Clinical Trials Liability Case Study

Clinical Trials Liability Case Study

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Clinical Trials Liability Case Study

Learn through this case study how a Clinical Trials Liability policy will respond in the event of a claim and understand the additional benefits available under certain insurance policies.

Case study

  • During a global multi-site Phase III trial, five research participants suffered an unexpected adverse immune system response to the study treatment.
  • As a precaution, the sponsor halted the trial and ordered all sites to return unused study drug for analysis.
  • It was discovered there was a higher than expected level of active ingredient in the drug.  All recalled product were destroyed.
  • A global news network ran the story of the injured research subjects and halted trial, and speculated that poor manufacturing controls were to blame for the incident.  Several key investors indicated they were considering withdrawing funding on the back o the negative press.  Sponsor engaged a public relations company to help with communicating work done to investigate and correct manufacturing process to the investment community.
  • As a precaution, a further 20 research subjects who had been treated with the contaminated batch but showed no side effects were monitored with monthly testing for 12 months by their study doctor.
  • A lawyer representing affected research participants issued writ against the sponsor seeking compensation for their clients.
  • Uninjured research subjects made claims for medical monitoring expenses.
  • Injured research subjects made claim via their lawyers for:
    • medical expenses for additional treatment
    • lost income from time of work
    • general damages for pain, suffering and emotional distress.

Coverage response

The following summarises, based on Chubb’s Clinical Trials Insurance Policy, how insurance would respond to various claims scenarios following the above case study.

Loss: Sponsor’s cost from recalling and destroying unused study drugs.

Coverage provided under Section 1.2.:  Clinical Trials Extras, Product Recall Expenses extension would cover costs associated with transportation of unused study drugs.

Loss: Sponsor’s cost’s of hiring a public relations company.

Coverage provided under Section 1.2.:  Clinical Trials Extras, Crisis Response Expenses extension would cover the insured’s costs of engaging the public relations company.

Loss: Medical expenses incurred by uninjured research subjects exposed to contaminated drug for monitoring tests.

Coverage provided under Section 1.2.:  Clinical Trials Extras, Medical Monitoring Expenses would cover the costs of the medical testing performed on these research subjects.

Loss: Compensation claims brought by research subjects who had suffered adverse immune system response.

Coverage provided under Section 1.1.:  Clinical Trials Liability coverage would response to cover costs associated with investigating claims and negotiating settlement of these claims.  Would also cover the settlement amounts agreed to with the injured research subjects.  Claim investigation expenses would not reduce policy limits, leaving full amount of those limits available for compensating injured research subjects.


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At HDL, our ability to design insurance solutions for clinical trials and service the needs of our multinational clients is virtually boundless. We have access to licensed insurers worldwide, with local representation in over 140 countries.

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