Who can’t see problems in medical device makers paying surgeons billions?

Patrick Malone & Associates P.C. | DC Injury Lawyers
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Patrick Malone & Associates P.C. | DC Injury Lawyers

devicemakerdocpay-300x225Billions of dollars have flown from medical device makers to specialists performing back, spine, knee, and hip surgeries, with unsavory cash and practices also accompanying that fiscal tide.

Industry officials and doctors defend the sizable and growing payment program, saying it results in better medical hardware that ultimately benefits patients, the independent, nonpartisan Kaiser Health News service reported. Data show the bulk of payments from medical-device makers to doctors were for royalties and licensing of products and consulting on them.

But investigative reporters Fred Schulte and Elizabeth Lucas have found that the enriching bonanza concerns regulators, ethicists, and patient advocates:

“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 — 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 — 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 critic 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.”

Patients suffer harms

The KHN report drills down on harmful and corrupt practices that have involved specialists in the area around the nation’s capital and others by examining federal prosecutions, lawsuits, and other sources:

“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 investigation describes in detail improprieties involving a company called Spine Frontier and other medical-device makers and their payments:

“The case of … 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 — from surgeon entrepreneurs … 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.”

Surgeons who admitted accepting “consulting” fees from Massachusetts-based SpineFrontier for services they did not perform paid the government hefty settlement fines. Among the doctors KHN identifies as paying fines were Dr. Jeffrey Carlson of Newport News, Va. ($1.75 million in fines) and Dr. Agha Khan, of Maryland ($310,843).

It’s just a screw

Critics of the medical-device makers’ payments say that, contrary to what industry officials insist about the sums helping to improve medical hardware, the practice may only encourage the proliferation of gear that differs in the smallest of ways. Still, because specialists have huge sway with hospitals about surgical hardware, patients and taxpayers may end up footing higher bills to stock an array of basically similar implements. Hospitals, of course, take their own markup on surgical items.

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

Schulte and Lucas reported that federal regulators have struggled to keep up with spiking industry payments to doctors — from Big Pharma, as well as medical-device makers:

“Concerns that industry payments can corrupt medical practice have been aired repeatedly at congressional hearings, in media exposés and in federal investigations. 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 Open Payments. 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 study found payments by device makers exceeded those of pharmaceutical companies by a wide margin.”

Not good. In my practice, I see not only the harms that patients suffer while seeking medical services, but also the damage that can be inflicted on them by defective and dangerous products, notably those used in health care. The large sums sloshing around doctors, hospitals, and device manufacturers should provide an urgent call to regulators and prosecutors to safeguard the public treasuries, as well as patients’ well-being from big money’s corruptive influences. Let’s not forget that government health programs like Medicare and Medicaid fork over billions of dollars annually for orthopedic procedures, notably the highly popular and common knee and hip procedures of older patients.

The public watchdog is snoozing

Critics have for some time now ripped the federal Food and Drug Administration for its lax oversight of increasingly complex, costly, and downright dubious medical devices and hardware. The FDA found to its horror that the watchdog and oversight agency allowed makers to stash millions of grievous complaints about these items out of public view and in ways that might have kept regulators themselves in knowing about products’ risks.

The agency also has come under fire for its pro-industry tilt, waving along regulations that allow minimal oversight of products before they get to market, simply because they sort of resemble the design or workings of already-approved items.

The FDA plays a crucial role in protecting the public and patients from potential harms from prescription drugs and medical devices — a heavy and major responsibility at which, signs show, the agency is sputtering, at best. President Biden needs to install a new chief at the agency, pronto, a no-nonsense, effective leader-politician-administrator who can work with the White House and Congress to get things back on tract. We have a lot of work to do to put patients and their safety and needs first. And to ensure that rivers of money gushing through the U.S. health care system do not sink into the mire.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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