Durham, N.C. — Two patients and the families of six others have filed suit against Duke University, the Duke University Health System and several affiliated physicians over clinical trials linked to a discredited researcher.
The group is seeking compensatory and punitive damages in the case, alleging that Duke tried to cover up questions about the research and performed unnecessary chemotherapy on people in hopes of patenting and spinning off a cancer-screening test.
Duke halted work on the clinical trial last year after learning that Dr. Anil Potti exaggerated his credentials, including claiming that he was a Rhodes scholar. Potti, who resigned in November, was an associate professor of medicine at Duke's School of Medicine and the university's Institute for Genome Science & Policy.
Two published papers based on his research were retracted last fall after a collaborator said the results of Potti's work couldn't be reproduced.
The lawsuit, filed Wednesday in Durham County Superior Court, alleges that researchers raised questions about Potti's research as far back as 2006, noting that Potti misused data and produced flawed results.
Despite repeated warnings by outside researchers, the lawsuit states, Duke enrolled patients in three clinical trials. The university finally began an internal investigation in late 2009, but the panel assigned to review Potti's research and the clinical trials had numerous ties to Potti and collaborator Dr. Joseph Nevins, according to the lawsuit.
Once details of the faulty research became public last year and the American Cancer Society stopped paying Duke on a grant, the university sent form letters to patients in the clinical trials that "minimized and misstated the extent of and severity of the problem and the potential risks" to patients, the lawsuit states.
The university also "threatened staff with retribution, including legal action," to prevent questions about Potti's research from being raised, according to the lawsuit.
"The entire response by Duke University and/or (the Duke University Health System) to the accusation of invalid and fraudulent science was deceptive misleading and fraudulent conduct designed to protect its reputation and proprietary interests ... rather than protecting the safety of the patients involved in the clinical trials," the lawsuit states.
Six of the eight plaintiffs have since died, according to the lawsuit. All suffered from lung cancer and enrolled in the clinical trials under the belief that they would receive "better than the standard chemotherapy" and would have "a higher likelihood of a favorable response."
The other two plaintiffs are a Richmond County man with lung cancer and a Buncombe County woman with breast cancer.
"The fact is Duke conducted clinical trials on cancer patients that should have never been done. The trials themselves were based on invalid science," said attorney Thomas Henson Jr. who represents the eight plaintiffs. "Respected researching in the oncology world were warning Duke and telling them about the invalid science and ultimately Duke failed to give full and informed consent in terms of what was being done to them."