Suthers v. Amgen, Inc.

Parkinson patients Robert Suthers and Niwana Martin (participants) (plaintiffs) participated in two research trials sponsored by Amgen, Inc., for an experimental treatment involving a glial-derived neurotrophic factor (GDNF) to stimulate a chemical that is diminished in Parkinson’s patients. The participants signed consent forms for both studies that acknowledged Amgen’s right to terminate the research trials. In the first study, both participants received and benefitted from the GDNF treatment. However, Amgen discontinued the study after it discovered that GDNF could worsen a patient’s condition and after it received test data that GDNF yielded no statistically significant result over a placebo. Principal investigators who administered the GDNF and disagreed with Amgen’s decision to end the trials prompted a meeting between GDNF investigators, Amgen representatives, and the Food and Drug Administration (FDA) that resulted in no action and Amgen’s announcement that it would not provide GDNF to Suthers and Niwana on a compassionate-use basis, despite the FDA’s proclamation that has often permitted such use. Suthers and Martin, believing that Amgen overreacted to the data and that it was safe and beneficial to many Parkinson’s patients, including themselves, sued Amgen and sought an injunction. They alleged three theories of recovery: breach of contract, promissory estoppel, and breach of fiduciary duty. Amgen denied that it made any enforceable promises to Suthers or Martin or that it stood in the position as fiduciary to either of them.