IN THE MATTER OF MICHAEL J. FALLON

NOT FOR PUBLICATION WITHOUT THE

APPROVAL OF THE APPELLATE DIVISION

SUPERIOR COURT OF NEW JERSEY

APPELLATE DIVISION

DOCKET NO. A-5751-07T15751-07T1

IN THE MATTER OF

MICHAEL J. FALLON,

an Incapacitated Person.

____________________________________________________

 

Argued September 15, 2009 - Decided

Before Judges Skillman and Simonelli.

On appeal from Superior Court of New Jersey, Chancery Division, Probate Part, Hunterdon County, Docket No. 42827.

Nina E. Weiss argued the cause for appellant William Fallon (Serra Weiss, attorneys; Ms. Weiss, on the briefs).

Susan J. Dougherty, Deputy Attorney General, argued the cause for respondent Hagedorn Psychiatric Hospital (Anne Milgram, Attorney General, attorney; Melissa H. Raksa, Assistant Attorney General, of counsel; Ms. Dougherty, on the brief).

PER CURIAM

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 Division. We granted the motion by an order entered on December 12, 2008.

William's certification indicates that Dr. Nathan wrote a prescription for a three-month supply of Solian (the brand name for amisulpride), which was filled by a London pharmacy and received by Dr. Nathan on October 13, 2008. No formal approval was obtained from the FDA for importation of the drug. However, William alleges that the amisulpride was "imported in accordance with the personal use exception and without incident as far as I know." William's supplemental certification also indicates that he has retained Dr. Nathan and a private nurse, who would be paid by him, to dispense and administer the drug to Michael two times daily. In addition, this certification states that William has "agreed to release Hagedorn from any and all liability associated with the administration of the drug."

William argues that Hagedorn's refusal to participate in the proposed administration of amisulpride to Michael is contrary to his best interests and therefore unreasonable. He also argues that the administration of this drug is appropriate, even though it has not been approved by the FDA, because the FDA's personal use exception applies under the circumstances of this case.

We conclude that the July 1, 2008 letter of the Deputy Attorney General representing Hagedorn and the Division does not constitute final state agency action reviewable by this court. We also conclude that the letter does not contain an adequate statement of reasons justifying Hagedorn's refusal to participate in the proposed administration of amisulpride to Michael. Therefore, the case must be remanded to the Assistant Commissioner for the Division of Mental Health Services, as the official with decision-making authority regarding the administration of the state mental hospitals, for reconsideration, and if he reaffirms the position heretofore taken by the Division, the issuance of a more complete statement of reasons for this agency action. In addition, we conclude that the Assistant Commissioner should undertake efforts to obtain an opinion by the FDA as to whether amisulpride is a drug that may be imported under the FDA's personal use exception, or alternatively, to decide whether there is other satisfactory medical evidence of the appropriateness of administration of this drug.

An opinion by the Attorney General is not final agency action subject to appellate review. N.J. Civil Serv. Ass'n v. State of N.J., 88 N.J. 605, 612 (1982); In re Proposed Xanadu Redevelopment Project, 402 N.J. Super. 607, 630 (App. Div.), certif. denied, 197 N.J. 260 (2008). Only the action or inaction of the State agency upon which the Legislature has conferred decision-making authority is subject to our review. See N.J. Civil Serv. Ass'n, supra, 88 N.J. at 612.

The Legislature has assigned responsibility to the Commissioner of Human Services for the operation and administration of the state mental hospitals. N.J.S.A. 30:1-12(b). The Commissioner has delegated this responsibility to the Assistant Commissioner for the Division of Mental Health Services. See N.J.S.A. 30:1-9. Consequently, when a dispute arises concerning the care or treatment of a patient in a state mental hospital, the Assistant Commissioner must make the final decision regarding that dispute. Although the July 1, 2008 letter from the Deputy Attorney General assigned to the Division indicates that she had "spoke[n] with staff from the Division of Mental Health Services," there is no indication the Assistant Commissioner personally reviewed the matter, and in any event, a letter from an attorney representing a State agency in litigation cannot serve as a substitute for a decision by the agency head.

Furthermore, the Deputy Attorney General's letter does not contain a reasoned justification for the refusal of Hagedorn and the Division to participate in the proposed administration of amisulpride to Michael. It simply indicates that the Division might be willing to reconsider its refusal if William were able to secure "written approval" from the FDA for administration of the drug to Michael.

We note that the Attorney General's brief on behalf of Hagedorn and the Division does present several reasons for the refusal to participate in the administration of amisulpride to Michael. Those reasons are summarized in the "preliminary statement" section of the Attorney General's brief:

Amisulpride has not been approved by the United States Federal Drug Administration (the FDA), and the State's Board of Pharmacy regulations, the hospital's own policies and procedures, and the State's contract with its pharmacy provider all prohibit the administration of a non-FDA approved drug to a patient admitted to Hagedorn. Moreover, the procedures proposed by appellant for the administration of the drug by an independent psychiatrist and a private nurse violate Hagedorn's own policies and procedures.

However, we have no way of knowing whether these reasons simply represent the arguments of an appellate advocate or reflect the considered views of the Assistant Commissioner. Therefore, before this court can undertake to determine the reasonableness of this agency action, the matter must be remanded to the Assistant Commissioner for reconsideration of the agency's decision, and if he reaffirms that decision, for a complete statement of reasons.

If the Assistant Commissioner concludes, as indicated in the Deputy Attorney General's July 1, 2008 letter, that "written approval from the [FDA] allowing the personal use of amisulpride by Michael" is a prerequisite to the Division's approval of the administration of this drug, we direct the Assistant Commissioner to seek an opinion by the FDA as to whether amisulpride is a drug that may be imported under the FDA's personal use exception.

This exception is set forth in section 9-2 of the FDA's Regulatory Procedures Manual. FDA, Regulatory Procedures Manual: Import Operations & Actions: Coverage of Personal Importations 9-2 (2009). Section 9-2 provides in pertinent part:

FDA personnel may use their discretion to allow entry of shipments of violative FDA regulated products when the quantity and purpose are clearly for personal use, and the product does not present an unreasonable risk to the user.

. . . .

In deciding whether to exercise discretion to allow personal shipments of drugs or devices, FDA personnel may consider a more permissive policy in the following situations:

. . . .

2. when a) the intended use is unapproved

and for a serious condition for which

effective treatment may not be avail-

able domestically either through commercial or clinical means; b) there is no known commercializa-tion or promotion to persons residing in the U.S. by those involved in the distribution of the product at issue; c) the product is considered not to represent an unreasonable risk; and d) the individual seeking to import the product affirms in writing that it is for the patient's own use (generally not more than 3 months supply) and provides the name and address of the doctor licensed in the U.S. responsible for his or her treatment with the product, or provides evidence that the product is for the continuation of a treatment begun in a foreign country.

. . . .

When a shipment is not refused entry, FDA personnel may consider issuing a "Release with Comment" and, as appropriate, advise the recipient that 1) the drug (or device) that has been obtained for personal use appears to be unapproved in the United States; 2) the drug (or device) should be used under medical supervision; 3) FDA may detain future shipments of this product; and 4) the patient's physician should consider for example, enrolling the patient in an Investigational study or applying for Investigation New Drug (IND), Compassionate IND, or Treatment IND exemption.

Although the FDA has set forth the terms of the personal use exception in the Regulatory Procedures Manual, William claims that the administration of this exception is "quite informal" and that a person who imports a non-FDA approved drug under the exception does not obtain any form of written approval from the FDA. Consequently, William claims that he has been placed in a "catch-22," in which the Division is requiring him to obtain a "written approval" from the FDA that the FDA will not issue. However, despite the informality with which the personal use exception is apparently administered, it is not self-evident from the record before us that the FDA will never render an opinion concerning the appropriateness of importation of a particular drug under the personal use exception, particularly if the request for that opinion comes from another government agency. Therefore, the Assistant Commissioner should seek such an opinion if he considers it to be a prerequisite for allowing the administration of amisulpride to Michael.

Alternatively, the Assistant Commissioner should consider whether there is other satisfactory evidence of the appropriateness of administration of this drug, including the medical literature relied upon by William and the opinions of Drs. Nathan and Ongur.

In addition, if the Assistant Commissioner concludes that N.J.A.C. 13:39-7.5(a), adopted by the Board of Pharmacy, may have some relevancy to this matter even though amisulpride has already been dispensed to Dr. Nathan by a London pharmacy and William proposes to have Dr. Nathan and a private nurse administer the drug to Michael, he should seek an opinion by the Board as to whether N.J.A.C. 13:39-7.5(a) would apply in these circumstances. We note in this respect that the Board of Pharmacy's jurisdiction only extends to the regulation of the practice of pharmacy and that the Board has no jurisdiction over the practice of medicine or nursing. See N.J.S.A. 45:14-48; N.J.A.C. 13:39-1.1.

Finally, the Assistant Commissioner should consider the relevancy of the Division of Mental Services' Pharmacology and Practice Guidelines to William's request that amisulpride should be administered to Michael. We note in this respect that Hagedorn's answering brief acknowledges that "none of the available FDA-approved drugs have been effective in [Michael's] treatment, and that Amisulpride in combination with Clozapine has been effective with other individuals who suffer from treatment-resistant schizophrenia."

Accordingly, we remand the case to the Assistant Commissioner for the Division of Mental Health Services for reconsideration in conformity with this opinion. We retain jurisdiction. The remand shall be completed no later than December 4, 2009.

 

William's complaint asserts that Michael's co-guardian, their mother, Marion Fallon, is in agreement with the proposed administration of amisulpride together with clozapine. Although not expressly stated, we presume she would join in this waiver of liability.

We are advised that the position of Director of the Division of Mental Health Services has been abolished and the responsibilities formerly performed by the Director are now performed by an Assistant Commissioner.

The authorization for this exception is provided by 21 U.S.C.A. 384(j)(1)(B), which states:

Congress declares that in the enforcement against individuals of the prohibition of importation of prescription drugs and devices, the Secretary should

. . . .

(B) exercise discretion to permit individuals to make such importations in circumstances which

(i) the importation is clearly

for personal use; and

(ii) the prescription drug

or device imported does not ap-

pear to present an unreasonable

risk to the individual.

In addition, 21 U.S.C.A. 384(j)(2) provides:

(A) In general

The Secretary may grant to individuals, by regulation or on a case-by-case basis, a waiver of the prohibition of importation of a prescription drug or device or class of prescription drugs or devices, under such conditions as the Secretary determines to be appropriate.

(B) Guidance on case-by-case waivers

The Secretary shall publish, and update as necessary, guidance that accurately describes circumstances in which the Secretary will consistently grant waivers on a case-by-case basis under subparagraph (A), so that individuals may know with the greatest practicable degree of certainty whether a particular importation for personal use will be permitted.

(end of footnote)

The suggestion in the Deputy Attorney General's letter that the FDA should be asked to approve the administration of amisulpride to Michael is clearly unreasonable. The determination whether the administration of this drug to Michael would be appropriate would require a review of his past course of treatment, such as was performed by Dr. Nathan, which the FDA could not be expected to undertake. Therefore, any inquiry to the FDA should be limited to the appropriateness of importation of amisulpride under the personal use exception.

(continued)

(continued)

2

A-5751-07T1

October 1, 2009