title: Litigating the science of breast cancer treatment.
abstract: Beginning in the late 1980s, many health insurers refused to cover high-dose chemotherapy with autologous bone marrow transplant (HDC/ABMT) for high-risk and metastatic breast cancer patients. Insurers denied coverage because there was no persuasive evidence of clinical effectiveness. In response, many women sued to compel coverage. After years of litigation and the expenditure of approximately $3 billion, randomized clinical trials (RCTs) showed that the procedure was no more effective and possibly more harmful than conventional therapy. To understand whether and how litigation contributed to the diffusion of the procedure, we conducted a series of case studies that examine the litigation tactics and strategies used by defense and plaintiffs' counsel. Despite the fact that HDC/ABMT lacked proven scientific effectiveness, insurance defense attorneys were unable to stop the procedure's diffusion. Plaintiffs' attorneys had a much easier and more sympathetic story to tell and were able to exploit vulnerabilities facing the defense.
authors.affiliation: University of Michigan, USA.
authors.forename: Peter D
authors.initials: PD
authors.lastname: Jacobson
authors.forename: Richard A
authors.initials: RA
authors.lastname: Rettig
authors.forename: Wade M
authors.initials: WM
authors.lastname: Aubry
mesh_terms: D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000191:economics*; D016026:Bone Marrow Transplantation / Q000191:economics* / Q000331:legislation & jurisprudence; D001943:Breast Neoplasms / Q000191:economics* / Q000473:pathology / Q000601:surgery; D003131:Combined Modality Therapy; D004059:Diffusion of Innovation; D019317:Evidence-Based Medicine; D005260:Female; D006801:Humans; D007345:Insurance Claim Review / Q000331:legislation & jurisprudence*; D019458:Insurance Coverage / Q000331:legislation & jurisprudence*; D009362:Neoplasm Metastasis; D016032:Randomized Controlled Trials as Topic; D016896:Treatment Outcome; D014481:United States
chemical_list: D000970:Antineoplastic Agents