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Medical Devices effect on Health Care Reform

By       Message Jim McGookin       (Page 1 of 1 pages)     Permalink    (# of views)   No comments

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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?

An argument can be made that if patients and/or their families can bring lawsuits against these companies, that companies would quit making these life saving devices or move their companies overseas and take jobs with them. First, these companies make billions of dollars here in America. Second, congress passed the Medical Device Amendments of 1976 (Public Law 94-295) - a law giving the right to patients and/or their families to file a lawsuit against defective medical devices. The makers of medical devices have survived that law since 1976 without going out of business or moving to other country. Third, how many people want to trust companies that have a "get out of jail free card" and have no recourse for any injuries or deaths that were inflicted by an unscrupulous company?

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For the people that depend on medical devices, (defibrillators, pacemakers, etc.) they should be able to expect safe and reliable products. There is legislation to help protect patients and their families, so please contact your congressmen and senators and ask them to support these bills. Medical Device Safety Act of 2009, Congress bill (H. R. 1346) and Senate bill (S.540).


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My granddaughter, Samantha, had a Guidant pacemaker implanted in her when she was three days old. She was just 14 months and 12 days old when her pacemaker failed and killed her. Guidant and companies that manufacture life saving devices need to (more...)

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