Law360, New York (December 5, 2014, 3:24 PM EST) -- The U.S. District Court for the District of Massachusetts recently refused to dismiss a plaintiff's negligent informed consent claim against the manufacturer of an investigational drug and medical device used in a clinical trial. The court in Zeman v. Williams, 2014 U.S. Dist. LEXIS 91501 (D. Mass. July 7, 2014), held the complaint adequately stated a claim because it alleged that the warnings in the informed consent form provided by the clinical investigator to the plaintiff did not adequately disclose the treatment's risks, and that the manufacturer, as the clinical trial sponsor, had approved the form. Zeman departs from existing law in imposing an informed consent duty on the drug or device manufacturer, rather than solely on the treating physician, and possibly in other ways as well. If left uncorrected, the decision not only would expand the potential liability of clinical trial sponsors but could also be applied to pharmaceutical or device manufacturers outside the clinical trial context....