Excerpts of lawsuit filed against Carle Clinic, officials
Some exceprts from the lawsuit filed by Suzanne Stratton against Carle Clinic and officials there:
– Stratton believed Dr. Kendrith Rowland and Carle Clinic were consistently attempting to interfere with the hospital Institutional Review Board's independence to prevent Rowland's protocols from being subjected to full review as required by law. She also believed Rowland was concealing information from the board about adverse events and mistakes made in trials and preventing the board from reporting them to the government as required.
– After a Sept. 18, 2008, e-mail Stratton sent to clinic and hospital officials, Rowland and clinic oncologists stating she knows Institutional Review Board reporting "may seem arduous and excessive" but it's required by law, Rowland came to her office angry and told her "everything was okay before" she came to Carle and "you don't know what you're doing and you will fail at everything you do in your life."
– On Oct. 7, 2008, Stratton learned from Carla Barnwell, then the interim director of the human subjects protection program, that one of Rowland's cancer trials had been running without the hospital Institutional Review Board's approval since December 2007. The hospital review board instructed the clinic to stop the trial immediately, and Rowland complained to Dr. James Leonard and Dr. Bruce Wellman about how "unreasonable" Stratton was being.
– On Oct. 10, 2008, she e-mailed Leonard about "widely distributed clinic e-mails containing full patient names and medical details in violation of federally patient privacy law." Leonard didn't respond.
– On Oct. 13, 2008, Stratton met with Rowland and other Carle officials about compliance issues. Rowland complained about the forms he had to fill out and the time it took for the hospital review board to approve his protocols.
– On Oct. 14, 2008, Stratton learned the North Central Cancer Treatment Group and Gynecological Oncology Group had months earlier issued "highly critical audits" of Rowland's clinical trials, but Rowland, Wellman and the clinic concealed the results from Stratton and the hospital review board.
The Gynecological Oncology Group audit "had uncovered several alarming deficiencies in the conduct of clinic studies with implications for patient safety or well-being. The GOG audit revealed that a patient had received an inappropriate dose of an experimental regimen of the chemotherapy drug Carboplatin."
– On Oct. 24, 2008, Statton sent an e-mail to a National Cancer Institute program director asking for help reinforcing regulations and informed Leonard she would be contacting Dr. Lori Minasian at the National Cancer Institute's Community Oncology and Preventive Trials Research Group to discuss her concerns.
– Around Nov. 10, 2008, Stratton spoke with Dr. Malcolm "Mike" Hill, a clinic doctor and member of the hospital's board of trustees, about ongoing problems with the research program and noncompliance issues, and Hill told her he would put it on the upcoming trustee board meeting agenda and talk to Leonard. Hill later told Stratton he got an angry response from Leonard. Leonard gave a "truncated and misleading description of the issue" to the board.
– Stratton listed some major deviations from the North Central audit in a Nov. 14, 2008, e-mail to Leonard, among them: Enrolling an ineligible patient in a study because he had a drug delivery device implanted in his brain and the experimental medication would cross the blood-brain barrier with no way to predict how it would interact with the brain implant; patients – mistakenly or deliberately – were receiving doses that didn't correspond with review board-approved protocol; administration of the drug prednisone that isn't permitted in a protocol, "another example of possibly harmful drug interactions"; lab tests being drawn one day after chemotherapy rather than before, though pre-chemotherapy tests are required for patient safety; and lack of follow-up after an adverse event.
– Nov. 18, 2008: Stratton informed Leonard about the Institutional Review Board's plans to audit Rowland and the clinic to search for evidence of harm to patients and that she planned to report the North Central audit to the Office for Human Research Protections. Leonard fired her later the same day, telling her she had done a great job but it was time for her to "move on."
– Just weeks before Stratton's termination, Leonard raised her salary from $164,000 to $171,000 and gave her a 15 percent merit-based bonus plus a $10,000 bonus as incentive to stay.
– Stratton's health deteriorated through her tenure at Carle and she became severely depressed after her termination.
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- Obituaries