A North Carolina law firm is looking into clinical trials connected to discredited cancer researcher Dr. Anil Potti.
The personal injury firm HensonFuerst is talking with experts and patients to get a better understanding of what occurred in the cancer treatment studies and how patients may have been affected.
“We’re in the initial stages of an investigation into what happened,” attorney Thomas Henson Jr. said.
Numerous patients and their relatives have called the firm to discuss the clinical trials, Henson noted. The firm has also posted a YouTube video and a notice on its website soliciting information. He said it is too early to say whether the firm will take legal action against Duke on behalf of any clients.
“The people that are calling us are scared and they want answers,” Henson said. “They want to know what the impact was to their health.”
Spokesmen for the University and the Duke University Health System declined to comment.
“We don’t plan to discuss or speculate on any potential legal issues related to the Potti situation,” Doug Stokke, DUHS associate vice president for communications, wrote in an e-mail Feb. 7.
HensonFuerst also represented patients in a previous suit against Duke. In that case, patients were accidentally operated on with surgical tools cleaned in hydraulic fluid.
The clinical trials HensonFuerst is currently investigating were halted in November after a scientific paper that provided justification for them was retracted. Potti was one of the main authors on the paper.
When Potti resigned from the University a few weeks later, a Duke official said the clinical trials should not have been conducted.
“In retrospect, these trials should not have been done,” said Dr. Michael Cuffe, DUHS vice president for medical affairs.
The studies were trying to determine whether genomic information could be used to pick the most appropriate cancer treatments for patients. They were suspended in July, after allegations that Potti misrepresented his credentials came to light.
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The trials were first suspended in Fall 2009, after two biostatisticians raised concerns about Potti’s work. But a Duke review allowed the trials to continue in early 2010.
Still, DUHS officials have said all patients in the trials received high quality treatment for their cancers.
Sharona Hoffman, co-director of the Law-Medicine Center at Case Western Reserve University School of Law, said that if patients received standard-of-care treatment, it might be difficult to take legal action. But patients could still sue based on the idea that the trials were conducted under false pretenses, she said.
“You could say that there’s some kind of harm to dignity because there’s something wrong with the clinical trial,” she explained.
The research misconduct investigation related to Potti’s work has not yet concluded, so it is not clear why there were mistakes in his research.
But if Potti intentionally falsified his research results, that could strengthen the hand of potential plaintiffs as well, Hoffman said. Even if the mistakes were made unintentionally, there could be claims of negligence.
Henson declined to say what legal actions HensonFuerst might pursue.
“Our investigation will tell us how we move forward,” he said.