The decade-long saga of Dr. Patrick McCarthy's experimental heart device at Northwestern has taken a new, potentially hopeful turn. The Chronicle of Higher Education has the story, but it is behind a paywall. Here are some excerpts.
Northwestern University’s teaching hospital and its chief of cardiac surgery have lost a court bid to dismiss a lawsuit alleging he used unsuspecting patients to test an experimental heart device. After six years of preliminary maneuvering in the case, a state-court judge ruled last week that key parts of the allegations brought by one patient could move forward.
The cardiac-surgery chief, Patrick M. McCarthy, is accused of leading an experiment in 2006 and 2007 in which about 100 patients received a heart ring — a circular piece of silicone and metal used to fix failing heart valves — without being told it was a test device.
The FDA ordered McCarthy to stop, but not before 600 patients were given the ring. McCarthy claimed that his modifications to earlier, pre-existing FDA-approved rings were minor and did not need regulatory approval, but the FDA disagreed. (And so apparently did McCarthy himself when he published articles on the ring and emphasized how novel it was.)
The investigation that uncovered Dr. McCarthy’s actions has largely been driven by Nalini M. Rajamannan, a former colleague at Northwestern Memorial Hospital, the university’s primary teaching hospital. Dr. Rajamannan was responsible for postoperative care of the patients and said she was surprised to find some were unaware they had been given experimental heart rings.
She brought her concerns to the university, which stood behind Dr. McCarthy. Dr. Rajamannan subsequently was denied tenure and lost her job as an associate professor of medicine at Northwestern after she continued to accumulate evidence suggesting Dr. McCarthy was intentionally experimenting on the patients.
One of those patients, Maureen Obermeier, is the plaintiff in the case involved in last week’s ruling.
In his findings published in 2008 by The Journal of Thoracic and Cardiovascular Surgery, Dr. McCarthy reported no significant problems, including no heart attacks, associated with the 100 implants of his heart-ring invention. But Ms. Obermeier’s lawyer later found medical records of an electrocardiogram from the day of her implant surgery, in November 2006, that showed she suffered an apparent heart attack in the hour after her surgery.
Dr. Rajamannan told the Chronicle that she had persisted in the matter because some affected patients may be suffering from health problems from the devices without realizing why. The case will go to trial in March.