Hi Cat, I googled it to see what I would find. I haven't heard of a case being brought against Johnson and Johnson, but there are some law groups looking for recruits for a class action suite if they can find enough patients with failed procedures.
I did think this paragraph over dramatized the risks of of ADR surgery, anyone that has any sort of implant faces the same risk if an implant fails or repair surgery needs to performed. Yes, metal can break, plastic can splinter, you can have nerve damage or get an infection. These are the same risks you have when you have a laminectomy or discecomy or fusion or any surgery?
"If these devices fail or when they wear out, the revision surgery may be extremely difficult and fraught with potential dangers of vascular, visceral or nerve injury and the risk compounds should they need to be removed. In addition to the potential complications associated with undergoing surgery and general anesthesia, the complications associated with artificial disc replacement may include: breakage of the metal plate, dislocation of the implant, splintering of the plastic and infection."
I don't know if every surgical failure warrants a law suite but a manufacturer of hardware used is certainly a multi million dollar target. This may come to the point of a law suite but that could be 10 years away when they have more clinical data. Here is a blurb from what I found, but I can't post the law group info. Sorry your having problems, but I really couldn't tell what kind of problems you're having from your post.
Failed Back Surgery Involving the Charite Artificial Disc |
New Jersey, USA A Lawyer group has created the International Charite Artificial Disc Practice Group in response to the serious problems encountered by the recipients of the artificial replacement disc. The devise was recently approved for use in the United States despite failures throughout Europe and Australia.
They have begun to review and accept injury cases from surviving family members and individuals who have suffered serious complications after receiving the Charite artificial disc. "Our Charite Artificial Disc Practice Group is international in scope as the device has been used and failing around the world for nearly 20 years," "We will be reviewing potential cases from the United States, Australia and Europe," said XXX lawyer
Johnson & Johnson became the first company in the US to receive approval for an artificial spinal replacement disc though it had been on the European market since 1987. The disc, approved by the FDA on October 26, 2004, is made of plastic and metal similar to the materials used in hip and knee replacements and is being marketed as an alternative to complex spinal fusion surgery. Currently, spinal fusion surgery, while reducing motion in patients, offers the only safe option for patients with chronic pain. Analysts believe the market for spinal discs could top $1 billion within a few years.
Johnson & Johnson's DuPuy Spine unit beat competitors to the US market by securing FDA approval of their device, but some orthopedic surgeons have strongly criticized the FDA for its approval of the Charite devices. They cite flaws in Johnson & Johnson's clinical study and over 17 years of evidence from Europe, where the devices have been in use for some time. They found the Charite artificial spinal discs have regularly failed in Europe, leaving patients with life-threatening complications.
"This is a technically demanding operation that very few, if any, surgeons are qualified to perform and the correct sizing and positioning of the device is critical for best functionality and lowest chance of failure," says Ricky Bagolie. The margin of error is so small and the chance of misplacement so great that these artificial disc replacements should be recalled to protect the public,”
If these devices fail or when they wear out, the revision surgery may be extremely difficult and fraught with potential dangers of vascular, visceral or nerve injury and the risk compounds should they need to be removed. In addition to the potential complications associated with undergoing surgery and general anesthesia, the complications associated with artificial disc replacement may include: breakage of the metal plate, dislocation of the implant, splintering of the plastic and infection. |
The lawyers believe there will be thousands of people in the USA, the UK,, Europe and Australia who suffer Charite artificial disc failure. "It appears from our initial investigation that Johnson and Johnson is responsible for manufacturing a medical device they knew or should have known was unreasonably dangerous in an attempt to capture some of the lucrative multi billion dollar back surgery market. They downplay the risks,"
Contact info deleted.
Cat, I didn't see where a medical group is declaring they have had an unusual number of failures, I would keep searching if your having problems with your AD but this article is just an edited recruitment add for participants in a class action suite with either the potential to move ahead or to go nowhere. Maybe this is the law firms way of getting a jump on the rights to a class action suite against the maker of a new medical device used in Billion dollar market.
If it fails at a higher rate than projected or submitted to the FDA, there will always be a lawayer ready to bring suite. Failure or rsisks of new meds and devices is a multi milion dollar market for attorneys.
From reading this it just looks like they are lookng for something down the road if they can find enough people willing and qualified to participate. Getting an infection after an implant is hardly failure of a dangerous device. It's a surgical risk.You have to seperate normal risk and failure from actual neglegence by the manufacturer and putting a dangerous product on the market. I am sorry that your surgery seems to have failed.
ADR may fall out of use if there is a large class action suite and after more than a year on the market they see poor long term or even short term outcomes but I couldn't find a failure rate. All I found was a lawyer speculating and gathering info. Excessive scarring after surgery, infection, misplacement aren't necessarily design flaws, It may may be lack of experience of a surgeon with a brand new device.
Certainly keep your eyes open for medical literature that is suggesting it has a higher failure rate than what was submitted to the FDA. I have an implanted pump. I'm sure there is a class action suite out there for anyone that as had a pump malfunction or leak that caused death or injury, but I understand there is a risk of anything failing. Was it rushed to market and the FDA provided non factual data, I don't know? It's too soon to tell.
You can certainly look into a class action suite but I wouldn't spend a penny if asked untill you see where the suite is going and what data shows up to support it, not just claims by a lawyer. If you find what you experenced is a direct result of device failure and outside the normal potential risks of any spinal surgery I would say certainly follow through and join a suite. From what I have found, no case has been filed and it looks more like legal speculation.
If you think you have a malpractice claim because of an untrained doc unfamiliar with the implant procedure, follow through with an atorney. Is there an implant certification process and what is it? Some docs have been working with different discs for years. How others were trained to implant a device less than a year old is a good question, especially if a device needs to be implanted with what the attorney describes as absolute precision.
Good luck and I would like to know what has happened with your ADR, when was it implanted and what went wrong or is going on now.
Take care, Dave