Tom Harkin actually said...

"So, it doesn't go right back and go through the whole process again."

"If a device manufacturer commits fraud on the FDA, puts a device out there, and injures people--but, they cannot sue and can't get discovery to get at these documents, then you will never know whether..."

"Well, the ultimate goal is to get the very best devices we can to really help people like Mr. Mulvihill, like Mr. Roman, in ways that they've got to be helped."

"I think sometimes they do good things, other times they don't do what they should be doing."