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.

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

J&J pressured to settle Australian hip lawsuits

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• When Doctors Keep Quiet about Dangerous Hip Devices (earlsview.com)
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• Compensation hopes for faulty hip implant victims (smh.com.au)
• VICTORY FOR MoM Sufferer – Johnson & – Johnson Ordered to Pay $8.3 Million in Hip Implant Case – NYTimes.com (earlsview.com)
• Common Problems Associated With Titanium Hip Replacements (orthopedics.answers.com)
• Learning the Truth About Sulzer Orthopedics (arthritis.answers.com)
• HELLO – Earth to Major Tom – What Planet is this guy on? At trial of Johnson & Johnson recalled hip implants, doctor testifies device wasn’t defective | NJ.com (earlsview.com)
• Signs Your Hip Implants Are Hurting You (earlsview.com)
• Smith & Nephew Failure Warning for Birmingham Hip Implant (earlsview.com)

VICTORY & JUSTICE:

J.&J. Loses First Case Over Faulty Hip Implant

By BARRY MEIER

Published: March 8, 2013

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• The Hip Replacement Case Shows Why Doctors Often Remain Silent – NYTimes.com (earlsview.com)
• Damages awarded in J&J’s DePuy hip implant case (wfaa.com)
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• Johnson & Johnson to award security guard $8.3m over faulty implant (guardian.co.uk)
• Recalls-R-US… Johnson & Johnson Confirms Inquiry Into Hip Devices – NYTimes.com (earlsview.com)
• DePuy ASR Hip Replacement Implant Lawsuit Trial Raises Questions About Johnson & Johnson’s Actions in Years Prior to DePuy ASR Hip Replacement Recall, According to Alonso (prweb.com)
• Johnson & Johnson Pays Out $8 Million In Lawsuit (huffingtonpost.com)
• Jury awards damages in Johnson & Johnson hip case (kfwbam.com)

Metal on Metal Hips – New Video

Posted by Lampkins Admin on Mar 5, 2013

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• Metal-on-metal hip implant risks ‘unique’ – Health – CBC News (earlsview.com)
• Safety Communications FDA Safety Communication: Metal-on-Metal Hip Implants (earlsview.com)
• US Drug Watchdog Now Urges All DePuy ASR And Pinnacle All Metal Hip Implant Recipients To Get A Blood Test And To Call Them Before The Time Runs Out To Get Identified (prweb.com)
• DePuy ASR Trial – Closing Arguments – Trial plaintiff says J&J hips defective, company says not liable (earlsview.com)
• US Drug Watchdog Now Urges All Metal Hip Implant Recipients Who Have Had Revision Surgeries To Call Them For The Names of Attorneys To Help Them Get Compensated (prweb.com)
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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.

Related articles

• FDA cracks down on all-metal hip replacements (earlsview.com)
• Metal-on-metal hip implant risks ‘unique’ – Health – CBC News (earlsview.com)
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• Smith & Nephew Failure Warning for Birmingham Hip Implant (earlsview.com)
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• US Drug Watchdog Now Urges All DePuy ASR And Pinnacle All Metal Hip Implant Recipients To Get A Blood Test And To Call Them Before The Time Runs Out To Get Identified (prweb.com)
• US Drug Watchdog Now Urges All DePuy Pinnacle Hip Implant Recipients to Call Them For the Names of the Best Law Firms if a Blood Test Reveals Elevated Metal Levels (prweb.com)
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Smith & Nephew Hip Implant Patient Diagnosed with Metallosis

March 3, 2013, 08:00:00AM. By Jane Mundy

Ramona, CA: Increasingly, more people are experiencing hip and knee replacement failure and undergoing revision surgery. Karen was given a metal-on-metal hip replacement and has recently been diagnosed with metallosis. “I had to get hip revision surgery and my kidneys are finally filtering out the heavy metals,” she says, exasperated.

Metallosis isn’t Karen’s only concern. She is also worried that the statute of limitations is running out – her first hip replacement was done in 2008; she had problems right from the get-go and they got worse.

“First of all it’s a pretty scary operation,” Karen says. “If you have ever bought a chicken and disjointed the leg from the breast you will know exactly how the surgeons bend you in half and pop the hip joint out of its socket.” Just eight weeks after she had that surgery Karen had her other hip done – she was only 60 years old.

“I got up the next day (after the second surgery) and discovered that my right leg was one inch longer than my left leg,” Karen explains. “They suggested that I wear orthotics – what a joke! Ten days later they pulled the staples, went back in and made my leg an inch shorter. Now I am about level. The right hip doesn’t have metal-on-metal everything; it has a plastic spacer. Why didn’t my first (left hip) replacement have the plastic spacer? Now my left hip is causing all the problems but the wear is uneven and my new surgeon is closely monitoring this issue.

“It wasn’t until the summer of 2011 that I researched metal-on-metal hips. About that time the DePuy recall hit the fan. I was never told that I had a metal-on-metal hip. I phoned my surgeon’s office and asked one of his staff if I had a DePuy hip. She said, ‘Don’t worry, you have a Smith & Nephew hip.’ My relief was temporary…”

(In June 2012 Reuters reported that Smith & Nephew recalled its metal hip replacement component due to a high incidence of complications associated with the device. At issue was the metal liner, which was marketed in 2007 – one year before Karen had her hip replacement. An estimated 7,700 individuals have been affected by the Smith & Nephew hip recall. According to the company, the majority of the recalled metal liners were used in stemmed total hip replacements.)

“Finally the pain got so bad that I found a new doctor,” Karen adds. “He took a lot of x-rays and ordered lab tests – I was diagnosed with heavy metal poisoning. The x-rays revealed the hip parts with no spacer and noted that the metal cup had slipped and was rubbing against a leg tendon with every step I took. That was the killer.”

Karen’s lab results showed dangerously high elevated levels of chromium and cobalt that are released into the blood as the metal components rubbed against each other. She was also diagnosed with stage 3 kidney failure, a direct result of metallosis. Her doctor recommended immediate revision surgery to get rid of metal components. Needless to say, she was shocked.

“In November 2011, two surgeons performed the surgery because they knew beforehand it was going to be difficult,” Karen says. “They removed the Smith & Nephew ball and cup, added the plastic spacer and secured the cup with a screw to my hip bone so it won’t slide. I still have a lot of soft tissue damage in both hips. To this day I can’t lie on my side, I have to sleep propped up and I have constant pain on bending my hips.

“I guess my kidneys are healing themselves but I can’t help but think if I had a better surgeon (than the first one) I wouldn’t be addicted to painkillers. Every time I complained and cried, he just kept giving me more Vicodin: Now I am totally hooked: I take six pills a day for pain and there is nothing more the surgeon can do, nothing can alleviate my problems. I am stuck with this.”

Back in 2008, Karen began to develop severe pain upon walking and it kept getting worse. She was very athletic and chalked it up to overuse. She found her original surgeon from an article in the San Diego newspaper “bragging” about how he did a hip replacement on a female firefighter and she was back on the job in six weeks. She contacted the woman who raved about this surgeon. What better recommendation could you get?

“I didn’t feel my age in 2008 but I sure do now,” she adds. “I found out that a lot of people in the US have Smith & Nephew parts. How do these medical device companies think their product is any different than, say, DePuy? I think the hammer is inevitably going to fall on all of them.

“I recently asked my new surgeon about all the pain in my hips and he just shrugged. I see a pain management specialist next week – I might have to go through a full drug withdrawal program; the more you take, the more you build up to the point that it can cause liver damage. Vicodan does nothing but dull the pain; it does not make me happy. It has just become a vicious cycle.

“I hate taking pills and now I am at my wits end, and I have spent tons of money with these revision surgeries. I just hope that a hip replacement lawsuit will get me some compensation.” Karen adds that she has kept all her surgery reports, all lab tests and she has the removed metal components from her first left hip surgery to serve as evidence.

Related articles

• Smith & Nephew Failure Warning for Birmingham Hip Implant (earlsview.com)
• DePuy Pinnacle Hip Replacement Lawsuits: Bernstein Liebhard LLP Comments on New Study Finding that Hip Replacement Failure More Likely in Women (earlsview.com)
• RLG Responds to Report of Higher Metal-on-Metal Hip Replacement Failure Rates in Women (earlsview.com)
• Biomet Hip Replacement Lawsuits: Bernstein Liebhard LLP Files Biomet Hip Implant Lawsuit on Behalf of Biomet M2a Magnum Hip Replacement Recipient (prweb.com)
• Metal-on-Metal Replacement Hip Implant Patients at Risk for Metallosis, Other Health Issues, Warns Wright & Schulte LLC (prweb.com)
• Looks like BS, Smells like BS, Must be BS…. Hip Study: Smith & Nephew touts study results for new metal-on-metal implants | MassDevice – Medical Device Industry News (earlsview.com)
• Laurel’s Story – Smith & Nephew BHR Hip Resurfacing Ruins Another Life (earlsview.com)
• Iowa Resident Brings Suit Against Stryker For Damages Caused By Recalled Hip Implant – News Press Release | PharmiWeb.com (earlsview.com)
• DePuy Pinnacle Hip Lawsuits: Bernstein Liebhard LLP Notes New Order in Federal DePuy Pinnacle Litigation (earlsview.com)

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

Related articles

• During Trial, New Details Emerge on DuPuy Hip – NYTimes.com (earlsview.com)
• FDA cracks down on all-metal hip replacements (earlsview.com)
• DePuy Pinnacle Hip Replacement Lawsuits: Bernstein Liebhard LLP Comments on New Study Finding that Hip Replacement Failure More Likely in Women (earlsview.com)
• DePuy ASR Hip Replacement Implant Lawsuit Trial Raises Questions About Johnson & Johnson’s Actions in Years Prior to DePuy ASR Hip Replacement Recall, According to Alonso (prweb.com)
• RLG Responds to Report of Higher Metal-on-Metal Hip Replacement Failure Rates in Women (earlsview.com)
• What DePuy Orthopaedics Knew About Its All-Metal Hips – NYTimes.com (earlsview.com)
• DePuy Hid Data About Failed Hip Implant, Documents Show – NYTimes.com (earlsview.com)
• Biomet Hip Replacement Lawsuits: Bernstein Liebhard LLP Files Biomet Hip Implant Lawsuit on Behalf of Biomet M2a Magnum Hip Replacement Recipient (prweb.com)
• Study shows cost-effectiveness and benefits to patients of early hip replacement (earlsview.com)
• Patients victims of untested medical devices – SFGate (earlsview.com)

I am so very happy to have discovered your website!  My husband had a total hip replacement in Aug 2008 in Las Vegas, NV.

He was 46 years old at the time.

We felt like we had done our homework and picked a good surgeon and hospital. We both sell medical products so felt good about making informed choices.

Our surgeon implanted the Biomet M2a assuring us it was the best choice for a young athletic patient.  Surgery went well.  Intitial recovery was a bit slower due to my husband becoming very anemic due to a large loss of fluid due to vascularity.   However, by Jan 2009 he was doing pretty well and exercising again on a fairly regular basis.

Later into 2009, my husband began having unusual symptoms: extreme anxiety and fatigue, forgetfulness, ears ringing, hearing loss etc. Symptoms came on very gradually but by the beginning of 2010, I was becoming very concerned with his mental health.

I was downsized from my job and my husbands company offered to transfer him back to NM so we could be closer to his elderly parents who were soon to need some assistance.

We moved in May of 2010 and by then I really thought I was going to have to need his family’s support to care for him instead.  He was confusing people for other people he knew.  Other symptoms included falling asleep in airports waiting for his flights (work required flying to Phoenix every week), wandering around parking garages looking for his car for an hour and a half, driving into not great areas and getting mugged because he input the wrong address into the GPS-include in these odd behaviors not being able to feel your hands and feet, hypothyroidism, tachycardia and tinnitus.  His hip was hurting as well as making popping, grinding and squeaking sounds.  (His surgeon in Las Vegas said it was “snapping hip” syndrome  at 1 year followup visit-so it was beginning to fail as soon as 1 year later).

We went to see an orthopedic surgeon in NM in Dec 2010 because of the pain and noises his hip was making.  Although the xrays showed the implant was in place, the surgeon suggested my husband get his cobalt and chromium levels tested since he had a MoM device.  Because of an insurance glitch, we decided to check the levels in Jan 2011 but never got around to it – at least not right away.

In early Feb 2011, the ortho surgeon’s office called to see if he had had his metal levels checked yet and so we had the blood drawn on Feb 24, 2011.  2 weeks later, we got an alarmed call from the ortho saying we needed to come in right away.  My husbands cobalt level was >100ug/L and Chromium was 49.5ug/L.  However, the NM surgeon could not do a revision until the end of May, 2011.

At that point, my husband went on medical leave and we flew back to Las Vegas to see the original surgeon.  Although the surgeon was carful not to verbally talk about the effects of the high metal levels, he was alarmed enough to schedule surgery the following week in Las Vegas.

His original plan was to replace the ball mechanism but due to it being ‘cold fused’ onto the femur component, it had to be a complete revision which lasted around 6 hours.  We stayed in Las Vegas for about a week and after the hospital discharged him I took him to the hotel for a few days and then flew home-not an easy trip.

While recovering from the surgery, my husband had a cardiac workup due to tachycardia and also was discovered to have hypothyroidism (march 2011).  On May 13th, my husband suffered an anterior dislocation of his hip.  It was reduced at the ER.  Then, it dislocated anteriorly again May 24th and during the reduction, a portion of his trochanter broke.  The ER discharged him and he was left to stay in bed with a brace for a week until we could once again fly to Las Vegas for yet another surgery (No surgeon in NM would treat him at this point).  Revision #2 was performed on June 2, 2011 with a plate screwed into his femoral component to secure the trochanter. Another 6 hour surgery and severe anemia.

Cobalt had dropped to 15ug/L.

We stayed in Las Vegas another week at the hotel and then once again flew back to NM.

My husband returned to work Aug 29th, 2011.  His territory was changed and he was flying to Denver every week.  By Thanksgiving, he was really run down(can’t imagine the cause?) and was hospitalized with pneumonia and a bowel obstruction.  He was close to dying but amazingly pulled through.

All of this due to a MoM hip replacement.

Like many, we have a suit against Biomet to be tried in Indiana-I will be shocked if we ever see anything come of this.  What I can tell you though is that this has changed our lives forever.

Viki

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J&J Profit Pursuit Led to Defective Hip, Lawyer Argues

By Maurice Possley & David Voreacos - Mar 1, 2013 12:17 PM ET

Johnson & Johnson (JNJ)’s pursuit of profit led it to sell a defective metal-on-metal hip that failed faster than any similar device, a lawyer argued at the first of 10,750 lawsuits over the recalled implant to go to trial.

Jurors in Los Angeles heard closing arguments today on claims by Loren Kranksy, 65, that J&J’s DePuy unit defectively designed its ASR hip and failed to warn of the risks. Kransky attorney Brian Panish asked for compensatory damages of $5.3 million and punitive damages of as much as $179 million.

J&J, the world’s largest seller of health-care products, failed patients before recalling 93,000 ASR hips in August 2010, Panish said. At the time, J&J’s DePuy unit said 12 percent failed within in five years, requiring follow-up revision surgeries. The Australian rate hit 44 percent in 2012, he said.

“That design was defective from the first day they put it out,” Panish argued to the state court jury at a trial that began Jan. 25. “It was beyond what any hip had ever done to anyone in the history of the world. It’s not even close.”

J&J, based in New Brunswick, New Jersey, denies that it defectively designed the device or failed to warn of the risks associated with it. Analysts say resolving the lawsuits could cost the company billions of dollars.

After the summations, Judge J. Stephen Czuleger instructed jurors on the law. Deliberations are expected to begin tomorrow.

Kransky, a retired prison guard from Montana, had his hip implanted in December 2007 and removed in February 2012. His “diabetes, cancer, kidney disease, heart disease, vascular disease and his many other health problems are unrelated” to his hip, J&J attorney Michael Zellers said in his summation.

Injury Causation

“This case is about what caused Mr. Kransky’s injuries,” Zellers said. “The evidence is clear that Mr. Kransky’s injuries were not caused by a defect in the ASR hip. It’s not a case about a recall. It’s not about revision rates of the ASR today.”

Zellers denied claims by Kransky and his attorneys that the tissue around his hip was damaged because the device, made of chromium and cobalt, shed metal ions.

Kransky testified that he believed the debris was poisoning him, and he feared the revision because he thought it would kill him. Records show his metals level was eight times higher than the level DePuy considered acceptable.

“There is no scientific support that Mr. Kransky’s metal ions were toxic,” Zellers said. “The evidence in this case was that Mr. Kransky was not being poisoned and that the cobalt and chromium levels in his system were not toxic.”

Hip Infection

Zellers said Kransky’s revision came after his hip grew infected, not because of problems with the ASR.

“Mr. Kransky had an infected hip,” Zellers said. “That caused him pain. That pain caused the revision.”

Panish asked jurors to award Kransky $338,000 for his medical expenses and $5 million for his pain and suffering. Jurors also should impose punitive damages of $72 million to $179 million on DePuy, or 2 percent to 5 percent of the company’s value, Panish argued.

“This is a company that needs a solid message sent to them,” Panish said. “Nobody has ever accepted responsibility from DePuy. For a company in today’s world to do this to patients — unfortunately, it happens because the money corrupts. They don’t have a soul.”

J&J failed to test the ASR adequately before it was sold in the U.S. in 2005, and ignored reports by leading surgeons of mounting patient complaints, Panish said.

Metal Cup

Surgeons implanted a metal cup in the hip and a metal ball atop the femur that rotated inside the cup. Panish said DePuy failed to test the cup at any angle other than the optimum one of 45 degrees. Witnesses said that the steeper the angle, the greater the amount of metal debris that was shed.

Panish said the ASR was “unsafe at any angle.”

Zellers responded to Panish’s criticism of DePuy for failing to conduct a clinical study before selling the ASR.

“This was the mostly extensively tested device in DePuy history at the time,” he said. “They worked hard to develop a product that had low wear and would last a long time.”

He denied that DePuy hid its testing data.

“DePuy shared its information with everyone,” he said. “This was not something DePuy hid and kept in its laboratory.”

Implant Angle

He said the evidence showed that Kransky’s hip was implanted at an angle greater than 55 degrees.

“If you are going to put a cup in at that angle, you are going to get more wear,” he said.

Zellers told jurors that complaints about the hip jumped after the recall, and not because it was defective.

“When the recall occurred,” he said, “there were many, many, many complaints related to the ASR. That’s understandable. There was a lot of publicity. There was worry by patients.”

Kransky’s lawyers “have tried to make you angry at DePuy,” Zellers said. “They have tried to convince you that DePuy acted maliciously. DePuy set out to make the very best hip device they could make. DePuy is a good company. It has a superb reputation. DePuy is an open and honest company.”

In a rebuttal argument, Kransky attorney Michael Kelly derided Zellers for suggesting that revisions rose after the recall because of lawyers, like it was a “global conspiracy.”

He said revisions came two to four years after the implant, with the biggest year of U.S. sales in 2007, at 10,581.

“Surprise, surprise, these are the ones that are hurting people right on schedule,” Kelly said.

He said for DePuy to say Kransky had an infected hip was “complete, total, utter bunk.”

Kelly also told the jury that Zellers said there’s “no perfect hip.”

“Ladies and gentlemen, this is not an imperfect hip,” he said. “This is a public health disaster.”

The case is Kransky v. DePuy, BC456086, California Superior Court, Los Angeles County (Los Angeles).

To contact the reporters on this story: Maurice Possley in Los Angeles Superior Court atmauricepossley@gmail.com; David Voreacos in Newark at dvoreacos@bloomberg.net

To contact the editor responsible for this story: Michael Hytha at mhytha@bloomberg.net

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