Marion Liu, Individually and as Successor in Interest to Augustine Liu, Deceased v. Janssen Research & Development, LLC

According to the National Institutes of Health, there are currently over 3,000 on-going clinical drug trials in the United States which are either currently active or currently recruiting test subjects.1 It is also estimated that 19 million Americans participate as test subjects in clinical research trials every year. 2 Numerous ethical codes, including the Nuremberg Code, developed after the human experimentation atrocities in World War II, the Belmont Report, issued by the United States National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, the Declaration of Helsinki, developed by an international consortium of researchers, and federal regulations, including 21 C.F.R. § 312.50 and 21 C.F.R. § 312.56, all emphasize the importance of protecting the health and safety of clinical trial test subjects as a paramount consideration in every research endeavor. The question presented is: Whether a drug company which is medically monitoring the participants of its drug study has a duty under federal regulations to exercise

1. See, https:// clinicaltrials.gov/ct2/results?term=number +subjects&cntry =US&Search=Apply&recrs=b&recrs=a&re crs=f&recrs=d&age_v=&gndr=&type=&rslt=, most recently accessed on July 5, 2018.

2. Scutti, Clinical Tr ials Do Go Wrong: How Many Human Subjects Are Injured By Scientific Research Each Year?, Innovation, 2/5/16 (available at http://www.medicaldaily. com/x-files-clinical-trials-human-experimental-subjects-372422, accessed on July 5, 2018.