Some of the bogus screws cost $300 to make but were billed at as much as $12,500 each, records say. Sersansie found his way to Bill Reynolds, an insurance fraud investigator who had been probing the scam since 2009. He also posted photos of spinal implants on his photo-sharing website. Six Spinal Solution screw caps cost $2,850 but sold to a hospital. Williams filed for bankruptcy last year, claiming $12.6 million in liabilities, including a plane, yacht and $50,000 Mercedes-Benz. 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. Drobot was allegedly involved in the sale of counterfeit spinal surgery hardware by Spinal Solutions, a Murrietta, California based company. After the devastating 2010 earthquake in Haiti, Williams used his planes to deliver needed medical supplies, and Davis traveled with him. Lawsuits suggest that hundreds of individuals may have undergone spinal fusion surgery in recent years where fraudulent or counterfeit parts could have been implanted in their bodies,. Moses initial reaction on hearing about the apparent scam was fear because a few metal pieces remain in her back. I never wanted to have surgery. Ive spent five years trying to identify my screws, said Joshua Lash, a former Los Angeles deputy sheriff. I was telling (White) for a long time that I didnt think (Williams) was a very savory character, Sargent said. The guy can barely even walk. This stuff went all the way across the United States and, in my opinion, is a threat to public safety, Reynolds said. Its probably the worst example where fraud has progressed from being a financial crime to hurting people for profit, said Thomas Fraysse, an Oakland attorney on the case. Or in many of the other bags that Hwang inspected over two days of testimony. CIR reports that Williams spent money flamboyantly, following the Los Angeles Lakers all over the country, and maintaining a BMW, a Mercedes-Benz, a yacht, a private jet and a 6,300-square-foot home. And getting everything out is extremely dangerous, and, in some cases, impossible. The counterfeit screws present real risks for spinal surgery patients. Golia had seven counterfeit devices implanted in his spine, according to the suit. Richard Walker, the South African executive who discovered forgeries of his golden screws back in 2009, had toured the machine shop years ago. Northcutt said he briefly dealt with Spinal Solutions but found its products inadequate. Spinal Solutions couriered the counterfeit parts via private jet to ensure its parts would be used at the hospital, the complaint alleges. In spring 2013, Spinal Solutions recalled surgical equipment that wasnt properly labeled and some implants that didnt match FDA-approved designs. Arnold Neves Jr., a former attorney for Spinal Solutions, said of the allegations, I dont know anything about that.. LOS ANGELES Fifteen surgeons and 17 hospitals nationwide along with more than a dozen other people, are accused of participating in a counterfeit spinal-hardware ring that resulted in patients receiving non-FDA approved implants, according to a civil complaint obtained by America Tonight. This is obviously not what we did, Hwang said. Joshua Lash, a retired Los Angeles County sheriffs deputy, shows an X-ray taken after his spinal fusion surgery with what may be counterfeit hardware at his San Bernardino home on Tuesday, May 21, 2019. Another consultant who used the companys implants, Dr. Paul McDonough of Texas, received at least nine $8,000 checks in 2012 from Spinal Solutions, according to court records. This story was produced by The Center for Investigative Reporting, an independent, nonprofit newsroom based in the San Francisco Bay Area. The complaint unsealed Thursday asks for the establishment of a medical monitoring fund to cover the cost and expense of treating patients who may have had unnecessary surgeries, and who may have the fake parts implanted inside their bodies. Spinal Solutions, McGrath and the Surgeons Roger and Mary Williams, the owners of Spinal Solutions had marketing agreements with Randall and Michael "Mic" McGrath. According to the Center for Investigative Reporting (CIR), the mastermind behind Spinal Solutions counterfeiting schemes was Roger Williams, who founded the company and built it into an $18 million a year business. Pacific Hospital didnt use counterfeit implants. This step requires legal representation by an experienced medical malpractice attorney who understands how to make the strongest case possible for just compensation. Riverside Community Hospital in California is one of 17 hospitals nationwide named in a lawsuit unsealed Thursday, alleging that knock-off spinal implants were used in patients in California, Texas, Maryland, Wisconsin and Nevada. He also followed the Los Angeles Lakers all over the country. She also contributed to the OCR's Pulitzer Prize-winning investigation of fertility fraud at UC Irvine, covered what was then the largest municipal bankruptcy in Americas history, and is the author of "The Strangest Song," the first book to tell the story of a genetic condition called Williams syndrome and the extraordinary musicality of many of the people who have it. Spinal Solutions is also at the center of a 2012 lawsuit brought by patients who received spinal fusion surgery implants. A federal judge said that, because of the complexity of restitution, civil litigation may provide a more appropriate remedy for victims. 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. for engaging in a "systematic pattern of fraud and deceit, fueled by the payment of illegal kickbacks, designed to illegally profit from grossly inflating the charges for implantable medical hardware used in . I think they should all lose their licenses and go to jail and pay heavy fines, Lederhaus said. "Like you, through recent news reports, Aurora Health Care was made aware of a lawsuit involving former medical device distributor Spinal Solutions," said the letter to Jean Morin of Racine.. One of those attorneys strongly disagrees. Meanwhile, he said, Williams was pushing a product that was second-rate crap.. Ms. Moses told them This has been terrible, worst thing thats ever happened to menot knowing if the stuff still in me they couldnt get out will one day kill me. The FDA issued a warning letter to Roger Williams and Spinal Solutions in 2012 regarding the adulteration of certain spinal implant systems, and sent a list of objectionable conditions witnessed by FDA inspectors, including a lack of adequate quality control procedures and device history records, spokeswoman Alison Hunt said by email. Golia trusted his doctor to use medical implants approved by the Food and Drug Administration, his lawsuit states. Authorities allege that state senator Ronald Calderon took bribes from Michael Drobot, the former owner of Pacific Hospital in Long Beach. I wish I had been making thousands, but I didnt, he told CIR. Theres just a whisper of bone, ghostly and gray, in the X-ray image of Joshua Lashs spine. Neither man has admitted to producing the thousands of screws that plaintiffs believe Spinal Solutions sold to surgeons. It was so blatantly obvious to even the untrained eye. The FDA began investigating Spinal Solutions in 2011, when the sales representative reported that the company was counterfeiting hardware. For more, visit cironline.org. Assertions about criminal counterfeiting of hardware, when the hardware is in peoples bodies and record-keeping is as haphazard as its apparently been, are difficult to prove beyond reasonable doubt in court and are beyond the scope of the criminal proceedings, court filings assert. 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. He was paid $250,000 for one of the agreements, he said. And I saw these screws being shipped all over the United States, he said. The chance to break the rules and tap into this lucrative industry can be tempting, Lederhaus said, adding that he thinks more than just a lawsuit is needed to fight that temptation. Home; Uncategorized; spinal solutions lawsuit; Posted on January 19, 2023; By . And theres big money in the spinal hardware. Parkview Community Hospital, where Golia was treated, did not respond to questions by press time. Researcher Emily McKellar contributed to this story. And now these people in Wisconsin, in Texas, are walking around with time bombs in their bodies and they dont even know it.. Some doctors who used the bogus hardware took kickbacks including cash and private plane rides, while middlemen and hospitals profited by wildly inflating the cost of the screws, according to one suit filed in Sacramento. 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. To many, that doesnt seem like enough. Diagnostic facilities are accused of also taking kickbacks in return for false reports justifying the need for surgeries. The vertebrae spiral down, diffuse as smoke, until they reach a brutal and jagged conclusion: six stark-white images of screws embedded deep into bone, lashed together by metal rods. Please try again later or using a different browser. He wanted to see whether it could repair tools used to implant his firms hardware. You will not see all the features of some websites. It soon became apparent, Sersansie says, that unsavory things were happening. Crowder attached a one-year, $50,000 contract with the implant firm to his suit. Patients, though, may end up paying the steepest price. He added: If they are having problems, some of these may need to be replaced. According to the lawsuits, Spinal Solutions asked William Crowder, owner of Crowder Machine & Tool of Temecula, to make the rods and screws. 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. But neither has regrets. The doctor pleaded guilty to billing for nerve monitoring that didnt happen and was sentenced in April to six months in prison and six months on house arrest. She hoped to fashion them into a necklace, she said, as a symbol of the pain she had endured. The latest lawsuit accuses defendants of fraud and battery, saying the hardware has put the life of the patient, Arthur Golia of Riverside, at risk. WISN 12 News obtained court records that claim, "Spinal Solutions would pay defendant White unlawful kickbacks to surgically implant the counterfeit spinal hardware." The lawsuit also. On his YouTube page, Zavilenski boasts of owning a laser engraver. Like several other doctors, Wisconsin-based surgeon Cully White is accused of entering into a "sham design and development agreement with Spinal Solutions, which would then pay the surgeon a kickback in return of using the products. Some were blatantly inferior, he said, at times with metal shavings and burrs in the threads. But the dead giveaway was the logo, they said, which lacks the firms signature forward-leaning font. People are dying and no ones doing anything, Sersansie said. As a result of the intrusive nature of the operation, the surgical hardware cannot be removed without reversing the fusion and without significant risk of death or injury to the patient, says a lawsuit filed by Derika Moses of Riverside. They worked with authorities and, in 2012, filed whats known as a qui tam lawsuit a type of whistleblower suit brought under the False Claims Act that rewards whistleblowers when the government recovers funds lost to fraud. Testing confirmed his fears. And people remain in pain. Dr. Randy Davis said he didnt take any bags of cash or free vacations. (Courtesy of Joshua Lash), Joshua Lash, a retired Los Angeles County sheriffs deputy, shows an X-ray taken after his spinal fusion surgery with what may be counterfeit hardware at his San Bernardino home on Tuesday, May 21, 2019. He withdrew thousands of dollars from Spinal Solutions account to patronize strip clubs like the Spearmint Rhino Gentlemen's Club. He was convicted of misdemeanor domestic violence in 2013. Drobot, the memo said, was motivated by greed and ultimately profited millions of dollars through the scheme.. This is not only fraud, but a criminal offense, to say the least.. The Mayo Clinic warns that spinal fusion can be no more effective than nonsurgical treatments for some types of back pain. Derika Moses Los Angeles Superior Court case. Spinal Solutions completed a low-severity recall of some product due to a lack of labeling and use instructions in 2013, records show. Theyre so greedy, you cant believe it. Efforts to reach Williams were unsuccessful. 1. Toggle navigation. Drobot admitted to paying doctors kickbacks of up to $15,000 to operate in his hospital. It suggested she might be the victim of medical fraud. If you break this down to the core of right and wrong, it really is using people as pieces of meat to make money, said Santa Ana attorney Chris Purcell, who filed the Solomon case in Los Angeles Superior Court. Doctors around the world drive them into the vertebrae of patients with devastating back injuries. I had to know.. We just reported that these allegations are out there, said Brian Park, the companys New York attorney. All about greed.. Why arent these guys indicted? Garrison, Spinal Solutions private pilot, said he then reached out to the FDA at the sales reps suggestion, telling investigators he delivered screws in plastic bags labeled with felt-tipped pens. Williams sold hardware manufactured by a legitimate company, said Sargent, who took a 25 to 30 percent commission. I really believe that I do not make decisions for patients based on money, he said. And Sersansie said he and his family have suffered serious harassment and intimidation. This weekly current affairs program asks the tough questions others avoid and digs deep into issues affecting us all. Like you, through recent news reports, Aurora Health Care was made aware of a lawsuit involving former medical device distributor Spinal Solutions, said the letter to Jean Morin of Racine. He wore me down, Lash said of Simon Lavi, the surgeon he is suing. After making numerous phone calls, the rep set up a meeting with the FDA in June 2011. As a court reporter typed, a video camera rolled and a throng of attorneys scribbled notes, he peered through a magnifying glass, turning the screws this way and that. In desperation, Moses opted for spinal fusion surgery. Sargent said he didnt personally see most of the implants White used, but he had a spider sense that the doctor never implanted any bogus hardware. U&I is not alone in concluding that its product had been copied. It was edited by Amy Pyle and copy edited by Sheela Kamath and Nikki Frick. (Photo by Bill Alkofer, Contributing Photographer). Whites successful career faltered when he was hit with an unrelated federal indictment and medical board investigation last year. Hospitals allegedly turned a blind eye to the surgeon, the vendor and products in order to submit false and misleading billings to insurance companies. A court declaration from Williams brother-in-law says that Fields work was sloppy and that hed seen him use methamphetamines on the job. It doesnt surprise me. They dont have computerized machines, he said. But one former company insider says knockoff screws were mixed in with real ones. White amassed a $22 million fortune, then scammed insurance companies for a little more, prosecutors said. X-ray of Joshua Lashs spine. jim martin death couples massage class san diego beaver falls football spinal solutions lawsuit. The disturbing and bold allegations made in the lawsuit claims that a company called Spinal Solutions, based in California itself, and other parties were involved in manufacturing knock-off spinal hardware (which cost virtually nothing when compared to the original products) and then deliberately mixed up real and fake products and made it . Aria Sabit, spinal implant company Reliance Medical Systems, two Reliance distributorshipsApex Medical Technologies and Kronos Spinal Technologiesand the companies' owners, Brett Berry, John Hoffman and Adam Pike, the Justice Department Its not mine.. Lavi and other doctors and hospitals targeted by patient lawsuits who have not been charged in the federal criminal probe deny any wrongdoing, including knowingly using inferior product in surgeries. . They deserve some relief.. Crowder sued Spinal Solutions last July, saying the firm owed him $29,900 to machine, repair and prototype tools for doctors. Williams had an especially volatile relationship with his wife, Mary, whom he once described as the companys chief financial officer. Operation Spinal Cap is a mammoth federal health-care fraud investigation that began in 2013 and is so enormous that it continues today. 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. A genuine U&I product is sandblasted after manufacturing to remove metal burrs and debris, rendering the once-bright metal a darker gray, he said. A federal appeals court handed Medtronic Inc. (NYSE:MDT) a win in a patent infringement lawsuit filed by Synthes Inc. subsidiary Spine Solutions Inc. over . Fields did not respond to letters and Facebook messages. Spinal Solutions is also currently facing another lawsuit for significantly marking up the prices of their spinal hardware. This scheme has led to patients receiving dangerous medical implants that have a substantial likelihood of failure. In a statement, Dignity Health said that it has not seen evidence that any of the plaintiffs assertions apply to its St. Bernardine Medical Center. The FDA has been quite quiet, and hasnt done anything to support us. Her back popped, leaving the former softball star frozen in excruciating pain. We got a clean bill of health from them.. The allegations are false, he said. Instead, the case alleges, Dr. Jack Akmakjian used counterfeit implants in Golias back because he was being paid a kickback to do so. Harlands surgeon went to prison on unrelated health care fraud charges in 2014. The machine shop is now closed and the owner, who used to make parts for sailboats, is in poor health, said Crowders lawyer, Alan Mohill. Nor was the hardware in Bag No. I just want some justice for these people. Company engineers noted the finishes and lot numbers on some of Moses screws and connectors did not match their product. I cant. I have no idea whats going on inside me.. He started Spinal Solutions in 1999 and launched a firm selling knee and hip implants three years later. She earned her M.F.A. Law firms in the Bay Area and Los Angeles plan to continue to file cases on behalf of people with counterfeit implants studding their backs. Drobots sentencing is scheduled for December, according to news reports. A few years ago, Crowder stopped making the screws because Spinal Solutions was unwilling to pay a fair price, he said. If I had a surgery that used a component from that workshop, Id be worried.. Sersansie is a whistleblower in spinal surgery fraud cases. The insurance carriers object to paying to reverse the surgery. She referred CIR to her attorney, who declined to comment. I also impressed upon her, you need to go sirens blazing and door-kicking and stop this, the sales rep said. Then theres the U&I logo itself. This is all about money. There are thousands of patients out there who arent getting help. All I do I take advantage of their greed, Garrison told CIR. The company is the exclusive manufacturer of its surgical-grade, U.S. Food and Drug Administration-registered spinal hardware used in many surgeries here in America. (Photo by Watchara Phomicinda, The Press-Enterprise/SCNG), Derika Moses Los Angeles Superior Court case, College Medical Center, formerly Pacific Hospital of Long Beach, is a community-based teaching hospital located in Long Beach, California. Follow them on Twitter: @JewettCIR and @willCIR. There are 17 hospitals and 15 physicians named in the lawsuit. But Lashs diagnosis grew more and more grim over the course of a year. She earned her M.F.A. 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. Calderon has been indicted in a corruption case accused of taking about $100,000 in bribes. 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. Eager for relief, Moses had the surgery at Riverside Community Hospital in 2008. Additionally, various pieces had oddities and inconsistencies in the tracking numbers. The FDA cited Spinal Solutions in 2012 for a variety of quality control violations. I wanted to go back to work. Hes just a small little machine shop.. David Solomon had these screws removed from his back. A private jet was also used to deliver the parts, according to the complaint. From nothing, he built an $18 million-a-year business based in Murrieta, California. The lawsuit alleges Dr. Davis received $458,962, primarily in consulting fees, and the hospital purchased more than $1 million in Spinal Solutions hardware. Doctors who were Williams clients deny using substandard hardware, but CIR quotes an anonymous sale representative who claimed that he saw inferior screws: You couldnt ignore that they were counterfeit. (Photo by Watchara Phomicinda, The Press-Enterprise/SCNG). Zero-calorie sweetener linked to heart attack and stroke, study finds, Fountain Valley collision leaves one driver dead, another hospitalized, OC sheriffs deputies foil attempted jail escape, SoCalGas unveils $10 million to help customers hit by high prices, Thousands in Southern California are expected to lose out on Medi-Cal after April, Status Update: Life Time country club gym opening in Irvine, Chicago Mayor Lori Lightfoot concedes defeat, Denver just got a direct flight to this Caribbean island known for music history and vegetarian cooking, NYC Mayor Adams dismisses need to separate church and state, declares himself a servant of God, Zero-calorie sweetener linked to heart attack and stroke, study finds, Do Not Sell/Share My Personal Information. Mark Sersansie might be forgiven for often looking over his shoulder. Calderon pleaded guilty to corruption and was sentenced to 3 1/2 years in federal prison in 2016. Williams and Spinal Solutions have been named in scores of lawsuits, but attorneys have been unable to serve him the court paperwork. 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. There were a couple of people who put the FDA on the scent early on, said Berger, the attorney for Reynolds and Sersansie. 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. The company shut down, and owner Williams filed for bankruptcy that same year. McDonough did not respond to repeated phone calls and a list of questions faxed to his Abilene office. Then, crippled by debt, it shut down. More than $1 million in sales were made to Baltimore Washington Medical Center, according to the filing, although it's unclear over what period of time. During an interview at the companys U.S. office in Orange County, California, General Manager Sung Hwang identified three of Moses four screws as fakes. The DOJ said it has been doggedly pursuing the criminal threads in this case. The procedure offered little relief: Chronic pain and infections plagued her. The screws also might loosen or fail. (Photo by Brittany Murray / Press Telegram). Once, Derika Moses was a force to be reckoned with on the softball field. He told CIR that she did not ask for samples of screws or talk about implants. Northcutt recalls seeing one Spinal Solutions representative pull up to a doctors office in a gleaming white Rolls-Royce and hearing that the company ferried its goods by private plane. Federal regulators sent Spinal Solutions a warning letter in early 2012, ordering the company to fix its quality control problems. In the flood of civil lawsuits against doctors and hospitals in Los Angeles, Riverside and San Bernardino counties, patients say copycat spinal screws and hardware manufactured in an unsanitary machine shop in Temecula, mixed with genuine product and then shipped for surgeries all over the country may be inside them. The accused hail from Manhattan Beach, Newport Beach, Redondo Beach, Palos Verdes Estates, Santa Ana, San Clemente and many other cities. Roger Williams lured them with private plane rides, generous consulting contracts and even cash, interviews and records show. The latest lawsuit, filed in mid-June in Los Angeles, says the knockoff spinal implants could harm patients because they could get an infection or react to metal that is not surgical grade. The United States has filed two complaints under the False Claims Act against Michigan neurosurgeon Dr. If the engineer designed them wrong then thats his fault. Many patients received spinal fusion surgeries that utilized counterfeit screws and rods, placing patients lives at risk, and subjecting them to further surgeries to replace the counterfeit hardware.. When the set came in, I said theres no way Im bringing this into the hospital, Sargent said. 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. Sign up for our daily newsletter. Theyre so greedy, you cant believe it. Spinal Solutions could not have raked in millions or spread its products across the U.S. if not for doctors eager to do business. Trent Northcutt, chief executive of Aurora Spine in Carlsbad, said devices like rods and screws are relatively simple to make. The screws didnt look like the other ones, said the sales rep, who declined to be identified out of fear of retribution. In a nutshell, what he is doing is firstly introducing the genuine registered article (our product) for a period on which he defaults on payment, and when this source dries up he substitutes the product with counterfeits and cheap inferior Asian products under the genuine product FDA registration, Walker continued. The company increasingly relied on Lenders. Spinal Solutions LLC is the company accused of . Thomas Mansor, an independent contractor who worked for Spinal Solutions and attended surgeries with their products, said the allegations sound bogus. Mansor said he went to Crowders machine shop for repairs on tools like screwdrivers. The FDAs website shows the inspector ended a review on July 30, 2012, and did not call for any changes. 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. To learn more about how we use your information, please read our privacy policy. The couples taxable income topped $5 million each year. Thats how it came to be that, in February, Sung Chul Hwang carefully placed screws that were once in Moses spine on a clean white cloth in a Los Angeles law office. All rights reserved. CBS Los Angeles reports that in total, there are 32 pending lawsuits against the perpetrators of the health care fraud scheme. It has known security flaws and a limited feature set. Why would I be worried? he said. Company engineers examined those photos at the request of CIR and reported that none looked authentic. On another, Garrison said he handed a doctor a bottle of wine in a canister packed with $100 bills. Whether a spinal injury results from a car accident, a fall, or some other cause, the impact on the lives of spinal injury victims and families can be devastating -- and the lifetime medical costs associated with spinal injury can be enormous. No, that was not a genuine U&I product, either. Thats not how things have worked out for Lash, a former Los Angeles County sheriffs deputy, or for dozens of others who say theyre collateral damage in Operation Spinal Cap, the $1 billion medical-fraud investigation that has led to federal charges against more than a dozen Southern California doctors, chiropractors, hospital administrators and others but to no relief for them. 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. The U.S. Department of Justice says it involved some $40 million in illegal kickbacks to doctors, chiropractors, marketers and other medical professionals. Operation Spinal Cap is a mammoth federal health-care fraud investigation that began in 2013 and is so enormous that it continues today. Crowder also said he didnt etch anything on the screws he made for Spinal Solutions. 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