Opinion
Case No. 01-1259-JTM.
August 10, 2001.
ORDER
This matter comes before the court on plaintiff's petition for a temporary restraining order seeking to enjoin defendant from denying coverage for a prescribed leukemia treatment. Plaintiff also requests waiver of the security bond requirement pursuant to Fed.R.Civ.P. 65(c). For the reasons set forth below, plaintiff's request for a temporary restraining order is denied.
I. Factual Background
Plaintiff is a resident of Sedgwick County, Kansas, an hourly employee of Raytheon who is covered under the terms of defendant's PCP Plan and Group Membership Agreement (the "Plan"). Defendant is a Kansas Corporation with all appropriate authorizations to offer insurance in the State of Kansas. Plaintiff suffers from acute myelogenous leukemia ("AML"). His primary care physician referred him to a local oncologist, Dr. Elshami Eliman, who further referred plaintiff to Dr. Francis Giles at the University of Texas, M.D. Anderson Cancer Center ("M.D. Anderson"). Dr. Giles is currently conducting a clinical trial involving the treatment of plaintiff's condition. The clinical trial is aimed at the actual treatment of AML as opposed to the mere maintenance of those with AML. Regarding the maintenance regimen, plaintiff has been prescribed certain maintenance doses of medications by his primary physicians. The maintenance medications are not experimental but are instead well accepted medications for AML. Without the maintenance medications, an AML sufferer has a very short life expectancy. Paragraph ten of plaintiff s verified petition suggests that plaintiff is currently receiving his maintenance dosages.
Dr. Giles evaluated plaintiff and approved him for the clinical trial at M.D. Anderson. Plaintiff asserts that defendant's refusal to pre-approve coverage for the clinical trial will cause plaintiff to miss the commencement of the protocol. Plaintiff has appealed defendant's denial of preapproval and appears to have taken the steps necessary to exhaust his administrative remedies. Defendant premised its denial of preapproval upon the Plan's experimental or investigational treatment exclusion. Section 5.15 of Article 5 of the Plan states:
Experimental and investigative procedures or treatments are excluded. Any treatment, procedure, facility, equipment, drug, device, or supply that We determine is not accepted as standard medical treatment for the condition being treated; or any item or technology requiring federal or other government agency approval which has not been granted at the time services are rendered are also excluded.Id. Dr. Giles's clinical trial involves, among other medications and forms of treatment, the treatment of plaintiff s condition with a new drug known as Gleevac. Plaintiff's petition argues that the "clinical trial is an appropriate treatment for Vick's condition, and not in its entirety `experimental or investigational' within the generally-accepted meaning of that term." Plaintiff's Verified Petition, at 5 (emphasis added). Further, in a letter from plaintiff's counsel to defendant, plaintiff's counsel argues:
Simply because a therapy is in the context of a clinical trial does not automatically make it "experimental or investigational" within the generally-accepted meaning of that phrase. Mr. Vick has been advised that only a single drug in the proposed protocol may possibly fit that definition. If that is indeed the case, denial of coverage for the full trial is not an appropriately measured reaction.
Plaintiff's Verified Petition, Ex. B, at 2 (emphasis added). It is clear from the context of the letter that plaintiff's counsel is referring to Gleevac as the single drug that may fit the "experimental" definition. The court notes that the clinical trial will pay for the Gleevac.
Defendant responded to plaintiff's counsel's letter by its own letter dated August 8, 2001, which plaintiff attaches to the Verified Petition as Exhibit C. After contacting M.D. Anderson and obtaining the details of the clinical trial protocol, defendant's chief medical officer reviewed the information and determined that Gleevac is untested as treatment of plaintiff s condition. As such, he determined that the Gleevac portion of the trial was "experimental and investigative." In response to plaintiff's arguments, defendant states:
The experimental exclusion applies to Gleevac and not to the continued management of his condition. It is only the Gleevac itself and any complications, associated testing and any required follow up related to this that is not covered. Anything determined by us not to be related to Gleevac will be considered for coverage at the appropriate benefit level."
Plaintiff's Verified Petition, Ex. C, at 3. Defendant's responsive letter also reflects a contact with Jody Bing, a case manager at M.D. Anderson. Ms. Bing indicated that plaintiff had incurred several visits at M.D. Anderson and had, in fact, started experimental treatment with Gleevac without any prior approval from either defendant or his primary care physician. As such, it appears based on the limited facts before the court, that M.D. Anderson may not require preapproval prior to the commencement of treatment.
II. Standards for Temporary Restraining Order
A temporary restraining order is an emergency remedy which may only issue in exceptional circumstances and only until the court can hear arguments or evidence on the subject matter of the controversy. It "is an extraordinary and drastic remedy, one that should not be granted unless the movant, by a clear showing, carries the burden of persuasion." Mazurek v. Armstrong, 520 U.S. 968, 117 S.Ct. 1865, 1867 (1997).
In order to obtain a temporary restraining order or a preliminary injunction, the plaintiff must establish: (1) that he will suffer an irreparable injury absent an injunction; (2) that the threatened injury outweighs the harm an injunction may cause the opposing party; (3) that an injunction would not be adverse to the public interest; and (4) that he is substantially likely to prevail on the merits. State of Utah v. Babbitt, 137 F.3d 1193, 1200 n. 7 (10th Cir. 1998). If the movant has satisfied the first three requirements, he may establish the "likelihood of success" requirement by showing there are questions going to the merits so serious or doubtful as to make the issues ripe for litigation and deserving of more deliberate investigation. Walmer v. U.S. Dept. of Defense, 52 F.3d 851, 854 (10th Cir. 1995).
III. Analysis and Discussion
Plaintiff's petition must fail because he has not established that he will suffer irreparable injury absent the temporary restraining order nor that he is substantially likely to prevail on the merits. Plaintiff argues that, absent injunctive relief, he will be irreparably harmed because any delay in treatment will compromise its effectiveness. Even assuming that M.D. Anderson will not allow plaintiff to participate in the protocol absent pre-approval, the impact of a brief delay is simply too speculative to support a temporary restraining order. Additionally, plaintiff does not suggest that the present dispute effects, in any way, his ability to obtain his required maintenance medications. As such, plaintiff's maintenance care is not hanging in the balance, but only the question of whether defendant will provide coverage for the more aggressive protocol. Here, plaintiff can obtain his maintenance care and has not established that great harm will occur if he does not immediately begin the protocol. To the end of making the protocol delay as brief as possible, the court intends to fully expedite this case toward its conclusion. While plaintiff may suffer some hypothetical and unquantifiable harm in the absence of injunctive relief, he has simply failed to make a sufficient showing of irreparable injury.
Nor has plaintiff established a substantial likelihood of success on the merits. Throughout his petition and accompanying statements by his counsel, plaintiff seems to recognize that the Gleevac treatment is arguably an experimental treatment for plaintiff's condition. Moreover, defendant's correspondence makes clear its position that the experimental exclusion applies only to the Gleevac treatment protocol and not to unrelated treatments for the management of plaintiff's condition. With plaintiff admitting that Gleevac very well could be considered an experimental treatment and defendant denying coverage only for that specific aspect of the protocol, the court finds that plaintiff has not shown a substantial likelihood of success on the merits of his underlying declaratory judgment action.
IT IS THEREFORE ORDERED this 10th day of August, 2001 that plaintiff's request for a temporary restraining order is denied and the accompanying request for waiver of the security bond is moot.