I read more of the amended complaint against Medtronic and Dr Gary Michelson. It reads like a horror story about stupid science, greed and innocent victims who end up worse than they started. It's 125 pages of the main amended complaint double spaced, 7.4 MB. It's more compelling than a suspense horror drama movie. There is so much corruption, criminal acts, illegal kickbacks, outright lies, whistle blowers being paid off that it's difficult to believe. That UCLA whistle blower getting $10,000,000 to shut up and go away is nothing. Tip of the iceberg of greed and corruption. This is Dr. Gary Michelson's disgusting business of pure and utter personal and corporate greed.
Medtronic was only allowed to use Infuse (TM) with the L-T spinal cage (TM) with morphogenetic protein type 2 over a collagen frame when they are surgically accessed from the front. FDA approved this use only in lumbar patients, lower back. It did not approve it for cervical (neck) patients or for use in surgery accessed from the back. There is very good reason for that.
This product is for people with disc degeneration who need to have two or more vertebrae fused together. Gary Michelson's stolen invention the spinal cage is put between the two vertebrae. A collagen frame is inserted into the cage. Morphogenetic protein type is inserted onto the collagen frame. This protein causes bone to grow. Previously for many years they successfully used bone grafted from another part of the person's body or cadaver bone. That was considered the gold standard. This protein eliminated the need for a bone graft.
While I was reading the amended complaint I instantly had questions about the bone growth. How do they control how much bone grows and where? Can they isolate the protein to one specific site and limited growth? Is the cage enclosed so bone only grows in a specific area? Is there a way to make sure none of the protein escapes the cage or a certain area around the cage? No, they can't and that's the problem. How incredibly irresponsible!
Two to seven days after surgery with Infuse 87% of patients had complications. The protein leaked into surrounding tissue causing inflammation. For example if you used this off-label for cervical vertebra it could cause your throat to swell to the point that you would need emergency surgery for a breathing tube. Other patients experienced excessive bone growth which caused even more back problems. Patients needed multiple surgery to remove the excess bone then to remove the cage and bone. When the protein grew back after removal it would grow back even faster than before. If you used it off-label to perform surgery from the back, the negative effects were even worse because the protein could enter the spinal area from the incision.
That sounds like a horrible enough story but that's just the beginning of this horror story. Normally you would think they use the product off label, see monstrous results then stop. Nope, not Medtronic. They continued to use Infuse off-label knowing full well of all the horrible negative effects. They did this because they make more money with off-label uses than with on-label uses.
All the while Medtronic is giving kick backs to doctors who promote, use, sell, talk about Infuse. These doctors in turn lie and say everything is fine. Meanwhile whistle blowers contact FDA and DOJ. Medtronic paid doctors say "there's nothing wrong with using this for on-label uses." They continue to say it won't be used off label. FDA asks them how they will make sure it's not. They said they would educate doctors.
Many other doctors, hospitals used Infuse and noted horrible results. They write journal articles, make presentations, reports are made, more whistle blowing. What does Medtronic do? They pay off the whistle blowers.
I think they need to soak the collage frame in the bone protein before they insert it in the cage. Squirting the protein onto the frame after inserting the cage and frame seems to cause it to leak. The protein should be glued to the frame so it won't grow outside of the area.
I only read the parties, claims, history of events. I'll read the rest tomorrow. What truly horrible people. I actually almost signed up for a study that sounds like this. A doctor in Texas made some gel product that he injects in a herniated disc which causes it to stop leaking. The surgery is performed almost outpatient from the back. It doesn't sound like bone protein but I didn't get all the info. Nightmare. This is how Gary Michelson made all his money. If Gary hadn't made sure he owned the patent for any product put in his cage, not just bone, he wouldn't be on the hook for this. If he said his product was only for bone grafts, he'd be fine. Greedy.
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