Former Northwestern cardiologist Prof. Dr. Nalini Rajamannan, who has been at the center of a medical misconduct controversy for the past few years, is questioning the circumstances under which she was denied tenure by the University.
“She was under consideration for tenure, and the University followed the customary and clearly defined procedures for tenure review,” University spokesman Al Cubbage said. “Dr. Rajamannan was not granted tenure, and that was a decision she appealed unsuccessfully.”
The denial of tenure has Rajamannan, former professor for the Feinberg School of Medicine Department of Cardiology, concerned whether NU has violated various federal and University policies protecting employees who make good faith reports of misconduct. The policy prohibits retaliation by the University on whistle-blowing employees via punishment or termination.
Cubbage declined to comment on why Rajamannan, whose official faculty appointment ended Sept. 30, was denied tenure, but Rajamannan has speculated that it may partially have had to do with her involvement in a controversy sparked by the use of a Myxo annuloplasty ring, the FDA approval status of which has since been debated, in heart procedures carried out by her colleague, Dr. Patrick McCarthy.
In 2008, Rajamannan accused McCarthy of implanting an experimental Myxo ETlogix annuloplasty ring in a patient without informed consent. The ring, manufactured by Edwards Lifesciences and invented by McCarthy, was similar to one that had already been cleared for use in the 510(k) approval process carried out by the Food and Drug Administration. The updated ring did not undergo the 510(k) process but was commercially available at the time of the procedure and was in turn thought to be approved by the FDA for implementation, according to Holli Salls, vice president for public relations, marketing and physician services at Northwestern Memorial Hospital.
“We rely on the manufacturer to go through the process to make it commercially available. It was our belief all along that it had been cleared for use,” Salls said.
Salls said the FDA later told Edwards that the company should have undergone the more stringent 510(k) approval process to clear the updated Myxo ring for use. According to her, the Myxo device was voluntarily recalled, but was then deemed safe and effective by the FDA.
Salls said she does not believe any violations were committed in performing the heart procedure.
“It was not human experimentation, and that is what (Rajamannan) continues to say it is. We wouldn’t be doing that.”
Still, Rajamannan insists her decision to “blow the whistle” negatively affected her career.
“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,” Rajamannan told heartwire, a cardiology news website, in an email last week. “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.”
Rajamannan’s accusation in part helped to garner national attention for the case, which made it to the front page of The Wall Street Journal and sparked a Senate inquiry.
Rajamannan also told Heartwire she is still conducting research at NU, as doing so does not require a tenure.
“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,” she said in her email to Heartwire. “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.”
Cubbage said he does not know if the University is seeking a replacement cardiologist.
