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Waxman and Pallone reintroduce their bill to overturn medical device preemption today.
Supporters of preemption claim that without preemption it will -
produce a chilling effect on medical innovation, create more lawsuits and ultimately result in higher health care costs for all Americans.Those against preemption claim that the decision to impliment preemption -
ignored decades of precedent, in which lawsuits brought by patients in state courts helped bolster safety regulation at the federal level.See the full report by the AP here
The chilling effect was the pain felt by medical device victims and their loved ones when they were denied justice.
ReplyDeleteYeah Representatives Waxman and Pallone!!
It is only right that this bill be introduced and, ultimately, passed.
ReplyDeleteLike drug manufacturers, medical device companies conduct clinical trials and report their results to the FDA (no, the FDA does not conduct the trials, they rely upon the manufacturers to do so and then, in all good faith, report their results to the FDA)
Like drug manufacturers, adverse events are required to be reported to medical device manufacturers who, in turn, report them to the FDA (no, the FDA is not the clearing house for adverse events, it's the manufacturers who, in all good faith, report them to the FDA)
Like drug manufacturers, medical device manufacturers pay huge amounts of money to the FDA to review their products in order to get approval (no, this is not entirely funded by the United States government, it is highly funded by the manufacturers)
Like drug manufacturers, medical device manufacturers occasionally "fudge" their trial results and under report adverse events in order to get and keep their products on the market (no, the FDA is not all knowing...sometimes fraudulent activity slips by)
Unlike drug manufacturers, medical device manufacturers have enjoyed a brief period of no accountability (despite what pro-premptors would have you believe, it's been a year, not forever So when they say that, if preemption is removed, all hell will break loose and the medical device world, as we know it, will end, remember that, until February of last year, medical device preemption did not exist)
Congressman Pallone and Congressman Waxman are only doing what is reasonable and right. They are correcting the wording on the Medical Device Safety Act of 1976 (which, incidentally, had served us well up until last year) to clarify that lawsuits are not considered additional state requirements upon the FDA.
My gratitude goes out to the congressmen for their efforts to clarify what the true intent of the law is and, once again, hold medical device manufacturers accountable for the products they place on the market.