On appeal from Superior Court of New Jersey, Chancery Division, Probate Part, Hunterdon County, Docket No. 42827.
NOT FOR PUBLICATION WITHOUT THE APPROVAL OF THE APPELLATE DIVISION
Argued September 15, 2009
Before Judges Skillman and Simonelli.
Appellant William Fallon is a co-guardian of his brother Michael Fallon, who is a patient residing in the Hagedorn Psychiatric Hospital, which is operated by the Division of Mental Health Services. Michael has suffered from schizophrenia for approximately thirty years and has undergone multiple treatments with anti-psychotic drugs during that period. However, he has not responded favorably to those treatments and his condition has continued to deteriorate.
Michael has been a patient at Hagedorn since 2006, and before that, he was a patient at Ancora Psychiatric Hospital. Michael has been treated in recent years primarily with a drug called clozapine. However, Michael has not received any significant benefit from clozapine, either administered alone or in combination with other anti-psychotic drugs. Consequently, he has been diagnosed with "treatment refractory" chronic schizophrenia.
William undertook independent research to determine whether there was any other drug regimen that might be more effective in treating Michael. This research disclosed that a drug called amisulpride, administered in conjunction with clozapine, has provided a degree of relief to some treatment refractory chronic schizophrenics. This drug is available in Europe under the trade name Solian. However, amisulpride is not approved by the Food and Drug Administration (FDA) for administration to patients in the United States. According to William, amisulpride is unlikely ever to be approved by the FDA because the manufacturer must bear the substantial costs of such an approval and the limited market for amisulpride would not justify the expenditure.
After William determined that amisulpride, administered in conjunction with clozapine, could potentially provide his brother with more effective treatment than his previous drug regimens, he retained a consulting psychiatrist, Dr. David L. Nathan, to review Michael's treatment plan. Dr. Nathan met with Michael on several occasions and reviewed his prior course of treatment. One of the conclusions reached by Dr. Nathan was that consideration should be given to the "addition of amisulpride as adjunctive treatment to ongoing clozapine therapy."
William subsequently inquired as to whether Hagedorn and the Division of Mental Health Services would allow the administration of amisulpride to Michael if William were able to obtain this drug from a foreign source under the FDA's "personal use exception," which is discussed later in this opinion. However, Hagedorn and the Division declined William's request that Michael be given access to this drug. This administrative decision was apparently not memorialized in writing.
William then brought an action in the Chancery Division seeking an order directing Hagedorn to allow for the administration of amisulpride in conjunction with clozapine to Michael as recommended by Dr. Nathan.
While the action was pending, the parties engaged in further discussion regarding the administration of amisulpride to Michael, which resulted in a letter to William's counsel from the Deputy Attorney General representing Hagedorn and the Division, dated July 1, 2008, which stated:
I spoke with staff from the Division of Mental Health Services yesterday, and the Division believes that written approval from the Federal Food and Drug Administration allowing the personal use of amisulpride by Michael Fallon may constitute "other Federal Food and Drug Administration approval" required by N.J.A.C. 13:39-7.5. Although we cannot guarantee at this time that such an approval will remove all obstacles from your client's efforts to have amisulpride administered to Michael Fallon, without that approval, Hagedorn Psychiatric Hospital cannot permit the administration of the drug. Therefore, we urge you and your client to take whatever steps are necessary to obtain that approval.
Thereafter, the trial court entered an order transferring the case to this court on the ground that it constitutes a challenge to final state agency action. See R. 2:2-3(a)(2).
After the case was transferred to this court, William filed a motion to supplement the record with his own certification and attached exhibits, which included information concerning relevant developments subsequent to the filing of his complaint in the Chancery ...