Ana Abreu-Velez, a former Emory postdoctoral fellow, is suing Emory University and Georgia Regents University. In her complaint, she alleges that officials and employees at the schools conspired to damage her reputation after she exposed safety and legality issues with clinical trials conducted at Georgia Regents.

Representatives from both schools strongly deny the claims, saying they are without merit.

In the 24-page lawsuit, filed Dec. 18 and obtained by the Wheel, Abreu-Velez alleges that the retaliation against her involved attempting to thwart the renewal of her green card and planning attacks on her family and property.

Abreu-Velez claims in the lawsuit that this conspiracy resulted from her whistleblower activity, including reporting her concerns with clinical trials conducted at Georgia Regents, which was formerly known as the Medical College of Georgia. She disclosed issues with the trials to Georgia Regents officials and other employees, and later to the FBI and the Office of the U.S. Attorney, the lawsuit says.

The lawsuit was filed against the two schools as well as the Board of Regents of the University System of Georgia, which operates Georgia Regents.

Before becoming employed at Emory in 2005, according to the lawsuit, Abreu-Velez was a research assistant and study coordinator in the Department of Ophthalmology at Georgia Regents. Her employment was terminated in November 2004, which she alleges occurred after she disclosed her concerns with clinical trials conducted at the school, including one that involved radiation and “invasive surgery” and was funded by the pharmaceutical company Theragenics, Inc.

She was employed at Emory until 2007, and the University declined to release the reasons for her departure as per Emory policy.

Abreu-Velez – who declined to comment to the Wheel because the litigation is ongoing – says in the complaint that she believes Emory worked with Georgia Regents to damage her reputation and that both schools receive research grants from Theragenics.

Nancy Seideman, Emory’s interim vice president for communications and marketing, said records indicate that Theragenics only funded one study at the University from 2004 to 2010.

In a statement to the Wheel, Emory University said via its communications office, “Dr. Abreu-Velez has made unsupported and irresponsible allegations in her complaint, and her legal claims are completely meritless.” Seideman said she anticipates a Motion to Dismiss to be filed next week.

Jack Evans, Georgia Regents University’s associate vice president for communications and creative services, wrote in an email to the Wheel that Abreu-Velez’s allegations “are unsubstantiated and false.”

The matter has been referred to the Georgia Attorney General, and the Board of Regents has requested and obtained representation from the Attorney General’s Office, Evans wrote, adding that he also expects a Motion to Dismiss to be filed.

Abreu-Velez has filed the lawsuit pro se, according to the lawsuit, meaning she is defending herself without representation from a lawyer.

Emory is confident that the case will be dismissed, just as a similar lawsuit that she filed in 2005 was dismissed in 2009, according to the Emory University statement. She filed her previous lawsuit against the Board of Regents, Georgia Regents (then known as the Medical College of Georgia) and Dennis Marcus – the school’s former head of the Department of Ophthalmology – but not Emory.

The case was dismissed on the grounds that Abreu-Velez’s claims about retaliation for her reporting the issues with clinical trials was not sufficient for the case to go to a jury trial, according to a 28-page court order.

Abreu-Velez alleges in the recent lawsuit that the specific issues with the Theragenics clinical trials at Georgia Regents included illegal payments, inadequate measures taken to prevent exposure to radiation and the incorrect billing of study participants. She also alleges that Georgia Regents failed to report deaths and “severe adverse events” that resulted from the study.

Moreover, she claims that Georgia Regents violated federal and state laws, rules and regulations during the Theragenics trials as well as during other studies.

She believes, the lawsuit says, that the recent case of Elliot v. Emory University proves her assertions that Georgia Regents was improperly billing study participants. In Elliot, Emory paid $1.5 million to settle claims that some patients enrolled in clinical trial research at Emory’s Winship Cancer Institute were overbilled Medicare and Medicaid from 2001 to 2010, the Wheel reported in September.

According to the lawsuit, Abreu-Velez also believes that Thomas Lawley, former dean of the School of Medicine and current William P. Timmie Professor of Dermatology, resigned from his position as dean, and that some human resources employees were dismissed from the University, as a result of their involvement in the conspiracy against her.

When contacted by the Wheel, Lawley referred an inquiry to Emory’s communications office, which has denied the allegations. The Wheel reported in November 2011 that Lawley was stepping down after 16 years in that position.

And Abreu-Velez claims that Georgia Regents and Theragenics officials have resigned, and that U.S. Senator Saxby Chambliss (R-Ga.) decided not to run again this year because of Abreu-Velez’s reports to the FBI and the Office of the U.S. Attorney. The lawsuit does not provide any specifics about Chambliss’ alleged involvement.

Chambliss’ spokeswoman Lauren Claffey wrote in an email to the Wheel, “I can assure you, Sen. Chambliss’ decision not to seek re-election this year was in no way influenced by Dr. Abreu-Velez’s claims.” A statement released by his office last January states that he is not running again due to his frustration with a “lack of leadership” from the White House and Congress in addressing U.S. economic issues.

Once Abreu-Velez became a postdoctoral fellow at Emory, the lawsuit claims, Lawley and employees in Emory’s Human Resources Department “interfered” with the processing of her green card renewal application.

Her application contained errors and missing documents, the lawsuit says, but does not elaborate on the alleged specific roles of each of these parties.

The lawsuit says that Abreu-Velez’s family has faced “multiple documented attacks” in the past several years, “which she believes were orchestrated by Emory University and [Georgia Regents].” For example, the lawsuit cites an example from 2006 in which her daughter was hospitalized for a month but does not offer specifics about the schools’ alleged involvement.

Additionally, Abreu-Velez claimed in both the current and previous lawsuits that Georgia Regents University refused to rehire her for any of the numerous jobs at the school for which she applied after she was terminated from her position in 2004.

Officials from Theragenics declined to comment.

– By Jordan Friedman

Follow Jordan Friedman on Twitter @jmfriedman8

Editor’s Note: While not required by law, the Wheel chose to remove Abreu-Velez’s contact information and address from the lawsuit for privacy reasons.

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