Estate of Gelsinger v. Trustees of University of Pennsylvania: Money, Prestige, and Conflicts of Interest In Human Subjects Research

Abstract

Robin Fretwell Wilson, “Estate of Gelsinger v. Trustees of University of Pennsylvania: Money, Prestige, and Conflicts of Interest In Human Subjects Research,” in Health Law and Bioethics: Cases In Context (Sandra H. Johnson, Joan H. Krause, Richard S. Saver, & Robin Fretwell Wilson, eds., 2009).

This chapter re-examines the death of Jesse Gelsinger on September 17, 1999, the first person reported to die in a human gene-therapy trial. Unlike many of the cases in the book in which it appears, HEALTH LAW AND BIOETHICS: CASES IN CONTEXT, no public court record exists anywhere of the mistakes made in Jesse’s clinical trial. After Jesse’s death, the Food and Drug Administration (FDA) charged that a cascade of mistakes culminated in Jesse’s death. The consent forms Jesse signed failed to disclose both the death of monkeys in an earlier animal study using higher dosages of the viruses infused into Jesse’s liver and ‘‘significant adverse events’’ experienced by other subjects in the same trial — ‘‘important evidence,’’ the FDA said, ‘‘of increased risk.’’ The researchers failed to adequately alert the FDA about the adverse events, denying the agency the opportunity to stop the study well before Jesse’s infusion. The researchers infused Jesse even though his liver was not functioning within the study’s limits 24 hours prior to infusion. Less than four days later, Jesse died.

In the early days following Jesse’s death, his father, Paul Gelsinger, publicly defended the researchers. All that changed as news emerged of one researcher’s, Dr. James Wilson’s, financial interests in the trial. Paul Gelsinger filed suit against Wilson; Drs. Mark Batshaw and Steve Raper, the trial’s two principal investigators; Penn, which approved and sponsored the research through IHGT; Genovo, the gene-therapy company that partially funded IHGT and in which Wilson had shares; the Dean of Penn’s medical school; Arthur Caplan, Penn’s world famous medical ethicist who had advised the researchers to test the virus on relatively healthy adults rather than dying infants; Children’s Hospital of Philadelphia; and Children’s National Medical Center. The suit sought compensatory and punitive damages for using an adenovirus that was ‘‘unreasonably dangerous,’’ a product liability claim; intentional assault and battery; breach of the duty to secure informed consent; intentional infliction of emotional distress; fraud and intentional misrepresentation; and fraud on the FDA.

When the suit ultimately settled, no one accepted responsibility for Jesse’s death. When the government subsequently brought and settled a civil false claims suit against the researchers and sponsoring institutions, no one admitted any wrongdoing or apologized. No one grappled in detail with the substance of the FDA’s original charges. Each defendant maintained that it acted lawfully at all times, even as Penn and CNMC together paid more than a million dollars and the government restricted the researchers’ ability to do human experimentation — terms that arguably say as much about the crushing power of federal false claims investigations as they do about the underlying merits. What remains of Jesse’s story sat in document boxes crammed full by the Gelsingers’ attorneys and set aside after the insurers, the parties, and the court signed off on the settlement. This chapter resurrects that story and fills in those missing pieces.

Keywords: Health Law, Bioethics, Human gene therapy

JEL Classification: K10, K32