Sen. Chuck Grassley of Iowa is asking Northwestern University for documents on a medical device implanted in patients for heart valve repair. Grassley wrote to the university in 2008 and 2009 about the Myxo device over allegations that the device had not been cleared by the Food and Drug Administration (FDA) before it was implanted in patients as part of an outcomes study.
Since then, new allegations have come to light that Northwestern did not provide all of the documents to Grassley that were squarely within the scope of his request, and that Northwestern failed to provide any notice or explanation of why it was withholding certain documents. In a letter this week to the presidents of Northwestern University and Northwestern Memorial Hospital, Grassley asks for the documents apparently withheld from him in response to his earlier inquiries.
The documents are important to reviewing whether Northwestern’s use of the devices was appropriate and whether notification to patients was adequate.
Grassley has a longstanding interest in FDA oversight and patient safety.