NIESE v. UNITED HEALTHCARE SERVICES INC (2020)

ORDER

This is an Employee Retirement Income Security Act (“ERISA”) suit. Plaintiff Brent Niese seeks damages and equitable relief from the Claims Administrator and health insurance provider, United Healthcare Services, Inc. (“United Healthcare”) and the Specialized Alternatives for Families and Youth of America, Inc. Health Benefit Plan (the “Plan”).

Pending is the defendants’ motion to dismiss, (Doc. 10), plaintiff opposes the motion, (Doc. 14), and defendants have replied (Doc. 16).

For the following reasons, I grant defendants’ motion to dismiss.

Background

In 2017, doctors diagnosed the plaintiff with brain cancer. (See Doc. 1, pgID 5-6). The plaintiff's treating physician recommended proton beam radiation therapy (“PBRT”) as the best available treatment option. (Id., pgID 4).

The plaintiff argues that PBRT is a well-established, widely recognized, and appropriate brain cancer treatment. (Id.). In April 2017, plaintiff submitted a request for prior authorization to United Healthcare for PBRT treatment. (Id., pgID 6). United Healthcare denied the request on the basis that PBRT was an “unproven” treatment. (Id., pgID 7). Plaintiff and his physician engaged in several follow-up requests and appeals to United Healthcare. (Id.). All were fruitless.

Plaintiff nonetheless began a course of PBRT. He paid out of pocket for the treatment.

On April 16, 2020, the plaintiff filed this lawsuit. (Doc. 1). The gravamen of plaintiff's complaint is that the PBRT treatment was necessary, constituted appropriate medical treatment, and was not experimental, investigational, or unproven. Plaintiff's first cause of action is for denial of his claim under ERISA. Plaintiff's second cause of action is for equitable relief.

On June 29, 2020, the defendants filed their motion to dismiss the complaint for failure to state a claim on which relief can be granted. (Doc. 10). The defendants claim that the Plan's policy excludes PBRT. More specifically, the defendants point to the Plan's definition of experimental and investigational services. The Plan excludes coverage for services that are:

• Not approved by the U.S. Food and Drug Administration (FDA) to be lawfully marketed for the proposed use and not identified in the American Formulary Services or the United States Pharmacopoeia Dispensing Information as appropriate for the proposed use.

• Subject to review and approval by any institutional review board for the proposed use. (Devices which are FDA approved under the Humanitarian Use Device exemption are not considered to be Experimental or Investigational.).

• The subject of an ongoing Clinical Trial that meets the definition of a Phase I, II or III Clinical Trial set forth in the FDA regulations, regardless of whether the trial is actually subject to FDA oversight.

(Doc. 1-1, pgID 118).

The defendants argue that the plaintiff has not adequately pled that, when plaintiff received his treatment, PBRT was not subject to review and approval by any institutional review board and that PBRT was not subject to any ongoing clinical trials. I agree.

Legal Standard

A motion to dismiss is properly granted if the plaintiff has “fail[ed] to state a claim upon which relief can be granted.” Fed R. Civ. P. 12(b)(6). To survive a motion to dismiss, the plaintiff must allege facts that are sufficient “to state a claim to relief that is plausible on its face.” Bell Atl. Corp. v. Twombly, 550 U.S. 544, 570, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007). “A claim has facial plausibility when the plaintiff pleads factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged.” Ashcroft v. Iqbal, 556 U.S. 662, 678, 129 S.Ct. 1937, 173 L.Ed.2d 868 (2009). “Threadbare recitals of the elements of a cause of action, supported by mere conclusory statements, do not suffice.” Id. I must accept the factual allegations in the complaint as true and construe the complaint in the light most favorable to the plaintiff. Hill v. Blue Cross & Blue Shield of Mich., 409 F.3d 710, 716 (6th Cir. 2005).

“[W]hen a document is referred to in the pleadings and is integral to the claims, it may be considered without converting a motion to dismiss into one for summary judgment.” Commercial Money Ctr., Inc. v. Ill. Union Ins. Co., 508 F.3d 327, 335–36 (6th Cir. 2007). Here, the Plan and its definitions are integral to plaintiff's claims and were attached to his complaint.

Discussion

Although defendants raise various contentions in their motion to dismiss, they primarily rely on the Plan's policy definitions of excluded service and its related definitions. The thrust of the defendants’ claim is that the plaintiff has failed to allege that PBRT treatment is outside these definitions.

“[B]enefits payable under an ERISA plan are limited to the benefits specified in the plan.” Clair v. Harris Trust & Sav. Bank, 190 F.3d 495, 497 (7th Cir. 1999).

Here, as set forth above, United Healthcare's policy provides three definitions for excluded services: 1) services not approved by the FDA; 2) services subject to review and approval by any institutional review board for the proposed uses; or 3) services that are the subject of an ongoing clinical trial.

Thus, to overcome the defendant's motion to dismiss, the plaintiff has to show that none of these definitions applies. LuK Clutch Systems, LLC v. Century Indem. Co., 805 F. Supp. 2d 370, 376 (N.D. Ohio 2011) (The party seeking to recover under an insurance policy bears the burden to demonstrate coverage under the policy).

The parties agree that the complaint adequately states that the FDA approved PBRT for brain cancer in 1988.

However, the defendants claim that the plaintiff does not address the second or third criterion. More specifically, defendants allege that plaintiff has not alleged facts sufficient to show that PBRT was not subject to review and approval by any institutional review board. Defendants also argue that plaintiff has not alleged facts to show that PBRT is not subject to any ongoing clinical trials.

Instead, the complaint merely asserts that defendant should cover PBRT treatment because it is not “experimental, investigational or unproven.” (Doc 1., pgID 50).

In plaintiff's opposition, he argues that defendants’ contention that he allege facts to show the second and third criteria are too burdensome a standard and not appropriate at this stage in the pleadings. Plaintiff argues that the “[d]efendants’ argument would essentially convert plaintiff's complaint into a mini-trial, at which Plaintiff would have to present all conceivable evidence that might support his claims.” (Id., pgID 319).

But that is not so. All plaintiff would have to do to survive defendants’ motion to dismiss is to allege facts to support an assertion that PBRT is not currently subject to review and approval by any institutional review board and that it is not the subject of an ongoing clinical trial. Plaintiff does not have to prove those things at this stage, but he needs to provide an adequate factual underpinning for his presently conclusory assertions. Iqbal, 556 U.S. at 678, 129 S.Ct. 1937.

Plaintiff argues that PBRT is not an “experimental-investigational service” because it “has been recognized for decades by the medical community as an established, medically appropriate treatment for cancer, including brain cancer.” (Doc. 14, pgID 3). While the plaintiff relies on the plain meaning of terms such as “investigational” and “experimental,” the definitions under the Plan are what control. See, e.g, Bondex Intern., Inc. v. Hartford Acc. and Indem. Co., 667 F.3d 669, 677 (6th Cir. 2011) (“Where the policy language sets forth the relevant coverages and exclusions in unambiguous terms, we must apply the terms as written.”). And the Plan clearly and unambiguously defines an “experimental-investigational service” as a service that is:

• Not approved by the U.S. Food and Drug Administration (FDA) to be lawfully marketed for the proposed use and not identified in the American Formulary Services or the United States Pharmacopoeia Dispensing Information as appropriate for the proposed use.

• Subject to review and approval by any institutional review board for the proposed use. (Devices which are FDA approved under the Humanitarian Use Device exemption are not considered to be Experimental or Investigational.)

• The subject of an ongoing Clinical Trial that meets the definition of a Phase I, II or III Clinical Trial set forth in the FDA regulations, regardless of whether the trial is actually subject to FDA oversight.

(Doc. 1-1, pgID 118).

The defendants also argue that plaintiff has not adequately alleged facts to support an inference that the Plan's “unproven-services” exception does not apply either. The complaint acknowledges that the defendant declined to cover plaintiff's PBRT treatment under the Plan's definition of an unproven treatment. The Plan, defines unproven services as services “determined not to be effective for treatment of the medical condition and/or not to have a beneficial effect on health outcomes due to insufficient or inadequate clinical evidence from well-conducted randomized controlled trials or cohort studies in the prevailing published peer-reviewed medical literature.” (Doc. 1-1, pgID 125).

The complaint cites scientific journal articles that endorse the use of proton therapy for brain tumors. (Doc. 10, pgID 292). Defendants argue that plaintiff's assertion regarding the articles does not support any inference that PBRT was the subject of “well-conducted randomized controlled trials or cohort studies.” Defendants do not disagree that PBRT has “proven” effective in practice. But that doesn't matter under the exclusion, which requires proof of efficacy through conventional clinical trials.

Plaintiff responds by arguing that what defendants are asking for is much too burdensome at this stage and beyond the standard set forth in Twombly/Iqbal and their progeny. Plaintiff argues that that at least two courts outside this Circuit have rejected claims that are like the ones the defendants make here. But one of those cases, Cady v. Anthem Blue Cross Life & Health Ins. Co., 583 F. Supp. 2d 1102, 1108 (N.D. Cal. 2008), predates Iqbal's heightened pleading standard. In the other, Hill v. United Healthcare Ins. Co., No. SA CV 15-0526-DOC, 2016 WL 11523589 (C.D. Cal), the court actually recognized that a plaintiff's allegations must track, as plaintiff's complaint here does not, the relevant plan definitions.

The decisions in Paragon Off. Servs. LLC, No. 3:11-cv-2205-D, 2012 WL 5868249 (N.D. Tex.), and Midwest Special Surgery, P.C., No. 4:09cv646 TIA, 2010 WL 716105 (E.D. Mo.), are instructive. In Paragon Off. Servs. the court held that a plaintiff must sufficiently allege, as plaintiff here does not, that the plan covered the requested services. 2012 WL 5868249, at *2. In Midwest Special Surgery, P.C., the court likewise held that a plaintiff must not only plead the existence of a plan, but also sufficiently plead facts, as plaintiff here does not, that support an inference that a carrier wrongfully excluded a service. 2010 WL 716105, at *2.

Ultimately, the complaint does not make specific factual allegations for me to infer that the the plan covered, rather than excluded coverage for plaintiff's PBRT treatment.

Because plaintiff predicates his claim for equitable relief on his ERISA claim, that claim also fails.

Conclusion

If ever there was a sympathetic plaintiff, it is Mr. Niese. Unfortunately, the policy's exclusionary terms and definitions are clear and unambiguous. That fact and the law, which I must follow, see, e.g., Bondex Intern., Inc. v. Hartford Acc. and Indem. Co., 667 F.3d 669, 677 (6ths Cir. 2011), compel me to grant defendants’ motion.

Accordingly, it is hereby

ORDERED THAT the defendant's motion to dismiss (Doc. 10) be, and the same hereby is granted.

So ordered.

JAMES G. CARR, Senior U.S. District Judge