Last week, the United States Court of Appeals for the District of Columbia Circuit granted a rehearing and vacated the May 2, 2006 decision of a three judge panel holding that a terminally ill mentally competent adult excluded from Phase II clinical trials has the right, under the Fifth Amendment Due Process Clause, to use post-Phase I investigational drugs that do not have FDA approval for commercial distribution. Chief Counsel for the Washington Legal Foundation speculates that all ten judges for the D.C. Circuit will hear the case sometime next summer.
In 2003, Abigail Alliance brought suit against Andrew C. von Eschenbach, acting Commissioner of the FDA, and Michael O. Leavitt, Secretary of the U.S. Department of Health and Human Services, after the FDA rejected Abigail Alliance's formal request to make post-Phase I drugs available to terminally ill patients who are not clinical trial participants. After the FDA's rejection of the proposed policy, Abigail Alliance filed a Citizen Petition challenging the FDA's decision. While the FDA acknowledged the receipt of the Citizen Petition, the FDA failed to respond within the requisite 180 day time period, thereby entitling Abigail Alliance to seek judicial review. Abigail Alliance then brought suit to enjoin the FDA from enforcing its current policy that bans the use of post-Phase I investigational drugs by terminally ill patients excluded from Phase II clinical trials.
The May 2, 2006 appellate court opinion in the Abigail Alliance case, filed by a three judge panel, applied the substantive due process test established in Washington v. Glucksberg, 521 U.S. 702, 710 (1997), which includes a two-fold analysis to determine whether a right is fundamental and warrants due process protection. The Glucksberg test requires a court to first determine whether the right asserted is "objectively, deeply rooted in this Nation's history and tradition." Second, the court must evaluate whether the asserted right is "implicit in the concept of ordered liberty, such that neither liberty nor justice would exist if [it] were sacrificed."
Examining the first inquiry, the court stated that, "[d]espite the FDA's claims to the contrary, . . . it cannot be said that government control of access to potentially life-saving medication 'is now firmly ingrained in our understanding of the appropriate role of government' . . . so as to overturn the long-standing tradition of the right of self-preservation." Regarding the second inquiry, the court held that the right asserted by Abigail Alliance could be inferred from the Supreme Court's ruling in Cruzan v. Director, Missouri Dept. of Health, 497 U.S. 261 (1990), which found that individuals have a constitutionally protected right to refuse life saving medical treatment. Accompanying this right, the court stated, is "the right to access potentially life-sustaining medication where there are no alternative government-approved treatment options . . . . [T]he key is the patient's right to make the decision about her life free from government interference."
After concluding that the right asserted by Abigail Alliance merits due process protection, the court remanded the case to the district court to determine whether the FDA's current policy withstands the application of the rigorous strict scrutiny review--essentially, to determine whether the policy is narrowly tailored to serve a compelling governmental interest.
Blogosphere Confusion
As noted by How Appealing, apparently there was some confusion in the blogosphere about the D.C. Circuit's ruling. On the same day that the D.C. Circuit issued the order vacating its decision, the three judge panel also denied the defendants' request for a panel rehearing. While the D.C. Circuit posted online the panel's explanation for denying rehearing, the "D.C. Circuit did not post online as a published opinion the court's order granting rehearing en banc in the case." Because the order granting a rehearing en banc was not published but the order denying panel rehearing was published, "[a]nother law blogger depicted yesterday's D.C. Circuit developments as a loss for the federal government, which was correct based on available information but absolutely incorrect once the previously unknown grant of the federal government's petition for rehearing en banc became public." The other blogger referenced maintains that the post was in fact correct, but nevertheless, this was very confusing.
Accordingly, How Appealing argues that "all federal appellate courts should begin to follow the approach of the Fifth and Ninth Circuits in posting online as published opinions those courts' orders granting rehearing en banc. A federal appellate court's decision to grant rehearing en banc in a case is a significant development that should not remain hidden from the public inside a password-required PACER docket."
