This is a one hour talk.

Consumer’s Union had Dr Steve talk last month at Columbia School of Journalism.

It covers a lot of ground not only about the metal-metal hips but about hip replacement in general.

I am in the process of watching it myself and so can’t give you a big review here – but please post your thoughts and comments below.

by Christy Rakoczy, a J.D.

Manufacturers of hip and knee replacement products made many promises to consumers.  This is especially true of DePuy Orthopaedics, Stryker, Zimmer and other manufacturers of the new generation of joint replacement products largely marketed as medical devices that would last longer and provide more flexibility than traditional joint replacement solutions.

Unfortunately, the marketing for many of the new hip replacement products may have turned out to be a lot of hype. In fact, many of the hip replacement products that came on the market in recent years not only fail to last longer but actually appear to have higher failure rates and may cause serious complications for many patients.  The extensive problems that patients allege they’ve experienced has even caused Consumer Reports to call for a “lemon law,” on replacement joints.

Consumer Reports Calls for a Warranty On Artificial Hips and Knees

Consumers Union, the policy arm of Consumer Reports, argues that medical device manufacturers should give consumers a warranty on hip and knee replacement products, promising to replace the medical devices at no costs.  This suggestion comes at a time when as many as 20 percent of all hip replacement procedures and 10 percent of all knee replacement procedures each year are revision surgeries that are necessary because of problems with the implanted artificial joint.

Consumer Reports believes a warranty would both be fairer to patients who need to undergo repeated surgeries and would prompt medical device manufacturers to make sure their products are safer and more durable.

While this idea has merit as a method of protecting customers, unfortunately a warranty may not be enough. Those whose artificial joints fail often experience significant pain and serious medical complications. A no-cost revision surgery wouldn’t compensate the victims of defective medical devices for these other losses, but a product liability claim can and does allow patients to take action for defective hip and knee replacement devices.

Patients Have Rights When Hip and Knee Products are Defective

A large part of the reason revision surgeries have become so common in recent years is that many of the newer hip replacement products are metal-on-metal devices that were brought to the market under a special FDA rule.

The FDA’s 501(K) clearance rules allow manufacturers to produce and sell medical devices with a fast-tracked approval process and minimal testing provided there are substantially similar devices on the market already. Unfortunately, many of the devices brought to market under these rules have now been recalled when it turned out the products weren’t so safe after all.

DePuy Orthopaedics, for example, instituted a voluntary recall of its ASR™ Hip System after data from a UK joint replacement registry indicated a higher-than-average failure rate. The Stryker Rejuvenate and ABG II Modular-Neck Hip Systems were also recalled because of high failure rates.

The FDA continues to review the safety and efficacy record of metal on metal hip implants. The agency continues to receive adverse event reports with regard to the devices.  Commonly alleged problems include:

• Aseptic loosening
• Infection
• Bone loss
• Metallosis (a/k/a “metal poisoning”)
• The formation of pseudo tumors
• Decreased range of motion and limited mobility
• Pain

Patients who experience these complications deserve to have the manufacturer of their defective device pay for revision surgery.  This is not all they deserve, though, and a warranty allowing for a no-cost revision procedure doesn’t go far enough. Victims whose lives are affected by defective medical products should also be compensated for time missed from work; for pain and suffering; for emotional distress and for any reduction they experience in their quality of life.

Bio:

Christy Rakoczy, a J.D. from the University of California, is a legal writer and advocate for consumer rights and patient safety. You can read more of her work on the Stryker hip implants, including recall information, complications, and ongoing legal action, at strykerhiprecall.co.

Related articles

• CIHI Study Reveals Problems with Metal-on-Metal Hip Implants (earlsview.com)

A Trip Abroad; Part 3: Joint Replacement; For Medical Tourists, Simple Math

By ELISABETH ROSENTHAL | Published: August 3, 2013 New York Times

WARSAW, Ind. — Michael Shopenn’s artificial hip was made by a company based in this remote town, a global center of joint manufacturing. But he had to fly to Europe to have it installed.

Mr. Shopenn, 67, an architectural photographer and avid snowboarder, had been in such pain from arthritisthat he could not stand long enough to make coffee, let alone work. He had health insurance, but it would not cover a joint replacement because his degenerative disease was related to an old sports injury, thus considered a pre-existing condition.

Desperate to find an affordable solution, he reached out to a sailing buddy with friends at a medical device manufacturer, which arranged to provide his local hospital with an implant at what was described as the “list price” of $13,000, with no markup. But when the hospital’s finance office estimated that the hospital charges would run another $65,000, not including the surgeon’s fee, he knew he had to think outside the box, and outside the country.

“That was a third of my savings at the time,” Mr. Shopenn said recently from the living room of his condo in Boulder, Colo. “It wasn’t happening.”

“Very leery” of going to a developing country like India or Thailand, which both draw so-called medical tourists, he ultimately chose to have his hip replaced in 2007 at a private hospital outside Brussels for $13,660. That price included not only a hip joint, made by Warsaw-based Zimmer Holdings, but also all doctors’ fees, operating room charges, crutches, medicine, a hospital room for five days, a week in rehab and a round-trip ticket from America.

“We have the most expensive health care in the world, but it doesn’t necessarily mean it’s the best,” Mr. Shopenn said. “I’m kind of the poster child for that.”

As the United States struggles to rein in its growing $2.7 trillion health care bill, the cost of medical devices like joint implants, pacemakers and artificial urinary valves offers a cautionary tale. Like many medical products orprocedures, they cost far more in the United States than in many other developed countries.

Makers of artificial implants — the biggest single cost of most joint replacement surgeries — have proved particularly adept at commanding inflated prices, according to health economists.Multiple intermediaries then mark up the charges. While Mr. Shopenn was offered an implant in the United States for $13,000, many privately insured patients are billed two to nearly three times that amount.

An artificial hip, however, costs only about $350 to manufacture in the United States, according to Dr. Blair Rhode, an orthopedist and entrepreneur whose company is developing generic implants. In Asia, it costs about $150, though some quality control issues could arise there, he said.

So why are implant list prices so high, and rising by more than 5 percent a year? In the United States, nearly all hip and knee implants — sterilized pieces of tooled metal, plastic or ceramics — are made by five companies, which some economists describe as a cartel. Manufacturers tweak old models and patent the changes as new products, with ever-bigger price tags.

Generic or foreign-made joint implants have been kept out of the United States by trade policy, patents and an expensive Food and Drug Administration approval process that deters start-ups from entering the market. The“companies defend this turf ferociously,” said Dr. Peter M. Cram, a physician at the University of Iowa medical school who studies the costs of health care.

Though the five companies make similar models, each cultivates intense brand loyalty through financial ties to surgeons and the use of a different tool kit and operating system for the installation of its products; orthopedists typically stay with the system they learned on. The thousands of hospitals and clinics that purchase implants try to bargain for deep discounts from manufacturers, but they have limited leverage since each buys a relatively small quantity from any one company.

In addition, device makers typically require doctors’ groups and hospitals to sign nondisclosure agreements about prices, which means institutions do not know what their competitors are paying. This secrecy erodes bargaining power and has allowed a small industry of profit-taking middlemen to flourish: joint implant purchasing consultants, implant billing companies, joint brokers. There are as many as 13 layers of vendors between the physician and the patient for a hip replacement,according to Kate Willhite, a former executive director of the Manitowoc Surgery Center in Wisconsin.

Hospitals and orthopedic clinics typically pay $4,500 to $7,500 for an artificial hip, according to MD Buyline and Orthopedic Network News, which track device pricing. But those numbers balloon with the cost of installation equipment and all the intermediaries’ fees, including an often hefty hospital markup.

That is why the hip implant for Joe Catugno, a patient at the Hospital for Joint Diseases in New York, accounted for nearly $37,000 of his approximately $100,000 hospital bill; Cigna, his insurer, paid close to $70,000 of the charges. At Mills-Peninsula Health Services in San Mateo, Calif., Susan Foley’s artificial knee, which costs about the same as a hip joint, was billed at $26,000 in a total hospital tally of $112,317. The components of Sonja Nelson’s hip at Sacred Heart Hospital in Pensacola, Fla., accounted for $30,581 of her $50,935 hospital bill. Insurers negotiate discounts on those charges, and patients have limited responsibility for the differences.

The basic design of artificial joints has not changed for decades. But increased volume — about one million knee and hip replacements are performed in the United States annually — and competition have not lowered prices, as would typically happen with products like clothes or cars. “There are a bunch of implants that are reasonably similar,” said James C. Robinson, a health economist at the University of California, Berkeley. “That should be great for the consumer, but it isn’t.”

‘Sticky Pricing’

The American health care market is plagued by such “sticky pricing,” in which prices of products remain high or even increase over time instead of dropping. The list price of a total hip implant increased nearly 300 percent from 1998 to 2011,according to Orthopedic Network News, a newsletter about the industry. That is a result, economists say, of how American medicine generally sets charges: without government regulation or genuine marketplace competition.

“Manufacturers will tell you it’s R&D and liability that makes implants so expensive and that they have the only one like it,” said Dr. Rory Wright, an orthopedist at the Orthopedic Hospital of Wisconsin, a top specialty clinic. “They price this way because they can.”

Zimmer Holdings declined to comment on pricing. But Sheryl Conley, a longtime Zimmer manager who is now the chief executive ofOrthoWorx, a local trade group in Warsaw, said that high prices reflected the increasing complexity of the joint implant business, including more advanced materials, new regulatory requirements and the logistics of providing a now huge array of devices. “When I started, there weren’t even left and right knee components,” she said. “It was one size fits all.”

Mr. Shopenn’s Zimmer hip has transformed his life, as did the replacement joint for Mr. Catugno, a TV director; Ms. Foley, a lawyer; and Ms. Nelson, a software development executive. Mr. Shopenn, an exuberant man who maintains a busy work schedule, recently hosted his son’s wedding and spent 26 days last winter teaching snowboarding to disabled people.

His joint implant and surgery in Belgium were priced according to a different logic. Like many other countries, Belgium oversees major medical purchases, approving dozens of different types of implants from a selection of manufacturers, and determining the allowed wholesale price for each of them, for example. That price, which is published, currently averages about $3,000, depending on the model, and can be marked up by about $180 per implant. (The Belgian hospital paid about $4,000 for Mr. Shopenn’s high-end Zimmer implant at a time when American hospitals were paying an average of over $8,000 for the same model.)

“The manufacturers do not have the right to sell an implant at a higher rate,” said Philip Boussauw, director of human resources and administration at St. Rembert’s, the hospital where Mr. Shopenn had his surgery. Nonetheless, he said, there was “a lot of competition” among American joint manufacturers to work with Belgian hospitals. “I’m sure they are making money,” he added.

Dr. Cram, the Iowa health cost expert, points out that joint manufacturers are businesses, operating within the constraints of varying laws and markets.

“Imagine you’re the C.E.O. of Zimmer,” he said. “Why charge $1,000 for the implant in the U.S. when you can charge $14,000? How would you answer to your shareholders?” Expecting device makers “to do otherwise is like asking, ‘Couldn’t Apple just charge $50 for an iPhone?’ because that’s what it costs to make them.”

But do Americans want medical devices priced like smartphones? “That,” Dr. Cram said, “is a different question.”

A Miracle for Many

When joint replacement surgery first became widely used in the 1970s, it was reserved for older patients with crippling pain from arthritis, to offer relief and restore some mobility. But as technology and techniques improved, its use broadened to include younger, less debilitated patients who wanted to maintain an active lifestyle, including vigorous sports or exercise.

In the first few decades, implants were typically cemented into place. But since the 1980s, many surgeons have used implants made of more sophisticated materials that allow the patient’s own bone to grow in to hold the device in place. For most patients, implants have proved miraculous in improving quality of life, which is why socialized medical systems tend to cover them. Per capita, more hip replacements are done in Britain, Sweden and the Netherlands, for example, than in the United States.

Motivated in part by science and in part by the need to create new markets, joint makers churn out new designs that are patented, priced higher and introduced with free training courses for surgeons. Some use more durable materials so that a patient requiring a hip implant at age 40 or 50 might rely on it longer than the standard 20 years, while other models are streamlined and require smaller incisions.

Zimmer got a big sales bump a few years ago when it began promoting its new “female knee,” a slightly slimmer version of its standard design, in an advertising campaign directed at patients. Hospitals on average pay about $800 more to buy the gender-specific knee implants, according to MD Buyline.

Many doctors say that for most patients, older, standard implants with a successful track record are appropriate. Expensive modifications make no difference for the typical patient, but they drive up prices for all models and have sometimes proved to be deeply flawed, they say.

In the last few years, joint manufacturers have faced lawsuits and have settled claims with patients after new, all-metal implants, which were meant to be more durable than the standard version, had unusually high failure rates. As for those “female knees,” a study featured at the meeting of the American College of Orthopedic Surgeons this year concluded, “While we certainly use the female components frequently in surgery, we don’t detect any objective improvement in clinical outcomes.”

That is why Dr. Scott S. Kelley, an orthopedist affiliated with Duke University Medical Center, generally tries to dissuade patients who request “new, improved” joints. “I tell them: ‘That’s taking a big riskfor the potential of a few percentage points of improvement. You wouldn’t invest your retirement account this way.’ ”

A Town’s Lifeblood

The power and profits of the medical device industry are on display here in Warsaw, which has trademarked itself the Orthopedic Capital of the World. Four of the big five joint manufacturers in the world are based in the United States; the other is in Britain. Three of these giants — Zimmer, Biomet and DePuy, a division of Johnson & Johnson — have their headquarters here, a town of 14,000.

An industry that began as a splint-making shop in 1895 has made Warsaw the center of a global multibillion-dollar business. The companies based here produce about 60 percent of the hip and knee devices used in the United States and one-third of the world’s orthopedic sales volume, local officials said. Nearly half the jobs in Kosciusko County, where Warsaw is, are tied to the industry. Residents joke that a mixed marriage is when one spouse works for Zimmer and the other for DePuy.

The industry’s benefits are evident. The county has the lowest unemployment rate in Northern Indiana, and the median family income of $50,000 puts it significantly above the state average. The town boasts lush golf courses and streets lined with spacious homes. The lobby of the elegant City Hall, which is in a restored 1912 bank, features plaques about device manufacturers.

“We eat, sleep and breathe orthopedics,” said Ms. Conley of OrthoWorx, which she said was set up to “plan for the future of the orthopedic industry here.” OrthoWorx’s board of directors includes executives from Biomet and DePuy.

With a high-tech industry as its lifeblood, Ms. Conley said, Warsaw needed to attract engineers and doctors from afar and train local youths for “the business.” It has upgraded the public schools and helped create programs at local colleges in orthopedic regulation and advanced machinist techniques.

Officials at OrthoWorx say the device makers do not discuss “competitive issues” among themselves, including the prices of implants, even as employees stand together watching their children play baseball. Still, it is in everyone’s interest not to undercut the competition. In 2011, all three manufacturers had joint implant sales exceeding $1 billion and spent about only 5 percent of revenues on research and development, compared with 20 percent in the pharmaceutical industry, said Stan Mendenhall, the editor of Orthopedic Network News. They each paid their chief executives over $8 million.

“It’s amazing to think there is $5 billion to $6 billion going through this little place in Northern Indiana,” said Mr. Mendenhall, adding that the recession has meant only single-digit annual revenue growth rather than the double-digit growth of the past.

Device makers have used some of their profits to lobby Congress and to buy brand loyalty. In 2007, joint makers paid $311 million to settle Justice Department accusations that they were paying kickbacks to surgeons who used their devices; Zimmer paid the biggest fine, $169.5 million. That year, nearly 1,000 orthopedists in the United States received a total of about $200 million in payments from joint manufacturers for consulting, royalties and other activities, according to data released as part of the settlement.

Despite that penalty, payments continued, according to a paper published in The Archives of Internal Medicine in 2011. While some of the orthopedists are doing research for the companies, the roles of others is unclear, said Dr. Cram, one of the study’s authors.

Although only a tiny percentage of orthopedists receive payments directly from manufacturers, the web of connections is nonetheless tangled.

Companies “build a personal relationship with the doctor,” said Professor Robinson, the Berkeley economist. “The companies hire sales reps who are good at engineering and good at golf. They bring suitcases into the operating room,” advising which tools might work best among the hundreds they carry, he said. And some studies have shown that operations attended by a company representative are more likely to use more and costlier medical equipment. While some hospitals have banned manufacturers’ representatives from the operating room, or have at least blocked salesmanship there, most have not.

No Gift Shop

There are, of course, a number of factors that explain why Mr. Shopenn’s surgery in Belgium would cost many times more in the United States. In America, fees for hospitals, scans, physical therapyand surgeons are generally far higher. And in Belgium, even private hospitals are more spartan.

When Mr. Shopenn arrived at the hospital, he was taken aback by the contrast with NewYork-Presbyterian Hospital, where his father had been a patient a year before. The New York facility had “comfortable waiting rooms, an elegant lobby and newsstands,” Mr. Shopenn remembered.

But in Belgium, he said, “I was immediately scared because at first I thought, this is really old. The chairs in the waiting rooms were metal, the walls were painted a pale green, there was no gift shop. But then I realized everything was new. It was just functional. There wasn’t much of a nod to comfort because they were there to provide health care.”

The pricing system in Belgium does not encourage amenities, though the country has among the lowest surgical infection rates in the world — lower than in the United States — and is known for good doctors.While most Belgian physicians and hospitals are in business for themselves, the government sets pricing and limits profits. Hospitals get a fixed daily rate and surgeons receive a fee for each surgery, which are negotiated each year between national medical groups and the state.

While doctors may charge more than the rate, few do so because most patients would refuse to pay it, said Mr. Boussauw, the hospital administrator. Doctors and hospitals must provide estimates. European orthopedists tend to make about half the income of their American counterparts, whose annual income averaged $442,450 in 2011,according to a survey by the Commonwealth Fund, a foundation that studies health policy.

Belgium pays for health care through a mandatory national insurance plan, which requires contributions from employers and workers and pays for 80 percent of each treatment. Except for the poor, patients are generally responsible for the remaining 20 percent of charges, and many get private insurance to cover that portion.

Mr. Shopenn’s surgery, which was uneventful, took place on a Tuesday. On Friday he was transferred for a week to the hospital’s rehabilitation unit, where he was taught exercises to perform once he got home.

Twelve days after his arrival, he paid the hospital’s standard price for hip replacements for foreign patients. Six weeks later he saw an orthopedist in Seattle, where he was living at the time, to remove stitches and take a postoperative X-ray. “He said there was no need for further visits, that the hip looked great, to go out and enjoy myself,” Mr. Shopenn said.

With baby boomers determined to continue skiing, biking and running into their 60s and beyond, economists predict a surge in joint replacement surgeries, and more procedures for younger patients. The number of hip and knee replacements is expected to roughly double between 2010 and 2020, according to Exponent, a scientific consulting firm, and perhaps quadruple by 2030. If insurers paid $36,000 for each surgery, a fairly typical price in the commercial sector, the total cost would be $144 billion, about a sixth of the nation’s military budget last year.

So far, attempts to bring down the price of medical devices have been undercut by the industry.

When Dr. Daniel S. Elliott of the Mayo Clinic decided to continue using an older, cheaper valve to cure incontinence because studies showed that it was just as good as a newer, more expensive model, the manufacturer raised its price.

“If there was a generic, I’d be there tomorrow,” he said.

With artificial joints, cost-trimming efforts have been similarly ineffective. Medicare does not negotiate directly with manufacturers, but offers all-inclusive payments for surgery to hospitals to prompt them to bargain harder for better implant prices. Instead, hospitals complain that acquiring the implant consumes 50 percent to 70 percent of Medicare’s reimbursement, which now averages $12,099, up 25 percent from $9,645 in 1993. Meanwhile, surgeons’ fees have dropped by nearly half.

With the federal government unwilling to intervene directly, some doctors and insurance plans are themselves trying to reduce the costs by mandating preset prices or forcing more competition and transparency.

After concluding that hip replacements billed at $100,000 yielded no better results than less expensive ones, the California Public Employees’ Retirement System, or Calpers, told members that it would pay hospitals $30,000 for a hip or knee replacement, and dozens of hospitals have met that number.

Dr. Wright’s orthopedic hospital near Milwaukee has driven down payments for joints by more than 30 percent by resolving to use only two types of hip implants and requiring blind bids directly from the manufacturers; part of the savings is passed on to patients.

The Affordable Care Act tries to recoup some of the medical device manufacturers’ profits by imposing a 2.3 percent tax on their revenues, effective this year. But Brad Bishop, the executive director of OrthoWorx and a former Zimmer executive, said that the approach would harm an innovative American industry, and that the cost would ultimately be borne by joint replacement patients “whose average age is 67.” He argued that the best way to reduce the cost of joint replacement surgery was to rescind the tax and decrease government interference.

The medical device industry spent nearly $30 million last year on lobbying, according to the Center for Responsive Politics. The Senate moved to repeal the tax, and the House is expected to take it up this fall. The bill’s supporters included both senators from Indiana.

Mr. Shopenn’s new hip worked so well that a few months after returning from Belgium he needed a hernia operation — a result of too much working out at the gym. He was home by 4 p.m. the day of the outpatient surgery, but the bill came to $16,500. Though his insurance company covered the procedure, he called the hospital’s finance department for an explanation.

He remembers in particular a “surreal” discussion with a “very nice” administrator about a $750 bill for a surgical drain, which he called“a piece of plastic in a sealed bag.”

“It was mind-boggling to me that the surgery could possibly cost this much,” he said, “after what I’d just done in Belgium.”

Related articles

• For Medical Tourists, Simple Math by Elisabeth Rosenthal (clubalthea.com)
• Here’s why U.S. patients pay inflated prices for new hips, knees (seattletimes.com)
• For medical tourists, it’s simple math (wnd.com)
• Medical Mysteries (justoneminute.typepad.com)
• Products Included in the Ceramic Hip Replacement Recall (arthritis.answers.com)
• Risks and Rewards of Cemented Hip Replacements (arthritis.answers.com)
• Four Basic Facts About Hip Replacement Surgery (theroadtohipsurgery.wordpress.com)
• In Need of _____, But Priced Out of America (mcleanparlor.com)
• The lobbyists have mounted up (digbysblog.blogspot.com)
• Metal-on-metal hip implants more likely to need replacement (cbc.ca)

Related articles

• Data show hip replacement revision rate low, though higher with metal-on-metal (globalnews.ca)
• Metal on Metal Long Term Risks Confirmed (earlsview.com)
• Products Included in the Ceramic Hip Replacement Recall (arthritis.answers.com)
• Risks, Benefits and Recovery From Birmingham Hip Procedures (arthritis.answers.com)
• Metal-on-metal hip implants more likely to need replacement (cbc.ca)
• Risks and Rewards of Cemented Hip Replacements (arthritis.answers.com)
• Hip Resurfacing an Alternative to Hip Replacement (hothealthnews.wordpress.com)
• Understanding Hip Revision Surgery: A Medical Overview (orthopedics.answers.com)

FDA Safety Communication: Metal-on-Metal Hip Implants

Date Issued: Jan. 17, 2013

Audience:

• Orthopaedic surgeons
• Health care providers responsible for the ongoing care of patients with metal-on-metal hip implants
• Patients who are considering or have received a metal-on-metal hip implant

Medical Specialties: Orthopaedics, General Medicine, Family Practice, Radiology, Radiologic Technology, Clinical Laboratory Managers and Directors

Device:

Metal-on-metal hip implants consist of a ball, stem and shell, all made from cobalt-chromium-molybdenum alloys.

There are two types of metal-on-metal hip implants:

• Traditional total hip replacement systems
• Resurfacing hip systems

Purpose: In February 2011, the FDA launched a metal-on-metal hip implant webpage. The FDA is providing updated safety information and recommendations to patients and health care providers.  This new information is based on the FDA’s current assessment of metal-on-metal hip implants, including the benefits and risks, the evaluation of the published literature, and the results of the June 2012 Orthopaedic and Rehabilitation Devices Advisory Panel meeting.

Summary of Problem and Scope:

Metal-on-metal hip implants have unique risks in addition to the general risks of all hip implants.

In metal-on-metal hip implants, the metal ball and the metal cup slide against each other during walking or running. Metal can also be released from other parts of the implant where two implant components connect.  Metal release will cause some tiny metal particles to wear off of the device around the implant, which may cause damage to bone and/or soft tissue surrounding the implant and joint. This is sometimes referred to as an “adverse local tissue reaction (ALTR)” or an “adverse reaction to metal debris (ARMD).”

Soft tissue damage may lead to pain, implant loosening, device failure and the need for revision surgery (a surgical procedure where the implant is removed and another is put in its place). Some of the metal ions released will enter the bloodstream and travel to other parts of the body, where they may cause symptoms or illnesses elsewhere in the body (systemic reactions).

Presently, the FDA does not have enough scientific data to specify the concentration of metal ions in a patient’s body or blood necessary to produce adverse systemic effects.  In addition, the reaction seems to be specific to individual patients, with different patients having different reactions to the metal wear particles.

Recommendations for Orthopaedic Surgeons:

Before Surgery

• Select a metal-on-metal hip implant for your patient only after determining that the benefit-risk profile of using a metal-on-metal hip implant outweighs that of using an alternative hip system (metal-on-polyethylene, ceramic-on-polyethylene, ceramic-on-ceramic or ceramic-on-metal).  Factors to consider include the patient’s age, sex, weight, diagnosis, and activity level.
  • Note that a 2012 FDA advisory panel of experts identified young males with larger femoral heads as the best candidates for hip resurfacing systems.
• Inform patients about the benefits and risks of metal-on-metal hip implants, including the risk that the hip implant may need to be replaced. Also discuss the patient’s expectations and review the potential complications of surgery with a metal-on-metal hip implant.
• Pay close attention to patient populations for which metal-on-metal hip systems are contraindicated.  Be aware of the risk factors that may predispose a device to excess wear and early failure.

Additional information on the FDA’s recommendations for orthopaedic surgeons before, during and immediately following metal-on-metal hip replacement surgery can be found in Information for Orthopaedic Surgeons.

Patient Follow-Up

• Follow-up of asymptomatic patients with metal-on-metal hip implants, including physical examinations and routine radiographs, should occur periodically (typically every 1 to 2 years).  If the hip is functioning properly, the FDA does not believe there is a clear need to routinely perform additional soft tissue imaging or assess metal ion levels in the blood.
• Be aware that there are certain patients who are at risk for increased device wear and/or adverse local tissue reactions (ALTR) and should be followed more closely. They may include:
  • Patients with bilateral implants
  • Patients with resurfacing systems with small femoral heads (44mm or smaller)
  • Female patients
  • Patients receiving high doses of corticosteroids
  • Patients with evidence of renal insufficiency
  • Patients with suppressed immune systems
  • Patients with suboptimal alignment of device components
  • Patients with suspected metal sensitivity (e.g. cobalt, chromium, nickel)
  • Patients who are severely overweight
  • Patients with high levels of physical activity.
• Pay close attention to signs and symptoms that may be associated with metal-on-metal hip implants. Please see the website for a list of common ALTRs and systemic symptoms/complications.
• Conduct a thorough evaluation if a patient with a metal-on-metal hip experiences local symptoms such as pain or swelling at or near the hip, a change in walking ability or a noise from the hip joint more than three months after metal-on-metal hip implant surgery.
• Follow symptomatic patients with metal-on-metal hip implants at least every 6 months.

Additional information on the FDA’s recommendations for patient follow-up can be found in Information for Orthopaedic Surgeons.

For additional information regarding soft tissue imaging or assessing metal ion levels, please review the FDA’s recommendations below.

Imaging

For some symptomatic patients with metal-on-metal hip implants, additional diagnostic imaging is required to assess and diagnose soft tissue findings surrounding the implant.  Please be aware of the FDA’s recommendations:

• Consider the benefits and risks of using different types of diagnostic imaging procedures (e.g. MRI with metal artifact reduction, CT, or ultrasound) as well as the availability of specialized radiology expertise when determining the most appropriate imaging modality for each patient.

If you determine that an MRI of a metal-on-metal hip implant patient is appropriate, the FDA recommends the following:

• Consult with the radiologist to evaluate the benefits and risks of utilizing MRI with metal artifact reduction;
• Review the available device-specific labeling from manufacturers for MRI Conditions; and
• Inform the MRI site that the patient has a metal-on-metal hip implant.

For additional information on the FDA’s recommendations about imaging a patient with a metal-on-metal hip implant, please see Imaging Evaluation.

Assessing Metal Ion Levels

Some patients with a metal-on-metal hip implant may have elevated metal ion levels (e.g. cobalt and/or chromium) in their bloodstream.  Several factors can impact the accuracy, reproducibility, and clinical interpretation of metal ion test results.  Please be aware of the FDA’s recommendations:

• The FDA does not believe there is a clear need to routinely check metal ion levels in the blood if the orthopaedic surgeon feels the hip is functioning properly and the patient is asymptomatic.
• Patients with metal-on-metal hip implants who develop any symptoms or physical findings that indicate their device may not be functioning properly, should be considered for metal ion testing.
• If measuring metal ions, consider obtaining and following serial measurements (using the same sample type, the same measurement method, and preferably the same laboratory) in determining metal ion levels in symptomatic patients.
• At this time, the FDA is not recommending a specific metal ion level as a trigger for revision or other medical intervention.  The metal ion concentration values, including increases in metal ion levels over time, should be considered in addition to the overall clinical scenario including symptoms, physical findings, and other diagnostic results when determining further actions.

For additional information on the FDA’s recommendations on metal ion test methods, selecting a test lab and interpreting test results, please see Metal Ion Testing.

Device Revision

The decision to revise a metal-on-metal hip implant should be made in response to the overall clinical scenario. In case of adverse local tissue reactions (ALTR), revision of a metal-on-metal hip implant may have a worse prognosis than revision of other types of bearing surfaces.

In selecting components for revision:

• Consider the benefits and risks of all bearing surfaces for each patient.
• Check the specific device labeling for compatibility of device components.
• If a patient is suspected to have developed metal sensitivity, carefully select the materials of the revision components (potentially avoiding materials with nickel or chromium).

For additional information, please review the FDA’s considerations on device revisions, which includes our recommendation for a retrieval analysis of every failed metal-on-metal hip implant.

Summary of FDA Recommendations for Orthopaedic Surgeons

*For chromium testing, a validated method that resolves potential interferences must be used.  Please reviewFDA’s recommendations for chromium testing.

Recommendations for Health Care Providers:

Metal-on-metal implant patients with systemic symptoms are more likely to visit their primary care practitioner than their orthopaedic surgeon, which makes it important for all health care providers to be aware of metal ion adverse events that may occur in metal-on-metal hip implant patients. Based on case reports, these events may include:

• General hypersensitivity reaction (skin rash)
• Cardiomyopathy
• Neurological changes including sensory changes (auditory, or visual impairments)
• Psychological status change (including depression)
• Renal function impairment
• Thyroid dysfunction (including neck discomfort, fatigue, weight gain or feeling cold.

Patients with systemic findings that are thought to be related to a metal-on-metal hip implant should be advised to follow-up with his or her orthopaedic surgeon to determine the appropriate course of action.

For additional information, please review the FDA’s considerations to Health Care Professionals.

Recommendations for Patients Considering Hip Implants:

• Be aware that every hip implant has benefits and risks.
• Discuss your options for hip surgery with your surgeon.

A list of some questions to ask your orthopaedic surgeon can be found in Patients Considering a Metal-on-Metal Hip Implant.

Recommendations for Patients with Metal-on-Metal Hip Implants:

• If you are not having any symptoms and your orthopaedic surgeon believes your implant is functioning appropriately, you should continue to routinely follow-up with the surgeon every 1 to 2 years.
• If you develop new or worsening problems such as pain, swelling, numbness, noise (popping, grinding, clicking or squeaking of your hip), and/or change in your ability to walk, contact your orthopaedic surgeon right away.
• If you experience changes in your general health, including new or worsening symptoms outside your hip, let your physician know you have a metal-on-metal hip implant.

Additional information for patients with a metal-on-metal hip can be found in Patients who have a Metal-on-Metal Hip Implant.

FDA Activities:

The FDA is committed to providing reliable safety recommendations to patients and health care providers about the utilization of these devices.  Recent activities include:

1. On May 6, 2011, the FDA instructed manufacturers of metal-on-metal total hip replacement (THR) systems to conduct postmarket surveillance study of these devices.  Five manufacturers currently market metal-on-metal hip implants in the U.S. and all five have approved postmarket surveillance study plans.  Data from these studies will provide patients and health care providers with additional information about the safety profiles of the implants, including the effect of metal ion concentrations in the bloodstream.
2. On June 27-28, 2012, the FDA convened the Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee to seek expert scientific and clinical opinion on the benefits and risks of metal-on-metal hip systems. Information from this panel meeting has helped form these recommendations.
3. On January 17, 2013 the FDA issued a proposed order requiring manufacturers of metal-on-metal total hip replacement systems to submit premarket approval (PMA) applications.  Metal-on-metal total hip replacement systems were evaluated under the 510(k) premarket notification program. Metal-on-metal total hip replacement systems were marketed in the U.S. prior to 1976 legislation that gave the agency premarket authority over medical devices. As “preamendment devices,” they were designated as Class III (higher risk) devices but were regulated under the 510(k) premarket notification program.

Additional information on FDA ongoing activities are provided in FDA’s Role and Activities.

Other Resources:

For additional resources, see Metal-on-Metal Hip Implants: Other Resources.

Reporting Problems to the FDA:

Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices. If you suspect a problem with a metal-on-metal device, we encourage you to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program. Health care personnel employed by facilities that are subject to the FDA’s user facility reporting requirements should follow the reporting procedures established by their facilities. Device manufacturers must comply with the Medical Device Reporting (MDR) regulations.

Reports to the FDA about adverse events related to metal-on-metal hip systems include, but are not limited to: pain, malposition, adverse local tissue reaction, metallosis, hypersensitivity (allergy), loosening, and dislocation.

To help us learn as much as possible about the adverse events associated with metal-on-metal hip implants, please include the following information in your reports, if available:

• Date of implantation
• Date of implant removal (if applicable)
• Clinical cause for revision (if available)
• System components affected by the adverse event.

Contact Information:

If you have questions about this communication, please contact the Division of Small Manufacturers, International and Consumer Assistance (DSMICA) via e-mail at DSMICA@FDA.HHS.GOV or by phone: 800-638-2041 or 301-796-7100.

This document reflects the FDA’s current analysis of available information, in keeping with our commitment to inform the public about ongoing safety reviews of medical devices.

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Trial plaintiff says J&J hips defective, company says not liable

3/1/2013

By Deena Beasley

(Reuters) – Johnson & Johnson‘s DePuy unit was well aware of defects in its all-metal hips when plaintiff Loren Kransky was implanted with one of the devices in 2007, lawyers for the 65-year-old man said in closing trial arguments.

The lawsuit filed by the retired Montana prison guard is the first to reach court out of more than 10,000 filed against J&J in the wake of its 2010 recall of the ASR artificial hips.

Kransky attorney Brian Panish told Los Angeles Superior Court jurors that J&J should be ordered to pay around $5 million for Kransky’s pain and suffering, and as much as $179 million in punitive damages. The proceedings were monitored over the Courtroom View Network.

J&J recalled 93,000 of its ASR metal hips after determining that they were failing at a higher-than-expected rate.

Kransky’s attorneys argued that the design of the hip was defective, leading to the shedding of metal debris that caused tissue poisoning and pain as well as the need for the plaintiff to undergo hip revision surgery.

“Any compensation should not be reduced simply because the plaintiff was more susceptible to injury than a normally healthy person,” Panish said.

Both sides in the case agreed that Kransky’s medical problems, including diabetes, cancer, kidney disease, heart disease and vascular disease, were not related to the ASR hip implant.

J&J attorney Michael Zellers argued that Kransky’s ASR hip was implanted at an incline that was steeper than company guidelines advised. He also said the plaintiff’s need for revision surgery was caused by an infection.

Testimony in the trial included DePuy executives explaining that the ASR hip was tested in the laboratory at a single angle of implantation. Plaintiffs’ lawyers contend that they should have tested it using multiple angles.

“We know there is no perfect hip design. There are always trade-offs,” Zellers said, adding that the company designed the all-metal device with the aim of developing a longer-lasting hip that would show less wear than existing devices.

The J&J attorney argued that there is no medical consensus on what levels of chromium and cobalt, the metals shed by ASR hips, could cause harm to patients.

“Ultimately the product did not perform as DePuy wanted it to perform or expected it to perform,” he said.

All-metal hip implants were developed to be more durable than traditional implants with ceramic or plastic components, but have been shown to fail at a higher rate than traditional implants.

Michael Kelly, another Kransky attorney, told jurors the evidence shows that J&J’s DePuy unit was primarily focused on making money from the all-metal ASR hips at the expense of patient safety.

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Oh Really Mr DePuy – are we as stupid as you look? 

Published: March 4, 2013

Re “What a Company Knew About Its Metal Hips” (editorial, Feb. 11):

All of us at DePuy are united by the goal of improving patients’ lives, so we understand that the Articular Surface Replacement Hip System recall has been of concern for patients, their family members and surgeons. I disagree with how your editorial described company actions regarding ASR testing, data analysis and communications.

ASR was tested for years before receiving regulatory clearance around the world. Once on the market, we carefully considered all the data and investigated product complaints individually, while also looking for broader performance trends. We continued to share appropriate and validated data with regulators and surgeons.

When we received new registry data reporting that ASR patients were undergoing a second hip replacement surgery sooner than expected, we recalled the product and immediately supported patients with a reimbursement program for their medical costs.

Joint replacement surgery is one of the greatest medical advances of our time. We remain dedicated to serving patients who need this important treatment option.

ANDREW EKDAHL

President, DePuy Orthopaedics

Warsaw, Ind., Feb. 25, 2013

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EDITORIAL

What a Company Knew About Its Metal Hips

Published: February 10, 2013

All-metal hip replacements have failed at a high rate and harmed many patients in recent years. Now there is evidence that a major manufacturer was aware of a serious problem with one of its models yet failed to alert patients or doctors and continued to market it aggressively.

The all-metal hips, in which a ball and a cup component are both made of metal, were thought to be superior in some respects to traditional hip replacements made of plastic and metal. Some 500,000 people in this country received all-metal devices over the past decade. They were not adequately tested because of regulatory loopholes the Food and Drug Administration is now moving to close, and began failing not long after implantation.

Thousands of patients have had to replace them in painful operations; hundreds more have suffered internal damage. Court documents now show that a major manufacturer, the DePuy Orthopaedics division of Johnson & Johnson, buried the bad news about a model known as the Articular Surface Replacement, the most failure-prone of the implants. The implants were recalled in 2010, but the documents show that as early as 2008 DePuy executives were told by a number of surgeons, including its own consultants, that the device appeared flawed. That was never disclosed to doctors who were putting the device into patients, nor were other unfavorable internal studies. By the time of the recall, the device had been implanted in about 93,000 patients around the world.

Surgeons have largely stopped using the device; even so, the company is facing more than 10,000 lawsuits in this country related to past implantations. Though the company says the evidence will ultimately show that it acted appropriately, it clearly has a lot of explaining to do.

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This week, a bioengineer for Johnson & Johnson’s DePuy Orthopaedics unit testified in Los Angeles state court in the first of 10,000 DePuy ASR lawsuits to go to trial. According to Bloomberg News, James Anderson worked on redesigning the ASR for three years before the project was ended; even though he found ways to potentially lower the amount of metallic debris released by the metal-on-metal hip implant, no changes were ever implemented.

(PRWEB) February 08, 2013

Parker Waichman LLP, a national law firm dedicated to protecting the rights of victims injured by defective medical devices, recounts the latest DePuy ASR trial developments reported by Bloomberg News. Bloomberg News reported on February 7th that James Anderson, a bioengineer for Johnson & Johnson’s DePuy unit, testified in Los Angeles state court at the trial of Loren Kransky, whose DePuy ASR lawsuit is the first of 10,000 to go to trial (Kransky v. DePuy, BC456086, California Superior Court, Los Angeles County). According to his videotaped testimony, Anderson worked on redesigning the ASR hip implant for three years before the project was ended. Anderson testified that he found ways to decrease wear on the cup, but no changes were ever made to the now-recalled metal-on-metal hip implant.

http://www.bloomberg.com/news/2013-02-07/j-j-engineer-studied-hip-redesign-for-3-years-jury-told.html

“Again, we have evidence that Johnson & Johnson was aware of problems with the ASR hip implant prior to the recall in 2010,” said Daniel C. Burke, Senior Litigation Counsel at Parker Waichman LLP. “Despite knowing that this hip replacement has a high rate of wear, J&J did not actually make the necessary changes to try and improve the ASR.” Parker Waichman continues to offer free legal consultations to hip replacement patients implanted with the DePuy ASR, along with other all-metal hip replacements. The firm advises hip replacement patients to speak with their surgeons if they experience symptoms such as:

•     Pain
•     Swelling
•     Difficulty walking, or a change in your ability to walk
•     Popping, creaking, or other sounds emanating from the area of the implant
•     Metallosis, high levels of metal ions
•     Early failure, revision surgery

According to Bloomberg News, this week jurors heard a videotaped testimony from Anderson stating that he was disappointed when the project to redesign the DePuy, known as “Project Alpha,” ended in 2008 without any changes to the all-metal hip implant. Anderson joined a team to study the “next generation ASR” in 2005. On April 7, 2008 he wrote to a superior, stating that “a small improvement to geometry could represent a large improvement for many patients.” In a separate document he wrote that by removing the groove on the ASR cup, wear on the cup “is approximately threefold less than the original design with the groove.”

Johnson & Johnson never implemented any changes to the ASR hip implant, which was recalled in 2010 due to a high failure rate. At the time of the recall, the company said that the implant failed in 12 percent of patients within five years. More recent data from an Australian national joint registry showed that the failure rate exceeded 40 percent.

This week, jurors also heard an expert witness testimony from a McGill University professor who stated that the ASR implant had a number of design defects causing it to fail more than other hip replacements. He said that cup shape, which is less than half a circle and has thin walls, attributed to the defective nature of the implant. 
http://www.bloomberg.com/news/2013-02-06/j-j-jury-told-hip-has-many-design-defects-causing-failure.html

The U.S. Food and Drug Administration (FDA) has issued new guidelines for patients implanted with metal-on-metal hip implants such as the DePuy ASR. In a Safety Communication issued January 17th, the agency advised physical examinations, diagnostic imaging and metal ion testing as needed. The FDA is also looking to tighten regulations on all-metal hip replacements that would require manufacturers to prove the devices are safe and effective before selling them. 
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm335775.htm

Parker Waichman LLP continues to offer free legal consultations to victims of metal-on-metal hip implant injuries. If you or a loved one experienced premature failure of your implant or other health problems associated with a metal-on-metal hip implant, please contact their office by visiting the firm’s Defective Hip Implants page at yourlawyer.com. Free case evaluations are also available by calling 1 800 LAW INFO (1-800-529-4636).

Contact: 
Parker Waichman LLP 
Gary Falkowitz, Managing Attorney 
(800) LAW-INFO 
(800) 529-4636 
http://www.yourlawyer.com

Read more: http://www.sfgate.com/business/prweb/article/DePuy-ASR-Trial-Update-J-J-Engineer-Suggested-4264231.php#ixzz2KRdsVdyA

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J&J metal hip failed because of toxic debris – expert at trial

By Deena Beasley

LOS ANGELES | Fri Feb 1, 2013 4:47pm EST

(Reuters) – Toxicity caused by debris from a metal-on-metal hip implant meant that the device had to be removed from a 66-year-old man who is suing manufacturer Johnson & Johnson, according to expert testimony heard at the trial on Friday.

“I concluded that his hip failed because of the toxic exposure,” said Robert Harrison, an occupational medicine specialist at the University of California, San Francisco, who was not involved in treating plaintiff Loren Kransky but did review the medical records.

The testimony was heard in Los Angeles Superior Court in the first lawsuit to go to trial involving all-metal hips made by J&J’s DePuy unit. More than 10,000 U.S. lawsuits have been filed since the hips were recalled from the market in 2010.

As many as 500,000 Americans are estimated to have received metal-on-metal hip replacements.

Lawyers for Kransky argue that J&J was aware of the defects in the ASR hip implants, including the risk of poisoning from cobalt and chromium metal debris, even before it started selling the devices in 2004.

Kransky’s blood tests showed that his levels of cobalt and chromium reached as much as seven times normal after he received the ASR hip.

The Food and Drug Administration last month proposed that companiesmaking all-metal hip replacements provide additional information proving they are safe and effective before being allowed to continue selling them.

The agency said it was not recommending a specific level of metals in the blood as a trigger for revision surgery because there was not enough evidence to demonstrate a correlation between those levels and patient outcomes.

J&J attorney Alex Calfo said the amount of cobalt measured in Kransky was not enough to cause any adverse systemic health effects.

Trial testimony earlier in the week included DePuy executives explaining that the ASR hip was tested in the laboratory at a single angle of implantation. Plaintiffs’ lawyers contend that they should have tested it using multiple angles.

All-metal hip implants were developed to be more durable than traditional implants with ceramic or plastic components, but have been shown to fail at a higher rate than traditional implants.

A J&J study presented at the trial showed that the company had estimated that 37 percent of the devices would fail within about five years of implant surgery.

(Reporting By Deena Beasley; Editing by Jilian Mincer and Matthew Lewis)

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