Clinical Trial Sponsor Not Liable for Sponsoring Clinical Trial

Litigation attorney Eric Alexander published a blog for Drug & Device Law analyzing Graw v. Eli Lilly & Co., a decision dismissing with prejudice a clinical trial participant's claims seeking to hold a trial sponsor liable for alleged injuries and site-level conduct during a diabetes drug study. Mr. Alexander explains that the U.S. District Court for the Eastern District of Missouri found the plaintiff failed to plead facts establishing a duty owed by the sponsor, rejecting theories based on purported "oversight," agency allegations and references to U.S. Food and Drug Administration (FDA) clinical trial regulations as a stand-in for an independent duty of care. The post also highlights the court's reasoning that informed consent and patient care obligations generally rest with the investigators and study site medical staff, not the sponsor.

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