Medical Devices Effect on Health Care Reform

OpEd News -- Right now the big news in Washington DC is legislation passing healthcare reform. Along with healthcare reform, I believe that drug companies and medical device manufacturers need to be considered while making these decisions. First, lets consider how much it cost insurance companies, Medicare and Medicaid for drugs and medical devices. Second, now lets consider how much it cost when the drugs and medical devices are recalled and the companies don’t have to pay the patients, doctors or hospitals for their mistakes, it all falls on the patient and their insurance, Medicare or Medicaid, if they have any. That is, if their insurance, Medicare or Medicaid will cover that charge. In the Supreme Court decision in 2008 in the case of Riegel v. Medtronic Corporation, a lawsuit cannot be filed against a medical device manufacturer if their product had FDA approval. Even if that product has any recalls or if the manufacturer knew that they misled or misinformed the FDA in their request for approval, or they found a problem after approval and didn’t tell the FDA, they cannot be sued. Now with this newfound freedom, how much do you think that the quality control will be put aside in some, if not all, of the makers of medical devices?

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