The Legal Duties of Clinical Trial Sponsors
In an article entitled, "The Legal Duties Of Clinical Trial Sponsors," published by Law360.com on July 11, 2011, Reed Smith attorney Kevin Lohman addresses the risks involved in human clinical trials and the responsibilities between the clinical study investigator and the manufacturer/sponsor. Although the unique roles and responsibilities of entities involved with clinical trials are clearly defined, plaintiffs oftentimes attempt to assign legal duties to the wrong entity — sometimes suing the clinical trial sponsor as if it were directly providing medical services to the participant — or attempt to create novel legal duties. Case law that has addressed this issue has consistently held that this is not appropriate. 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.
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