Qui Tam - The Lawsuit

Frustrated by my inability to persuade two Campus Committees on Research Integrity and the Office of Research Integrity (ORI) of the U.S. Public Health Service that research misconduct had occurred, I decided to file a qui tam case on October 10, 2003.

This resulted in charges being filed against Dr. Bishayee, Dr. Howell, and the University of Medicine and Dentistry of New Jersey for violating the Federal Civil False Claims Act Act.

During the search for expert witnesses, a colleague and friend of mine—Dr. Hei (or so I thought)—was subpoenaed. He filed a motion to quash in response, claiming that I was attempting to use him as an unpaid expert. Ultimately, his motion carried Judge Cavanaugh's ruling. This was my introduction to the unsympathetic stance that our judge would take.

Lenarczyk was first deposed, acknowledging his 16 experiments failed to replicate Bishayee's results. Next, Dr. Azzam offered little assistance and forgot a crucial 2001 conversation where he claimed to have convinced Howell to remove Bishayee. Howell's deposition suggested I was biased against foreigners.

Bishayee struggled to recall details from experiments nine years earlier, showing limited understanding. He denied involvement with the media for those experiments and claimed ignorance of deoxycytidine and cell synchrony.

Department Chairman Stephen Baker's deposition followed, He confirmed signing off on grants and his responsibility for departmental ethics. He noted that Howell didn’t inform him that Bishayee's results were unreproducible or follow up on his pledge to report after Lenarczyk repeated the experiments. My deposition concluded the process, with the defense attorney skillfully twisting my words.

Dr. Joel Pitt, Chairman of Computer Science and Mathematics at Georgian Court University, was my statistics expert. He quantified cell counts with a Coulter counter, revealing Bishayee's counts were non-random, while others showed randomness.

Dr. Mike Robbins was Associate Director of the Brain Tumor Center at Wake Forest Medical School in Winston-Salem, NC. He concludes that Lenarczyk and Howell's data align with expected results based on experimental protocols. The failure to replicate Bishayee's findings suggests those data were falsely generated.

Dr. Ludwig Feinendegen was a "rebuttal witness" for Robbins' report only. In his report, he reviewed Howell's list of possible explanations for the inability to replicate Bishayee's results, justifying each without finding evidence of their roles in Howell's experiments.

It was time for both sides to decide on filing a Motion to Dismiss. My lawyer, Pincus, submitted our 18-page reply brief by the June 21, 2010 deadline, while the defense turned in their 14-page brief late, which ideally should have favored us but didn’t. Pincus highlighted the robust science and expert opinions in his brief. He would have excelled in a court focused on scientific matters.

The defense dismissed my claims as lacking merit, suggesting I had a personal vendetta and failed to prove the defendants acted "knowingly, recklessly or with deliberate ignorance." I did not show that the data was false or influenced funding decisions. They argued my experts' reports were questionable and self-serving, claiming Howell's insights were based on my suspicions. Furthermore, I had not filed a formal complaint in 1999 after my initial observations or demonstrated that my alleged false data was significant to the funding decision.

Cavanaugh issued his decision on October 18, 2010, stating there was no violation of the False Claims Act (FCA). The government must be defrauded with money involved, the defrauder must knowingly defraud, and the action must be material.

The judge ruled Howell lacked scienter since he was unaware of the fraud when filing the grant. Reports received after the filing were deemed immaterial.

Regarding Bishayee, the judge found him neither scienter nor material, despite him supplying most preliminary data for the grant.

Howell was exonerated for not notifying the NIH about his inability to replicate Bishayee's results, with the judge asserting that even if the NIH had known of the falsified results, their granting decision wouldn't have changed.

Even though I knew it would be an exercise in futility, I had to give it one last try. The appeal would be heard in the appeals court in Philadelphia, where three judges would preside. Much of the discussion centered on Howell's knowledge. Pincus valiantly tried to highlight that Howell had concealed from the first CCRI both his and Lenarczyk's inability to reproduce Bishayee's results. The ruling on the appeal came through on October 20, 2011. As expected, Judge Cavanaugh's decision was upheld. I was informed that the only course of action would be to appeal to the US Supreme Court, which would be a futile endeavor. My only option was to publish the statistical analysis of the raw data we had gathered.