Exclusive: Cancer researcher sues med school for retaliation after research misconduct finding

A breast cancer researcher at SUNY Downstate in Brooklyn has sued the university for sex discrimination and retaliation after an institutional investigation found she committed research misconduct. 

Stacy Blain, an associate professor in the departments of pediatrics and cell biology at Downstate, has alleged that the university violated the Equal Pay Act by paying her less than her male colleagues; discriminated against her based on her sex since she joined the faculty in 2002, including by conducting multiple investigations into her lab’s work; and used the latest investigation and its finding that she committed research misconduct to retaliate against her for accusing the university of sex discrimination. 

From the lawsuit: 

This campaign to discredit Dr. Blain by using a fundamentally unfair investigation clearly gives rise to an inference of discrimination. The denigrating and sexist treatment she experienced (e.g., being referred to as “soccer mom”) bolsters this finding.

Blain alleges Downstate retaliated against her by asking journals to retract her papers that its investigation found contained fabricated or falsified images, replacing her as principal investigator on two NIH grants, and telling her it intends to initiate formal disciplinary proceedings. She further alleges the university has retaliated against her by abandoning a patent for breast cancer therapies she developed that was licensed to a biotech company she founded in 2016, Concarlo Therapeutics.

Her suit also alleges the university and some named professors on the investigation committee defamed her by telling some of her colleagues that the federal Office of Research Integrity had found she committed misconduct, when the agency’s review of the investigation report is still ongoing. 

Blain is seeking a jury trial, damages “for lost opportunities,” damages “for humiliation, mental anguish, emotional distress, and injury to reputation,” punitive damages, and attorney’s fees, according to court documents. 

SUNY Downstate did not send us a comment by deadline. 

Two of Blain’s lawyers, Paul Thaler, of Cohen Seglias Pallas Greenhall & Furman in Washington, D.C., and Jim Walden, of Walden Macht & Haran in New York City, sent us this comment on her behalf: 

Dr. Stacy Blain’s case is a prime example of what can result when a university mis-manages a research misconduct investigation and presents its flawed decisions to journals. SUNY Downstate’s handling of allegations against Dr. Blain was only the latest of many bad actions against Dr. Blain over a period of years necessitating the filing of a lawsuit against the university.

Blain experienced a “toxic and alpha-male dominated culture” and sex discrimination since she joined SUNY Downstate in 2002, the lawsuit alleges. The suit states that she received “unwanted memes depicting ‘soccer moms’” from a senior male advisor after he learned she was pregnant, that her tenure was delayed, and that she received less pay than her male colleagues. 

The first allegations of research misconduct in Blain’s lab date back to 2016.  At that time, one of her graduate students accused another student of doctoring images in unpublished work as well as figures in a paper published in Molecular and Cellular Biology in 2015, “​​Brk/protein tyrosine kinase 6 phosphorylates p27KIP1, regulating the activity of cyclin D–cyclin-dependent kinase 4.” 

The SUNY School of Graduate Studies conducted an inquiry in which multiple faculty members, one at the request of Blain and two others for the formal inquiry, reviewed the student’s data. Blain’s complaint stated that the review “did not find any evidence of research misconduct.” 

In a letter to the student and Blain dated Dec. 20, 2016 (which Blain’s lawyers filed in court), the dean of the school stated that the review had found “significant concerns with the draft figures,” and had identified “examples of concern” in the published paper and a recent grant application Blain had provided for the inquiry. 

The dean wrote: 

These concerns clearly indicate, at a minimum, a level of carelessness and poor record keeping that cannot continue. More significantly, the specific examples identified in the various figures raise concern that the final appearance of the figures is due to your own motivation to please or to follow instructions rather than to document actual results.

At this time, there will not be any disciplinary action stemming from this incident. You are encouraged to be much more careful with your record keeping and data handling going forward, and we will review your results at future works-in-progress or thesis meetings. If there any [sic] further concerns of mishandling data in the future, this incident will be brought back up and the consequences may be serious.

The graduate student’s thesis committee also did not find evidence of research misconduct in his work and allowed him to graduate in 2017, according to Blain’s lawsuit. He joined Blain’s company and worked there for about two years.

In June of 2019, the pseudonymous critic Claire Francis emailed SUNY officials a link to discussion of Blain’s publications on PubPeer, which Francis said contained “image duplication and flipped images pretending to be different things/different experiments.” 

Francis also forwarded the email to ORI, which in July of 2019 sent a letter to SUNY Downstate with the allegations, according to Blain’s complaint. 

Blain’s lawyers argue that the allegations were the same as the ones raised against Blain’s graduate student in 2016, and SUNY should have sent ORI the letter from the dean of the graduate school with the results of the earlier inquiry, instead of opening a new inquiry as it did. 

On Oct. 23, 2019, a lawyer for Blain sent SUNY Downstate a letter alleging sex discrimination by the university against Blain. “Enraged that Dr. Blain had the audacity to complain about her unfair treatment, Defendant SUNY Downstate quickly began using the inquiry as a tool for retaliating against Dr. Blain,” her lawsuit alleges. 

In a report dated Dec. 12, 2019 (which Blain’s lawyers filed in court), the inquiry committee concluded that an investigation was warranted. 

According to a copy of Downstate’s final investigation report Blain’s lawyers filed in court, dated Dec. 2, 2021, the institutional investigation:

 concluded by a preponderance of the evidence that Dr. Blain committed research misconduct through fabrication and/or falsification, as well as reckless evaluation of the raw data generated in her laboratory and preparation of resulting figures for her publications and grant submissions.

The investigation committee recommended that the school “consider serious action based upon these findings.” Specifically, the committee recommended that the university inform the journals that had published the papers identified in the investigation of the results so they could retract or correct the articles, and that the university administration “should confer with the Research Foundation to discuss SUNY Downstate’s license agreement with Concarlo and determine whether any actions should be taken.”

According to its website, Concarlo – the company Blain founded in 2016 – aims “to dramatically improve outcomes for patients with drug-resistant cancers by creating transformative therapies that control the p27 target,” beginning with drug-resistant metastatic breast cancer. 

In addition to licensing patents from SUNY, Concarlo is housed in the Downstate Biotechnology Incubator. It raised $100,000 in seed funding in 2018 from New York State and the Accelerate New York Seed Fund, according to Crunchbase. The president of the company listed on its website, Jason Mraz (not the singer), is also Blain’s spouse, according to SUNY’s final investigation report. 

SUNY Downstate had apparently begun acting on the committee’s recommendations. It notified Blain of impending disciplinary proceedings to revoke her tenure and fire her, when Blain filed her suit in May of this year. 

In a request for a temporary restraining order and preliminary injunction filed the same day as the lawsuit, Blain and her lawyers allege: 

Defendant SUNY Downstate is taking these drastic steps even though ORI’s review of the investigation report and exculpatory evidence that Dr. Blain provided is ongoing and despite the fact that, in light of the unsubstantiated conclusions of Defendant SUNY Downstate’s investigations, Dr. Blain will likely be exonerated. 

Blain asked for the court to order SUNY Downstate not to start disciplinary proceedings, tell journals to halt the retractions it had asked for, and restore her as principal investigator on two NIH grants until the court decides on her employment discrimination action. 

Universities are not obliged to wait for ORI before acting on their investigations. Earlier this year, we reported on a researcher who was fired from the Albert Einstein College of Medicine at the end of 2019, two years before ORI found he and a colleague faked data in 16 NIH grant applications. 

SUNY Downstate’s investigation committee identified data manipulations that occurred over a period of at least eight years, including an NIH grant application and four published papers: 

• “Differential modification of p27Kip1 controls its cyclin D-cdk4 inhibitory activity,” Molecular and Cellular Biology, 2008 (cited 96 times, according to Clarivate’s Web of Science)
• “p27Kip1 inhibits cyclin D–cyclin-dependent kinase 4 by two independent modes,” Molecular and Cellular Biology, 2009 (86 citations) 
• “Brk/protein tyrosine kinase 6 phosphorylates p27KIP1, regulating the activity of cyclin D–cyclin-dependent kinase 4,” Molecular and Cellular Biology, 2015 (32 citations)
• “Inflammatory Mediators of Esophagitis Alter p27Kip1 Expression in Esophageal Epithelial Cells,” Journal of Pediatric Gastroenterology and Nutrition, 2010 (4 citations)

In April of this year, SUNY Downstate contacted the journals and requested the retraction of the papers, according to Blain’s request for a temporary restraining order. The article in the Journal of Pediatric Gastroenterology and Nutrition remains unmarked, while the three Molecular and Cellular Biology papers all have similar expressions of concern. The one for the 2015 paper states: 

The American Society for Microbiology (ASM) and Molecular and Cellular Biology (MCB) are issuing this Expression of Concern regarding the following publication:

James MK, Ray A, Leznova D, Blain SW. 2008. Differential modification of p27Kip1 controls its cyclin D-cdk4 inhibitory activity. Mol Cell Biol 28:498–510. https://doi.org/10.1128/MCB.02171-06.

Molecular and Cellular Biology was notified that the above-mentioned paper was investigated by the SUNY Downstate Health Sciences University and that potential image duplications were found in Fig. 3A and 6B.

This Expression of Concern is issued pending the outcome of ongoing litigation between SUNY Downstate Health Sciences University and the corresponding author of the paper, Stacy Blain, in the United States. District Court of the Eastern District of New York.

We emailed the publisher of the Journal of Pediatric Gastroenterology and Nutrition, a Wolters Kluwer title, and heard from a spokesperson that “We’re checking with the journal’s society for an update for you.” 

We emailed Peter Tontonoz, the editor-in-chief of Molecular and Cellular Biology, with questions about the papers, and heard back that “ASM Ethics committee is considering your request.” 

Thaler and Walden sent us this comment about the expressions of concern on behalf of Blain: 

The Expressions of Concern are directly tied to the house of cards that was SUNY Downstate’s entirely unreliable, biased investigation and years of gender-based discrimination. For example, SUNY had— three years earlier—cleared a male scientist of any duplication of the same data; it found Dr. Blain, a female, responsible without any new or different evidence. Additionally, SUNY failed to interview the first authors of two of the three papers. These individuals not only prepared the figures in question, but also generated the data. Instead of questioning why these individuals refused to participate in the process, SUNY Downstate held their refusal against Dr. Blain, while simultaneously refusing to interview other individuals identified by Dr. Blain as having relevant and exculpatory evidence. These are just two of many instances of the university failing to abide by federal regulations, and university rules, which govern such investigations.

Dr. Blain firmly stands behind the scientific results reported in each of these papers, and has repeatedly offered to work with the journal to correct any errors. Dr. Blain looks forward to continuing to demonstrate in court that SUNY Downstate had no basis for its actions against her and seek the justice that has long been denied to her. Dr. Blain is seeking emergency intervention of the Court, having just learned of the Expressions of Concern, to have those expressions retracted.

Indeed, another of Blain’s lawyers filed a motion for a temporary restraining order about the expressions of concern on Thursday. 

We had emailed Blain asking for her comment on the expressions of concern on Wednesday, which the motion mentions. It further says: 

To make matters much worse, we have now been advised that Retraction Watch, an online publication with many readers in the academic and scientific communities, will publish an article dragging Dr. Blain’s name through the mud, and causing Dr. Blain’s reputation further irreparable harm.

Apparently, we’d already been mentioned in the court’s proceedings, according to the motion: 

As Paul Thaler testified at the hearing, “[a]s soon as [a] retraction happens, [Retraction Watch] [is] going to pick it up [and] put a big picture of the respondent at the top of [the] page with a headline underneath that essentially says, Here’s a bad scientist.”

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