2021 LS&HC Horizons - Flipbook - Page 19
Life Sciences and Health Care Horizons 2021
19
• State in the informed consent that the
investigational product is being provided during
the study free of charge and is not otherwise
available to the study participant in the stream
of commerce to provide documentary evidence
to support the defense to a strict liability that
such a cause of action is not appropriate for a
product that is not in the stream of commerce.
• State in the informed consent that the
document is not a contract between the sponsor
and the study participant to protect against
breach of contract claims.
• In the clinical trial agreement and informed
consent form, clearly define the scope of the
medical expenses for which the sponsor will be
responsible in the event of an injury, and make
clear that the injury must be directly related to
the proper administration of the investigational
product to preserve the lack of causation
defense.
Lauren Colton
Partner, Baltimore
lauren.colton@hoganlovells.com
Rob Church
Partner, Los Angeles
robert.church@hoganlovells.com
Learn more about our
Clinical Trials practice
on our website.
