Henry Waxman: “there are a number of very important reasons to oppose this bill, but I want to focus on one of the most egregious parts…”

“there are a number of very important reasons to oppose this bill, but I want to focus on one of the most egregious parts of the legislation that has nothing to do with medical malpractice. Under this legislation, if a drug or medical device manufacturer sells a dangerous product that causes harm to a consumer, so long as that product received FDA approval prior to being marketed, a court would be prohibited from awarding punitive damages against that manufacturer. This marks a dramatic change in current law by transforming FDA product approval into a shield against liability. Time and again we have seen that the FDA approval process cannot or does not guarantee the safety of drugs and other medical products. Every day our concerns increase about the adequacy of the FDA's postmarket safety programs. And we have seen numerous instances in which despite receiving FDA approval, drugs and medical devices, have been pulled from the market because of the emergence of severe dangers associated with their use. Mr. Speaker, we have not given the FDA the tools or the ability to approve a drug so that all the things that would happen after that approval will not occur, such as the failure of the company that manufactures it to make sure they follow their own safety standards; or that new risks that are not known at the time of the approval will never arise. We have to rely on the civil justice system as an additional layer of protection for American citizens.…”