Gelsinger v. Trustees of the University of Pennsylvania

Eighteen-year-old Jesse Gelsinger died after undergoing a medical experiment at the University of Pennsylvania. John Gelsinger (plaintiff), the administrator of Jesse’s estate, and Paul Gelsinger (plaintiff), Jesse’s father (collectively, Gelsinger), sued the Trustees of the University of Pennsylvania (university), the Institute for Human Gene Therapy (IHGT), Genovo, Inc., Dr. James Wilson, and others (collectively, researchers) (collectively, defendants) as a result of Jesse’s death. In the complaint, Gelsinger alleged that the IHGT was an institute within the university. Genovo was a biotech company founded by Wilson that conducted gene-transfer research. At all relevant times, Wilson owned up to 30 percent of Genovo’s stock. Wilson also served as the IHGT’s director and was an attending physician at the university’s medical center. Wilson and Genovo stood to financially profit from gene therapy that successfully utilized replication-defective-adeno-viral (RDAd) vectors. Because the university and the IHGT held an equity stake in Genovo, they, too, stood to profit from the successful use of RDAd vectors. Ornithine transcarbamylase deficiency (OTC) was a metabolic disorder that impacted the body’s ability to break down ammonia. Wilson sought to perform OTC gene-transfer experiments with an RDAd vector at the IHGT. The university’s conflicts-of-interest standing committee knew that a conflict would arise if Wilson were allowed to conduct such experiments at the IHGT because Wilson and Genovo stood to profit from the experiments’ success. The university allowed Wilson to conduct the OTC experiments at the IHGT, anyway. Jesse suffered from a mild form of OTC that was controlled through diet and medication. Jesse understood that he would not benefit from the experiment. However, Jesse agreed to participate because he was led to believe that the experiment posed little threat to him and would greatly benefit those born with OTC in the future. The information provided to Jesse regarding the experiment was allegedly false or misleading in numerous respects. For example, the researchers allegedly (1) failed to disclose that monkeys receiving the same injections had become ill or died, (2) downplayed the risk of the experiment’s toxic effects, and (3) failed to adequately disclose the extent to which Wilson and the university had a conflict of interest. On September 13, 1999, the vector was injected into Jesse. Jesse fell ill that evening and, after lapsing into a coma, died four days later. Jesse’s death was directly attributable to the vector injection. After Jesse’s death, the Federal Drug Administration (FDA) found that the researchers had violated numerous FDA guidelines by, for example, changing the informed-consent form to remove any reference to the test monkeys. Gelsinger asserted numerous claims, including a wrongful-death claim based on, among other things, the researchers’ failure to adequately (1) evaluate Jesse before the procedure, (2) treat and diagnose Jesse after the procedure, and (3) inform Jesse of the procedure’s risks. Gelsinger also asserted a claim for intentional assault and battery and lack of informed consent based on, among other things, the researchers’ failure to (1) adequately disclose Wilson’s and the university’s conflict of interest, (2) adequately disclose the extent to which Wilson and the university might profit from the experiment, and (3) disclose that monkeys undergoing the same procedure became ill or died. Gelsinger sought both compensatory and punitive damages.