The News-Gazette.com: Carle will 'vigorously' defend against lawsuit

Carle will 'vigorously' defend against lawsuit

By Debra Pressey

Saturday, November 7, 2009 6:30 AM CDT

URBANA – Carle Foundation Hospital and Carle Clinic say they will vigorously defend against a federal lawsuit filed by Suzanne Stratton, the hospital's former vice president for research who says she was fired for blowing the whistle on patient safety issues and other problems she found in Carle's cancer research program.

Stratton was fired nearly a year ago, on Nov. 18, 2008, 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 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 from 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.

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.

Carle Clinic spokeswoman Jennifer Hendricks said the restriction applied only to federally-funded research, but the clinic voluntarily halted new enrollments in industry-funded clinical trials until recently.

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, or OHRP – 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, OHRP 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.

Hendricks said Carle is due to respond again to OHRP later this month, and hasn't been given an indication when restrictions may be lifted.

In a written response to the lawsuit, Hendricks said the concerns identified in the ongoing audit by OHRP have been largely administrative and procedural and most have been resolved or unsubstantiated.

"Most significantly, this review has found that no patients have been harmed as a result of clinical studies at Carle Clinic," she said.

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 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 trials."

"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, the suit says, 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 documents several attempts she made to solicit 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.

In a written statement Friday afternoon, hospital officials said 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 statement from hospital spokeswoman Gretchen Robbins said.

The hospital also said it places the highest priority on compliance with regulations 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," Robbins said.

The clinic also takes adherence to all state and federal guidelines seriously, Hendricks said.

"Dr. Wellman and Dr. Rowland each have an outstanding reputation for the highest degree of integrity and commitment to clinical excellence," Hendricks said.

Comments

Disgusting. She sends the lawsuit to the media and then refuses to answer phone calls from the media? Typical strategy to malign the other party without the willingness to answer questions. Reinforces Carle's claim that this is about money. Also nice to know that a 'whistleblower' would have turned her back on the patients she seems so concerned about for a little cash. Nice. Sounds like Carle made the right move by getting rid of this person. I hope the News Gazette follows this story...always interseting to get the other side if it makes it to the courtroom.

Posted by enoughalready on November 7, 2009 at 7:22 AM Suggest Removal

Sheesh! Over-react much? The article says "she did not return A call" as in one call. Maybe she wasn't home when the reporter made the one call. What surprises me is that I continue to see commercials for their cancer research and the clinical leader that is the subject of a federal investigation.

Posted by ruralgirl on November 7, 2009 at 8:17 AM Suggest Removal

From what I've read about health care "whistleblowers", they generally turn to the press due to the extreme difficulty of getting regulatory agencies to act (our government not being well-known for speed and efficiency). As for Carle, having had my own encounter with them over a minor matter to which their attorneys responded as if I were an axe-murderer, it would not surprise me one bit if the allegations have some merit. That doesn't mean they're true, and yes, Carle deserves the chance to be heard -- in open court, where they can be judged the same as all others.

Posted by Diogenes on November 7, 2009 at 8:30 AM Suggest Removal

Again, we see the problem with allowing anonymous comments. The first person uses that opportunity to throw a rock from the cover of gutless anonymity.

The N-G should either delete comments like that one or require names on posts.

Posted by Wenalway on November 7, 2009 at 9:15 AM Suggest Removal

I was fired from Carle in 1997 because I didn't "kiss their a**" and play their political games. This is typical of Carle: Doctors are God. I'm sure the show "House" would be at home there. The docs get to do as they please, and the ancillary staff (except nursing) gets crapped upon. This proposed merger will do nothing but benefit the docs financially, and this lawsuit is potential financial penalty to the MD's. I fear for my family's health every time they go into the clinic/hospital (notice the staffing cuts?).

I am ananymous because to this day, 12 years later, they still harrass me if I challenge them. In a sick way, I was hoping Obamacare would bring Carle to it's knees.

Posted by firedbycarle on November 7, 2009 at 9:52 AM Suggest Removal

As an oncologist and cancer researcher originally at Carle and now in Springfield, I know that this is an extremely serious topic. Not all oncologists (cancer doctors) are allowed to perform research on human subjects. Cancer doctors must pass rigorous standards to do human research and failure to do so is a felony. Sour grapes doesn't apply to human patient research trials. A doctor can't just do what he/she wants. Deviation from a national trial's standard or failure to obtain a proper consent from the patient is the reason Carle Clinic was banned from entering new patientsa onto these important trials. The federal courts will handle this from now on.Cheating is not allowed in National Canter Institute or Mayo Clinic research trials. I have worked closely with Dr Rowland for 10 years and have found him to be one of the best oncologists I have ever worked with. I would readily have him treat me or my wife.This suit is NOT about his quality of medicine, it is about the Carle administrations continued attempts to gag people like Dr Stratton and myself when poor judgement has been identified. The other people in the lawsuit are the puppeteers pulling the strings, and when the dust settles, we will see behind the "Oz-like" curtain at Carle.

Posted by tgs0319 on November 9, 2009 at 7:23 AM Suggest Removal

READ THE FACTS PEOPLE!!! Below is an excerpt directly from the FEDERAL LETTER!! Dr Stratton was fired because she tried to do the right thing. Why does nobody get that? Furthermore, both CEOs, Bruce Wellman and James Leonard ADMITTED that they didn't know what they were doing

We (The office of human research protections) have received documentation indicating that as early as November 2008 both of you, as FWA Signatory Officials, were aware of the following:

(a)

A memorandum dated November 18, 2008 regarding a July 29-30, 2008 North Central Cancer Treatment Group (NCCTG) Audit Report, a scheduled internal IRB audit on the files that were the subject of the NCCTG Audit Report to be conducted on November 20, 2008, and the firing of the Carle Foundation Hospital Vice President for Research – the person requesting that such an audit occur - the day after the November 18, 2008 letter was forwarded to the Carle Foundation FWA Signatory Official for review;

(b)

The fact that the scheduled November 20, 2008 internal IRB audit was never completed on the NCCTG audited files as indicated in the above-referenced November 18, 2008 letter, although the NCCTG Audit Report revealed major deficiencies involving enrolled subjects;

(c)

The failure of the Carle IRB to review and take action on the NCCTG Audit Report findings, which revealed unanticipated problems involving risks to subjects and others, until after both of your institutions received an inquiry letter from our office inquiring about such audit findings;

(d)

The failure to report to our office the NCCTG Audit Report findings revealing unanticipated problems involving risks to subjects and others and continuing noncompliance regarding failure to obtain continuing review;

(e)

Problems between the Carle IRB and a Carle Clinic Cancer Center investigator without providing the Carle IRB with support to address the problems;

(f)

A lack of adequate IRB policies and procedures;

(g)

The need for additional IRB staff – of note “The staff (IRB) seems very stressed and overworked and admitted that they can’t keep up.” See November 13, 2008 email from Carle Clinic Chief Operating Officer to the Carle Foundation Vice President for Research and carbon copying, among others, the Carle Foundation Signatory Official.

In addition, we note that, during our July site visit, in an interview with you and the prior Carle Clinic Signatory Official, it was stated to the site visit team that, prior to November 2008, neither Signatory Official was aware of the regulatory responsibilities of a Signatory Official.

Posted by laurabell on November 9, 2009 at 9:03 AM Suggest Removal