FDA Defense
Between 2002 and 2004 a company named Synthes tested a product called Norian
XR in certain spine surgeries killing at least five patients. As the defense, we as attorneys, have the task of defending the FDA, whom had a clear pattern of explicitly telling
Synthes’ executives that Norian XR was not clear or approved for the use of VCF surgery
(vertebral compression fracture). Upon examining this case, there are several pieces of information that will be pointed out which prove the innocence of the FDA and also show the events that transpired afterwards which strengthen that argument. However the main point of this defense and argument is to show how through this tragic series of events, that a newly restructured FDA can be the product. First is the examination of how the
FDA is a broad agency, and that the scope and amount of resources they have is limited.
Next is the examination of the off label use of prescription drugs, and the penalties that should be incorporated for violations of this policy. Lastly is the issue of vesting between government agencies and the private sector, especially in cases like this, there needs to be some strict guidelines as to prevent incidents like this from happening in the future as well. First is some background on the case, and a brief description of what was happening. Synthes is a Medical device maker that was acquired by Johnson and
Johnson. This company in 2009 was accused of running illegal clinical trials on humans between 2002 and 2004 for a product called Norian XR in terms of off label use. This
Norian XR product that Synthes had came out with had seemed like a wonder drug ,in that it had the capacity to turn into bone when injected in the human skeleton. However the problem of Norian XR is that when it hits the bloodstream, the patient dies very quickly, blood clotting in the heart being the issue. Synthes was aware of Norian XR being deadly in regards to this nature of use, yet, it was
XR in certain spine surgeries killing at least five patients. As the defense, we as attorneys, have the task of defending the FDA, whom had a clear pattern of explicitly telling
Synthes’ executives that Norian XR was not clear or approved for the use of VCF surgery
(vertebral compression fracture). Upon examining this case, there are several pieces of information that will be pointed out which prove the innocence of the FDA and also show the events that transpired afterwards which strengthen that argument. However the main point of this defense and argument is to show how through this tragic series of events, that a newly restructured FDA can be the product. First is the examination of how the
FDA is a broad agency, and that the scope and amount of resources they have is limited.
Next is the examination of the off label use of prescription drugs, and the penalties that should be incorporated for violations of this policy. Lastly is the issue of vesting between government agencies and the private sector, especially in cases like this, there needs to be some strict guidelines as to prevent incidents like this from happening in the future as well. First is some background on the case, and a brief description of what was happening. Synthes is a Medical device maker that was acquired by Johnson and
Johnson. This company in 2009 was accused of running illegal clinical trials on humans between 2002 and 2004 for a product called Norian XR in terms of off label use. This
Norian XR product that Synthes had came out with had seemed like a wonder drug ,in that it had the capacity to turn into bone when injected in the human skeleton. However the problem of Norian XR is that when it hits the bloodstream, the patient dies very quickly, blood clotting in the heart being the issue. Synthes was aware of Norian XR being deadly in regards to this nature of use, yet, it was