Could One Company Be . . . Medtronic? St. Jude?

Replacing Faulty Heart Devices Costs Medicare $1.5 Billion in 10 Years

By FRED SCHULTE and CHRISTINA JEWETT   OCT. 2, 2017  The New York Times

WASHINGTON — Medicare paid at least $1.5 billion over a decade to replace seven types of defective heart devices, a government watchdog says. The devices apparently failed for thousands of patients.

A report released on Monday by the inspector general’s office for Health and Human Services said officials needed to do a better job tracking these costly product failures to protect patients from harm. More detailed reporting could lead to earlier recognition of serious problems with medical devices and faster recalls of all types of “poorly performing” ones, the inspector general’s office said.

The report marks the first effort by anyone in government to assess the losses to taxpayers and patients 65 and older from medical gear that proves faulty.

Officials said the $1.5 billion lost from the seven devices from 2005 through 2014 was a “conservative estimate.” Patients also paid $140 million in out-of-pocket costs for this care, the report noted.

The report found that nearly 73,000 people on Medicare had one of the seven devices replaced because of recalls, premature failures, medically necessary upgrades or infections. It did not outline specific injuries that patients suffered as a result.

The inspector general did not identify the manufacturers of the seven devices, but officials said they included implanted cardio defibrillators and a pacemaker that had either been recalled because of flaws or had “prematurely failed.” Pacemakers and implantable defibrillators are small devices placed under the skin to help treat irregular heartbeats.

How best to identify these defects and cut Medicare spending associated with fixing them has been under consideration at various times since 2007, according to the report. But it remains a contentious issue.

The inspector general recommended that hospitals and doctors be required to submit detailed information identifying failed devices, like serial and batch numbers, during the billing process.

“This could help reduce Medicare costs by identifying poorly performing devices more quickly, which could also protect beneficiaries from unnecessary costs and improve their chances of receiving appropriate follow-up care more quickly,” the report said.

David Lamir, an official in the inspector general’s Boston office, said the $1.5 billion figure represented a “drop in the bucket” of the true costs to Medicare from medical products that malfunction. He said device failures not only waste money, but also can expose patients to a “high risk of illness,” including needless surgeries.

The report said that medical device recalls nearly doubled from 2003 through 2012 and noted that they have probably cost Medicare billions of dollars. In the past five to six years, more than 200 cardiac devices have been recalled, according to the inspector general’s office. In most cases, manufacturers withdrew their products voluntarily after reports surfaced of injuries or malfunctions. Device makers are required to report problems they learn of, often from doctors and hospitals, to a database run by the Food and Drug Administration.

Diana Zuckerman, president of the National Center for Health Research who has testified before Congress on device safety, said her organization supports making hospitals report malfunctioning devices when they seek Medicare payments to cover an implant surgery. She said the change would help officials pinpoint faulty devices before issuing a recall for tens of thousands of products in patients.

“It would be much more obvious much more quickly which implanted devices were causing problems,” she said.

Ms. Zuckerman noted that the report did not touch on other high-profile device failures, like metal-on-metal hip implants or vaginal mesh.

Medical device companies and some doctors have opposed tighter reporting, arguing that it would be costly and difficult to integrate with existing payment claim forms and might not yield useful information.

“It is abundantly clear that data collected in electronic health records is a far superior and more cost-effective method for monitoring the performance of medical devices,” said Mark Leahey, who heads the Medical Device Manufacturers Association. The trade group represents nearly 300 device companies.

Mr. Leahey said that the electronic health record “captures the full clinical history of the patient, their changing health status and detailed information on their medical treatments,” including any surgically implanted devices.

A spokesman for the Centers for Medicare and Medicaid Services said the agency had not seen the report and would have no comment.

But in written remarks included in the report, Seema Verma, the agency’s administrator, said the tighter reporting requirement was “under consideration” and that the agency would “carefully evaluate the potential that this policy would impose a burden on physicians unnecessarily.”

This article was produced in collaboration with Kaiser Health News, an editorially independent program of the Kaiser Family Foundation. 

• https://www.nytimes.com/2017/10/02/health/heart-devices-medicare.html?_r=0

Patient advocates enlist orthopaedic surgeons' support: AAOS New Orleans

Docsfor Hip and Knee Warranties?

    

Posted by Daniela Nuñez, Consumers Union  FiDA highlight

Since last September, Consumers Union’s Safe Patient Project has been calling on the top hip and knee manufacturers to warranty their products. A warranty would cover revision surgery for patients if their implant is defective –for example, if the implant breaks, fails to adhere to the patient’s body or emits metal particles into tissue or blood. Shockingly, only one hip and knee implant part comes with a warranty, yet more and more patients are getting these implants installed in their bodies.

To help us understand what patients really need, we’ve asked thousands of people with artificial hips and knees to tell us what they expect from a good warranty. Now, we’ve started asking orthopedic surgeons who implant these hip and knee devices what they think about our warranty idea. As experts in their field, we think they’d give us some good input. A surgeon in Florida shared his thoughts on warranties in a guest blog post. Some orthopedic surgeons in Washington state had helpful comments, with several stating an interest in the idea. And a researcher who has analyzed hip and knee implants retrieved from patients over the past 30 years reached out to us with a very useful perspective on the issue.

In our newest effort to get more feedback from surgeons, our Safe Patient Project team will head to the American Academy of Orthopaedic Surgeons (AAOS) Annual Meeting in New Orleans March 10-14, 2014. We tried to pay the registration fee for us and several patient safety activists, but an AAOS representative told us that this is a “private meeting and not open to those outside the medical field or official exhibitors.” So, we will be outside the meeting and around New Orleans ready to talk to surgeons about why we think hip and knee manufacturers should back their products with a warranty and identifying supporters.

Unfortunately, many patients are left in the dark on how long their hip or knee implant will last — even though most people are given an estimate, there is not a solid guarantee to back that up. Patients also need a clear process to follow if their device fails unexpectedly, something that is routinely offered with warranties. And when a hip or knee implant fails, insurance companies, Medicare and patients are forced to foot the bill while the implant maker doesn’t have to pay a dime. That should change.

Surgeons play an important role in the success of a patient’s hip or knee replacement. We look forward to getting their feedback! And we hope we can enlist their support for warranties.

(If you are an orthopedic surgeon, please email us your thoughts on a warranty at safepatient@consumersunion.org. If you’ll be at the AAOS conference, let us know!)

Costs vary wildly for knee replacements! Patients and doctors are in the dark.

A personal encounter with the cost of health care

Jim Landers

jlanders@dallasnews.com

Published: 27 January 2014 09:37 PM

Dallas Morning News

WASHINGTON — I often write about the cost of health care, guided by the perception that Americans pay too much and get too little in return.

On Wednesday, it gets personal.

I am about to have knee replacement surgery at a hospital in Alexandria, Va., just across the Potomac River.

Both knees are shot. I played too much football, had two surgeries for torn cartilage and ran for too many years on unforgiving concrete sidewalks. An orthopedist told me in 2004 that I could keep on running and soon face knee replacements or quit running and postpone the inevitable.

Nine years later, it’s hard to dance or even walk the supermarket aisles with my wife. Running is out of the question. At my last physical, I explained this to Dr. Bilal Desai, my physician. She gave me a referral to an orthopedic group.

“You need total knee replacements — both knees,” said Dr. Daniel Weingold, the surgeon who explained my X-rays to me.

We discussed alternatives — Ibuprofen, weight loss, intense exercise — but none of those would repair the damage. Weingold said he could do the surgery at Inova Alexandria Hospital.

More expensive

Inova owns several hospitals in Northern Virginia, as well as the outpatient clinic where Dr. Desai practices.

I remembered reading that a knee replacement at Inova Alexandria Hospital would cost as much as $5,000 more than at Inova Mount Vernon Hospital, a few miles away.

I asked Weingold. He doubted there could be such a difference between two Inova hospitals. Well, what are the charges, I asked. He did not know. None of the surgeons in his group practices at Mount Vernon, he said, but if I wanted to go there, we could stop now and I could go to another orthopedic group.

I said I wanted to talk with my insurance company.

I emailed BlueCross BlueShield of Texas, which administers our health plan here at The Dallas Morning News. I asked: Do you have any information about which hospital does a better job? What the costs are? Does it make a difference to you if one is cheaper than the other?

High-deductible plan

I was told that both hospitals are in our health plan’s PPO, or preferred provider network, as is Dr. Weingold. Since the hospitals are in Virginia rather than Dallas, I was told, BlueCross Blue-Shield of Texas doesn’t have much information to go on in terms of a recommendation.

Like a lot of people working for Dallas companies, we have a high-deductible health plan designed to make employees better health care shoppers. My deductible is $1,500, and my out-of-pocket maximum is $3,000. I knew I would blow through that, regardless of which hospital I chose.

I’m not eligible for Medicare, but I looked at the Medicare charge information for 3,000-plus hospitals in the country. In 2011, Inova Alexandria Hospital charged $32,051 for a total knee replacement. Inova Mount Vernon Hospital charged $27,549.

I looked at the charges for Dallas hospitals. Medical City Dallas charged $117,616. Baylor University Medical Center charged $43,852. Texas Health Presbyterian charged $58,854.

None of the hospitals in Dallas charged less than $32,938, which was nearly $900 more than the Alexandria hospital.

‘Medicine in America’

I went back to Dr. Desai and told her she’d referred me to an orthopedic practice and hospital where the charges were $5,000 more.

“That’s a lot of money,” she said. “Go to Mount Vernon.”

“But I don’t know a surgeon at Mount Vernon. I went where you referred me,” I said.

“I can write you a blank referral and you can find a surgeon and fill it in,” she suggested.

“Well, why don’t you know about the difference in these hospital charges?” I asked.

“We don’t know about that,” she said. “That’s just medicine in America.”

I’m having the surgery on my right knee at Inova Alexandria. I’ll see how it goes but expect Mount Vernon Hospital will get my left knee.

Medical device industry is "unlike" just about any other consumer industry!

About 80 percent of hip doctors haveno idea how much a hip replacement costs

            BY JENNY GOLD   Washington Post  Wonkblog

            January 7 at 10:20 am

What will a gallon of milk set you back? How about a new car? You probably have a rough idea.

But what about a medical device, the kind that gets implanted during a knee or hip replacement? Chances are you have no clue. And you are not alone: The surgeons who implant those devices probably don’t know their cost, either, a new survey shows.

Medicare spends about $20 billion each year on implantable medical devices, nearly half of it for orthopedic procedures. And as the population ages and more Americans get joint replacements, that number is only going up, which will have a bigger and bigger impact on the nation’s health care spending.

But orthopedic surgeons don’t know much about how much their work contributes to that spending. They were able to correctly estimate the cost of a device only 21 percent of the time, according to a survey of 503 physicians at seven major academic medical centers published this week in the journal Health Affairs. Their guesses ranged from 1.8 percent of the actual price to 24.6 times the actual price. (Researchers could not release the actual costs because they signed nondisclosure agreements with the hospitals.)

Medical residents were worse at guessing — they were correct only 17 percent of the time. Estimates within 20 percent of the actual cost were considered correct. The study did not look at what patients know about cost.

“In orthopedic surgery, we’re never told how much things cost. We never see the cost displayed anywhere, and even if you were interested, there’s no great way to find it,” says Kanu Okike, lead author of the  study and an orthopedic surgeon at Kaiser Permanente Moanalua Medical Center in Honolulu (Kaiser Health News is not affiliated with Kaiser Permanente).

Unlike pretty much every other consumer industry, health care costs are not transparent, even for the surgeons. Each hospital system and purchasing group negotiates deals with device manufacturers and signs a nondisclosure form, promising not to share the details of those prices with anyone else.  That’s because “medical device manufacturers strive to keep their prices confidential so that they can sell the same implant at a different price to different health care institutions,” the study authors write.

But costs matter: For a total knee replacement, the actual piece of machinery that gets implanted can cost from $1,797 to $12,093, depending on the negotiated price. And there’s little evidence that one particular device is any better than another for the patient, says Okike.

The hospital actually has a financial incentive to use cheaper devices — it’s paid a lump sum for the procedure by Medicare (the government’s health insurance program for seniors and disabled people). That means that if a hospital uses a cheaper device, it ends up with a bigger profit.

But hospitals don’t tend to pressure surgeons to use the cheaper device, says Kevin J. Bozic, an orthopedic surgeon at the University of California San Francisco who studies the cost of medical devices. That’s because orthopedic surgeons are big moneymakers. “They don’t want to offend the doctors. They cater to them however they can, which includes not telling them which devices to use,” he explains.

And many orthopedic surgeons are aligned with a particular manufacturer, says Bozic, and receive a consulting fee or royalty for using that particular device. That makes them even less likely to take cost into consideration.

Some hospitals are seeking to make the devices' pricetags more transparent, in the hopes that just knowing what things cost will encourage surgeons to make different choices and lower spending. There are some glimmers of hope, including a national pilot project that makes a surgeon’s payment for each surgery dependent on the cost of the devices they use.

“But at the root of it, the biggest problem is the lack of price transparency across the industry,” says Okike. And device manufacturers aren’t in a hurry to change that without some sort of pressure.

Kaiser Health News is an editorially independent program of the Henry J. Kaiser Family Foundation, a nonprofit, nonpartisan health policy research and communication organization not affiliated with Kaiser Permanente.

Failed implant Device Alliance (JjrkCh) comment: 

Consumers must ask the orthopedic surgeon "What is the brand/model you are implanting?" and get a UDI- unique device identifier code.  "What is the warranty for this implanted product?"  "What are the validated clinical (live human) studies of patient outcomes from this specific implanted device?"  So far, the medical device industry has avoided accountability while gaining federal legal entitlements because of the ease of clearance by the FDA.  (The public believes there is a "regulator" for safety and effectiveness.)  If "informed consent" included this information, clarifying the loss of basic civil rights of the harmed patient, there would be no reason to discuss cost.  Who would purchase a car or a toaster this way?  My blog is Failed Implanted Device Alliance.  It compiles information about the safety and effectiveness issue. 

CMS Tracks/Publishes Joint Replacement Patient Outcomes!

Medicare identifies 97 best and 95 worsthospitals for hip and knee replacements

December 18, 2013 1:52 am by Jordan Rau | MedCity News

FiDA highlight

Medicare has begun tracking the outcomes of hip and knee replacement surgeries, identifying 95 hospitals where elderly patients were more likely to suffer significant setbacks. The government also named 97 hospitals where patients tended to have the smoothest recoveries.

The analysis, which was released last week, is the latest part of the government’s push to improve quality at the nation’s hospitals instead of simply paying Medicare patients’ bills. Medicare already assesses hospital death rates, how consistently hospitals follow basic medical guidelines and how patients rate their stays.  The evaluation of hip and knee surgery outcomes is significant because for the first time, Medicare is rating hospitals’ performance on two common elective procedures.

Many patients needing joint replacements want to know a hospital’s record when choosing where to have the procedure done.  This is not usually the case for treatment of conditions Medicare has evaluated previously, such as heart attacks.

Of the 95 hospitals where knee and hip surgery patients experienced difficulties after the operation, nine were rated having both high readmissions and high complication rates. Those hospitals were: Froedtert Hospital in Milwaukee; Grant Medical Center in Columbus, Ohio; Mercy St. Anne Hospital in Toledo, Ohio; Northwestern Memorial Hospital in Chicago; the Pennsylvania Hospital of the University of Pennsylvania Health System in Philadelphia; Peterson Regional Medical Center in Kerrville, Texas; Reston Hospital Center in Reston, Va.; Shannon Medical Center in San Angelo, Texas, and Southside Regional Medical Center in Petersburg, Va.

Some of those hospitals complained Monday that Medicare’s assessments were outdated since they covered operations between July 2009 through June 2012. A spokeswoman for Shannon Medical Center said the hospital has improved since then, adding better technology and opening a clinic to follow up with patients seven days after leaving.  A spokeswoman for Southside Regional Medical Center said that hospital adopted a new treatment model in 2012 for joint and spine patients and that their outcomes have “drastically improved.”

Medicare was cautious in how it marked hospitals, only categorizing them as outliers when their records in hip and knee replacements were statistically different from the national average.

The overwhelming majority of hospitals—about 19 out of 20—were branded average, a Kaiser Health News analysis found.

Table

Hospitals Judged Best And Worst For Hip And Knee Readmissions And Complications

Out of the 97 hospitals that did better than average in avoiding either readmissions or complications, 25 were rated as being better at both measures. Those included some big hospitals such as Sutter General Hospital in Sacramento, Calif., and the Hospital for Special Surgery in Manhattan. They also included some local hospitals such Holy Cross Hospital in Fort Lauderdale, and several physician-owned hospitals that specialize in these types of surgeries, such as Arkansas Surgical Hospital in Little Rock.

About 600,000 patients in the traditional Medicare program have their hips or knees replaced each year. The growing popularity of these operations has made them a more significant expense for Medicare and private insurers. In 2010, there were 719,000 knee replacements costing nearly $12 billion and 332,000 hip replacements nearly $8 billion, according to the National Center for Health Statistics.  

Medicare published the new outcomes data on its Hospital Compare website.  While few consumers use that site, this information may reach a greater audience later on through groups and publications, such as Consumer Reports, that tap Medicare’s data in devising their own hospital ratings.

“With elective procedures, consumers like to do a lot of research to pick the right doctor and the right hospital, so this is a good first step,” said Leah Binder, CEO of the Leapfrog Group, a nonprofit funded by employers that judges hospital quality. However, she said the new ratings would be of limited use for most patients because the Centers for Medicare & Medicaid Services judged most hospitals’ performance as normal.

“We know there’s a significant variation among hospitals, but CMS reports them all as average,” Binder said.

Financial Pressure

Hospitals may soon feel a financial pinch from the evaluations. Medicare plans to add hip and knee readmission rates to the criteria it uses when deciding whether to penalize hospitals each year.

Since October, Medicare has been paying less than it normally does to 2,225 hospitals after determining their rates of rebounds for patients with pneumonia, heart attacks and heart failure were too high, even by a small amount.  Starting in the fall of 2014, when the joint replacements are to be factored into the penalty program, hospitals are at risk of losing as much as 3 percent of Medicare payments for each patient stay.

In its new evaluation of hip and knee replacement patients, Medicare used two measures. One was how often the patients ended up being readmitted to the hospital within 30 days of discharge.  The other was how often they suffered one of eight complications after the operation.  Those included a heart attack, pneumonia, sepsis or shock within seven days of admission. They also included bleeding at the site of the surgery, a blood clot in the lung or death within a month of admission. Medicare also counted mechanical complications with implants and infections of the joint or wound within 90 days of admission.

The quality of joint implants has been under scrutiny for several years. Some of the surgical devices have been plagued by quality problems, especially among artificial hips made of interlocking metal parts.  The friction created by these joints can create metal debris that damages the surrounding flesh and bone. Two manufacturers have recalled their devices since 2010.

Problems Are Declining

Nationwide, the number of readmissions following hip and knee replacement surgeries has been dropping, but not as quickly as readmission rates for heart attack, heart failure or pneumonia patients, according to a Medicare-commissioned study by the Yale New Haven Health Services Corporation Center for Outcomes Research and Evaluation.  

Dr. Eric Coleman, an expert on readmissions at the University of Colorado Anschutz Medical Campus, said some hospitals are trying to prevent joint replacement patients from returning by educating them ahead of the surgeries about how to take care of themselves and warning signs of problems. This program provides “a chance to walk you through what to expect, what your family would expect, how to arrange your home,” Coleman said. “In most of the cases of readmission reductions, we’re still very reactive.”

Hospitals’ clientele appears to play some role in how they fared after these surgeries. The outcomes for hip and knee replacements tend to be slightly worse for hospitals that serve a high proportion of Medicaid patients, according to the Yale study. The study also found that hospitals where more than one out of every five patients were African-American tended to have slightly higher complication and readmission rates than did hospitals with no black Medicare patients. However, the report noted, some of these hospitals serving large numbers of Medicaid or black patients also performed very well.

These kind of racial and economic disparities in readmissions have long troubled health policy experts. Some hospitals mostly cater to prosperous patients who have the money, resources and education to get necessary post-surgical care after discharge. But safety net hospitals often have a harder time ensuring that low-income, less educated people follow the often complex instructions about how to recover from a major surgery or hospitalization.

In Medicare’s new analysis, on average, hip and knee patients had a 5.4 percent chance of having to return to the hospital. Nationally, the average complication rate for patients after hip and knee replacement surgery was 3.4 percent. One hospital, Beaumont Health System in Royal Oak, Mich., had a mixed record: Patients there were more likely to be readmitted but less likely to suffer serious complications.

Hospital-Wide Readmissions Published

The government also last week released its first ratings of how often Medicare patients of all diagnoses returned to hospitals within 30 days. That “all cause” measure is more encompassing than Medicare’s appraisals based on heart attack, heart failure and pneumonia.  A number of prominent experts, including Congress’ Medicare Payment Advisory Commission, have been pushing for this measure to be used in setting financial penalties for hospitals.

Medicare’s analysis found that 16 percent of Medicare patients ended up returning to a hospital within 30 days between July 2011 through June 2012. Again rates varied significantly.
At 364 hospitals, or 8 percent, patients were more likely than average to return within a month, the data show. These included the Cleveland Clinic, as well as the clinic’s hospital in Weston, Fla.; both of Johns Hopkins’s hospitals in Baltimore; and New York-Presbyterian Hospital in Manhattan.

Medicare did not count cases where the patient was scheduled to return to the hospital, such as when a lung cancer patient was admitted for pneumonia and later came back for a chemotherapy treatment that had been planned. Medicare calculated that patients were less likely than average to end up back for any reason at 315 hospitals, or 7 percent of the nation’s total.

Nancy Foster, an executive with the American Hospital Association, said that tracking hospital-wide readmissions was of limited value to hospitals that wanted to do better. “Most of the interventions you would use are built and targeted around particular conditions,” she said. “You have to know what’s driving patients back into the hospital to address the problem. When you get this lump of all-cause readmissions, you don’t know what to go after.”

KHN reporters Ankita Rao and Marissa Evans contributed.

jrau@kff.org

Read more: http://medcitynews.com/2013/12/medicare-identifies-97-best-95-worst-hospitals-hip-knee-replacements/#ixzz2nqCPLGSX

Public reporting of CMS patient outcome data from joint replacement surgery has been a 'grown-up Christmas wish' for the last 5 years!  Patient harm from lax oversight of implants has cost us our humanity, needless suffering of patients and their family members, trust in our government and care providers and a substantial chunk of healthcare spending.  Simply compiling the CMS data and making that information available to researchers like Consumers Union Safe Patient Project will clarify the true risks and benefits of implanted medical devices.  The legal system unfairly entitles Pharma and the medical device industry, so preventing harm is essential to patient safety.  My blog/personal story:  http://fida-advocate.blogspot.com

Medical Device Implants lead national hospital costs data.

	National Inpatient Hospital Costs: The Most Expensive Conditions by Payer, 2011
	Celeste M. Torio, Ph.D., M.P.H. and Roxanne M. Andrews, Ph.D.  Statistical Brief #160, August 2013
Introduction Health care costs continue to grow faster than the economy, and the health share of the Gross Domestic Product (GDP) has maintained its upward trend, reaching 17.9 percent in 2011.

▪   The top five conditions—septicemia; osteoarthritis; complication of device, implant or graft; liveborn (newborn) infants; and acute myocardial infarction—accounted for nearly one-fifth of the total aggregate cost for hospitalizations. Complication of device, implant or graft #3 most expensive condition treated in U.S. hospitals, all payers 2011 #3 most expensive condition billed to Medicaid #4 most expensive condition billed to Medicare

Osteoarthritis was ranked the second most expensive condition only for Medicare ($8.0 billion) and private insurance ($5.7 billion). Over 90 percent of the hospitalizations for osteoarthritis involved a knee or hip replacement.

About HCUP HCUP is a family of powerful health care databases, software tools, and products for advancing research. Sponsored by the Agency for Healthcare Research and Quality (AHRQ), HCUP includes the largest all-payer encounter-level collection of longitudinal health care data (inpatient, ambulatory surgery, and emergency department) in the United States, beginning in 1988. HCUP is a Federal-State—Industry Partnership that brings together the data collection efforts of many organizations—such as State data organizations, hospital associations, private data organizations, and the Federal government to create a national information resource.

Medtronic ignores patient harm for profit. Justice?

Injured Infuse users struggle to get their day in court against Medtronic

•                Article by: JIM SPENCER , Star Tribune Updated: July 6, 2013 - 8:24 PM

Constitutional concept, device law and Supreme Court rulings stymie suits.

Star Tribune photo galleries

WASHINGTON – Hundreds of people who say they’ve been harmed by a Medtronic spinal device are pursuing a new legal pathway around rulings that have kept them from getting a day in court.

They argue that the Food and Drug Administration, which approved limited use of the Infuse bone growth product in 2002, offered a 2008 warning to doctors about “life-threatening complications” from unapproved applications. Then, the Spine Journal in 2011 and the U.S. Senate Finance Committee in 2012 each harshly criticized Medtronic for allegedly paying physicians hundreds of millions of dollars to write scholarly articles about Infuse while editing those articles to downplay Infuse’s dangers.

Yet for all the claims of poor performance, dangerous outcomes and shoddy scholarship, Infuse has never been the subject of a personal-injury trial because of a legal concept called “pre-emption.” That means federal law takes precedence over state law. The Supreme Court has extended this premise to say that almost no one can sue for damages caused by medical devices that received premarket approval from the FDA.

Now, hundreds of new lawsuits — including dozens in Minnesota — aim to find a way around that obstacle by accusing Medtronic of illegally promoting uses of Infuse that differ from what the FDA specifically approved.

If the allegation is upheld, legal experts say the world’s biggest medical device maker could find itself awash in settlements or judgments that could push the entire medical device industry into a new era of corporate liability.

“The cases are important,” said Prof. David Prince of the William Mitchell College of Law. “The whole area of law certainly doesn’t make sense, especially to consumers.”

Medtronic declined a Star Tribune request for an interview, but issued a statement that denied any wrongdoing and disputed “any suggestion that the company improperly influenced or authored any of the peer-reviewed published manuscripts discussed in the [Senate] report, or that Medtronic intended to under-report adverse events.”

Landmark case

Judges have ruled that pre-emption requires them to throw out Infuse cases before a jury hears evidence. Their decisions are based on a landmark 2008 case, Riegel vs. Medtronic, in which the Supreme Court ruled that patients generally are forbidden from suing device manufacturers because that would let state courts trump federal regulators who review clinical test results and let devices onto the market.

In the case of Infuse, however, patients’ lawyers think they have found a way to get to trial by linking Medtronic to so-called “off-label” uses that the FDA did not approve.

Doctors can legally use devices in off-label applications, and federal health statistics show that Infuse is used off-label 85 percent of the time. Jennifer Fuson, a spokesman for the American Association for Justice, said a critical question is who is responsible “if you are injured by a product that was used in a way not approved by the FDA?”

The Department of Justice dropped a criminal investigation of Medtronic’s off-label promotion of Infuse without explanation in May 2012 and did not respond to a request for comment.

In a statement, the FDA declined to say if it has investigated the promotion of Infuse.

“Promotional materials are unlawful if they promote an unapproved use for the product; contain claims relating to the dosing, safety or effectiveness of the product that are inconsistent with the approved labeling; or if they lack a fair and balanced presentation of information, i.e., of benefits and risks,” the agency said.

In a December 2012 report, the Senate Finance Committee claimed that Medtronic employees, including some in the marketing department, wrote, edited and otherwise influenced the content of scholarly articles about Infuse written by doctors who were collectively paid $210 million by Medtronic from November 1996 through December 2010.

A spokesman for the Finance Committee declined to say whether Chairman Max Baucus, D-Mont., thought Medtronic violated any regulations or laws. “The editing of the journal articles and large payments to the authors of those articles raises troubling questions about whether Medtronic crossed the line regarding off-label promotion of Infuse,” the spokesman said.

Lou Bograd of the Center for Constitutional Litigation said the overwhelming off-label use of Infuse suggests that promotion is going on. Doctors are free to use medical devices any way they see fit, he acknowledged, but in this case more than eight in 10 uses are not FDA-approved.

“[It] defies credibility to say it’s just doctors deciding to do this on their own,” Bograd said. “Medtronic engaged in a false, misleading promotional campaign.”

Bograd argued this point to Hennepin County District Judge Laurie Miller in May in what could become an influential case nationally.

Minneapolis lawyer Stuart Goldenberg, Bograd’s co-counsel, represents clients in 35 Infuse cases in Minnesota who will be affected by ­Miller’s decision. Goldenberg said he has “hundreds more” suits that might be filed.

In the Hennepin County case, Medtronic’s lawyers denied off-label promotion of Infuse and argued that none of the 35 Minnesota plaintiffs has the right to sue.

“Many [cases] have already been dismissed based on the pre-emption doctrine established in Riegel,” Medtronic said in its statement to the Star Tribune. “We have a number of defenses for these cases, including pre-emption, and will stand behind our product and vigorously defend it in court.”

Conflicting opinions

Miller’s decision is expected this summer. It will add to a handful of conflicting lower-court opinions that almost everyone believes will eventually end in a Supreme Court decision.

Prince also believes the issue “cries out for federal legislation.”

“Off-label promotion is prohibited by federal law, but state law could also prohibit it,” he said. In that case, a personal injury law suit might be allowed to go forward. But the courts have thus far “confused this by going off in all directions.”

On June 18, a two-year, $2.5 million Medtronic-funded comprehensive re-analysis of all past Infuse research showed that the bone growth product did not perform as well and had more adverse effects than Medtronic-sponsored researchers had said.

The only use of Infuse that has received FDA approval is to implant it through the front of an adult’s body to help recovery from lower-back spinal fusion surgery and then only if the bone growth factor is constrained in a specific brand of cage.

Otherwise, studies show that unwanted and potentially dangerous bone growth can occur and cancer risks may arise, said Dr. Eugene Carragee, editor of the Spine Journal. Carragee devoted the June 2011 issue to a scathing critique of the Infuse research that Medtronic sponsored.

Carragee said he took on Medtronic because its sponsored research results differed so markedly from research the company did not pay for and because of Medtronic’s influence on the content of scholarly articles.

Still, that may not rise to the level of off-label promotion.

“Manufacturers can send representatives to medical conferences and say, ‘Doctors A, B and C used the device in this way,’ ” said Prince. Doctors can also write about off-label device use in scholarly journals. “That’s not considered promotion.”

Ron Goldman could be the first lawyer in the country to actually get an Infuse off-label-promotion case before a jury. The Los Angeles attorney persuaded a judge there to let his client go to trial. The case is set for November, although Goldman expects a delay.

“Underlying all the legal mumbo jumbo,” he said, “we have people who are severely injured.”

Jim Spencer • 202-383-6123