Former research official sues Carle over firing
URBANA — Suzanne Stratton, the former vice president for research at Carle Foundation Hospital, has filed a federal lawsuit accusing the hospital of firing her for alerting authorities to patient safety issues and other problems she found in Carle’s cancer research program.
Stratton, recruited by Carle in 2006, was fired nearly a year ago, Nov. 18, by Carle hospital CEO Dr. James Leonard.
Her lawsuit was filed at the close of the day Thursday by the Washington D.C. law firm of Katz, Marshall & Banks in the U.S. District Court in Urbana.
It names as defendants Leonard, Carle Clinic, the clinic’s CEO Dr. Bruce Wellman, and Dr. Kendrith Rowland, director of the cancer center program.
Stratton, who did not return a call to The News-Gazette, contends Leonard, Rowland, Wellman and Carle Clinic violated the Illinois Whistleblower Protection act, which forbids retaliation against an employee for disclosing violations of the law to government regulators or law enforcement.
Her suit states she was fired in retaliation for reporting the failure of the hospital and clinic to comply with federal human research subject protection regulations in connection with the medical trials performed on Carle cancer patients.
The lawsuit seeks reinstatement of Stratton to her job, compensation for lost wages and benefits and other financial damages.
In a written statement early this afternoon, hospital officials vowed to vigorously defend the organization and its chief executive.
The hospital contends the lawsuit was filed in response to Carle’s recent refusal to pay Stratton and her attorney the money they demanded to avoid litigation.
“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 Carle statement said.
The hospital also said it places the highest priority on compliance with regulations and directs employees to bring concerns to light as soon as they’re aware of them.
The Carle Cancer Center, a joint service of Carle hospital and Carle Clinic, was prohibited earlier this year by the National Cancer Institute from enrolling new patients in clinical trials, pending the resolution of issues brought to light in the ongoing investigation.
Findings of the investigation and corrective actions being required of Carle have been documented in two determination letters sent by the Office for Human Research Protections — an arm of the U.S. department of Health and Human Services that looks after the safety of human subjects participating in federally-funded medical research.
In both June 9 and Sept. 21 letters sent to Wellman and Leonard, the Office for Human Research Protections identified 11 research studies — involving experimental treatments in various kinds of breast cancer, colorectal cancer, lymphoma, glioblastoma and head and neck cancers — for which issues and corrective actions were identified.
A Long Island, N.Y. native and former prostate cancer researcher at the University of Arizona, Stratton first visited Carle to advise the clinic and hospital on building its fledgling medical research program.
Carle recruited her to head the program in late 2006, and she left her position at Arizona for the challenge of building a new program in East Central Illinois, she said in a 2007 story in The News-Gazette.
Stratton said one of her roles would be to serve as a link between doctors at Carle and medical researchers at the University of Illinois. The hospital formally announced Stratton’s appointment in February 2007, stating she had been selected for the job “because of her background in obtaining government funding and managing clinical trails.”
“Dr. Stratton’s background is suited for this position,” Carle hospital CEO Dr. James Leonard said in the 2007 announcement. “She has proven that she can take an idea for a research project and turn that into a full-fledged, funded study with results that could very well lead to a breakthrough in patient care. Dr. Stratton is exactly the type of person we want as we further our mission of discovering health care advances.”
The honeymoon didn’t last long.
After Stratton began in her new position, she began to discover deficiencies in Rowland’s trials at the cancer center. She also discovered that she’d inherited a “weak” Institutional Review Board at Carle that was rubber-stamping the protocols Rowland was using in medical experiments on patients instead of subjecting the protocols to the rigorous review required by law, the lawsuit states.
It also states Stratton made repeated attempts to persuade Carle officials to address the problems and repeated requests for support from Leonard, who had legal responsibility for the research conducted under the hospital’s Institutional Review Board.
Stratton’s concerns were dismissed by hospital administration, “including a cancer clinic director who callously asserted that failure to follow the regulations was of no consequence because the cancer patients were ‘going to die anyway,’” the suit states.
Ultimately, Stratton urged Carle Clinic to stop enrolling new patients in research trials and formally self-report the noncompliance issues to the Office of Human Research Protections and the Food and Drug Administration. She also advised the hospital and clinic that the hospital would need to conduct a comprehensive audit into the files of patients enrolled in the trials she knew had violated federal regulations and experimental protocols to determine whether the patients had been harmed, the suit states.
“Within hours of informing hospital CEO Dr. Leonard of her planned audit of clinic patient medical records, Dr. Leonard terminated her employment,” the suit states. “He did so at the behest of clinic officials and with the collusion of Dr. Wellman and Rowland who actively demanded Dr. Stratton’s removal.”
The lawsuit goes on to state that within hours of firing Stratton, Leonard instructed a Stratton staff member not to send a letter to Rowland announcing the audit and the audit never took place.
For more information, see Saturday’s News-Gazette.
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