Whistleblower Retaliation Lawsuit Filed Against Carle Cancer Doctors and Executives in Connection with Violations of the Federal Safety Laws Protecting Patients in Experimental Clinical Cancer Trials

URBANA, Ill., Nov. 6 /PRNewswire/ -- Dr. Suzanne Stratton, the former Vice President for Research at the Carle Foundation Hospital in Urbana, IL, filed a whistleblower lawsuit yesterday in federal court against the hospital's Chief Executive Officer, the Carle Clinic Association, Dr. Kendrith Rowland, a lead physician at the Carle Clinic, and Dr. Bruce Wellman, the Carle Clinic CEO. Dr. Stratton alleges that she was fired in retaliation for her repeated warnings that the Carle Hospital and the Carle Clinic had violated federal regulations intended to protect cancer patients enrolled as subjects in clinical trials.

The lawsuit alleges that Dr. Stratton made repeated attempts to stop the violations, which were repeatedly ignored by Dr. Leonard and others, including the Carle Clinic Cancer Center director, who stated that the clinical trial violations were of no consequence because the cancer patients in the trials "were going to die anyway."

Dr. Stratton's concerns were further confirmed, according to the suit, when an outside audit by a private research organization revealed that multiple Carle Clinic trials suffered from "major deficiencies," resulting in what Dr. 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 Dr. Stratton and others tasked with overseeing the Clinic's compliance with federal regulations, the complaint says. When Dr. Stratton informed Dr. Leonard of the 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 today's filing. The lawsuit alleges that physicians at the Cancer Clinic, including Dr. Rowland, demanded Dr. Stratton's removal and Dr. Leonard ultimately bowed to their wishes.

After Dr. Stratton's termination, an investigation by the Department of Health and Human Service's Office of Human Research Protections ("OHRP") determined that the Carle Clinic and the Carle Hospital had in fact failed to comply with the regulations. The agency determined that Dr. 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 ("NCI"), also part of the United States Department of Health and Human Services, then ordered the Carle Clinic to stop enrolling new patients in trials, according to the complaint.

According to Ms. Katz, "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."

Debra S. Katz and Maura Dundon, attorneys at Katz, Marshall & Banks, LLP, in Washington, D.C., represent Dr. Stratton. A copy of the complaint is available here, and additional information about Dr. Stratton's case can be found at www.kmblegal.com.