Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements. All clinical trials must report all data.
Please share what you have learned!
Twitter: @JjrkCh

Tuesday, July 11, 2017

Disruption and Mistreatment: Healthcare CEO/Doctor



Dr. Robert Pearl: His book offers a prescription to cure wait ails American medicine

By Patt Morrison

July 5, 2017   FiDA highlight
Dr. Robert Pearl has spent his life in medicine — most recently 18 years as executive director and CEO of Kaiser Permanente’s medical group in California, and president and CEO of its mid-Atlantic group. But it was the death of his father, and a simple medical miscommunication, that prompted him to look long and hard at an American medical system that doesn’t always deliver bang for its billions of bucks. In his book, “Mistreated, Why We Think We’re Getting Good Health Care — And Why We’re Usually Wrong,” Pearl lays out his four ways though the morass of American medical practice: integrated, not fractured care; a flat-fee capitated payment system instead of pay-per-treatment; embracing mobile and video medical technology; and most of all, care that’s led by doctors themselves.


Let me take a classic American playground taunt and turn it around: The line is, if you’re so smart, why aren’t you rich? So if the United States is so rich, and so smart, why aren’t we healthier?
This is exactly why I wrote “Mistreated,” because we spend 50% more than any other nation on the globe and our results are in the lower half. And the reason is because the American healthcare system is broken. It most closely reflects a 19th century cottage industry. It’s fragmented, with doctors scattered across most communities, hospitals in every town.
It’s paid on a piecemeal basis; we call it fee-for-service. It uses technology from the last century. You’d never bank someplace where you couldn’t access information on your account 24/7, but if you want to get your radiology results, your laboratory results, you’d have to call the doctor’s office between 9 and 5 Monday through Friday, or go there. You can’t use video; all the modern tools are not available.
You say our results as a country are in the lower half. Can you get specific?
We’re last in the world [among the 20 most industrialized nations] when it comes to life expectancy. A girl in Seoul, [South] Korea, being born now has on average a life expectancy of 90. The same girl in the United States, 83 — seven years fewer.
We’re second to last in terms of childhood mortality.
Colon cancer — half the colon cancer deaths in the United States are preventable with proper screening, and I don’t necessarily mean a colonoscopy. It’s called a FIT test, which is basically done in the privacy of a bathroom once a year, five minutes, no bowel prep required, you can do it every year for 10 years. It’s just as good as a colonoscopy, and yet across this nation, it’s done 50 to 60% of the time. The best medical groups do it 90% of the time.
What other industry, what business can you think of that would function like American medicine today?
— Robert Pearl
Americans are dying unnecessarily. Half a million people die every year from either failures of prevention, or from medical errors, like my father, or from avoidable complications of chronic illness that simply were not addressed.
We value intervention over prevention; we value the newest advance over the things that are tried and true.
You make a distinction between malpractice and mistreatment, which can simply result from haste or error.
You’re right. I think most physicians are dedicated, smart, hard-working, knowledgeable. That is not the big problem. I’ll give you an example, again my father. He was someone who had tremendous energy. He slept four hours a night, until one day he got tired. And he had to have his spleen taken out because he had hemolytic anemia.
Now, he spent half his time in New York and half his time in Florida. His doctors in New York knew he needed to have the vaccine, the pneumococcal vaccine, to prevent the complications that often follow removal of the spleen. The doctors in Florida knew that he had to have that same exact vaccine, but they each thought the other had given it.
And that’s the system. That’s the lack of an integrated, comprehensive electronic health record. If he had had that, he would have gotten the vaccine. He didn’t die because of malpractice. He died because of a broken system.
If you were able to wave your magic stethoscope and redesign the American healthcare system, what of it would you keep and what of it would you jettison?
What I would jettison or replace is the fragmented fee-for-service, out-of-date technology, lack of leadership that we have today. I’d replace it with an integrated system with the physicians and hospitals working together as one, paid in a prepaid or capitated way, using the most modern electronic health records along with the most modern and mobile devices, things like video, secured email. And I’d put it all inside a leadership structure with physicians.
And I would have multiple groups competing to provide the best value, making information available and transparent for patients so they can make the best choice for themselves and their families.
The main thing, though, that I would keep, and I’m afraid we’re losing it, is all of the mission-driven, wonderful spirit of American medicine that’s been handed down through five millennia. I think we’re seeing right now that physicians are spending almost half of their day hunched over a computer, trying to document things for a billing system rather than looking at the patients, being able to communicate or other things. We’re asking physicians to squeeze more and more into every day with less and less time.
I think we’re reaching a breaking point where one of two things will happen: If we don’t address the concerns and transform American medicine, what we’re going to see is we’re going to devolve into a two-tier system. Not the two-tier system of today, with the poor and everyone else, but the middle class and the Medicare patients not able to get access, similar to the Medicaid patient of today.
Or we’re going to see disruption. I think if we don’t do something about American medicine, the system will simply disintegrate, dissolve, and we’ll run the risk of being disrupted, as Kodak learned.
What’s the resistance to adding technology, when technology seems to be one of the great drivers in American healthcare?
Today what you’re describing, the ability to get paid to do a video visit, for most physicians doesn’t exist. It could happen. It’s just that it doesn’t exist. And I think part of why it doesn’t exist is that insurance companies are concerned that doctors will just generate more and more and more visits whether they’re needed or not, in order to be able to bill for them.
I was struck by your point in the book that the medical system is driven by fear, and it’s not necessarily the patient’s fear of pain or death.
What happens is that in part of our brain, the reward center and the fear center, we call it lighting up, because it activates, and within fractions of a nanosecond, the perceptual side changes. And so medicine is filled with reward and fear.
The problem is that in American medicine, that same brain process leads doctors and patients to do things that don’t make sense when you look at it through the lens of objective reality. As an example: I live in Silicon Valley, and between San Jose and San Francisco, there’s 10 hospitals doing heart surgery, three of which do 200 or 300 cases a year.
That means there’s at least 65 days a year when the team’s going to be there and available, with nothing to do. It’s hard to imagine you’re going to get great results when you’re doing less than one case a day. And similarly, the cost is going to be much higher.
Take the hospital administrators, and put them in one of my classes at the Stanford graduate school of business. They’ll immediately say, bring the three together, close two of the services and have one service that does 800 or 900 a year, a much higher volume service. But what they know is they’ll lose their jobs. They know the hospitals will lose their revenue. Fear of loss — how powerful losses are compared to gains.
I talk about sepsis, which is an infection that is now the leading cause of death among hospitalized patients, a systemic infection, the same problem that my father died from. The fear there is that, what we know is that half the people who come through the hospital with sepsis are very, very sick. Everyone in the United States knows how to treat them.
But a woman named Diane Craig, one of my associates at Kaiser Santa Clara, found that half of these patients looked very sick coming in. But she also found that the other half — they were sick, because otherwise they would not be at a hospital — but they were not nearly as sick. They were often younger people, sometimes with a kidney infection or maybe a mild kind of pneumonia, and then they progress rapidly over the next couple of days, [into] that intermediate zone [where] no one quite knows what to do. And if you treat all the people in the intermediate zone, you’re going to save lots of lives.
What’s the problem? Because the intervention requires doing very aggressive treatment, and the physician is worried because some patients who might have lived will actually be harmed. And in the mind of a doctor, not all deaths are the same. I hate to say it that way. The ones they cause are far worse than the ones they could have avoided.
And so there’s an imbalance. So rather than aggressively treating the patient, they just put them in the hospital, put them on some antibiotics, and they call a consultation. It’s now no longer on their hands.
It’s not that the doctor intentionally wants to harm anyone, it’s just their fear of being the one to cause the problem.
Again, it’s how our brains change perception. Those things that we cause, the problems we cause, the deaths we cause, are significantly greater in magnitude than the ones we otherwise could have saved. It’s also why we see intervention as being so much more valuable than prevention.
You saw some of these things first-hand when your father fell ill and died.
My dad survived the first acute episode he had, but he never overcame the complications. My brother and I got called; my dad had had a bleed into his brain in Florida. We got on an airplane and we flew there. When we arrived, there were a lot of doctors at the door. There was the [ears, nose and throat] doctor who wanted to do the tracheostomy, the [gastrointestinal] doctor who wanted to put the feeding tube in place, the neurosurgeon who wanted to take a piece of bone from his skull to let his brain expand. And we looked at the X-rays — we’re both physicians — and we said no, he’s not going to get better. It’s not what he wants.
The next two and a half days he was in the hospital, we never saw a physician. There’s no [current procedural terminology] code for how doctors bill for compassion. Doctors in the fee-for-service world don’t get paid for coming by and comforting a family in its time of greatest grief.
The system is making the lives of patients worse.
And I want to add one piece: It’s making the lives of doctors worse. What we see today is one in every three doctors reports being depressed. Over half of physicians say they would not tell their children to enter into medicine. There are over 400 physician suicides every year.
And the reason is, medicine is becoming less and less fulfilling. And yet somehow, because of the context, ask most Americans and they will tell you the medical care in the United States is the best in the world, even if it’s a little expensive. The data says exactly the opposite.
How do your suggestions work when, as you pointed out in your book, about 50% of medical care costs go to 5% of people?
If you look at the 50% that go to 5% of people, you have really three groups within it: one group of people who just have a terrible, unexpected problem. A baby is born very, very premature. But the reality is, they’re not going to have another baby born premature next year.
There are some people who have severe disease, and the problem in that group is that we missed the opportunity 20 or 30 years before to actually prevent them from developing those kinds of diseases.
But the places that most people look are individuals with chronic disease, multiple chronic diseases. And that’s where I think the approach I’m describing will make the biggest difference. All these patients are seeing physicians. It’s just that when they see the physicians, the system is not focusing in a way to get that best outcome. And what do I mean by that? People often have five or six doctors. Well, are those doctors working together as one, or are they all duplicating the same kinds of things? Are the computer systems they’re using coordinated with each other? Or does everyone basically have an office-based system?
Is there a leadership structure? Doctors are not going to follow hospitals or insurance executives — they don’t trust ’em. But they will follow physicians who are well-trained, whom they know and whom they respect.
What other industry, what business can you think of that would function like American medicine today? Try to think of a business where you wouldn’t have coordination between the people who design the products, the people servicing the products, the people selling the products, where you wouldn’t have modern 21st century computing systems so that everyone has information not just to do the care at the time, but to be able to analyze it in order to improve performance.
It just doesn’t exist in most of American medicine today.
I believe that change can best happen through the businesses of this nation, that if the businesses said, in a certain number of years — let’s say five years from now — we’re not going to purchase insurance from any organization, from any doctor, from any hospital that is not integrated, where the care is not coordinated among primary care, specialty care, inpatient care, outpatient care, where it’s not paid on a capitated or prepaid basis, where they don’t have the most modern electronic health records — I believe the American healthcare system would respond and would improve.
If we’re able to accomplish that, then my dad’s death will have served a purpose, because the result will be hundreds of thousands of patients who live who otherwise would die.

http://www.latimes.com/opinion/op-ed/la-ol-patt-morrison-robert-pearl-healthcare-20170705-htmlstory.html

Friday, July 7, 2017

Gasp!: Surgeon/Designer Calls His Own Pelvic Mesh Device Garbage

Joanne McCarthy

4 Jul 2017, 12:04 p.m  FiDA highlight


LANDMARK CASE: Gai Thompson, lawyer Rebecca Jancauskas and Jo Manion outside the federal court on Tuesday. Picture: Joanne McCarthy

A FRENCH doctor who invented a Johnson & Johnson pelvic mesh device told another doctor in 2005 that "I would not want my wife to undergo this procedure", the federal court in Sydney was told today.
Dr Bernard Jacquetin made the comment in an email to another doctor in the same year his Johnson & Johnson Prolift device was cleared for use in Australia.
The comment, revealed in a Johnson & Johnson internal document on the first day of a landmark class action by more than 700 Australian women, drew gasps from some of the women sitting in the public gallery at the federal court.
Tony Bannon SC, for the women, told Justice Anna Katzmann that Dr Jacquetin, who was part of a Johnson & Johnson transvaginal mesh evaulation team, concluded his comment about not wanting to have his wife to have a mesh procedure by saying "and I don't think I'm alone in that".
Mr Bannon told the court the comments' message was "those of us who were in the know".
"Once one understands what is really involved with this you wouldn't want your wife, your sister, your mother to undergo this, except in extreme circumstances," Mr Bannon said.
The landmark case, which has attracted international media attention, is expected to take six months.
Mr Bannon told the court each of the 700 women had suffered continuous, frequent and often unbearable pain.
"Their enjoyment of life has been seriously compromised,” he said.
"Their lives have been dramatically altered for the worse.”
Up to 100,000 Johnson & Johnson pelvic mesh devices for incontinence or pelvic organ prolapse were implanted in Australian women.
The three lead complainants in the case were seeking substantial damages in the hundreds of thousands of dollars, Mr Bannon told the court.
The court heard evidence from another internal Johnson & Johnson document from May 2010 which described the kind of doctor the mesh devices were aimed at.
They were doctors who could "do" a Johnson & Johnson TVT mesh device in eight minutes.
Johnson & Johnson envisaged these doctor-clients as the kind who would see the devices helping enhance their reputations and revenues.
They were more likely "mid-career doctors" who saw their practices as businesses.
The court heard the internal Johnson & Johnson document pictured doctors who would use the product as the type who would also enjoy holidays in St Moritz and Lamborghinis.
The document quoted one of the imagined doctor-clients as saying "that makes four (mesh surgeries) before lunch, that works for me".
Mr Bannon told the court the document exhibited the internal approach of Johnson & Johnson to the mesh devices.
He said there was a valuable market to be gained out there by emphasising the speed of the mesh surgery.
The court will also hear of the lack of evidence supporting the safety and efficacy of pelvic mesh devices.
One of the women implanted with a pelvic mesh device, Jo Manion, left the courtroom after Mr Bannon read the internal Johnson & Johnson documents.
Ms Manion was visibly upset through some of the evidence.

The hearing continues.
http://www.theherald.com.au/story/4769832/i-would-not-want-my-wife-to-undergo-this-procedure-pelvic-mesh-inventor/?cs=305

Tuesday, July 4, 2017

Johnson & Johnson Pelvic Mesh: Sell, Sell, Sell !!!! Profit over Safety.




Nine years ago Gai Thompson had a mesh implant that she said changed her life forever.
“The mesh destroys lives, it destroys you physically and emotionally,” Ms Thompson told reporters outside the court in Sydney.
Ms Thompson is one of the seven hundred women involved in one of the country's largest product liability class actions, taking on Johnson & Johnson and its subsidiary Ethicon.
“Today is their chance to be heard and seek justice for what was lost,” Shine Lawyers’ Rebecca Jancauskas said.
“This is about accountability and ensuring this never happens again.”
The mesh is used to treat common complications after childbirth, such as prolapse and incontinence.
Shine’s Barrister Tony Bannon SC told the court many of the women now live in excruciating pain due to inflammation and infection.

Some are unable to work or be intimate with partners, meaning their "enjoyment of life had been seriously compromised and dramatically altered for the worse."
The court heard Johnson & Johnson conducted an aggressive "tidal wave of promotion" towards surgeons, spruiking the procedure without conducting appropriate clinical trials.
Lawyers for the claimants say removing the implant is near impossible and "is a highly complex, life threatening surgery. Even if removed the pain and disability will continue."
The court heard patients weren't properly advised of the risks involved with the surgery, and that if they were they never would have gone ahead with it.
More than 100,000 women have started legal action against the pharmaceutical giant in the US, the UK and Canada.
Some of the products involved in the suit are still available to purchase.
“There’s too many women who are injured,” implant victim Joanne Maninon said.
“The pain, the complication, the autoimmune diseases. It’s lifelong. You don’t just have the mesh removed and then recover and go on with life. You’re damaged for life.
Johnson & Johnson says the products were developed in consultation with specialist surgeons and the majority of women had a positive result.
A statement from Johnson & Johnson said: “We have sold over 100,000 mesh products in the Australian market.
“We have been notified of fewer than 200 total product events. 67 of these product events were assessed as reportable to the TGA and Medsafe, in line with their requirements.
“It is always a concern to us when a patient doesn’t get the outcome they had hoped for, or believes they have experienced an adverse event.
“However it is important to remember that the majority of women who have undergone this surgery have had a positive result, and it has improved their quality of life.”

Their lawyers will give evidence next week.
http://www.sbs.com.au/news/article/2017/07/04/court-told-how-johnson-johnson-conducted-tidal-wave-promotion

J&J Pelvic Mesh Inventor: Dr. Bernard Jacquetin email exposed in court document.






Joanne McCarthy

4 Jul 2017, 12:04 p.m





LANDMARK CASE: Gai Thompson, lawyer Rebecca Jancauskas and Jo Manion outside the federal court on Tuesday. Picture: Joanne McCarthy

A FRENCH doctor who invented a Johnson & Johnson pelvic mesh device told another doctor in 2005 that "I would not want my wife to undergo this procedure", the federal court in Sydney was told today.
Dr Bernard Jacquetin made the comment in an email to another doctor in the same year his Johnson & Johnson Prolift device was cleared for use in Australia.
The comment, revealed in a Johnson & Johnson internal document on the first day of a landmark class action by more than 700 Australian women, drew gasps from some of the women sitting in the public gallery at the federal court.
Tony Bannon SC, for the women, told Justice Anna Katzmann that Dr Jacquetin, who was part of a Johnson & Johnson transvaginal mesh evaulation team, concluded his comment about not wanting to have his wife to have a mesh procedure by saying "and I don't think I'm alone in that".
Mr Bannon told the court the comments' message was "those of us who were in the know".
"Once one understands what is really involved with this you wouldn't want your wife, your sister, your mother to undergo this, except in extreme circumstances," Mr Bannon said.
The landmark case, which has attracted international media attention, is expected to take six months.
Mr Bannon told the court each of the 700 women had suffered continuous, frequent and often unbearable pain.
"Their enjoyment of life has been seriously compromised,” he said.
"Their lives have been dramatically altered for the worse.”
Up to 100,000 Johnson & Johnson pelvic mesh devices for incontinence or pelvic organ prolapse were implanted in Australian women.
The three lead complainants in the case were seeking substantial damages in the hundreds of thousands of dollars, Mr Bannon told the court.
The court heard evidence from another internal Johnson & Johnson document from May 2010 which described the kind of doctor the mesh devices were aimed at.
They were doctors who could "do" a Johnson & Johnson TVT mesh device in eight minutes.
Johnson & Johnson envisaged these doctor-clients as the kind who would see the devices helping enhance their reputations and revenues.
They were more likely "mid-career doctors" who saw their practices as businesses.
The court heard the internal Johnson & Johnson document pictured doctors who would use the product as the type who would also enjoy holidays in St Moritz and Lamborghinis.
The document quoted one of the imagined doctor-clients as saying "that makes four (mesh surgeries) before lunch, that works for me".
Mr Bannon told the court the document exhibited the internal approach of Johnson & Johnson to the mesh devices.
He said there was a valuable market to be gained out there by emphasising the speed of the mesh surgery.
The court will also hear of the lack of evidence supporting the safety and efficacy of pelvic mesh devices.
One of the women implanted with a pelvic mesh device, Jo Manion, left the courtroom after Mr Bannon read the internal Johnson & Johnson documents.
Ms Manion was visibly upset through some of the evidence.

The hearing continues.
http://www.theherald.com.au/story/4769832/i-would-not-want-my-wife-to-undergo-this-procedure-pelvic-mesh-inventor/?cs=305

Friday, June 30, 2017

The FDA Owes Patients Improved Medical Device Regulation After Dr. Amy Reed's Death

Kirsten Clodfelter  JUN 30, 2017 @ 07:05 AM   FiDA highlight

Dr. Amy Reed, an anesthesiologist and patient-safety advocate, died in May 2017 after a four-year battle with leiomyosarcoma of the uterus. The cancer was spread by a power morcellator, the medical device used for her 2013 hysterectomy.
The surgical tool, released in 1995, was once lauded for facilitating minimally invasive surgery that decreased recovery times and minimized the risk of post-surgical infections. Morcellation, used to remove uterine fibroids or conduct complete hysterectomies, was performed on approximately 50,000 women a year in the U.S. in the early 2010s.
Yet for patients like Dr. Reed, whose uterine fibroids appeared benign but hid an aggressive type of cancer, morcellation can become a death sentence. The device is equipped with a spinning blade, which slices up tissue for removal piece by piece through small incisions. When the blade cuts through a cancerous tumor, it sprays malignant cells around the body, spreading the disease. Following her procedure, Dr. Reed, a mother of six, was left with advanced, Stage 4 cancer.

Monday, June 26, 2017

J&J hips, mesh, Bayer Essure: FAILED devices: webinar HealthwatchUSA

https://m.youtube.com/watch?feature=youtu.be&v=k1tA3H7i3s0

Joleen Chambers, a resident of Dallas, TX,  is a 2010 FDA/CDRH-trained Patient Representative with an M.S. in Rehabilitation Counseling.  She is a national patient advocate for patients PREVENTABLY harmed by implanted medical devices such as Bayer Essure, pelvic and hernia surgical mesh and toxic metal-on-metal hips.  Joleen is a graduate of Leadership America 2010, board member of Leadership Women and HealthWatch USA.  Recently she has been an observer at state and federal jury trials and a protester at several corporate shareholder meetings.  Please visit her blog http://fida-advocate.org/, Twitter @JjrkCh and Facebook  Joleen Chambers.



Title of 6/21/2017 presentation:


An Update on PREVENTABLE Medical Device Harm:  Indemnity & Justice
Keynote Slides 1-10







Saturday, June 10, 2017

Governor Chris Christie, Medical Device Industry Kick Backs & History Repeats Itself Ad Nauseam



on June 11, 2010 at 9:17 AM, updated June 11, 2010 at 9:20 AM  FiDA Highlight

A stabbing pain in the hip forced Mark Hirschbeck to abandon his post at third base during an April 2003 game between the Arizona Diamondbacks and the Colorado Rockies.
He was 42, among the best umpires in professional baseball and unwilling to quit a job that paid more than $350,000 a year. Dr. John Keggi offered a hip replacement that could get him back on the field by 2004, Hirschbeck says. That didn’t happen. The ceramic joint made by Wright Medical Group Inc. shattered, leading to an infection and four more surgeries that left Hirschbeck permanently sidelined.
He later learned that Wright paid tens of thousands of dollars to a foundation Keggi helps run and gave him a trip to a conference in the Bahamas. Keggi recommended the ceramic device over the kinds of implants used in 97 percent of cases.
“He was in bed with Wright and picked their product,” says Hirschbeck, who is suing the company and the surgeon, alleging Wright’s product was defective and Keggi failed to install it correctly. “It’s disgusting it would come to that.”
Wright’s professional agreements with surgeons are under investigation by the Justice Department, according to filings with the Securities and Exchange Commission. It’s not clear whether the payments to Keggi were improper or are being examined by prosecutors, who declined to comment. The company and the doctor have denied the allegations in the umpire’s suit.
‘Truly Extraordinary’
Andrew Mills/The Star-Ledger
Gov. Chris Christie holds a town hall meeting before a capacity crowd at the Roxbury Township Municipal Complex in Morris County to discuss property tax plan and affordable housing, June 10, 2010.
The government declared last year that it had overhauled the financial relationships between surgeons and the biggest makers of knees and hips, saying the threat of criminal prosecution for “kickbacks” had forced them to slash payments to physicians. Results of the crackdown were “truly extraordinary,” said Chris Christie, a former U.S. attorney for New Jersey who is now governor, in testimony to Congress in June 2009.
It was too good to be true. Compensation ended up being higher after the September 2007 deferred prosecution agreement because payments were postponed, according to data compiled by Bloomberg and interviews with seven surgeons.
“It’s back to business as usual,” says Charles D. Rosen, president of the Association for Medical Ethics, who is a spine surgeon in Irvine, California. “Nothing will change until someone goes to jail. It’s a big game.”
Prosecutors in the New Jersey U.S. Attorney’s Office, which headed the case, reported a “satisfactory completion” in March 2009 of the probe of Biomet Corp., Johnson & Johnson’s DePuy unit, Smith & Nephew PLC, Zimmer Holdings Inc. and Stryker Corp. Payments in 2008 fell to $105 million from $272 million the year before, the Justice Department lawyers said.
‘Common Happenstance’
The companies increased doctor compensation for 2008 to about $300 million, according to the data compiled by Bloomberg from reports posted on the device makers’ websites. Fees for 2008 were delivered in 2009, the surgeons say.
Payment delays were “a common happenstance,” says Teresa Ford, a Seattle attorney who represents 150 doctors who have consulting or royalty agreements with orthopedic device makers. “None of them had significant changes in their relationships.”
The government numbers were lower than those reported by the companies because Justice Department officials didn’t count payments made to buy out the consulting contracts of some physicians, says Michael Drewniak, a spokesman for Christie, a Republican who resigned in December 2008 to run for governor. A “large number” of implant makers paid to end multiyear arrangements, Drewniak says, because they might not comply with new standards under the settlement.
$300 Hips
“We weren’t just making up numbers,” Drewniak says.
Justice Department officials declined to comment.
The reports on the company websites don’t specify whether any payments were to buy out contracts.
The financial ties between device makers and surgeons help explain why health-care costs in the U.S. rose at 2.5 times the rate of inflation in the past 10 years and account for a sixth of the economy. The $300 million works out to $300 for each of the 1 million hips and knees implanted in Americans in 2008.
The payments show how hard it is for government to hold down costs in a system where pricing is opaque and largely unregulated. In the $14 billion-a-year orthopedic device business, payments to doctors squelch competition, says Chad Rodine, a partner in Castle Rock, Colorado-based Echelon Consulting LLC, which advises hospitals on implant costs.
Four Times Higher
Hip and knee list prices have increased 5.6 percent so far this year, on top of a 130 percent increase in the average selling price of a hip between 1996 and 2008, according to Orthopedic Network News, a trade journal that tracks costs.
In the U.S. in 2010, the average price of a primary artificial hip was $7,200, more than four times the $1,600 in Germany, says Melissa Hussey, a senior analyst on the orthopedic team at Millennium Research Group, based in Toronto. In Germany and other countries, she says, sales representatives have restricted access to surgeons.
“These items are ridiculously expensive, and a lot of the monies in that bucket are to keep the surgeon tied to that product,” Rodine says. He figures about half the price charged for devices can be traced to funds companies pour into persuading doctors to pick their goods.
Device makers work to form bonds early, in medical school, where they underwrite residency programs, or buy books, or sponsor fellowships. Later, they pay surgeons as consultants, speakers or instructors.
Sales Rep’s Car
Company sales representatives attend operations. The reps enjoy wide access to surgeons at a time when some hospitals are moving to limit the interactions that pharmaceutical representatives have with doctors. Academic medical centers, including Stanford University and Yale University, restrict when and where drug company salespeople can visit doctors, and ban them from patient areas.
The connection between device makers and surgeons is hard to break, says Jeffrey Lerner, chief executive officer of the ECRI Institute in Plymouth Meeting, Pennsylvania, which collects pricing data.
“The relationship between the manufacturer and surgeon is so deep,” Lerner says. “The first thing they want to see when they pull into the hospital in the morning is their manufacturer representative’s car.”
As joint replacements became more complex and numerous, implant makers increasingly relied on surgeons to help them develop new products and train colleagues. Physicians became involved in testing new implants.
‘Routinely Violated’
“Engineers don’t know how to do it,” says Joseph Zuckerman, an orthopedic surgeon at NYU Langone Medical Center who has worked as a consultant. “Advances in the design of orthopedic devices would not be possible if physicians were not part of the development process.”
Along the way, according to government investigators, the system was perverted so that many consulting deals, royalty agreements and trips to conferences were intended not to develop better products but to persuade surgeons to use a company’s products. The government charged that the industry “routinely violated the anti-kickback statute by paying physicians for the purpose of exclusively using their products.”
Federal prosecutors began looking into the incentives in 2005. The government’s settlement was with the five companies that make 95 percent of artificial hips and knees. They agreed to an 18-month monitoring plan. Four of the producers also paid $311 million in fines to settle civil complaints filed under the Federal False Claims Act. Stryker was monitored, not fined.
Ashcroft’s $52 Million
Since the agreement, payments to surgeons have been appropriate and for legitimate purposes, according to spokespeople for the five companies. Wright says on its website that it adheres to industry ethical standards in its dealings with consultants.
As for 2008 fees that weren’t delivered until 2009, three of the companies say they froze payments while monitors were reviewing contracts with surgeons to ensure they were proper. Spokesmen for Stryker and Smith & Nephew declined to comment. Three of the court-appointed monitors say they’re barred from talking about the details of their work. The two others, including former U.S. Attorney General John Ashcroft, didn’t return telephone calls. The department declined to release reports the monitors filed.
‘Paying the Price’
A month after the government closed its case, Zimmer CEO David Dvorak told analysts on a conference call that the action didn’t result in a “material change” to what it pays surgeons. Warsaw, Indiana-based Zimmer is the largest implant maker, with 2009 revenue of $4 billion.
Christie was criticized by some members of Congress for appointing Ashcroft, his one-time boss, to monitor Zimmer. Zimmer said then that it would have to pay Ashcroft’s consulting firm as much as $52 million, and complained about the amount.
The biggest change from the settlement is more paperwork, surgeons say, because they have to document in greater detail the work they do. Some say companies have been stricter with entertainment expenses and have cut the number of meetings at resort locations.
“No one is really paying the price,” says U.S. Representative Bill Pascrell Jr., a Democrat from New Jersey. Deferred prosecution deals “don’t work.”
In June 2003, Hirschbeck says, a Wright salesman was in the operating theater when his ceramic hip was installed at Waterbury Hospital in Connecticut, which the former umpire says he was stunned to learn later.
“I didn’t know this guy,” he says. “What right does he have to be there?”
2001 World Series
Back then, Hirschbeck says, he knew next to nothing about artificial implants or the companies that make them. Stout, of medium height and with a fondness for flat-top haircuts, he loved his job, and just wanted to find a way to do it pain-free.
He’d had his moments in the baseball sun. He umpired two World Series, including in 2001 when he became part of the story in game 2 between the New York Yankees and the Diamondbacks. In the 8th inning, Hirschbeck called Yankees third baseman Scott Brosius out on strikes. The Yankees were being shut out. An irate Brosius was soon in Hirschbeck’s face, and a photo of the confrontation ran in sports pages.
“I was about to throw him out,” says Hirschbeck, whose bother John is also a Major League umpire. He didn’t. Brosius backed off and the Yankees lost the game 4-0 and the series 4 games to 3. “It was the most pressure I ever felt. One bad call could ruin your entire winter.”
Cortisone Shots
After joining the major leagues following an eight-year tour in the minors, he was reaping the rewards. But getting into position behind home plate was starting to mean a jolt of piercing pain in his hip, he says, akin to being stabbed with a sharp knife. Cortisone shots provided temporary relief.
Then pain forced him off the field in Phoenix, and he started doing his homework on orthopedic surgeons. His choice of John Keggi of Middlebury, Connecticut, was motivated not just by Keggi’s reputation -- “I heard he was the best in the state,” Hirschbeck says -- but by the notion that he could recuperate close his own home in Shelton, Connecticut.
While some others recommended metal implants, Hirschbeck says Keggi pushed a new ceramic hip from Wright. “I will have you back on the field within a year,” Hirschbeck says Keggi told him. Keggi, in a deposition taken in Hirschbeck’s lawsuit, said he told Hirschbeck the replacement “may allow you to return to work” and that the ceramic hip “had the best chance of lasting the longest.”
Splintered Pieces
Less than two months after surgery, Hirschbeck was on the couch, watching TV, when he heard a pop. The pain was intense; the hip had shattered. On July 26, Keggi opened the patient up, picked out the splintered pieces and installed another ceramic implant. Within a month, Hirschbeck was back on the table.
This time, an infection had developed; Keggi washed the joint out and removed infected tissue. The pain didn’t go away, Hirschbeck says, and he his wife decided to seek out a new doctor, visiting the Hospital for Special Surgery in New York City, which performs the most replacements in the U.S.
A specialist there told Hirschbeck his hip was infected, he says, and delivered an additional jolt of bad news: Fixing the problem would mean taking out the joint and putting in a temporary spacer loaded with antibiotics. That would stay in until the infection cleared. Hirschbeck consented.
$344,813 Bill
For all of September and most of October in 2004, he lay in a hospital bed in the family room. Nurses visited daily to administer additional antibiotics. His wife emptied his bed pan. When he returned to New York in the back of his van in late October to receive yet another hip, he got a combination of components from Zimmer and Waldemar Link GmbH & Co. That operation, his fifth in 16 months, was successful.
There are an estimated 80,000 revisions of hip and knee replacements in the U.S. each year in which an artificial joint is removed because it is causing pain, became loose, failed or is limiting a patient’s mobility, according to a study published in 2007 in the Journal of Bone & Joint Surgery.
The bill for all his repairs was $344,813, Hirschbeck says, mostly covered by workers’ compensation.
In September 2005, Hirschbeck sued Keggi and Wright in Connecticut Superior Court. Keggi’s lawyer, Eugene Cooney, says in an e-mail that his client “has denied these claims and intends to fight them.” Keggi declined to comment.
‘Cooperating Fully’
Officials with Wright, which has denied liability, won’t answer questions about Keggi, Hirschbeck or its products while the suit is pending, according to Tom McAllister, assistant general counsel for the Arlington, Tennessee-based company. It’s the sixth-largest hip and knee maker, with revenue of $487.5 million last year.
Wright is “cooperating fully” with the Justice Department probe that began with a December 2007 subpoena, according to a May 5 filing with the SEC. It’s “probable” there will be a settlement that may require a payment of about $8 million, the company says in the filing.
Keggi, in a deposition, said Wright had given grant money, though he didn’t know how much, to the Keggi Orthopaedic Foundation, where he said he is director of research and his uncle, Kristaps Keggi, is president. “The Keggi foundation was paid nominal sums by various product manufacturers to collect data on the results of hip replacement surgeries,” Cooney says.
Keggi and his uncle, also an orthopedic surgeon, jointly owned the practice at the time of Hirschbeck’s ceramic implant.
Bahamas Conference
Kristaps Keggi was a clinical investigator for the trial by Wright to get its ceramic hip approved for sale in the U.S. The Wright website features testimonials from two patients of Kristaps Keggi touting the company’s ceramic hip.
John Keggi said in his deposition that he attended a Wright conference in the Bahamas and brought his wife. He couldn’t remember the dates or details, according to his deposition. Keggi said the Wright salesman at the time for Connecticut, Scott Fitzgerald, was usually in the operating room to instruct him on the installation of implants. In his deposition, Fitzgerald said that before joining Wright, he had worked in the ski industry and sold outdoor power equipment.
Keggi no longer uses the Wright ceramic hip, having switched to a joint made by Smith & Nephew, he said in his deposition. Last year, Smith & Nephew paid Keggi $25,001 to $50,000 for consulting work and reimbursed him for $7,061 in travel and meal expenses, according to financial records posted on the company website.
The company’s physician-consultants are “compensated fairly” and their input is “central to the development and introduction of new orthopedic medical device technology,” says Andrew Burns, a spokesman for London-based Smith & Nephew, in an e-mail. The company is the fourth largest hip and knee maker with revenue of $3.8 billion last year.
In Ansonia, Connecticut, Hirschbeck lives alone, collecting disability from the league, about 40 percent of his former pay. His marriage ended in divorce, partly, he says, because of the stress of his multiple surgeries.

“I’m miserable,” he says. “It screwed up my life big- time.”