Weaver v. Reagen, 87-4314-CV-C-5.

• Decision Date: 29 September 1988
• Docket Number: No. 87-4314-CV-C-5.,87-4314-CV-C-5.
• Citation: 701 F. Supp. 717
• Parties: Glenn C. WEAVER, T.G., and Mark Momot, individually and on behalf of all others similarly situated, Plaintiffs, v. Michael REAGEN, Director of the Missouri Department of Social Services; and Jane Y. Kruse, Director of the Missouri Division of Medical Services, Defendants.
• Court: U.S. District Court — Western District of Missouri

701 F. Supp. 717

Glenn C. WEAVER, T.G., and Mark Momot, individually and on behalf of all others similarly situated, Plaintiffs, v. Michael REAGEN, Director of the Missouri Department of Social Services; and Jane Y. Kruse, Director of the Missouri Division of Medical Services, Defendants.

No. 87-4314-CV-C-5.

United States District Court, W.D. Missouri, C.D.

September 29, 1988.

Herbert A. Eastman, St. Louis University Law School, Ann Lever, Legal Services of Eastern Missouri, St. Louis, Mo., for plaintiffs.

Missouri Atty. Gen., Jefferson City, Mo., for defendants.

ORDER

SCOTT O. WRIGHT, District Judge.

Before the Court are plaintiffs' motion for class certification, and cross-motions for summary judgment filed by plaintiffs and defendants. For the following reasons, the Court concludes that this action is properly certifiable as a class action. Additionally, the Court concludes that defendants' motion for summary judgment must be denied and that summary judgment must be entered in favor of plaintiffs.

Factual Background

Plaintiffs Glenn C. Weaver, T.G., and Mark Momot bring this action individually and also seek certification of a class of Medicaid recipients who are unable to obtain the drug Retrovir ("AZT") under the Missouri Medicaid Programs. Plaintiffs claim that defendants' refusal to place the drug AZT on the Missouri Medicaid Drug List, or otherwise provide Medicaid coverage for the drug through defendants' exception process, violates federal regulations 42 C.F.R. §§ 440.230(b) and 440.240(b), and 42 U.S.C. § 1983. Thus, they allege that this denial is invalid under the Supremacy Clause of the United States Constitution. Plaintiffs seek declaratory and injunctive relief for themselves and the proposed class to enable them to obtain Medicaid coverage for AZT. In other words, plaintiffs seek to enjoin defendants from continuing to deny coverage of AZT to Medicaid recipients under the Missouri Medicaid Program.

The defendants in this action are Dr. Michael Reagan, Director of the Department of Social Services and Jane Kruse, Director of the Division of Medical Services.

The facts, as set forth in the pleadings and the affidavits filed in support of the parties' motions for summary judgment, are generally undisputed. This action was initially filed on October 5, 1987, with plaintiff Weaver being the only named class representative.

In plaintiff's initial complaint, plaintiff Weaver alleged that he was first diagnosed as suffering from Acquired Immune Deficiency Syndrome ("AIDS") in November of 1986. Plaintiff Weaver alleged that he had been determined to be eligible for Medicaid and that since that time he has suffered from a variety of medical problems resulting from AIDS, specifically pneumocystis carinii pneumonia, substantial weight loss, fevers, night sweats, and numerous infections. Plaintiff Weaver further alleged that his physician had prescribed AZT for the treatment of plaintiff Weaver's AIDS, and that plaintiff Weaver could not fill that prescription because he lacked the financial resources to pay the cost himself and Missouri's Medicaid Program would not, at that time, cover AZT for Medicaid-eligible individuals. In that first complaint, plaintiff Weaver alleged that he applied under Missouri's exception procedure for coverage of his Retrovir prescription, but that defendants would not cover Retrovir under their exception procedures. At the time this complaint was filed, the State of Missouri did not provide any Medicaid coverage for AZT.

The drug AZT is the only approved treatment for AIDS. AZT has been approved by the United States Food and Drug Administration ("FDA") as a safe and effective treatment for AIDS and is the only drug for AIDS which has been approved by the FDA. The Health Care Financing Administration has advised state Medicaid agencies to include AZT under the Medicaid program for recipients who have AIDS.

Shortly after the filing of this action, the Missouri Department of Social Services promulgated an emergency rule, which has since become a final state rule, including AZT under the Missouri Medicaid Program under certain circumstances. This rule, 13 C.S.R. 70-20.110 Medicaid Program Coverage of Approved Drugs for Treatment of Acquired Immunodeficiency Syndrome (AIDS), now provides for coverage for the drug AZT as follows:

"(1) The availability of the drug Zidovudine, formerly known as Azidothymidine AZT, for Missouri Medical Coverage shall be limited to only those eligible Medicaid recipients for whom the prescribing physician has established a medical diagnosis of acquired immunodeficiency syndrome (AIDS) and who have a history of cytologically confirmed pneumocystis carinii pneumonia (PCP) or an absolute CD4 (T4 helper/inducer) lymphocyte count of less than two hundred (200) per cubic millimeter in the peripheral blood before therapy is begun."

This language is virtually identical to FDA's approval statement for the drug.

On March 20, 1987, the FDA announced its approval of AZT for marketing under the brand name "Retrovir" by the Burroughs Wellcome Company. Missouri received notification from the Health Care Financing Administration ("HCFA") with the FDA's approval statement as follows:

"Retrovir capsules are indicated for the management of certain adult patients with symptomatic HIV infection (AIDS and advanced ARC AIDS Related Complex) who have a history of cytologically confirmed Pneumocystis carinii or an absolute T4 helper/inducer lymphocyte count of less than 200/cu mm in the peripheral blood before therapy is begun."

Thus, it is undisputed that the FDA has approved the use of AZT for AIDS patients who either have a history of cytologically confirmed Pneumocystis carinii or an absolute T4 helper/inducer lymphocyte count of less than 200. It is also undisputed that the Missouri Medicaid program provides reimbursement for the use of AZT in patients who meet either of those criteria.

Based upon this change in position, defendants, on August 26, 1987, moved for dismissal of this action, alleging that plaintiff Weaver had become eligible as a Medicaid recipient for coverage of AZT and, thus, the action was rendered moot for lack of a case or controversy.

In response to defendants' motion to dismiss, plaintiffs filed a first amended complaint on December 8, 1987, adding plaintiff T.G., proceeding under a psuedonym and allegedly suffering from AIDS, but who did not meet the criteria set forth in Missouri's Medicaid program for coverage of the drug AZT. More specifically, the first amended complaint was identical to the original complaint except that it further alleged in ¶ 22:

"Plaintiff T.G., who is proceeding under a pseudonym, was first diagnosed as infected with the AIDS virus in February of 1987. He has applied for and has been informed by the Missouri Department of Social Services that he is eligible for Medicaid. Since the diagnosis, he has suffered from a variety of diseases, including Kaposi's sarcoma. Plaintiff's physician has prescribed Retrovir for the plaintiff's treatment. Plaintiff cannot fill and will not be able to fill the prescription because he lacks the financial resources to pay the cost himself and Missouri's Medicaid Program does not cover Retrovir."

On May 10, 1988, defendants filed motions for summary judgment, alleging essentially two grounds in support thereof. First, defendant alleges that since plaintiff T.G. has never applied for Medicaid coverage of AZT, then there is no case or controversy between plaintiff T.G. and the defendants. As to plaintiff Weaver, defendants allege that his application has been sustained and that Medicaid is currently covering his use of AZT to the extent the drug is prescribed and taken by him. Thus, defendants argue that the case is now moot.

Second, defendants argue that Medicaid coverage of AZT may be limited if there is a rational basis and that when that limitation is based upon the FDA's approved indications for the use of that drug, defendants cannot be legally forced to provide unlimited Medicaid coverage. Furthermore, defendants argue that if Missouri is forced to provide Medicaid coverage of AZT for individuals who do not fall within the FDA definition, then the State would be in violation of federal food and drug laws.

On July 21 and 26, 1988, plaintiffs filed their cross-motion for summary judgment and their suggestions in support of this motion, respectively. In these suggestions, plaintiffs argue that they have submitted numerous, uncontroverted affidavits establishing the medical necessity of AZT for treatment of these plaintiffs and that, under the controlling law in this Circuit, they are entitled to judgment as a matter of law, given the lack of any genuine dispute of material fact on this issue.

Also, on July 26, 1988, plaintiffs filed a motion to intervene on behalf of plaintiff Mark Momot, along with a second amended complaint that was tendered to the Clerk's Office. In this motion to intervene, plaintiff Momot stated that:

"2. He is a member of the class of persons proposed to be certified as a plaintiff class pursuant to Rules 23(a) and 23(b)(2) in this suit. Specifically, applicant Mark Momot has been determined eligible for Medicaid, is infected with the AIDS virus, his physician has prescribed Retrovir for treatment of his AIDS infection, and defendants have denied him coverage of his Retrovir because he has never been diagnosed as having Pneumocystis carinii Pneumonia or an absolute CD4 lymphocyte count of less than 200 per cubic millimeter in the peripheral blood as required by defendants' rule, 13 C.S.R. 70-20.110.

"3. Since defendants contend that their rule moots the claim of the named plaintiff Glenn Weaver and that plaintiff T.G. lacks standing because he did not apply through prior authorization for Medicaid coverage of his Retrovir prescription, applicant's interest in this action may not be adequately represented by the named plaintiffs. Furthermore,

...