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

Results of Gov. Christie's implant kick-back case questioned again

By Bloomberg News 

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.”

New Zealand: Stryker strikes out with FAILED metal hips!

One woman's toxic surgery ordeal

9:55 AM Saturday Aug 22, 2015

David Fisher

David Fisher is a senior reporter for the NZ Herald.

Lynne McKay had both her hips replaced in 2007 with metal implants.
• The implants failed, causing her intense physical pain and violent mood swings.
• When the implants were eventually removed in 2012, a company representative attended the surgery and took photographs.
• A Health and Disability Commission investigation found no fault with McKay's medical care.
• About half the 5,000 metal hip implants given to New Zealanders have proved defective in some way but follow-up is left to the companies and surgeons involved.

"When I licked my lips I could taste metal," says Lynne McKay, who has had six hip replacements in six years. "There was a metallic film on top of the water in the toilet and I was having to clean it every day. I was peeing [metal] ions."

The new life she expected to come with her double hip replacement in 2007 never arrived. Instead came fears of madness and near-constant misery, which only partly abated when the metal hips were removed after being recalled as faulty in 2012.

The time in between was awful. Almost immediately, there was pain. Inside McKay's body, the connection between the ball and the cup created a "grinding" which produced an "ionic soup".

When McKay walked, she heard "click, click" as the ball ground against the edge of the cup. Unknown to her, there were "actual chips coming off the back. And the [metallic] dust". The joints - when they eventually came out - were abraded, ground and scratched.

Her body was "trying desperately to sort it out" by collecting the metal fragments into tumours around the hip area. "There was a tumour the size of a small hen's egg."

Then came other changes. "About two years after having my hips done, in hindsight, I started to experience toxicity."

McKay had yellow, green and blue curtains, which first dulled, and then lost their yellow tones. At first she thought the curtains were fading, then she realised she was losing her ability to see colours. She started to experience hearing loss and tinnitus, and had frequent unexplained rashes.

McKay thought she was losing her mind. "I couldn't hold a thought. I was always in tears. My words weren't coming out right. I was cutting my nose off with all my friends. I thought I had Alzheimer's. I really thought I was losing the plot."

With her life falling apart, McKay tried harder to keep it together. She walked the streets for hours doing letterbox drops to build a massage business, which was suffering. "I was desperate for work. I was begging people. I really lowered my professional life. I was fighting for my life on a lot of different levels without knowing what was going on."

Understanding arrived in 2012, when the Stryker Mitch THR (total hip replacement) System was subject to a recall notice. A blood test showed McKay had high levels of chromium and cobalt in her bloodstream. Normal levels are between zero and 20 microscopic nanomoles per litre. McKay had 326 nmol/l. Cobalt was also high - safe was 0-16 nmol/l but she had a 378 nmol/l reading.

Mackay believes her metal hips poisoned her. It's a belief shared by other implant patients with elevated cobalt and chromium readings. The British Medical Journal raised this in 2012 in a story on regulatory failure around metal-on-metal implants, saying the ongoing uncertainty around the impact of the metal ions would never be tolerated in drug regulation.

There is still argument in medical circles as to whether the high levels have any effect, even though concerns have been raised for more than 40 years. The official position is that the long-term effects are unknown.

For McKay, not knowing is unacceptable. She says efforts should be made to find out the effects of metal ions in her body, rather than adopting a "wait and see" approach.

But then, she's long lost faith that the medical system will listen to her.

Back when she was a believer, the former registered nurse anticipated life-changing results from the metal hips surgeon Rocco Pitto put into her body during surgery at Middlemore hospital in 2007.

She was 50 at the time and life had become increasingly painful. "I got to a place where I could only walk to the letterbox with two walking sticks."

Diagnosed with dysplasia, a condition in which abnormal growths form at the joints, she had both hips replaced in March 2007. In hip replacements, the femur is removed for an artificial replacement; in McKay's case, the metal stem was attached to a metal ball that moved inside a metal cup, mimicking the worn-out original.

The metal hip replacements were enjoying a resurgence in surgical popularity, with the belief they would be more durable and last longer than ceramic or plastic alternatives. But by 2010, concerns were raised widely about the safety of metal-on-metal with the recall of a DePuy-branded device.

In April 2012, the recall notice for McKay's device went out.

The Lancet medical journal raised the alarm with a study showing 6.2 per cent of implants had to be replaced five years after being put in. It compared to 2.3 per cent for ceramic-on-ceramic implants and 1.7 per cent for metal-on-plastic types. British figures showed McKay's implants - the Stryker Mitch THR System with an Accolade femoral stem - had a revision rate of 8.8 per cent over four years. The alert to surgeons in Britain included advice that they screen patients annually for the presence of chromium and cobalt in the body.

In New Zealand, documents released under the Official Information Act show Stryker initially wanted to class the notice as a "safety alert", saying it no longer distributed the device in New Zealand. Medsafe wrote back to say it did not agree and insisted the notice be classified as the more serious "hazard alert", effectively matching the British response.

The letter announcing the recall on the Mitch head went out to surgeons on April 13 2012. Under the New Zealand system, the state has no role to play in contacting surgeons.

Instead, the regulator - Medsafe - asks the medical device company to make contact with the surgeons to whom it sold the implants and for them to notify patients. The OIA papers show Stryker didn't hear back from all surgeons (who it calls "customers" in emails to Medsafe) who used the device until three months later on July 6 2012.

McKay believes her metal hips poisoned her. Photo / Jason Oxenham

In McKay's case, Pitto's recalls were handled through Middlemore Hospital. Furious at the impact on her life over the past five years, she says she developed strong feelings of anger and frustration towards Stryker.

She wanted to sue. She wanted justice: "I had asked for medical photographs to record the damage to my hip. The kids had started to tell me I needed to collect things for class action."

She wanted to get Stryker into court and sue the company for the grief it had caused.

When McKay went into surgery in July 2012, she says she had no knowledge of - and did not consent to - a Stryker representative being among the gowned and masked surgical team preparing to operate. She says she objected strongly and was even more upset on waking after surgery to see on her notes: "The representative of Stryker Medical was attending today's surgery and also took some photos."

McKay: "That's when I lost it. Those photos were my evidence of what had happened to me." The faulty parts were also removed.

Though Pitto later told a Health and Disability Commission investigation he did discuss consent with Ms McKay, the Counties-Manukau District Health Board has said he didn't need her permission to have a Stryker representative in surgery and didn't ask her. The board also told the Herald - and Ms McKay says it's the first she's heard - that the Stryker photographs were not of the surgery but only of the faulty parts, removed from her body. She can't see the images to assure herself - the board says Stryker has deleted the photographs.

There are no signed consent forms showing permission was granted for either Stryker's presence, or the company's decision to take photographs or for the removal of the faulty parts. In all those cases, the health board says no consent was needed. It says consent is not required when someone is part of a surgical team.

For McKay, it felt as if the system was aligned against her - and even aligned with the company she blamed for the faulty part

In the end, McKay had a further three operations - a total of four hip replacements in 13 months after the recall. The replacement of the first metal hip in July 2012 was a failure - it dislocated less than two months later and needed replacing in November 2012.

One foot after another, neither working properly, "I fought to keep moving," says McKay. The replacement hip went in backwards so was replaced again on May 29, 2013. And then it was the other side. The right hip was revised in August 2013 and she then went into recovery for a year, getting $257 a week from ACC with a small accommodation top-up. Now, at least, "the metal taste was gone and energy levels were back up. But I'm in constant pain." She hisses with frustration.

"I'm sick of saying that actually. I walk like a drunk woman. I've no sense of stability in my hips. It hurts me to walk upstairs. My body is managing the indiscrepancies in core balance muscles but I pay for it in other ways. The body reorganises itself around weak muscles.

"I'm back massaging but I have to do it differently. I do my gardening and my housework on my knees."

McKay doesn't want anyone's sympathy. She's angry with nothing to strike out at. A complaint to the Health and Disability Commission talked of the "benefit of hindsight" and said Pitto's professional practice was appropriate given the knowledge at the time. Pitto declined to speak to the Weekend Herald.

And that's it. The metal hips that went bad inside her body were never approved for use in New Zealand, because our system doesn't require approval for medical devices.

The surgery took place largely in public hospitals, paid for with public money, and the taxpayer has since supported her recovery with a (meagre) salary supplement. ACC has never kept track of how much it cost the public to cover surgery to replace defective products or to cover rehabilitation afterwards.

No public body is taking action to discover the extent of the issue and whether it could have been handled better. When a group of Kiwi patients set off to Britain courts to unsuccessfully sue Stryker for negligence, they did so without Government support.

A spokeswoman for the Counties Manukau District Health Board pointed to a Health and Disability Commission investigation which found "the care provided to Mrs McKay was appropriate in the circumstances.

The DHB acknowledges the distress and pain that Mrs McKay has suffered as a result of the metal on metal hip implant and apologises that she had to undergo further surgery to replace the device."

A spokeswoman for Stryker said the company had "strict policies" guiding the behaviour of its staff in and out of operating theatres and investigated any complaints against them. The company would not provide a copy of its policies and would not comment on the specific case.

The scale of the issue is difficult to gauge. A Medsafe briefing counted about 1200 metal-on-metal devices that were recalled or subject to hazard notices. A further 1300 metal-on-metal devices had failure rates so high that surgeons were advised to check on their patients regularly.

In some cases, the surgeons who carried out the operations have died or retired - Medsafe's hope is that their successors will reach out on their behalf.

Health Minister Jonathan Coleman's office hasn't had any briefings on the issue in the past two years.

A spokeswoman says the regulatory system worked as it was meant to - but that system is about to be completely overhauled. "Health care is always rapidly changing, including emerging technologies, and we need to look at how legislation can better support that."

A law for the new regulatory scheme is expected to be put before Parliament next year and will "regulate the quality, safety and efficacy/performance of all therapeutic products across development and manufacture, market entry, and use".

Among the patients given the 2500 implants that were never good enough, McKay and a small cluster of unknowns have had extreme adverse experiences.

"I worry about what the future holds after being toxic for so long," McKay says. "Sometimes you just have to suck it up and get on with it - but somebody should be accountable."

Implants approved before risk known

Metal hip implants were recognised as a risk to patients after they were approved for use, says a surgeon who advised the Australian Government on the technique.

Surgeon Peter Devane - a hip replacement and revision specialist - says metal implants and metal caps on affected joints grew in popularity through the 2000s although use varied around the world. New Zealand was more conservative than most.

Devane was part of the system that cleared the devices for use in Australia. Between 1998 and 2008 he sat on the orthopaedic committee of Australia's Therapeutic Goods Association, the body that advises government on which devices can be used. The Australian system approved products under guidelines developed by the Global Harmonisation Task Force, a collection of volunteer regulatory bodies and medical device companies from around the world. At the time, metal-on-metal hips were in the "2b" category which meant they faced few regulatory hurdles because they were considered to be a modification of a previously-approved product.

From about 2007, work began to upgrade the categorisation to reflect a higher risk, but metal-on-metal hips had already gone through. Devane says governments were left playing catch-up. A British Medical Journal article later labelled it regulatory failure.

In New Zealand, the use of the products peaked in 2007. "Then those reports on metal-on-metal started coming out. We were aware of them - regulatory bodies were aware of them. By 2010, metal-on-metal was down to 3 per cent (of hip replacements)."

The comparative low number of replacements here - about 5000 replacements - tempered the surgeons' responses. "We didn't want to create a panic culture because it's not as big a problem (as abroad)," says Devane.

New Zealand's regulator Medsafe doesn't have an "approval process". In a statement, it told the Herald: "The [New Zealand] legislation does not require any form of pre-market assessment of medical devices." Medsafe takes guidance from other regulatory authorities -including the TGA - while medical device companies sell direct to surgeons.

Medsafe has "no mandate to approve medical devices or to monitor their import into the country", the statement said. Instead, companies are obliged to register devices on a database. "A notification on the database does not signify that a medical device has been 'approved' in any way."

Stryker: $1.43 BILLION Settlement Offer (Criminal ?!)

http://www.nytimes.com/2014/11/04/business/stryker-settles-suits-by-hip-implant-patients-for-dollar1-billion.html?emc=edit_tnt_20141103&nlid=50639700&tntemail0=y&_r=0

Stryker Settles Suits by Hip Implant Patients for $1 Billion

By BARRY MEIER NOV. 3, 2014

Stryker, the major producer of artificial hip implants, said on Monday that it had reached a settlement of thousands of patient lawsuits involving now-recalled all-metal devices that is expected to cost the company about $1 billion.

The Stryker deal, negotiated with lawyers representing the patients, would be one of the highest amounts paid in the last year by an implant manufacturer to resolve claims by patients who said they were injured by a hip replacement in which a device’s ball and cup components were both made from metal.

Last November, the DePuy division of Johnson & Johnson agreed to pay about $2.5 billion to resolve lawsuits filed by 8,000 patients who said they were injured by an all-metal implant that it once sold, known as the Articular Surface Replacement or A.S.R.

All-metal implants once accounted for about one of every three devices used in the estimated 250,000 hip replacement procedures that are performed annually in this country. The devices have been largely abandoned after evidence emerged several years ago that the metal components could rub together, creating tiny particles of metallic debris that could severely damage a patient’s tissue and muscle.

In announcing the settlement, Stryker, which is based in Kalamazoo, Mich., said that it covered patients who had received the Rejuvenate Modular-Neck or the ABG II Modular-Neck and who underwent operations to have the implant replaced. Stryker recalled both models in 2012 as complaints increased.

Stryker said that it had set aside $1.45 billion to settle the claims but that it expected the eventual expenses to be higher.

“This settlement program provides patients compensation in a fair, timely and efficient manner,” said William J. Huffnagle, the president of Stryker Orthopaedics.

Since abandoning all-metal implants, surgeons have returned to devices made of a mix of materials, such as plastic and metal.

http://atlanta.legalexaminer.com/defective-dangerous-products/hip-implant-settlement-proposal-announced-on-stryker-rejuvenate-and-abgii-cases/

Hip Implant Settlement Proposal Announced On Stryker Rejuvenate and ABGII Cases

Posted by Richard R. Schlueter

November 3, 2014 4:00 PM

Just over two years since the Stryker Rejuvenate and ABGII hip implant products were recalled from the market in June 2012, national leadership in the multi-district litigation (MDL) today announced a global settlement proposal for all Stryker Rejuvenate and ABGII hip implant victims who have undergone revision surgery to remove and replace their recalled Stryker hip implant on or before November 2, 2014.  The settlement proposal includes a base award amount of $300,000.00 to each claimant who has undergone revision surgery on or before to November 2, 2014, and otherwise qualifies for the settlement. There are certain limited potential reductions to the base award for age, prior hip revisions, and other relevant factors.  Claimants may also receive additional compensation, referred to in the proposed settlement as “Enhancements,” at a later date if they can demonstrate that they meet the eligibility requirements for the categories set forth in the settlement agreement.

Although participation is voluntary, it is expected that many of those that qualify (those who have had their recalled Stryker hip removed and replaced on or before November 2, 2014) will benefit from the settlement program, and may ultimately decide to participate in the settlement.  Any such decision should be made on an individual, case-by-case basis.

The following is a basic summary highlighting key aspects of the Master Settlement Agreement:

http://atlanta.legalexaminer.com/wp-content/uploads/sites/5/2014/04/Stryker-Rejuvenate-Hip-Replacement-Recall-.jpg

Stryker Hip Settlement

The settlement program applies to patients who are U.S. citizens and residents who had either an ABG II Modular Neck System or a Rejuvenate Modular Neck System implanted in their bodies in the United States, and who had a qualified surgery to remove and replace the recalled device on or before November 2, 2014.  The settlement program is also open to certain patients who have been deemed to be too sick or medically unstable to undergo a necessary revision surgery.

At Childers, Schlueter & Smith, our attorneys will immediately undertake to determine how the proposed settlement will affect each of our clients, and will work with each client individually to carefully consider the benefits of the proposed settlement so that they can make an informed personal decision on whether or not to participate.  As a nationally appointed leader in this litigation, founding partner Richard R. Schlueter will ensure each and every one of our clients has all of the information he/she needs to make the best choice for his/her unique situation.   Richard Schlueter has been involved in the various hip implant litigations (including DePuy ASR/Pinnacle, Zimmer Durom Cups, Biomet M2a Magnum and Wright Conserve Plus among many others) for several years, and has unique knowledge relating to hip implant failures and the injuries caused by those failures. Our current and future clients will be continue to be very well represented and informed during the entire process.

Attorneys representing those interested in participating in the Stryker hip implant settlement will have to register their clients in the program on or before the initial reporting deadline of December 14, 2014.  After that, the next deadline will be the formal enrollment of each individual patient who chooses to participate into the Settlement Program.  Those qualified claimants who would like to participate in the settlement program must enroll by March 2, 2015.  If less than 95% of the qualified claimants elect to participate in the settlement, Stryker has the ability to walk away and cancel the settlement program.  Stryker must make that decision on or before June 15, 2015.  Assuming the participation threshold is met and the settlement continues after June 15, 2015, the deadline to file claims for Enhanced benefits is September 30, 2015.  Additional compensation through the Enhanced benefits portion of the settlement will relate to damage to the femur, soft tissue damage, additional procedures and infection.  There is a cap on the Enhanced damages so that most total claims (Base award and Enhanced benefits) will be no more than $550,000.00 per claimant.

Based on the timing of the deadlines in the proposed settlement, it is unlikely that any settlement payments will be made prior to late summer or early fall 2015.

For patients who are not eligible for the settlement program, Stryker’s existing program for reimbursement of eligible out of

pocket costs, administered by Broadspire, remains available.  The decision to undergo a revision surgery is a medical decision, not a legal decision, and should be made only by patients in consultation with their surgeons.  If you were implanted with a recalled Stryker Rejuvenate or ABGII hip implant product but are not eligible for the settlement program, all of your legal rights and claims are preserved and you will not be affected so long as you have a filed legal claim with the Court.  Patients who have been implanted with a recalled Stryker hip in both hips (referred to as “bilateral” hip implants), in whom only one hip has been revised, will retain all of their claims and legal rights in regard to the unrevised hip, even if they participate in the settlement for their revised hip.

Childers, Schlueter & Smith is committed to continue litigating all claims for our clients who don’t qualify, who are arbitrarily penalized so as to not receive an offer under this proposal, who have not had revision surgery by today’s date, and those who choose not to participate in the proposed settlement.  If you have a recalled Stryker Rejuvenate or ABGII, please call us for a free consultation regarding your legal options.

For those looking for answers and guidance on these and/or any other Stryker hip implant related issues, we welcome you to contact our office for more information.

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http://abcnews.go.com/Business/wireStory/stryker-pay-143b-settle-hip-implant-cases-26664666

Stryker to Pay $1.43B to Settle Hip Implant Cases

ST. PAUL, Minn. — Nov 3, 2014, 9:04 PM ET

Medical implant maker Stryker will pay at least $1.43 billion to settle thousands of lawsuits from patients who had to have surgery to remove problematic hip implants, under a deal announced Monday.

The agreement, brokered by a New Jersey Superior Court judge, resolves state and federal lawsuits against the maker of orthopedics. It was announced Monday in U.S. District Court in St. Paul, Minnesota.

Stryker said the $1.43 billion figure represents the "low end of the range of probable loss to resolve these matters."

The lawsuits stem from two hip implants that Stryker recalled due to corrosion and other problems in 2012. One year ago Johnson & Johnson paid $2.5 billion to settle 8,000 lawsuits from patients who had to have the company's metal ball-and-socket hip implant removed or replaced.

Plaintiffs in 39 states alleged Kalamazoo-based Stryker sold defective hips that corroded while in patients' bodies and caused illness, including pain and swelling in the tissue around the implant.

"The settlement represents one of the largest medical device settlements with an unlimited compensation fund," said Minneapolis lawyer Charles Zimmerman, who helped negotiate the deal as part of the lead-counsel committee for the case. "We are pleased that we were able to reach a settlement with such meaningful relief."

Stryker Corp. expects to make most of the payments by the end of 2015.

Thousands of cases from patients across the country have been consolidated under a single federal judge in Minnesota in a "multi-district litigation," a common type of mass lawsuit filed against health care companies, the Star Tribune of Minneapolis reported.

Stryker Corp. to pay at least $1.4 billion to settle hip replacement lawsuits

Stryker Corp., whose Kalamazoo headquarters is shown here, has entered an agreement intended to resolve a wave of state and federal lawsuits related to two hip replacement products that it recalled in July of 2012.

Al Jones on November 03, 2014 at 6:39 PM, updated November 03, 2014 at 7:22 PM

KALAMAZOO, MI – Stryker Corp. has agreed to pay at least $1.4 billion to settle thousands of lawsuits by U.S. patients who had surgeries to revise problematic Stryker hip replacements.

The settlement in New Jersey's Bergen County Superior Court is intended to compensate individuals who had to have surgery to replace either of two Stryker products -- the Rejuvenate Modular-Neck hip stem and/or ABG II Modular-Neck hip stem.

Following complaints by patients of pain and swelling that were attributed to fretting and corrosion of the metal-on-metal hip implants, Stryker voluntarily conducted a worldwide recall of the products in July of 2012.

The company did not provide an estimate of how many people may have been effected or how many may be compensated. It also did not offer a representation of how much individuals stand to receive.

"The ultimate cost to entirely resolve these matters will depend on many factors that are difficult to predict and may be materially different than the amounts accrued to date," the company stated in a press release. "Further charges to earnings may need to be recorded in the future as additional information related to patient enrollment in the Settlement Program becomes available."

The company stated that it expects to make the majority of the payments under the settlement agreement by the end of 2015. The agreement, which is intended to resolve a wave of state and federal lawsuits, was brokered by New Jersey Superior Court Judge Brian R. Martinotti with the help of former United States Magistrate Judge Diane M. Welsh, acting as chief mediator.

It covers individuals who have already had surgery to replace the Stryker products. It also covers those who are already party to a lawsuit as well as those who are not.

In a June report, MT Services LLC reported that some cases involving revisions of Stryker Rejuvenate and ABG II hips could be worth more than $500,000.

According to Stryker, patients eligible for compensation should talk with their attorneys, if they have one, or contact the Settlement Program claims administrator at www.strykermodularhipsettlement.com or 1-855-382-6404. Patients do not need an attorney to participate in the Settlement Program.

A program called Broadspire, being done in partnership with third-party claims administrator Broadspire Services Inc., offers support for recall-related care among U.S. patients who have not had surgey to remove the recalled products.

In its press release, Stryker advised those patients to visit http://www.aboutstryker.com/modularneckstems/or call 1-888-317-0200 for more information. It stated that patients do not need an attorney to participate in the Broadspire program.

Kalamazoo-based Stryker produces a wide range of medical technologies including surgical devices, patient-handling devices, hospital beds and orthopedic implants such as replacement hips and joints.

MLive business writer Al Jones may be contacted at ajones5@mlive.com. Follow me on Twitter at ajones5_al.

Consumers Union communicates to AAOS: 50,000 patients want hip/knee warranty

 Activists Take Fight to Obtain Hip,Knee Product Warranties to AAOS. Will They Succeed?

Posted in Orthopedics by Arundhati Parmar on March 12, 2014

FiDA highlight

At AAOS, Consumers Union, through its Safe Patient Project, is asking surgeons to support their demand to obtain hip, knee warranties from device makers when implants fail early. 

A consumer advocacy group has seized upon the fairly mundane concept of product warranties to turn the heat on medical device makers.

Consumers Union, the lobbying and advocacy arm of Consumer Reports, sent letters to six top hip and knee makers last September asking them to provide product warranties for early implant failures. The letter quoted the American Academy of Orthopaedic Surgeons in saying that 10% of implants fail.

The group has now made a big push in publicizing its message by organizing a campaign outside the annual meeting of the American Academy of Orthopaedic Surgeons, which kicked off Tuesday and ends on Saturday, March 15.

Activists were handing out flyers outside the Morial Convention Center in New Orleans that urged orthopedic surgeons to text their support for manufacturer warranties. Here's what the flyer looked like:

In an interview at AAOS Wednesday, Lisa McGiffert, director of Consumers Union’s Safe Patient Project, said that only Smith & Nephew formally responded to the letter sent to orthopedic manufacturers in September. Two others acknowledged receving the letter via email but never actually responded to the request. The others did not respond. McGiffert couldn't recall which two companies sent the acknowledgment.

What the group is asking for is not unprecedented in the medical device world, she said.

"Biomet provides a warranty for a partial knee and cardiac products have warranties," she said.

After receiving Consumers Union's letter, Smith & Nephew responded that it is a "complicated issue" because hips and knees can fail for a number of reasons, McGiffert said. It could be the caused by the patient, the surgical technique or the device, McGiffert recalled the company as saying in its response.

But McGiffert clarified that the group is focused on "when the products are the problem." In other words, Consumers Union is not looking for a blanket product warranty, but wants device makers to take responsibility and stand behind the products when device-related problems cause the joint replacement to fail.

"You get warranties for flashlights, toasters and cars, for almost everything in the U.S.," she declared. "I know they are less complicated, but this is something that is going inside people's bodies. We think they ought to stand behind their products for a certain number of years. They can decide how long."

The purpose to bring the campaign to AAOS is to win support from surgeons and get feedback from them, McGiffert said.

However, Consumers Union may not win too much sympathy from the top brass at AAOS.

In a phone interview Wednesday, outgoing AAOS president Dr. Joshua Jacobs said that the "vast majority of orthopedic implants for joint replacement perform exceedingly well - 90% of total joint replacements work 10, 15 years and beyond."

Jacobs did acknowledge that "sometimes implants fail early, " but argued that "while warranties seem like a good idea on the face of it, the issue is more complex." 

Echoing McGiffert's portrayal of Smith & Nephew's response, Jacobs said that early failures could be caused by patients, due to the manner the surgeon did the procedure or it could be because of device problems. But sometimes "a complex interaction of the three" can also lead to early implant failure. So it may not be as easy to tease out which of the three factors caused the implant to fail.

And then there is the potential for infection, which is out of everyone's control, that can contribute to a failure.

"That cannot be addressed with a warranty," Jacobs declared. 

Overactive or obese patients can also lead to implant failure, Jacobs noted. 

However, another well-known orthopedic surgeon and healthcare social media maven, Howard Luks, disagreed with that assesment. 

"I don't think it's fair to blame the patient," he contended. "Once the joint replacement is done, it's stable, it's done. They should  be ready to go. If the patient is obese, then why did you put it in? Device makers understand who these implants are going into and the implants should meet those needs. Or there should be a big red sticker on that says 'Do not put in a patient with a BMI over 30.' So I think the patients have a right to ask for a guaranty or a warranty on a product that is going in their body."

Luks said that unless surgeons push the issue, device makers wouldn't move to provide such warranties.

And it certainly appeared that way. In an interview with DePuy Synthes Joint Reconstruction at AAOS, executives punted the question of warranties to the company's spokeswoman Mindy Tinsley, who responded like this:

"We understand the position that Consumers Union has taken. We are interested in continuing to have a dialogue about this. But I think with joint replacements, it's a complex interaction of factors and revisions have sometimes to do with the implant, sometimes with the patients, sometimes with the technique. We acknowledged the letter but we haven't taken a position. This is an issue we are continuing to explore."

Stryker declined comment via email. A Zimmer spokesman at AAOS said that "it's a complex issue and has a lot of factors surrounding it." The spokesman, James Gill, also forwarded a statement from AdvaMed, the device industry association, which argued that warranties for hip and knee implants that involve complex procedures and involving many different players, involving the patient and the hospital, may not be appropriate. However, it left the decision to provide warranties to individual manufacturers.

Meanwhile, McGiffert said that Consumers Union has secured the support of 50,000 patients who have sent emails to the top orthopedics device makers asking for product warranties-- By Arundhati Parmar, Senior Editor, MD+DI
arundhati.parmar@ubm.com

Great Reporting

Submitted by falascoj on March 14, 2014 - 9:32am.

Great graphics and story. I believe you have only hit the surface on this story. Hopefully we will see followup stories on you asking the medical device companies to come clean on why they are fighting the idea of warranty. They are the only major industry or activity that operates that way. The arguments that Mr.Gill has mentioned and the ortho surgeon are lame and I can just see an automotive guy saying --- well be can't do bumper to bumper because an F-150 is different then a Mustang. -Not
I've forwarded this article to numerous groups as an example of a publication actually getting out in front of the biggest deception on the American public since the Warren Commission.