Is there non-surgical-grade hardware in your body right now?
05/17/2016 12:41 pm PDT
What if the hospital where you had your back surgery notified you that the unthinkable may have happened: You might have fake medical parts implanted in your spine.
A dozen people who say they are still suffering from neck and back surgeries sat down with Crime Watch Daily at our affiliate WITI-TV in Milwaukee, Wisconsin, to share their emotional stories. Their complaints include shooting pains, numbness, difficulty walking and sitting.
A letter they received from Aurora St. Luke's Medical Center in Milwaukee warns in part: "From 2007 to 2012 Spinal Solutions produced counterfeit implantable hardware that was mixed with genuine product."
"What the whistleblower lawsuit alleges is that the counterfeit parts were made and manufactured at a machine shop in Temecula under the direction of a company called Spinal Solutions," said attorney Brian Kabateck.
Attorney Brian Kabateck is now suing Spinal Solutions, representing about 100 patients in California.
According to a lawsuit filed last year, more than 50 hospitals, doctors and others are named as defendants in an alleged "massive healthcare fraud scheme."
The suit claims Spinal Solutions "knowingly produced and manufactured fake, knock-off ... implantable hardware."
Crime Watch Daily reached out to Aurora St. Luke's Medical Center for comment but they did not respond to our calls.
Aurora says in its letter to potentially affected patients: "No evidence to confirm the claims involving Spinal Solutions, we obviously are disturbed by the allegations. ...
"Please understand that your health is of the utmost importance to us, and that we take this situation very seriously."
And while the parts may have been cheap knockoffs, the delivery system was not.
Attorney Brian Kabateck's lawsuit against Spinal Solutions alleges the company used private jets to deliver the counterfeit medical parts and alleged kickback money around the country, which he says could be as high as $15,000 per surgery.
Those bogus parts reportedly brought in big profits. Kabateck claims the charge for one counterfeit screw was $300, but the insurance companies were allegedly charged as much $12,500.
"We also have been in touch with the U.S. Attorney, the Attorney General's Office, and we're cooperating with them, but we've been asked not to disclose what's actually going on in those investigations," said Kabateck.
Even though Spinal Solutions is now out of business, Kabateck says the case against them could turn criminal.
"I personally represent a number of people who allege that they've had this counterfeit hardware installed in their bodies and it's caused them irreparable harm," said Kabateck.
Kabateck does not represent any of the Wisconsin patients, and the alleged medical fraud in California has not been proven. He met Crime Watch Daily in Milwaukee to help answer questions.
"What we do know is that if you have something in your body that's not FDA-approved, you are at risk," said Kabateck.
Dr. Charles Rosen, expert in spine surgery and professor at University of California, Irvine Medical Center, is worried. He has not seen any of these patients, but says the consequences of having non-medical-grade implants in your body could be devastating.
"They can break, they can give off metal ions, they can degrade, they can cause the surgery to fail by not being rigid enough to cause a fusion," said Rosen. "There can be numerous complications from them."
Patients who were operated on by neurosurgeon Dr. Cully White met with Crime Watch Daily. White, 47, denies he ever knowingly used fake parts on his patients. White was originally named in the Spinal Solutions lawsuit filed in California, but he was recently dropped from that suit.
In court documents, White denies receiving any kickbacks, and claims he "never billed for, paid for, or took delivery of any implantable hardware at anytime."
Dr. Cully White may have been dropped from the California lawsuit, but he's still facing accusations that he implanted fake medical parts in a Wisconsin lawsuit filed by former patient Linda Haynes.
Dr. White denies all the allegations and claims Haynes's condition is a result of natural disease progression and pre-existing conditions.
Dr. White was a prominent neurosurgeon, once called one of the best and the busiest neurosurgeons in the country, reportedly performing about 600 surgeries a year, according to federal prosecutors, twice what the average neurosurgeon does.
According to IRS records, White made $10 million on his best year, with assets estimated at $22 million. He lives in a plush lakefront mansion, while some of his former patients say they suffer.
A dozen of his former patients gathered in a TV studio at WITI-TV in Milwaukee. They lifted their shirts and showed us their scars covering a mangled mess inside. They brought medical records and X-rays. Most of all they wanted to share the hell they say they've all been through, including the frightening news some received from Aurora Medical Center alerting them they might have counterfeit medical parts surgically implanted.
These 12 are part of a much larger group of patients who started a Facebook page with more than 500 patients complaining about Cully White.
Neurosurgeons reportedly have the highest rate of medical malpractice lawsuits. A search of court records reveals Dr. White has been sued for malpractice at least nine times since 2004. One case alone reportedly settled for $3 million.
What these patients did not know was that at the time of some of their surgeries, Dr. White's competency was under investigation by Wisconsin's Medical Examining Board because of a complaint White operated on the wrong side of someone's back, a charge he denied.
Crime Watch Daily has uncovered other shocking revelations. In a disciplinary report, the medical board determined, in part, Dr. White had "difficulty processing information." And while the board found Dr. White demonstrated good knowledge of surgical technique, the board had concerns about his "foundational knowledge" of "neurosurgical spine conditions."
The report went on to say his "clinical judgment" ranged "from good to poor." It even questioned his "decision-making."
Worst of all, the Medical Examining Board concluded his "unprofessional conduct" tended "to constitute dangers to the health, welfare and safety of his patients."
Robyn Rockwell and Lori Moore, two former patients who met with Crime Watch Daily, were both operated on by Dr. White while all this was going on, and they say they had no idea the doctor was under investigation.
Just months before White took a scalpel to Rockwell's back, Dr. White was indicted by a federal grand jury on 13 counts of medical health care fraud involving fake insurance claims.
Rockwell had her surgery on November 4, and just two weeks later, on Nov. 20, Dr. White agrees to surrender his license. He stops practicing medicine altogether on December 17.
Five months after Rockwell's surgery, while she was still recuperating, the disgraced doctor pleaded guilty to one count of health care fraud. He was sentenced to six months in prison followed by six months of house arrest at his $3-million mansion on the water.
Crime Watch Daily tried to find Cully White to get his side of what happened, but we never saw him leave his home. In order to capture the grandeur of his mansion on the lake, we had to get a boat just to see it.
At his sentencing, court records show White told the judge he was "sorry," "embarrassed" and "made a horrible mistake," and just wanted to "improve the quality of my patients' lives."
We repeatedly asked White, and several of his attorneys to sit down for an interview. One attorney did call us back to remind us White was dropped from the larger lawsuit involving fake medical parts and had no further comment. But in court documents White repeatedly denies ever knowingly using counterfeit implantable hardware on any of his patients.
Despite his denial, those patients want White to feel their pain.
But this story of allegedly profiting off pain doesn't end here. These former patients are still in pain. And those who fear they may have fake medical parts still in their bodies face a terrible decision.
"Taking out the hardware and seeing if it's counterfeit is really the only way I would know that you could definitively see if it's fake hardware or not," said UCI's Dr. Charles Rosen.
Rosen fears these patients can't even rely on their medical records being accurate.
"It's definitely a red flag for a patient if in the surgical record it doesn't record what the implants were that were put in the body," said Dr. Rosen. "They have to be."
Visit the Association for Medical Ethics site, an organization consisting of physicians providing increased public awareness on medical issues. The AME Board of Directors and the AME members receive no remuneration for their efforts.