## Facts

- Michael J. Boldon, age 54, was covered under an employer-sponsored group medical plan insured and administered by Humana Insurance Company and governed by ERISA.
- In May 2006, Boldon was diagnosed with advanced unresectable hepatocellular carcinoma (HCC), a rare, terminal liver cancer often described as an “orphan disease” because relatively few patients are diagnosed in the United States each year.
- Boldon also had hepatitis C and was HIV positive. Multiple transplant programs determined he was not an appropriate candidate for liver transplantation.
- Boldon’s interventional radiologist recommended yttrium-90 radioembolization using TheraSphere, an outpatient procedure delivering radioactive microspheres through the hepatic artery to target liver tumors.
- The FDA had approved TheraSphere for a limited indication: neoadjuvant (pre-transplant) treatment for HCC patients who are transplant candidates.
- Boldon’s treating physician concluded TheraSphere was the best option because it offered the most realistic chance to prolong Boldon’s life while posing fewer negative effects than other available treatments; published, smaller clinical studies reported safety and suggested efficacy in reducing tumor size and extending survival.
- Humana denied coverage under the plan’s exclusion for “experimental or investigational” drugs/treatments. The denial was driven by Humana’s medical director, whose review focused on Humana’s policy position rather than Boldon’s medical record; the medical director had no independent familiarity with TheraSphere.
- Boldon appealed. An independent review affirmed the denial, reasoning that the absence of Phase III randomized trials prevented a conclusion of efficacy despite literature describing safety and positive outcomes in limited studies.
- The Arizona Department of Insurance also denied coverage, reasoning that because TheraSphere’s FDA approval was for neoadjuvant use in transplant candidates, and Boldon had not had surgery or a transplant (and was not eligible for transplant), he did not qualify under that approved use.
- Boldon filed suit in federal court under ERISA and sought a temporary restraining order and preliminary injunction requiring Humana to cover TheraSphere without delay.

## Issues

1. Under an ERISA plan that grants the administrator discretion to interpret plan terms and decide benefit claims, was Humana’s denial of TheraSphere coverage as “experimental or investigational” likely an abuse of discretion/arbitrary and capricious?
2. Did Humana likely misapply the plan’s “experimental or investigational” exclusion by relying on a categorical Phase III-trial requirement and by failing to evaluate Boldon’s individual medical circumstances and the available medical literature?
3. Did Boldon satisfy the requirements for preliminary injunctive relief, including likelihood of success on the merits and irreparable harm from delayed treatment for terminal cancer?

## Decision

- The court granted a preliminary injunction ordering Humana to provide coverage for TheraSphere treatment pending final resolution of the ERISA claim.
- The court found Boldon made a strong showing that Humana’s denial was likely unreasonable even under deferential review, because Humana’s process did not reflect a careful, case-specific medical judgment and relied heavily on a blanket policy view.
- The court credited evidence that HCC is life-threatening and time-sensitive; delaying potentially life-prolonging therapy could permanently eliminate any chance for benefit, which could not be repaired by later monetary relief.
- The court found the balance of hardships favored Boldon, given the risk of shortened survival if treatment was delayed compared to Humana’s financial and administrative burdens.
- The court concluded the requested injunction was appropriate to preserve Boldon’s ability to obtain the prescribed treatment while the merits of the ERISA dispute were litigated.

## Legal Principles

- When an ERISA plan grants discretionary authority to the administrator, a court reviews a benefits denial under an abuse-of-discretion/arbitrary-and-capricious standard, but the denial must still have a reasonable basis grounded in the plan terms and the record.
- A plan administrator must use a reasoned decision-making process; a denial may be unreasonable where it rests on a rigid, across-the-board policy rather than an evaluation of the claimant’s medical record and the relevant clinical evidence.
- An “experimental or investigational” exclusion is not properly applied by treating the absence of Phase III trials as dispositive in all cases, particularly where the condition is rare and the available evidence includes safety data, peer-reviewed literature, and treating-physician support.
- Preliminary injunctive relief may be warranted in ERISA medical-benefit disputes where the claimant shows a strong likelihood of success and irreparable harm, such as the loss of a meaningful opportunity for life-prolonging treatment due to delay.

## Conclusion

In *Boldon v. Humana Insurance Co.*, the District of Arizona ordered Humana to cover TheraSphere on a preliminary-injunction basis, concluding that Boldon was likely to succeed on his ERISA claim that Humana unreasonably treated TheraSphere as “experimental or investigational” and that delaying treatment for advanced HCC posed irreparable, time-sensitive harm that later damages could not fix.


Boldon v. Humana Insurance Co., 466 F.Supp.2d 1199 (2006)