Clinical trials are an important part of developing new medical and other interventions that may improve the health and wellbeing of all Australians – they allow researchers to try out new treatments, tests or procedures that may prevent, detect or diagnose, treat or manage diseases or condition but require groups of volunteers to take part in the trials to test the effectiveness of what is being developed. This testing may result in adverse effects to the trial participants who make compensation claims against the trial sponsor, the hosting institution or the professionals involved in conducting the trial.

Our team is experienced in managing these clinical trial compensation claims, including claims that involve catastrophic injury or death arising from drug research and the use of medical devices. We routinely manage the competing interests of all stakeholders, including the patient, the sponsor, the insured organisation, the insurer and the relevant ethics committee.

W+K strives to resolve all clinical trial compensation claims in accordance with Medicines Australia’s Compensation Guidelines and civil liability legislation, without recourse to litigation (if appropriate) and to the mutual satisfaction of all stakeholders.

Our focus is to:

  • establish causation (i.e. did the treatment cause the adverse event?)
  • investigate the extent of the patient’s ailments, prior to commencing the trial, and
  • where appropriate, attempt to resolve the claim without the expense of litigation.

Recent work

Assisting a global biopharmaceutical company to manage high volume compensation claims brought by patients for adverse events sustained throughout the course of their participation in a cancer drug clinical trial. The adverse events varied in severity but included catastrophic brain injuries and death. As the clinical trial was run in various Australian jurisdictions, the claims were required to be assessed under the common law and pursuant to the various State statutory civil liability regimes.

Acting for a Chinese pharmaceutical company in defence of a claim for injuries arising out of participation in a clinical trial where the Claimant had advanced metastatic cancer, which made him eligible to participate in the trial. He alleged the clinical trial caused Type 1 Diabetes. After investigating his cancer prognosis, verifying the causal link between the clinical trial and the onset of his diabetes, and ruling out contribution avenues, we settled the claim in accordance with the Clinical Trial Guidelines and without litigation being issued.

Acting for a global pharmaceutical company to resolve compensation claims brought by clinical trial patients. These claims required an assessment of damages under the Medicines Australia Compensation Guidelines and the ongoing management of various stakeholders involved in the compensation process (including the Ethics Committee, sponsors and sites).

Advising a global insurer in relation to a claim for personal injury damages made by a claimant who alleged injuries/disabilities arising from participation in a company-sponsored clinical trial. We are working on driving this claim towards a favourable settlement to minimise costs, in circumstances where quantum is significant.