Carefully read Goodman v. United States, 298 F.3d 1048 (9th Cir. 2002), an informed consent case, in which Goodmans wife JoAnn, diagnosed with incurable melanoma, participated in a clinical trial at the National Institutes of Health and died from a toxic reaction to one of the medicines used in the study.

Sources:

http://openjurist.org/298/f3d/1048/goodman-v-united-states(Links to an external site.)

http://biotech.law.lsu.edu/cases/immunity/ftca.htm(Links to an external site.)

http://biotech.law.lsu.edu/cases/immunity/malpractice_ftca.htm(Links to an external site.)

Directions

The students are expected to summarize the facts of the case (what happened that led to the lawsuit and how it progressed through the courts) and prepare a case brief using the IRAC method. IRAC (Issue, Rule, Analysis, and Conclusion) is an acronym for a method for summarizing legal opinions. The Issue is the question or problem that the court was addressing (this should be in a form of a question). The Rule is the rule or legal principle announced by the courts holding. The Analysis is a brief summary of the courts reasoning behind the ruling. This may include references to particular laws, policy implications, or other court cases. Finally, the Conclusion addresses the applicability of the holding to similar cases. Did the court limit the holding to certain facts or situations? Did the analysis leave room for change or were parameters clearly defined so that the rule is limited in application?

The students are expected to carefully read the assignment instructions, then thoroughly and explicitly address each component of the case summary and brief. The responses should reflect higher level cognitive processing (analysis, synthesis, and evaluation), which is essential for someone being prepared to serve in an operational capacity within the healthcare and related industry. The submission will not exceed two (2) pages in length, excluding the title and the reference list pages. The document must adhere to the APA writing style. Finally, the document should be prepared as a Microsoft Word document and uploaded under the correct unit assignment page.