Physicians acting as investigators for a clinical trial testing a new therapy are required to present to each patient or study subject a consent form, indicating that the patient understands the risks, benefits and alternatives of participating in the trial and voluntarily elects to do so. Federal law imposes several specific items to be included in the consent form. Where all pertinent risks, benefits and alternatives have been disclosed, and the patient signs the form, the patient is said to have given “informed consent.”
A patient injured in a clinical trial studying a new therapy for Parkinson’s Disease sued the manufacturer of the equipment used in the procedure. In addition to a claim of negligent design and manufacture of the equipment itself, the patient asserted that the manufacturer, as the sponsor of the clinical trial, was negligent in drafting and approving the informed consent documents that the patient signed to participate in the clinical trial. Can a manufacturer be liable for an improperly drafted consent form?
In an opinion decided in July 2014, the United States District Court for the District of Massachusetts, in the case of Zeman v. Williams, refused to dismiss this novel claim against the manufacturer, which was also the sponsor of the clinical trial. The court held that “both investigators and sponsors [may] have a role in the obtaining of informed consent from a clinical trial subject”. The sponsor’s role is to provide the information the investigator needs to properly inform the patient of the risks and benefits of participation.
The court agreed with the manufacturer that federal regulations “do not themselves authorize a cause of action” by a clinical trial subject against the sponsor of the trial, and that the physician-investigator “has a major, if not the major, role in obtaining a properly informed consent.” But the patient pleaded his claim under Massachusetts state law of negligence, and the court held that the possibility that the trial’s sponsor might also bear some responsibility was not foreclosed by either state or federal law, particularly where the complaint alleged that the sponsor had approved the protocol for the trial, including the consent form.
The takeaway here is that pharmaceutical and medical device manufacturers that sponsor clinical trials should not simply defer to the investigator the content of the consent form, but should take care that the form accurately and completely describes the risks, benefits and alternatives to participation in the study.