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July 23, 2012 / Admin

Medical Device and Safety Act of 2009

After the Supreme Court’s decision in Riegel v. Medtronic, which, in a nutshell, took away a consumer’s right to sue a medical device manufacturer for injuries and/or death caused by their faulty devices if the device had received FDA approval, Congress introduced the Medical Device and Safety Act which will restore a consumer’s right to state tort remedies.

Is there really a doubt that this needs to pass? For 30 years state law and FDA regulations worked together to ensure the safety of medical devices both pre and post approval and then with one flawed decision, injured consumers were stripped of their ability to hold medical devices liable. Now, so long as they receive FDA approval, they are immune. That’s an interesting concept, seeing that the manufactures are the ones that conduct their own studies, and then submit their findings to the FDA for approval. Basically, the manufacturers are the ones approving their own products and then they are in the clear.  There was already a concern about the “findings” from their studies that they used to get the approval but now there is the added concern that the medical device manufacturers have absolutely no incentive to conduct post-approval safety studies of their products?

Currently, if a patient is implanted with a faulty medical device and endures injuries and hospitalizations, the medical bills are the responsibility of the patient and in some cases the taxpayers. So, in short, a medical device manufacturer can conduct its own studies, submits its results for FDA approval and then once approved sit back and let the profits come in while the general public is left footing the bill for any problems with their products.

Any argument made against the passing of this bill does not compare to the necessity of this bill for public safety reasons.    Here is an idea for the manufacturers who are against the passage of this bill, conduct proper pre-market studies, warn about any safety problems learned of post –market and recall devices that have problems. It may be a stretch but I am confident that if those few simple steps are followed the manufacturers wouldn’t be affected by the p

 

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