Over a dozen law firms now after Nuvasive

There's over a dozen law firms in Canada and the U.S. now filing Federal Lawsuits againts Nuvasive. You can use Google News or Yahoo News searches using "Nuvasive" as the search to find the stories.

Appears all cases will commence in October of this year, only "people" who bought NUVA Stock are going to be plaintiffs. The Lawfirms are only looking for "people" who bought atleast $100,000 in NUVA Stock.

Isn't that odd? It was HEDGE FUNDS that kept throwing unlimited money at NUVA to keep it going.

They're not even giving legal recourse to all the people they've killed and maimed. NUVA advising surgeons it was OK to hammer plastic spacers into peoples spines and NOT use fixation...for fast money billing Medicare/VA/Insurance companies as a "SPINE FUSION"....when there were no spine fusions.

Nuvasive doesn't have the cash to settle these new lawsuits (let alone liability to those they killed and maimed)......what's going to happen to them?

Their Board of Directors/CEO should be put on suicide watches......

 

Interesting comment…but last time I checked the surgeon is ultimately responsible for making appropriate clinical decisions as to what is the best construct to use with a patient. Despite what industry advises or published, surgeons have always had to balance that advice and data with his or her best clinical judgment, standard of care and his/her training. Grant you, NO vendor should ever advise or publish inappropriate information, as that simply discredits the quality work the rest of us are delivering. However, it is ultimately on the surgeon to know what is appropriate and best for their patients not industry. Shame on any surgeon for not knowing what the scientifically sound clinical construct is for a given pathology and subsequently what the appropriate billing procedure is!

 

That's a company typical response. "Surgeons can use medical implants for 'off-label' uses and doesn't have to follow implant instructions".

But it's false. SOME Medical Implants are a higher class and greatly regulated by the FDA. The Nuvasive Coroent XL Peek Plastic spine spacer is one of those highly regulated devices...and surgeons can't use it for 'off-label' uses.


Look at that Spine Surgeon in Hawaii who lost his job using a Titanium Screwdriver for an implant. During his surgery on a patient he needed a Titanium rod to insert in the patient, and didn't have one. So he used his cut off tool and cut a Titanium screwdriver to get the straight piece of titanium he needed for his spine surgery.

He lost in court and no longer is a Doctor. TECHNICALLY, what he did was 100% safe and ethical....he lost his job because.....Medcal Implants that are permanent inside a human body are under strict regulation. He's no longer a DOCTOR now.

The FDA adopted "Bayesian Statistics" for medical devices/implants....which means they ignored their strict regulation and allowed anything...and everything to get approved....To create $$$$$ and jobs. EVEN IF IT MEANT KILLING AND MAIMING AMERICANS.

So Surgeons now in America are under that Federal Amnesty program...they can't he held liable for using medical implants however they want...cuz the FDA adopted "Bayesian Statistics" to generate $$$$...."Bayesian Statistics" for medical devices meant the FDA would "look at the data as it came in down the road"....and approved everything...without clinical trials to prove safety and ignoring the stringent controls on medical implants.

Right now a surgeon in America could use a Nuvasive Coroent XL plastic spine spacer and insert it into a patients NOSE if they wanted. There's no more regulation of Medical Implants in America by the Federal Government.

 

Mom, go home. You're drunk again!

 

All I have to say about this is if you know the difference between a 501k cleared product, Class II and a PMA approved class III-this would not be a discussion

Majority of spine and orth o implants are Class II-510k cleared---less regulated than Class II, like an ICD or a cardiac stent

 

Titanium Screwdriver?

 

Even Nuva's 510k premarket letter said "Fixation" was required when the plastic spine spacer (Coroent XL) is used.

Their marketing push / media to the public and doctors all said "Fixation" wasn't required...totally going against their own 510k they submitted.

So the Doc's didn't "use them off-label" when they hammered them into patients without using Fixation. Nuva's mass marketing push said "fixation" wasn't required. The FDA did slap them on the hand and told them to stop saying that.....but didn't really do anything about it.

The Hawaii Surgeon who used the titanium screwdriver and cut it down for a titanium rod to use in surgery was Robert Ricketson.

You're right, he ain't a doc no more.

 

what a moron! nobody makes a titanium screwdriver, it was non implant grade stainless steel. A titanium screwdriver would bend and strip before the 1st case with it was over. Get a clue you Nuvasive idiot!

 

The new labeling on the Coroent plastic spine spacer now say it isn't capable of bearing loads (weight):


""""potential risks identified with the use of this device system, which may require additional surgery, include: device component fracture, loss of fixation, non-union, fracture of the vertebra, neurological injury, and vascular or visceral injury. If healing is delayed, or does not occur, the implant may eventually loosen, bend or break. Loads of the device produced by load bearing and by the pt's activity level will dictate the longevity of the implant.""""


And still the FDA has done nothing............


The Coroent XL ain't able to bear weight without fixation. Many people have showed up in Emergency Rooms where these plastic spacers broke inside them...some came out of their inserted space....poor poor Americans gettin' crippled by their own Government to generate $$$ and jobs.

Google's been doing a good job scrubbing those xray/mri pictures from the web to hide what's going on. San Diego is indeed protected....can't have the Japanese finding out what's been going on....they're the new sheep getting these.

 

Here is a link of interest:

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTPLC/tplc.cfm?id=4167

Look at allllll those recalls by other companies of their peek plastic spine implants.

No Nuvasive Recall. notta.....

Obama might be sending the wolves to shake down San Diego for money......Nuvasive's put money on the israeli's laps to keep em clean. These "Medicare Fraud- Securities Fraud" lawsuits aint goin' nowheres.

I've got $5 that says Nuva stock doubles in 10 months.

 

"""""On July 30, 2013, NUVASIVE disclosed that it had received a federal administrative subpoena from the Office of the Inspector General of the U.S. Department of Health and Human Services in connection with an investigation into "possible false or otherwise improper claims submitted to Medicare and Medicaid""""""""


Anyone READ the Federal Subpoena?

What did the Fed's claim? That the Nuvasive XLIF process of hammering plastic spacers into people's spines wasn't a spine fusion?

NO!!!!.....it couldn't have possibly said that.......LOL!

Thousands of people died from this...acceptable losses to generate $$$.

 

Put BMP into the Coroent plastic spine spacer and it becomes Class III.

What have all the surgeons been putting into the Coroent plastic spine spacers for the growth material? They ain't been using the patients own bone. What have they all been using?

The FDA doesn't regulate these implants. They've been looking the other way since the early 90's.

 

I work at the distribution warehouse and if you knew how dirty the instruments are and the complaints we get from surgeon, you would never use Nuvasive products.

 

Do all instruments come back to be cleaned between use?

 

You work at the distribution warehouse? You've never met a surgeon. Well, unless he's about to do surgery on you, idiot.

 

Ummmmm.....have the Coroent PEEK plastic spine spacers been leaching Bakelite plastic fumes/toxins into patients bodies making them disabled/dead?

Any Xlif patients who are military veterans been getting a special secret dose of something causing the Bakelite plastic smell and oil to come from their skin...hair??

There seems to be some secret experiments being conducted on the few surviving Xlif patients to counter toxicity effects....

 

Keith Valentine is leaving NuVasive. I hope he is not being pushed out. He cashed out! Good for him. Going to miss the cheetah pants and hat.

 

There was a FDA Maude Report saying the XLIF surgical tools couldn't be disassembled to be sterilized between patients. Supposedly Nuvasive was gonna have the tools redesigned to fix the design flaws....

Does anyone know if they ever did?

How many Xlif patients developed infections in their spines from the surgery? Would explain the medical journal article that said 75% of all the old people operated on....died.

 

Citation please.

It's a little known fact around here that eventually, 100% of patients die.

 

From what? That Nuvasive trash?^^^^^