Northwestern University denies tenure to Myxo ring whistleblower

Shelley Wood

October 11, 2011

Chicago, IL - The cardiologist who spoke out about an investigational valve device she believed was being used by the surgeon who invented it without patient informed consent and prior to obtaining appropriate FDA clearance will no longer be working at the university where she first raised those concerns[1].

Dr Nalini Rajamannan's departure is the latest twist in the "Myxo-ring mix-up" first reported by heart wire in 2008. The device in question, originally known as the Myxo annuloplasty ring, has been at the center of an FDA investigation, a Senate inquiry, and a number of lawsuits against the annuloplasty ring's inventor, Dr Patrick McCarthy (Northwestern University, Chicago, IL), his hospital, and ring manufacturer Edwards Lifesciences.

Rajamannan, who had been an associate professor at Northwestern since 2007, confirmed to heartwire today that her position was terminated September 30. She believes the decision not to grant her tenure, despite the fact that she has federal grant funding for work at Northwestern until the summer of 2012, is "retaliation" in part because she helped uncover new evidence showing that one of two patients who has sued McCarthy—both patients of Rajamannan's—experienced a periprocedural MI during her Myxo ring implantation. The first lawsuit reported by heart wire has since been dropped.

However, Alan K Cubbage, Northwestern's vice president for university relations, told heart wire in an email that Rajamannan "was not dismissed" and that "Northwestern University has a policy that specifically defends the right of faculty and staff members to make complaints without retaliation. That policy and related procedures were followed in this case. There was no retaliation by Northwestern University against Dr Rajamannan."

According to Cubbage, Rajamannan was under consideration for tenure, and the customary and clearly defined procedures, including peer review, were followed. "Dr Rajamannan was not granted tenure, a decision she appealed unsuccessfully to the appropriate faculty committee."

The plaintiff in the second lawsuit says she was not informed of the MI, nor was the information included in her medical records, and according to Rajamannan, it only came to light after Rajamannan herself reviewed her patient's files and noted that she'd been billed for an ECG.

McCarthy's response to the plaintiff's third amended complaint-at-law acknowledges that an electrocardiogram was performed less than one hour after her surgery and that this ECG demonstrated that the plaintiff had suffered a heart attack.

Importantly, the original paper by McCarthy and colleagues describing their initial experience with the Myxo ring reports a postoperative MI rate of 0%[2].

At the time the FDA approved the Myxo ring—under the name dETlogix annuloplasty ring 5100—the FDA would not say whether it considered that paper in its decision. However, the Chronicle o f Higher Education, which reported on Rajamannan's dismissal today, says that the FDA cited McCarthy et al's study when it approved the ring.

The Chronicle also reported that McCarthy, in a written response to the newspaper, "said some patients given the Myxo ring were excluded from his study's summary of results because they had other medical conditions that could have caused a heart attack." Rheumatic-valve disease is listed as an exclusion criterion in the article, but this specific patient exclusion is not noted. McCarthy's response to the plaintiff's complaint-at-law says that his operative report and other portions of the medical record state that during the surgery he found the presence of rheumatic disease.

The plaintiff has stated that she was informed she would not receive a valve repair using the Myxo ring if evidence of rheumatic disease was found during the operation.

Rajamannan emailed a comment to heart wire saying: "Prior to the time I first brought this issue to the attention of my superiors at Northwestern, I was enjoying a successful career and anticipated making tenure and ending my career at that institution. However, I didn't know my career would end so quickly and end, no doubt, as a result of the revelations I made. Since I brought the issue of the implantation of the Myxo ring without informed consent to the attention of hospital officials, my career has taken an unexpected downward spiral."

She noted that she has an R01 grant that was successfully renewed until the summer of 2012 and American Recovery and Reinvestment Act funding that had a no-cost extension until at least October 31, 2011. "Further, I have three other grants in the early application phase," her email continues. "I was informed that tenure was not necessary to keep my research position at Northwestern University as long as I had federal funding. Had I been advised otherwise, I would have sought an alternative location for my research. Certainly, there are many physicians that stay on at Northwestern University as a faculty or volunteer faculty member while their research funding is still in place.  Many of my colleagues have kept their status at Northwestern with this research process. What is the difference between them and me?  Perhaps they didn't blow the whistle on the activities of the hospital."

Calls to McCarthy were not returned before this story went live.

Comments

3090D553-9492-4563-8681-AD288FA52ACE
Comments on Medscape are moderated and should be professional in tone and on topic. You must declare any conflicts of interest related to your comments and responses. Please see our Commenting Guide for further information. We reserve the right to remove posts at our sole discretion.

processing....