I must also say, regardless of the difference between drugs and devices, we're getting new drugs on the market all the time, and they are not preempted from tort claims.
But, under Riegel, if there is--if they can say, 'My gosh, we'll never have to give those documents up.'
It was inevitable that something like this would happen.
Senator Kennedy, as he did 30 years ago, is fighting to ensure that consumers are safe.
This bill is really about real people who have been let down--let down, sometimes catastrophically.
More than 30 years ago, Senator Kennedy championed the Medical Device Amendments, a bill that gave the Food and Drug Adm...
I happen to be for innovation, I happen to be for new devices, I happen to think that these are good things, but I also ...
The Committee on Health, Education, Labor, and Pensions will come to order for this hearing on protecting patients from ...
Before Riegel was decided, the device manufacturers were subject to tort laws.
They could penalize the company. They could seize the offending illegal products.
Manufacturers who commit fraud on the FDA are not immune from lawsuits.