‘Kafkaesque nightmare’: Judge wants researcher reinstated as NIH grant PI after med school’s misconduct finding

A federal judge has denied a request for a preliminary injunction by a breast cancer researcher at SUNY Downstate in Brooklyn who sued the university last year after an institutional investigation determined that she committed research misconduct. 

However, the judge noted “troubling aspects of this case that bear on serious public health concerns” – namely the discontinuation of the scientist’s research – and also expressed concern about SUNY Downstate and the NIH’s treatment of her. 

As we’ve previously reported, Stacy Blain, an associate professor of pediatrics and cell biology at SUNY Downstate, has alleged the university discriminated against her for decades because of her sex, and that the investigation’s finding of misconduct was the result of retaliation after she complained of the discrimination. 

In a request for a preliminary injunction filed the same day as she filed the lawsuit, Blain asked a judge to order SUNY Downstate not to initiate disciplinary proceedings or other “adverse employment actions” against her, not to contact journals asking for retractions of her papers, and to reinstate her as the principal investigator on two grants from the National Institutes of Health from which she’d been removed. 

In denying the request, Judge Frederic Block ruled this week that Blain had failed to prove “that there is a likelihood of success that she will prevail on the merits.” He also wrote:

The tangled circumstances that flowed from the anonymous whistleblower’s complaint back in 2019 has embroiled Dr. Blain in a Kafkaesque nightmare. She stands accused by SUNY Downstate of research misconduct, but she might very well be exonerated at her disciplinary hearing. Only time will tell.

On the federal level, ORI is reviewing the finding of research misconduct. Its decision will not be rendered for some indeterminate period of time and there is no certainty that it will agree that Dr. Blain is culpable. 

The opinion summarized the evidence that Block found concerning. Among it was testimony from Andrew Koff, a molecular biologist at Memorial Sloan Kettering Cancer Center. 

Koff testified that an experimental cancer drug Blain had invented could make it to clinical trials “within two years,” and that SUNY Downstate’s requests to retract Blain’s papers would “end the program.” He also said that he disagreed with the conclusion in SUNY Downstate’s investigation of Blain that the data falsification would be obvious to any cell biologist. 

Koff – whom Block described as “one of the world’s leading molecular biologists” – serves as a scientific advisor to Concarlo Therapeutics, the biotech company Blain founded in 2016 to commercialize her research. A lawyer for Blain said Koff did disclose his role in court. 

Block wrote that, as a result of the evidence Blain presented, he had: 

became concerned about NIH’s wisdom in jettisoning Dr. Blain. Her discovery of the drug that holds out the promise of reducing cancerous growths suggests that it was in the public’s best interest for NIH to have allowed her to continue her quest to rid the world of cancer.

It is the Court’s hope that Dr. Blain can be returned as the PI on the grant. Although the Court has acknowledged that it has no jurisdiction to adjudicate the decisions and actions of SUNY Downstate, ORI and NIH, it believes that this is a rare occasion when a court should stray from the strictures of its jurisdiction and speak to the public in dicta because of the profound public interests at stake.

Still, Block concluded that the evidence Blain presented thus far did not establish sex discrimination or retaliation by SUNY Downstate: 

There is no evidence that SUNY Downstate took any action that it would not have taken against a similarly situated male professor.

Block also wrote that he believed “the investigation of Dr. Blain was not in SUNY Downstate’s reputational or financial interest,” and was “convinced that only the most serious and legitimate reasons would lead SUNY Downstate to act against those interests.” 

A spokesperson for SUNY Downstate has previously told us that the university “does not comment on pending litigation.” 

James Walden, an attorney at Walden, Macht & Haran in New York who represents Blain, commented: 

First, we thank U.S. District Judge Frederic Block, for identifying and addressing what is at the heart of this matter.  As Judge Block stated, SUNY’s plagued research misconduct investigation against Dr. Blain has been a “Kafkaesque nightmare.”  As we have maintained all along, this investigation, as Judge Block found, was “compromised.”  For example, Judge Block was “greatly troubled” by the final investigation report’s exclusion of exculpatory evidence; Judge Block questioned the integrity of the investigation committee, noting that they failed to include witness statements supporting Dr. Blain’s research or interview witnesses who would have testified that Dr. Blain did not and would never engage in research misconduct.  Judge Block emphasized that one of the world’s leading molecular biologists – who was “eminently qualified” to take issue with the investigation committee’s findings – disagreed with the investigation committee’s conclusion that Dr. Blain committed research misconduct. 

For these reasons, Judge Block expressed that SUNY’s actions against Dr. Blain have harmed science and raised “serious public health concerns” and, to correct this travesty, Dr. Blain should be “returned as the [principal investigator] on the grant” from which she was removed as a result of the investigation.  The fact that a federal judge took the extraordinary step of making a public pronouncement of his disapproval and concern speaks volumes about the case and the integrity of Dr. Blain’s research. 

Although Judge Block did not grant Dr. Blain a preliminary injunction against SUNY, as Judge Block noted, all of the claims litigated survive and remain to be litigated with full discovery as to SUNY’s biased and unfair investigation.

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