Federal Appeals Court Rules Terminally Ill Patients Can Sue FDA for Treatment with Experimental Drugs

In reversing a 2004 dismissal by the U.S. District Court, the U.S. Court of Appeals for the D.C. Circuit reinstated the complaint in a lawsuit that seeks access to experimental drugs, with only limited preliminary testing, by terminally ill patients.

Prescription drugs, especially those designed to combat potentially fatal diseases, are required to undergo clinical testing that is broken down into three “phases” that can often take many years to complete.  

Phase I trials focus on safety and usually involve very small test groups. Phase II trials are concerned with establishing a drug’s effectiveness. Phase III trials are the largest studies and seek to determine as many of the adverse reactions and side effects of a drug as possible. There may be multiple tests at each level (such as Phase IIa and Phase IIb, for example). Only drugs that successfully complete Phase III trials are submitted for approval by the FDA in what is known as a New Drug Application (NDA).For terminally ill patients, however, the wait for a potential treatment may simply be too long. There is also the consideration that such patients are going to die anyway thereby making the possible risks, of even an experimental drug, far less of an obstacle.

In short, terminally ill patients have very little or nothing to lose by acting as test subjects for experimental drugs that are still in Phase I trials where they may only have been tested on as few as 20 people. The FDA has always prohibited terminally ill patients from access to potentially lifesaving medications that have not been approved.

The Circuit Court, by a 2 to 1 vote, determined that the suit brought by the Abigail Alliance for Better Access to Developmental Drugs and the Washington Legal Foundation against the Food and Drug Administration in 2003 should have been permitted to proceed.

The Court found that: “Barring a terminally ill patient from the use of a potentially lifesaving treatment impinges on this right of self-preservation.”  This decision is seen as a major loss for the FDA, which now must decide on whether to (1) ask for a rehearing by the full D.C. Circuit sitting en banc, (2) to seek a writ of certiorari to the U.S. Supreme Court, or (3) go back to the district court and proceed to conclusion of the case and then appeal any adverse determination. In any case, the action will likely take years to finally resolve.

While the decision of the circuit court does reinstate the complaint, it does not preordain any particular result. The lone dissenting judge saw the majority decision as problematic in that it opened the door to potentially “vexing questions” such a what treatments could a doctor prescribe as potentially lifesaving thereby forcing such issues as the use of medical marijuana and stem cell treatment.

Sen. Sam Brownback (R-Kansas), introduced a bill (SB1956) in 2005 that would require the FDA to institute a program to expand access to experimental drugs for patients with serious or life-threatening conditions and diseases. The bill was referred to committee in November of last year.

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