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Contracts Keyed to Barnett
Dahl v. HEM Pharmaceuticals Corp
Citation:
7 F.3d 1399 (9th Cir. 1993)Facts
Dahl and seventeen other patients suffering from chronic fatigue syndrome participated in HEM Pharmaceuticals’ clinical trial for Ampligen, an experimental drug. The study was designed as a double-blind test where some patients received Ampligen and others received a placebo, with neither doctors nor patients knowing which they received. Participants signed consent forms that included a promise of continued Ampligen for one year after the study if statistical analysis showed efficacy compared to placebo. After the double-blind study ended, HEM applied for FDA permission to proceed with a “treatment IND” that would allow use of Ampligen for patients not in clinical trials. The FDA rejected this application citing safety concerns but allowed an “open label” study to continue. Despite this, HEM refused to provide the promised year of Ampligen to the study participants, claiming that FDA approval of efficacy was required first. The patients sued, and the district court granted a preliminary injunction requiring HEM to provide Ampligen for twelve months.
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