Off Label Use of Devices - Uninformed Consent
I am pretty much at the end of my wits as to what to do about this issue: In September, 2010, my wife and I met with a neurosurgeon to discuss a long-coming need for cervical surgery. At the consultation, we came to the conclusion that I really needed to get it done. The doctor discussed in layman terms the procedure. This was going to be a 2-level Anterior Cervical Disc Fusion procedure. I told him how I had taken quite a while to make this final decision because I was in hopes that newer technology has finally been approved, besides using the bone plug from the hip. He said, Oh no, they don't do that anymore. So with relief, we continued. He talked about the plastic cages that would be used and that he had done thousands of these with great success. Feeling confident, we proceeded. The surgeon's office obtained Pre-Authorization from my insurance.
The surgery was a one-night stay ordeal. Awesome! However, immediate complications set in. Swelling of the vocal area, difficulty swallowing, difficulty breathing. My wife called his office and explained that there may be something wrong. They said, No, everything was expected, but to keep taking the steroid prescribed. Two days go by. Even more swelling, loss of voice, swallowing was very hard and difficult. Called office again. Same reply. Just keep taking the prescription. Day four: Called again with same complaint. We were told that everything was expected and to keep taking the meds. That weekend we considered going to the local ER we were very concerned. It seemed to settle down late that night so I didn't go. My first post-surgery office visit was one month after surgery. At that visit, the doctor asked how I was doing. I could barely speak with a wispy voice, my neck was swollen big time, swallowing was like swallowing a quarter sideways, and I was having headaches. He said he did not know why I would be having this problem and that everything would be okay. He set another visit for one month later. Month Two: Went to doctor. Still having continued swelling, hoarse voice, aching into my chest and tips of my shoulders, swallowing was still same. He just said again that he did not know what would be causing this and that I should not be having problems. Needless to say, he did not help very much. He set another visit for one month later. Month Three: By this time, I convinced there was something wrong and at the office visit asked him if there one of the other surgeons has reviewed my case. There are 4 surgeons in this clinic. I said that it seemed prudent that if a patient is having ongoing problems that the surgeon didn't know their causes, that he would consult with his comrades. But he said he did not need to do that. I asked if there was something that could be done to check. A test or anything? He said, yes. An CT scan could be done. He couldn't do an MRI because of the titanium metal that held the neck together. He said he would see me in ONE month again. This meant waiting for another month just to get the CT scan done. On the way home my wife and I marveled over why he would wait another month even to get the test done?? At 3 and 1/2 months post-surgery, we received a letter from my insurance company saying that the payments already made to the surgeon and hospital were going to be denied and retracted because the BMP (Bone Morphogenetic Protein) used in the ACDF procedure was considered Experimental or investigative, Non-FDA approved for cervical appliation, and the insurance would not cover this. This is AFTER they had paid most all the bills mind you. Needless to guess, we were shocked! At NO time or in any way did the surgeon tell us, infer, or allude to the fact that this material he used was experimental or the like. IF he had said anything to cause us to even maybe think this was experimental, I know I would have declined the procedure, knowing my insurance would not cover it. Many people at my work talk about the denial of service due to things like this.
At the 4th month office visit, I brought the letter with me. Well, I was reacting to this BMP big time. The surgeon continued to say there was no reason for my complications and he did not know why this was happening. I asked why would my insurance company consider this to be experimental? He said it was their way of trying to get out of paying the bill. I asked him point blank, was this BMP experimental? He said that it was Off-Label, but was not experimental. I asked him to explain the difference. He could not clearly without mumbling say just what that difference was. He took a copy of the letter and said he would get with his business office and would work something out. I immediately went to the internet and googled BMP. There are hundreds of pages of information about it on the web. Detailed explanations of complications Exactly as I was experiencing. So? I have ended up going to Stanford University Neurology and they said that they are very aware of this BMP use Off-label in cervical and that is why they do not use it at all. They also said there was nothing could be done, that the procedure was irreversible. I am now unemployed and permanently disabled on SSI and have continued to have pain and loss of strength in my arms. I still have swallowing difficulty although the hoarseness has gotten better. The sides of my neck and collar bones where they near my voice box are constantly nagging and aching and I am still on long term pain meds. I talked at length with the surgeon's administrative office and the insurance company and have found out that the way they got the Pre-Authorization was by hiding the specific code number for the BMP inside another code number such that the use of BMP was not clearly disclosed to the insurance company. It was the hospital's billing that uncovered the BMP to my insurance company, thus the letter.
I have discussed my issue with 10 attorneys over the last 1 1/2 years. They say I have a very strong or merited case, BUT, professional witnesses are expensive and contingency cases are difficult to get an attorney to take. Through perseverance and arguing with the hospital, the amount of the bill ($65,000) has been reduced, but we are stuck with paying the remainder. I just went to see a pain specialist today for my annual check-in for medication review. Also Stanford returned a reply to me that they are in receipt of the last MRI which they suggested strongly I get once or twice a year due to osteophyte possibilities in my cervical fusion area. They are concerned with bone growth in adjacent areas around the plastic cages inside which they used these sponge spacers and the Bone Morphogenetic Protein as a bone growth stimulant.
I have pages of details from the FDA including their printed Medical Alerts dating back to two years before my surgery, regarding the life-threatening issues with BMP in the cervical area. I know there is no way that this surgeon had no idea why I was having my difficulties immediately following surgery, and mostly persists to today.
If anyone knows anyone that could help me, I need to get this financial burden off my back. And lastly, there should be a way to warn people about this surgeon and the admitted fact that he actually has only done a few 2-level discectomies and has used the BMP only on 10% of his cases. This is what he notes in his office notes of which I have copies. I have lost my career and put a burden on my wife who has been a champion in taking care of me during the months in which I could hardly lift my head. Thanks for reading.