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Showing posts with label Howmedica Osteonics. Show all posts
Showing posts with label Howmedica Osteonics. Show all posts

Thursday, April 17, 2014

Cervicore Lawsuit Cervicore Victims


 


It's not just the weight loss industry that is a criminal enterprise. The American orthopedic industry is every bit as corrupt if not more than the weight loss industry, the pharmaceutical and hospital industries.

You've probably seen the TV advertisements regarding product liability lawsuits for victims of the Stryker metal on metal knee and hip implants. Stryker and their cabal of orthopedic surgeons along with the FDA knew from  published information that hip implants & knee implants using metal-metal articulating surfaces came with egregious safety concerns, e.g., the risk of tumor formation, chromosomal aberrations, carcinogenic potential in human patients -- and yet these highly trained medical professionals and orthopedic surgeons allowed these lethal devices to be implanted into their patients without providing them with any warning. To put it into simpler terms; everyone at Stryker knew from it's own testing that its metal on metal joint implants would degrade, deform and shed toxic metal ions into their human recipients. Stryker knew all along that implanting metal on metal implants into human beings would cause catastrophic health problems that would lead to prolonged and agonizing deaths. In their depraved indifference the power that be at the amoral Stryker corporation and the surgeons involved just didn't care. The sinister saga continues

Stryker Strikes again only worse this time!  Their latest batch of victims were injured even more grievously than the 1000's of hip and knee implant  victims and in this case there was even more medical malfeasance involved. Stryker Spine's CerviCore disc is a metal on metal artificial total replacement prosthetic. Thomas Errico, MD designed the  articulating saddle shaped device with the aim of preserving motion after implanting it into the intervertebral space between two vertebrae of the cervical spine. The inherently unstable saddle shape design of the CerviCore device in combination with the use of a heat treatment was known by Stryker to escalate the deterioration and wear properties of cobalt chromium (nickel and molybdenum with titanium plasma spray) in metal on metal articulating devices was a well known red flag for causing catastrophic outcomes in the device industry. Ironically, it was Stryker Howmedica's own research team of engineers, Wang, Wang & Gustavson who demonstrated that the heat treatment caused rapid deterioration of articulating wear properties in their published research  titled:  Metal on Metal Wear Testing of Co-Cr Alloyshttp://www.surfacehippy.info/pdf/corinheattreatingdebate.pdf 

The FDA did NOT approve the application for the legally required investigational device exemption (IDE) that had been submitted by Stryker Howmedica Osteonics in 2004. Without an order from the FDA granting a valid IDE to the sponsor, Howmedica Osteonics, dba Stryker Spine, the CerviCore device was absolutely prohibited for use on human subjects in clinical trials. And it stands to reason, that shipping the unauthorized device for experimental use or marketing anywhere in US jurisdiction would be prohibited and a violation of Interstate Commerce Act 21 USC 331. 

Stryker's Sinister Bait and Switch

Instead of complying with the FDA decision for further testing of the CerviCore disc, Stryker switched the CerviCore Disc that was used in the application for an IDE  that was denied with and replaced it with a second CerviCore disc that you see in the picture above. This was done to thwart federal laws governing the protection of  human research subjects in clinical trials. 

Related: 

Test Subjects Were Deceived 

The second rogue CerviCore disc was never tested in any pre-clinical trial tests and was arbitrarily implanted into the spines of any patient that the surgeons could coerce into becoming participants in what was an illegal clinical trial. The Stryker Spine CerviCore CT-002-04 had to be registered in the Government database for trial devices that were NOT approved for any usehttp://clinicaltrials.gov/ct2/show/NCT00588601



Stryker CeriCore Victims Product Liability Case

On Friday April 11, the law firm of Zoll, Kranz & Borgess, LLC filed a lawsuit behalf of a group of fourteen plaintiffs against Howmedica Osteonics Corp. (which does business as Stryker Spine) alleging Howmedica’s trial device called called CerviCore injured them.


Read Here About Stryker's Sinister Bait and Switch