Senior Trial Partner Bruce G. Habian, with discovery having been conducted by partner Gregory Radomisli, obtained a unanimous defense, in Supreme Court, New York County, before Judge Joan Madden. The case involved a phase I safety clinical trial wherein chemotherapy – Temodar – was injected directly into the residual tumor site via middle cerebral and posterior cerebral arteries. The decedent had previously undergone removal of a glioblastoma brain tumor. As a result of the intra-arterial experimental trial, the brainstem tissue was affected resulting in a toxic stroke. The paralysis sustained lasted 2 years prior to the patient’s death.
Plaintiff claimed that the closeness of the brainstem tissue to the injection site contraindicated the enrollment of the patient into the clinical trial; in addition, lack of informed consent was asserted with the plaintiff claiming that the toxic reaction should have been an anticipated result and, therefore, discussed with the patient. The Federal rules concerning clinical trial oversight were involved in addition to New York State statutes. Expert witnesses for both sides included the specialties of pharmacology, clinical trials, neuro-surgery and neuro-oncology.