Verdicts

In a recent decision subject to multiple flaws, the United States District Court for the District of Massachusetts refused to dismiss a suit against the manufacturer of an investigational drug and medical device used in a clinical trial based on the allegedly inadequate warnings the clinical trial investigator provided to patients in obtaining their informed consent to the trial. If left unchanged, the decision could be applicable even outside the clinical trial context if it is alleged that a pharmaceutical or device manufacturer had knowledge of a physician's warnings to his or her patients. Zeman v. Williams, 2014 U.S. Dist. LEXIS 91501 (D. Mass. July 7, 2014)

The plaintiff participated in a clinical trial designed to investigate the treatment of Young-Onset Parkinson's Disease by delivering an investigational gene therapy agent through an investigational brain infusion delivery system. Although the study protocol required the gene therapy to be delivered to both sides of the plaintiff's brain, the clinical trial investigator allegedly erroneously delivered it only to one side, thereby causing serious harm. The plaintiff filed suit against multiple defendants, including the investigator for medical malpractice and failure to obtain an adequate informed consent to the clinical trial, asserting that the consent form he gave the plaintiff failed to warn, among other things, of the possibility and risks of improper placement of the therapeutic agent and that the therapy was experimental. The plaintiff also sued the alleged manufacturer of both the gene therapy agent and brain delivery system, alleging it participated in drafting and approving the consent form.