Medical Devices

Lots more information since we last wrote about defective metal-on-metal hip replacements. The first trial is underway, and plenty of details are emerging. From all the reports, this looks to be a particularly heinous story of corporate greed causing injury to many thousands of unsuspecting individuals.

First, a little background:

While all hip replacements pose risks, research has shown that metal-on-metal hip implants carry unique risks. In metal-on-metal hip implants, the metal ball and the metal cup slide against each other during walking or running, causing tiny bits of metal to “shed” from the device. These tiny metal particles may cause damage to bone and/or the soft tissue (e.g., muscle, cartilage) surrounding the implant and joint. 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). In addition, 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). The type and severity of physical symptoms and illness seem to be specific to individuals, with different patients having different reactions to the metal particles.

http://www.youtube.com/watch?v=18BkrJnKf3g

What’s New

Previously, we told you that recalls were issued for some DePuy metal-on-metal hip replacement devices after research revealed that the failure rate of some hip replacement devices was higher than usual. Back in 2010, at the time of the recall, Johnson & Johnson (J&J—manufacturer of DePuy hip replacements), reported a high 12% failure rate after five years.

BUT…new research shows that the failure rate was much, much higher than that. Australian data showed that the DePuy ASR LX hip had a failure rate of 22% after five years and 44% after seven years. The same study revealed that the ASR produced 16 times more potentially toxic chromium and cobalt debris than other DePuy products. At these levels, the ASR should have failed, but DePuy allowed the ASR device to pass.

According to an article in The New York Times, an internal J&J analysis reported a failure rate of nearly 40% within five years from date of surgery, but the company never released those projections. The article also mentions that DePuy officials were aware–as early as 2008–that one of the recalled devices was releasing high levels of metallic ions, particularly in women.

But DePuy didn’t test for the effects of those metals. According to Robert Harrison, a professor of medicine at the University of California, San Francisco:

“I would have advised to do a very thorough and careful analysis of chromium and cobalt toxicity and the potential that this could be a problem from this particular hip design,” Harrison said. He also said DePuy should have done studies “before the product was put on the market.” [from Bloomberg.com]

The California Poison Control System says that cobalt levels above 7 micrograms/liter are harmful. One patient, Loren Kransky, whose lawsuit is currently being heard, had his ASR hip implanted in December 2007. On September 1, 2011, he had blood cobalt levels of 53.6, or almost eight times the acceptable level. After Kransky had the ASR replaced in a revision surgery in February 2012, his level dropped to 5 micrograms/liter. According to Dr. Harrison:

“The higher the dose, the greater the poisonous effect”…. The poisoning can damage tissues near the hip, and it can be systemic as the metal circulates in the bloodstream. The metals can kill cells, he said.

A Pattern of Obfuscation?

As the first lawsuits began, documents relating to the case became public. The more one reads about the DePuy executives and their decisions, the more it sounds as though negative information was deliberately hidden, withheld, or downplayed. Some examples include:

• In 2008, a surgeon who served as one of DePuy’s top consultants told company officials that he was concerned about one of the ASR components and believed it should be redesigned. That surgeon’s suggestions were ignored.
• In the face of high failure rates, company officials maintained that the problems were related to how surgeons were implanting the device, not to the device design. But at least one executive wrote to marketing officials in early 2009 that failures were related to the product’s design.
• Later in 2009, the FDA asked DePuy for more safety data about the ASR. Shortly afterward, DePuy decided to “phase out” the ASR device, and sell existing inventory–not stop selling the unsafe product, but stop manufacturing it.
• The FDA did not approve one version of the hip implant, the “resurfacing” version, but DePuy didn’t disclose the FDA ruling to regulators in other countries where the device was being sold.

Recommendations for People Who Have Metal-On-Metal Hip Implants

You and your doctor should pay close attention to any signs or symptoms that may be associated with metal-on-metal hip implants. These include:

• Pain or swelling at or near the hip
• A change in walking ability
• A noise from the hip joint
• Local nerve palsy
• A palpable mass or lump at the hip
• Infection
• Hypersensitivity
• Skin rash (not just at the hip)
• Neurological changes, including sensory changes (auditory or visual impairment)
• Change in psychology (depression)
• Thyroid dysfunction (neck discomfort)
• Fatigue
• Weight gain

The FDA recommends routine long-term follow-up of patients every one to two years, for life. People experiencing symptoms should be seen by a physician every 6 months to monitor the progression of symptoms.

Along with a general physical examination, patients may also receive an x-ray or MRI to look for bone and soft tissue damage. Patients with severe symptoms may also have metal ion testing, although there isn’t necessarily a link between blood ion levels and actual damage–some people may have physical damage without having elevated levels of ions.

When To See an Attorney

HensonFuerst Attorneys has been investigating the legal side of metal-on-metal hip replacement devices for years, ever since DePuy Orthopaedics issued a recall of two of their top-selling hip implants. Since then, other metal-on-metal hip manufacturers have also issued recalls or warnings about their products.

If you know that you have one of the recalled hip replacement devices… OR if you have severe pain around your hip… OR if you have been told that you have a defective hip replacement, call HensonFuerst Attorneys for important information about your rights. You may have a legal case and we will fight to help you collect compensation for the injury caused by the faulty medical device.

What’s most important: DO NOT contact any medical device manufacturer, or SIGN RELEASES OF YOUR MEDICAL RECORDS to any company before you talk with a lawyer. Don’t “register” or attempt to file a claim on your own. Let a lawyer handle everything. Big corporations look out for their own financial interests, not the interests of people who may have been harmed.

If you are worried about your future health, or if you would finally like your questions answered, call us at 1-800-4-LAWMED. Or, visit our website at www.lawmed.com for more information.  At HensonFuerst, your health is at the top of our priority list. We dedicate ourselves to protecting individuals from the greed and callousness of large corporations. Let us work for you.

Life Doesn’t Wait…get help today. Call HensonFuerst.

This week, the U.S. Food & Drug Administration (FDA) released updated safety recommendations for metal-on-metal hip replacement devices. This is the FDA’s most comprehensive set of recommendations to date.

What’s the Problem with Metal-on-Metal Hip Implants?

While all hip replacements pose risks for patients, research has shown that metal-on-metal hip implants carry unique risks. In metal-on-metal hip implants, the metal ball and the metal cup slide against each other during walking or running, causing tiny bits of metal to “shed” from the device. Metal can also be released from other parts of the implant where two implant components connect. Any time the metals rub, some tiny metal particles to wear off of the device around the implant, which may cause damage to bone and/or the soft tissue (e.g., muscle, cartilage) 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 type and severity of physical symptoms and illness seem to be specific to individuals, with different patients having different reactions to the metal particles.

Recommendations for Patients Considering Hip Implants

According to the FDA, people considering a hip replacement should be aware that every hip implant has benefits and risks, and that they should discuss options for surgery or other treatments with their physician.

When discussing your options for hip surgery with a surgeon or physician, some questions you should ask include:

• What are the benefits and risks of each type of hip implant system (metal-on-metal, metal-on-polyethylene, ceramic-on-polyethylene, ceramic-on-ceramic, and ceramic-on-metal total hip systems, as well as, resurfacing hip implants)?
• Why is a metal-on-metal hip implant the best for your situation?
• What are the surgeon’s outcomes and personal experience in performing surgical procedures with metal-on-metal hip implants? If the surgeon recommends a resurfacing hip system, what are the surgeon’s results and personal experiences with the recommended hip resurfacing system?
• What are the surgeon’s outcomes and personal experience in performing surgical procedures with other types of hip systems?
• What symptoms can you expect to experience after surgery and for how long?
• What types of activities, if any, should be limited or restricted with a metal-on-metal hip implant?
• What results can you expect after surgery with a metal-on-metal hip implant?
• Which specific symptoms should you report after the surgery?
• What types of reactions may occur due to the implant and/or metal ions and how would they be evaluated and treated?
• If you end up with a complication related to the metal-on-metal hip implant, how likely is it that the implant would need to be removed and what would be the consequences?

Metal-on-metal hip implants are usually NOT recommended for some people due to an increased risk of adverse local reactions. These include people who have kidney problems…have allergies or sensitivity to metals…have a suppressed immune system…are currently receiving high doses of corticosteroids (such as prednisone)…or are women of childbearing age.

Recommendations for People Who Already Have Metal-On-Metal Hip Implants

You and your doctor should pay close attention to any signs or symptoms that may be associated with metal-on-metal hip implants. These include:

• Pain or swelling at or near the hip
• A change in walking ability
• A noise from the hip joint
• Local nerve palsy
• A palpable mass or lump at the hip
• Infection
• Hypersensitivity
• Skin rash (not just at the hip)
• Neurological changes, including sensory changes (auditory or visual impairment)
• Change in psychology (depression)
• Thyroid dysfunction (neck discomfort)
• Fatigue
• Weight gain

If you know that you have one of the recalled hip replacement devices… OR if you have severe pain around your hip… OR if you have been told that you have a defective hip replacement, call HensonFuerst Attorneys for important information about your rights. You may have a legal case and we will fight to help you collect compensation for the injury caused by the faulty medical device.

What’s most important: DO NOT contact any medical device manufacturer, or SIGN RELEASES OF YOUR MEDICAL RECORDS to any company before you talk with a lawyer. Don’t “register” or attempt to file a claim on your own. Let a lawyer handle everything. Big corporations look out for their own financial interests, not the interests of people who may have been harmed.

If you are worried about your future health, or if you would finally like your questions answered, call us at 1-800-4-LAWMED. Or, visit our website at www.lawmed.com for more information.  At HensonFuerst, your health is at the top of our priority list. We dedicate ourselves to protecting individuals from the greed and callousness of large corporations. Let us work for you.

Life Doesn’t Wait…get help today. Call HensonFuerst.

RESOURCES

Click any of these links for more information:

FDA Guidelines

Stryker Hip Replacement Recall

DePuy Hip Replacement Recall

Hip Replacements Fail, Sometimes Without Symptoms

Diagnosing Hip Replacement Injury

In previous videos and blogs, we told you about the recall of two hip replacement devices by DePuy Orthopaedics, a division of Johnson & Johnson.  Now, a similar recall has been announced by another company, Stryker Corporation.  Stryker has recalled two hip replacement devices: the Rejuvenate, and the ABG II modular-neck stems.

These devices are being recalled because of risks of corrosion and “fretting,” which is when portions of the hip replacement are worn away by abrasion. The corrosion may cause harmful tissue reactions in the hip area, which leads to pain and/or swelling.  Other adverse effects can include bone damage, tissue death (or “necrosis”), or metallosis–when metal debris causes inflammation in the surrounding tissue. This type of inflammation may cause long-term, or even permanent damage.

At this point, many experts are saying that people who have had any brand of metal-on-metal hip replacement should contact their physician and request testing to make sure that their hip replacement devices aren’t harming them. That’s especially true if you have had a Stryker or DePuy hip replacement, because these companies have admitted that at least some of their hip replacement devices are capable of causing damage.

So…what should you do if you have a Stryker, DePuy, or other metal-on-metal hip replacement?

WHAT TO DO

First, schedule a follow-up appointment with your surgeon, even if you’re not currently having symptoms. It’s possible that your hip could be failing, even before you experience pain. Your doctor will be able to evaluate how your hip is functioning. In addition, your physician may also want to test for the presence of microscopic metal particles around your hip, a sign that an implant is failing.

Second, if you know that you have one of the recalled Stryker or DePuy devices… OR if you have severe pain around your hip… OR if you have been told that you have a defective hip replacement, call HensonFuerst Attorneys for important information about your rights. You may have a legal case and be able to collect compensation for the injury caused by the faulty medical device.

What’s most important: DO NOT contact Stryker or DePuy, or SIGN ANY RELEASES OF YOUR MEDICAL RECORDS to any company before you talk with a lawyer. Don’t “register” or attempt to file a claim on your own. Let a lawyer handle everything. Big corporations look out for their own financial interests, not the interests of people who may have been harmed.

If you are worried about your future health, or if you would finally like your questions answered, call us at 1-800-4-LAWMED. Or, visit our website at www.lawmed.com for more information.  At HensonFuerst, your health is at the top of our priority list. We dedicate ourselves to protecting individuals from the greed and callousness of large corporations. Let us work for you.

Life Doesn’t Wait…get help today. Call HensonFuerst.

To see the video on YouTube, click here:  Stryker Hip Replacement

To read our previous blogs about hip replacement recalls and issues, click the following links:

Britain concerned about hip implants

Diagnosing hip replacement injury

Hip replacements fail, sometimes without symptoms

[This law firm is not affiliated with, sponsored by, or associated with the Stryker Corp., DePuy Orthopaedics, Inc., Johnson & Johnson, or any other hip replacement manufacturing company.]

According to an article in The New York Times, Dr. Robert Hauser, a cardiologist who studies the safety of heart devices, is recommending that surgeons stop using a potentially dangerous device: St. Jude implanted defibrillator leads. A material used by St. Jude to coat the wires connecting a defibrillator to the heart is liable to break down, which could lead to failure of the devices.

This means that patients who depend on a defibrillator to put their heart back into normal rhythm may risk serious consequences, potentially even death, if the Optim wire coatings break down and “disconnect.”

Dr. Hauser told The New York Times:  “There is no need to use this lead until we have more confidence in its performance.”

According to Dr. Hauser’s research, the potentially dangerous abrasion and break-down can occur within 4 years of implantation.

According to the article, Dr. Hauser noted that:

…the study was limited because the F.D.A. database he used to collect the data is problematic. Information is often missing or incomplete, and the agency relies on physicians or hospitals to voluntarily report problems with medical devices. “Therefore, the number of lead failures in this study likely underestimates the actual number that has occurred,” he wrote in the study.

To read the full article in The New York Times, click here:  Cardiologist Warns About Safety of St. Jude Heart Device Component

Another hip replacement recall.  Stryker Corp. has recalled two hip replacement devices: the Rejuvenate, and the ABG II modular-neck stems.

The devices are being recalled because of risks of corrosion and “fretting,” or corrosion made worse by abrasive wear. The company says that the corrosion “may result in adverse local tissue reactions manifesting in pain and/or swelling.” Other adverse effects can include bone damage, tissue death (necrosis), or metallosis–when metal debris causes inflammation in the surrounding tissue. This type of inflammation may cause long-term, or even permanent damage.

HIP REPLACEMENT DANGERS

In 2010, we told you about a recall of two hip replacement devices by DePuy Orthopaedics:  the ASR XL Acetabular System, and the ASR Hip Resurfacing System. The recall was due to higher-than-usual failure rates, which caused thousands of patients to require second surgeries to replace the replacement. (To read that original blog, click here:  DePuy Hip Replacement Recall Raises Mores Questions)

Now, the Stryker recall.

At this point, many experts are saying that people who have had any brand of metal-on-metal hip replacement should contact their physicians and request testing to make sure that their hip replacement devices aren’t harming them. That’s especially true if you have had a Stryker or DePuy hip replacement.

WHAT TO DO

If you already know that you received one of the recalled Stryker or DePuy hip replacement systems, we recommend two things:

1. Schedule a follow-up appointment with your surgeon, even if you’re not currently having symptoms. It is possible that you could have early signs of failure before you recognize the pain. Your doctor will be able to evaluate how your hip is functioning and whether the recalled implant is in need of replacement.

In that visit, your orthopedic surgeon may also want to test for the presence of microscopic metal particles around your hip. Metal particles are a sign that recalled implant is failing. 

2. Call HensonFuerst Attorneys for important information about your rights. If you or someone you care about received one of these defective joint replacement components, we would like to speak with you right away.  You may have a legal case and be able to collect compensation for the injury caused by a faulty medical device.

What’s most important: DO NOT contact Stryker or DePuy, or SIGN ANY RELEASES OF YOUR MEDICAL RECORDS to any company before you talk with a lawyer. The hip replacement companies are asking patients to register with them and receive a claim number. DO NOT DO THIS YOURSELF. Let a lawyer handle everything. Big corporations look out for their own financial interests, not the interests of people who may have been harmed.

HensonFuerst Attorneys is continuing its investigation into hip replacement failure rates. If you have questions and would like answers, call us.

If you are worried about your future health, call us.

If you can’t get straight answer from your surgeon or hospital, call us.

With HensonFuerst, your health is at the top of our priority list. We dedicate ourselves to protecting individuals from the greed and callousness of large corporations. Let us work for you. Our attorneys are available 24 hours a day, every day of the year at 1-800-4-LAW-MED (1-800-452-9633). Or, visit our website at www.lawmed.com for more information. You can also fill out a free online consultation form for an immediate evaluation of your case.

Life Doesn’t Wait…get help today. Call HensonFuerst.

This law firm is not affiliated with, sponsored by, or associated with the Stryker Corp., DePuy Orthopaedics, Inc., Johnson & Johnson, or any other hip replacement manufacturing company.

People who require dialysis have it tough enough without also having to risk sudden death from faulty dialysis machines.

According to an article in The New York Times, the U.S. Food and Drug Administration (FDA) is looking into potential violations of federal regulations by Fresenius Medical Care, the nation’s largest operator of dialysis centers, which treats more than a third of the 400,000 Americans receiving dialysis.

Last November, Fresenius’s medical office sent an internal memo to doctors practicing in the company’s dialysis centers, warning them that failure to properly use one of the company’s products appeared to be contributing to a sharp increase in the risk of patients dying suddenly from cardiac arrest.

“In light of these troubling findings,” the memo said, doctors should take corrective action. “This issue needs to be addressed urgently,” the memo added later.

Great, right? Except that the memo only went to Fresinius’s own dialysis centers. The company did not warn other centers that use their dialysis machine, the GranuFlo.

“Personally, I’m troubled by the fact that Fresenius on its own initiative didn’t notify its entire customer base of this particular concern,” Steven Silverman, director of compliance for the F.D.A.’s medical devices division, said in an interview this week…. “Candidly, I just think it’s bad business and not in the interest of public health to sit on information about risks.”

The Problem

Dialysis works by clearing toxic waste from the blood, a job typically done by the kidneys. Part of the process involves adding bicarbonate–an alkaline–to neutralize toxic acid in the blood. GranuFlo dialysis machines include adding an ingredient that the body converts to bicarbonate, and it adds more of it than other machines. Because many doctors have not been accounting for this extra bicarbonate, patients have been getting an overdose.

The result:  In the Fresenius memo dated November 4, 2011, 941 patient had suffered cardiac arrest. The company’s medical staff figured out that the higher levels of bicarbonate gave patients a 6 times greater risk of cardiac arrest.

The memo only went o Fresenius clinics–not to all doctors, and not to the FDA. In fact, the FDA only learned of the problem in late March after it received an anonymous copy of the memo. In May, after its own investigation, the FDA issued an alert about GranuFlo and similar dialysis products.

So now, finally, patients can receive the treatment they need without an increased risk of sudden death. How many additional deaths occurred in the seven months between November 4, 2011, and late May 2012 that could have been prevented had Fresenius publicized its finding appropriately so that all doctors and all regulatory agencies had fair warning of the risks?

Shameful.

To read the full article in The New York Times, click here: Dialysis Company’s Failure to Warn of Product Risk Draws Inquiry

Surgical mesh is a common medical product used to repair conditions in which body organs need extra support because the muscles and ligaments supporting internal organs weaken, causing the organs to sag inside the body cavity. Surgical mesh is used to create a kind of sling or hammock to keep the organs in their proper place. In women, it can be used to treat pelvic organ prolapse and stress urinary incontinence.

Unfortunately, this surgical solution is flawed. Over the past three years, the U.S. Food and Drug Administration (FDA) received nearly 4,000 reports of serious and severe complications associated with surgical mesh used to treat pelvic organ prolapse and SUI, including 3 fatalities. The most frequent complications include:

• Erosion through inner wall of the vagina;
• Mesh contraction, leading to vaginal shortening and pain;
• Infection;
• Abscesses;
• Pain;
• Urinary problems;
• Recurrence of prolapse and/or incontinence.

There were also reports of surgical complications when the insertion of the mesh perforated bowel, bladder, or blood vessels. In some cases, vaginal scarring and mesh erosion led to a significant decrease in patient quality of life due to discomfort and pain, including painful sexual intercourse.

Now, according to an article in The New York Times, some of the dangerous products will no longer be available. Johnson & Johnson’s Ethicon division has decided to stop selling four types of mesh implants: Gynecare TVT Secur system, Gynecare Prosima, Gynecare Prolift, and Gynecare Prolift+M.

“This is very good news for women because it takes several products off the market that have harmed a lot of women,” said Diana Zuckerman, president of the National Research Center for Women and Families, a public health advocacy group. However, she said, “the bad news is that there are many other surgical meshes still on the market that are just as dangerous.”

And the products won’t be removed from market immediately, but phased out over the next three to nine months. That means more women will be put at risk before these brands of mesh are gone for good. And to add insult to injury, Johnson & Johnson is positioning this move to stop selling these brands of mesh as a response to “changing market dynamics,” not to safety or efficacy concerns. However, according to The New York Times:

In 2008, the Food and Drug Administration warned that use of the implants was associated with complications but that the problems were rare. But between 2008 and 2010, the agency reported a fivefold increase in reports related to the use of the devices. In January, the F.D.A. ordered makers of the implants to study their risks in patients.

Under the law, women who have been seriously injured by surgical mesh complications have the right to seek compensation for their losses and suffering from Johnson & Johnson, or any other company that manufactures the products.

If you or someone you care about has had surgery using transvaginal mesh to correct pelvic organ prolapse or urinary incontinence, you have the right to seek compensation for your losses and for your suffering. If you believe you have been seriously injured by transvaginal mesh, HensonFuerst Attorneys may be able to help. Someone is available 24 hours a day, 7 days a week to take your call, at 1-800-4-LAWMED; or contact us via our website at www.lawmed.com.

Life Doesn’t Wait, and neither should you. If you have questions, HensonFuerst has answers.

To read the full article in The New York Times, click here:  Johnson & Johnson Unit to Halt Urinary Implants

We also have a YouTube video about the dangers of transvaginal surgical mesh (although it was created before this latest move by J&J):  Dangers of Transvaginal Surgical Mesh

For over a year, we’ve been telling you about the problems with metal-on-metal hip replacement devices. Some, such as the DePuy devices by Johnson & Johnson, were recalled due to a higher-than-usual failure rate, causing patients to require second surgeries to replace the replacements. In May 2011, the U.S. Food and Drug Administration (FDA) ordered all producers of “metal-on-metal” hip replacements to study the implants to make sure patients remain as safe as possible.

You can read those earlier blogs here:

Hip Replacements Fail, Sometimes Without Symptoms

Diagnosing Hip Replacement Injury

Now, according to an article in The New York Times, British help regulators recommend that patients in Britain who received metal-on-metal artificial hips — which were also used widely in the United States — should undergo annual examinations for as long as they have the device to make sure they are not suffering tissue damage or other problems. This recommendation was made out of concern that serious problems could surface 15 or even 20 years after the original surgery.

“By monitoring patients every year, any complications will get picked up earlier and more complex surgery on the patient can be avoided,” said Dr. Susanne Ludgate, the clinical director of the Medicines and Healthcare Products Regulatory Agency.

It has been estimated that about 500,000 people in the United States received an all-metal hip during the past 10 years. Thousands of them have been forced to undergo second surgeries to have the replacements replaced. Hundreds have suffered crippling injuries due to the tissue and muscle tissue damage caused by metallic debris shed by the devices.

In the U.S., the FDA is not changing its recommendation that all hip replacement patients undergo “regular” follow-up with their physicians. That’s good advice…and we recommend that these follow-ups occur even if patients don’t think they have any special problem with their hip replacements. Some people with significant damage to the surrounding muscle tissue don’t have any pain until the injury is severe.

If you have had a metal-on-metal hip replacement that failed early, or if you have had tissue damage due to the device and would like to explore your legal options, feel free to contact the attorneys of HensonFuerst. Someone is available 24 hours a day, 7 days a week at 1-800-4-LAWMED…or view our website at http://www.lawmed.com/.

If you have questions, HensonFuerst has answers.

To read the full article in The New York Times, click here:  Britain Extends Monitoring for People with Metal Hips

In 2010, DePuy Orthopaedics, a division of Johnson & Johnson, sent a letter to doctors announcing a recall of two of their hip replacement systems, the ASR XL Acetabular System, and the ASR Hip Resurfacing System due to their higher-than-usual failure rates. The failures necessitated that patients have a second surgeries to replace the replacement, but some people still ended up with severe tissue damage that left them in pain.

Before the recall, Johnson & Johnson refused to acknowledge that the medical device was flawed. But now, in an article published in The New York Times, it seems that Johnson & Johnson was aware of the high failure rate—and an email stating so was written by a DePuy vice president and sent to top executives in the corporation. In the email, Pamela Plouhar:

…reported that the device had not met F.D.A. approval standards and that a major concern was its high rate of early failure, or “revision,” during clinical trials. She also cautioned that providing the F.D.A. with more data might not change its stance and that it might take years to conduct new studies of the hip, known as the ASR, or articular surface replacement.

In addition, Ms. Plouhar’s email stated that there had been “a significant number of revisions in the ASR group” compared with “very few in the control group.”

That means that the FDA, Ms. Plouhar, and—after the email was sent—other J&J executives all knew that there were significant problems with the hip replacement devices. And yet, the company did not notify doctors or patients about the problems. In fact, they continued marketing and selling the device in the United States and around the world…at least until the recall was announced in August 2010. In all, about 93,000 people received a DePuy hip replacement.

Throughout the episode, DePuy blamed orthopedic surgeons for the model’s failures, saying that doctors were not positioning a component properly. But the clinical findings rejected by the F.D.A. came from A.S.R. studies run by surgeons hand-picked by DePuy, including some who had developed the implant and received royalties or consulting fees in connection with it.

This new information is not going to help Johnson & Johnson’s reputation, which has recently been turning from gleaming to rusty.  Perhaps this is why J&J CEO William C. Weldon announced that he will step down in April. Analysts believe he would rather retire by choice than be forced to resign.

HensonFuerst Video about the DePuy recall:  DePuy Orthopaedics Hip Replacement Recall

If you believe you have been injured by a DePuy hip replacement and would like to discuss your legal options, please feel free to call HensonFuerst Attorneys at 1-800-4-LAWMED, or visit our website at http://www.lawmed.com/. If you have questions, HensonFuerst has answers.

RESOURCES

To read the full story in The New York TImes, click here:  Hip Maker Discussed Failures

To read our blog about the DePuy recall, click here:  DePuy Hip Replacement Recall

On August 24, 2010, DePuy Orthopaedics, a division of Johnson & Johnson, sent a letter to doctors announcing a recall of two of their hip replacement systems, the ASR XL Acetabular System, and the ASR Hip Resurfacing System. Why? Because they have a higher-than-usual failure rates, causing people to have to have second surgeries to replace the replacement. Since then, we’ve written extensively about DePuy and other metal-on-metal hip replacement devices, and the sometimes-extensive destruction they can cause in the human body.

Now, The New York Times reveals that Johnson & Johnson continued to market the defective devices in Europe and elsewhere overseas. In addition, the company also continued to sell a related model in the United States, which earlier went on the market using a regulatory loophole. However, the U.S. Food and Drug Administration (FDA) wrote a confidential letter to Johnson & Johnson in August 2009 basically saying that the agency couldn’t determine the implant’s safety and effectiveness, and therefore couldn’t approve it for sale in the U.S.

According to the article:

There is no suggestion that Johnson & Johnson broke the law. Regulatory standards in other countries, like those in Europe, for approving the sale of medical devices are typically lower than here. A spokeswoman for a British regulatory agency, the Medicines and Healthcare Products Regulatory Agency, said that companies like Johnson & Johnson were not required to notify it when the F.D.A. refused to approve a product that was used in patients there.

However, the F.D.A.’s rejection may further deepen the company’s legal and financial problems surrounding the ASR. Last month, the company took a special $3 billion charge, much of it related to anticipated legal and medical expenses associated with the recall. An estimated 5,000 lawsuits involving the device are pending, including some from patients crippled by tiny particles of metallic debris shed by the implants.

There seem to be two moral issues at stake here:  The morality of Johnson & Johnson continuing to sell a product that was clearly raising safety flags…and the morality of the FDA, which keeps its evaluations secret and confidential. A lawyer who specializes in FDA regulation said that companies that withhold a non approval letter containing important safety information could face damage to its brand. Funny, that doesn’t seem quite as important as the damage done to the unwitting patients who received these potentially harmful devices. And if the FDA is keeping secrets on behalf of corporations, who is looking out for our health?

To read the full article in The New York Times, click here:  Hip Implants U.S. Rejected Sold Overseas

If you believe you have been injured as the result of a metal-on-metal hip implant and would like to investigate your legal options, feel free to contact HensonFuerst Attorneys at 1-800-4-LAWMED, or visit our website at http://www.lawmed.com/.

Previous HensonFuerst blogs:

DePuy Hip Replacement Recall Raises More Questions

Hip Replacements to be Evaluated for Safety

Hip Replacements Fail, Sometimes Without Symptoms

Diagnosing Hip Replacement Injury

VIDEO: DePuy Hip Replacement Recall (http://www.youtube.com/watch?v=18BkrJnKf3g)