David Allen Hendricks v. Central Reserve Life Insurance Company

Citations: 39 F.3d 507; 18 Employee Benefits Cas. (BNA) 2249; 1994 U.S. App. LEXIS 31301; 1994 WL 617910Docket: 94-1709

Court: Court of Appeals for the Fourth Circuit; November 8, 1994; Federal Appellate Court

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David Allen Hendricks, diagnosed with small cell lung cancer, sought health care benefits from Central Reserve Life Insurance Company for a proposed multiphase treatment involving high-dose chemotherapy and peripheral stem cell rescue. Central Reserve denied coverage, labeling the treatment as 'experimental/investigative,' which led Hendricks to file suit under the Employee Retirement Income Security Act (ERISA). The district court found in favor of Central Reserve, concluding that the proposed treatment was not covered under the insurance policy. Hendricks appealed, claiming the court should not have relied on specific definitions from the welfare benefit plan documents, argued that the treatment should not be classified as 'experimental' or 'investigative,' and contended that even if some treatment phases were excluded, others should be covered based on precedent. The appeals court affirmed the district court's ruling, noting that while Hendricks initially received standard treatment that was covered, the proposed high-dose chemotherapy was deemed investigational, aligning with the insurer's policy definitions.

Clinical trials are governed by the FDA and the Department of Health and Human Services, requiring a detailed protocol document that standardizes procedures and outlines treatment plans and data collection methods. Investigators must inform participants about the treatment and associated risks. Dr. Giguere's proposed clinical trial for small cell lung cancer aimed to assess the effects of high-dose chemotherapy on the duration of complete response and overall survival in patients in remission after standard chemotherapy. Hendricks signed an informed consent form in January 1994, acknowledging the experimental nature of the treatment and understanding that participation might not guarantee personal benefit but could contribute to scientific advancement. 

The treatment protocol consists of multiple phases: 

1. **Induction Phase** - Patients undergo standard-dose chemotherapy to evaluate their response, which is necessary for proceeding to high-dose chemotherapy.
2. **Mobilization Phase** - The chemotherapy dosage is increased to mobilize stem cells from the bone marrow into peripheral blood, preparing for leukapheresis, where stem cells are separated and preserved.
3. **High-Dose Chemotherapy** - This phase aggressively targets lung cancer but also eliminates the body’s white blood cells, increasing infection risk.
4. **Stem Cell Reintegration and Monitoring Phase** - After high-dose chemotherapy, preserved stem cells are reintroduced into the bloodstream, with a two-week hospitalization for monitoring and managing potential infections as the stem cells regenerate white blood cells.

In December 1993, Hendricks' doctors sought preauthorization from Central Reserve for this treatment. In February 1994, Central Reserve classified the proposed treatment as "experimental/investigational," which was not covered under Hendricks' insurance policy.

Central Reserve upheld its denial of Hendricks' request for preapproval for high-dose chemotherapy (HDC) following a second administrative review. The review noted that Hendricks was informed that the treatment was part of a research study and that it might not provide personal benefit. Central Reserve highlighted that existing studies indicated no statistically significant difference in long-term survival between HDC and standard therapy for small-cell lung cancer, classifying HDC as experimental and not medically necessary under its policy, which excludes coverage for investigational treatments.

Hendricks initiated legal action in April 1994, leading to a bench trial on May 2, 1994. The district court determined that HDC for small-cell lung cancer is experimental rather than an accepted standard practice, supported by evidence from the protocol, consent forms, and medical literature. The court ruled that the treatment was not medically necessary, as its efficacy was undetermined.

Hendricks argued that the district court improperly relied on definitions of 'experimental' and 'investigative' from Central Reserve's official plan document instead of the summary plan description, which lacked such definitions. He contended that using common understandings of these terms might have led to a ruling in his favor regarding coverage for his treatment. The summary plan description is mandated to be clear and comprehensible to plan participants, as per 29 U.S.C. Sec. 1022(a)(1).

In Aiken v. Policy Management Systems Corp., the court established that when there is a conflict between the complex terms of a plan and the simpler language of a summary plan description, the latter prevails if a participant relied on it or was harmed by it. This principle is rooted in the summary plan's role as the primary means of conveying plan terms to participants. In Aiken, the summary allowed a retiring employee to secure a vested pension after 20 years of service, while the formal plan required both 20 years of service and reaching age 60. The court ruled that the summary prevails in such conflicts.

However, if there is no conflict between the summary and the official plan, the official plan serves as the authoritative document for understanding benefits. In this case, the district court found that the definitions of 'experimental' and 'investigative' in the official plan aligned with their commonly understood meanings, indicating no substantial conflict. The definitions in the plan were compared to dictionary definitions, confirming their consistency. The court agreed with the district court's conclusion that the plan's definitions were appropriate and did not error in relying on them, even though they were not included in the summary plan description.

Hendricks argues that the district court incorrectly classified high-dose chemotherapy with peripheral stem cell rescue for small cell lung cancer as experimental or investigative, thereby denying coverage under the Central Reserve policy. The determination of whether a treatment is experimental involves contract interpretation, reviewed de novo, and factual evaluations, which are reviewed for clear error. The district court analyzed the terms of the policy and the factual context, noting that a treatment is excluded if it is conducted under controlled conditions to discover unknown effects or lacks general acceptance in medicine.

The court found no error in its legal definitions and proceeded to assess the factual findings. Conflicting expert testimonies were presented regarding the effectiveness of high-dose chemotherapy. The district court, tasked with evaluating expert credibility, found that while some studies showed optimism, they were cautious in endorsing the treatment. The pivotal study by Dr. Yves Humblet indicated no significant improvement in overall survival rates with high-dose chemotherapy. Testimony from Hendricks’ experts highlighted short-term responses but did not outweigh evidence from the defense, particularly from Dr. William Gradishar, who affirmed that the treatment remained investigational based on existing protocols and literature.

Dr. Gradishar's deposition indicates that while high-dose chemotherapy can yield higher response rates for some patients, most patients experience similar disease progression as those receiving conventional therapy, with no demonstrated survival advantage from high-dose chemotherapy. Dr. Giguere characterized the proposed multiphase high-dose chemotherapy for Hendricks' cancer as an experimental clinical trial requiring a protocol and informed consent. The trial aimed to assess if this new treatment could improve the duration of a complete response and survival rates. Hendricks acknowledged that he might not benefit personally and that his participation could contribute to scientific advancement. Notably, Hendricks would be the first patient in South Carolina with small cell lung cancer to undergo this treatment. Despite the known components of high-dose chemotherapy, data does not support its superiority over standard chemotherapy for small cell lung cancer. This context suggests the treatment is experimental and has not gained general acceptance in medicine, leading the district court to appropriately determine it as such.

Hendricks argued that even if high-dose chemotherapy is not accepted, the separate phases of his treatment—specifically the mobilization and hospitalization phases—should be covered under his policy as standard medical practices. However, the district court rejected this view, emphasizing that the treatment should be considered as a whole rather than in isolated phases. The court concluded that since the entire treatment is investigative, it is excluded from coverage under the policy, and any otherwise covered elements are part of the investigational treatment. The court's decision to deny coverage for the entire treatment was upheld.

Fragmenting the phases of treatment in relation to the policy language leads to a distorted analysis. Although the policy covers hospitalization for low white blood cell counts, Hendricks would not have required such hospitalization if not for high-dose chemotherapy, which depletes white blood cells. Evidence shows that Hendricks had a normal white blood cell count prior to chemotherapy. The low count would only occur as a treatment complication from the non-covered high-dose chemotherapy for small cell lung cancer. Similarly, while the policy may cover the mobilization phase of chemotherapy, this coverage is only applicable for harvesting stem cells and not as a standalone treatment for illness. Consequently, all treatment phases related to high-dose chemotherapy are excluded from coverage, either as complications of a non-covered treatment or as medically unnecessary. A fragmented analysis is inappropriate as the policy defines exclusions by the entire scope of the excluded treatment. Accepting a fragmented approach could allow coverage for treatments inconsistent with accepted medical practice, which was not the intention of the policy parties. Hendricks' reliance on the case Doe v. Group Hospitalization is misguided; in that case, high-dose chemotherapy was covered separately from the excluded autologous bone marrow transplant. Here, the exclusion applies to all phases of the experimental high-dose chemotherapy treatment. The judgment of the district court is therefore affirmed.