Tom Harkin actually said...

"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."

"Manufacturers who commit fraud on the FDA are not immune from lawsuits."