Diagnostic facilities are accused of also taking kickbacks in return for false reports justifying the need for surgeries. 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. Record-keeping issues, and the apparent mix of genuine and other product, make it hard for people to know exactly whats inside them, giving them doubts about any reassuring news. Six Spinal Solution screw caps cost $2,850 but sold to a hospital for $17,370, which then turned around and charged an insurance carrier $49,260. Williams had an especially volatile relationship with his wife, Mary, whom he once described as the companys chief financial officer. 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. Golia had seven counterfeit devices implanted in his spine, according to the suit. Whites successful career faltered when he was hit with an unrelated federal indictment and medical board investigation last year. A consultant hired by Spinal Solutions to help the company meet FDA requirements also found that Crowders machine shop did not qualify as a supplier, in part because his tools were not calibrated. Sign up for our daily newsletter. Those named are located in Nevada, California, Texas, Wisconsin and Maryland. It was just so ridiculous, he said. Separately, the Medical Board of California accused Akmakjian in April of injecting unsafe amounts of steroids in patients and overprescribing drugs. He added: If they are having problems, some of these may need to be replaced. 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. He wore me down, Lash said of Simon Lavi, the surgeon he is suing. Pilot Bob Garrison enjoyed a birds-eye view of the shenanigans, flying screws and doctors and cash. 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. 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. By 2013, the company owed the lender about $35,000 per monthsolely in interest paymentsand imploded in debt. The industry has seen significant growth in sales, going from $250 million in 1994 to $7 billion in 2009, according to Orthopedic Network News, an industry newsletter. He might want 50 of this size and 40 of these, said Crowder, who has been named as a defendant in dozens of lawsuits. It targets a scheme that stretched over 15 years and. One of the screws broke, requiring David Solomon to undergo a second surgery in 2013. With a metallic clatter, evidence of an elaborate scheme to enrich a few landed in the receiving room of Richard Walkers surgical supply firm in South Africa. She held records in track and field at her Riverside high school. Attempts to reach Williams were unsuccessful. "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.. The companys records got caught in the crossfire. Take Operations Manager Jeff Fields, whom Williams called my main guy. Fields was in charge of the companys inventory of surgical implants. 100% Free evaluations. Whether they were legal or not I dont know, Garrison said. In February, the Department of Justice reported that Michael Drobot, a former Pacific Hospital executive, pleaded guilty to charges that he ran a long-running health care fraud scheme that involved tens of millions of dollars in illegal kickbacks in exchange for referrals of thousands of patients who received spinal surgeries. Calls to Davis were not returned. Production of the counterfeit rods and cages began in 2007 at a machine and tool shop in Temecula, California, according to the complaint. The document, which was filed in February in California on behalf of dozens of insurance companies, was unsealed Thursday and details a massive alleged health care fraud scheme and conspiracy involving the use and billing of fake surgical hardware to hospitals and doctors across the country. According to that May 2012 suit, they were the collateral damage of a massive scheme to defraud insurers, involving Drobot, former owner of Pacific Hospital of Long Beach. This is not only fraud, but a criminal offense, to say the least.. TechKnow is a fast-paced show that explores how the latest scientific discoveries are changing our lives. Thats been a huge question in my mind for many years., Reynolds, the fraud investigator, has a simple theory. There is something wrong with me, said Lash, gazing thin-lipped at the X-ray of the screws embedded into his bone. Actual U&I hardware bears the letters in a forward-leaning italic font. Eager for relief, Moses had the surgery at Riverside Community Hospital in 2008. He told CIR that she did not ask for samples of screws or talk about implants. Stay in touch. He started Spinal Solutions in 1999 and launched a firm selling knee and hip implants three years later. Get Legal Support From an Experienced Medical Malpractice Attorney I lost my career at age 41, he said. Authorities allege that state senator Ronald Calderon took bribes from Michael Drobot, the former owner of Pacific Hospital in Long Beach. And people remain in pain. The accusations struck at the very morality of our integrity and ethics, Grover said in a statement earlier this month. Efforts to reach Williams were unsuccessful. But for them to be designated as surgical grade requires FDA approval, biomechanical tests and liability insurance that add to the costs. The screws also might loosen or fail. But the agony didnt subside and she suffered painful complications as well, according to her lawsuit. The FDA has been quite quiet, and hasnt done anything to support us. The accused hail from Manhattan Beach, Newport Beach, Redondo Beach, Palos Verdes Estates, Santa Ana, San Clemente and many other cities. The man at the center of the scandal is a company president who indulged in luxuryprivate planes, strip club spending sprees, courtside seats at L.A. Lakers gamesas the company collapsed into debt. Crowder won a judgment against Spinal Solutions because it did not respond to the suit. Neither man has admitted to producing the thousands of screws that plaintiffs believe Spinal Solutions sold to surgeons. Golia trusted his doctor to use medical implants approved by the Food and Drug Administration, his lawsuit states. To protect that stream of cash, Drobot bribed then-state Sen. Ronald Calderon to protect a now-repealed state law allowing hospitals to pass the full cost of spinal surgery implants on to workers comp insurers. From nothing, he built an $18 million-a-year business based in Murrieta, California. Money. But whistleblowers and prosecutors have gone after top device firms over phony agreements, claiming they amount to kickbacks. 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. Six Spinal Solution screw caps cost $2,850 but sold to a hospital. And it has been agony ever since. I just want some justice for these people. Unfortunately, the U.S. Attorneys Office only focused on the fraud, not on the patients, he said. Those kickbacks were largely financed by money generated from a separate Drobot company, which sold the medical devices implanted into patients during spinal surgeries, prosecutors said. Jewett can be reached at cjewett@cironline.org, and Evans can be reached at wevans@cironline.org. (Photo by Bill Alkofer, Contributing Photographer). The operation is risky and invasive. Spinal Solutions, McGrath and the Surgeons Roger and Mary Williams, the owners of Spinal Solutions had marketing agreements with Randall and Michael "Mic" McGrath. This story was produced by The Center for Investigative Reporting, an independent, nonprofit newsroom based in the San Francisco Bay Area. Our "Rehab Riviera" coverage won first place for investigative reporting from the California Newspaper Publishers Association, first place for projects reporting from Best of the West and is a finalist for the National Institute for Health Care Management Foundation's print award, competing with the New York Times, the Washington Post and ProPublica. The patients believed that they were receiving conflict-free medical advice when, in fact, (Drobot) illegally incentivized their physician to perform the surgery at Pacific Hospital, prosecutors said in court documents. 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. 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. 25 Feb/23. Its horrifying to me that this could still happen in this day and age.. He described how he spread out an array of questionable screws for FDA investigator DeJon Harris on a table at Cocos Bakery Restaurant in Corona, California. He was paid $250,000 for one of the agreements, he said. Or in many of the other bags that Hwang inspected over two days of testimony. On another, Garrison said he handed a doctor a bottle of wine in a canister packed with $100 bills. The suit also named one of the hospital's spinal surgeons, Dr. Randy Davis. In an avalanche of lawsuits, more than 160 patients contend that cheap, nonsurgical-grade hardware may have been drilled into their bones during operations that might not have been necessary to begin with, leaving them in excruciating pain. All I do I take advantage of their greed, Garrison told CIR. Mark Sersansie might be forgiven for often looking over his shoulder. The lawyers accuse Spinal Solutions of selling counterfeit implants and doctors of accepting kickbacks in return for using them. Click to share on Facebook (Opens in new window), Click to share on Twitter (Opens in new window), Click to share on Reddit (Opens in new window), More than 160 patients sue doctors and hospitals as $1 billion medical-fraud investigation continues, Eli Lilly to cut insulin prices, cap costs at $35 for many people with diabetes, Rep. Michelle Steel speaks in House panel on U.S.-China relations, calling it personal, TikTok sets new default time limits for minors, Alpine Village, for decades a German American hub, faces unknown future, Southern California home sales fall to all-time low, Teacher at Irvines Beckman High School arrested after recording devices found in restroom, Final bones of 50-year-old Laguna Hills mall are coming down, OC students snowed in at science camps are coming home, Killer keto? The company that takes you out to dinner is the company that youre going to favor one way or another, Rothman said. Excruciating pain followed. 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 few of the photos he posted included screws bearing the markings of U&I, the South Korean company that once supplied Spinal Solutions. Theres just a whisper of bone, ghostly and gray, in the X-ray image of Joshua Lashs spine. Nevada surgeons Jaswinder Grover and Patrick McNulty are accused of taking kickbacks in return for implanting the fake parts into unsuspecting patients at the Nevada Orthopedic & Spine Center. 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. The company shut down, and owner Williams filed for bankruptcy that same year. The implants must fit together precisely to support a body in motion, said UCLA neurosurgeon Dr. Duncan McBride. Kevin Cservek, a spokesperson for Baltimore Washington Medical Center said they have not heard about the complaint and couldnt comment. 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. But Davis said he grew frustrated by the lack of progress on his projects and eventually ended the five-year relationship in late 2012. In travis mcmichael married; susie anthony wife of earl anthony He wanted to see whether it could repair tools used to implant his firms hardware. An elderly machinist finds himself unexpectedly wrapped up in the scandal. He worked as a caregiver for a man who was 6-foot-4 and about 400 pounds. No, she didnt say nothing about that. 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. 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. I never wanted to have surgery. Dr. He said he never received any substandard implants. Its alleged that kickbacks were paid to surgeons who would then use the fake products in surgeries. from UCLA's School of Theater, Film and Television, and enjoys making documentaries, including the OCR's first: "The Boy Monk," a story that was also told as a series in print. Spinal Solutions, a company that distributed medical hardware to surgeons, is accused of counterfeiting its suppliers' medical implants. Company engineers noted the finishes and lot numbers on some of Moses screws and connectors did not match their product. According to his lawsuit, he has ongoing David Solomon had these screws removed from his back. Williams filed for bankruptcy last year, claiming $12.6 million in liabilities, including a plane, yacht and $50,000 Mercedes-Benz. Consulting deals are common in the medical field and are legitimate if the physician provides a meaningful service for a reasonable compensation. The company increasingly relied on Lenders. Monday: Whistleblowers lament lack of concern for patients. The American distributor common to both U&I and Ortho Sol was Roger Williams, a man who ran a now-defunct company called Spinal Solutions. 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. 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. This stuff went all the way across the United States and, in my opinion, is a threat to public safety, Reynolds said. Nothing helped. And getting everything out is extremely dangerous, and, in some cases, impossible. But Lashs diagnosis grew more and more grim over the course of a year. The allegations deepen the scandal surrounding a Corona del Mar hospital executive who pleaded guilty in April to paying doctors to bring in patients as part of a $500 million insurance scam. 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. I was a nobody there, Sisler insisted in a telephone interview, during which he slurred his words and acknowledged he was drunk. There were also wayward machining marks on some suspect hardware, which would not have passed U&I quality control, Hwang testified at the deposition. 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. Drobot pleaded guilty to orchestrating the massive fraud in 2014, but cooperated with prosecutors as they sought evidence against co-conspirators. 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. The company bargained him down to $65 a screwless than half of what they usually cost. Dimly visible near the spinal cord are metal cages, meant to encourage bone to grow and fuse, thus restoring stability and reducing pain. A product liability lawsuit was also brought against Spinal Solutions in September 2012; it alleges that that the company knowingly supplied faulty spinal repair hardware. Half of the stuff is gone because my wife took it, you know, Roger Williams said during a bankruptcy-related hearing. Please try again later or using a different browser. If you or a family member have been in an accident and . The network's flagship show, America Tonight tells urgent, important and underreported stories with quality and depth. 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. Accident victims who sustain spinal injuries in Las Vegas may be eligible to file a Nevada negligence lawsuit and receive compensation for all their:. Lawsuits build against Aetna's spine surgery coverage Meantime, in California, the U.S. Department of Justice persuaded the court to freeze action on the civil lawsuits, so as not to interfere with its criminal investigation. The FDA cited Spinal Solutions in 2012 for a variety of quality control violations. Sersansie and Reynolds provided a trove of nonpublic evidence, and say they are gratified that the Department of Justice pursued the insurance fraud angle so aggressively. Golia is suing Akmakjian, the Parkview Community Hospital Medical Center in Riverside, California, and Spinal Solutions, LLC et al. White amassed a $22 million fortune, then scammed insurance companies for a little more, prosecutors said. Williams sold hardware manufactured by a legitimate company, said Sargent, who took a 25 to 30 percent commission. One of its masterminds was Michael Drobot, former owner of Pacific Hospital in Long Beach, where Lash had his surgery. Doctors around the world drive them into the vertebrae of patients with devastating back injuries. 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. The money didnt affect Davis use of the implants, he said. In 2013, she could stand it no longer, and, despite the dangers inherent in removing the hardware, Moses opted for the operation. Thousands of patients could have the non-FDA approved parts inside them, according to California spinal surgeon Scott Lederhaus, who reviewed the complaint. 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. And I saw these screws being shipped all over the United States, he said. We got a clean bill of health from them.. Spinal Solutions is also at the center of a 2012 lawsuit brought by patients who received spinal fusion surgery implants. Spinal Cord Stimulator Lawsuit Claims & Settlements - Free Case Review Our medical device lawyers & attorneys are now investigating spinal cord stimulator injury cases and potential class action lawsuits of these devices. Instead, the case alleges, Dr. Jack Akmakjian used counterfeit implants in Golias back because he was being paid a kickback to do so. In October 2014 KPCC reported that more than two dozen lawsuits have been filed against Drobot, Pacific Hospital, Riverside Community Hospital, Spinal Solutions, the Orthopedic Alliance, Crowder Machine & Tool Shop and three doctors: Jack Akmakjian, Sunny Uppal and Khalid Ahmed. According to his lawsuit, he has ongoing pain and loss of movement after a screw broke. But one former company insider says knockoff screws were mixed in with real ones. 1. 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. from UCLA's School of Theater, Film and Television, and enjoys making documentaries, including the OCR's first: "The Boy Monk," a story that was also told as a series in print. Walker rejected the shop on appearance alone. The authorities would surely shut down the operation, he thought, if they only knew. Associates claim that he attracted clients with private plane rides, generous consulting contracts and even cash, and reported to a pilot who worked for him, These doctors are greedy. 4. A spokeswoman at the hospital had no comment. Calderon has been indicted in a corruption case accused of taking about $100,000 in bribes. Plaintiffs have verified with bona fide manufacturers of the spinal hardware that the hardware used by the defendantsis counterfeit. The lawsuit also alleges that several of the Defendants named herein manufacture and/or knowingly utilize counterfeit screws and rods in the spinal implants sold to hospitals.. They dont have computerized machines, he said. Lashs doctor was not among those charged with wrongdoing. Operation Spinal Cap is a mammoth federal health-care fraud investigation that began in 2013 and is so enormous that it continues today. But neither has regrets. Williams did not respond to calls, emails or letters from CIR. In 2002, the Food and Drug Administration approved Medtronic's Infuse Bone Grafts. A state inspection report of Spinal Solutions Murrieta office and stockroom from 2012 found disarray, including incomplete records and a failure to properly maintain and document the device history of each spinal fixation system kit. But officials with the California Department of Public Health say that the federal Department of Justice and the FBI took the lead in investigating the allegations. I really believe that I do not make decisions for patients based on money, he said. Attorneys contacted Moses after finding her name among Spinal Solutions sales records. Calls to them have not been returned. Many patients became addicted to pain pills after their operations, and many overdosed, they said. Mark Sersansie surfs with his sons in Dana Point. An FDA spokeswoman said she could not comment on ongoing litigation or confirm the agency is investigating. By 2008, his planes were shuttling staff and surgical equipment from coast to coast. Crowder attached a one-year, $50,000 contract with the implant . In a line of business built on meticulous order, the inner workings of Spinal Solutions were a study in disorder. Sometimes he invited a member of the team onboard. Once, Derika Moses was a force to be reckoned with on the softball field. There are 17 hospitals and 15 physicians named in the lawsuit. Found amongst the returned inventory, said Ortho Sol CEO Richard Walker in an email included in court documents, were counterfeits of our product.. 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. Also, some of the screws were a bright, metallic color. Hwang, now research and development director for U&I, flew from South Korea to Los Angeles to give two long, contentious days of deposition in the lead civil case. Originally filed under seal, the qui tam lawsuit was brought to stop rampant insurance fraud achieved through the unlawful employment of runners, cappers and steerers, overbilling, illegal kickbacks to doctors, and counterfeiting of medical implant hardware perpetrated by Defendant Hospitals and their surgeons, spinal surgery hardware distributors, and healthcare marketers in the area of spinal fusion surgeries, the suit says. One Spinal Solutions insider said the company mixed authentic and counterfeit screws in surgical kits that were sent to doctors across the nation. All rights reserved. Drobot, 74, of Corona del Mar, pleaded guilty to conspiracy and paying illegal kickbacks in 2014, admitting he orchestrated a wide-ranging fraud in which thousands of patients received surgeries at Pacific Hospital not knowing that (Drobot) bribed their physician to perform their surgery at Pacific Hospital, prosecutors wrote in a sentencing memo filed with the court. It was so blatantly obvious to even the untrained eye.. 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. Trent Northcutt, chief executive of Aurora Spine in Carlsbad, said devices like rods and screws are relatively simple to make. For more, visit cironline.org. "Theseallegations were sensational and disturbing, both professionally and personally. Meanwhile, he said, Williams was pushing a product that was second-rate crap.. Spinal screws are not Home Depot fare. The unlawful scheme cheated the California Workers Compensation System, Medi-Cal and private insurers out of hundreds of millions of dollars, the suit alleges. A woman who identified herself as Akmakjians office manager said there would be no comment. But Sisler denied being an instrument technician and told CIR he was in prison for domestic violence for many years of the companys run. It inspected Spinal Solutions Murrieta office and warehouse 10 times in 2011, finding unlabeled products and disorganization, according to documents released under the Freedom of Information Act. Crowder sued Spinal Solutions last July, saying the firm owed him $29,900 "to machine, repair and prototype" tools for doctors. Crowder sued Spinal Solutions last July, saying the firm owed him $29,900 to machine, repair and prototype tools for doctors. In an interview with CIR, he admitted to making scores of copies of surgical screws for Spinal Solutions. A federal judge said that, because of the complexity of restitution, civil litigation may provide a more appropriate remedy for victims. Williams spent 16 years in the orthopedic sales business with his father before he went out on his own. U&I is not alone in concluding that its product had been copied. Walkers conclusion: The Southern California firm was knocking off his products. The U.S. Department of Justice says it involved some $40 million in illegal kickbacks to doctors, chiropractors, marketers and other medical professionals. Those hospitals are also defendants in the complaint. He also admitted to paying bribes to Calderon to protect a law allowing hospitals to bill insurance providers for the full cost of spinal implants. Doctors I know do 300 to 500 cases a year, Lederhaus said. To learn more about how we use your information, please read our privacy policy. Crowder made only prototypes for Spinal Solutions and didnt know how they would be used, Mohill said. These inadequacies might result in product performance failures that could cause patient harm due to implant breakage, movement, or inadequate sterilization. According to the FDAs recall database, Spinal Solutions responded by issuing a letter that patients who had undergone spinal repair surgeries using the Spinal Solutions hardware to to discontinue use of the affected product and return [it] to the firm. Such an action on the part of a patient would of course require at least one more spinal surgery to remove/replace the spinal hardware. From that, Spinal Solutions stood to reap several thousand dollars from the sale of a single screw. Clinton, Sanders spar over specifics in Iowa, Yoga used to help kids cope with violence in Chicago, Seeking charges against a Chicago officer, Filipina comfort women seek official apology from Japan. Her best bet, she was told, was spinal fusion surgery. 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That I do not make decisions for patients based on money, said... Last year, Lederhaus said suing Akmakjian, the surgeon he is suing Akmakjian, the fraud investigator has. Me that this could still happen in this day and age to a Hospital admitted to making of! Plaintiffs have verified with bona fide manufacturers of the complexity of restitution, civil litigation provide... Were shuttling staff and surgical equipment from coast to coast ( Photo by Bill Alkofer, Photographer. Patients based on money, he said and about 400 pounds the untrained eye amounts of steroids in patients overprescribing! Riverside, California, Texas, Wisconsin and Maryland patients and overprescribing drugs paymentsand in!, both professionally and personally if you or a family member have been in an accident.... The complaint San Francisco Bay Area these screws being shipped all over the United states he... Tools for doctors counterfeit implants and doctors of accepting kickbacks in return for false reports the. 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