Rottenstein Law Group Responds to News That J&J Marketing Department Knew of Implant Risks

Hip Implant

The Rottenstein Law Group continues to monitor DePuy ASR news and has learned that in the ongoing trial in Los Angeles Superior Court jurors were shown emails from Johnson & Johnson’s marketing department that indicated that the company knew of the hip implant’s risks well in advance of the August 2010 DePuy hip recall.

(PRWEB) February 12, 2013

The Rottenstein Law Group continues to monitor with concern DePuy ASR news and has learned that in the ongoing trial in Los Angeles Superior Court jurors were shown emails from Johnson & Johnson’s marketing department that indicated that the company knew of the hip implant’s risks well in advance of the August 2010 DePuy hip recall.


According to Bloomberg,* Paul Berman, marketing director for Johnson & Johnson subsidiary DePuy, wrote in September 2009 that he intended to “reiterate my concern” over the safety of the ASR hip implant because of device failure and metal poisoning. This was about 11 months before the recall. Berman added that a majority of surgeons recommended discontinuing the ASR because of problems.

Read more: DePuy Hip Recall News: Rottenstein Law Group Responds to News That J&J Marketing Department Knew of Implant Risks






Tai Chi May Help Reduce Arthritis Pain

Tai Chi Exercise
Tai Chi Exercise

Tai chi is being considered to reduce stress, increase balance and flexibility and may improve a person’s overall mind, body and spirit to prevent the development of arthritis, medical experts say. Arthritis is a condition that prompts hip replacement against which the artificial devices were being reported as substandard and which persuaded the European Union in creating a medical device registry.


A primordial practice in Asia, certain forms of tai chi have been proven to lessen pain and improve a  person’s mental and physical well-being.


There is more than one reason why many believe tai chi helps lessen the painful effects of arthritis. It’s because it doesn’t just put the attention on the medical aspects but also in the healing properties of the mind and an inner energy that is called as qi.


The power of the positive mind may indeed cure a lot of sickness and disabilities. A positive mind can help assimilate and hasten healing. Tai chi associates the mind and body manipulation of the mind that is conscious. It guides the internal force within the body and the inner force guides the movement that is produced. Upon practicing tai chi, a person focuses on the coordination and focuses on the movements of the body. Through mental training, it boosts mind clarity, uplifts the mood and improves proper relaxation.


There have been studies about tai chi as a substitute treatment for arthritis. As concluded, it has been discovered that it complements and can stand on its own as a cure. The great power of the mind is improved as one of the most powerful and effective tool to prevent arthritis.


Qi is commonly recognized as the energy in the life of a person. This kind of energy results from the combination of three essential elements such as the air that we breathe in, qi of kidney and qi from water and food that is enthralled by the body from the digestive system. Once qi circulates in the body, it performs numerous tasks to let the systems in the body perform well. If you let qi penetrate in your body and maintain strong relativity with it, then you will become stronger and healthier.


Through the slow and gentle movements of tai chi, it enables the opening of channels, keeping them supple and strong. It maintains the muscle’s rhythmic exhibitions. If you are someone who wanted qi to radiate inside the body and be further enhanced, tai chi is the answer. Fields of Chinese medicine stated that arthritis can be also the end effect of a very slow and sluggish flow of the internal energy.


Programs for tai chi have been confirmed in a lot of ways but all ends up in three objectives such as 1) offering safety and precision to learn the different techniques in the most accepted practices that will fit people of all ages; 2) relieving the pain that is caused by stiffness of the muscles and bones and the other causes of arthritis that is related to the problem and Improve the body’s relaxation, and 3) maintaining a healthy way of life to prevent arthritis from getting worse and may lead to surgical procedure such as hip implant which has been the subject of several hip replacement recall.


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Defective Hip Devices May Cause Cancer

Metal-on-metal hip replacement devices may cause cancer, according to a news feature published in the Telegraph. The article was based on a study by orthopedic consultants in Bristol, England. It was meant as a follow-up  on an advisory from the Medicines and Healthcare Products Regulatory Agency (MHRA) warning 40,000 Britons who had "metal-on-metal" devices against metal toxicity. The agency also asked implant recipients to undergo annual checks, with scans and blood tests, if doctors find symptoms that suggest metal leakage.

The incidence of cancer, including its parallel diseases, are influenced by many factors such as age, sex, race, local environment, diet, and genetics.  Medical specialists say that cancer is a class of medical condition characterized by out-of-control cell growth. There are over hundreds various types of cancer, and each is classified by the type of cell that is initially affected. It may develop in almost any organ or tissue, such as the lung, colon, breast, skin, bones, or nerves.

In 2007, cancer claimed the lives of about 7.6 million people in the world, as was reported by Medical News Today.

Other than cancer, the following are some of the risks brought about by flawed DePuy hip replacement implants:~

    * Additional hip replacement or revision surgery
    * Loosening of hip device
    * Detachment of the hip device from the bone
    * Unexplained hip pain
    * Hip dislocation
    * Swelling
    * Complete hip failure
    * Metallosis (metal toxicity or blood poisoning)
    * Pseudotumors
    * Tissue damages
    * Genotoxicity (genetic damage)
    * Bone fractures
    * Bone loss
    * Inflammatory reactions
    * Presence of chromium and cobalt in the blood that may lead to cancer

The treatment of cancer mainly depends on the type, stage or extent, patient’s age, health status, and additional personal characteristics. There is no single treatment for it, and patients often receive a combination of therapies and palliative care.

According to medical journals, treatments generally fall into one of the following categories: surgery, radiation, chemotherapy, immunotherapy, hormone therapy, or gene therapy. Some clinicians and medical researchers are convinced that many cancers can either be prevented or the risk of developing cancers can be markedly reduced, says an article quoting Dr. Charles Patrick Davis as saying.

The Telegraph further reports that experts have not established why the DePuy devices have such a high failure rate. The MHRA said orthopaedic surgeons should contact every patient who were given either a DePuy ASR or DePuy ASR XLsystem to ensure that they were monitored. The hip replacement recall for these DePuy models have been announced in August 2010.








Symptoms of a Defective Hip Device

DePuy Orthopaedics has released two types of metal-on-metal hip implants, ASR XL Acetabular System and ASR Hip Resurfacing System, in 2003 Worldwide, there are more or less 93,000 individuals who have received these implants.  In August 2010, however, the company voluntarily recalled the device The company cited early failure of the devices, resulting in about one in eight patients requiring revision surgery
The acetabular cup component of the device was the first problem According to reports, its cup was shallower compared to other available implants  Because of its shallow design, the device is particularly susceptible to flaking debris. Also, when compared to the socket, the femoral head appears to be larger. With incongruent ball and socket sizes, a bigger part of the femoral head is exposed  Reportedly, metallosis may happen due to corrosion and flaking of metal particles at the femoral head part.
The potential complications should be known to patients who had the device. Pain in the groin, hip or leg; change in walking ability; and swelling at or near the hip joint are some of the symptoms linked with the device. Additionally, patients may feel pain when walking, rising from a seated position or when bearing weight on the affected hip.
Implant loosening and dislocation is sometimes experienced by patients  When the implant is detached from the bone, loosening happens  Displacement of the femoral head out of the hip joint occurs in hip dislocation. Weakening of the muscles surrounding the hip joint and stretching of the capsule may have caused the dislocation.
DePuy’s hip replacement cup design is the cause for the early failure, as believed by orthopedic specialists  The design, according to Dr. Harlan C. Amstutz, a Los Angeles orthopedic surgeon, was prone to problems. Dr. Thomas P. Schmalzreid, designer of the ASR hip system, stated that DePuy has known for years that their device, when compared to other hip implants, is more difficult to embed.
Regular check-up is highly recommended to individuals who were given the hip implants.Yearly monitoring is also given importance to ensure that the device is functioning well even if the patient does not manifest any hip replacement symptoms. Additionally, doctors are advised to immediately report these symptoms and other complaints that may signal a failing device






What Went Wrong With DePuy ASR Hip Design

Hip replacement devices functions like the anatomic hip joint after it is implanted in the human body. The device comes in various designs and materials depending on its manufacturer.  A new line of hip implants, with all metal materials was introduced by DePuy Orthopedics in 2003 but due to high failure rate, a recall was made in 2010. According to reports, Australian Orthopedics expert testifies the evidence that DePuy hip failure existed 3 years before recall.  More evidences on metal-on-metal implants causing tissue damage were provided by the New York Times.


The hip or acetabulofemoral joint is found between the femur and the acetabulum of the pelvis which supports the weight of the body. It is a ball-and-socket joint where the head of the femur articulates with the cuplike acetabulum. The ball fits snugly into the concave socket.  With strong surrounding ligaments and tight fitting of the bones, the hip joint is a sturdy joint.


In order to duplicate the hip joint’s function, implants have mainly two parts: the ball which takes the place of the femoral head, and the cup which assumes the socket role.  In 2003, Johnson & Johnson’s DePuy Orthopedics released an all-metal hip implant. Included in the ASR hip replacement system are the ASR XL Acetabular System and the ASR Hip Resurfacing System.  However, the company had to recall the devices after reports show a high failure rate.  Faulty design is one of the said causes of failure.


The acetabular cup component of the device is the 1st problem.  Reports say that compared to other implants, DePuy ASR’s cup is shallower.  It is particularly vulnerable to shedding debris because of its shallow design.  Also, when compared to the socket, the femoral head appears to be larger. The femoral head is more exposed because ball and socket components do not perfectly fit. Corrosion at the head of the device has reportedly resulted to flaking off of metal particles which may eventually cause metal toxicity.


The reason for failure of the DePuy hip replacement, as believed by orthopedic specialists, is the design of its cup.Dr. Harlan C. Amstutz, an orthopedic surgeon in LA believed that the design was prone to problems.  DePuy Orthopedics knew, according to the creator of the device, Dr. Thomas P. Schmalzreid, that the ASR hip system is more difficult to embed when compared to hip implants of the same kind.


A DePuy hip replacement recall has started a year ago and is still happening right now.  An additional surgery may be advised for those patients who have received the faulty device. With this, patients, together with their orthopedic surgeons are advised to carefully consider their options as to what hip device they will use.








MoM Hip Implants and the Steps FDA is Taking

The US Food and Drug Administration designates preamandment device like metal-on-metal hip systems, as a Class III or higher risk devices. The FDA was given a premarket authority on 1976, devices released prior to that year were considered preamendment device. The device was regulated under the 510 (k) premarket notification program of the FDA.  However, study shows that metal-on-metal hip implants present some complications and many recipients of the device have experienced major problems and have taken legal actions. Based on the article published on New York Times, the metal-on-metal device complaints have surged this year, greater than the combined numbers of the past four years.

The 510(k) approval process of the FDA was questioned by the Institute of Medicine, saying that the process does not provide “a reliable and premarket screen of the safety and effectiveness” of devices submitted for approval.  In response to the report, FDA acknowledged the agency’s need to be “open to additional proposals and approaches for continued improvement of our device review programs.”


In April 2010, the United Kingdom’s Medicines and Healthcare products Regulatory Agency issued a medical device alert that included specific follow-up recommendations for patients implanted with MoM hip implants. Blood tests and imaging for patients experiencing pain are included in the recommendations. August of the same year, a voluntary recall was initiated by the DePuy ASR on their total hip system.  The DePuy ASR hips revision rates within 5 years were about 13 percent, according to the new, unpublished data of the UK joint ministry.


The safety and effectiveness of metal-on-metal hip implants is further evaluated by the FDA by looking and assessing at different areas. Manufacturers of the hip systems were asked to submit device retrieval analyses to the agency.  FDA constantly appraises Medical Device Reports, post-approval study reports, data from several orthopedic device registries and published literature. With this strategy, they can have a clearer view and understanding of the association between metal debris and MoM hip systems.


Asymptomatic recipients of the metal implant are not obliged to submit themselves for blood tests and special imaging. The FDA recommends that asymptomatic patients continue to follow-up with their orthopedic surgeon as prescribed.  Patients who are slowly developing symptoms of complication are advised to seek early help from orthopedic surgeon for major complications like DePuy hip recall to be prevented.






DePuy Hip Replacement Patients Should Weigh Their Legal Options Carefully

The fallout from the August 2010 recall of defective hip replacement devices manufactured by DePuy Orthopaedics (a division of Johnson & Johnson) has left many patients wondering what to do. Those who were implanted with the ASR XL Acetabular System and/or the ASR Hip Resurfacing system were presented with two options: they could either deal directly with DePuy, through its claims administrator, Broadspire; or hire a hip replacement lawyer to represent them. It is crucial to understand the consequences of each course of action before deciding which one to choose; there are many reasons hiring a hip replacement lawyer is the option patients should consider, rather than dealing directly with DePuy. 


Patients considering dealing directly with DePuy should know that demands will be made to gain access to sensitive medical records, as well as the explanted hip replacement device if it was removed during a revision surgery. DePuy plans to use whatever it finds in patients’ records as potential evidence to prove that it is not at fault for the failure of the hip replacement devices. Medical records and the device itself are crucial forms of evidence that need to be preserved while considering whether or not to file a lawsuit. 


Patients with insurance coverage most likely did not incur significant expenses for their hip replacement surgeries. Therefore, DePuy is proposing to reimburse “reasonable and customary” charges to insurance companies, rather than disburse compensation directly to patients. This means there is no chance of reimbursement for pain and suffering, travel expenses, or lost wages. Compensation will be paid directly to the patient’s insurance company on a case-by-case basis. The current claim system in place offers little, if nothing, to the patient; insurance companies will likely receive all of the compensation. 


Conversely, filing a hip replacement lawsuit includes a demand for damages for pain and suffering, as well as other damages incurred from the defective hip replacement device. Statistics have shown that patients are experiencing severe and debilitating side effects that the claims process is simply ignoring. Consulting a hip replacement lawyer is the best course of action to determine the correct course of action, ensuring that patients receive the appropriate compensation they are entitled to.


 The Rottenstein Law Group has set up a Web site to provide DePuy hip recall patients with the information they need to make an informed decision. Litigation proceedings are ongoing, and a hip replacement lawyer can help patients determine whether or not they are eligible to participate. 


About the Rottenstein Law Group 


The Rottenstein Law Group is a New York-based law firm that represents clients in mass tort actions. The firm was founded by Rochelle Rottenstein, a lawyer with over two decades of experience in compassionate representation of clients in consumer product injury, mass tort, and class action law suits. For more information, please visit their Web site at, or call (888) 9-ROT-LAW.