Medical Procedure Provided to New Mexico Man Causes Additional Damage
A man in New Mexico suffering for years from debilitating back pain consented to a new medical treatment at a Veterans Affairs hospital in Albuquerque to try to alleviate his pain. His doctor at the time told him the cutting-edge procedure was safe, telling him he would be able to play golf the same day after receiving the injection of a Plexiglas-like cement.
What the doctor did not tell him was that the procedure was not approved by the Food and Drug Administration. Nor did he warn him that the injection would eventually deteriorate, breaking into shards that would migrate to other areas of his spine, causing even more damage and pain. The man has since had surgery to remove the cement shards, but it was too dangerous to remove them all and he continues to be at risk for further damage to his back and spine.
The FDA, an agency governed by the U.S. Department of Health, is responsible for protecting the public health by assuring, among other things, the safety and effectiveness of medical:
To obtain FDA approval, each must be tested and shown to be effective on humans, as well as reasonably safe. Legally, medical care providers cannot advertise experimental or non-FDA approved medical products or treatment. However, doctors may use non-FDA approved products and procedures provided that:
- Full disclosure is made to the patient that the product or procedure is not FDA-approved
- Full disclosure of risks and dangers is given
- Firm scientific rationale and sound medical evidence prove the procedure will safety accomplish what it purports to achieve
Failure to provide full disclosure or to provide care that has not been proven to be effective may amount to medical malpractice.
If you are injured or suffer from medical care that was not approved by the FDA, or you were not made aware of the risks associated with the care you received, you may be entitled to compensation for your losses, pain and suffering. Consult with an experienced medical malpractice lawyer who is knowledgeable about personal injuries and negligence.