2021 LS&HC Horizons - Flipbook - Page 18
18
Hogan Lovells
Clinical trials litigation risks
Clinical trials play a critical role in the
understanding, detection and treatment of
illnesses, and the number of clinical trials is
increasing at a rapid pace. As of February 1,
2021, approximately 366,000 clinical studies
were registered globally on ClinicalTrials.gov, as
compared to approximately 2,119 registered in
2000. As the number of clinical trials conducted
by pharmaceutical, biotechnology, and medical
research companies increases each year, so does
the possibility that these companies will become
embroiled in litigation relating to these trials.
While companies conducting clinical studies have
to navigate complex medical, scientific, regulatory
and ethical issues, it is important to be cognizant
of the potential litigation risks and the steps that
can be taken to mitigate those risks.
A clinical trial participant who experiences an
adverse reaction during a trial may seek recovery
from the sponsor based on theories of negligence,
lack of informed consent, or strict liability. Such
claims tend to be based on allegations that the
participant was not adequately warned of the
risks associated with the experimental product,
was not an appropriate candidate for the study or
that the study was not appropriately designed or
conducted. A breach of contract claim may also be
asserted based upon the compensation provision
of the consent document. On the other end of the
spectrum, a clinical trial participant may file a
lawsuit seeking expanded or continued access to an
experimental treatment after the study has ended.
Clinical trial documentation is key to the defense
of clinical trial claims. Sponsors should consider
taking the following steps to mitigate potential
litigation risks:
• Include clear statements in the informed
consent regarding the known risks and the
potential for unknown risks to assist with the
defense to lack of informed consent cases and
to support the assumption of risk defense. Also,
consistent with FDA regulations, the consent
document should be updated regularly and
approved by the responsible ethics committee
as new safety information is obtained about the
investigational product.
• Ensure that the Investigator’s Brochure
documents the known and potential risks
associated with the investigational product to
support the learned intermediary defense to a
litigation claim.
• State in the clinical trial agreement with the
investigator and in the informed consent
document that the investigator is not an agent of
the sponsor to preserves the sponsor’s defense
to a claim for lack of informed consent, which
is consistent with the regulatory framework
requiring the investigator to obtain consent.
Such a statement may also support the defense
to a negligence claim that the sponsor owed no
duty to the study participant.
• Include appropriate indemnification provisions
in the clinical trial agreement pursuant to
which the investigator and institution agree to
indemnify the sponsor for any claims resulting
from their negligence or misconduct.
• State in the informed consent that the
investigational product will be provided only
during the course of the study, that there is
no commitment to provide the investigational
product after the study has concluded, and that
the sponsor may stop the trial at any time for
any reason to protect against continued access
claims.
