The recent death of a patient participating in the Targeted Genetic’s Phase I/II trial of tgAAC94, a potential treatment for rheumatoid arthritis, has raised the issue about recovery for injuries suffered during clinical trials [see Death in Gene Therapy Treatment is Still Unexplained]. This is a very difficult situation since there is death of a young mother and a shattered family.
Lawsuits against researchers generally fall into one (or more) of the following 3 categories: breach of the standard of care; lack of informed consent; and/or conflicts of interest.
Basing your legal argument on informed consent forms or conflicts of interest is weak at best. Clinical investigators, pharmaceutical companies and IRBs are hip to litigation exposure so they carefully craft informed consent forms and disclose conflicts of interest to the study participant. The key is to argue that there was a breach of the standard of care.
Key to a breach of standard of care argument is whether or not the pharmaceutical company and/or the principle investigator owes a duty to the study participant. Traditionally there was no duty of care between the investigator and the study subjects. Where there is no duty of care there is no basis for recovery.
Clinical trial subjects must sign extensive informed consent forms, which will most likely include the injury in question. Various devices, including informed consent forms, used in the clinical trial process can arguably create a duty of care between the investigators and the study subjects. If you can prove that a duty exists and prove that the investigator and/or pharmaceutical company violated that duty and that violation was more likely than not the cause of the injuries then you maybe able to make a claim for damages.
The next question is how does one get around making a claim for an injury when the clinical trial subject signs a mountain of paper releasing the investigator from liability a/k/a the informed consent form. This is a very tricky issue but, in simple terms, an injured party must show that the injury resulted from a violation of the study protocol (the “rules” that govern the study) by the pharmaceutical company and/or principle investigator through gross negligence or explicit intent.
Suggested reading:
Myron Higgins, et al. v Kennedy Krieger Institute.