Law360, New York (July 11, 2011, 11:57 AM ET) -- Given the risks involved in human clinical trials, there are fewer lawsuits brought by clinical trial participants than one might expect. However, when participants do bring suit, oftentimes they will attempt to blur the lines of legal responsibility between the clinical study investigator and the manufacturer/sponsor. When faced with this scenario, it is important to clearly identify the role that the manufacturer/sponsor played in the clinical trial to determine whether they owed any legal duty to the plaintiff.
The U.S. Food and Drug Administration established guidelines...
The Legal Duties Of Clinical Trial Sponsors
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