American Journal of Law & Medicine

Clinical Research: Pharmaceutical Manufacturer Sponsoring Terminated Clinical Trial Not Obligated to Continue Providing Drug to Volunteers--Abney v. Amgen, Inc., 443 F.3d 540 (6th Cir. 2006).(Select Recent Court Decisions)

Clinical Research: Pharmaceutical Manufacturer Sponsoring Terminated Clinical Trial Not Obligated to Continue Providing Drug to Volunteers--Abney v. Amgen, Inc. (1)--The United States Court of Appeals for the Sixth Circuit unanimously affirmed the District Court's refusal to force Amgen, Inc. ("Amgen") to continue supplying an experimental drug during litigation over claims for breach of contract, promissory estoppel, and breach of fiduciary duty after finding that: (1) no contract directly arose between Amgen and Abney, et al. (the "Volunteers"); (2) the principle investigators and physicians lacked agency status or apparent authority to bind Amgen and the Volunteers to a contract or quasi-contract; and (3) Amgen undertook no fiduciary duties with respect to the Volunteers.

Seeking to evaluate a method of delivering a potential breakthrough drug, glial cell line-derived neutrotropic factor ("GDNF"), to dopamine-producing neurons in the brain, (2) Amgen conducted two open-label studies and a Phase II trial, which it later converted to an open-label study. The delivery method, known as bilateral intraputaminal ("IPu") administration, requires researchers to implant into a Volunteer's abdomen a drug reservoir and pump, drill a hole in the Volunteer's skull, and run an attached catheter from the pump through the Volunteer's neck, cheek, and skull, and into the brain, where the GDNF from the reservoir is delivered by the pump via the catheter. (3)

In 2000, Amgen supported an open-label trial involving five volunteers suffering from Parkinson's disease in the United Kingdom, which "yielded favorable results." (4) Desiring further support, Amgen supported, and later sponsored, a second open-label trial in 2001, showing improvement in ten Volunteers at the University of Kentucky Medical Center ("UKMC"). (5) Lacking control groups to validate these positive results in the open-label studies, Amgen next sponsored a 2003 "multi-center Phase II, randomized, double-blind, placebo-controlled study of GDNF['s efficacy]." (6) Amgen selected eight sites to carry out the Phase II trial, but the Sixth Circuit and the district court differed on whether UKMC participated in this trial, or in the second open-label study. The district court reported that Amgen supported, and eventually sponsored, a 2001 open-label study involving ten volunteers, eight of whom were the Volunteers in the present suit. (7) The Sixth Circuit, on the other hand, fails to carefully distinguish the open-label study conducted at UKMC from the Phase II trial, which the district court reports was conducted at "eight selected sites[, not including UKMC]." (8)

Amgen's protocol, approved by Institutional Review Boards ("IRBs") at the study centers agreeing to follow it, provided that after an initial study period, volunteers may elect to continue treatment for up to an additional 24 months. …

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