- Posted March 7, 2014 by
- Part II: Myxo Ring Dispute: Tale of Two Studies Plunges Northwestern's IRB Into Controversy
- Part I: Myxo Ring Dispute: Tale of Two Studies Plunges Northwestern's IRB Into Controversy
- Northwestern University Medill Journalism Student Covers Senate Judiciary Investigation of Northwestern University
- Orange County Register Reports: FDA warns Edwards over broken heart devices
- Security Exchange Commission Annual 10k Filings and the Heart.org Confirm the Myxo and the IMR rings are on Voluntary recall from 2008-2009
Crain's Chicago Breaking News:Senator revives inquiry into Northwestern heart-valve implants
"By Kristen Schorsch March 07, 2014
Sen. Chuck Grassley has resurrected an inquiry into a medical device implanted by a prominent heart surgeon at Northwestern Memorial Hospital that allegedly wasn't cleared by the Food and Drug Administration.
The Iowa Republican alleges the university and Chicago-based hospital have withheld several documents he requested in 2008 as part of his probe into allegations that a ring used in heart valve repairs had not been cleared for marketing by the FDA before it was implanted in patients as part of a study, according to a letter Mr. Grassley sent on March 4 to Northwestern University President Morton Schapiro and Northwestern Memorial Hospital President Richard Gannotta.
The senator also questioned if Dr. Patrick McCarthy, who implanted the device in patients and invented the product, made contradictory statements regarding how similar the device was to other existing devices, and whether patients received “sufficient notice” of the safety questions that arose regarding the ring being implanted at the hospital, the letter said.
“The documents are important to reviewing whether Northwestern's use of the devices was appropriate and whether notification to patients was adequate,” Mr. Grassley, ranking member on the judiciary committee, said in a separate statement.
In a written response, a spokesman for Northwestern University said, “The university will look into the issues raised and respond to Sen. Grassley.” A hospital spokeswoman did not respond to a message to comment. Dr. McCarthy, director of Northwestern's Bluhm Cardiovascular Institute and chief of the division of surgery and cardiac surgery, did not return a message to comment.
Mr. Grassley first brought the issue to light in 2008. He outlined “troubling allegations” and requested information in letters to then-Northwestern University President Henry Bienen, Northwestern Memorial Hospital President and CEO Dean Harrison, and Michael Mussallem, CEO of Edward Lifesciences Corp., which manufactured the ring.
Dr. Nalini Rajamannan, then an associate professor and valve director at Bluhm Cardiovascular Institute, and a patient expressed their concerns to the senator about the lack of FDA approval and patient consent for the implanted device, one of the letters said.
Dr. Rajamannan, who is now in private practice, told Crain's she recently alerted Mr. Grassley's office that documents she found in court records as part of a patient's 2008 pending lawsuit against Dr. McCarthy and others were not disclosed to the senator as part of his previous records request.
Mr. Grassley cited Dr. Rajamannan in his latest letter and listed the documents he thought were withheld, including a waiver Dr. McCarthy received from the university from having to get patient consent."