Charging that the Carle Foundation Hospital and Carle Clinic failed to protect cancer patients in their clinical trials, Suzanne Stratton, Ph.D, the former vice president for research at the Carle Foundation Hospital in Urbana, Ill., filed a whistleblower lawsuit in federal court against the hospital’s chief executive officer, the Carle Clinic Association, Kendrith Rowland, M.D., a lead physician at the Carle Clinic, and Bruce Wellman, M.D., the Carle Clinic CEO. 

Stratton alleges she was fired in retaliation on Nov. 18, 2008 for her repeated warnings that the Carle  Foundation Hospital and the Carle Clinic had violated federal regulations intended to protect cancer patients enrolled as subjects in clinical trials. She was hired in early 2007 to help oversee cancer trials there. 

“Her concerns were global, but her specific concern that led directly to her termination was her wanting to go investigate whether there had been any actual patient harm,” said Maura Dundon, an attorney with the law firm Katz, Marshall & Banks, LLP that is representing Stratton. 

The lawsuit alleges that Stratton made repeated attempts to stop the violations, which were ignored by Leonard and others, including the Carle Clinic Cancer Center director. 

The Carle Foundation Hospital responded to the lawsuit with a statement: “As expected, a former employee, Mimi Suzanne Stratton, has filed a lawsuit naming The Carle Foundation President and CEO James C. Leonard, M.D., as one of the defendants. We believe the allegations in the lawsuit are without merit and we intend to vigorously defend the organization and its CEO. 

 “We believe this filing is in response to the defendant’s recent refusal to pay Mimi Suzanne Stratton and her counsel the money they demanded to avoid this lawsuit. We believe this lawsuit was filed to further pressure the defendants into a settlement, which is why we believe they provided copies of this suit directly to the press. The organization would rather spend its money on healthcare delivery than on a former employee’s demands for money. While Ms. Stratton has made this information public through the press, we intend to vigorously fight this in the courts and not in the press. 

“The leaders of Carle Foundation Hospital place the highest priority on being compliant with all state and federal regulations, including those that govern research activities and patient protection, and employees are expected to bring concerns to light. In fact, employees are directed to raise concerns and report problems as soon as they become aware of them, no matter how big or small, and to consider it part of their duty to the mission of the organization. Allegations of retaliatory termination of any employee because he or she reported questionable organizational activity are totally contradictory to this philosophy and practice, and we deny those allegations.” 

In responses to federal regulators, hospital officials have said they have responded by retraining the principal investigator and other investigators, appointing new oversight managers and reviewing protections for patients in clinical trials there. 

The Carle Clinic Association also responded to the lawsuit with a statement: “We anticipate successfully refuting claims as we believe the allegations are without merit and we intend to vigorously defend the organization and its physicians. Dr. Wellman and Dr. Rowland each have an outstanding reputation for the highest degree of integrity and commitment to clinical excellence. 

“There is an audit underway by the U.S. Department of Health and Human Services Office for Human Research Protections. Concerns have been largely administrative and procedural. We are pleased that the majority of issues involving Carle Clinic have been unsubstantiated or adequately addressed. Most significantly, this review has found that no patients have been harmed as a result of clinical studies at Carle Clinic. We take seriously the responsibility to adhere to all state and federal guidelines. We remain focused on providing high quality patient care and look forward to refuting this complaint.” 

Dundon said Stratton is considered an expert in conducting clinical trials, has industry experience and was a member of an institutional review board at the University of Arizona. 

The suit claims that Stratton’s concerns were further confirmed when an outside audit by a private research organization revealed that multiple Carle Clinic trials suffered from major deficiencies, resulting in what Stratton believed to constitute risks to patient safety—including incorrect drug dosages and enrolling patients who should not have been enrolled in the trial. 

The Carle Clinic had withheld the results of this audit from Stratton and others charged with overseeing the clinic’s compliance with federal regulations, the complaint said. When Stratton informed Leonard of her plans to conduct an audit of patient files to determine if any patients had been harmed, and her intention to report the matter to federal regulators, he fired her just a few hours later, according to the suit. 

After Stratton’s termination, the Department of Health and Human Services Office for Human Research Protections determined that the Carle Clinic and the Carle Foundation Hospital had failed to comply with the regulations. The agency determined that Leonard and his counterpart at the Carle Clinic had “failed to fulfill the obligations imposed by the . . . regulations for the protection of human subjects.” The National Cancer Institute then ordered Carle Clinic to stop enrolling new patients in trials, according to the complaint. 

“The complaint alleges that Dr. Stratton saw blatant violations of federal law designed to protect vulnerable patients who agreed to participate in cancer clinical trials, and she tried repeatedly to fix them. For her to be fired for these conscientious actions is a clear violation of Illinois law, which provides very strong protections to whistleblowers like Dr. Stratton,” said Debra Katz, an attorney representing Stratton.