether to assume risks unap proved life-saving medicine. Judge Rogers cited to Sir William Blackstone and common-law doctrines of self-defense and self-preservation, contrasted them with the more recent phenomena of drug regulation in America. Her conclusion: the right of self-preservation is “an individual liberty deeply rooted in our Nation’s history and tradition.” Judge Thomas B. Griffith dissented in a separate opinion.

It seems odd that the decision frequently invokes only the “liberty interests” of 5th and 14th Amendment Due Process Clauses. Particularly so because those clauses also contain the word “life”—the presence of which suggests a presumption favoring life in law.

Self-preservation is so basic to liberal democracy that it seldom seems necessary to explicitly defend. It has long been all too obvious for explicit recognition in judicial opinions. After all, the very purpose of government is to protect the life and rights of its citizens.

This “too-obviousness” might go to explain why the D.C. Circuit’s majority described the right of self-preservation as something deduced from an individual’s right to refuse life-saving medication. As a matter of first principle, one may better argue that persons first have a “life interest” in seeking such medication. This would be consistent with John Locke’s insistence that people have property in their own person and a right to defend it. Such a life interest should also inform an individual’s “liberty interest” in choosing whether to obtain or refuse life-saving medication.

A presumption of life should therefore serve as the backdrop of any judicial examination of such government regulation. Properly understood, it would present no absolutist or radical barrier to regulation of medications. Presumptions can be overcome where there is sufficient reason. For instance, an individual’s right to informed consent and refusal of unwanted life-saving treatment can certainly provide compelling basis for overcoming a presumption of life. Recognition of a presumption of life also harmonizes with the Supreme Court’s rejection of any right to assisted suicide under the U.S. Constitution.

The D.C. Circuit ruling is itself confined to patients seeking life-preserving medications that have passed Phase I clinical trials. Judge Rogers rightly rejected any suggestions that the majority implicitly created a welfare right to drugs or to have implicitly legalized marijuana. Contrary to the dissent of Judge Griffith, the majority did neither of those things.

While not establishing any per se right to post-phase I medications for terminally ill patients, FDA must now prove at trial that a compelling governmental interest supports its regulations. This is a higher threshold than it faced before. The trial judge previously dismissed the plaintiffs claim and upheld FDA regulations by applying the more deferential “rational basis” standard. It is no high bar for a judge to ask an unelected administrative agency to demonstrate there is a conceivably rational relation between its regulation and a conceivably legtimite governmental interest. Now the FDA has to better articulate the importance of its regulatory schema.

If the FDA can establish such a compelling interest (such as public health and safety) and pursuasively argue that the interest is narrowly tailored to achieve that purpose, the FDA will be able to override the right of self-preservation claim. The FDA claims it has existing procedures to make potentially lifesaving drugs available before official approval, which could tip the scale in its favor. But even if the FDA satisfies this test, the D.C. Circuit’s decision has given important respect and constitutional recognition to the natural and common-law right of self-preservation.

Seth Cooper is an attorney in Washington State. He is a contributing blogger at Guns and Butter.

Seth Cooper

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