Meg Health Care, run by Dallas personal injury attorney Manuel Green and his wife, Melissa Green, is the focus of a search warrant recently unsealed by a Massachusetts federal court in an alleged health care fraud prosecution there. The probe is unusual because it uses a little-known law meant to crack down on organized crime racketeering across state lines.

Investigators alleged in the 2019 affidavit that the Texas company accepted thousands of dollars in bribes from SpineFrontier, a Massachusetts medical device company. SpineFrontier; its CEO, Dr. Kingsley Chin; and its chief financial officer, Aditya Humad, on charges of paying kickbacks to surgeons. All have pleaded not guilty.

No charges have been filed against the Greens or their company, and federal officials declined to discuss the investigation, which is detailed in the now-unsealed 2019 search warrant.

The Greens could not be reached for comment.

Meg Health Care sets up spine surgery and other medical treatment through “letters of protection,” or LOPs, legal contracts in which patients agree to pay medical bills using proceeds from a lawsuit or other claims against the party responsible for their injuries. These contracts are common in personal injury cases when people either lack health insurance or choose not to use it to pay for medical treatments after an accident. The downside is that patients can be left to foot the bill if their cases settle for less than they owe.

On its website, Meg Health Care says it “represents a group of doctors and hospitals who were tired of seeing injured people without access to medical care they needed after an accident. We hold firm to the belief that under the law, and as a matter of basic decency, the person or business that caused the injury should be held responsible.”

According to investigators, Manuel Green steered injured patients with LOPs to a local neurosurgeon who used SpineFrontier implants in surgeries at two Dallas-area hospitals.

“In exchange for attorney Green’s referral, SpineFrontier agreed to pay attorney Green forty percent (40%) of the revenue SpineFrontier received in connection with those surgical procedures as a bribe,” according to the search warrant affidavit.

Chin and SpineFrontier were the subjects of a KHN investigation published in June that found that manufacturers of hardware for spinal implants, artificial knees, and hip joints had paid more than $3.1 billion to orthopedic and neurological surgeons from August 2013 through 2019.

Government officials have argued for years that payments from device makers to surgeons and other medical providers can corrupt medical decisions, endanger patients, and inflate health care costs. The alleges that the company paid millions of dollars in bogus consulting fees to spine surgeons in exchange for their using its products, often in surgeries paid for by Medicare or other government-funded health insurance plans.

The Texas investigation adds a new dimension to the case by focusing on medical care that is paid for privately, which is not covered under federal anti-kickback statutes. Instead, the search warrant alleges violations of a law called the Travel Act. Enacted by Congress in the early 1960s to combat the mob, the Travel Act makes it a federal offense to commit crimes like bribery, prostitution, and extortion across state lines, including through the mail or by phone or email. Convictions can bring up to five years in prison, more if violence is involved.

Jonathan Halpern, a New York white-collar criminal defense attorney, said that such a use of the Travel Act reflects “an aggressive expansion” of the U.S. government’s power to prosecute health care fraud.

One of the first health care fraud prosecutions under the Travel Act took place in Texas and led to convictions on bribery and kickback charges of 14 people, including six doctors, associated with Forest Park Medical Center in Dallas. They drew and were ordered to pay $82.9 million in restitution.

Chris Davis, a Dallas lawyer who specializes in government investigations, said the Travel Act grants federal prosecutors jurisdiction in cases “where you don’t have state or federal money involved.”

The Meg Health Care search warrant cites payments of more than $93,000 in 10 checks allegedly sent by SpineFrontier to the Texas company between April 2017 and October 2018. Investigators allege that the money was paid as a bribe for referring patients for surgeries using SpineFrontier products.

Investigators also cited a February 2016 email in which Melissa Green told the device company that a patient’s legal case had been settled and asked: “Please let me know when MEG can expect to receive payment per our agreement. Thank you!”

About two months later, the device maker cut the company a check for $3,953.60, according to the search warrant.

Nine of the 10 checks were signed either by Chin, a Fort Lauderdale spine surgeon and SpineFrontier’s founder, or Humad, according to the search warrant affidavit. Chin and Humad are the two executives indicted in September. Their lawyers had no comment.

Federal investigators sought the search warrant for Melissa Green’s email account at Meg Health Care in August 2019, arguing that they had “probable cause” to investigate the company for Travel Act violations, court records show. A federal judge in Massachusetts unsealed the warrant and related documents late last year.

Meg Health Care invites lawyers whose clients have a “significant medical need” to apply to the company, according to its website. If approved, Meg Health Care schedules an appointment with one of its doctors. “From there, our doctors will handle every aspect of the treatment sought, including surgery (if necessary),” the website says.

In a 2019 court filing in Dallas County, unrelated to the search warrant issued in the Massachusetts case, Manuel Green said he was the “founder and owner” of the company. He said it “assists physicians and medical facilities with reducing their exposure to risk when providing treatments to patients under [a] letter of protection.”

He went on to say the company’s “business model and the consulting services it provides are unique within the healthcare industry in the state of Texas.” The company’s website lists medical providers in 11 Texas cities.

According to investigators in the Massachusetts case, Green referred patients with LOPs to Dr. Jacob Rosenstein, an Arlington, Texas, neurosurgeon who used implants that SpineFrontier sold to two hospitals, Pine Creek Medical Center in Dallas and Saint Camillus Medical Center in Hurst, Texas. Pine Creek has since declared bankruptcy.

Neither Rosenstein nor representatives of the hospitals could be reached for comment.

Although proponents say that LOPs may be the only option for uninsured or underinsured crash victims to get medical care, a recent KHN investigation found that doctors and hospitals that accept them often charge much higher rates than Medicare or private insurance would pay for similar care and that the process can saddle patients with medical debt or expose them to safety risks.

Disputes over the size of medical bills and even whether the care was necessary are common in personal injury lawsuits in Texas. In one 2016 Dallas County case, for instance, a spine surgeon billed more than $100,000 for his services, while the hospital charged more than $435,000. By contrast, an expert hired by the defense set a reasonable fee at less than $4,000 for the surgeon and about $25,000 for the hospital, court records show. The case has since been settled.

Christine Dickison, a Texas nurse and medical coding consultant, said she routinely sees “hugely inflated” bills in car-crash lawsuits 鈥� and in some cases doubts whether the care was necessary.

“I see people who are undergoing surgery when there are literally no objective findings that support it,” Dickison said. “That is very disturbing to me.”

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That never happened.

Louis-Charles, 68, died hours after the operation at a South Florida outpatient surgery center in March 2019. The surgery center had put him in an Uber with his wife, Marie Julien, according to depositions. After a 60-mile ride home, he collapsed, court records show.

Her husband’s death left Julien to deal with more than $100,000 in medical debt, as described in the “letter of protection,” or LOP, that Louis-Charles had signed.

In signing an LOP, people generally pledge to cover the costs of their care even if it exceeds what they win in a lawsuit or other settlement 鈥� and even if the prices are far higher than most doctors would charge.

The agreements are legal and binding in many states, though Florida appears to be the epicenter of their use in personal injury cases. Advocates say the letters throw a lifeline to low-income people who need vital medical care for injuries caused by the negligence of others and don’t have the money or insurance coverage to pay for it. Doctors and surgery centers that accept LOPs say they often wait years for a lawsuit to settle before being paid, if at all.

A KHN investigation found that letters of protection can saddle patients with medical debt 鈥� and drive a personal injury care system that operates with little oversight despite widespread complaints of grossly inflated billings and other problems that can place patients at risk.

Marie Julien blamed Dr. Kingsley R. Chin 鈥� a controversial Hollywood, Florida, surgeon who has accepted LOP payments for more than a decade 鈥� for her husband’s death after the spinal fusion procedure. Last year, she filed a malpractice suit against Chin alleging that Louis-Charles died after he “was discharged home while still in pain and with signs and symptoms of post-operative complications.” In court papers, Chin denied any negligence.

“We felt that the way the whole thing happened was very bizarre,” Julien, 71, a certified nursing assistant, recalled in a deposition taken in the case.

A 鈥楾errible Situation’

Just before 8 a.m. on New Year’s Day 2018, Louis-Charles’ car was stopped at a red light near his home. Suddenly a white police vehicle, driven by a Palm Beach County Sheriff’s Office detective, backed into his Toyota Corolla, hitting the passenger side door, according to a police report.

In her deposition, Julien said Chin operated on her husband’s shoulder in 2018. But that didn’t help much, and Chin recommended more extensive surgery, she said. “I wasn’t happy at all with that idea,” she added.

Julien said she relented because Louis-Charles’ pain was getting worse “day by day” and he had confidence in the surgeon. The Aventura Surgery Center in Hallandale, Florida, where Chin had served as medical director, sent an Uber to collect the couple the morning of March 12, 2019, Julien said.

During the two-hour spinal fusion, Chin replaced three disks with an implant he invented, according to his deposition. The patient spent an hour or so in a recovery room before a nurse wheeled him out to a waiting Uber just after 3 p.m., according to Chin’s testimony.

Louis-Charles couldn’t speak, but signaled he was in pain and struggled to breathe during the hourlong ride home, according to Julien’s deposition. She helped him walk through the front door of their Riviera Beach home. Once inside he collapsed, she testified.

A fire rescue crew rushed him to a hospital in West Palm Beach, where he died just after 5:30 p.m., according to a Palm Beach County Medical Examiner’s autopsy report. The medical examiner ruled the death an accident caused by “post-surgical bleeding with airway compression.”

In his deposition, Chin said that Louis-Charles “looked great” heading out to the car and that traveling along the urban Interstate 95 corridor the driver was “at any given time probably within 10 minutes or so” from a “major hospital or emergency room.”

Chin called the outcome a “terrible situation” and told Julien’s lawyer during the deposition: “I just hope you can appreciate how much I regret what happened.”

Asked how her husband’s death has affected her life, Julien said: “How can you find words to explain such a thing?” The couple wed in 1987 in Miami after moving from their native Haiti, where he worked as a house carpenter.

“It’s been almost two years now. I have not been able to sleep on [the] bed” she shared with him, she said.

In late September, Julien and Chin settled the suit under confidential terms and the bills were “written off,” according to Kevin Smith, an attorney who represented Julien. Chin has denied any liability.

鈥楢 Mixed Bag’

Though little-known to the public, letters of protection are commonly used to finance major medical care in personal injury cases, including costly orthopedic surgery.

Attorneys who refer injured clients to willing doctors say the liens are their best tool for ensuring clients not only gain access to care, but also are in a position to win fair settlements from insurance companies that fight to minimize their liability and costs.

An LOP form used by some Florida medical providers says they agree to wait for payment as a “courtesy” to the injured person, adding in boldface: “We understand insurance companies have unlimited resources, will hire defense lawyers and defense experts that will cause our payment to be delayed for months or years.”

The business community and insurers counter that LOP providers grossly inflate their medical fees to give juries a false picture of the costs of medical care.

“The sole purpose of the LOP, why it exists, is to drive up verdicts and settlements,” Lauren McBride, a lawyer for Publix Super Markets, a chain with more than 800 stores in Florida, testified in a state legislative hearing in February 2019.

McBride said that nearly two-thirds of “slip-and-fall” injury claims in Publix stores involve letters of protection. In more than half those cases, the injured person had some form of insurance but declined to use it, she said. In some cases, injured people traveled long distances for costly care they could have received closer to home at far less expense, she said. She also argued that LOPs give doctors an incentive to overtreat patients “to keep driving up medical bills” 鈥� and persuade juries to award big verdicts.

Kevin Leahy, an Austin, Texas, lawyer who has the practice there and represented clients on both sides of the debate, said LOPs deserve more scrutiny. “It’s a mixed bag,” he said. “There are definitely abuses going on. There are also hurt people getting care they need to get better.”

Leahy said LOPs have helped create a “liability-based” health care network with few checks on its financial dealings or other standards. He called it “unregulated, opaque and not fully accurate about charges.”

Across the country, LOPs have been tied to a range of alleged medical overcharges or other billing abuses, court records show.

Nearly 200 women from 42 states, for example, have joined a class-action suit that alleges doctors and lawyers talked them into signing LOPs promising to pay for surgical removal of pelvic mesh 鈥� whether they needed it removed or not.

The women allege that the doctors billed sky-high rates and told them their insurance would not cover the cost, so signing an LOP was the only way to safeguard their health. Private insurance would have paid about $8,000 for these services, far less than the $76,000-plus the women were charged under the LOP, according to the suit, filed in late August. The case is pending. Six doctors have filed motions to dismiss the case.

In a 2020 federal civil case, evidence emerged that a Texas spine surgeon charged nearly $400,000 under an LOP for procedures that Medicare would reimburse at less than $20,000, court records state.

Reviewing court cases in Florida, KHN found dozens of examples in which patients who signed LOPs alleged they were later sued for payment of excessive fees or received substandard medical care.

鈥楿nnecessary and Dangerous’

On the day of his spinal surgery, Louis-Charles signed a letter of protection that read in part: “While I am injured and need care, I cannot financially afford to pay your bill at the time services are rendered, I therefore, grant this provider a lien on my claim against any and all proceeds from any settlement, insurance benefits or judgment.”

The documents said he would be charged “what is usual and customary for our area.” But the fees were much higher than private health insurance would cover or what the Medicare fee schedule provides for.

The Aventura Surgery Center, co-owned by Miami personal injury attorney Sagi Shaked, billed nearly $100,000 for the operation, court records show. Two other Shaked-affiliated companies billed more than $35,000 for surgical supplies and anesthesia, according to the court records. Shaked did not respond to numerous requests for comment. In his deposition, Chin said he no longer operates at the Aventura Surgery Center.

Mark Woodard, 54, who was rear-ended in an April 2017 car crash in Fort Lauderdale, had three spine operations at the Aventura Surgery Center performed by Chin under a letter of protection.

His bills topped $430,000, including $179,500 for the surgery center, $177,972 billed by Chin’s medical office and $39,327 for implants from SpineFrontier, a Massachusetts medical device company Chin owns, court records show.

“These charges are way out of line,” said Michael Arrigo, a medical billing expert in California asked by KHN to review Woodard’s bills. Arrigo said “usual and customary” charges would be less than one-fourth of what was billed.

Woodard, who has worked as a painter and maintenance technician at beachfront hotels in Fort Lauderdale, argues in his lawsuit that his injuries from the crash were “nothing more than cervical and lumbar sprains and strains 鈥� such that no reasonable physician would have performed surgery other than for monetary purposes.”

According to Woodard’s lawsuit, Chin persuaded him to have multiple operations and during one tore a 1-centimeter hole through a nerve root, leaving him in “extreme agony and excruciating pain.”

The suit, filed in March 2021, alleges the surgery center offered Chin a “safe haven to perform his unnecessary and dangerous surgeries.” It also alleges that Chin “was unable to perform surgery at any hospital in the state of Florida and most if not all surgery centers where he had applied had either denied him privileges or he had his privileges revoked at multiple hospitals.” In court filings, Shaked has denied the allegations and any liability.

Chin also has denied any negligence in court filings and in a deposition called the fees he charged “reasonable within the community.” Woodard’s lawsuit is pending in Broward County Circuit Court.

Chin has been sued repeatedly for medical negligence, including several cases involving LOPs. He has been sanctioned by physician-licensing boards in three states, unrelated to his use of LOPs.

In early December, the Florida Department of Health, which licenses doctors, issued Chin a “letter of concern” and fined him $8,000. The action settled a state administrative complaint alleging that in August 2019 Chin sent home a 73-year-old man who suffered from complications of spinal surgery who should have been transferred “to a higher level of care in an inpatient setting (such as a hospital).” Chin disputed the allegations.

Separately, federal agents arrested Chin in early September in Fort Lauderdale on kickback charges as CEO at SpineFrontier, which sells spinal implants he invented and used in operations on Louis-Charles and Woodard. Chin has denied the civil allegations and has pleaded not guilty to the criminal charges.

In October, a federal judge ordered Chin to post a $500,000 bond secured by his Florida home. He is free to travel within the country “for business purposes only” and may travel one time per month to Jamaica “only for the purpose of practicing medicine there,” the order states. Chin has active medical licenses in Florida, Arizona, New Jersey, New York and in Jamaica, according to documents he filed with the court.

A 鈥楥omplete Shock’

By its own account, the Broward Outpatient Surgical Center and its affiliates in Pompano Beach, Florida, have treated more than a thousand patients under letters of protection. But the billing practices 鈥� one lawsuit called its fees “astronomically unreasonable and inflated” 鈥� have been criticized in court filings for years. These cases often settle under confidential terms.

One patient argued in a lawsuit that injured patients were “bounced around” a web of affiliated clinics for services that included chiropractic care, pain injections, physical therapy and, finally, surgery, all done with no caps on the costs. The center denied the allegations, and the case has since been settled.

Albert Frevola, an attorney for the center, said that prior to treatment patients are given a price list and sign an agreement to pay the bills out of any settlement of their personal injury claims. He said the center serves many patients “who can’t afford to get medical care. It’s a service that is valuable and needed.”

Some three dozen former patients have filed a recent mass tort lawsuit alleging medical malpractice and billing fraud by the surgery center and its owners, chiropractors Brian and Craig Bauer, who are brothers. The suit also names spine surgeon Dr. Merrill Reuter, court records show. Neither Reuter nor his lawyer responded to requests for comment.

The patients allege they visited the center after a car crash or other accident and were persuaded to have spinal surgery. In some cases, the operations either were billed as more complex than they were, or not done at all, according to the suit. Patients often have run up bills of $100,000 or more under LOPs, court records show. “Due to the fact that personal injury patients rarely, if ever, use their private health insurance for such health care services, the Bauers and the Bauer entities were able to get away with charging inflated amounts,” according to the suit.

Frevola, who represents the brothers, said they “flatly deny” the allegations and “are sad and distressed that these accusations are being made by the same people they gave great care and medical treatment to.”

In a separate malpractice case, Terrell Harris, 37, alleged he was guided down a “treatment path” after a car crash in July 2017 that ended in surgery at prices “far beyond the scope of reason, let alone custom.” The center denied the allegations and filed a counterclaim accusing Harris of failing to pay for his care under the LOP.

The suit is one of eight pending in Broward County Circuit Court that make similar claims, including that of a woman who alleged she had the same pain after spinal surgery as she had beforehand. Nearly five years later, to her “complete shock,” an MRI found no evidence the operation she was billed for had been done, according to the suit.

In a February 2020 court filing in one of the cases, the center and Brian Bauer denied the allegations and called them “frivolous and scandalous.” They filed a counterclaim demanding to be paid for their services. The case is pending.

Warring Creditors

When fees are inflated under an LOP, patients can take home more money under an insurance settlement or jury verdict. But if a case settles for less than the sum of those bills, patients may be on the hook to pay the balance.

Lawyers who typically co-sign the LOPs try to persuade medical providers to reduce their fees, which often happens. When that fails, however, lawyers file a court action called an interpleader, which asks a judge to decide who gets what among warring creditors.

KHN reviewed dozens of Florida court cases in which medical creditors holding LOPs demanded payment in full. While many of these cases settled under confidential terms, court records show some accident victims ended up mired in debt or saw their damage awards drastically reduced by outsize medical billings and legal fees. In some cases, lawyers took home more than their injured clients.

That happened to Jose Merced, who fell and hurt himself after stepping into a hole outside his apartment in the Orlando area. He received a $75,000 settlement but incurred bills of more than $850,000 for operations and other medical costs, which he contested as “highly inflated,” court records show. The bills included more than $700,000 in orthopedic surgical and facility fees.

In August 2020, a judge allowed just over $35,000 to pay for the surgeries. Merced was awarded $10,000, while his lawyer got nearly $27,000, just over $18,000 of it for professional fees and the rest for expenses.

In some interpleader cases, lawyers asked judges for one-third of the total settlement for their fees, plus expenses, which can add hundreds, if not thousands, of dollars more to their share.

A law group founded by South Florida personal injury lawyer Robert Fenstersheib filed at least 50 interpleader cases in Broward County Circuit Court between January 2019 and October of this year. Fenstersheib, who was a fixture of local television ads as the “lawyer who listens,” was shot to death by his son in a murder-suicide in September 2020, though his Fenstersheib Law Group still operates under his relatives.

Many of the LOP patients now suing the Broward Outpatient Surgery Center and its owners were clients of the Fenstersheib firm, court records show. The center and the law firm did business for years, but the center sued the law firm in 2019 alleging the lawyers failed to pay it millions of dollars owed under LOPs. The law firm responded that it was a victim of a $6.5 million embezzlement by former employees who pocketed settlement money meant for the center. The suit was settled under confidential terms this year.

Federal prosecutors filed criminal charges against two former Fenstersheib employees in connection with the theft. In late November, one of the men, Michael Wihlborg, a 47-year-old high school dropout who had worked for the law firm for nearly two decades, admitted receiving more than $2.1 million in stolen funds from the scheme; he pleaded guilty to one count of conspiracy to commit wire fraud and three counts of filing a false income tax return, court records show. He faces up to 29 years in prison, according to court records. Co-defendant Matthew Matlock pleaded guilty to similar charges on Dec. 15, court records show. The law firm had no comment.

Ethics Question

Some lenders also accept LOPs as collateral for patients who borrow money to tide them over while their personal injury case winds through the courts, which typically takes years. Interest charges pile up fast.

A Miami man who was injured after a pile of wood fell on him at a home improvement store borrowed $51,400 from a finance company backed by an LOP in September 2014. He owed the company $140,322 three years later because of an interest rate of 18% charged every six months, court records show.

Doctors also can generate cash from letters of protection. While they argue they must wait years for payment, some spine surgeons sell the liens on a burgeoning medical debt market.

Court records in Florida show millions of dollars of these liens have changed hands when doctors sold them. Buyers paid 10% to 25% of the total amount of the bill and gambled they would be able to collect a tidy profit once a patient’s lawsuit was settled.

The ethics of doctors wheeling and dealing in patient bills and having a financial stake in the outcome of litigation has been questioned. An American Medical Association says such deals are unethical because “there is the ever-present danger that the physician may become less of a healer and more of an advocate or partisan in the proceedings.”

Dr. Scott Lederhaus, a retired California neurosurgeon who has reviewed personal injury cases for the defense, said some patients argue in depositions that under an LOP they never saw bills, so they had no idea of the extent of the medical costs they were incurring over time.

Lederhaus said there is little agreement on what is a reasonable medical fee and, as a result, doctors “are able to charge whatever they want” in personal injury cases.

And it remains unclear whether the No Surprises Act, which Congress passed last year amid a national outcry over huge and unexpected medical bills, offers patients who signed LOPs any protection.

“A lot of these doctors are under the impression they can do whatever they want and there’s not going to be any oversight by anyone,” Lederhaus said.

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Dr. Kingsley R. Chin, 57, of Fort Lauderdale, Florida, is the founder, chief executive officer and owner of SpineFrontier, a device company based in Malden, Massachusetts. He and the company’s chief financial officer, Aditya Humad, 36, of Cambridge, Massachusetts, were each indicted on one count of conspiring to violate federal anti-kickback laws, six counts of violating the kickback statute and one count of conspiracy to commit money laundering, officials said.

The indictment alleges that SpineFrontier, Chin and Humad paid surgeons between $250 and $1,000 per hour in sham consulting fees for work they did not perform. In exchange, the surgeons agreed to use SpineFrontier’s products in operations paid for by federal health care programs such as Medicare and Medicaid. Surgeons accepted between $32,625 and $978,000 in improper payments, according to the indictment.

“Kickback arrangements pollute federal health care programs and take advantage of patient needs for financial gains,” said Nathaniel Mendell, acting U.S. attorney for the District of Massachusetts.

“Medical device manufacturers must play by the rules, and we will keep pursuing those who fail to do so, regardless of how their corruption is disguised.”

Chin and SpineFrontier were the subjects of a KHN investigation published in June that found that manufacturers of hardware for spinal implants, artificial knees and hip joints had paid more than $3.1 billion to orthopedic and neurosurgeons from August 2013 through 2019. These surgeons collected more than half a billion dollars in industry consulting fees, federal payment records show.

Chin, a self-styled “doctorpreneur,” formed SpineFrontier about a decade after completing his training at Harvard Medical School.

Chin has patented dozens of pieces of spine surgery hardware, such as doughnut-shaped plastic cages, titanium screws and other products that generated some $100 million in sales for SpineFrontier, according to government officials. In 2018, SpineFrontier valued Chin’s ownership of the company at $75 million, though its current worth is unclear. He maintains a medical practice in Hollywood, Florida. Neither Chin nor Humad could be reached for comment Tuesday.

Seth Orkand, a Boston attorney who represents Humad, said his client “denies all charges, and looks forward to his day in court.”

The Department of Justice filed a civil lawsuit against Chin and SpineFrontier in March 2020, the company of illegally funneling more than $8 million to nearly three dozen spine surgeons through the “sham” consulting fees. Chin and SpineFrontier have yet to file a response to that suit.

However, at least six surgeons have admitted wrongdoing in the civil case and paid a total of $3.3 million in penalties. Another, Dr. Jason Montone, 45, of Lawson, Missouri, to criminal kickback charges and is set to be sentenced early next year. Federal law prohibits doctors from accepting anything of value from a device-maker for agreeing to use its products, though most offenders don’t face criminal prosecution.

The grand jury indictment lists seven surgeons as having received bribes totaling $2,747,463 to serve as “sham consultants.” One doctor, identified only as “surgeon 7,” received $978,831, according to the indictment. Many of the illicit payments were made through a Fort Lauderdale company controlled by Chin and Humad, according to the indictment.

The SpineFrontier executives set up the separate company partly to evade requirements for device companies to report payments to surgeons to the government, according to the indictment. Some surgeons were told they could bill for more consulting hours if they used more expensive SpineFrontier products, officials said.

Conspiring to violate the kickback laws can bring a sentence of up to five years in prison, while violating the kickback laws can result in a sentence of up to 10 years, officials said.

“Kickbacks paid to surgeons as sham medical consultants, as alleged in this case, cheat patients and taxpayers alike,” said Phillip Coyne, special agent in charge of the U.S. Department of Health and Human Services Office of Inspector General.

“Working with our law enforcement partners, we will continue to investigate kickback schemes that threaten the integrity of our federal health care system, no matter how those schemes are disguised.”

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Kyocera Corp., which was eager to expand its U.S. spine and joint implant sales, bought Renovis’ assets in 2019. While the parties kept the sale price under wraps, Renovis’ physician stockholders held stakes valued at over $34 million by the end of that year, with nearly half that sum to company founder and chief executive Dr. John Steinmann, according to the federal government’s “Open Payments” database, which tracks payments to doctors from device and drug companies.

Hundreds of orthopedists and neurosurgeons have cashed in on stakes in companies that design, manufacture or distribute orthopedic implants 鈥� sometimes after investing little or no money 鈥� and despite ongoing ethical and legal concerns, a KHN investigation has found.

KHN found that surgeons had stakes in more than 200 privately owned device companies from 2013 through 2019. At the end of 2019, their holdings topped $300 million in value. Doctors can dispute the payments but rarely do so.

Device makers often reach out to orthopedic surgeons for help designing or evaluating new implants, a practice they say spurs innovation and leads to safer, more durable devices. Offering feedback can land surgeons lucrative royalty and consulting deals or stock holdings that escalate in value when startup device companies are sold. In other cases, surgeons have owned a piece of distributorships that buy implants from manufacturers and resell them at a profit.

Whistleblowers and government fraud fighters have argued for years that money passing from industry to doctors can corrupt medical judgment, inflate costs and lead to unnecessary operations or otherwise harm patients.

Some of the harshest criticism has been directed at surgeons who profit from the sale of orthopedic devices 鈥� from spinal implants and screws and other hardware to artificial knees and hips that typically cost thousands of dollars. Federal officials as far back as 2013 that these sales could violate federal anti-kickback laws.

Steinmann, a Southern California orthopedic surgeon, has been a staunch defender of the profitable distribution companies and has held a stake in at least nine of them, according to Open Payments data. He and four other surgeons at Arrowhead Orthopedics in Redlands, California, were paid nearly $2.5 million in “dividend, profit or other return on investment” by a single distributorship of implants in 2019, according to the .

The biggest surgeon investors in implant maker Renovis also owned a stake in distributorships. Steinmann received $16.4 million in “ownership and investment interest” from Renovis in 2019, according to Open Payments data, which says he invested $6.7 million in the company. Five other surgeons had holdings worth $1 million or more, according to the data.

Steinmann told KHN that he and the other surgeons invested millions in Renovis and worked for years building it. “We earned every dollar that we made,” he said. Renovis developed innovative products over a decade and the investment return was “good, but not out of line in any respect,” Steinmann said. He added: “I didn’t do any better than if I invested in the stock market. I don’t think it is fair to say otherwise.”

In testimony before Congress, Steinmann has conceded that a few may have endangered patients by performing needless, or overly complex, operations for quick profits on implant sales, but testified his distribution companies have operated legally and ethically and have saved hospitals millions of dollars on implants.

Critics counter that surgeons should collect only professional fees for operating on patients 鈥� and steer clear of taking profits from devices they choose to implant in patients. Orthopedic and neurosurgeons typically earn upward of $500,000 annually for their professional services and are among the highest-paid specialists in medicine.

“Doing surgery is a loss leader for what you can get for selling your own products,” said Dr. James Rickert, an orthopedic surgeon and head of the Society for Patient Centered Orthopedics, an advocacy group.

A 鈥楥rowded and Cutthroat Field’

The orthopedic surgery industry is awash in cash; more than $3.1 billion flowed from device makers to surgeons from August 2013 through 2019, according to KHN’s analysis of payments that device makers reported to the government-run .

Much of that money paid surgeons for consulting work, including helping to market new products to their peers, or royalties for inventing or fine-tuning surgical tools.

“Orthopedic surgeons are the type who design things. That is inherent in their nature,” said Mark Weiss, a California lawyer who represents physicians.

They also accounted for nearly a third of physicians with stakes in device and drug companies of $250,000 or more during 2019. While some surgeons lost money, many saw their stakes in these companies shoot up in value.

Consider Parcus Medical, a Sarasota, Florida device maker with a self-described “lust for innovation and creativity.” Parcus, which takes its name from the Latin word for “thrifty,” specializes in implants for repairing sports injuries. Massachusetts-based Anika Therapeutics swallowed it for $35 million in January 2020, and 22 surgeon investors saw their Parcus holdings at least triple in value, Open Payments records show.

Dr. Brian McKeon, a Waltham, Massachusetts, orthopedic surgeon and former head physician for the Boston Celtics of the NBA, held Parcus stock in 2019 valued at just over $1.4 million based on an investment of $146,000, according to the Open Payments database. The site states that McKeon did not dispute the figures as posted. But in an email to KHN, McKeon called the Open Payments numbers “way off,” adding “if you find that money please forward to me.” He said he invested in the company in 2006 and has disclosed ownership interest to his patients.

Also in January 2020, Anika Therapeutics paid $60 million for implant company Arthrosurface, which had about 20 surgeon investors; nine paid just $1 for their shares of stock, according to the company. These investments grew in value from $12,600 to $151,200 in 2019, depending on the surgeon, Open Payments records show.

Mark Namaroff, Anika’s executive director for investor relations and corporate communications, said that most of the surgeons invested in the companies prior to the acquisition.

“It was also our understanding that Arthrosurface granted certain surgeons (likely those referenced as paying $1 for stock) common stock in the company during the company’s early years as compensation for services rendered or inventions assigned to the company. As the investments by these individuals all took place prior to our purchase of the companies, we can’t provide additional information about them,” he wrote in an email.

Both Parcus and Arthrosurface had prominent sports orthopedists among their owners, including a dozen who have served as medical consultants to professional sports or U.S. Olympic teams.

It is legal for doctors to work for, or own a piece of, a medical business as long as their compensation is not tied to the volume of its products they use and provided that medical decisions are made in the best interests of patients. Several surgeons’ organizations encourage members to keep detailed records of the services they provide, accept only “fair market” compensation from device makers, and fully disclose industry ties to patients and their peers in scientific journal articles and professional meetings.

Device companies are not required to specify what work surgeons did to justify their stock awards, which more than 100 companies have granted to one or more surgeons who invested $100 or less, according to Open Payments data.

Stock can skyrocket in value after a device company’s sale.

That happened with Titan Spine, a titanium implant maker in Mequon, Wisconsin, bought by industry giant Medtronic in June 2019. In all, two dozen physician investors received more than $17 million in payments. The company reported that a few who put up no money of their own between 2014 and 2019 gained shares worth hundreds of thousands of dollars. One was Dr. Andrew Cappuccino, an orthopedic surgeon and team doctor for the NFL’s Buffalo Bills, who received “vested LLC units” valued at $387,500, according to the company’s report to Open Payments for 2019. Cappuccino had no comment.

A spokesman for Medtronic said: “Collaboration with physicians is critical to innovation and the development of medical devices that save and improve the lives of patients, as well as the training of surgeons who use them.”

Not all investors were happy with their financial gains, however. Utah orthopedic surgeon Dr. Kade Huntsman is among a group of doctors and former Titan sales executives suing the company, for which he once worked as a consultant. The lawsuit calls Titan a “glittering Cinderella success story in an otherwise crowded and cutthroat spinal implant field.”

Huntsman argues he dwelt on the “dark side” of the fairy tale after spending years providing “the voice, prestige and reputation” that made Titan’s products appealing to surgeons.

In legal filings, Huntsman said a Titan sales executive brought him into the fold in April 2014 and persuaded him to try out a Titan device in the operating room. He was so impressed with it that he quickly became “one of the company’s top utilizers” of hardware, according to the suit. Through his lawyer, Huntsman declined to comment.

Huntsman said in the lawsuit that Titan regarded him as a “potential game-changing advocate” for its implants. He talked up Titan’s products at spinal surgery conferences and later taught other surgeons how to use them, according to the suit.

Huntsman agreed to help develop a new spinal fusion implant for Titan and was “certain it would be groundbreaking” 鈥� so much so that he declined a salary in favor of company “membership units,” according to the suit.

But he alleged that Titan executives restructured his holdings, so that upon the sale to Medtronic for more than $150 million he saw a return of $180,000, “far less than the $828,750 he calculated he was entitled to receive,” according to the suit. Medtronic denied the allegations and filed a motion to dismiss the case. In June, a judge in Milwaukee dismissed most of the case. Medtronic and Titan are opposing a bid by the plaintiffs to amend their complaint, calling it “futile,” court records state.

鈥楥orruption of Their Medical Judgment’

More than a decade ago, then-New Jersey Attorney General Anne Milgram investigated global device maker Synthes for failing to disclose stock payments to surgeons conducting pre-market trials on orthopedic hardware. She called that a conflict of interest and a “betrayal of the public trust [that] has the potential to jeopardize patient well-being.”

The case centered on a spinal implant from Spine Solutions, a company partly financed by New York investment firm Viscogliosi Brothers. According to Milgram, Viscogliosi Brothers had offered the researchers “substantial investment opportunities in Spine Solutions, as well as consulting contracts that included gifts of company stock and stock options.”

Milgram argued that Synthes failed to tell the Food and Drug Administration about the stock payments after it bought Spinal Solutions for $350 million in February 2003. The FDA the device in 2006 largely on the basis of research results. In May 2009, Synthes the New Jersey investigation by agreeing to disclose any payments to physician researchers.

Viscogliosi Brothers, which went on to help finance other spinal device startups, was not a defendant in the New Jersey case. But one of its companies, Paradigm Spine, later was accused by a former sales executive of paying kickbacks through “investor opportunities” offered to dozens of spine surgeons.

The surgeons were selected “because they are in a position to generate substantial business for Paradigm, and they have done so,” according to the whistleblower’s suit, which said four of Paradigm’s top 10 users were investors. “This is a corruption of their medical judgment,” according to the suit.

The whistleblower also accused Paradigm of prompting surgeons to try an implant for an unapproved use and bill for the operation improperly, allegations the company denied. In May 2016, Paradigm to pay the government $585,000 to settle the errant billing claims, court records show. It denied any wrongdoing.

Paradigm Spine was sold to RTI Surgical, a Florida device company, in March 2019 for $300 million. A few surgeon investors wound up with $1 million or more in “ownership and investment interest,” though the company reported that many of the surgeons saw their holdings shrink in value.

When Surgeons Profit Off Implant Sales

The Front Range Center for Brain & Spine Surgery in Fort Collins, Colorado, uses implants supplied by Highline Surgical Solutions LLC, whose owners include three of the center’s surgeons, according to Open Payments filings.

The doctors their stakes in the implant company and other medical businesses, including two local surgery centers and a diagnostic imaging center, assure them of a “strong influence on the quality, cost and effectiveness” of medical services.

Highline Surgical Solutions also generated a total of more than $3 million for five surgeons from 2016 through 2020, according to Open Payments data. The Front Range Center discloses the ownership ties and notes patients “will not be treated any differently” should they ask for products from other sources. The Front Range Center had no comment.

A few companies have joined the American Association of Surgeon Distributors, a nonprofit group advised by Steinmann that has set standards for “ethical and legal” physician-owned implant distributors. Most of the distributorships with ties to Steinmann have been members, according to the distributors’ association website. As of 2018, Renovis was listed on the association’s website as a “corporate member.”

The association argues that the nation’s five largest orthopedic device companies have established an “oligopoly” that its members fight to compete with, offering “meaningful” cost savings. Steinmann has presented state and federal regulators with research papers that he says document these savings and show how these companies can be run legally and ethically, by taking steps such as forbidding a distributorship from pressuring physician owners to use its products. “There is a right way and a wrong way,” Steinmann said.

Yet the U.S. Department of Health and Human Services Office of Inspector General has argued that physician ownership in device distributors tends to prompt costlier and more-complex surgeries, calling the practice “inherently suspect” in 2013. Last December, officials these deals could violate anti-kickback laws and “induce physician owners to perform more procedures (or more extensive procedures)” and use its products “in lieu of other, potentially more clinically appropriate devices.”

KHN identified more than three dozen implant supply companies that generated millions of dollars for surgeons from 2013 through 2019. Farallon Surgical LLC, for instance, earned three California surgeons more than $7 million from 2014 through 2020, Open Payments records show. The surgeons had no comment.

About three dozen surgeons have bought stock in the Orthopaedic Implant Co., of Reno, Nevada. Most put in $1,250, an investment the company valued at $31,250 for each of those investors in 2019.

Company president Itai Nemovicher said the doctors would make money only if the company were sold. He said the company offers “high-quality implants at a lower price” to benefit patients. “We are aboveboard in everything we do,” he said in an interview.

Thomas Bulleit, a Washington lawyer who has represented device makers opposed to doctor-owned distributorships, said he sees no reason for physicians to have a stake in the implant supply trade. “The problem is doctors steering patients to products that make them money,” he said.

For their part, federal officials told KHN in interviews that they could not comment on any company’s business practices without first reviewing “all of the facts and circumstances on a case-by-case basis.” But they said the inspector general’s office has repeatedly warned physicians about ownership deals that among other things distribute “extraordinary returns on investment compared to the level of risk involved.”

Just what is permissible could be clarified by a Justice Department civil case in California that has dragged on for nearly a decade. The suit alleges that Reliance Medical Systems LLC and its non-physician owners paid kickbacks to orthopedic surgeons who agreed to use its products. One surgeon paid nothing for a 20% ownership in one of Reliance’s companies and was paid “an average of more than $500,000 per year between 2007 and 2012,” according to the suit. The suit alleges that 25 of Reliance’s 35 physician investors increased their rate of complex spinal fusions and, in some cases, elderly patients on Medicare suffered complications from operations that were “more extensive than necessary.”

Reliance and its owners have repeatedly denied violating any laws. “Our clients will never settle. They believe they have done nothing wrong and they want their day in court,” said Reliance attorney Patric Hooper.

The trial is set for early 2022.

Payments Less Than Transparent

While device companies must report physician ownership stakes, patients are largely on their own in deciphering what it all means.

The federal Centers for Medicare & Medicaid Services, or CMS, which runs the Open Payments website, offers little help. CMS “is unable to speak to how the public should interpret the data,” according to an agency spokesperson. Though it has the authority to do so, CMS has not conducted an audit to verify the accuracy of the reports it receives. One action CMS took in 2018 suggests that, at least in past years, tens of millions of dollars in orthopedic surgery-related payments was not reported.

Responding to written questions, CMS said that in 2018 it contacted about 38,000 orthopedic or neurosurgeons to remind them of the reporting requirements. The action “identified 388 new ownership records associated with 235 physicians, totaling $162,301,018 in reported payments and financial transactions,” according to the agency. “CMS considered this outreach a success,” the spokesperson said.

Much remains less than transparent, however. Some companies report paying thousands of dollars to surgeon owners one year only to disappear from the database the next. And it is rarely clear what percentage of a device company’s total stock is owned by surgeons who may influence hardware sales, an important legal and ethical distinction.

The Open Payments website refers to an ownership interest as a “payment” expressed in dollars but does not always say whether it was paid out in cash or exists only on paper 鈥� or how the surgeons obtained their holdings in the company. Some surgeons apparently invested cash, sometimes hundreds of thousands of dollars. Yet there is no explanation of how some surgeons put up $100 or less for stakes that later soared in value. That makes it all but impossible to know whether the compensation paid to a surgeon was reasonable as required by ethics standards and federal anti-kickback laws.

“There are legitimate arrangements and possibly illegitimate ones,” said Richard Saver, a University of North Carolina School of Law professor who has the reporting system. “Separating the two is proving very difficult.”

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Dr. Ra’Kerry Rahman went ahead with the operation, and Martinez awoke feeling pain and some numbness, she alleges. When Rahman removed the plastic device four days later and replaced it with a smaller one, Martinez suffered nerve damage and loss of feeling in her left leg, she claims.

Martinez is suing the surgeon, implant maker Life Spine Inc., and its distributor and sales representatives, alleging their negligence led to her injuries because the right part wasn’t available during her first surgery. All deny wrongdoing. The case is set for trial in November.

The lawsuit takes aim at the bustling sales networks that orthopedic device manufacturers have built to market ever-growing lines of costly surgical hardware 鈥� from spinal implants to replacement knees and artificial hips commonly used in operations. Sales in 2019 topped $20 billion, though covid-19 forced many hospitals to suspend elective surgeries for much of last year.

Device makers train sales reps to offer surgeons technical guidance in the operating room on the use of their products. They pay prominent surgeons to tout their implants at medical conferences 鈥� and athletes to offer celebrity endorsements. The industry says these practices help ensure that patients receive the highest-quality care.

But a KHN investigation found these practices also have been blamed for contributing to serious patient harm in thousands of medical malpractice, product liability and whistleblower lawsuits filed over the past decade.

Some patients allege they were injured after sales reps sold or delivered wrong-size or defective implants, while others accuse device makers of misleading doctors about the safety and durability of their products. Six multi-district federal cases have consolidated more than 28,000 suits by patients seeking compensation for injuries involving hip implants, including painful redo operations.

In other court actions, patients and whistleblowers repeatedly have accused device companies of failing to report injury-causing defects to federal regulators as required 鈥� or of doling out millions of dollars in illegal kickbacks to surgeons who agreed to use their products. Device makers have denied the allegations and many such cases are settled under confidential terms.

At least 250 companies sell surgical hardware, and many more distribute it to doctors and hospitals across the country. Spine companies alone obtained more than 1,200 patents for devices in 2018, according to an industry report. Many come to market through a streamlined Food and Drug Administration process that approves their use because they are essentially the same as what is already being sold.

“In orthopedics, we are inundated with a multitude of new implants that debut each year,” Dr. James Kang, chairman of the orthopedic surgery department at Brigham and Women’s Hospital, remarked at a Harvard Medical School roundtable discussion in 2019.

Kang said surgeons often rely on industry “reps” in the operating room for guidance because it is “usually burdensome and difficult” for surgeons to know “all of the intricate details and nuances” of so many products.

Martinez’s lawsuit says the process went awry during her May 2018 spinal fusion in Houston, an operation in which an implant is inserted into the spinal column to replace a worn or damaged disc.

Martinez was under anesthesia, with her spine destabilized, when Rahman discovered the Life Spine surgical kit did not contain any implants shorter than 50 millimeters, or about 2 inches. That was too large, according to the complaint. Martinez, a former day care worker, blames her injuries on the redo operation, which replaced the implant with a 40 mm version Life Spine supplied later.

Through his lawyer, Rahman declined to comment. In court filings, the surgeon has denied responsibility. His operating notes, according to court pleadings, say he had ordered “all lengths available” of the implant through a Life Spine distributor and its sales reps. In a June court filing, Rahman contends the “small area of leg numbness experienced by Ms. Martinez was a known complication of the first surgery 鈥� and was not the result of any alleged negligence.”

In the court filing, Rahman also argues it was “appropriate” for him to rely on the sales reps and hospital staff to “inform him as to whether all materials and equipment needed for surgery were available.”

Illinois-based Life Spine also denies blame. In court filings, it says the sales reps initially ordered a sterile kit that included only implants from 50 mm to 55 mm long, which it duly shipped to Houston.

At the time of Martinez’s operation, Life Spine was the target of a sealed whistleblower lawsuit accusing it of paying improper consulting fees and other kickbacks to more than 60 surgeons who agreed to use its wares. Court records in the whistleblower case identify Rahman as one of the company’s paid consultants, although he and the other surgeons were not named as defendants. Life Spine and two of its executives settled the matter in November 2019 by paying a total of nearly $6 million. An orthopedic surgery expert hired by Martinez for her suit faulted Rahman for not making sure he had the right gear “prior to the start of surgery,” according to his report. The expert also criticized the sales rep for failing to bring “all available lengths to the procedure or to inform Dr. Rahman that the necessary implants were not available,” court records show. The sales rep and distributor denied any blame, arguing in court filings that they “met all applicable standards of care.”

Frenzied Competition for Sales

Major device makers train a corps of sales agents, some recruited right out of college, to cultivate and work closely with surgeons 鈥� one likened the relationship to a caddy and an avid golfer. Duties can include lugging 20-pound sets of surgical hardware to the operating room, assuring it is sterile and knowing its specifications, though the reps are not required to have medical training or credentials.

Stryker, one of the nation’s top four spine implant manufacturers, spends what it calls “a significant amount of time and money” to train reps. When hired, they typically “shadow” other reps for three to six months, then attend a 10-day intensive “Spine School” and other training. In all, the company said in a court filing, it typically takes eight to 18 months, often longer, to develop “long-term relationships” with customers.

For those who do, the jobs can pay handsomely. Veteran reps who influence which brands of hardware surgeons select command salaries and bonuses that can stretch into the low six figures and beyond, court records show.

The market is so hotly competitive that device makers typically require reps to sign contracts that prohibit them from working for a rival company in the same territory for a year or more 鈥� and aren’t shy about suing to fend off raids on their staffs, court records show.

In 2019, DePuy Synthes sued an Alabama sales rep who jumped ship, blaming him for stealing away accounts “worth millions of dollars practically overnight.” An arm of health care giant Johnson & Johnson, DePuy Synthes filed at least two dozen similar suits from 2014 through the end of 2020, court records show. Most, including the case of the Alabama sales rep, have been settled under confidential terms.

Some companies have spent lavishly to poach experienced sales agents 鈥� practices that can violate business conduct laws. One allegedly paid a New York sales pro a “staggering, seven-figure signing bonus.” Another is said to have dangled an $800,000-a-year job as “director of surgeon education,” while a gambit to make inroads in the Phoenix market dubbed “Sun Devil” guaranteed a branch manager a $500,000 annual salary, court records show. Another promised a sales agent $900,000 paid out over three years.

Whistleblowers and government investigators have argued for years that so much money changing hands can lead to kickbacks or other marketing schemes that corrupt medical judgment and endanger patients. Some injury suits also have blamed sales reps and distributors for staying mum about product deficiencies they observed in the operating room. These cases often are settled with no admission of wrongdoing.

Sometimes, surgeons help promote implants at medical meetings and other gatherings. Orthopedic surgeons and neurosurgeons received a total of about $511 million in industry consulting fees from 2013 through 2019 and nearly $300 million more for “serving as faculty or speaker” at industry-sponsored events, a KHN analysis of government data found. AdvaMed, the device industry’s trade group, says doctors often take “primary responsibility” for training other doctors to use new devices. “Unlike a pill or injection, procedures to implant or equip medical devices for patients can be extremely technical and complex,” said Scott Whitaker, the group’s president and CEO.

Some prominent surgeons who touted products that later were recalled, or who helped train surgeons to use implants, have been criticized in pending injury lawsuits.

One is Dr. Brad Penenberg, an orthopedic surgeon in Beverly Hills, California, paid by Wright Medical Technology as a “key opinion leader,” according to court filings. Multiple lawsuits cite a webinar for orthopedic surgeons that featured Penenberg and said hip surgery patients could resume “activities and lifestyles that include such things as tennis, horseback riding and snow skiing.”

Injured patients are arguing in court filings that Penenberg and several other experts paid by the company knew of significant failures of the hip device. Penenberg did not respond to numerous requests for comment but in court papers denied the allegations.

Hundreds of patients are claiming injuries they blame at least partly on overly aggressive marketing by Wright Medical. In one 2020 lawsuit, a Montana man who had received a hip implant said he was taking a walk while in Arizona on vacation when he “felt a severe jolt in his groin and fell.” He was out of cell range and could not get up or call for help. A “good Samaritan” called for an ambulance, which took him to a hospital in Gilbert, Arizona, where X-rays showed a fracture of the implant. It was removed and replaced. Wright Medical has denied the allegations.

Retired California psychologist Herb Glazeroff is suing Penenberg and Wright Medical Technology over a hip replacement that allegedly failed about five years after the surgeon installed it. In May 2019, Glazeroff was walking when he “suddenly dropped to his knees as his left leg gave out on him,” according to the suit. He alleges that the hip had fractured, which required a painful second operation and “a long and arduous rehabilitation program” from which he has “yet to fully recover.” Glazeroff argues that Penenberg failed to warn him about the implant’s dangers even though the surgeon had been named in “multiple lawsuits” alleging device defects. Penenberg has denied the allegations.

Dozens of lawsuits have taken aim at Indiana device maker Biomet’s advertising a hip replacement for “younger, more active patients” that showcased Olympic gold medal gymnast Mary Lou Retton. One ad says “Mary Lou lives pain-free, and so should you.” Yet Retton suffered painful heavy-metal poisoning requiring the implant’s removal and sued the company for damages, according to court records.

In a January 2020 court filing in Houston, Retton tried to block a subpoena seeking her deposition in a product liability lawsuit filed against Biomet by two patients in King County, Washington. The Washington case has since been settled and the deposition did not occur. But in a court filing opposing the subpoena, Retton confirmed she had a Biomet implant put in her left hip in 2005 and one on her right side about six years later. She said she promoted Biomet products from April 2006 through April 2013 and sued the company in January 2018, alleging the implants were defective. Retton said she and Biomet settled the suit in early 2019 “under confidential terms the parties find favorable to their respective positions. [Ms. Retton] values her long relationship with Biomet and her continued use of her [Biomet hip implants] and [Biomet] appreciates the support it has received over the years from [Ms. Retton].”

Defects Ignored, Downplayed

Whether touted by renowned surgeons or celebrities, orthopedic surgery marketing materials stress quick improvement in a person’s quality of life. That proves true for most patients. Yet researching how often implants fail or cause life-changing injuries 鈥� and which brands have the best safety records 鈥� can be daunting.

The FDA requires device makers to advise the agency of information “that reasonably suggests” a device they sell “may have caused or contributed to a death or serious injury or has malfunctioned” in a way that could recur. The FDA posts the reports on a public , with the caveat that they may convey “incomplete, inaccurate, untimely, unverified, or biased data.”

KHN found that thousands of malpractice and product liability lawsuits have accused device marketers of concealing or downplaying hardware defects, leaving patients and their doctors in the dark about possible risks. In many cases, these claims are bolstered by company records, or actions by state or federal regulators. In 2019, for instance, DePuy Synthes $120 million to settle a lawsuit filed by 46 state attorneys general; the suit accused the company of advertising that a replacement hip it sold lasted three years in 99.2% of operations, when it knew of data showing that 7% had failed within that time. The company did not admit wrongdoing in settling the case.

British device company Smith & Nephew faces a federal civil proceeding comprising nearly 1,000 injury suits, including one that says the company “underreported and withheld” notices of malfunctions and “willfully ignored the existence of numerous complaints about [its] failures.” An expert hired by the patients cites a company audit showing “significant adverse events” were logged from two days to 142 days late, while a corporate memo circulated among executives to push sales was titled “Milk the Cash Cow,” according to court records. Smith & Nephew has denied the allegations and in one court paper called the expert’s opinions “speculative.”

A cluster of Florida injury cases pertaining to a knee implant from German manufacturer Aesculap alleges that the FDA the company for failing to report 25 adverse incidents 鈥� in some cases for a year or more 鈥� as a result of an inspection at its Hazelwood, Missouri, plant in September 2015. Aesculap has denied the allegations and the suits are pending in Florida’s Indian River County Circuit Court.

John Saltis is suing spinal device company NuVasive over its handling of his complaint that a screw holding his spinal implant in place snapped in May 2016, about 17 months after his operation.

Saltis, 68, was two hours into his workday as a toolmaker at General Electric in Rutland, Vermont, when he felt sharp pain in his neck and shoulder, bad enough to send him to the hospital emergency room. A few days later, X-rays revealed the screw had broken and, according to Saltis, fractured vertebrae in the process.

Saltis said the San Diego-based device company told the FDA the incident caused no harm. But Saltis said he has lingering numbness and pain in his right hand. As a result, he said, his lifestyle has “changed dramatically.” He sold his motorcycle and stopped biking and now relies on his left hand for simple tasks like opening doors and shaking hands 鈥� even plucking chips out of a bag.

“I miss things like bowling and playing toss with my grandkids,” he said.

In 2019, Saltis sued NuVasive without a lawyer, hoping to show the $600 screw was defective. In a court filing, NuVasive said Saltis is arguing “the screw is defective because it broke.” That’s not good enough, according to NuVasive, which argues that Saltis must show the screw was “unreasonably dangerous” to press his claim. In late June, a federal judge agreed and dismissed the suit, though she allowed Saltis to amend his complaint, which he is pursuing. The case is pending.

“I was pain-free for a few months and would have stayed that way if the screw hadn’t broken,” Saltis said. “This can change somebody’s life completely.”

A Push for Change as Pandemic Eases

As hospitals resume elective operations stalled by the coronavirus, some industry critics see an opportunity to rethink orthopedic surgery practices 鈥� from sales to tracking of injuries.

Some want to keep industry reps out of operating rooms and place tighter restrictions on their access to hospitals. They say the current system needlessly drives up health care costs and exposes patients to risks such as infection from extra people in the operating room. Reps counter that their incomes have been dropping due to global purchasing arrangements that give hospitals greater say over prices for surgical equipment.

Sales reps say their technical knowledge and skills make operations safer for patients and note that many surgeons enjoy the security of having them present in the operating room. Reps also say they perform tasks that hospitals would need to hire additional personnel to do, such as keeping track of device inventories.

“The industry has embedded reps into the supply chain, and it is a hard culture to break,” said Itai Nemovicher, president of the Orthopaedic Implant Co., which seeks to produce lower-cost implants.

Yet guidelines for “reentry” after covid put out by AdvaMed and the American Hospital Association say medical device reps should deliver “services, information and support remotely whenever possible.” The guidelines advise hospitals to use videoconferencing gear when it “does not compromise patient safety or privacy.”

Dr. Adriane Fugh-Berman, a professor of pharmacology and physiology at Georgetown University, said device reps are viewed as part of the operating room team even though they are there “to sell products. That is pretty horrifying from a patient’s point of view.” She said hospitals should train staff to perform these functions. “Relying on sales reps in the OR is appalling. We need to come up with a better system.”

Greater transparency might have helped Little Rock, Arkansas, resident Christopher Paul Bills. He sued Consensus Orthopedics, the maker of a hip implant system that he alleged failed and sent metal through his hip joint that his surgeon said in 2016 looked “as if a bomb had gone off.” An Australian registry that tracks outcomes of operations had in September 2014 identified the implant as having a “higher number” of hip failures compared with other manufacturers, according to the suit.

Bills underwent four operations and spent more than a year in the hospital and in rehabilitation, costs borne by Medicare and private insurance.

“Mr. Bills was left with no right hip at all and his surgeon does not plan to install a replacement hip,” the suit says. Bills uses an electric scooter to get around and hopes to graduate to hand-held crutches. “Since his right leg is useless, he will require a vehicle with hand-controls to drive,” according to the suit. The company disputed Bills’ claims and denied its hip system had any defects.

The case ended in 2019 when Bills died of cancer unrelated to his operations, said his lawyer, Joseph Saunders.

“He never did get justice,” Saunders said.

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Chin has patented more than 40 pieces of such hardware, including doughnut-shaped plastic cages, titanium screws and other products used to repair spines 鈥� generating $100 million for his company SpineFrontier, according to government officials.

Yet SpineFrontier’s success arose not from the quality of its goods, these officials say, but because it paid kickbacks to surgeons who agreed to implant the highly profitable devices in hundreds of patients.

In March 2020, the Department of Justice accused Chin and SpineFrontier of illegally funneling more than $8 million to nearly three dozen spine surgeons through “sham consulting fees” that paid them handsomely for doing little or no work. Chin had no comment on the civil suit, one of more than a dozen he has faced as a spine surgeon and businessman. Chin and SpineFrontier have yet to file a response in court.

Medical industry payments to orthopedists and neurosurgeons who operate on the spine have risen sharply, despite government accusations that some of these transactions may violate federal anti-kickback laws, drive up health care spending and put patients at risk of serious harm, a KHN investigation has found. These payments come in various forms, from royalties for helping to design implants to speakers’ fees for promoting devices at medical meetings to stock holdings in exchange for consulting work, according to government data.

Health policy experts and regulators have focused for decades on pharmaceutical companies’ payments to doctors 鈥� which research has shown can influence which drugs they prescribe. But far less is known about the impact of similar payments from device companies to surgeons. A drug can readily be stopped if deemed harmful, while surgical devices are permanently implanted in the body and often replace native bone that has been removed.

Every year, a torrent of cash and other compensation flows to these surgeons from manufacturers of hardware for spinal implants, artificial knees and hip joints 鈥� totaling more than $3.1 billion from August 2013 through the end of 2019, a KHN analysis of government data found. These bone specialists make up a quarter of U.S. doctors who have accepted at least $100,000 or more, and two-thirds of those who raked in $1 million or more, from the medical device and drug industries last year, the data shows.

“It is simply so much money that it is staggering,” said Dr. Eugene Carragee, a professor of orthopedic surgery at the Stanford University Medical Center and of the medical device industry’s influence. Much of the money is deemed to be compensation for consulting duties or medical research, or royalties for inventing, or fine-tuning, new surgical tools and techniques. In some cases, it pays for trips or splashy junkets or rewards surgeons for promoting products to their peers.

Device makers say the long-established practice leads to higher-quality, safer products. “Doctors help develop and refine medical devices, and they even create new devices themselves, sharing their intellectual property with companies to help save and improve patients’ lives,” said Scott Whitaker, president and CEO of AdvaMed, the medical technology industry’s trade group.

But industry whistleblowers and government investigators say all that money changing hands can corrupt medical judgment and tempt surgeons to perform unnecessary and wasteful operations. In ongoing lawsuits, patients say they have suffered life-altering injuries from screws or other spinal hardware that snapped apart or live with disabilities they blame on defective knee or hip implants. Patients alleging injuries range from seniors on Medicare to celebrities such as Olympic gold medalist Mary Lou Retton, who had surgery to replace both her hips. The gymnast sued device maker Biomet in January 2018, alleging the hip implants were defective. The suit has since been settled under confidential terms.

The case of Chin’s company, SpineFrontier, is among more than 100 federal fraud and whistleblower actions, filed or settled mostly in the past decade, that accuse implant surgeons of taking illegal compensation from device makers 鈥� from surgeon entrepreneurs like Chin to marquee names like Medtronic and Johnson & Johnson. In some cases, device makers have paid hundreds of millions of dollars in fines to wrangle out of trouble for their involvement, often without admitting any wrongdoing.

Court pleadings examined by KHN identified more than 700 surgeons who have taken money, including dozens who pocketed millions in royalties, fees or other compensation from 2013 through 2019.

The names of hundreds more surgeons were redacted in court filings or sealed by judges.

Court filings 35 spine surgeons who used SpineFrontier’s surgical gear, some for years. At least six of those surgeons have admitted wrongdoing and paid a total of $3.3 million in penalties. Another has to criminal charges. It’s illegal under federal law to accept anything of value from a device maker for using its wares, though most offenders don’t face criminal prosecution.

Chin, 57, who lives in Fort Lauderdale, Florida, and owns SpineFrontier through his investment company, declined comment about the DOJ lawsuit or the consulting agreements.

“There is a court date [for the DOJ case] as ordered by a judge,” Chin said via email.鈥�“If we get to that point the facts of the case will be litigated.”

Back Surgeries Under Scrutiny

The nation’s outlay for spine surgery to treat back pain, or to replace worn-out knees and hips, tops $20 billion a year, according to one industry .

Taxpayers shoulder much of that cost through Medicare, the federal program for those 65 and older, and Medicaid, which caters to low-income people.

In one common spinal procedure, surgeons may replace damaged discs with an implant and screws and metal rods that hold it in place. The demand for surgery to replace worn-out knees and hips also has mushroomed as aging boomers and others seek relief from joint pain that restricts their movement.

Perhaps not surprisingly, the competition for sales of orthopedic devices is fierce: Some 250 companies proffer a dizzying array of products. Industry critics blame the Food and Drug Administration, which allows manufacturers to roll out new hardware that is substantially equivalent to what already is sold 鈥� though it often is marketed as more durable, or otherwise better for patients.

“The money is just phenomenal for this medical hardware,” said Dr. James Rickert, a spine surgeon and head of the Society for Patient Centered Orthopedics, an advocacy group. He said most of the products are “essentially the same,” adding: “These are not technical instruments; [it’s often] just a screw.”

Hospitals can end up charging patients $20,000 or more for the materials, though they pay much less for them. Spine surgeons 鈥� who make upward of $500,000 a year 鈥� bill separately and may charge $8,000 to $20,000 for major procedures.

Which equipment hospitals choose may fall to the preference of surgeons, who are wooed by manufacturing sales reps possibly present in the operating room.

And it doesn’t stop there. Whistleblower cases filed under the federal False Claims Act allege a startling array of schemes to influence surgeons, including compensating them for joining a medical society created and financed by a device company. In other cases, companies bought billboard space or other advertising to promote medical practitioners, hired surgeons’ relatives, paid for hunting trips 鈥� even mailed checks to their homes.

Orthopedic and neurosurgeons collected more than half a billion dollars in industry consulting fees from 2013 through 2019, federal payment records show.

These gigs are legal so long as they involve professional work done at fair market value. But they have drawn fire as far back as 2007, when four manufacturers that dominated the hip and knee implant market, including a J&J division, to pay $311 million to settle charges of violating anti-kickback laws through their consulting deals.

KHN found at least 20 whistleblower suits, some settled, others pending, that have since accused device makers of camouflaging kickbacks as consulting work, including paying doctors to sit on suspect “advisory boards” or other activities that entailed little work to justify the fees.

In November 2019, device maker Life Spine and two of its executives admitted to paying consulting fees to induce dozens of surgeons to use Life Spine’s implants in the operating room. In all, 21 of the top 30 Life Spine adopters were paid and they accounted for about half its total device sales, according to the Justice Department. Life Spine and the executives a total of $6 million in penalties. The company did not respond to requests for comment.

Similarly, SpineFrontier received “the vast majority” of its sales, more than $100 million worth, from surgeons who were compensated, the Justice Department alleges. Often, they were paid by way of a “sham” company run by Chin’s wife, Vanessa, from a mail drop in Fort Lauderdale, according to the Justice Department. Vanessa Dudley Chin, a defendant in the DOJ civil case, had no comment.

Kingsley Chin told KHN via email that he takes no salary from SpineFrontier, based in Malden, Massachusetts. In 2013, Chin received $4.3 million in income from the company, according to court filings in a divorce case in Philadelphia from an earlier marriage. In 2018, SpineFrontier valued Chin’s interest in the company at $75 million, according to government records, though its current worth is unclear.

SpineFrontier’s management thought paying doctors was “the only reliable way to steadily increase its market share and stave off competition,” Charles Birchall, a former business associate of Chin’s, alleged in a whistleblower complaint. The case is one of two whistleblower suits filed against SpineFrontier that the DOJ has joined and consolidated. Chin has yet to file a response in court.

From March 2013 through December 2018, the company offered some surgeons $500 or more an hour for “consulting,” which could include the time they spent operating on patients 鈥� even though they already were being paid by Medicare or other health insurers. Other surgeons were paid repeatedly to “evaluate” the same products, though their feedback was “often minimal or nonexistent,” according to the DOJ complaint.

Patient Injuries Pile Up

While the payments have piled up for doctors, so have injuries for patients, according to lawsuits against device makers and whistleblower testimony.

Orthopedic surgeon-turned-whistleblower Dr. Manuel Fuentes is suing his former employer, Florida device maker Exactech, alleging it offered “phony” consulting deals to surgeons who had complained about alarming defects in one of its knee implants.

Their findings should have been forwarded to the FDA to protect the public, Fuentes and two former Exactech sales reps alleged in their suit. Instead, the company paid the surgeons “to retain their business and secure their silence” about patients needlessly undergoing a second operation to address the defects implanted in the first, according to the suit. Lawyer Thomas Beimers, who represents Exactech in the case, said the company “emphatically denies the allegations and looks forward to presenting the real facts to the court.” In a court filing, the company said the suit was “full of conclusory, vague and immaterial facts” and said it should be dismissed.

In Maryland, spine surgeon Dr. Randy F. Davis faces a lawsuit filed in early 2020 by 14 former patients who claim he implanted counterfeit hardware from a device distributor that had paid him hundreds of thousands of dollars in consulting fees and other compensation.

Davis used the hardware, which had not been FDA-approved, on about 250 patients at the University of Maryland Baltimore Washington Medical Center in Glen Burnie, Maryland, according to the suit. Several patients say screws or other implants failed and they sustained permanent injuries as a result. One woman said she was left with little feeling in her right foot and needs a cane or walker to get around. Others claim “extreme mental anguish” for fear the hardware inside them will fail, according to the suit.

The patients allege that Davis improperly disposed of defective screws and other hardware he removed rather than send the items for analysis or report the failures to authorities. Instead, the University of Maryland hospital sent “hush” letters to patients that falsely told them that no defects had been found, according to the suit. A spokesperson for the hospital, which also is a defendant in the suit, denied the allegations, noting: “We will vigorously defend this lawsuit and at its conclusion are quite confident we will prevail.” Davis and his lawyer didn’t respond to repeated requests for comment. The lawsuit is pending in Anne Arundel County state court.

Surgeons are free to implant devices they helped bring to market or promoted, though doing so can prompt criticism when injuries or defects occur.

That happened when three patients filed lawsuits in 2018 against Arthrex, a Florida device company. The patients argued they were forced to undergo repeat operations to replace defective Arthrex knee devices implanted by Pennsylvania orthopedic surgeon Dr. Thomas Meade.

Meade was not a defendant in the cases. But the patients accused him of misleading them about the product’s safety and a recall. One noted that Meade had served as a prominent consultant to Arthrex and had “participated in the design, testing, marketing, promotion and sales” of the knee implant. The patient alleged that Arthrex had paid Meade more than $250,000 for work that included “promotional speaking, travel, lodging, and consulting.”

In court filings, Arthrex admitted making payments to Meade for “consulting and royalties” but denied wrongdoing. The cases were settled in 2020. Meade did not respond to requests for comment.

Chin’s dual roles as SpineFrontier’s CEO and user of its hardware was called a “huge” conflict of interest by a judge in a pending malpractice case filed against him and the company in South Florida.

In that case, Miami resident Patrick Chapoteau alleges Chin performed back surgery in 2014 using SpineFrontier hardware even though it had little chance of success. According to the suit, a Chin-designed screw implanted to stabilize Chapoteau’s spine broke in half, causing him pain and disabling injuries.

In a legal brief, Chin’s lawyers argued that he regularly operates on people with disabling back problems, noting: “The surgery is sophisticated and challenging. On a few rare occasions, his patients have not obtained the relief they expected or experienced unanticipated complications that required additional care.”

Joseph Wooten, a former Chin patient and Florida power company employee, alleged in a 2014 lawsuit in Broward County Circuit Court that Chin had 15 previous malpractice claims that had ended in more than $8 million in settlements, an assertion Chin’s lawyers disputed.

“He never told me of his bad record injuring people,” Wooten, 64, wrote in a court filing. He and his wife, Kim, said the surgery caused “debilitating and life-altering injuries.” The case has since been settled. Chin acknowledged no wrongdoing and the terms are confidential.

KHN reviewed court pleadings in nine settled malpractice cases in Philadelphia, where Chin served on the faculty of the University of Pennsylvania Medical School from 2003 to 2007, and six in South Florida filed since 2012. Details of the settlements are confidential. Five of the six South Florida cases are pending, including one filed in December by the widow of a man who died shortly after spine surgery. In all the cases and settlements, Chin has denied negligence.

In her lawsuit pending against Chin in South Florida, Nancy Lazo of Hialeah Gardens, Florida, said she slipped and tumbled down the stairs outside her Miami office, landing on her back and arm. When the pain would not go away, she turned to Chin and had two operations, in 2014 and 2015. Her lawyers allege that a SpineFrontier screw Chin implanted in her spine in the second procedure caused nerve damage. Lazo, 51, a former billing clerk with two adult sons, said she can no longer work and remains in “constant” pain. “Based on what my doctors have told鈥痬e,” she said, “I will never get back to normal.” Chin denied any negligence and the case is pending.

“Based on what my doctors have told鈥痬e, I will never get back to normal.”

鈥� Nancy Lazo

Government Struggles to Keep Pace

Concerns that industry payments can corrupt medical practice have been aired repeatedly at congressional , in media and in federal . The recurring scandals led Congress to require that device makers and pharmaceutical companies report the payments, starting in August 2013, to a government-run website called . That website shows that payments to all doctors have risen from $8.6 billion in 2014 to just over $10 billion last year. A recent found payments by device makers exceeded those of pharmaceutical companies by a wide margin.

Both the North American Spine Society and the American Academy of Orthopaedic Surgeons told KHN that close ties with the industry, while seeming to generate huge payouts to some surgeons, lead to the design of safer and better implants. “These interactions are really essential for good outcomes in patient care and that needs to be preserved,” said Dr. Joshua J. Jacobs, who chairs the orthopedic surgery department at Rush University Medical Center in Chicago and the AAOS’鈥痚thics committee.

Although more than 600,000 American doctors lap up industry largesse, most do so through small payments that cover the cost of food, drinks and travel to industry-sponsored events. When it comes to big money, however, orthopedists and neurosurgeons dominate, collecting 25% of the total 鈥� even though they represent only 5% of the doctors accepting payments, according to the KHN analysis of Open Payments data.

Dr. Charles Rosen, a spine surgeon and co-founder of the advocacy group Association for Medical Ethics, said he was once offered $2,000 just to show up and watch an industry-sponsored panel. “It was quite unbelievable,” he said.

Rosen said while he believes a “relatively small number” of surgeons cash whopping industry checks, many who do so are influential figures who can “help direct medical care.”

Government data confirms that even as several orthopedic and neurosurgeons received tens of millions of dollars in 2019, 81% of them got less than $5,000 from industry.

Federal officials recently signaled their displeasure with the hefty fees paid to doctors who promote their products to peers, especially at restaurants, entertainment or sports venues that feature free food and booze but little educational content. In November, the inspector general at the Department of Health and Human Services issued a that such gestures could violate anti-kickback laws.

Companies that ignore the reporting law can be fined up to $1 million, though no fines were levied from 2014 through spring 2020, according to a CMS . That changed in October, when device giant Medtronic to pay the government $9.2 million to settle allegations that it paid kickbacks to Sioux Falls, South Dakota, neurosurgeon Dr. Wilson Asfora to promote its goods. Officials said the company sponsored more than 100 events at a Brazilian restaurant owned by the surgeon to clinch the sales. Just over $1 million of the fine was assessed for failing to report the transactions. A Medtronic spokesperson said the company fired or took other disciplinary action against the sales employees involved and “remains committed to maintaining the highest standards of ethical conduct.”

KHN identified four spinal device makers 鈥� including SpineFrontier 鈥� that have been accused in whistleblower cases of scheming to hide consulting payments from the government.

Responding to written questions, a CMS spokesperson said the agency “has multiple formal compliance actions pending which it is unable to discuss further at this time.”

But penalties for paying, or accepting, kickbacks often are small compared with the profits they can generate.

“Some people would say if you penalize companies enough, they won’t be making these offers,” said Genevieve Kanter, an assistant professor at the University of Pennsylvania Perelman School of Medicine. She said small fines may be chalked up to the “cost of doing business.”

The Federation of State Medical Boards does not keep data on how often its members discipline doctors for civil kickback offenses, according to spokesperson Joe Knickrehm. The federation has “long advocated for stronger reporting requirements,” Knickrehm said.

Justice Department officials would not discuss whether they are seeking fines from more surgeons. But in a in April 2020, then-U.S. Attorney for the District of Massachusetts Andrew E. Lelling noted that the government will investigate any doctor “who accepts money from a device manufacturer simply for using that company’s products.”

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