Tom Harkin actually said...

"Before Riegel was decided, the device manufacturers were subject to tort laws."

"They could penalize the company. They could seize the offending illegal products."

"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..."