Anyone here familiar with the Infuse lawsuits?

Factual Questions
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Hello Everyone,
Well, after ten years of pain I may finally have a reason why. I’ve been reading and seeing ads on TV from attorneys representing patients who have had spinal surgery in which the Infuse bone graft device was used. Apparently this device was used off label and wasn’t approved for spinal sureties by the FDA. Worse yet, the manufacture of the product allegedly knew the product was unsafe to use, but paid doctors to use it anyways. (this of course brings up so many ethical questions about these doctors).

So, I was very curious if my problems were caused by this device, but I had no idea if it was used on me. I contacted one of the law firms, they took my information and signed me on as a client. Today I was informed that infuse was used in two if my lumbar surgeries. The news was irritating and relieving at the same time. Irritating because I’m pissed that I’ve been suffering for ten years and it seems this company and my surgeon conspired together to make a few dollars at my expense. Relieved because for once I might have an answer to why I’m in so much pain, as none if my doctors can figure out why. But at this point I’m left with many more questions than answers, so I’m turning here and maybe someone had done insight.

I’ll say upfront that the decision to contact an attorney was not motivated by the thought of getting money from the company for the sake if getting money. I’m really not one for suing, but that’s the only option for recourse. Not to mention perhaps with some money from a lawsuit I can afford to pay for another surgery that seems to be the only option to alleviate the pain I’m in. The surgical group uses keyhole surgery to remove no longer needed hardware from my spine, doctors have told me that it us the only thing they can think of that might solve the issue. Problem is, I’m disabled and this specialized surgical group does not accept Medicare. They require an upfront payment of $20 grand to do the surgery. I’ve been saving, but maybe proceeds from a legal Acton could get me there. So, here are the questions:

1: This is not a class action type lawsuit, individuals are treated as such. I’ve looked online but I can’t find any information about settlement amounts received by affected parties. Does anyone have a clue?

2: The internet is also very quiet on any treatment options to fix the problems caused by this product. Is anyone here aware of a medical fix?

3: The only penalty I can see the manufacturer if getting is from the lawsuits from affected parties. I would hope that the government would be coming down on them like a hammer if what had been alleged is true. Are they?

Well, that’s about it. I apologize that this is so long. Cheers!

2

I just reread my post. My apologies for the grammatical errors. I would have gotten away with a perfect post if it hadn’t been for that meddling auto-correct!

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I’m bumping this because I just read a news piece in the Journal of the American Medical Association that’s relevant: http://jama.jamanetwork.com/article.aspx?articleid=1719734. (If you don’t have access to the full text, PM me for a copy.)

Now, I really have no expertise on the clinical or legal sides of this matter, though I am acquainted with the basic science aspects. (I happened on this particular article on my pubmed alerts for “bone morphogenetic protein”.)

Still, as far as I can tell:

Bone graft was the previous standard of care for spinal fusions. Medtronic developed the Infuse “device”, consisting of BMP-2, a bone growth factor, in a gelatin matrix. In theory this was supposed to offer the benefits of a bone graft, without requiring surgical removal of bone from some other part of the body. Medtronic, sponsored several publications showing that Infuse was superior to bone grafts for spinal fusions. This research was the basis for a lot of off-label use and eventual FDA approval for spinal surgery in 2002. It turns out that the Medotronic-sponsored publications did not report adverse effects, and Medtronic gave lots of money improperly to the authors of those studies. Recent follow up studies have found that Infuse is not superior to bone grafts for spinal surgery, and has substantial side effects.

In your case, I doubt there’s any basis for malpractice on your doctor’s part. Based on the time line you gave, you received the Infuse device after it had FDA approval. Your surgeon was acting on the best available data, even though we now know the data was manipulated.

I don’t know if you have any basis for suing Medtronic directly.

Finally, I don’t think there’s anything that can be removed. My understanding is that the device stimulates growth of your own bones, and is eventually completely absorbed. However, one of the side effects I’ve read about is “unintended bone growth”. Perhaps this happened to you, and the excess bone could be surgically removed.

There was a Senate investigation in 2012. Go here for the summary and a link to the whole Senate investigation report: Chairman's News | Newsroom | The United States Senate Committee on Finance.

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Did your meddlesome phone nanny changes “surgeries” to “sureties”? Maybe they’re trying to sell you spinal surgery insurance.