Update, March 9, 2015: California attorneys suing Spinal Solutions for making counterfeit screws are gearing up to file another 25 lawsuits on behalf of individual patients in the coming months, adding to the 32 already pending. But they faced a setback last month when a Los Angeles County Superior Court judge threw out allegations of a conspiracy involving multiple hospitals. Meanwhile, lawyers still can’t find the former head of Spinal Solutions, Roger Williams, to serve him with court papers. It’s unclear what he plans next, but a new “Reveal” radio report adds an intriguing detail: The last time Maryland surgeon Dr. Randy Davis heard from him, Williams was pitching a medical technology project in American Samoa.
With a metallic clatter, evidence of an elaborate scheme to enrich a few landed in the receiving room of Richard Walker’s surgical supply firm in South Africa.
Although the true extent of the caper remains buried in the necks and backs of people scattered around the U.S., it began to unravel that day in 2009.
Ortho Sol makes precision screws for the most delicate of construction projects: spinal fusion. Doctors around the world drive them into the vertebrae of patients with devastating back injuries.
The company had repossessed some of its screws after one U.S. distributor – Spinal Solutions LLC – stopped paying its bills. But now, nestled with the returns, the brighter yellow luster of a few screws caught Walker’s eye.
Testing confirmed his fears. Some were not made of his firm’s medical-grade titanium. Their uneven threads showed potential for backing out or breaking, he said. He feared the laser-etched markings intended to make them look authentic could be toxic to patients.
Walker’s conclusion: The Southern California firm was knocking off his products.
Yet it would be two more years before an employee of Spinal Solutions alerted the U.S. Food and Drug Administration to the counterfeiting, and even then, the agency didn’t shut down the company.
By the time Spinal Solutions went broke in 2013, the company had sold millions of dollars in implants to a nationwide network of surgeons, The Center for Investigative Reporting has found.
Now patients are left with more questions than answers.
“What do they do if they find out there are these bogus parts that can come unscrewed?” said Susan Reynolds, a Riverside County, California, woman whose doctor used Spinal Solutions screws on her in 2009, following years of intractable pain. “I’m a walking time bomb.”
The man at the center of the scandal is a company president who indulged in luxury – private planes, strip club spending sprees, courtside seats at L.A. Lakers games – as the company collapsed into debt. Attorneys lined up to serve him with legal documents now say they can’t find him.
The company sold its wares to doctors who received consulting deals from Spinal Solutions worth thousands per month, rides on company planes, even bundles of $100 bills, company insiders allege. In turn, the physicians ordered the company’s implants for their surgeries at hospitals in California, Nevada, Texas, Wisconsin and Maryland.
Surgeons insist they never used subpar implants, and CIR has no evidence the doctors were involved in the scheme. But one former company insider says knockoff screws were mixed in with real ones.
An elderly machinist finds himself unexpectedly wrapped up in the scandal. In an interview with CIR, he admitted to making scores of copies of surgical screws for Spinal Solutions. The company bargained him down to $65 a screw – less than half of what they usually cost.
The screws, real or fake, all funneled into what lawsuits claim was a larger scheme to bilk California’s workers’ compensation system, an employer-funded program designed to help those injured on the job. Some hospitals billed insurance carriers as much as $12,500 a screw before a 2012 change in state law shut down the astronomical markups. From that, Spinal Solutions stood to reap several thousand dollars from the sale of a single screw.
Patients, though, may end up paying the steepest price.
Patient’s hardware raises questions
Derika Moses hefted a case of 2-liter soda bottles while setting up a grocery store display in 2007. Her back popped, leaving the former softball star frozen in excruciating pain.
Nothing helped. In desperation, Moses opted for spinal fusion surgery.
The procedure offered little relief: Chronic pain and infections plagued her. Five years later, she had most of her spinal hardware removed, convinced that the erector set of metal in her spine was the source of ongoing problems.
She begged hospital staff to let her keep the rods and screws. She hoped to fashion them into a necklace, she said, as a symbol of the pain she had endured.
A nurse slipped them under her pillow.
Moses, 38, of Riverside, had all but forgotten the bag of hardware until she received a letter from an Oakland, California, law firm in March. It suggested she might be the victim of medical fraud.
“I had to know if I was part of it,” Moses said. “I had to know.”
Attorneys contacted Moses after finding her name among Spinal Solutions’ sales records. The law firm, Knox Ricksen, is working with other firms to file lawsuits – more than 30 and counting – on behalf of Moses and other patients. The lawyers accuse Spinal Solutions of selling counterfeit implants and doctors of accepting kickbacks in return for using them.
Spinal screws are not Home Depot fare. The implants must fit together precisely to support a body in motion, said UCLA neurosurgeon Dr. Duncan McBride.
“It’s like building a bridge in the back of someone’s spine. So if you have inferior material, it’s not going to work as well,” he said. “It’s going to be less successful and potentially harmful.”
CIR showed photos of Moses’ hardware to U&I Corp., the South Korean company whose logo was etched on it.
Company engineers noted the finishes and lot numbers on some of Moses’ screws and connectors did not match their product. But the dead giveaway was the logo, they said, which lacks the firm’s signature forward-leaning font.
During an interview at the company’s U.S. office in Orange County, California, General Manager Sung Hwang identified three of Moses’ four screws as fakes.
“This is obviously not what we did,” Hwang said. “I feel sorry because (patients) got the surgery with improper devices, so they might suffer from it.”
Hwang said the company first heard about Spinal Solutions’ counterfeiting from plaintiffs’ attorneys in 2012 and is not happy about the matter.
Moses’ initial reaction on hearing about the apparent scam was fear because a few metal pieces remain in her back. But she says her feelings changed as she learned more from her attorneys about kickbacks that Spinal Solutions is accused of paying to doctors.
“It always, always turns to anger,” she said, “every time I sit and think about what they did.”
Moses lost her job, and then her home, as she grappled with pain and illness after her spinal surgery. The flashy businessman who sold her implants, meanwhile, lived a life of luxury.
An executive’s lavish lifestyle
One private plane wasn’t enough for the Spinal Solutions founder. Roger Williams had three.
Williams spent 16 years in the orthopedic sales business with his father before he went out on his own. He started Spinal Solutions in 1999 and launched a firm selling knee and hip implants three years later. From nothing, he built an $18 million-a-year business based in Murrieta, California.
By 2008, his planes were shuttling staff and surgical equipment from coast to coast. He also followed the Los Angeles Lakers all over the country.
He ordered his seven-seat jet painted with stripes of Lakers purple and gold, and he and his wife sat courtside among celebrities, according to interviews with former employees. Sometimes he invited a member of the team onboard.
“He lived like the richest guy on earth. Like a movie star or something,” said Andreas Leuthold, a pilot who worked for Williams.
Williams and his wife had a BMW, a Mercedes-Benz, a yacht named “Spare Change” and a 6,300-square-foot Murrieta home, according to court records and interviews.
He withdrew thousands of dollars from Spinal Solutions’ account to patronize strip clubs like the Spearmint Rhino Gentlemen’s Club. When creditors later asked why, he said, according to court transcripts, “Because I felt like it.”
But Spinal Solutions also racked up big debts with hardware manufacturers and then refused to pay, according to industry executives and lawsuits.
The company increasingly relied on Lenders Funding LLC, a firm that fronted cash at an interest rate of 35 percent. By 2013, the company owed the lender about $35,000 per month – solely in interest payments – and imploded in debt.
It remains unclear when Spinal Solutions began to counterfeit surgical implants. And it is nearly impossible to trace each knockoff to each patient or to confirm how many were affected.
In a line of business built on meticulous order, the inner workings of Spinal Solutions were a study in disorder.
Take Operations Manager Jeff Fields, whom Williams called “my main guy.” Fields was in charge of the company’s inventory of surgical implants.
A court declaration from Williams’ brother-in-law says that Fields’ work was “sloppy” and that he’d seen him use methamphetamines on the job. Fields did not respond to letters and Facebook messages. When reached by phone, he said, “I’ve got no interest in speaking to anybody,” and hung up.
The brother-in-law, Carl Sisler, was Spinal Solutions’ first employee and knows more about the company than anyone else, Williams said in a court filing. Sisler is described as a “Medical/Surgical instrument technician” in his own court declaration.
But Sisler denied being an instrument technician and told CIR he was in prison for domestic violence for many years of the company’s run. Sisler’s convictions also included making a terrorist threat and indecent exposure, but he was paroled in 2008, according to prison records.
“I was a nobody there,” Sisler insisted in a telephone interview, during which he slurred his words and acknowledged he was drunk. “I was the gofer guy who made $285 a week cleaning toilets.”
Williams, meanwhile, accused his bookkeeper of sabotage and embezzlement in a court declaration and said the books never were made right.
Williams had an especially volatile relationship with his wife, Mary, whom he once described as the company’s chief financial officer. He was convicted of misdemeanor domestic violence in 2013.
The IRS determined the Williamses underpaid their taxes by a combined half a million dollars due to fraud in 2009 and 2010, according to court filings. The couple’s taxable income topped $5 million each year.
Mary Williams filed an appeal to the IRS in tax court last year, blaming her “controlling, abusive” husband for the problem.
She referred CIR to her attorney, who declined to comment.
The company’s records got caught in the crossfire. In a deposition related to creditors, she described getting law enforcement to open the Spinal Solutions offices so she could take hard drives.
“Half of the stuff is gone because my wife took it, you know,” Roger Williams said during a bankruptcy-related hearing.
Flying screws, doctors and cash
Spinal Solutions could not have raked in millions or spread its products across the U.S. if not for doctors eager to do business.
Roger Williams lured them with private plane rides, generous consulting contracts and even cash, interviews and records show.
Williams did not respond to calls, emails or letters from CIR.
Williams made it clear the consulting deals and free flights were tools to keep doctors hooked on his products, said Quin Rudin, a businessman who poured money into the company when it hit a cash crunch in 2012.
“He said that many times. ‘In order to do business with these guys, I gotta take care of them,’ ” Rudin recalled from behind thick glass in a downtown Oakland jail, where he landed after pleading guilty in an unrelated fraud case.
Pilot Bob Garrison enjoyed a bird’s-eye view of the shenanigans, flying screws and doctors and cash.
“Roger told me …, ‘These doctors are greedy. They’re so greedy, you can’t believe it. All I do … I take advantage of their greed,’ ” Garrison told CIR.
On one occasion, Garrison said Williams had him hand one out-of-state doctor an envelope stuffed with $20,000 in cash. On another, Garrison said he handed a doctor a bottle of wine in a canister packed with $100 bills.
One Spinal Solutions sales representative said he suspected Williams was using perks to woo surgeons.
“He said that any doctor that I could bring on board would be taken care of,” said Robert Ashcraft, who worked for Spinal Solutions in Nevada. Meanwhile, he said, Williams was pushing a product that was “second-rate crap.”
One busy spinal surgeon, Dr. Cully White of Pewaukee, Wisconsin, took breaks from his suburban mansion on Spinal Solutions plane trips to the snowy resort town of Vail, Colorado, and the sunny Mexican beach retreat of Cabo San Lucas.
The doctor’s longtime sales representative, John Sargent, went along for the rides in 2007 and 2008. Sargent said they went skiing in Vail and fishing in Cabo but also talked business. He encouraged White to reimburse the company, he said, but doesn’t know if White did.
“I was telling (White) for a long time that I didn’t think (Williams) was a very savory character,” Sargent said.
Williams sold hardware manufactured by a legitimate company, said Sargent, who took a 25 to 30 percent commission. But he did recall that Spinal Solutions once sent a set of implants without labels.
“When the set came in, I said there’s no way I’m bringing this into the hospital,” Sargent said. “It just didn’t look like what you know it’s supposed to look like.”
In more than a dozen operative reports from 2010 and 2011, White noted that the screws he put into patients’ backs came from Spinal Solutions, according to documents obtained by CIR.
Sargent said he didn’t personally see most of the implants White used, but he had a “spider sense” that the doctor never implanted any bogus hardware.
White’s successful career faltered when he was hit with an unrelated federal indictment and medical board investigation last year.
White amassed a $22 million fortune, then scammed insurance companies for a little more, prosecutors said. The doctor pleaded guilty to billing for nerve monitoring that didn’t happen and was sentenced in April to six months in prison and six months on house arrest. He didn’t respond to letters sent to his Minnesota prison.
Wining, dining and flying surgeons used to be commonplace in the medical technology industry, said David Rothman, director of the Center on Medicine as a Profession at Columbia University. The practice has faded in recent years, he said, with government scrutiny, new transparency rules and growing awareness that gifts create a psychological obligation to give back.
“The company that takes you out to dinner is the company that you’re going to favor one way or another,” Rothman said.
Dr. Randy Davis said he didn’t take any bags of cash or free vacations. The Baltimore-area spine surgeon did once accept a seat close to actor Jack Nicholson at a Lakers game with Roger Williams but told CIR, “I can’t stand basketball … that’s the worst thing you could bribe me with.”
Davis said Williams was a fast-talking pitchman who persuaded him to sign up for Spinal Solutions’ implants, which he estimated he used in several hundred surgeries, and for consulting agreements to develop new surgical tools and implants. He was paid $250,000 for one of the agreements, he said.
The money didn’t affect Davis’ use of the implants, he said. “I really believe that I do not make decisions for patients based on money,” he said.
The counterfeiting claims don’t ring true to him, either. He said he never received any substandard implants.
After the devastating 2010 earthquake in Haiti, Williams used his planes to deliver needed medical supplies, and Davis traveled with him.
The doctor believed Williams was doing good things, he said, and thought the ideas he offered as a Spinal Solutions consultant would help patients. But Davis said he grew frustrated by the lack of progress on his projects and eventually ended the five-year relationship in late 2012.
Another consultant who used the company’s implants, Dr. Paul McDonough of Texas, received at least nine $8,000 checks in 2012 from Spinal Solutions, according to court records. McDonough helped create an implant prototype, but in the end, “nothing happened to it,” Williams said in court testimony.
McDonough did not respond to repeated phone calls and a list of questions faxed to his Abilene office.
Consulting deals are common in the medical field and are legitimate if the physician provides a meaningful service for a reasonable compensation. But whistleblowers and prosecutors have gone after top device firms over phony agreements, claiming they amount to kickbacks.
Williams’ ability to connect with surgeons across the country meant that when counterfeit hardware slipped into the mix, the problem went national, according to one company insider.
The former sales representative remembers watching another employee pluck a few screws from a tray in the company warehouse for shipping to an out-of-state surgery.
The screws didn’t look like the other ones, said the sales rep, who declined to be identified out of fear of retribution. He grabbed a few to examine them. Some were blatantly inferior, he said, at times with metal shavings and burrs in the threads.
“And I saw these screws being shipped all over the United States,” he said.
Employee alerts FDA
The sales rep grew increasingly disturbed thinking about patients waking up from surgery with what he described as garbage in their spines.
“To do that to somebody when they’re already experiencing tremendous pain, then to take a counterfeit screw so your (profit) margins are more, especially a poorly crafted counterfeit screw. … It was just so ridiculous,” he said.
The authorities would surely shut down the operation, he thought, if they only knew.
After making numerous phone calls, the rep set up a meeting with the FDA in June 2011. He described how he spread out an array of questionable screws for FDA investigator DeJon Harris on a table at Coco’s Bakery Restaurant in Corona, California.
“I also impressed upon her, you need to go sirens blazing and door-kicking and stop this,” the sales rep said. “Every day you guys don’t do something, some loved one is getting these fucking screws put in their spine.”
The sales rep said he gave Harris screws to take back to the FDA district office in Ontario, California. “You couldn’t ignore that they were counterfeit,” he said. “It was so blatantly obvious to even the untrained eye.”
In cases of alleged counterfeiting, the FDA could bring in its Office of Criminal Investigations or call the FBI, spokesman Christopher Kelly said. The agency did not answer questions about whether either happened with Spinal Solutions, citing an ongoing investigation.
Garrison, Spinal Solutions’ private pilot, said he then reached out to the FDA at the sales rep’s suggestion, telling investigators he delivered screws in plastic bags labeled with felt-tipped pens.
“Whether they were legal or not … I don’t know,” Garrison said.
The month after the meeting with the sales rep, Harris and another FDA investigator inspected Spinal Solutions’ headquarters, FDA records show, and encountered a company in disarray.
The firm was assembling kits with dozens of screws, rods and other components without any formal process or paperwork to indicate what went where, inspection records say. Required systems for setting aside flawed products and preventing mix-ups didn’t exist.
Federal regulators sent Spinal Solutions a warning letter in early 2012, ordering the company to fix its quality control problems. The company pledged to make changes.
Around that time, U&I Corp., the South Korean medical hardware firm, alerted the FDA that it was hearing from plaintiffs’ attorneys that Spinal Solutions was counterfeiting hardware.
“We just reported that these allegations are out there,” said Brian Park, the company’s New York attorney. “Do something.”
But the FDA allowed Spinal Solutions to continue selling its products while the company tried to shape up, court filings show. If the agency found evidence of counterfeiting, it didn’t mention it in documents provided to CIR under the Freedom of Information Act.
In spring 2013, Spinal Solutions recalled surgical equipment that wasn’t properly labeled and some implants that didn’t match FDA-approved designs. Then, crippled by debt, it shut down.
But by then, Spinal Solutions had profited from a 14-year run, and its hardware studded the backs of patients from Los Angeles to Baltimore.
The source of the counterfeits, plaintiffs’ attorneys allege, was 85-year-old machinist William Crowder. He owns a small office park machine shop in Southern California’s Inland Empire. He had experience working on parts for boats, planes and, it appears, the human body.
In an interview with CIR, Crowder said Spinal Solutions’ operations manager, Jeff Fields, gave him professional-looking medical screws and asked for exact copies.
“He might want 50 of this size and 40 of these,” said Crowder, who has been named as a defendant in dozens of lawsuits.
Plaintiffs’ attorneys believe that thousands of counterfeit screws went into unsuspecting patients, though Crowder testified in a recent deposition to making “maybe 500.”
“I wish I had been making thousands, but I didn’t,” he told CIR.
A few years ago, Crowder stopped making the screws because Spinal Solutions was unwilling to pay a fair price, he said. His doctor, he added, had been after him for years to quit work anyway.
A consultant hired by Spinal Solutions to help the company meet FDA requirements also found that Crowder’s machine shop did not qualify as a supplier, in part because his tools were not calibrated.
Richard Walker, the South African executive who discovered forgeries of his golden screws back in 2009, had toured the machine shop years ago. He wanted to see whether it could repair tools used to implant his firm’s hardware. Walker rejected the shop on appearance alone.
“It wasn’t conducive to the manufacture or taking care of medical products,” Walker told CIR. “If I had a surgery that used a component from that workshop, I’d be worried.”
There was some “old stuff” in his shop, Crowder acknowledged, but also modern equipment and a quality control system.
His memory is faltering these days, Crowder said, but he recalled that a woman from the FDA spent two days in his shop a few years ago. He told CIR that she did not ask for samples of screws or talk about implants.
“No, she didn’t say nothing about that. No,” he said. “We got a clean bill of health from them.”
The FDA’s website shows the inspector ended a review on July 30, 2012, and did not call for any changes. CIR filed a Freedom of Information Act request for the report, but the agency has failed to provide it or answer questions about the scope of the review.
Crowder also said he didn’t etch anything on the screws he made for Spinal Solutions. Instead, that trail seems to lead to another Spinal Solutions contractor, Ryan Zavilenski.
On his YouTube page, Zavilenski boasts of owning a laser engraver. He also posted photos of spinal implants on his photo-sharing website.
From behind the screen door of his Santa Rosa, California, apartment, Zavilenski confirmed that he did laser engraving for Spinal Solutions several years ago. He said he engraved only a few screws, however, which he called prototypes.
The photos Zavilenski posted online included implants with other company markings etched on them. He didn’t engrave those, he said, but instead photographed items he found at Spinal Solutions to demonstrate to potential customers the kind of work he could do.
A few of the photos he posted included screws bearing the markings of U&I, the South Korean company that once supplied Spinal Solutions. Company engineers examined those photos at the request of CIR and reported that none looked authentic.
“Font, logo, edge finish, surface finish … everything is different from ours,” said Sung Hwang, the general manager.
Crowder said the screws in Zavilenski’s photos looked similar to the ones he made, but not quite the same. The ones Crowder recalls making also were prototypes, he believed. Still, he said he would not be worried if they ended up in people’s backs and necks.
“Why would I be worried?” he said. “If the engineer designed them wrong then … that’s his fault. It’s not mine.”