Cardiologist Nalini M. Rajamannan, an accomplished surgeon and former associate professor of medicine, has contested since 2007 that Northwestern Memorial’s chief cardiac surgeon, Patrick M. McCarthy, both implanted cardiac devices in patients without their knowledge and lied about the devices’ safety. Rajamannan was released from her post last month, despite the fact that she has federal grant funding at Northwestern through 2012.
“Most of these patients still do not know this occurred and may be suffering as a result,” Rajamannan said in a recent statement. “Northwestern rejected this notion, although it has since been confirmed that the experimental device was not, in fact, approved by the FDA at the time of implantation.”
Northwestern officials have denied Rajamannan’s claims about McCarthy’s rocky safety record and the reasons behind her termination.
McCarthy’s device in question, a Myxo ring, is a heart implant that holds weak heart valves together. Its use has brought accusations in two separate lawsuits that he implanted the device in patients without their consent, according to an Oct. 10 report in the Chronicle of Higher Education. Both parties, along with Rajamannan, claim the ring can weaken patients’ valves and potentially lead to heart failure.
Questions initially surfaced about the device in 2006, when one of Rajamannan’s patients had an adverse reaction to the device following surgery. After developing shortness of breath and other symptoms, the patient learned the Myxo ring was never explicitly approved by the FDA.
McCarthy and the device’s distributor, Edwards Lifesciences, were forced to stop implanting the ring in 2008 pending both FDA investigation and Senate inquiry. However, the ring was approved by the FDA following a safety study by McCarthy.
While the Myxo ring is a close variation of a device that already won FDA approval in 2000, McCarthy’s device has led to a much larger number of negative outcomes, according to Rajamannan. The cardiologist brought forth evidence that shows the Myxo ring has been associated with more than 4,000 adverse outcomes, leading to more than 600 deaths. These numbers are drastically higher than those associated with the FDA-approved ring.
Rajamannan’s removal is the most drastic step Northwestern has taken in defending McCarthy since he joined the university in 2004.His previous position at the Cleveland Clinic was also marked with controversy after reportedly accepting financial interest in AtriCure, Inc., a company that produced equipment used in clinical procedures, according to the Chronicle.
The experimental nature of McCarthy’s procedure has gone unchecked because of monetary incentive, according to Rajamannan. The Chronicle’s article found that each 100 surgeries performed by McCarthy can earn upward of $100,000 for the hospital and university.
Rajamannan has won at least 15 awards and scholarships, including honors sponsored by the National Institutes of Health and the American Heart Association. Despite her release by the university, Rajamannan believes it was her ethical responsibility to report McCarthy’s alleged unlawful acts.
“These laws were meant to protect human beings from being subjected to human experimentation,” Rajamannan said. “I believe these laws are not being followed in this instance, and that innocent people are suffering as a result.”