Potti Mess: 8 patients file first lawsuit, naming University, Duke Health and five doctors as defendants

Search terms Anil Potti Duke University

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✔✔✔✔✔ Eight patients -- six of them dead and thus being represented by their families -- have joined to file the first lawsuit in the Potti Mess.

FC predicts this is just the tip of the iceberg. Potti had 109 patients in his clinical trials for lung, breast and ovarian cancer when Duke halted them last year. Earlier, an unknown number of other people had either completed the trials, quit or died. And still other patients underwent painful invasive tests to see if they qualified for the genome-based treatment.

In all instances, the patients gave "informed consent" to medical studies that were not what they were led to believe. The plaintiffs say Potti promised "better than the standard chemotherapy" that would have "a higher likelihood of a favorable response." He also promised that his work -- with huge grants from the American Cancer Society and others for cutting edge genome research -- was enhancing "the public good."

In fact, Potti had falsified both his theories and his tallies of patient experience. And the cancer society demanded and got its money back.

As Loyal Readers know, so far five of about 40 articles that Potti and colleagues wrote for distinguished medical journals have been retracted. There are at least two investigations underway, a public one by the Institutes of Medicine, and a faculty misconduct investigation held confidentially under federal law. We have no idea how many faculty are included in the latter investigation.

The defendants in the lawsuit are the University, its wholly owned Duke Health subsidiary, the cancer quack Dr. Anil Potti, his mentor Dr. Joseph Nevins, and three other Duke doctors with administrative positions. A cancer diagnostic lab, believed to be owned by Nevins, was also named.

The administrators are:

Dr. John M. Harrelson, a retired orthopedic surgeon who headed the institutional review board that gave a ringing endorsement to Potti's work in early 2010.

And Vice Deans Michael Cuffe and Sally Kornbluth of the Medical School who were among administrators who signed off on the Harrelson board's recommendations. (Dr. Cuffe is also in the news today because of his unrelated resignation to become president of the Hospital Corporation of America. See separate FC post)

Potti was finally uncovered last year, initially because The Cancer Letter spotted a faked Rhodes Scholarship on his resume. He resigned his faculty position several months later.

Duke has a tradition of refusing comment on litigation, so we did not even bother to ask. It also has a tradition of dragging lawsuits out, hoping to wear down plaintiffs and build up their expenses. This litigation will take years and years. The plaintiffs' complaint alone is 78 pages of legalese.

Yes, delay and delay. That's our university.

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Separately, by coincidence, the director of all genome research at Duke, Dr. Huntington Willard of the Institute for Genome Sciences and Policy, sent a lengthy and very candid evaluation of the Potti Mess to his colleagues yesterday, saying the start of a new academic year is a good time to reflect on "a teachable moment."

Fact Checker will post on this document over the weekend. Loyal Readers can jump the gun on us by reading the document themselves!

http://www.genome.duke.edu/people/faculty/willard/dirmessages/Message%20to%20IGSP%20Faculty%20-%20A%20Teachable%20Moment.pdf

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It is impossible to say how much money is at stake in the lawsuit already filed, which seeks actual compensatory and punitive damages. The plaintiffs ask innumerable times for "more than $10,000" but that is just pro-forma.

The cases were filed in Durham Superior Court. The plaintiffs are represented by the Raleigh firm HensonFuerst, and its partner Thomas W. Henson Jr. This firm has tangled with Duke before, most notably in litigation growing out of Duke's negligent use of used hydraulic fluid from elevators to wash sterile surgical instruments.

One of the most frequent questions asked of Fact Checker is whether Dr. Potti will pay for his own defense. While this gets bogged down in insurance and liability issues, the simple answer is "probably not." The school is going to be hit.

✔✔✔ The lawsuits go well beyond problems arising directly from the fake research and clinical trials conducted by Potti. Clinical trials are experiments on human beings to see whether a drug, a test or a procedure lives up to its promise, or whether risks outweigh benefits. And in Potti's trials, the plaintiffs say they were exposed to "improper and unnecessary chemotherapy."

Duke's response to the accumulating evidence of fraud is deeply involved in the lawsuits.

The plaintiffs say Duke knew about issues with Dr. Potti as far back as 2006 but chose to ignore them because he was a rising star who roped in big grants.

There is also an allegation that Duke's internal review -- started in late 2009 -- which cleared Potti with a glowing report -- was conducted by a panel with numerous ties to Potti and his mentor.

The plaintiffs allege Duke "threatened staff with retribution, including legal action" if anyone spoke up about Potti to reveal his fraud.

"The entire response by (Duke) 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.

✔✔✔ Duke's motive allegedly included profit, a hope to create tests based upon Potti's research, that would tell precisely what drugs should be used against a given cancer, considering also the patient's DNA. This would replace the current trial and error evaluation that doctors use.

The plaintiffs say that had Duke been able to license these tests, it stood to gain "billions" of dollars, a substantial fee every time a test was given world-wide.

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 extra help fighting their disease.

The living patients are a Richmond County man with lung cancer and a Buncombe County woman with breast cancer.

After his resignation, Potti joined a cancer care clinic in South Carolina, that treats patients and does clinical research. He applied for and was granted a SC medical license.

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